阅读说明：本技术 用于植入式医疗装置的递送设备的释放机构 (Release mechanism for a delivery apparatus of an implantable medical device ) 是由 L·P·加夫尼 S·X·瓦伦西亚 H·拉菲 S·小曼泽拉 于 2021-06-10 设计创作，主要内容包括：本发明涉及用于植入式医疗装置的递送设备的释放机构,公开了一种用于递送设备的释放机构和用于操作该释放机构的相关方法。作为一个示例,递送设备的手柄部分可包括配置成调节递送设备的部件的线性方位的释放机构。释放机构可包括带螺纹的驱动螺钉,该驱动螺钉包括布置在驱动螺钉的近端的一个或多个保持元件和形成驱动螺钉的螺旋螺纹部分的一个或多个凹槽,每个凹槽从相应保持元件延伸到驱动螺钉的远端,驱动螺钉耦连到部件；以及围绕驱动螺钉并与驱动螺钉同轴的可旋转旋钮,该旋钮包括设置在旋钮近端的一个或多个齿,每个齿被配置为与驱动螺钉的相应保持元件和凹槽接合。(A release mechanism for a delivery apparatus and associated method for operating the release mechanism are disclosed. As one example, a handle portion of a delivery device may include a release mechanism configured to adjust a linear orientation of a component of the delivery device. The release mechanism may include a threaded drive screw including one or more retaining elements disposed at a proximal end of the drive screw and one or more grooves forming a helically threaded portion of the drive screw, each groove extending from a respective retaining element to a distal end of the drive screw, the drive screw coupled to the component; and a rotatable knob surrounding and coaxial with the drive screw, the knob including one or more teeth disposed at a proximal end of the knob, each tooth configured to engage with a respective retaining element and groove of the drive screw.)

1. A delivery apparatus for an expandable, implantable medical device, the delivery apparatus comprising:

a handle portion comprising a release mechanism configured to adjust a linear orientation of a component of the delivery device relative to a central longitudinal axis of the delivery device, the release mechanism comprising:

a threaded drive screw comprising a helically threaded portion having a lead of at least one inch, wherein the helically threaded portion comprises one or more grooves extending around the drive screw, the drive screw coupled to the component; and

a rotatable knob surrounding and coaxial with the drive screw, the knob comprising one or more teeth disposed at a proximal end of the knob, each of the one or more teeth configured to engage a respective one of the one or more grooves of the drive screw, wherein each of the one or more teeth extends from the proximal end to a distal end of the knob for only a portion of a total distance between the proximal end and the distal end, wherein the portion is less than 1/4 of the total distance.

2. The delivery apparatus of claim 1, wherein the threaded drive screw comprises one or more retaining elements disposed at a proximal end of the drive screw, wherein each of the one or more grooves of the helically threaded portion is connected to and extends around a respective retaining element of the one or more retaining elements from the respective retaining element to a distal end of the drive screw, and wherein each tooth of the one or more teeth is configured to engage with a respective retaining element.

3. The delivery apparatus of claim 2, wherein each tooth is configured to mate with and travel along the respective groove when the knob is rotated about the central longitudinal axis, wherein the drive screw is configured to move linearly relative to the knob in an axial direction when the knob is rotated and the tooth travels along the respective groove, wherein the knob is fixed from translating in the axial direction, wherein the axial direction is relative to the central longitudinal axis, wherein the knob comprises a collar extending distally from the distal end of the knob to an interior of a housing of the handle portion, the collar comprising one or more collar grooves extending about a circumference of the collar, each collar groove mating with a respective annular protrusion extending radially from an interior surface of the housing of the handle portion, and wherein the knob is fixed from translation in the axial direction and is configured to rotate about the central longitudinal axis relative to the housing of the handle portion through a mating connection between each collar groove and the respective annular protrusion.

4. The delivery apparatus of claim 2 or claim 3, wherein the drive screw is linearly movable between a home locked configuration in which each tooth is coupled to the respective retaining element and an entire helically threaded portion of the drive screw is disposed inside the knob and handle portion, and a released configuration in which each tooth mates with a distal portion of the respective recess, the distal portion being disposed closer to the distal end than the proximal end of the drive screw, and a majority of the helically threaded portion of the drive screw extends outwardly from the proximal end of the knob in the axial direction.

5. The delivery apparatus of claim 4, wherein each retaining element comprises a protruding member, a first linear threaded portion disposed on a first side of the protruding member, and a second linear threaded portion disposed on a second side of the protruding member, the second linear threaded portion connected to and continuous with a respective groove of the one or more grooves of the drive screw, and wherein in the start locking configuration, each tooth is disposed within the first linear threaded portion of the respective retaining element.

6. The delivery device of any of claims 2-5, further comprising a rod including a distal end fixedly coupled to an inner surface of the handle portion, and wherein the drive screw includes an extension portion extending axially outward from the distal end of the drive screw, the extension portion including an internal bore mounted around the rod and configured to slide linearly along the rod.

7. The delivery apparatus of claim 6, wherein a proximal end of the rod includes a stop element that is wider than a maximum width of the internal bore of the drive screw, and wherein the stop element is disposed within an internal open cavity of the drive screw, the open cavity being disposed between the proximal end and the distal end of the drive screw.

8. The delivery apparatus of claim 6 or claim 7, wherein the extension portion further comprises a central bore centered along the central longitudinal axis, wherein the inner bore is radially offset from the central bore, and wherein the central bore is configured to receive an inner shaft of the delivery apparatus therethrough.

9. The delivery apparatus of any of claims 1-8, wherein the component of the delivery apparatus with the release mechanism configured to adjust the linear orientation comprises one or more release members removably coupled to the implantable medical device.

10. The delivery apparatus of claim 9, further comprising an inner shaft comprising a proximal end fixedly coupled to a cap of the release mechanism coupled to the proximal end of the drive screw, wherein the inner shaft extends to a distal end of the delivery apparatus, and wherein the one or more release members are fixedly coupled to a distal portion of the inner shaft.

11. The delivery apparatus of any one of claims 1-10, wherein the thread formed by the one or more grooves of the helically threaded portion is a double-threaded thread formed by two grooves, and wherein the drive screw has two retaining elements, each groove extending from a different one of the two retaining elements, and wherein the knob includes two teeth, each tooth configured to mate with and slide along a different one of the two grooves, the two teeth being spaced apart from each other around a circumference of the proximal end of the knob.

12. The delivery device of any of claims 1-11, wherein the handle portion further comprises a steering mechanism comprising a steering knob configured to rotate relative to the housing of the handle portion at the distal end portion of the delivery device and adjust the curvature of one or more shafts of the delivery device.

13. The delivery apparatus of any of claims 1-12, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size of the prosthetic heart valve.

14. The delivery device of any of claims 1-13, wherein the portion of the total distance between the proximal end and the distal end is less than 1/10 of the total distance.

15. A method for operating a release mechanism of a handle portion of a delivery apparatus configured to deliver an implantable medical device to a target implantation site, the method comprising:

moving, from a starting locked orientation of the release mechanism, in response to rotation of the knob, one or more teeth of a knob of the release mechanism along one or more respective grooves of a drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches a released orientation, wherein in the starting locked orientation a body of the drive screw including the one or more grooves is disposed inside the knob, and in the released orientation a majority of the body extends outside the knob;

linearly translating an inner shaft fixedly coupled with the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release the implantable medical device mounted on the distal end portion of the delivery apparatus from the delivery apparatus when the drive screw is translated in the proximal direction; and is

Releasing the distal end portion of the delivery apparatus in response to actuation of a steering mechanism of the delivery apparatus, and during the releasing, passively retracting the drive screw partially into the knob in a distal direction to automatically release tension in the distal end portion of the delivery apparatus and enable the releasing, the distal direction being opposite the proximal direction.

16. The method of claim 15, wherein moving the one or more teeth of the knob from the starting locked orientation comprises, in response to rotation of the knob, initially moving each of the one or more teeth over a protruding member of the respective retaining element to pass from a first linear threaded portion of the respective one of the one or more retaining elements disposed at a proximal end of the body of the drive screw to a second linear threaded portion disposed on an opposite side of the protruding member, the second linear threaded portion extending from the first linear threaded portion and connecting to a proximal end of a respective one of the one or more grooves to release each of the one or more teeth from the respective retaining element, each tooth then continues to move along the respective groove and linearly translate the drive screw in the proximal direction.

17. The method of claim 15 or claim 16, wherein the one or more grooves of the drive screw comprise two helical grooves that curve around an outer surface of the body of the drive screw from a proximal end of the body to a distal end of the body, wherein the drive screw has a bifilar thread formed by the two grooves, wherein the one or more teeth of the knob comprise two teeth spaced apart from each other around a circumference of the proximal end of the knob, and wherein the lead of the bifilar thread is at least one inch.

18. The method of any of claims 15-17, wherein each of the one or more teeth of the knob is disposed at a proximal end of the knob and extends only a portion of an overall length of an inner surface of the knob that extends in an axial direction parallel to the central longitudinal axis from the proximal end of the knob to a distal end of the knob, wherein the portion is less than 1/4 of the overall length, and wherein each of the one or more grooves curves around an outer surface of the body of the drive screw from a proximal end of the body to a distal end of the body, the body being longer than the inner surface of the knob.

19. The method of any one of claims 15-18, wherein in the release orientation, each of the one or more teeth of the knob engages a respective one of the one or more recesses of the drive screw at a distal portion of the body of the drive screw, and the release member is disposed distal to and separated from the implantable medical device.

20. The method of any of claims 15-19, wherein linearly translating the drive screw in the proximal direction includes slidingly disposing an internal bore in an outwardly extending extension of the drive screw in the distal direction from a distal end of the body of the drive screw along a rod coupled to an interior of the handle portion at a distal end of the rod, and wherein in the released orientation a stop element disposed at a proximal end of the rod is disposed proximate an internal surface of the distal end of the body of the drive screw, the internal surface disposed perpendicular to the rod.

21. The method of any of claims 15-20, wherein linearly translating the drive screw until the drive screw reaches the release orientation comprises translating the inner shaft and the one or more release members until a spool coupled to the distal portion of the inner shaft reaches a spool stop of the delivery apparatus that is axially fixed relative to the inner shaft.

22. The method of any of claims 15-21, wherein passively retracting the drive screw comprises retracting the drive screw in the distal direction and back inside the knob and moving the one or more teeth of the knob along the one or more respective grooves of the drive screw from a distal end of the one or more respective grooves toward a proximal end of the one or more respective grooves in response to a force that pulls the inner shaft in the distal direction during loosening.

23. A delivery apparatus for an expandable, implantable medical device, the delivery apparatus comprising:

an inner shaft;

one or more release members, each release member including a proximal end coupled to an outer surface of a distal end portion of the inner shaft and a distal end configured to releasably couple to an implantable medical device disposed about the distal end portion of the inner shaft, the distal end being distal to a location at which the proximal end is coupled to the inner shaft; and

a handle portion, comprising:

a steering mechanism configured to adjust a curvature of and flex one or more shafts of the delivery apparatus at a distal portion of the delivery apparatus, the one or more shafts including the inner shaft; and

a release mechanism configured to adjust a linear orientation of the inner shaft and the one or more release members relative to a housing of the handle portion along a central longitudinal axis of the delivery apparatus, the release mechanism comprising:

a threaded drive screw coupled to a proximal end of the inner shaft and including a helically threaded portion disposed in a body of the drive screw, wherein one or more grooves forming the helically threaded portion extend from a proximal end to a distal end of the body of the drive screw; and

a rotatable release knob coupled to the housing of the handle portion and surrounding and coaxial with the drive screw, the release knob including one or more teeth disposed at a proximal end of the knob and configured to engage with the one or more recesses of the drive screw, wherein the drive screw is adapted to move linearly along the central longitudinal axis relative to the release knob in response to rotation of the release knob and sliding of the one or more teeth along the one or more recesses, and wherein actuating the steering mechanism to release the one or more shafts of the delivery device allows the drive screw to move distally along the central longitudinal axis to release tension created in the distal portion of the delivery device.

24. The delivery apparatus of claim 23, wherein each of the one or more teeth of the release knob is less than full thread and curves less than 45 degrees around a circumference of the proximal end of the release knob.

25. The delivery apparatus of claim 23 or claim 24, wherein the body of the drive screw further comprises one or more retaining elements disposed at the proximal end of the body, wherein each of the one or more grooves of the helically threaded portion is connected to a respective retaining element of the one or more retaining elements and curves around an outer surface of the body and extends from the retaining element to the distal end of the body.

26. The delivery apparatus of claim 25, wherein the drive screw is linearly movable between an initial locked configuration in which each tooth of the one or more teeth is coupled to a respective retaining element of the one or more retaining elements and an entire helically threaded portion of the drive screw is disposed inside the release knob and the handle portion, and a released configuration in which each tooth mates with a distal portion of a respective recess of the one or more recesses, the distal portion disposed closer to the distal end than the proximal end of the body, and a majority of the helically threaded portion of the drive screw extends outside of the proximal end of the release knob in an axial direction.

27. The delivery apparatus of any one of claims 23-26, wherein the thread formed by the one or more grooves of the helical threaded portion is a double-start thread formed by two grooves, wherein the release knob comprises two teeth, each tooth configured to mate with and slide along a different one of the two grooves, wherein the two teeth are spaced apart from each other about a circumference of the proximal end of the release knob, and wherein the thread of the drive screw has a lead in a range of 1-1.75 inches.

28. The delivery apparatus of any one of claims 23-27, wherein each of the one or more teeth of the release knob extends from the proximal end of the release knob to a distal end of the release knob for only a portion of a total distance between the proximal end and the distal end, wherein the portion is less than 1/10 of the total distance.

Technical Field

The present disclosure relates to embodiments of a release mechanism for a handle of a delivery apparatus of an implantable medical device, such as a prosthetic heart valve.

Background

Delivery devices, such as intravascular delivery devices, are used in a variety of procedures to deliver prosthetic medical devices to locations within the body that are not readily accessible surgically or where surgical accessibility is desirable. Access to a target site within the body is achieved by a medical professional inserting and guiding a delivery device through a passageway or lumen within the body, including but not limited to a blood vessel, esophagus, trachea, any portion of the gastrointestinal tract, lymphatic vessels, to name a few. The prosthetic medical device may include an expandable valve or an instrument (e.g., a stent). In one particular example, an expandable prosthetic heart valve may be mounted in a radially compressed (or crimped) state at the distal end of a delivery device and then deployed from a capsule of the delivery device at the implantation site such that the prosthetic valve may self-expand to its functional size.

