阅读说明：本技术 瓣膜小叶连接装置 (Valve leaflet attachment device ) 是由 迈克尔·艾伦·卡曾斯 加里·史蒂文·罗塞尔 普雷恩·阿加斯蒂安·佩鲁马尔 杰里米·道格拉斯·贾 于 2018-06-11 设计创作，主要内容包括：一种瓣膜小叶连接装置,包括：基座；以及从基座延伸的第一和第二从动件。第一臂从第一从动件沿着远离第二从动件和远离基座的方向延伸,以在第一从动件和第一臂之间限定锐角,用于在该范围内捕获第一瓣叶。第二臂从第二从动件沿着远离第一从动件和远离基座的方向延伸,以在第二从动件和第二臂之间限定锐角,用于在该范围内捕获第二瓣叶。所述第一和第二从动件可在以下位置之间弹性变形：(1)打开状态,其中：所述第一臂从所述第一从动件延伸的点；以及所述第二臂从所述第二从动件延伸的点,间隔大于15mm；以及(2)闭合状态,其中：所述第一臂从所述第一从动件延伸的点以及所述第二臂从所述第二从动件延伸的点,间隔小于5mm。变形装置使从动件朝向闭合状态变形。定位器从基座延伸,位于第一从动件和第二从动件之间,并且紧固件可释放地固定到定位器上,所述紧固件包括第一和第二紧固件爪。所述第一和第二紧固件夹爪：远离所述基座延伸；并且可在以下位置之间移动：(1)张开状态,其中在第一和第二紧固件夹爪之间可以接收瓣叶；以及(2)固定状态,其中第一和第二紧固件夹爪将瓣叶固定在它们之间。在使用中：(1)第一和第二从动件可以是在第一和第二瓣叶之间轴向通过瓣膜,并且通过瓣膜小叶的打开和闭合而弹性变形；(2)第一臂可以在第一臂和第一从动件之间捕获第一瓣叶,并且第二臂可以在第二臂和第二从动件之间捕获第二瓣叶,其中,第一和第二从动件设置在第一和第二瓣叶之间；(3)变形装置可以使第一和第二从动件朝向闭合状态变形,从而使第一和第二瓣叶朝向彼此移动；(4)当紧固件夹爪处于张开状态时,紧固件可将第一和第二瓣叶接收在紧固件夹爪之间；以及(5)将紧固件夹爪朝向固定状态移动,从而将所述第一瓣叶和第二瓣叶彼此固定。可替代的,所述臂和紧固件夹爪可以朝向基座延伸。(A valve leaflet attachment device comprising: a base; and first and second followers extending from the base. The first arm extends from the first follower in a direction away from the second follower and away from the base to define an acute angle between the first follower and the first arm for capturing the first leaflet within the range. A second arm extends from the second follower in a direction away from the first follower and away from the base to define an acute angle between the second follower and the second arm for capturing the second leaflet within the range. The first and second followers are elastically deformable between: (1) an open state, wherein: a point at which the first arm extends from the first follower; and the points at which the second arm extends from the second follower are spaced more than 15mm apart; and (2) a closed state, wherein: the point at which the first arm extends from the first follower and the point at which the second arm extends from the second follower are separated by less than 5 mm. The deforming means deforms the follower toward the closed state. A retainer extends from the base between the first follower and the second follower, and a fastener is releasably secured to the retainer, the fastener including first and second fastener jaws. The first and second fastener jaws: extending away from the base; and is movable between: (1) an open state in which a leaflet can be received between the first and second fastener jaws; and (2) a secured state in which the first and second fastener jaws secure the leaflets therebetween. In use: (1) the first and second followers may be axially through the valve between the first and second leaflets and elastically deformed by opening and closing of the valve leaflets; (2) the first arm may capture a first leaflet between the first arm and the first follower, and the second arm may capture a second leaflet between the second arm and the second follower, wherein the first and second followers are disposed between the first and second leaflets; (3) the deforming means may deform the first and second followers towards the closed state, thereby moving the first and second leaflets towards each other; (4) the fastener can receive the first and second leaflets between the fastener jaws when the fastener jaws are in the open state; and (5) moving the fastener jaw toward a secured state, thereby securing the first and second leaflets to one another. Alternatively, the arms and fastener jaws may extend toward the base.)

