阅读说明：本技术 缝合线抓紧器械 (Suture grasping instrument ) 是由 S·K·帕里哈尔 J·L·哈里斯 F·E·谢尔顿四世 于 2018-06-19 设计创作，主要内容包括：本发明提供一种缝合线穿引器,该缝合线穿引器包括纵向延伸并且被构造成能够在扣接位置和释放位置之间被操纵的针以及第一缝合线凹口和第二缝合线凹口。第一缝合线凹口和第二缝合线凹口分别通过具有第一扣接底切和第二扣接底切的针延伸。第一缝合线凹口和第二缝合线凹口中的每一者被构造成能够在其中接纳缝合线并且当针朝向扣接方向被操纵时可释放地径向向内捕获缝合线。(The present invention provides a suture passer including a needle extending longitudinally and configured to be manipulated between a fastening position and a release position, and first and second suture recesses. The first and second suture recesses extend through a needle having first and second fastening undercuts, respectively. Each of the first and second suture recesses is configured to receive a suture therein and releasably capture the suture radially inward when the needle is manipulated in a fastening direction.)

1. A suture passer comprising:

(a) a needle extending longitudinally and configured to be manipulated between a fastening position and a release position;

(b) a first suture recess extending through the needle, wherein the first suture recess comprises a first catch undercut configured to receive a suture therein and releasably capture the suture radially inward when the needle is manipulated in a catch direction; and

(c) a second suture recess extending through the needle, wherein the second suture recess comprises a second catch undercut configured to receive the suture therein and releasably capture the suture radially inward when the needle is manipulated toward the catch direction.

2. The suture passer of claim 1, wherein the first suture recess further includes a first release cam surface configured to push the suture radially outward from the first clasp undercut when the needle is manipulated toward a release direction.

3. The suture passer of claim 2, wherein the needle further includes an outer radial surface, and the first release cam surface protrudes between the first catch undercut and the outer radial surface of the needle.

4. The suture passer of claim 3, wherein the first catch undercut defines a hooked surface within the first suture recess, wherein the first release cam surface extends continuously from the hooked surface to the outer radial surface of the needle.

5. The suture passer of claim 4, wherein the first release cam surface extends distally and radially outward from the hooked surface to the outer radial surface of the needle.

6. The suture passer of claim 1, further comprising a sheath having a longitudinal bore extending therethrough, wherein the longitudinal bore slidably receives the needle therein such that the needle is configured to move distally relative to the sheath within the longitudinal bore from a retracted position to an extended position.

7. The suture passer of claim 6, wherein the sheath includes a radial wall extending distally to a distal sheath end, wherein the radial wall includes a first aperture in communication with the longitudinal bore, and wherein the first aperture is configured to be longitudinally aligned with a first suture recess, thereby exposing the first suture recess for capturing the suture therethrough.

8. The suture passer of claim 7, wherein the distal sheath end is configured to pierce tissue.

9. The suture passer of claim 1, further comprising a driver operably connected to the needle and configured to selectively longitudinally translate the needle from a retracted position to the extended position.

10. The suture passer of claim 9, wherein the driver is further configured to selectively rotate the needle from the retracted position to the extended position.

11. The suture passer of claim 9, wherein the driver further comprises a resilient member configured to bias the needle toward the retracted position.

12. The suture passer of claim 1, wherein the second suture recess includes a second release cam surface configured to push the suture radially outward from the second buckle undercut when the needle is manipulated toward the release direction, wherein the needle extends along a longitudinal axis, and wherein first suture recess is positioned angularly opposite the second suture recess about the longitudinal axis.

13. The suture passer of claim 12, further comprising a third suture recess extending through the needle, wherein the third suture recess comprises a third fastening undercut configured to receive the suture therein and releasably capture the suture radially inward when the needle is manipulated toward the fastening direction.