In some embodiments, the delivery device may include an articulating portion having one or more steering mechanisms that allow the distal portion of the delivery device to articulate (e.g., bend or flex) when guided through the vasculature of a patient. For example, it may be desirable for at least a distal portion of the delivery device to articulate on the aortic arch in order to deliver a prosthetic aortic valve disposed on the distal end of the delivery device to its target implantation site. The delivery device may include a plurality of shafts having concentric lumens that may shorten or lengthen relative to each other as the distal portion of the delivery device articulates/flexes.

In some embodiments, after flexing the distal portion of the delivery device to reach the target implantation site, and while the distal portion remains flexed, the valve can be released from the delivery device by rotating a knob of a release mechanism of the delivery device. This results in linear motion (proximal, axial) of an inner shaft coupled to a release member releasably coupled to the valve. However, such linear translation of the concentric lumen may cause the inner shaft to shorten upon buckling, thereby creating tension in the distal portion of the delivery device upon loosening. If the release mechanism is not unlocked (via the locking mechanism) during release to release the tension, the distal portion can be held under tension, thereby preventing removal of the delivery device from the implantation site.

Such locking mechanisms can add complexity to the implantation process and create tension problems, which can increase the difficulty of removing the delivery device from the implantation site after implantation of the valve.

Accordingly, there is a need for an improved delivery apparatus that can relieve tension created during release of the valve from the delivery apparatus prior to release of the catheter.

Disclosure of Invention

Disclosed herein are embodiments of improved delivery apparatus for implantable medical devices (e.g., prosthetic heart valves), and related methods of using such apparatus to implant implantable medical devices in a patient. In some embodiments, the delivery device can include a handle portion that a user (e.g., physician, medical technician, etc.) can grasp and use to operate the delivery device. In some embodiments, the handle portion may include a release mechanism configured to adjust a linear orientation of a component of the delivery apparatus, the handle portion including a rotatable knob and a drive screw disposed within the knob. The knob and the drive screw may cooperate such that rotation of the knob results in linear translation of the drive screw and a component of the delivery device. In some embodiments, the knob and drive screw may be configured to automatically release tension in the distal portion of the delivery device during the implantation procedure.

In one representative embodiment, a delivery apparatus for an expandable, implantable medical device includes: a handle portion including a release mechanism configured to adjust a linear orientation of a component of the delivery device relative to a central longitudinal axis of the delivery device. The release mechanism includes: a threaded drive screw including a helically threaded portion having a lead of at least one inch, wherein the helically threaded portion includes one or more grooves extending around the drive screw, the drive screw coupled to the component; and a rotatable knob surrounding and coaxial with the drive screw, the knob comprising one or more teeth disposed at a proximal end of the knob, each tooth of the one or more teeth configured to engage a corresponding groove of the one or more grooves of the drive screw, wherein each tooth of the one or more teeth extends from the proximal end to a distal end of the knob for only a portion of a total distance between the proximal end and the distal end, wherein the portion is less than 1/4 of the total distance.

In one representative embodiment, a method of implanting an implantable medical device with a delivery apparatus includes: advancing a distal portion of a delivery apparatus to a target implantation site using a handle portion of the delivery apparatus, the implantable medical device being arranged to have a radially compressed configuration on the distal portion; and upon reaching the target implantation site, exposing the radially compressed medical device implantable medical device and releasing the medical device implantable medical device from the delivery apparatus, the releasing comprising: from a starting orientation, rotating a knob of a release mechanism of a handle portion of a delivery apparatus and moving one or more teeth of the knob along one or more corresponding grooves of a drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery apparatus until the drive screw reaches the release orientation; linearly translating an inner shaft fixedly coupled with the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release the implantable medical device from the delivery apparatus when and as a result of the drive screw translating in the proximal direction; and actuating a steering mechanism of the delivery apparatus to loosen a distal portion of the delivery apparatus and passively retracting the drive screw in a distal direction, the distal direction being opposite the proximal direction, partially into the knob to automatically release the tension during the loosening.

In another representative embodiment, a method for operating a release mechanism of a handle portion of a delivery apparatus configured to deliver an implantable medical device to a target implantation site, the method comprising: starting from a locked orientation of the release mechanism, in response to rotation of the knob, moving one or more teeth of the knob of the release mechanism along one or more corresponding grooves of the drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches a released orientation, wherein in the starting locked orientation, a body of the drive screw including the one or more grooves is disposed inside the knob and in the released orientation, a majority of the body protrudes outside of the knob; linearly translating an inner shaft fixedly coupled with the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release the implantable medical device mounted on the distal end portion of the delivery apparatus from the delivery apparatus when the drive screw is translated in the proximal direction; and in response to actuation of a steering mechanism of the delivery apparatus, loosening the distal end portion of the delivery apparatus and, during the loosening, passively retracting the portion in a distal direction into the drive screw in the knob, thereby automatically releasing tension in the distal end portion of the delivery apparatus and enabling the loosening, the distal direction being opposite the proximal direction.

In another exemplary embodiment, a delivery apparatus for an expandable, implantable medical device includes: an inner shaft; one or more release members, each release member including a proximal end coupled to the outer surface of the distal end portion of the inner shaft and a distal end configured to releasably couple to an implantable medical device disposed about the distal end portion of the inner shaft, the distal end being distal of the location of proximal coupling to the inner shaft; and a handle portion comprising: a steering mechanism configured to adjust a curvature of and flex one or more shafts of the delivery apparatus at a distal portion of the delivery apparatus, the one or more shafts including an inner shaft; and a release mechanism configured to adjust a linear orientation of the inner shaft and the one or more release members relative to the housing of the handle portion along a central longitudinal axis of the delivery apparatus, the release mechanism comprising: a threaded drive screw coupled to the proximal end of the inner shaft and including a helically threaded portion disposed in a body of the drive screw, wherein one or more grooves forming the helically threaded portion extend from the proximal end to the distal end of the body of the drive screw; and a rotatable release knob coupled to the housing of the handle portion and surrounding and coaxial with the drive screw, the release knob including one or more teeth disposed at a proximal end of the knob and configured to engage with the one or more recesses of the drive screw. The drive screw is adapted to move linearly along the central longitudinal axis relative to the release knob in response to rotation of the release knob and sliding of the one or more teeth along the one or more grooves and actuate the steering mechanism to loosen the one or more shafts of the delivery device to allow the drive screw to move distally along the central longitudinal axis to release tension generated in the distal end portion of the delivery device.

The foregoing and other objects, features and advantages of the invention will become more apparent from the following detailed description of the invention with reference to the accompanying drawings.

Drawings

Fig. 1 is a side view of an exemplary embodiment of an implantable prosthetic heart valve that can be implanted using any of the delivery devices disclosed herein.

Fig. 2 is a side view of an exemplary embodiment of a delivery apparatus for delivering the prosthetic heart valve of fig. 1.

Fig. 3 is a side cross-sectional view of the distal portion of the delivery device of fig. 2 showing the prosthetic valve contained within the delivery capsule in a compressed state.

Fig. 4 is a side view of a distal portion of the delivery device of fig. 2 showing a capsule of the delivery device advanced over a portion of a prosthetic heart valve frame.

Fig. 5 is a side view of a handle portion of the delivery device of fig. 2.

FIG. 6 is a side view of the handle portion of FIG. 5 with one half of the housing of the handle portion removed to show the internal components of the handle portion.

Fig. 7 is a side cross-sectional view of the handle portion of the delivery device of fig. 2 showing a portion of the internal components of the handle portion.

Fig. 8 is a side cross-sectional view of a portion of a handle portion of a delivery apparatus including a locking mechanism for a valve release mechanism of the handle portion, under an embodiment.

Fig. 9 is a side view of a distal portion of a delivery device, such as the delivery device of fig. 2, in a starting configuration prior to release of a prosthetic heart valve from the delivery device.

Fig. 10 is a side view of the distal portion of the delivery device of fig. 9 in a released configuration after release of the prosthetic heart valve from the delivery device.

Fig. 11 is an exemplary schematic view of a distal portion of a delivery apparatus articulated about a simulated aortic arch on its way to a target implantation site for a prosthetic medical device disposed on the distal portion.

Fig. 12 is a side view of an embodiment of a handle portion of a delivery device, the handle portion including a release mechanism configured to automatically release tension in a distal portion of the delivery device.

FIG. 13 is a side cross-sectional view of the handle portion of FIG. 12 with the release mechanism in an initial, locked configuration.

FIG. 14 is a side view of the handle portion of FIG. 12 with the cover of the steering mechanism knob and release mechanism removed.

FIG. 15 is a side cross-sectional view of the handle portion of FIG. 14 showing the release mechanism in an initial, locked configuration.

FIG. 16 is a side view of the handle portion of FIG. 12 with the steering mechanism knob removed and showing the release mechanism in a released configuration.

FIG. 17 is a side cross-sectional view of the handle portion of FIG. 16 showing the release mechanism in a release configuration.

FIG. 18 is another side cross-sectional view of the handle portion of FIG. 16 showing the release mechanism in a release configuration.

FIG. 19 is a perspective cross-sectional view of a portion of the release mechanism of the handle portion of FIG. 12 showing an end-of-stroke feature of the release mechanism.

Fig. 20 is a side view of the handle portion of fig. 16 showing the release mechanism in a partially retracted configuration while automatically releasing tension during an implantation procedure using the delivery device.

FIG. 21 is a perspective view of the rotatable knob of the release mechanism of FIG. 12 from the distal end.

Fig. 22 is a side cross-sectional view of the knob of fig. 21.

FIG. 23 is a proximal end view of the knob of FIG. 21.

Fig. 24 is a top perspective view of the knob of fig. 21.

Fig. 25 is a perspective view of the knob of fig. 21 from the proximal end.

FIG. 26 is a perspective view of a drive screw of the release mechanism of FIG. 12.

Fig. 27 is a top view of the drive screw of fig. 26.

Fig. 28 is a proximal end view of the drive screw of fig. 26.

Fig. 29 is a side sectional view of the drive screw taken along section a-a of fig. 28.

Fig. 30 is a side view of the drive screw of fig. 26.

FIG. 31 is a first end sectional view of the drive screw taken along section B-B of FIG. 30.

FIG. 32 is a second end cross-sectional view of the drive screw taken along section C-C of FIG. 30.

Fig. 33 is a distal end view of the drive screw of fig. 26.

Fig. 34 is a flow chart of a method for operating a handle portion of a delivery apparatus (e.g., the handle portion of fig. 12) to deliver a prosthetic medical device to a target implant site.

Detailed Description

General notes

For the purposes of this specification, certain aspects, advantages and novel features of the embodiments of the disclosure are described herein. The described methods, systems, and devices should not be construed as limiting in any way. Rather, the present disclosure is directed to all novel and nonobvious features and aspects of the various disclosed embodiments, alone and in various combinations and subcombinations with one another. The disclosed methods, systems, and apparatus are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed methods, systems, and apparatus require that any one or more specific advantages be present or problems be solved.

Features, integers, characteristics, compounds, chemical moieties or groups described in conjunction with a particular aspect, embodiment or example of the disclosure are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive. The present disclosure is not limited to the details of any of the foregoing embodiments. The disclosure extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth below. For example, operations described sequentially may in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed methods, systems, and apparatus can be used in conjunction with other systems, methods, and apparatus.

As used herein, the terms "a," "an," and "at least one" include one or more of the specified elements. That is, if there are two particular elements, one of those elements is also present, and thus there is "one" element. The terms "plurality" and "plural" refer to two or more specified elements.

As used herein, the term "and/or" as used between the last two of a list of elements refers to any one or more of the listed elements. For example, the phrase "A, B and/or C" means "a", "B", "C", "a and B", "a and C", "B and C", or "A, B and C". "

The term "coupled," as used herein, generally means physically coupled or linked, and does not exclude the presence of intermediate elements between coupled items, unless a specific contrary language is used.

Directions and other relevant references (e.g., inner, outer, upper, lower, etc.) may be used to facilitate the discussion of the figures and principles herein, but are not intended to be limiting. For example, certain terms may be used such as "inner," "outer," "top," "down," "inner," "outer," and the like. Where applicable, such terms are used to provide some clear description of the relevant relationships when dealing with them, particularly with respect to the illustrated embodiments. However, these terms are not intended to imply absolute relationships, orientations, and/or orientations. For example, for an object, the "upper" portion may become the "lower" portion by simply turning the object over. Nevertheless, it is still the same part, the object remains unchanged. As used herein, "and/or" means "and" or ", and" or ".

As used herein, with respect to prosthetic heart valves and delivery devices, "proximal" refers to a position, direction, or portion of a component outside of the patient's body that is closer to the user and/or the handle of the delivery device, while "distal" refers to a position, direction, or portion of a component that is further away from the user and/or the handle of the delivery device and closer to the implantation site. Unless otherwise specifically defined, the terms "longitudinal" and "axial" refer to an axis extending in the proximal and distal directions. Further, the term "radial" refers to a direction disposed perpendicular to an axis and pointing along a radius toward the center of the subject (where the axis is located at the center, e.g., the longitudinal axis of a prosthetic valve).

Examples of the disclosed technology

Described herein are examples of delivery apparatus that may be used to deliver an implantable, expandable medical device, such as a prosthetic heart valve, to a target implant site within a patient. The delivery device may include a handle portion and one or more concentric shafts extending distally away from the handle portion. The implantable medical device may be mounted on the distal portion of the delivery apparatus in a radially compressed configuration. For example, the delivery capsule may be coupled to the outer shaft of the delivery apparatus at the distal end portion and cover and retain the implantable medical device thereon in a radially compressed state. The handle portion may include a housing and one or more buttons and/or knobs that may be actuated by a user and configured to adjust the operation of the delivery device during an implantation procedure. In some embodiments, the handle portion may include a steering knob configured to adjust an amount of curvature of one or more shafts of the delivery apparatus at a distal portion of the delivery apparatus, thereby allowing delivery of the implantable medical device by bending a body lumen of a patient.