1. A valve leaflet attachment device comprising:

a base defining a longitudinal axis;

first and second followers extending from the base;

a first arm on the first follower, the first arm extending from the first follower in a direction away from the second follower and away from the base to define an acute angle between the first follower and the first arm for capturing the first leaflet between the first follower and the first arm;

a second arm on the second follower, the second arm extending from the second follower in a direction away from the first follower and away from the base to define an acute angle between the second follower and the second arm for capturing a second leaflet between the second arm and the second follower;

the first and second followers are elastically deformable between:

an open state, wherein:

a first virtual line intersecting a point at which the first arm extends from the first follower; and extends parallel to the longitudinal axis of the base; and

a second virtual line intersecting a point at which the second arm extends from the second follower; and extends parallel to the longitudinal axis of the base,

the first and second virtual lines are spaced more than 15mm apart; and

a closed state, wherein the first and second virtual lines are spaced less than 5mm apart; and is

Deformation means for deforming the follower towards the closed condition such that, in use:

(1) the first and second followers may be between the first and second valve leaflets, passing axially through the valve; and elastically deformed by the opening and closing of the valve leaflets;

(2) the first arm is configured to capture a first leaflet between the first arm and a first follower, and the second arm is configured to capture a second leaflet between the second arm and a second follower, wherein the first and second followers are disposed between the first and second leaflets; and is

(3) The deforming means is capable of deforming the first and second followers toward the closed state, thereby moving the first and second leaflets toward each other.

2. The valve leaflet attachment device of claim 1, further comprising:

a locator extending from the base between the first and second followers;

a fastener releasably secured to the locator and including first and second fastener jaws that:

extending away from the base; and is

Is movable between: (1) an open state in which the leaflets can be received between the first and second fastener jaws; and (2) a secured state in which the first and second fastener jaws secure the leaflets therebetween,

such that, in use, when the first and second leaflets move towards each other:

(1) the fastener receives the first and second leaflets between the fastener jaws when the fastener jaws are in an open state; and

(2) moving the fastener jaw toward the secured state secures the first and second leaflets to one another.

3. A valve leaflet attachment device comprising:

a base defining a longitudinal axis;

first and second followers extending from the base;

a first arm on the first follower, the first arm extending from the first follower in a direction away from the second follower and toward the base to define an acute angle between the first follower and the first arm for capturing the first leaflet therebetween;

a second arm on the second follower, the second arm extending from the second follower in a direction away from the first follower and toward the base to define an acute angle between the second follower and the second arm for capturing a second leaflet therebetween;

the first and second followers are elastically deformed between:

an open state, wherein:

a first imaginary line intersecting the point at which the first arm extends from the first follower and extending parallel to the longitudinal axis of the base; and

a second imaginary line intersecting a point at which the second arm extends from the second follower and extending parallel to the longitudinal axis of the base,

the first and second virtual lines are spaced apart by more than 15 mm; and

a closed state, wherein the first and second virtual lines are spaced less than 5mm apart; and

deformation means for deforming the follower towards the closed condition, whereby, in use:

(1) the first and second followers passing axially through the valve between the first and second valve leaflets and being elastically deformed as the valve leaflets open and close;

(2) the first arm captures a first leaflet between the first arm and a first follower, and the second arm captures a second leaflet between the second arm and a second follower, wherein the first and second followers are disposed between the first and second leaflets; and

(3) the deforming means deforms the first and second followers toward the closed state, thereby moving the first and second leaflets toward each other.

4. The valve leaflet attachment device of claim 3, further comprising:

a locator extending from the base between the first and second followers,

a fastener releasably secured to the retainer, the fastener including first and second fastener jaws that:

extending toward the base; and is

Move between: (1) an open state in which the leaflets are received between the first and second fastener jaws; and (2) a secured state in which the first and second fastener jaws secure the leaflets therebetween,

such that, in use, when the first and second leaflets move towards each other:

(1) the fastener receives the first and second leaflets between the fastener jaws when the fastener jaws are in an open state; and is

(2) Moving the fastener jaw toward the secured state secures the first and second leaflets to one another.

5. The valve leaflet attachment device of claim 2 or 4, wherein:

the first arm extends at least 3mm away from the first follower; and is

The second arm extends at least 3mm away from the second follower.

6. The valve leaflet attachment device of claim 5, further comprising a catheter, and the base is disposed at or defined by a first axial end of the catheter.

7. The valve leaflet attachment device of claim 6, wherein the first and second followers and positioner: (1) extending from an axially extending lumen defined by the catheter at the base; (2) axially movable along an axially extending lumen defined by the catheter.

8. The valve leaflet attachment device of claim 7, further comprising a control device at or near the second axial end of the catheter for:

controlling the relative axial movement of the conduit on the one hand and the first and second followers on the other hand;

controlling relative axial movement of the catheter and the positioner to change the position of the fastener relative to the first and second arms; and

movement of the fastener jaws from an open condition to a secured condition is controlled.