14. The suture passer of claim 13, wherein the third suture recess includes a third release cam surface configured to push the suture radially outward from the third buckle undercut when the needle is manipulated toward the release direction, wherein the needle extends along a longitudinal axis, and wherein first, second, and third suture recesses are positioned longitudinally and angularly about the longitudinal axis in a helical arrangement.

15. The suture passer of claim 1, wherein the distal needle end has a domed end extending distally therefrom.

16. A suture passer comprising:

(a) a needle extending longitudinally along a longitudinal axis and configured to be manipulated between a fastened position and a released position;

(b) a first suture notch extending through the needle at a first location about the longitudinal axis, wherein the first suture notch comprises:

(i) a first fastening portion configured to receive a suture therein and releasably capture the suture when the needle is manipulated in a fastening direction, an

(ii) A first release portion configured to urge the suture from the first fastening portion when the needle is manipulated in the release direction; and

(c) a second suture notch extending through the needle at a second location about the longitudinal axis, wherein the second suture notch comprises:

(i) a second fastening portion configured to receive a suture therein and releasably capture the suture when the needle is manipulated in the fastening direction, an

(ii) A second release portion configured to urge the suture from the second fastening portion when the needle is manipulated in the release direction,

wherein the first position of the first suture notch is different from the second position of the second suture notch.

17. The suture passer of claim 16, wherein a first suture notch is positioned angularly opposite the second suture notch about the longitudinal axis.

18. The suture passer of claim 16, further comprising a third suture notch extending through the needle at a third location about the longitudinal axis, wherein the third suture notch comprises:

(i) a third fastening portion configured to receive a suture therein and releasably capture the suture when the needle is manipulated in the fastening direction, an

(ii) A third release portion configured to push the suture from the third fastening portion when the needle is manipulated toward the release direction, wherein the third position of the third suture recess is different from the first position of the first suture recess and the second position of the second suture recess, respectively.

19. The suture passer of claim 18, wherein first, second, and third suture notches are positioned longitudinally and angularly about the longitudinal axis in a helical arrangement in the first, second, and third positions.

20. A method of grasping a suture in a patient with a suture passer having a needle and a suture recess extending through the needle, wherein the suture recess comprises a catch portion and a release portion, wherein the catch portion is configured to receive the suture therein and releasably capture the suture, and wherein the release portion is configured to push the suture from the catch portion, the method comprising:

(a) manipulating the needle from a fastening position toward a release position;

(b) pushing the suture and the cam surface from the catch portion of the suture recess; and

(c) releasing the suture from the fastening portion of the suture recess.

Background

A surgical procedure may require a clinician to access a cavity or other desired surgical site within a patient. To perform such a surgical procedure, an incision may be made through the patient's tissue into the cavity. Some conventional surgical procedures may apply a knife, such as a surgical knife, to tissue for creating an incision, while some less invasive surgical procedures, such as laparoscopic and endoscopic surgical procedures, may access a cavity through a trocar assembly. The trocar assembly typically includes a trocar plug received within the trocar cannula. In use, a clinician guides the trocar plug and cannula through tissue to access a cavity at a desired surgical site. Once accessed, the clinician withdraws the trocar plug from the trocar cannula so that the trocar cannula can be used to introduce surgical instruments into the cavity for treatment.

Merely exemplary trocar assemblies, components thereof, and other various wound closure devices are provided in the following applications: U.S. patent No.7,981,092 entitled "vibrant Trocar" issued on 19.7.2011; U.S. patent No.8,226,553 entitled "Access Device with Insert" issued on 24.7.2012; U.S. Pat. No.8,251,900 entitled "Surgical Access Devices and Methods Providing seat movement Predefined Paths" issued at 28/8/2012; U.S. patent No.8,579,807 entitled "Absorbing Fluids in a scientific Access Device" issued 11, 12.2013; U.S. patent No.8,568,362 entitled "scientific Access devices with Sorbents" issued 2013, 10, 29; U.S. patent No.8,636,686 entitled "scientific Access Device," issued on 28.1.2014; U.S. Pat. No.8,690,831 entitled "Gas Jet Fluid Removal in aTrocar" issued 4, 8/2014; U.S. patent publication No.2008/0200950 entitled "Surgical Hook" issued on 21.8.2008; U.S. patent publication No.2015/0038793 entitled "Devices, Systems, and Methods for providing Surgical Access and cosmetic Closure of Surgical Access Openings" published on 5.2.2015; U.S. patent publication No.2015/0038994 entitled "Devices, Systems, and methods for Providing Surgical Access and facility Access of Surgical Access" published on 5.2.2015; and U.S. patent publication No.2015/0094741 entitled "wound chlorine Device including Mesh Barrier" published on 4/2/2015. The disclosures of each of the above-referenced U.S. patents and publications are hereby incorporated by reference.