In some embodiments, the handle portion can include a valve release mechanism configured to adjust a linear orientation (along a central longitudinal axis of the delivery device) of one or more components of the delivery device and automatically relieve tension created at the distal portion of the delivery device during bending of the distal portion and linear adjustment of the orientation of the one or more components at the distal portion. For example, in some embodiments, the steering mechanism is configured to adjust a linear orientation of one or more release members coupled with the implantable medical device in order to release the implantable medical device from the delivery apparatus. In some embodiments, the release mechanism includes a rotatable knob coupled to the housing of the handle portion and a threaded drive screw disposed inside the knob. Rotation of the knob may translate the drive screw axially through a mating connection between one or more grooves of the drive screw and one or more teeth of the knob. The drive screw may be coupled to an inner shaft that is coupled to the one or more release members. Thus, linear movement of the drive screw may result in simultaneous linear movement of the inner shaft and the one or more release members. The pitch and lead of the threads of the drive screw (formed by the one or more grooves) may be relatively long, while the length of the teeth of the knob is relatively short. As a result, after the release member is separated from the implantable medical device, the knob can be manually rotated by the release mechanism, and upon loosening of the distal portion of the delivery apparatus (e.g., by the steering mechanism), the drive screw can passively translate in the distal axial direction and retract into the knob, thereby relieving tension at the distal portion of the delivery apparatus and facilitating loosening. As a result, the delivery device may be more easily removed from the implantation site and the overall implantation process using the delivery device may be simplified.

In some embodiments, the delivery device is configured to deliver and implant a prosthetic heart valve, such as the exemplary prosthetic heart valve of fig. 1, at a selected implantation site within a patient (e.g., within a native aortic, mitral, tricuspid, or pulmonic valve). In addition to prosthetic heart valves, the disclosed delivery apparatus may be adapted to deliver and implant other types of prosthetic valves (e.g., venous valves) and various other types of prosthetic devices, such as stents, grafts, docking devices for prosthetic heart valves, heart valve repair devices (e.g., leaflet clips), embolic coils, and the like; thereby positioning an imaging device and/or components thereof, including an ultrasound transducer; and positioning an energy source, such as a device for performing lithotripsy, an RF source, an ultrasound transmitter, an electromagnetic source, a laser source, a heat source, and the like.

Fig. 1 illustrates a prosthetic heart valve 10 according to one embodiment that may be implanted by a delivery device, such as the delivery device 100 of fig. 2. In some embodiments, the prosthetic heart valve is a self-expanding valve that is delivered in a radially compressed state to the deployment site via a delivery device. The prosthetic valve may self-expand radially to its functional size when advanced from a delivery capsule at a distal end of a delivery device (e.g., the delivery device of fig. 2).

The prosthetic heart valve 10 includes a stent or frame 12 and a valvular structure 14 (e.g., a leaflet or butterfly valve) supported by the frame 12. The frame 12 may have a plurality of interconnected struts 16 arranged in a lattice pattern and forming a plurality of vertices 18 at an inflow end 20 and an outflow end 22 of the frame 12, respectively.

The frame 12 may include a plurality of angularly spaced apart posts 24 extending from the respective apices 18 at the outflow end of the frame 12. The frame 12 in the illustrated embodiment includes three such posts 24, although a greater or lesser number of posts may be used. In one embodiment, the frame 12 may have a post 24 extending from all of the apices 18 at the outflow end 22 of the frame 12. Each post 24 may have an eyelet or aperture 26 that may be used to form a releasable connection with a delivery device (e.g., delivery device 100), such as by using one or more cords or tethers 118 (e.g., see fig. 3), as described further below.

In some embodiments, the frame 12 may not have a post 24 and the aperture 26 may be formed in the apex 18 at the outflow end 22 of the frame 12. In the embodiment shown in fig. 3, an orifice is formed at the outflow end of the frame such that when loaded within the delivery device 100, a releasable connection may be formed between the tether manifold 120 and the outflow end 22 of the frame 12 by the tether 118, as described further below. This arrangement facilitates delivery of the prosthetic valve 10 to the native aortic valve using a retrograde delivery method whereby the delivery device 100 is advanced through the femoral artery and aorta to access the native aortic valve.

In other embodiments, the aperture 26 (whether formed in the post 24 or in the apex 18) may be formed at the entry (or inflow) end 20 of the frame 12, where other delivery device configurations or other delivery techniques require an aperture at the entry end of the frame, such as transapical delivery methods. In further embodiments, the delivery device 100 can include a tether manifold 120 positioned distal to the prosthetic valve when loaded within the delivery device, wherein the tether manifold is coupled to the inlet (or inflow) end 20 of the frame.

In certain embodiments, the prosthetic heart valve 10 is a self-expanding heart valve in which the frame 12 is made of a superelastic, self-expanding material (e.g., a nickel-titanium alloy such as nitinol) as is known in the art. When used with a delivery device 100 (fig. 2), the prosthetic valve 10 can self-expand from a radially compressed state to a radially expanded state when advanced from a delivery capsule (e.g., a delivery sheath) of the delivery device.

In other embodiments, the frame 12 may be made of any of a variety of suitable plastically-expandable materials (e.g., stainless steel, cobalt chrome, etc.), and the prosthetic heart valve may be expanded from a radially-compressed state to a radially-expanded state by inflating a balloon of the delivery apparatus or by actuating other expansion devices of the delivery apparatus and causing radial expansion of the prosthetic valve.

The lobe structure 14 may include a plurality of leaflets 28. The valvular structure typically includes three leaflets 28 arranged in a tricuspid arrangement, although a greater or lesser number of leaflets 28 can be used. The leaflets 28 can be made of any of a variety of suitable materials, including natural tissue (e.g., bovine pericardium or pericardium from other sources) or synthetic materials (e.g., polyurethane). Adjacent side portions at the outflow edges (upper edges in the figures) of adjacent leaflets may be secured to one another to form commissures 30 of the petal structure, which may be secured to the frame with sutures 32.

The prosthetic valve 10 can also include an inner skirt 34 mounted on the inside of the frame 12. The skirt 34 helps to establish a seal with the surrounding tissue after implantation. The skirt 34 may also be used to mount portions of the leaflets 28 to the frame 12. For example, in the illustrated embodiment, the inflow edge (lower edge in the figures) of the leaflet may be sewn to the skirt 34 along a seam 36. The skirt 34 may be attached directly to the frame 12, such as with sutures. Although not shown, the prosthetic valve 10 can include an outer skirt mounted on the outside of the frame in place of the inner skirt 34 or mounted with the inner skirt 34 to further seal the prosthetic valve against/against surrounding tissue. The inner and/or outer skirts may be made of any of a variety of suitable materials, including natural tissue (e.g., pericardial tissue) or any of a variety of synthetic materials, which may be woven, non-woven, braided, knitted, and/or combinations thereof. In one embodiment, the inner skirt 34 is made of polyethylene terephthalate (PET) fabric.

Exemplary configurations of prosthetic heart valves are further disclosed in U.S. patent application publication nos. 2014/0343670, 2012/0123529, 2010/0036484, and 2010/0049313, the disclosures of which are incorporated herein by reference.

A prosthetic heart valve 10, or another type of implantable, expandable medical device, such as an expandable stent, may be delivered to the implantation site by a delivery apparatus, an embodiment of which is shown in fig. 2.

Fig. 2-7 illustrate an exemplary embodiment of a delivery apparatus 100 that may be used to deliver a prosthetic medical device (e.g., the prosthetic heart valve 10 shown in fig. 1) to a target implantation site within a patient. In some embodiments, the handle portion 132 of the delivery device 100 may include a locking mechanism for a release mechanism of a release assembly of the delivery device 100, as shown in fig. 8. Exemplary distal portions of release assemblies that can be used with the delivery device 100 are shown in fig. 9 and 10.

As shown in fig. 2, the delivery device 100 may include a handle portion 132 and a first shaft 134 extending distally from the handle portion. A user, such as a physician or clinician, may operate the delivery device 100 by actuating a plurality of knobs 136, dials, and/or buttons 138a, 138b located on the handle portion 132. The first shaft 134 has a proximal portion 140 and a distal portion 142. The proximal end portion 140 of the first shaft 134 may be coupled to the handle portion 132. Handle portion 132 may include a housing 133. In some embodiments, the housing 133 may include two housing portions.

As shown in fig. 3, the delivery device 100 may include a second shaft 150 and a third shaft 152. A second shaft 150 extends distally from handle portion 132 and coaxially through first shaft 134. A third shaft 152 extends distally from handle portion 132 and is coaxial with second shaft 150. In the illustration, the first shaft 134 is the outermost shaft of the delivery apparatus 100 and thus may be referred to as the outer shaft 134 of the delivery apparatus 100. In the illustrated embodiment, the first shaft 134 is the outermost shaft of the delivery apparatus 100, and thus may be referred to as the outer shaft 134 of the delivery apparatus 100. In the illustrated embodiment, the third shaft 152 is the innermost shaft of the delivery apparatus and thus may be referred to as the inner shaft 152 of the delivery apparatus 100. In the illustrated embodiment, the second shaft 150 is located between or intermediate the innermost and outermost shafts, and thus may be referred to as an intermediate shaft.

The nose cone 144 can be attached or mounted to the distal end portion 152d of the inner shaft 152. The nose cone 144 may have a tapered outer surface as shown for atraumatic tracking of the delivery device 100 through the vasculature of a patient. Inner shaft 152 extends distally beyond intermediate shaft 150, through the lumen of tether manifold 120, and through prosthetic valve 10.

In certain embodiments, the first, second, and third shafts 134, 150, 152, respectively, may be configured to be movable relative to one another, including relative axial movement (in proximal and distal directions) and/or relative rotational movement (clockwise and counterclockwise directions). A guidewire 154 (fig. 4) can extend through the central lumen of the inner shaft 152 and the lumen of the nose cone 144 such that the delivery apparatus 100 can be advanced over the guidewire 154 within the vasculature of a patient during delivery of the prosthetic valve 10 to a target implantation site. Guidewire 154 can exit inner shaft 152 via proximal port 155 (fig. 5) of cap 157 of handle portion 132. As shown in fig. 5 and 8, the cap 157 may be coupled to an end of a drive screw 161 of the release mechanism 200 of the delivery device 100 (as further described below with reference to fig. 8-10).

A delivery capsule 146 is coupled to the distal portion 142 of the first shaft 134 proximate the nose cone 144. The delivery capsule 146 receives the prosthetic valve 10 therein in a radially compressed state, as shown in fig. 3-4. In one embodiment, the delivery capsule 146 covers and holds the underlying compressed prosthetic valve of fig. 1. The delivery device 100 is particularly suited for delivering and implanting a self-expanding prosthetic valve 10 that radially expands under its own elasticity to its functional size when deployed from the delivery capsule 146.

Alternatively, however, the prosthetic heart valve 10 may be a plastically-expandable prosthetic valve or a mechanically-expanded heart valve. If the delivery device is used to implant a plastically-expandable valve, the delivery device can include a balloon catheter known in the art for expanding a prosthetic valve, such as disclosed in U.S. publication No.2009/0281619, which is incorporated herein by reference. If the delivery device is used to implant a mechanically expandable valve, the delivery device may include one or more actuators for expanding the prosthetic valve, such as disclosed in international application No. pct/US2020/063104, which is incorporated herein by reference.

As shown in fig. 3, the delivery capsule 146 is configured to receive the prosthetic heart valve 10 or another type of implantable medical device in a radially compressed state for delivery into the vasculature of a patient. Tether manifold 120 is configured to form a releasable connection with prosthetic heart valve 10 via a plurality of tethers or tethers 118 (fig. 3). The tether manifold 120 is coupled to the distal end of the first shaft 134 proximate to each of the nose cone 144 and the crimped prosthetic valve 10.

As shown in fig. 3, tether manifold 120 may include a proximal portion 122 and a distal portion 124, with distal portion 124 being axially spaced from proximal portion 122. The proximal portion 122 of the tether manifold 120 may be fixedly coupled to the distal end portion 142 of the first shaft 134 using a suitable technique or mechanism, such as by a mechanical connector, welding, press-fit, and/or adhesive. For example, in some embodiments, the distal end portion 142 of the shaft 134 may extend into the lumen of the proximal portion 122, and the proximal portion 122 may be coupled to the shaft 134 using any of the connection techniques described above.

Tether 118 may be made of any of a variety of suitable biocompatible materials for use within a patient. In certain embodiments, tether 118 may comprise a monofilament tether or a multifilament or multistrand tether formed by weaving, braiding, knitting, twisting, and winding multiple filaments or strands together. The filaments or strands may comprise polymeric fibers, such as ultra high molecular weight polyethylene, nylon, polyester, and/or aramid, or flexible wires (e.g., metal wires).

Each tether 118 may have a first end 118a attached to a tether manifold 120 (e.g., to a proximal portion 122). Each tether 118 extends through an opening of frame 12 of the prosthetic valve (e.g., through opening 26) and may have a second end 118b in the form of a loop that is retained on release member 156. Release members 156 are configured to maintain tethers 118 in a state connected to frame 12 of prosthetic valve 10 until they are actuated by a user to release tethers 118. Two release members 156 are shown for illustrative purposes. It should be appreciated that any number of release members 156 may be used.

Similarly, two tethers 118 are shown for purposes of illustration, but it should be understood that any number of tethers may be used. Likewise, the same number of tethers and release members 156 are not required. For example, ends 118b of multiple tethers 118 may be retained on a single release member 156. Ideally, at least three tethers 118 are used to balance the attachment of the frame 12 to the tether manifold 120. In certain embodiments, the number of tethers 118 is equal to the number of apices 18 of the frame 12 of the prosthetic valve 10 (fig. 1). Further, in other embodiments, a single root rope may be used to connect the frame 12 to the tether manifold 120 at multiple locations along the outflow end of the frame by forming multiple passages extending through the frame opening.

Each release member 156 may slidably extend through a respective opening in the proximal and distal portions 122, 124 of the tether manifold 120 (fig. 3). In some embodiments, each release member 156 may extend along its entire length through the first shaft 134 and may have a proximal end portion that is operably coupled to a knob 136 on the handle portion 132 to control movement of the release member 156. In an alternative embodiment, each release member 156 may have a proximal end coupled to an outer surface of the third shaft 152 of the delivery device 100.