9. The valve leaflet attachment device of claim 8, wherein the first arm is hingedly connected to a first follower and the second arm is hingedly connected to a second follower.

10. The valve leaflet attachment device of claim 9, wherein the first and second arms are movable along the first and second followers, respectively.

11. The valve leaflet attachment device of claim 10, wherein the first arm is movable along the first follower independent of movement of the second arm along the second follower.

12. The valve leaflet attachment device of claim 11, further comprising a clamping device for moving the first and second arms from: (1) a receiving state in which the free ends of the first and second arms are spaced from the first and second followers, respectively, for receiving a leaflet therebetween; and (2) a clamped state in which the first and second arms are biased toward the first and second followers, respectively, to clamp the leaflets therebetween.

13. The valve leaflet attachment device of claim 12, wherein the clamping device is independently operable or operable by a deformation device.

14. The valve leaflet attachment device of claim 13, wherein each of the first and second followers defines: (1) a divergent region proximate the base along which the first and second followers diverge from one another as they extend from the base; and (2) a converging region along which the first and second followers converge toward each other as they extend from the end of the diverging region remote from the base.

15. The valve leaflet attachment device of claim 14, wherein: (1) diverging regions on the first and second followers extending from the base to the first and second arms, respectively; and (2) converging regions on the first and second followers extending from the first and second arms to free ends of the first and second followers, respectively.

16. The valve leaflet attachment device of claim 2, wherein:

each of the first and second followers includes: (1) a first portion extending from the base and terminating before the point at which the first and second arms extend from the first and second followers, respectively; and (2) a second portion extending from the end of the first portion to the free ends of the first and second followers, respectively; and is

For each of the first and second followers, the first portion is releasably secured to the second portion.

17. The valve leaflet attachment device of claim 16, wherein the fastener is aligned with the first and second arms such that (1) the first and second arms are received between the fastener jaws when the fastener jaws are in the open state; and (2) subsequent movement of the fastener jaws toward the secured state causes the first and second arms to grip the first and second followers, respectively.

18. The valve leaflet attachment device of claim 2, wherein the first and second arms are resilient and axially retractable within and extendable from the first and second followers, respectively.

19. The valve leaflet attachment device of claim 4, wherein each of the first and second followers is bifurcated toward a free end thereof for receiving a fastener between the bifurcations.

20. The valve leaflet attachment device of claim 5, further comprising a stabilizing claw disposed in hinged connection between the first and second followers, an end of the stabilizing claw distal from the hinge being connected to the first and second followers, and the hinged connection of the stabilizing claw being:

between the first and second followers; and is

Is spaced apart from the base and is provided with a plurality of grooves,

such that deformation of the first and second followers between the open and closed states causes the hinged connection of the stabilizing claw to move relative to the base.

21. The valve leaflet attachment device of claim 20, further comprising a resistance device for resisting movement of the hinged connection of the stabilizing fingers relative to the base, thereby changing the stiffness of the first and second followers.

Background

The present invention relates to a valve leaflet attachment device. More particularly, the present invention relates to a device for attaching mitral valve leaflets, the device comprising:

(1) a pair of resilient followers that can be disposed between the valve leaflets and are sufficiently flexible and resilient (i.e., deformable) to follow the valve leaflets as they open and close;

(2) an arm extending from each follower to capture a valve leaflet between the arm and the respective follower;

(3) deforming means for moving the follower and the arm toward each other; and

(4) a locator that positions the fastener over the free ends of the leaflets to secure the leaflets together.

Various connection devices are known. For example:

US5015246 "endoscopic stapling device and method" describes staples arranged between forceps jaws which "open" the staples (i.e. open/spread the staple legs). Retraction of the staple within the tube "closes" the staple (i.e., moves the staple legs toward one another). Optionally, the forceps may also be used to: clamping body tissue; and helps close the staples. It will be appreciated that closure of the forceps causes the staples to close.

US5403326 "method for performing gastric wrapping of the esophagus for treating esophageal reflux" describes a device comprising an internal grasper which grabs body tissue and pulls the grasped tissue between the stapler jaws. Closure of the stapler jaws secures the staples to the grasped body tissue. It will be appreciated that closure of the stapler results in closure of the grasper.

US20100137887 "devices, systems, and methods for tissue repair" describe a device for resiliently biasing a grasper toward an open state, and jaws for abutting and closing the grasper. The grasper is axially movable relative to the jaws to retract a body part grasped by the grasper for suturing. It will be appreciated that closure of the jaws results in closure of the grasper.