Surgical instruments used with such trocars may have distal end effectors (e.g., endocutters, graspers, cutters, staplers, clip appliers, access devices, drug/gene therapy delivery devices, and energy delivery devices using ultrasonic vibrations, RF, laser, etc.) for engaging tissue through the trocar cannula in a variety of ways to achieve a diagnostic or therapeutic effect. Laparoscopic and endoscopic surgical instruments may include a shaft between an end effector and a handle portion manipulated by a clinician. Such a shaft may enable insertion to a desired depth and rotation about the longitudinal axis of the shaft, thereby facilitating positioning of the end effector within a cavity of a patient. Positioning the end effector may be further facilitated by including one or more articulation joints or features that enable the end effector to be selectively articulated or otherwise deflected relative to the longitudinal axis of the shaft.

While various surgical instruments have been made and used, including trocar assemblies and end effectors, as well as other associated components, it is believed that no one prior to the inventors has made or used the invention described in the appended claims.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the invention.

FIG. 1 illustrates a perspective view of an exemplary trocar assembly;

FIG. 2 illustrates a partially exploded side elevational view of the trocar assembly of FIG. 1 having a trocar housing, a trocar cannula and a plug;

FIG. 3A illustrates a cross-sectional side view of patient tissue with the trocar assembly of FIG. 1 being manipulated through the tissue by a clinician;

FIG. 3B illustrates a cross-sectional side view of the tissue and trocar assembly of FIG. 3A with the trocar assembly of FIG. 1 inserted through tissue and received within a cavity of a patient;

FIG. 3C illustrates a cross-sectional side view of the tissue and trocar assembly of FIG. 3A with the obturator withdrawn from the trocar cannula for passage through the trocar cannula and trocar housing into the cavity via the working channel;

FIG. 3D illustrates a cross-sectional side view of the tissue and trocar assembly of FIG. 3C with the trocar housing and trocar cannula removed from the patient's cavity and tissue;

FIG. 4A illustrates another cross-sectional side view of the tissue illustrated in FIGS. 3A-3D after removal of the trocar assembly of FIG. 1, wherein an opening through the tissue and a suture are introduced into a portion of the tissue for suturing the closed opening;

FIG. 4B shows a cross-sectional side view of the tissue of FIG. 4A with a suture introduced through another portion of the tissue and pulled through the tissue;

FIG. 4C shows a cross-sectional side view of the tissue of FIG. 4A with the suture tightened and tied to at least partially close the opening;

FIG. 4D shows a cross-sectional side view of the tissue of FIG. 4A with additional sutures to further close the opening;

FIG. 5 illustrates a perspective view of an exemplary suture passer having a first needle;

FIG. 6 shows a partially exploded side elevational view of the suture passer of FIG. 5;

FIG. 7A illustrates a cross-sectional side view of the suture passer of FIG. 5 taken along a centerline thereof with the needle in a retracted position and the biasing member in an expanded state;

FIG. 7B shows a cross-sectional side view of the suture passer similar to FIG. 7A, but with the needle in an extended position and the biasing member in a compressed state;

FIG. 8 shows a side elevational view of the first needle of the suture passer of FIG. 5;

FIG. 9 shows a side elevational view of the second needle;