Each release member 156 is movable in the proximal and distal directions relative to proximal and distal portions 122, 124 of the tether manifold between a distal position where each release member 156 holds a respective tether 118 and a proximal position where each release member 156 is released from a respective tether 118. The knob 136, the release member 156, and the tether manifold 120 may together form a release assembly of the delivery device 100, as further described below with reference to fig. 8 (e.g., a release mechanism 200 of the release assembly disposed within the handle portion 132 is shown in fig. 8).

Further details regarding attachment of the prosthetic valve 10 to the delivery apparatus 100 via one or more tethers or sutures are disclosed in U.S. publication nos. 2014/0343670, 2012/0239142, and 2010/0049313 and international application No. pct/US2020/024130, all of which are incorporated herein by reference.

Further, in alternative embodiments, different valve retention mechanisms can be used to form the releasable connection between the prosthetic valve 10 and the delivery apparatus 100. For example, in some embodiments, the posts 24 of the frame 12 may be retained in corresponding recesses of a shaft or retaining member of the delivery device, which allows the posts of the frame to expand out of their corresponding recesses when the capsule 146 is retracted to deploy the prosthetic valve. In other embodiments, the retention mechanism may include an inner metallic fork member and an outer metallic fork member that form a release connection between the delivery device and the prosthetic valve. Further details regarding the replacement valve retention mechanism are disclosed in U.S. publication nos. 2012/0239142 and 2010/0049313.

As further shown in fig. 3, the second shaft 150 may include an externally threaded portion 162 along a distal end portion thereof. The threaded portion 162 may include threads formed on the outer surface of the shaft or may be a separate screw attached to the distal end of the proximal shaft section. The capsule 146 is operatively connected to the second shaft 150 by an internally threaded nut 164 disposed on the threaded portion 162. The nut 164 may have radially extending projections 166 (see fig. 2) that extend into corresponding openings in the capsule 146. The rotation of the nut 164 is limited by one or more tracks 165 extending from or formed along the distal portion of the first shaft 134.

Thus, rotation of the second shaft 150 relative to the first shaft 134 produces axial movement (in the distal and proximal directions) of the nut 164, which in turn produces corresponding axial movement of the capsule 146 in the same direction during loading, deployment and/or recapturing of the prosthetic valve. For example, when the nut 164 is in the distal position, the delivery capsule 146 extends over the prosthetic valve 10 and holds the prosthetic valve 10 in a compressed state for delivery. Movement of the nut 164 in the proximal direction causes the delivery capsule 146 to move in the proximal direction, thereby deploying the prosthetic valve. Rotation of second shaft 150 may be achieved by a motor and/or manual control features operatively coupled to the second shaft, as described further below.

In certain embodiments, the delivery device 100 may include one or more steering mechanisms configured to control the curvature of one or more of the shafts 134, 150, 152 to assist in steering the delivery device through the vasculature of the patient. For example, the steering mechanism may include one or more eccentrically positioned pull wires extending through the shaft and operatively connected to an adjustment mechanism, such as a steering knob 418 located on or near the handle portion 132 of fig. 2. The adjustment of the adjustment mechanism can effectively change the tension of the stay wire, so that the shaft is bent or straightened along a given direction. In one embodiment, one or more pull wires extend through the outer shaft 134, and adjustment of the adjustment mechanism is effective to adjust the distal portion of the outer shaft 134 and the curvature of the delivery apparatus 100. Further details regarding the steering mechanism are disclosed in U.S. publication nos. 2007/0005131 and 2013/0030519, which are incorporated herein by reference.

In certain embodiments, as shown in fig. 6-8, the delivery device 100 is a motorized device that includes a motor 168 housed within the handle portion 132. The motorized embodiment automates the deployment of the prosthetic valve 10. In particular, motor 168 is operatively coupled to second shaft 150 to produce rotation of second shaft 150 relative to first shaft 134 and corresponding axial movement of capsule 146, as further described below.

The proximal portion 140 of the first shaft 134 may be coupled to a distal end of the handle portion 132. As shown in FIG. 6, proximal portion 151 of second shaft 150 may extend into handle portion 132 through distal opening 170 of handle portion 132. A rotatable member 172 (which may be referred to as a drive cylinder in some embodiments) is disposed within handle portion 132 and is operatively coupled to second shaft 150.

In one embodiment, as best shown in fig. 7, the proximal portion of the rotatable member 172 includes a gear 174, the gear 174 having a plurality of gear teeth 176 circumferentially aligned with respect to one another. The rotatable component 172 further includes a body 178 configured as an extended shaft having an inner cavity 173. In the illustrated embodiment, the body 178 and the gear 174 are integrally formed, but they may be separately formed components that are connected to one another by any of a variety of attachment means. The body 178 of the rotatable member 172 may be coaxial with a central longitudinal axis L-L' (shown in fig. 5) of the handle portion 132 and also coaxial with the first shaft 134. The inner cavity 173 of the body 178 may be sized to receive and retain the proximal portion 151 of the second shaft 150 therein.

In some embodiments, the inner surface of the lumen 173 can have a non-circular cross-section in a plane perpendicular to the longitudinal axis L-L', and the proximal portion 151 of the second shaft 150 can have a similar cross-sectional profile that corresponds to the shape of the lumen such that rotational motion of the rotatable member 172 is transferred to the second shaft 150. For example, the cavity 173 and proximal portion 151 may be generally cylindrical with a series of circumferentially spaced flat sections. Instead of or in addition to providing the lumen 173 and the proximal portion 151 with non-circular cross-sections, the proximal portion 151 may be coupled to the rotatable component with a fastening device, such as a mechanical fastener (e.g., a screw), an adhesive, a press fit, a snap connection, or the like.

As best shown in fig. 6, the motor 168 may be held within a holding box or cradle 190. The motor may be an electric motor and the handle portion may include a battery compartment containing one or more batteries (not shown) for powering the motor 168. One or more operating buttons 138a, 138b on the handle portion 132 allow a user to activate the motor 168, such as by electrically coupling an electrical current from a battery source to the motor. As described below, the motor may be rotated in either direction, moving the capsule 146 in a proximal or distal direction. One button (e.g., button 138a) may be operable to rotate the motor in a first rotational direction to move the capsule 146 in a distal direction, e.g., for loading a prosthetic valve into the capsule 146, while the other button (e.g., button 138b) may be operable to rotate the motor 168 in a second rotational direction to move the capsule 146 in a proximal direction, e.g., for deploying the prosthetic valve. Instead of or in addition to one or more batteries, the motor 168 may be configured to receive a power tether that provides current to the motor from a power source external to the handle portion 132 (e.g., a wall outlet).

As best shown in fig. 7, the motor 168 may be coupled to the rotatable member 172 by a drive shaft 184 connected to a motor shaft 188 and an intermediate drive gear 182 connected to the drive shaft 184. The drive gear 182 may have a circumferential array of gear teeth 192, and the gear teeth 192 may mesh with the circumferentially arranged gear teeth 176 of the rotatable member 172. When driven by the motor, the motor 168 rotates the motor shaft 188, which in turn rotates the drive shaft 184 and the drive gear 182. The drive gear 182 engages and rotates the gear 174 of the rotatable member 172, thereby rotating the rotatable member 172 and the second shaft 150. The drive gear 182 may be positioned radially offset from the central axis of the rotatable member 172 and the central longitudinal axis L-L' of the handle portion 132 such that when engaged, the gears are vertically aligned. In further embodiments, one or more additional gears may be disposed between the drive gear 182 and the rotatable member 172 to transfer rotation from the motor to the rotatable member.

In an alternative embodiment, the motor shaft 188 or the drive shaft 184 may be connected to the rotatable member 172 without any intermediate gears. For example, the motor shaft 188 may be positioned proximally of the rotatable member along the axis L-L', and the motor shaft 188 may be connected to the rotatable member 172 in a direct drive arrangement.

In the illustrated embodiment, the carriage 190 housing the motor 168 and drive shaft 184 may also be configured to support the rotatable member 172 for rotational movement within the handle portion. As best shown in fig. 6, the carriage 190 may have a first distal portion 194, the first distal portion 194 including a distal sleeve 195 surrounding the distal end portion of the body 178 of the rotatable member 172. The carriage 190 may also have a proximal portion 196, the proximal portion 196 including a proximal sleeve 197 that surrounds a proximal end portion of the body 178 of the rotatable member 172.

Referring to fig. 3 and 7, rotation of the motor 168 in a first direction (e.g., clockwise or counterclockwise) causes rotation of the rotatable member 172. This in turn causes rotation of the second shaft 150 coupled to the rotatable member 172. Rotation of the second shaft 150 causes rotation of the threaded portion (screw) 162 of the second shaft 150. As described above, rotation of the threaded portion 162 produces axial movement of the drive nut 164 and the capsule 146 (fig. 3). For example, rotation of the rotatable member in a first direction may cause the delivery capsule 146 to retract in a proximal direction and expose the prosthetic valve at the distal end of the delivery device 100. Conversely, rotation of the motor in a second direction opposite the first direction causes the second shaft 150 to rotate in the opposite direction, which causes the nut to move axially in the opposite direction, moving the delivery capsule 146 in a distal direction back over the prosthetic valve. The operator may actuate the buttons 138a, 138b (fig. 2 and 6) on the handle portion 132 to actuate the motor 168 and axially move the delivery capsule 146 in a motorized manner. This allows for rapid deployment or retraction of the prosthetic valve 10.

In use, the prosthetic valve 10 can be connected to the delivery device 100 and loaded into the capsule 146 as described below. A releasable connection may be made between each apex 18 at one end of the frame 12 and a tether manifold 120 having individual tethers 118. Optionally, the length of tether 118 is selected such that the fixed end of the frame is held in a state at least partially radially compressed by the tether. After securing the end of frame 12 with tether 118, delivery capsule 146 may be advanced distally over tether manifold 120, tether 118, and frame 12 (e.g., by pressing button 138a), thereby folding the frame into a radially compressed state under the force of capsule 146 (as shown in fig. 4). The delivery capsule 146 is advanced distally until the distal end of the delivery capsule 146 abuts the nose cone 144 to completely surround the prosthetic valve 10, as shown in fig. 3.

As described above, after loading the prosthetic heart valve 10 into the delivery device 100, the delivery device 100 can be inserted into the patient's vasculature and advanced or navigated through the patient's vasculature to the desired implantation site (e.g., through the femoral artery and aorta when delivering the prosthetic valve 10 to the native aortic valve in a retrograde delivery method).

Once the prosthetic valve 10 is delivered to a selected implantation site (e.g., a native aortic valve) within a patient, the delivery capsule 146 can be retracted (e.g., by pressing the button 138b) to deploy the prosthetic valve 10. When the delivery capsule 146 is retracted (fig. 4), the prosthetic valve 10 can radially self-expand under the resiliency of the frame 12. After the delivery capsule 146 is fully retracted from the prosthetic valve 10, the prosthetic valve remains attached to the delivery device 12 by the tether 118. While still attached to the delivery apparatus 100, the user can manipulate the delivery apparatus (e.g., by moving it in the proximal and distal directions and/or rotating it) to adjust the position of the prosthetic valve 10 relative to the desired implant location.

If desired, the delivery capsule 146 can be advanced back over the prosthetic valve 10 to fully or partially recapture the prosthetic valve (bringing the prosthetic valve back into the capsule) to facilitate repositioning of the prosthetic valve. For example, after passing through the native aortic valve leaflets and deploying the prosthetic valve in a retrograde delivery method, it may be necessary to recapture the prosthetic valve back into the capsule 146, retract the delivery device 100 to bring the prosthetic valve back into the aorta, then advance the prosthetic valve through the native aortic valve leaflets, and deploy the prosthetic valve from the capsule.

Once the prosthetic valve is deployed from capsule 146 and positioned at the desired implantation location, release member 156 may be retracted, for example, by rotating knob 136 on handle portion 132. In some cases, tether 118 slides outwardly from aperture 26 and releases itself from frame 12 as a result of further expansion from expanding frame 12 when release member 156 is retracted. In other instances, the user may slightly retract the delivery apparatus 100, which in turn pulls the tether 118 proximally relative to the frame 12 to pull the tether out of the aperture 26.

Alternatively, the orientation of the prosthetic valve may be reversed such that the inflow end of the prosthetic valve is the proximal end and the outflow end of the prosthetic valve is the distal end when coupled to the delivery device. This may facilitate delivery of the prosthetic valve to different implant locations (e.g., native aorta, lung, mitral and tricuspid annulus) and/or for various delivery methods (e.g., antegrade, transseptal, transventricular, transatrial). Further details of the components and operation of a delivery apparatus for delivering a prosthetic medical device (e.g., a prosthetic heart valve) to a target location are disclosed in international patent application No. pct/US2021/023696, which is incorporated herein by reference.

Fig. 8 shows a portion of an embodiment of the handle portion 132 of the delivery device 100 that includes a release mechanism 200, the release mechanism 200 including a knob 136, a drive screw 161, and a locking mechanism 202. The release mechanism 200 is configured to facilitate release of the prosthetic heart valve from the delivery apparatus via control of the release member 208, which release member 208 may be the same as or similar to the release member 156 in some embodiments, as described above with reference to fig. 3. The release mechanism 200 and the release member 208 may together form a release assembly of the delivery device 100. Fig. 9 and 10 show an embodiment of a distal portion of a release assembly of delivery device 100, the release assembly including release member 208.

As described above, the delivery apparatus 100 can include an inner shaft 152 having an inner guidewire lumen configured to receive a guidewire (e.g., guidewire 154) therein. The inner shaft 152 can be releasably connected at its proximal end to a drive screw 161 (fig. 8) and at its distal end to a valve release member 208 (fig. 9 and 10). Thus, as described further below, axial movement of the inner shaft 152 can result in axial movement of the release member 208 (fig. 9 and 10).