US20100022823 "method and device for tissue grasping and assessment" describes a fixation device comprising an inner arm (with barbs) biased toward an outer jaw, and a means for closing the outer jaw to capture a valve leaflet between the outer jaw and the inner arm. It will be appreciated that closure of the outer jaw causes closure of the inner arm.

US3874388 "shunt defect closure system" describes a pair of radially expandable, axially spaced umbrella elements for covering a septal defect which can be locked in place sandwiching the ventricular septum therebetween. Similar clamping devices are described in US5425738 "endoscopic anastomotic ring insertion device and method of use" and US "locking member for PFO closure" and US2014/0088640 "delivery/retrieval system for septum occlusion".

One disadvantage of the known connection devices is that: the valve leaflets cannot be captured by the attachment device while allowing continuous opening and closing of the valve. In prior attachment devices, the capture of the valve leaflets/body tissue often resulted in "closure" and pinching of the valve leaflets/body parts.

Another disadvantage of the known connection devices is: large leaflet capture devices are required to capture the valve leaflets as the valve opens and closes. In addition, complex controls are required to position the leaflet capturing device in the correct position to achieve satisfactory capture of the valve leaflets. In existing connection devices, a large capture device results in a large connection device and a transport and access system.

It is an object of the present invention to provide a valve leaflet attachment device comprising: a follower for following the valve leaflets as they open and close; capturing the valve leaflets while continuing to allow the valve leaflets to open and close; and only after the valve leaflets are properly captured in this manner is the valve leaflets moved to the closed state to facilitate their attachment to one another.

Disclosure of Invention

According to a preferred embodiment of the present invention, there is provided a valve leaflet attachment device, including:

a base defining a longitudinal axis;

first and second followers extending from the base;

a first arm on the first follower, the first arm extending from the first follower in a direction away from the second follower and away from the base to define an acute angle between the first follower and the first arm for capturing the first leaflet between the first follower and the first arm;

a second arm on the second follower, the second arm extending from the second follower in a direction away from the first follower and away from the base to define an acute angle between the second follower and the second arm for capturing a second leaflet between the second follower and the second arm;

the first and second followers are elastically deformable between:

an open state, wherein:

a first virtual line intersecting a point at which the first arm extends from the first follower; and extends parallel to the longitudinal axis of the base; and

a second virtual line intersecting a point at which the second arm extends from the second follower; and extends parallel to the longitudinal axis of the base,

the interval between the first virtual line and the second virtual line is larger than 15 mm; and

a closed state, wherein the first and second virtual lines are spaced less than 5mm apart; and

a deforming means for deforming the driven member to the closed state;

so that in use:

(1) the first and second followers may pass axially through the valve between the first and second valve leaflets; and elastically deformed by the opening and closing of the valve leaflets;

(2) the first arm can capture a first leaflet between the first arm and a first follower, and the second arm can capture a second leaflet between the second arm and a second follower, the first and second followers disposed between the first and second leaflets; and is

(3) The deforming means may deform the first and second followers toward the closed state to move the first and second leaflets toward each other.

Generally, the valve leaflet attachment device according to the preferred embodiment of the present invention further comprises:

a positioner extending from the base between the first and second followers; and

a fastener releasably secured to the locator, the fastener comprising first and second fastening jaws, wherein the fastener jaw:

extending outwardly from the base; and is

Movable between: (1) an open state in which the leaflets can be received between the first and second fastener jaws; and (2) a secured state in which the first and second fastener jaws secure the leaflets therebetween,

thus, in use, when the first and second leaflets move towards each other:

(1) the fastener can receive the first and second leaflets between the fastener jaws when the fastener jaws are in an open state; and is

(2) Moving the fastener jaw toward the secured state secures the first and second leaflets to one another.

According to an alternative embodiment of the present invention, there is provided a valve leaflet attachment device comprising:

a base defining a longitudinal axis;

first and second followers extending from the base;

a first arm on the first follower, the first arm extending from the first follower in a direction away from the second follower and away from the base to define an acute angle between the first follower and the first arm for capturing the first leaflet between the first follower and the first arm;

a second arm on the second follower, the second arm extending from the second follower in a direction away from the first arm and away from the base to define an acute angle between the second follower and the second arm for capturing a second leaflet between the second follower and the second arm;

the first and second followers are elastically deformable between:

an open state, wherein:

a first imaginary line intersecting the point at which the first arm extends from the first follower and extending parallel to the longitudinal axis of the base;

a second imaginary line intersecting the point at which the second arm extends from the second follower and extending parallel to the longitudinal axis of the base,

the first and second virtual lines are spaced apart by more than 15 mm; and

a closed state in which the first and second virtual lines are spaced less than 5mm apart; and

a deforming means for deforming the driven member toward the closed state,

thus, in use:

(1) the first and second followers are capable of: axially through the valve between the first and second valve leaflets; and elastically deforms as the valve leaflets open and close;

(2) the first arm may capture a first leaflet between the first arm and a first follower, and the second arm may capture a second leaflet between the second arm and a second follower, the first and second followers being disposed between the first and second leaflets; and is

(3) The deforming means deforms the first and second followers toward the closed state, thereby moving the first and second leaflets toward each other.