FIG. 10 shows a side elevational view of a third needle of the suture passer of FIG. 5;

FIG. 11 shows a distal end view of the needle of FIG. 10;

FIG. 12 illustrates a cross-sectional side view of another exemplary suture passer having a rotary drive and a fourth needle;

FIG. 13A shows an enlarged cross-sectional side view of the needle of FIG. 12 taken along its centerline with the needle in a retracted position;

FIG. 13B shows an enlarged side view of the needle similar to FIG. 13A, but with the needle in an extended position;

FIG. 13C shows an enlarged cross-sectional side view of the needle similar to FIG. 13B, but with the needle in a third position;

FIG. 14A shows an enlarged side elevational view of the needle of FIG. 13A with the needle in a retracted position and grasping a suture in the suture recess;

FIG. 14B shows an enlarged side elevational view of the needle of FIG. 13B with the needle in an extended position and with suture secured within the suture recess;

FIG. 14C shows an enlarged side elevational view of the needle of FIG. 13C with the needle returned to a retracted position and with the suture released from within the suture recess;

FIG. 15A shows an enlarged side elevational view of the needle of FIG. 13A with the needle in a retracted position and grasping a suture in another suture recess;

FIG. 15B shows an enlarged side elevational view of the needle of FIG. 13B with the needle in an extended position and with suture released from within another suture recess; and is

FIG. 15C shows an enlarged side elevational view of the needle of FIG. 13C with the needle returned to a retracted position and with suture secured within another suture recess.

The figures are not intended to be limiting in any way and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily shown in the figures. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention and, together with the description, serve to explain the principles of the invention; it should be understood, however, that the invention is not limited to the precise arrangements shown.

Detailed Description

The following description of certain examples of the invention should not be used to limit the scope of the invention. Other examples, features, aspects, embodiments and advantages of the invention will become apparent to those skilled in the art from the following description, which is given by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not as restrictive.

I. Exemplary surgical Access device

Fig. 1-2 illustrate an exemplary surgical access device in the form of a first exemplary trocar assembly (10) that includes a trocar cannula (12) and a trocar plug (14). A trocar plug (14) is removably received within the trocar cannula (12) through a trocar housing (16) of the trocar cannula (12). With the trocar plug (14) positioned within the trocar cannula (12), as shown in fig. 1, the clinician inserts the trocar assembly (12) through the tissue (17) of the patient (see fig. 3A) into the desired surgical site to access a cavity (18) within the patient (see fig. 3A). By way of example only, the trocar assembly (10) may be inserted into the abdomen of a patient from between the patient's two ribs or elsewhere. The tip (20) of the trocar plug (14) protrudes distally from the trocar cannula (12) to penetrate the tissue (17) (see fig. 3A) to introduce the distal end portion of the trocar cannula (12) into the cavity (18) (see fig. 3B). The clinician withdraws the trocar plug (14) proximally from the trocar cannula (12) to place a cavity (18) within the patient (see fig. 3C) in communication with the surgical environment via the trocar cannula (12). The clinician may then introduce a fluid, such as a gas, through the trocar cannula (12) for inflating the cavity (18) (see fig. 3A) and/or introduce an end effector of the surgical instrument through the trocar cannula (12) for engaging tissue (17) for a diagnostic or therapeutic effect.

It should be understood that terms such as "proximal" and "distal" are used herein with reference to a clinician gripping the trocar housing (16). Thus, the tip (20) is distal with respect to the more proximal trocar housing (16). It will also be appreciated that, for convenience and clarity, spatial terms such as "vertical" and "horizontal" are used herein in connection with the illustrations. However, surgical instruments are used in many orientations and positions, and these terms are not intended to be limiting and absolute. Additionally, in some instances, component designations are interchangeable with and without the term "assembly" (e.g., trocar and trocar assemblies). The absence of a term is intended to mean a particular intention of the different components. Also, terms such as "instrument" and "device" may be used interchangeably.