As shown in fig. 8, the release mechanism 200 may include a drive screw 161 disposed within and engaged with the knob (release knob) 136. Cap 157 is coupled to the proximal end of drive screw 161. The locking mechanism 202 may be coupled to a proximal end of the drive screw 161 and disposed within a portion of the cap 157. The locking mechanism 202 may be rotated by a knob 204 (which may be manually actuated by a user). For example, rotation of knob 204, and thus locking mechanism 202, can cause washer 206 to clamp onto an outer surface of inner shaft 152 (the locked orientation) and to disengage from an outer surface of inner shaft 152 (the unlocked orientation). The washer 206 may be fixedly coupled to the drive screw 161 and, thus, may move axially with axial translation of the drive screw 161. Thus, when release mechanism 200 is locked to inner shaft 152, rotation of knob 136, which causes axial translation of drive screw 161, causes axial translation of inner shaft 152.

As shown in fig. 9 and 10, the inner shaft 152 can extend to and/or into the nose cone 144. The spool 212 may be coupled (e.g., fixedly coupled) to a portion of the outer surface of the inner shaft 152, and the proximal end of the release member 208 may be coupled to the spool 212. As described above with reference to fig. 3, the distal end of the release member 208 may be removably coupled to a coupling element (e.g., a tether, a cord, a suture, etc.) that is coupled to the prosthetic heart valve.

Fig. 9 shows the distal portion of the release assembly in an initial configuration prior to releasing the prosthetic heart valve from the delivery apparatus 100. For illustrative purposes, the prosthetic heart valve is not shown in fig. 9 and 10. However, as shown in fig. 9, the distal end of release member 208 may be in an orientation that couples the valve to delivery device 100 (e.g., prevents axial movement of the valve relative to delivery device 100). In this configuration, the locking mechanism 202 may be in a locked state.

After the distal portion of the delivery device 100 containing the prosthetic heart valve reaches the target implantation site, the prosthetic heart valve can be deployed by moving the capsule 146 away from the valve to expose the valve. Knob 136 may then be rotated to axially move inner shaft 152 in a proximal direction 214 (toward handle portion 132) to retract release member 208 away from the prosthetic heart valve.

As used herein, "proximal direction" may refer to a direction of movement or travel toward a handle portion or user of the delivery device along an axial direction parallel to a central longitudinal axis of the delivery device, while "distal direction" may refer to a direction of movement or travel opposite the proximal direction along the axial direction, i.e., away from the handle portion and closer to a target implant site.

Fig. 10 illustrates the distal portion of the release assembly in a retracted (e.g., released) configuration after release of the prosthetic heart valve from the delivery apparatus 100. In this configuration, the inner shaft 152 has been translated proximally, thereby proximally translating the spool 212. In some embodiments, as shown in fig. 10, the spool 212 may be in contact with a spool stop 216 that prevents further axial movement of the spool 212 and the release member 208 in the proximal direction 214.

The spool stop 216 may be axially fixed relative to the inner shaft 152 and the spool 212. In some embodiments, the spool stop 216 may be secured to a component of another shaft of the delivery apparatus, such as the second shaft 150 or the first shaft 134.

Since release member 208 has also moved proximally with spool 212, the prosthetic heart valve can now be released from delivery device 100 and delivery device 100 can be removed from the implantation site.

In some embodiments, when a delivery device (e.g., delivery device 100) is used to deliver a prosthetic aortic valve to its target implant site, at least a distal portion of the delivery device must traverse a curved portion of the patient's vasculature, such as the patient's aortic arch. An exemplary simulated aortic arch 300 is shown in fig. 11. Thus, as described above, in some embodiments, the delivery device may include one or more steering mechanisms configured to control the curvature of one or more shafts (e.g., shafts 134, 150, 152, and/or 152) of the delivery device 100 to assist in steering the delivery device through the vasculature of the patient.

For example, as shown in fig. 11, one or more steering mechanisms may allow at least a distal portion 302 of a delivery device 304 (which may be the same or similar to the delivery device 100) to flex and articulate (e.g., bend) about the aortic arch 300. The distal portions of the concentric shafts (e.g., shafts 134, 150, 152, and/or 152) of the delivery device 304 may shorten or lengthen relative to one another as the distal portion 302 of the delivery device 304 articulates about the aortic arch. In some embodiments, after flexing the distal portion 302 of the delivery device 304 to reach the target implantation site, and while the distal portion 302 remains flexed (as shown in fig. 11), the valve can be released from the delivery device 304 by rotating the knob 136 of the release mechanism 200. This results in linear movement (axially, in a proximal direction) of the drive screw 161, the inner shaft 152, and the release member 208. However, such linear translation of the concentric lumen may cause the inner shaft 152 to shorten when flexed, thereby creating tension in the distal portion 302 when released. In this state, the inner shaft 152 may become a tensioned pull wire. If the release mechanism 200 is not unlocked (e.g., to release the tension) during loosening, the distal portion 302 is held under tension, thereby preventing removal of the delivery device from the implantation site.

In this manner, the locking mechanism of the release mechanism 200 can increase the complexity of the implantation process and cause tension problems, which can increase the difficulty of removing the delivery device from the implantation site after implantation of the prosthetic heart valve. Thus, it may be desirable to have a delivery device that does not include a locking mechanism for the release mechanism.

Fig. 12-33 illustrate an embodiment of a release mechanism 402 for a handle portion 400 of a delivery device. In some embodiments, handle portion 400 may replace handle portion 132 of delivery device 100 shown in fig. 8. In some embodiments, the handle portion 400 may control the operation of a distal portion of a delivery device, such as the distal portion shown in fig. 9 and 10. Further, the delivery apparatus may be configured to deliver a radially compressed prosthetic medical device (e.g., the prosthetic heart valve 10 of fig. 1 disposed on a distal end of a distal portion of the delivery apparatus) to a target implantation site.

As described above, the release mechanism 402 of fig. 12-33 is configured to automatically provide a tension release of tension created by flexing the distal portion of the delivery apparatus and releasing a radially compressed medical device mounted on the distal portion of the delivery apparatus. Thus, the release mechanism 402 does not include a locking mechanism (e.g., the locking mechanism 202 of fig. 8). Fig. 12-20 illustrate an assembled handle portion 400 that includes a release mechanism 402 in different orientations or configurations during a prosthetic medical device implantation procedure with a delivery apparatus. Fig. 21-25 show different views of the release knob 404 of the release mechanism 402 (detached from the rest of the handle portion), while fig. 26-33 show different views of the drive screw 406 of the release mechanism 402 (detached from the rest of the handle portion).

As shown in fig. 12-18 and 20, the handle portion 400 may include a housing 410 (e.g., an outer housing). The housing 410 may house internal components of the handle portion 400, such as those described above with reference to fig. 2-8 and with further reference to fig. 13, 15, 17, and 18 below. In some embodiments, the handle portion 400 may include a plurality of knobs and buttons that may be actuated by a user (e.g., a physician or clinician) to control the operation of the delivery device. For example, in some embodiments, the handle portion 400 may include buttons 412a and 412b, which may be similar to the buttons 138a and 138b, as described above with reference to fig. 2, 5, and 6.

In some embodiments, as shown in fig. 12 and 13, a steering knob 418 of a steering mechanism of the delivery device may be coupled to the distal end 416 of the housing 410. By adjustment (e.g., rotation) of the steering knob 418, the steering mechanism may be configured to adjust the curvature or amount of flexion of the shaft or shafts of the delivery device at the distal portion of the delivery device, as previously described.

The release knob 404 of the release mechanism 402 may be coupled to the proximal end 414 of the housing 410 and configured to rotate about a central longitudinal axis 420 of the release mechanism (which may also be the central longitudinal axis of the knob 404, the drive screw 406, and the delivery device). However, the movement of the release knob 404 may be fixed in the axial direction (along the central longitudinal axis 420). In this manner, the release knob 404 may be rotated but may be fixed from linear translation in the axial direction.

For example, as shown in fig. 21, 22, and 24, the release knob 404 may include a body 428 having a distal end 424 and a proximal end 426. The body 428 may be a portion of the release knob 404 that is configured to be held and rotated by a user. The release knob 404 may also include a collar 422 extending axially outward from a distal end 424 of the release knob 404. The outer diameter 430 of the collar 422 may be smaller than the outer diameter (e.g., the outer most diameter of the widest portion) 432 of the body 428, as shown in FIG. 22. The collar 422 may include one or more grooves (or channels) 434 extending around a circumference (e.g., the entire circumference) and recessed into the outer surface of the collar 422. As shown in fig. 21, 22 and 24, the collar 422 includes two recesses 434 on the collar 422 spaced from each other in the axial direction. However, in alternative embodiments, the collar 422 may include more or less than two recesses 434 (e.g., one, three, etc.). Each groove 434 is configured (e.g., shaped) to mate with a corresponding annular protrusion 436 of housing 410.

For example, as shown in fig. 13, 15, 17, and 18, the inner surface 438 of the housing 410 includes one or more annular projections 436 at the proximal end 414 thereof, each annular projection 436 extending radially inward from the inner surface 438 of the housing 410 toward the central longitudinal axis 420. Collar 422 may extend into the interior of proximal end 414 of housing 410. Each annular protrusion 436 of the collar 422 may extend around the entire circumference of the inner surface 438. The number of annular protrusions 436 may match the number of grooves 434. In this manner, each annular projection 436 may extend into and mate with a respective groove 434. Sufficient clearance may be provided between the mating annular projection 436 and the recess 434 to allow the release knob 404 to rotate while the housing 410 remains fixed from rotation and also to prevent the release knob 404 from moving axially relative to the housing 410. In this manner, the release knob 404 is configured to rotate but is fixed from linear translation (both axially and radially) relative to the housing 410 due to the mating connection between the groove 434 and the annular projection 436 of the housing 410.

Returning to fig. 21-25, the release knob 404 may include an internal cylindrical bore (or cavity) 440 defined by an inner surface 442 of the release knob 404, the inner surface 442 extending from the proximal end 426 of the body 428 to the distal end of the collar 422. The inner surface 442 may define an inner diameter 444 of the release knob 404 (fig. 22). The bore 440 is configured to receive the drive screw 406 therein, as shown in fig. 13, 15, 17, and 18. The drive screw 406 and the release knob 404 may be coaxial with each other (e.g., the central longitudinal axis 420 may be a common axis).

As shown in fig. 22-25, the release knob 404 may include one or more teeth 446 extending radially from the inner surface 442 toward the central longitudinal axis 420. Each tooth 446 is disposed at the proximal end 426 of the release knob 404. For example, each tooth 446 may extend along the inner surface 442 from the proximal end 426 to the distal end 424 of the release knob 404 for only a portion of the total distance (length) 448 between the proximal and distal ends 426, 426. In some embodiments, the portion may be less than 1/4 of the total distance 448. In other embodiments, the portion may be less than 1/10 of the total distance 448. Accordingly, the length of each tooth 446 may be relatively short compared to the length of the helical groove 452 of the thread of the drive screw 406, the tooth 446 being configured to mate with (engage) and travel along (slide) the helical groove 452, as described further below.

As shown in fig. 23-25, each tooth 446 is curved along the inner surface 442 to match the helical profile of the groove 452 with which the tooth 446 is configured to engage. For example, each tooth 446 may have a pitch and lead that matches the pitch and lead of drive screw 406, as described further below. However, each tooth 446 is less than fully threaded and may be bent less than 90 degrees around the circumference of the proximal end 426 of the knob 404 (as shown in fig. 23-25). In some embodiments, each tooth 446 is curved about or less than 45 degrees around the circumference of the proximal end 426. In some embodiments, each tooth 446 curves between 30 and 80 degrees around the circumference of the proximal end 426.

The release knob 404 is shown having two teeth 446 that are spaced apart from each other around the circumference of the inner surface 442. In some embodiments, two teeth 446 may be spaced about 180 degrees apart from each other around the circumference of the inner surface 442. For example, as shown in the distal end view of fig. 23, the two teeth 446 may include a first tooth 446a and a second tooth 446 b. In alternative embodiments, the release knob 404 may include only one tooth or more than two teeth (e.g., three), such as when the drive screw is a single start screw or a different multi-start screw (multi-start screw).

In some embodiments, as shown in fig. 21, 22, 24, and 25, the outer surface of the body 428 of the release knob 404 may have a curved profile with one or more protruding elements 450 (e.g., a diameter of the middle portion is smaller than a diameter of the end of the body 428). The one or more protruding elements 450 may be configured to provide an ergonomic knob surface for a user to grasp and turn. However, in alternative embodiments, the body 428 may not include the protruding element 450 and/or may have a different shaped profile.

The drive screw 406 may be disposed within an interior (e.g., bore 440) of the release knob 404 (fig. 12-20). In some embodiments, as shown in fig. 26-33, the drive screw 406 may have threads defined by one or more grooves 452 that retract into an outer surface 454 of a body 456 of the drive screw 406. Each groove 452 may form a helical track along the helical threaded portion of the body 456 of the drive screw 406 along which a corresponding tooth 446 of the release knob 404 may travel as the release knob 404 is rotated (e.g., turned). The body 456 also includes one or more retaining members 458 (fig. 26-32). Each groove 452 may be connected to a respective retaining element 458 of the drive screw 406. Further, each retaining element may be disposed at a proximal end 476 of the drive screw 406 (e.g., a proximal end of the body 456).

In some embodiments, each retaining element 458 includes a protruding member (also referred to as a pawl) 460, a first linear threaded portion 462 disposed on a first side of the protruding member 460, and a second linear threaded portion 464 disposed on a second side of the protruding member 460 (fig. 26 and 27). In some embodiments, as shown in fig. 26, 27, and 30, the second linear threaded portion 464 connects to and is continuous with a respective groove 452. Thus, the first and second linear threaded portions 462, 464 may be grooves recessed into the outer surface 454 and extending circumferentially along the body of the drive screw on either side of the protruding member 460. In some embodiments, the first and second linear threaded portions 462, 464 may not be helical (e.g., they are relatively straight or linear). As described in further detail below, when the corresponding tooth 446 of the release knob 404 is disposed in the first linear threaded portion 462, the tooth 446 is trapped behind the protruding member 460, thereby maintaining the release knob 404 in the locked configuration.

In some embodiments, each retention element 458 may include a tab 485 disposed internally (in a distal, axial direction) of a protruding member 460 (fig. 26, 27, 30, and 32). The tab 485 may set the length, width, and height of the cantilever of the tab 485 and the projecting member 460, which sets the force required to depress the projecting member 460 and allow the tooth 446 to begin traveling along the second linear threaded portion 464 and the groove 453. As a result, the release knob 404 may rotate and cause linear travel of the drive screw 406.