Generally, a valve leaflet attachment device according to an alternative embodiment of the present invention further comprises:

a retainer extending from the base between the first and second followers; and

a fastener releasably secured to the locator, wherein the fastener includes first and second fastener jaws that:

extending from the base; and is

Is movable between: (1) an open state in which the leaflets can be received between the first and second fastener jaws; and (2) a secured state in which the first and second fastener jaws secure the leaflets therebetween,

whereby, in use, when the first and second leaflets move towards each other,

(1) the fastener is capable of receiving the first and second leaflets between the fastener jaws when the fastener jaws are in an open state; and is

(2) The fastener jaws are moved toward a secured state, thereby securing the first and second leaflets to one another.

According to the first and second embodiments of the invention:

in general: (1) the first arm extends at least 3mm from the first follower; and (2) the second arm extends at least 3mm from the second follower.

Typically, the first and second followers and the positioner: (1) extending from an axially extending lumen defined by the catheter and the base; and (2) axially movable along an axially extending lumen defined by the catheter.

Typically, the valve leaflet attachment device further comprises a control device located at or near the second axial end of the catheter for:

controlling the relative axial movement of the conduit on the one hand and the first and second followers on the other hand;

controlling relative axial movement of the catheter and the positioner to change the position of the fastener relative to the first and second arms; and

movement of the fastener jaws from an open condition to a secured condition is controlled.

Optionally, the first arm is hingedly connected to the first follower and the second arm is hingedly connected to the second follower.

Further optionally, the first and second arms are movable along first and second followers, respectively. Further, the first arm is movable along the first follower independently of movement of the second arm along the second follower.

Still further optionally, the valve leaflet attachment device further comprises a clamping device for moving the first and second arms from: (1) a receiving state in which the free ends of the first and second arms are spaced from the first and second followers, respectively, for receiving a leaflet therebetween; and (2) a clamped state in which the first and second arms are biased towards the first and second followers, respectively, for clamping the leaflets therebetween.

The clamping means may be independently operable or may be deformable means.

Generally, each of the first and second followers defines: (1) a divergent region proximate the base along which the first and second followers diverge from one another as they extend from the base; and (2) a converging region along which the first and second followers converge toward each other as they extend from the end of the principle base of the diverging section.

Preferably: (1) diverging regions on the first and second followers extending from the base to the first and second arms, respectively; and (2) converging regions on the first and second followers extend from the first and second arms to free ends of the first and second followers, respectively.

Generally, with respect to the second embodiment of the present invention:

each of the first and second followers includes: (1) a first portion extending from the base and terminating before the point at which the first and second arms extend from the first and second followers, respectively; and (2) a second portion extending from an end of the first portion to free ends of the first and second followers, respectively; and

with respect to each of the first and second followers, the first portion is releasably secured to the second portion.

Optionally, the fastener is aligned with the first and second arms such that (1) the first and second arms are receivable between the fastener jaws when the fastener jaws are in an open condition; and (2) subsequent movement of the fastener jaws toward the secured state causes the first and second arms to grip the first and second followers, respectively.

The valve leaflet attachment device may further comprise a hingedly connected stabilizing claw disposed between the first and second followers, an end of the stabilizing claw distal from the hinge being connected to the first and second followers, and the hinged connection of the stabilizing claw is:

between the first and second followers; and is

Is spaced apart from the base and is provided with a plurality of grooves,

such that deformation of the first and second followers between the open and closed states causes the hinged connection of the stabilizing claw to move relative to the base.

Further, the valve leaflet attachment device may further comprise a resistance device for resisting movement of the hinged connection of the stabilizing fingers relative to the base, thereby changing the stiffness of the first and second followers.

Optionally, in accordance with an alternative embodiment of the valve leaflet attachment device of the present invention, the first and second arms are resilient and axially retractable within and extendable from the first and second followers, respectively.

Optionally, in accordance with the valve leaflet attachment device of a preferred embodiment of the present invention, each of the first and second followers is bifurcated toward a free end thereof to receive the fastener between the bifurcations.