A. Exemplary trocar Assembly with cannula and obturator

The trocar assembly (10) of fig. 1-2 includes a cannula (12) extending distally from a trocar housing (16). In this example, the trocar housing (16) has a generally cylindrical shape with a proximal removable cover (22) on top of a distal housing chamber (not shown). The cover (22) is selectively attachable and detachable from the housing chamber (not shown). The trocar housing (16) includes a housing sidewall (24) extending circumferentially through the trocar assembly (10) about a central longitudinal axis (26) and thus extending along the trocar cannula (12). The trocar housing (16) also includes a central lumen (27) extending from a proximal housing end opening (28) to a distal housing end opening (not shown). As shown, the cap (22) is selectively engageable with the housing sidewall (24) via a distal engagement member (not shown), and further includes a proximal engagement member, such as a slot (not shown), configured to be removably connected to a pair of tabs (32), respectively, that extend distally from a portion of the plug (14). However, it should be understood that alternative structures and devices may also be removably connected to the cover (22) during use.

The cannula (12) extends distally from the trocar housing (16) and is also generally defined by a cannula sidewall (33), the cannula sidewall (33) extending circumferentially about the central longitudinal axis (26). The cannula sidewall (33) extends distally to a beveled end (34) such that the cannula sidewall (33) and the beveled end (34) are configured to be insertable through tissue (17) (see fig. 3A) as discussed in more detail below for the cavity (18) (see fig. 3A). To this end, the cannula (12) typically has a smaller diameter than the trocar housing (16), which is configured to remain outside of the tissue (17) (see fig. 3C). In addition, the cannula (12) defines an internal lumen (35) having a proximal cannula end opening (not shown) and a distal cannula end opening (36) extending through the beveled end (34). In this example, a distal housing end opening (not shown) of the trocar housing (16) is fluidly connected to a proximal cannula end opening (not shown) such that the central lumen (27) of the trocar housing (16) and the inner lumen (35) of the cannula (12) define a working channel (38). Thus, a working channel (38) extends from the proximal housing end opening (28) to the distal cannula end opening (36) and is configured to receive one or more surgical instruments therethrough to access the chamber (18).

In addition, an insufflation port (40) is operatively connected to the trocar housing (16) to control the flow of insufflation fluid, such as carbon dioxide, through a portion of the cannula (12) and into the cavity (18). More specifically, the insufflation port (40) includes a stopcock (42) and a stopcock valve stem (44) that can work together to allow and/or prevent insufflation fluid from entering the tube (not shown) through the trocar housing (16) and into the trocar cannula (12). The trocar housing (16) and cannula (12) have proximal and distal seal assemblies (not shown) positioned within the central lumen (27) and the inner lumen (35) of the working channel (38), respectively. In this example, the proximal seal assembly is an instrument seal (not shown) and the distal seal assembly (not shown) is a zero closure seal, such as a duckbill seal (not shown). An instrument seal (not shown) is retained with the cap (22) and is configured to fluidly seal against a surgical instrument extending through the working channel (38). In contrast, a duckbill seal (not shown) is configured to form a seal in the working channel (38) when no instrument is disposed therethrough, thereby preventing leakage of insufflation fluid during use. Of course, it should be understood that alternative sealing assemblies may be positioned within the working channel (38) for preventing such leakage of such insufflation fluid.

As briefly discussed above, the obturator (14) is used in conjunction with the cannula (12) to insert the trocar assembly (10) into the patient. The plug (14) of the present example includes a handle head (46) having a cylindrical shaft (48) extending distally therefrom to a tip (20), which is generally configured to penetrate tissue (17) (see fig. 3A), as described in more detail below. The handle head (46) is configured to be grasped by a clinician during use and includes a selectively movable tab (32) extending distally to removably connect with the trocar housing (16) for selective securement. The shaft (48) is received through the working channel (38) such that the tip (20) extends distally from the beveled end (34). Of course, the plug (14) may be selectively removed from the cannula (12) and trocar housing (16) to release the working channel (38) for use. While the present example of trocar assembly 10 has a plug (14), it should be understood that in some examples, cannula (12) may be inserted without plug (14), or may alternatively be configured to assist insertion without the use of plug (14).