Each groove 452 may extend from the second linear threaded portion 464 of the respective retaining member 458 and be helically curved about the outer surface 454 of the body 456 of the drive screw 406 from the respective retaining member 458 to the distal end 474 of the body 456.

In some embodiments, as shown in fig. 26-33, the helical threaded portion has a double start thread formed by two helical grooves 452, including a first groove 452a and a second groove 452b (e.g., as shown in fig. 16 and 30). The proximal end of the first groove 452a may originate at a first retaining member and the proximal end of the second groove 452b may originate at a second retaining member spaced apart from the first retaining member. In some embodiments, as shown in fig. 26 and 28-33, the two retaining elements 458 may be disposed 180 degrees apart from each other about the circumference of the body 456 of the drive screw 406.

In some embodiments, the helical threaded portion may have a lead 466 greater than 1 inch and a pitch 468 greater than 0.5 inch. As used herein and shown in fig. 30, the pitch 468 is the distance between the notch of one thread (groove) and the next notch of an adjacent thread (groove), while the lead 466 is the distance along the axis of the drive screw that is covered by one full rotation of the knob (e.g., the knob teeth along the drive screw groove). In the case of a double start thread, the lead 466 is twice the pitch 468. In some embodiments, the helical threaded portion may have a lead 466 of about 1.5 inches and a pitch 468 of about 0.75 inches. In some embodiments, the lead 466 may be in the range of 1-1.75 inches and the pitch 468 may be in the range of 0.5-0.875 inches.

In an alternative embodiment, the helical threaded portion may instead have a single start thread formed by a single groove 452. In these embodiments, the release knob 404 may include only a single tooth 446 configured to mate with a single groove 452. In a single-start threaded embodiment, the helical threaded portion may have a lead of 1.5 inches and a pitch of 1.5 inches or a lead of at least 1 inch and a pitch of at least 1 inch.

As shown in fig. 18, each tooth 446 of the release knob 404 engages a respective one of the grooves 452 and is configured to slide along the respective one of the grooves 452. For example, in the case of a two wire release mechanism, as described above, as the release knob is rotated (fig. 18), the first tooth 446a of the release knob 404 engages with and slides (e.g., rides) along the first groove 452a, and the second tooth 446b of the release knob 404 engages with and slides along the second groove 452 b.

Accordingly, each tooth 446 may be shaped to fit within a respective groove 452. As shown in fig. 29, each groove 452 may have a profile 470. In some embodiments, profile 470 may have a trapezoidal shape, such as a triangular shape with flat peaks. As shown in fig. 22-25, each tooth 446 may have a profile 472 that corresponds to (e.g., matches) the profile 470 of the groove 452 so that they can fit together while still having sufficient clearance between them to allow the tooth 446 to slide along the groove 452. For example, in some embodiments, the profile 472 may also have a trapezoidal shape, such as a triangular shape with flat peaks. However, as described above, each tooth 446 may be a protrusion (e.g., protruding radially outward from the inner surface 442 of the release knob 404) and each recess 452 may be a recess (e.g., pressed into the outer surface 454 of the drive screw 406) allowing each tooth 446 to extend into and mate with a respective recess 452.

While each groove 452 curves around the outer surface 454 and extends from the proximal end 476 to the distal end 474 of the body 456 of the drive screw 406, each tooth 446 extends only a portion of the total distance (e.g., length) 448 between the proximal end 426 and the distal end 424 of the release knob 404. Accordingly, the path length 478 (shown in fig. 25) of each tooth 446 (e.g., from its proximal end to its distal end) is relatively short compared to the path length of the corresponding groove 452.

As explained further below with reference to fig. 34, by having a relatively shorter tooth 446 on the release knob 404 and a threaded drive screw 406 having a relatively longer lead 466 and pitch 468, the engagement between the tooth 446 of the release knob 404 and the groove 452 of the drive screw 406 (as opposed to the tooth 446 which would be bent around and extend through a larger portion of the inner surface of the release knob 404) may be reduced. This reduced level of engagement may be sufficiently large to allow the teeth 446 to travel along the grooves 452 as the release knob is rotated until the release mechanism reaches a release configuration in which the drive screw 406 extends proximally outward in an axial direction from a proximal end (as shown in fig. 16-19) of the release knob 404. At the same time, this reduced level of engagement may be small enough to allow the drive screw 406 to automatically slide distally (e.g., by manually actuating the release knob 404), back into the release knob 404 to release the tension of the delivery device during implantation (e.g., after retracting the capsule and upon loosening the distal portion of the delivery device, as further described below, and as shown in fig. 20).

In some embodiments, the materials of the drive screw 406 and the release knob 404 may also be selected to provide a desired amount of engagement between the teeth 446 of the release knob 404 and the grooves 452 of the drive screw 406. For example, in some embodiments, the material of the drive screw 406 and at least the teeth 446 of the release knob 404 may be selected to allow the teeth 446 to slide along the groove 452 more easily. In some embodiments, the drive screw 406 and/or the release knob 404 may include a material that provides a relatively low friction contact surface for each of these components, such as a thermoplastic polymer. In some embodiments, the drive screw 406 and the release knob 404 may comprise different polymeric materials (e.g., different thermoplastic polymers) configured to facilitate sliding between surfaces of the drive screw 406 and the release knob 404. Possible polymeric materials may include polycarbonate, Acrylonitrile Butadiene Styrene (ABS), Polytetrafluoroethylene (PTFE), ABS impregnated with PTFE or other lubricious additives, nylon, and/or polyethylene. For example, in some embodiments, the drive screw 406 may comprise polycarbonate and the release knob may comprise ABS (or vice versa). Further, in some embodiments, the materials of the lead and teeth 446 of the drive screw 406 and/or release knob 404 and the groove 452 may be selected together to provide a desired level of engagement, as described above.

As shown in fig. 26-33, the drive screw 406 may include a collar (or collar portion) 480 extending proximally outward in an axial direction from the proximal end 476 of the body 456. The collar 480 may be an annular collar 480 that extends around the circumference of the drive screw 406. The outer diameter 482 of the collar 480 may be greater than the outer diameter 484 of the body 456 (FIG. 29). The collar 480 may also have an inner surface that defines an inner diameter 486 of the collar 480. The inner diameter 486 may be shaped to receive a portion of the cap 408 of the release mechanism 402 therein. For example, as shown in fig. 12, 13, 16-20, the cap 408 is coupled to the proximal end 476 of the body 456 of the drive screw 406 via a collar 480. In some embodiments, the collar 480 may include one or more apertures 481, each aperture 481 configured to receive a fastener therein to couple the cap 408 to the collar 480.

In some embodiments, as shown in fig. 13, the inner shaft 488 (e.g., inner shaft 152 of fig. 8) may be fixedly coupled (e.g., bonded, glued, press-fit, etc.) to the interior of the cap 408. For example, similar to that shown in fig. 8-10, the inner shaft 488 can be coupled to the cap 408 and then extend from the cap 408 through the delivery apparatus to a distal portion or end of the delivery apparatus (e.g., to the nose cone 144). Inner shaft 488 can be configured to receive a guidewire therein, and thus, in some embodiments, inner shaft 488 can be referred to as a guidewire lumen. Because inner shaft 488 is fixedly coupled to cap 408 and cap 408 is coupled to drive screw 406, linear translation of drive screw 406 in the axial direction results in linear translation of inner shaft 488 (e.g., they translate together). .

26-33, the drive screw 406 may further include an extension portion 490 extending distally axially outward from the distal end 474 of the body 456. The extension portion 490 can include a central bore (channel) 492 and one or more side holes 494 (as seen in the distal view of fig. 33) offset from the central bore 492. The central bore 492 may be configured to receive the inner shaft 488 therein. In some embodiments, the central bore 492 of the extension portion 490 may be continuous with and connected to a central bore portion 496 extending through the interior of the body 456, as shown in fig. 29. The central bore portion 496 may provide additional support to the inner shaft 488 and prevent kinking. However, in alternative embodiments, the drive screw 406 may not include a central bore portion 496.

As shown in fig. 15 and 17-19, each of the side apertures 494 can be configured to receive a respective rod 499 (of the two rods) therein (only one of the two pairs of apertures 494 and rod 499 is shown). The rod 499 may be coupled to an internal connection element 417 disposed in the interior of the housing 410 of the handle portion 400 (fig. 17). The drive screw 406 may be configured to travel linearly in an axial direction along the rod 499. In this manner, rod 499 may guide the linear travel of drive screw 406 within release knob 404.

In some embodiments, as shown in fig. 15 and 17-19, the proximal end of each rod 499 includes a stop (or end of travel) element 497, at least one dimension of the stop element 497 being wider than the diameter of the rod 499. Stop member 497 may also be wider than the maximum width of interior side holes 494 of drive screw 406. As shown in fig. 15 and 17-19, stop member 497 is disposed within open cavity 495 within body 456 of drive screw 406, open cavity 495 being disposed between proximal end 476 and distal end 474 of body 456 of drive screw 406. The distal end 474 of the body 456 may include an inner surface 493, the inner surface 493 being disposed perpendicular to the central longitudinal axis 420 (fig. 19). Inner surface 493 and stop element 497 together may form an end stop that prevents further advancement of drive screw 406 in the proximal axial direction. In this manner, the drive screw 406 is prevented from traveling too far beyond the release knob 404. In some embodiments, the linear travel of the release mechanism 402 may be stopped by the spool 212 (in or beyond the release configuration, as further described herein) from contact with the spool stop 216 at the distal portion of the delivery device (as shown in fig. 10) before the stop element 497 contacts the inner surface 493 (at the proximal end of the delivery device).

In some embodiments, as shown in fig. 33, extension portion 490 may have a major axis (e.g., a long dimension) with a major diameter 491 and a minor axis (e.g., a short dimension) with a minor diameter 489. The central bore 492 and the two side bores 494 may be spaced apart from each other along the main axis. The major diameter 491 can be smaller than an outer diameter 484 of the main body 456 (FIG. 33).

In some embodiments, as shown in fig. 33, the extension portion 490 may include a raised (e.g., protruding) region surrounding the central bore 492, forming a wider portion having a diameter 487 that is wider than the minor diameter 489.

Fig. 34 is a flow chart of a method 500 for operating the handle portion 400 to deliver a prosthetic medical device (e.g., a prosthetic heart valve) to a target implant site. As described above, the handle portion 400 including the release mechanism 402 may be part of a delivery device, such as the delivery device 100 of fig. 1-10. The method 500 may also provide a method for operating the release mechanism 402. The method 500 is described below with reference to fig. 9-20.

The method 500 begins at 502 and includes advancing a distal portion of a delivery device (e.g., the distal portion shown in fig. 9 and 10, which may be included in the delivery device 100 of fig. 1-8) toward a target implant site within a patient and adjusting a steering mechanism of the delivery device to flex and articulate the distal portion about a curved portion of the patient's vasculature. In some embodiments, an implantable medical device, such as a prosthetic heart valve (e.g., valve 10 of fig. 1), is disposed on the distal portion of the delivery apparatus in a radially compressed configuration. For example, the prosthetic heart valve may be contained within a capsule (e.g., capsule 146 shown in fig. 2-4) of the delivery device in its radially compressed configuration.

In some embodiments, the curved portion of the patient's vasculature may include the aortic arch. An example of a distal portion of a delivery device articulated about a simulated aortic arch is shown in fig. 11.

At 504, the method includes, after reaching the target implantation site, translating a capsule covering the radially compressed prosthetic heart valve (or alternative implantable medical device) away from the valve to expose the prosthetic heart valve. In some embodiments, the valve may self-expand to a radially expanded configuration after retracting the capsule away from the radially compressed valve. In some embodiments, translating the capsule may be in response to actuation of one or more buttons on a handle portion of the delivery device. For example, when a user actuates one or more buttons, as described above with reference to fig. 2 and 5-7, the motor may be activated, thereby moving the capsule axially to expose the valve.

After exposing the prosthetic heart valve or other medical device at 504, method 500 proceeds to 506. At 506, the method includes rotating a knob of the release mechanism (e.g., a release knob 404 of the release mechanism 402, as shown in fig. 12-25) to linearly translate a drive screw of the release mechanism (e.g., a drive screw 406 shown in fig. 12-20 and 26-33) in a proximal direction (e.g., a proximal direction, an axial direction, or proximal in the axial direction) and linearly translate an inner shaft fixedly coupled with the drive screw and one or more release members fixedly coupled to a distal end of the inner shaft to release the valve from the delivery device. For example, rotating the knob at 506 to linearly translate the drive screw may include rotating the knob 404 of the valve release mechanism from a starting locked orientation (as shown in fig. 12-15) and moving one or more teeth 446 of the knob 404 along a corresponding groove 452 of the drive screw 406 to linearly translate the drive screw 406 proximally in the axial direction until the drive screw 406 reaches a released orientation (as shown in fig. 16-19).

In some embodiments, as described herein with reference to fig. 26-33, the drive screw 406 may have a bifilar thread with a relatively long lead and pitch, and the knob 404 may have two teeth disposed opposite each other (e.g., about 180 degrees apart) around the circumference of the inner surface of the knob 404. The threads of the drive screw 406 may be defined by two helical grooves 452. Each tooth 446 is configured to mate with a respective groove 452 and translate (e.g., travel or slide) along the respective groove 452.

As shown in fig. 12-15, in the initial locked orientation or configuration, the drive screw 406 is retracted into the handle portion 400 and a majority of the body 456 of the drive screw 406 is disposed within the interior of the knob 404. For example, only the collar 480 of the drive screw 406 may extend axially outside of the knob 404 in the proximal direction in the initial, locked orientation.

Further, in the start locking orientation or configuration, each tooth 446 may be disposed within the first linear threaded portion 462 of the respective retaining element 458 (as shown in fig. 15). Each tooth 446 may be retained in the retaining element 458 by a projecting member 460 of the retaining element 458, the projecting member 460 projecting radially outwardly relative to the first linear threaded portion 462. The protruding member 460 prevents the knob 404 from rotating in response to the force generated by articulating (e.g., flexing) the distal portion of the delivery apparatus during step 502 of the method. In this way, accidental, premature release of the prosthetic heart valve (by inadvertent actuation of the knob 404) from the delivery device may be prevented.

Upon initial rotation of the knob 404 (e.g., by a user), each tooth 446 may overcome the protruding member 460 of the retaining element 458 by moving over the protruding member 460 and past the protruding member 460 to the second linear threaded portion 464 connected to the respective groove 452. As such, rotating the knob at 506 may first include initially rotating the knob to disengage (or release) the teeth 446 from the respective retaining element 458. The user may feel an initial resistance in overcoming the retaining element 458 due to the protruding member 460. However, after passing over the protruding member 460, the user may feel less resistance when turning the knob 404. As the knob 404 is turned, the teeth 446 may slide and travel along the path of the groove. As the teeth 446 ride along the grooves 452, the drive screw 406 translates proximally in an axial direction in response to rotation of the knob 404 while the axial orientation of the knob 404 remains fixed. For example, as each tooth 446 continues to travel along the respective groove 452, the proximal end 476 of the drive screw 406 extends further outside of the knob 404.

The method at 506 may further include linearly translating an inner shaft 488 fixedly coupled with drive screw 406 (fig. 13) and one or more release members fixedly coupled to a distal end of the inner shaft (e.g., release member 208 coupled to shaft 152 in fig. 9 and 10) to release the valve from the delivery device when drive screw 406 is translated in the proximal axial direction. For example, as explained above with reference to fig. 13, a proximal end of inner shaft 488 may be fixedly coupled to cap 408, cap 408 is coupled to a proximal end of drive screw 406 and a release member (e.g., release member 208) may be fixedly coupled to a distal portion of inner shaft 488. Thus, linear translation of drive screw 406 in the proximal axial direction results in linear translation of the release member in the proximal axial direction (e.g., these components move together). As described above, by moving the release member in a proximal axial direction away from the prosthetic heart valve (or other implantable medical device), the release member becomes separated from the prosthetic heart valve, thereby disconnecting and releasing the prosthetic heart valve from the delivery apparatus.

In the release position or configuration of the release mechanism 402 (and drive screw 406), the drive screw 406 extends proximally outward in an axial direction from a proximal end of the release knob 404 (as shown in fig. 16-19). Additionally, the teeth 446 of the release knob 404 may engage corresponding grooves 452 of the drive screw 406 at or near the distal end 474 of the body 456 of the drive screw 406 (as shown in fig. 18). In this released orientation, stop member 497 of rod 499 may be disposed proximate to inner surface 493 of distal end 474 of body 456 (as shown in fig. 18 and 19). Also, in the release configuration, the release member (e.g., release member 208) is disposed distal to the prosthetic heart valve. For example, as shown in fig. 10, in the release configuration, the spool 212 may be disposed proximate to or in contact with the spool stop 216, and thus, the release member 208 may be disposed closer to the spool stop 216 (as compared to the starting configuration shown in fig. 9).

Continuing to 508, the method can include, after releasing the prosthetic heart valve (or other implantable medical device), adjusting (e.g., actuating) the steering mechanism to loosen the distal portion of the delivery apparatus and passively retracting a drive screw partially into the knob in a distal axial direction to release tension during the loosening. As described above, when the distal portion of the delivery device is released, tension is created in the shaft of the delivery device during release of the valve from the delivery device. Thus, the tension needs to be reduced to enable complete and successful release of the distal portion of the delivery device and removal of the delivery device from the implantation site. By allowing the drive screw 406 to passively retract into the knob 404, thereby linearly translating the inner shaft 488 distally in an axial direction, when the distal portion of the delivery device is loosened (e.g., by actuating a steering mechanism, such as by rotation of the steering knob 418), the tension generated during the loosening may be reduced.

For example, with the release configuration of the release mechanism 402 (shown in fig. 16-19), when the distal portion of the delivery device is loosened (e.g., as the steering knob 418 is rotated), the drive screw may translate in the distal, axial direction, at least partially back inside the release knob 404, as shown in fig. 20. As used herein, "passively" refers to the free movement of the drive screw without manual actuation of the knob 404 (e.g., by a user turning the knob 404). During loosening of the distal portion of the delivery device, the tension at the distal portion of the delivery device may be great enough to overcome the resistance of the mating connection between the teeth 446 of the knob 404 and the grooves 452 of the drive screw 406, thereby allowing the drive screw 406 to be pulled back into the knob 404. When the drive screw 406 is pulled back into the knob 404, the tooth 446 moves along the groove 452, which passively rotates the knob 404. In this manner, the tension build-up at the distal portion of the delivery device may be automatically reduced (without user intervention) by the release mechanism 402, and the distal portion of the delivery device may be loosened and removed from the implantation site and the patient. This may simplify the implantation process while allowing the user to more easily remove the delivery device from the implantation site. As described above, the relatively short teeth 446 of the knob 404 and the long lead/pitch of the grooves 452 of the drive screw 406, along with the lower friction contact surfaces of the knob 404 and the drive screw 406, enable the drive screw 406 to be passively drawn back into the knob to relieve tension during loosening.

Accordingly, step 510 of the method includes, after loosening the distal portion of the delivery device at step 508, removing the delivery device from the implantation site (and the patient).

Other examples of the disclosed technology

In view of the foregoing embodiments of the disclosed subject matter, the present application discloses additional examples that are enumerated below. It should be noted that one feature of a single example or more features of a combined example, and optionally one or more features of one or more other examples, are also further examples of the disclosure that fall within this application.

Example 1. a delivery apparatus for an expandable, implantable medical device, the delivery apparatus comprising: a handle portion including a release mechanism configured to adjust a linear orientation of a component of a delivery device relative to a central longitudinal axis of the delivery device, the release mechanism comprising: a threaded drive screw including a helically threaded portion having a lead of at least one inch, wherein the helically threaded portion includes one or more grooves extending around the drive screw, the drive screw coupled to the component; and a rotatable knob surrounding and coaxial with the drive screw, the knob comprising one or more teeth disposed at a proximal end of the knob, each tooth of the one or more teeth configured to engage a corresponding groove of the one or more grooves of the drive screw, wherein each tooth of the one or more teeth extends from the proximal end to a distal end of the knob for only a portion of a total distance between the proximal end and the distal end, wherein the portion is less than 1/4 of the total distance.

Example 2. the delivery device of any example herein, particularly example 1, wherein the threaded drive screw comprises one or more retaining elements disposed at a proximal end of the drive screw, wherein the one or more grooves of the helically threaded portion are respectively connected to and extend around the drive screw from a respective retaining element of the one or more retaining elements to a distal end of the drive screw, and wherein each tooth of the one or more teeth is configured to engage the respective retaining element.

Example 3. the delivery device of any example herein, particularly example 2, wherein each tooth is configured to mate with and travel along a respective groove when the knob is rotated about the central longitudinal axis, wherein the drive screw is configured to move linearly in an axial direction relative to the knob as the knob is rotated and the tooth travels along the respective groove, wherein the knob is fixed from translating in the axial direction, wherein the axial direction is relative to the central longitudinal axis, wherein the knob comprises a collar extending distally from a distal end of the knob to an interior of the housing of the handle portion, the collar comprising one or more collar grooves extending around a circumference of the collar, each collar groove mating with a respective annular protrusion extending radially from an interior surface of the housing of the handle portion, and wherein the knob is fixed from translating in the axial direction and configured to pass through each groove and the corresponding groove and the collar The mating connection between the respective annular protrusions is rotatable relative to the housing of the handle portion about a central longitudinal axis.

Example 4. the delivery device of any of the examples herein, particularly any of examples 2-3, wherein the drive screw is linearly movable between an initial locked configuration in which each tooth is coupled to the respective retaining element and the helically threaded portion of the entire drive screw is disposed inside the knob and the handle portion, and a released configuration in which each tooth is mated with a distal portion of the respective recess, the distal portion is disposed closer to the distal end than the proximal end of the drive screw, and a majority of the helically threaded portion of the drive screw extends outward in the axial direction from the proximal end of the knob.

Example 5. the delivery apparatus of any example herein, particularly example 4, wherein each retaining element comprises a protruding member, a first linear threaded portion disposed on a first side of the protruding member, and a second linear threaded portion disposed on a second side of the protruding member, the second linear threaded portion connected to and continuous with a respective one of the one or more grooves of the drive screw.

Example 6. the delivery device of any example herein, particularly example 5, wherein in the initial locked configuration, each tooth is disposed within the first linear threaded portion of the respective retaining element.

Example 7. the delivery device of any example herein, particularly any example 2-6, further comprising a rod including a distal end fixedly coupled to the inner surface of the handle portion, and wherein the drive screw includes an extension extending axially outward from the distal end of the drive screw, the extension including an internal bore mounted around the rod and configured to slide linearly along the rod.

Example 8 the delivery device of any example herein, particularly example 7, wherein the proximal end of the rod comprises a stop element that is wider than a maximum width of the inner bore of the drive screw, and wherein the stop element is disposed within an open cavity inside the drive screw, the open cavity being disposed between the proximal end and the distal end of the drive screw.

Example 9 the delivery device of any example herein, particularly any example 7-8, wherein the extension portion further comprises a central bore centered along the central longitudinal axis, wherein the inner bore is radially offset from the central bore, and wherein the central bore is configured to receive the inner shaft of the delivery device therethrough.

Example 10 the delivery apparatus of any of the examples herein, particularly any of examples 1-9, wherein the component of the delivery apparatus whose release mechanism is configured to adjust its linear orientation comprises one or more release members removably coupled to the implantable medical device.

Example 11 the delivery device according to any of the examples herein, in particular example 10, further comprising an inner shaft comprising a proximal end fixedly coupled to a cap of the release mechanism, the cap coupled to a proximal end of the drive screw, wherein the inner shaft extends to a distal end of the delivery device, and wherein the one or more release members are fixedly coupled to a distal portion of the inner shaft.

Example 12. the delivery apparatus of any of the examples herein, particularly any of examples 1-11, wherein the thread formed by the one or more grooves of the helically threaded portion is a double-start thread formed by two grooves, and wherein the drive screw has two retaining elements, each groove extending from a different one of the two retaining elements, and wherein the knob includes two teeth, each tooth configured to mate with and slide along a different one of the two grooves.

Example 13. the delivery apparatus of any example herein, particularly example 12, wherein the two teeth are spaced apart from each other around a circumference of the proximal end of the knob.

Example 14. the delivery device of any of the examples herein, particularly any of examples 1-13, wherein the handle portion further comprises a steering mechanism comprising a steering knob configured to rotate relative to the housing of the handle portion at the distal portion of the delivery device and adjust the curvature of one or more shafts of the delivery device.

Example 15. the delivery device of any example herein, particularly example 14, wherein the steering knob is coupled to a distal end of a housing of the handle portion and the knob of the release mechanism is coupled to a proximal end of the housing of the handle portion.

Example 16 the delivery apparatus of any of the examples herein, particularly any of examples 1-15, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size of the prosthetic heart valve.

Example 17 the delivery device of any example herein, particularly any example 1-16, wherein the portion of the total distance between the proximal end and the distal end is less than 1/10 of the total distance.

Example 18a method of implanting an implantable medical device with a delivery apparatus, the method comprising: advancing a distal portion of a delivery apparatus to a target implantation site using a handle portion of the delivery apparatus, the implantable medical device being disposed in a radially compressed configuration on the distal portion; and upon reaching the target implantation site, uncovering the radially compressed implantable medical device and releasing the implantable medical device from the delivery apparatus, the releasing comprising: from a starting orientation, rotating a knob of a release mechanism of a handle portion of a delivery device and moving one or more teeth of the knob along one or more corresponding grooves of a drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches the release orientation; linearly translating an inner shaft fixedly coupled with the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release the implantable medical device from the delivery apparatus while and as a result of the drive screw translating in the proximal direction; and actuating a steering mechanism of the delivery device to loosen a distal portion of the delivery device and passively retracting a drive screw partially into a knob in a distal direction to automatically release tension during the loosening, the distal direction being opposite the proximal direction.

Example 19. the method of any example herein, particularly example 18, wherein rotating from the starting orientation includes initially rotating the knob to release each of the one or more teeth of the knob from a respective retaining element disposed at the proximal end of the drive screw and connected to a respective recess of the one or more recesses, and then continuing to rotate the knob to move the one or more teeth along the one or more recesses of the drive screw and linearly translate the drive screw in the proximal direction.

Example 20. the method of any example herein, particularly example 19, wherein in the starting position, each tooth is disposed within a first linear threaded portion of the respective retaining element and retained within the first linear threaded portion via a protruding member of the retaining element that protrudes radially outward relative to the first linear threaded portion, and wherein the retaining element comprises a second linear threaded portion disposed on an opposite side of the protruding member from the first linear threaded portion and directly connected to the respective groove.

Example 21. the method of any example herein, particularly any of examples 19 and 20, further comprising: during advancement of the distal portion to the target implantation site, a steering mechanism of the delivery device is adjusted to flex and articulate the distal portion of the delivery device about one or more curves of a body lumen of the patient, en route to the target implantation site, and during adjustment of the steering mechanism, one or more teeth of the knob are retained within corresponding retaining elements of the drive screw.

Example 22. the method of any of examples herein, particularly any of examples 18-21, wherein in the starting orientation, the release member is coupled to the implantable medical device.

Example 23. the method of any example herein, particularly any example of examples 18-22, wherein the one or more grooves of the drive screw comprise two helical grooves curved around an outer surface of the body of the drive screw from the proximal end of the body to the distal end of the body, wherein the drive screw has a double-start thread formed by the two grooves, and wherein the one or more teeth of the knob comprise two teeth spaced apart from each other around a circumference of the proximal end of the knob.

Example 24. the method of any example herein, particularly example 23, wherein the lead of the bifilar thread is at least one inch.

Example 25. the method of any example herein, particularly any example 18-24, wherein each of the one or more teeth of the knob is disposed at a proximal end of the knob and extends only a portion of an overall length of an inner surface of the knob, the length extending in an axial direction from the proximal end of the knob to a distal end of the knob, the axial direction being parallel to the central longitudinal axis, wherein the portion is less than 1/4 of the overall length, and wherein each of the one or more grooves curves around an outer surface of a body of the drive screw from the proximal end to the distal end of the body, the body being longer than the inner surface of the knob.

Example 26. the method of any example herein, particularly any example 18-25, wherein in the released orientation, each of the one or more teeth of the knob engages a respective one of one or more grooves of the drive screw disposed in the body at a distal portion of the body of the drive screw.

Example 27. the method of any example herein, particularly any example 18-26, wherein linearly translating the drive screw in the proximal direction includes sliding an internal bore disposed in an outwardly extending extension of the drive screw in the distal direction from a distal end of a body of the drive screw, the body including one or more helical grooves therein, along a rod coupled to an interior of the handle portion at a distal end of the rod, and wherein in the released orientation, a stop element disposed at a proximal end of the rod is disposed proximate an internal surface of the distal end of the body of the drive screw, the internal surface disposed perpendicular to the rod.

Example 28. the method of any example herein, particularly any example 18-27, wherein in the released orientation, the release member is disposed away from and separated from the implantable medical device.

Example 29. the method of any example herein, particularly any example 18-28, wherein linearly translating the drive screw until the drive screw reaches the release orientation includes translating the inner shaft and one or more release members until a spool coupled to a distal portion of the inner shaft reaches a spool stop of the delivery apparatus that is axially fixed relative to the inner shaft.

Example 30. the method of any example herein, particularly any example of examples 18-29, wherein passively retracting the drive screw comprises retracting the drive screw in a distal direction in response to a force that pulls the inner shaft in the distal direction during loosening, and returning to an interior of the knob and moving one or more teeth of the knob proximally along one or more respective grooves of the drive screw from a distal end of the one or more respective grooves.

Example 31. the method of any of the examples herein, particularly any of examples 18-30, further comprising: during advancement of the distal portion to the target implantation site, the steering mechanism of the delivery device is adjusted to flex and articulate the distal portion of the delivery device about one or more curves of the body lumen of the patient en route to the target implantation site.

Example 32. the method of any example herein, particularly example 31, wherein the steering mechanism includes a steering knob coupled to a distal end of a housing of the handle portion, and wherein the knob of the release mechanism is coupled to a proximal end of the housing of the handle portion.

Example 33. the method of any example herein, particularly any example 18-32, further comprising removing the delivery device from the implantation site after loosening the distal portion of the delivery device.

Example 34 the method of any of the examples herein, particularly any of examples 18-33, wherein exposing the radially compressed implantable medical device comprises retracting a capsule coupled to an outer shaft of the delivery apparatus away from the radially compressed implantable medical device in response to actuation of one or more buttons on the handle portion.

Example 35. the method of any example herein, particularly any example 18-34, wherein the implantable medical device is a self-expanding prosthetic heart valve.

Example 36 a method for operating a release mechanism of a handle portion of a delivery apparatus configured to deliver an implantable medical device to a target implant site, the method comprising: moving, from a starting locked orientation of the release mechanism, in response to rotation of the knob, one or more teeth of the knob of the release mechanism along one or more corresponding grooves of the drive screw of the release mechanism to linearly translate the drive screw in a proximal direction along an axis parallel to a central longitudinal axis of the delivery device until the drive screw reaches a released orientation, wherein in the starting locked orientation, a body of the drive screw including the one or more grooves is disposed inside the knob, and in the released orientation, a majority of the body extends outside the knob; linearly translating an inner shaft fixedly coupled with the drive screw and one or more release members fixedly coupled to a distal end portion of the inner shaft to release the implantable medical device mounted on the distal end portion of the delivery apparatus from the delivery apparatus when the drive screw is translated in the proximal direction; and in response to actuation of a steering mechanism of the delivery apparatus, loosening the distal end portion of the delivery apparatus, and during the loosening, passively retracting a portion of the drive screw in a distal direction into the knob to automatically release tension in the distal end portion of the delivery apparatus and enable the loosening.

Example 37. the method of any example herein, particularly example 36, wherein moving the one or more teeth of the knob from the starting locked orientation includes initially moving each of the one or more teeth over the protruding member of the respective retaining element to pass from a first linear threaded portion of the respective one or more retaining elements disposed at the proximal end of the body of the drive screw to a second linear threaded portion disposed on an opposite side of the protruding member from the first linear threaded portion and connected to the proximal end of the respective one or more grooves to release each of the one or more teeth from the respective retaining element, and then continuing to move each tooth along the respective groove and linearly translate the drive screw in the proximal direction in response to rotation of the knob.

Example 38. the method of any example herein, particularly any example 36-37, wherein in the initial locked orientation, the release member is coupled to the implantable medical device.

Example 39. the method of any example herein, particularly any example 36-38, wherein the one or more grooves of the drive screw comprises two helical grooves that curve around an outer surface of the body of the drive screw from the proximal end to the distal end of the body, wherein the drive screw has a double-start thread formed by the two grooves, and wherein the one or more teeth of the knob comprise two teeth that are spaced apart from each other around a circumference of the proximal end of the knob.

Example 40. the method of any example herein, particularly example 39, wherein the lead of the bifilar thread is at least one inch.

Example 41. the method of any example herein, particularly any example 36-40, wherein each of the one or more teeth of the knob is disposed at a proximal end of the knob and extends only a portion of an overall length of an inner surface of the knob, the length extending in an axial direction parallel to the central longitudinal axis from the proximal end of the knob to a distal end of the knob, wherein the portion is less than 1/4 of the overall length, and wherein each of the one or more grooves curves around an outer surface of a body of the drive screw from the proximal end of the body to the distal end of the body, the body being longer than the inner surface of the knob.

Example 42. the method of any example herein, particularly any example of examples 36-41, wherein in the released orientation, each of the one or more teeth of the knob engages a respective one of the one or more grooves of the drive screw at the distal portion of the body of the drive screw.

Example 43. the method of any example herein, particularly any example 36-42, wherein linearly translating the drive screw in the proximal direction includes slidingly disposing an internal bore in an outwardly extending extension portion of the drive screw in the distal direction from a distal end of a body of the drive screw along a rod coupled to an interior of the handle portion at a distal end of the rod, and wherein in the released orientation, a stop element disposed at a proximal end of the rod is disposed proximate to an internal surface of the distal end of the body of the drive screw, the internal surface disposed perpendicular to the rod.

Example 44. the method of any of the examples herein, particularly any of examples 36-43, wherein in the released orientation, the release member is disposed distal to and separate from the implantable medical device.

Example 45. the method of any example herein, particularly any example of examples 36-44, wherein linearly translating the drive screw until the drive screw reaches a release orientation includes translating the inner shaft and one or more release members until a spool coupled to a distal portion of the inner shaft reaches a spool stop of a delivery apparatus that is axially fixed relative to the inner shaft.

Example 46. the method of any example herein, particularly any example of examples 36-45, wherein passively retracting the drive screw comprises: in response to a force pulling the inner shaft in a distal direction during loosening, the drive screw is retracted in the distal direction, back into the interior of the knob and moves one or more teeth of the knob proximally along the one or more corresponding grooves of the drive screw from a distal end of the one or more corresponding grooves.

Example 47. the method of any example herein, particularly any example 36-46, wherein the steering mechanism includes a steering knob coupled to a distal end of the housing of the handle portion, and wherein the knob of the release mechanism is coupled to a proximal end of the housing of the handle portion.

Example 48. the method of any of examples herein, particularly any of examples 36-47, wherein the implantable medical device is a self-expanding prosthetic heart valve.

Example 49 a delivery apparatus for an expandable, implantable medical device, the delivery apparatus comprising: an inner shaft; one or more release members, each release member including a proximal end coupled to the outer surface of the distal end portion of the inner shaft and a distal end configured to releasably couple to an implantable medical device disposed about the distal end portion of the inner shaft, the distal end being distal of the location of proximal coupling to the inner shaft; and a handle portion, the handle portion comprising: a steering mechanism configured to adjust a curvature of and flex one or more shafts of a delivery apparatus at a distal portion of the delivery apparatus, the one or more shafts including the inner shaft; and a release mechanism configured to adjust a linear orientation of the inner shaft and the one or more release members relative to the housing of the handle portion along a central longitudinal axis of the delivery apparatus, the release mechanism comprising: a threaded drive screw coupled to the proximal end of the inner shaft and including a helically threaded portion disposed in a body of the drive screw, wherein one or more grooves forming the helically threaded portion extend from the proximal end to the distal end of the body of the drive screw; and a rotatable release knob coupled to the housing of the handle portion and surrounding and coaxial with the drive screw, the release knob including one or more teeth disposed at a proximal end of the knob and configured to engage with the one or more grooves of the drive screw, wherein the drive screw is adapted to move linearly along the central longitudinal axis relative to the release knob in response to rotation of the release knob and sliding of the one or more teeth along the one or more grooves, and wherein actuating the steering mechanism to release the one or more shafts of the delivery device allows the drive screw to move distally along the central longitudinal axis to release tension generated in the distal portion of the delivery device.

Example 50 the delivery device of any example herein, particularly example 49, wherein each of the one or more teeth of the release knob is less than full thread and bends less than 45 degrees around a circumference of a proximal end of the release knob.

Example 51 the delivery device of any example herein, particularly any example of examples 49-50, wherein the body of the drive screw further comprises one or more retaining elements disposed at a proximal end of the body, wherein each groove of the one or more grooves of the helically threaded portion is connected to a respective retaining element of the one or more retaining elements and curves around an outer surface of the body and extends from the retaining element to the distal end of the body.

Example 52. the delivery device of any example herein, particularly example 51, wherein the drive screw is linearly movable between an initial locked configuration in which each of the one or more teeth is coupled to a respective one of the one or more retaining elements and an entire helically threaded portion of the drive screw is disposed inside the release knob and the handle portion, and a released configuration in which each tooth mates with a distal portion of the respective recess, the distal portion disposed closer to the distal end than the proximal end of the body, and a majority of the helically threaded portion of the drive screw extends outside of the proximal end of the release knob in the axial direction.

Example 53 the delivery apparatus of any example herein, particularly example 52, wherein each retaining element comprises a protruding member, a first linear threaded portion disposed on a first side of the protruding member, and a second linear threaded portion disposed on a second side of the protruding member, the second linear threaded portion connected to and continuous with a respective groove of the one or more grooves of the drive screw.

Example 54 the delivery apparatus of any example herein, particularly example 53, wherein in the initial locked configuration, each tooth is disposed within the first linear threaded portion of the respective retention element.

Example 55 the delivery apparatus of any example herein, particularly any example 49-54, wherein the drive screw comprises an extension portion extending axially outward from the distal end of the body, the extension portion comprising a central bore centered along the central longitudinal axis and two side bores radially offset from the central bore on each side of the central bore.

Example 56 the delivery apparatus of any example herein, particularly example 55, wherein the inner shaft extends through the central bore.

Example 57 the delivery device of any example herein, particularly any example 55-56, further comprising two rods, each rod comprising a distal end fixedly coupled to an internal connection element of the handle portion and a proximal end comprising a stop element having a wider dimension than a diameter of the rod, wherein each rod extends through a respective one of the two side holes of the drive screw, and the stop element is disposed within an open cavity inside a body of the drive screw, the open cavity being disposed between the proximal end and the distal end of the body, and wherein the drive screw is configured to move linearly along the two rods.

Example 58 the delivery device of any example herein, particularly example 57, wherein the stop element is wider than a maximum width of the side hole of the drive screw, and wherein the open cavity is formed by an inner wall of the body and an inner surface disposed between the extension portion and the distal end of the body, the inner surface being disposed perpendicular to the central longitudinal axis.

Example 59. the delivery device of any example herein, particularly any example 49-58, wherein the thread formed by the one or more grooves of the helical threaded portion is a double-start thread formed by two grooves, and wherein the release knob comprises two teeth, each tooth configured to mate with and slide along a different one of the two grooves.

Example 60. the delivery device of any example herein, particularly example 59, wherein the two teeth are spaced apart from each other around a circumference of the proximal end of the release knob.

Example 61. the delivery apparatus of any example herein, particularly any example 59-60, wherein the threads of the drive screw have a lead of at least 1 inch and a pitch of at least 0.5 inch.

Example 62. the delivery apparatus of any example herein, particularly any example 59-60, wherein the threads of the drive screw have a lead in the range of 1-1.75 inches.

Example 63 the delivery device of any example herein, particularly any example 49-62, wherein the steering mechanism comprises a steering knob configured to rotate relative to a housing of the handle portion, and wherein the steering knob is coupled to a distal end of the housing of the handle portion and the release knob of the release mechanism is coupled to a proximal end of the housing of the handle portion.

Example 64 the delivery device of any example herein, particularly any example 49-63, wherein each of the one or more teeth of the release knob extends from the proximal end of the release knob toward the distal end of the release knob for only a portion of a total distance between the proximal end and the distal end, wherein the portion is less than 1/10 of the total distance.

Example 65 the delivery apparatus of any example herein, particularly any example of examples 49-64, further comprising an outer shaft comprising a proximal portion coupled to the handle portion and a distal portion, and further comprising a capsule coupled to the distal portion of the outer shaft, wherein the inner shaft is concentric with an interior of the outer shaft, and wherein the capsule is configured to receive the implantable medical device in a radially compressed state on the distal portion of the inner shaft.

Example 66 the delivery apparatus of any example herein, particularly any example 49-65, wherein the implantable medical device is a prosthetic heart valve configured to radially self-expand to a functional size of the prosthetic heart valve.

Example 67. the delivery device of any example herein, particularly any example 49-66, wherein the release knob includes a body disposed outside of the housing of the handle portion and a collar extending distally from a distal end of the body of the release knob to an interior of the housing of the handle portion, the collar including one or more collar recesses extending around a circumference of the collar, each collar recess mating with a respective annular protrusion extending radially from an interior surface of the housing of the handle portion, wherein the release knob is fixed against translation in an axial direction and is configured to rotate about a central longitudinal axis relative to the housing of the handle portion through a mating connection between each collar recess and the respective annular protrusion.

In view of the many possible embodiments to which the principles of the disclosed technology may be applied, it should be recognized that the illustrated embodiments are only preferred examples of the disclosed technology and should not be taken as limiting the scope of the claimed subject matter. Rather, the scope of the claimed subject matter is defined by the appended claims and equivalents thereof.