B. Exemplary methods of accessing a body lumen of a patient

Fig. 3A-3D illustrate the entry of a cavity (18) through tissue (17) using the trocar assembly (10) described above. The tissue (17) of the present example more particularly has a shallow layer relatively outward and a deep layer relatively inward. The superficial layer generally includes an outer layer of skin (52) and an inner layer of fat (54); while the deeper layer comprises a layer of fascia (56) that is fibrous and flexible, having a higher tensile strength than the shallow layer. With the obturator (14) received within the cannula (12) and connected to the trocar housing (16), the clinician manipulates the trocar assembly (10) to urge the tip (20) of the obturator (14) against the skin (52) and inwardly toward the cavity (18) while rotating the trocar assembly (10) back and forth, as shown in fig. 3A. Arrows (49) and (50) indicate the inward and rotatable movement, respectively. As shown in fig. 3B, continued inward pushing of the trocar assembly (10) further guides the tip (20) and beveled end (34) of the cannula (12) through the layers of fat (54) and fascia (56) and into the cavity (18). The clinician then disconnects the plug (14) from the trocar housing (16) and withdraws the obturator plug (14) from the cannula (12) to establish access to the cavity (18) from outside the tissue (17) via the working channel (38), as shown in fig. 3C, for diagnostic or therapeutic effects with another surgical instrument (not shown). Once the diagnostic or therapeutic effect is complete, the clinician withdraws the cannula (12) and trocar housing (16) outwardly for removal from the tissue (17), as shown in fig. 3D.

As shown in fig. 4A, removal of the cannula (12) from the tissue (17) typically results in a tissue opening (58), which may also be referred to as a tissue aperture or tissue wound, that the clinician closes to promote tissue healing (17). While some tissue openings may be sufficiently closed as the tissues (17) come together, other openings, such as tissue openings (58), are closed with sutures (60). In one example shown in fig. 4A-4D, the suture (60) is removably coupled with the needle (62) for guiding the suture (62) through the tissue (17) as the clinician manipulates the needle (62). More specifically, as shown in fig. 4B, the clinician guides the needle (62) down through the fascia (56) on one side of the tissue opening (58) and then up through the fascia (56) on the other side of the tissue opening (58) as the needle (62) clears tissue (17). Notably, the clinician advances the needle (62) through the fascia (56) a desired distance from the tissue opening (58) to provide a location relatively close to the tissue opening (58); but also at a sufficient distance to provide sufficient fascia (56) for anchoring the suture (60) therein. As shown in fig. 4C, sutures (60) from respective sides of the tissue opening (58) are brought together and pulled to similarly draw the tissues (17) together and at least partially close the tissue opening (58). The clinician then ties the suture (60) to secure the tissues (17) together and substantially closes the tissue opening (58) with the formed suture (64), as shown in fig. 4D. Additional sutures (64) may be placed along the tissue (17) to further close the tissue opening (58) and promote healing of the tissue (17).

While the above-described suturing technique shown in fig. 4A-4D is one exemplary procedure for closing a tissue opening (58) with suture (60) after use of the trocar assembly (10) (see fig. 1), other exemplary procedures and devices may alternatively be used to close such tissue openings. By way of example, U.S. patent publication No.15/088,723 entitled "Surgical access devices with Integrated Wound Closure needles," filed 4/1/2016, which is incorporated herein by reference in its entirety, describes an alternative trocar assembly and suturing technique. To this end, alternative trocar assemblies and suturing techniques may be used in any combination as desired by the clinician.

Exemplary suture passers

In some cases, grasping the suture (60) to manipulate the suture (60) to close the tissue opening (58) can be difficult, particularly with limited access within the tissue opening (58) and relatively small sizes of the suture (60). Therefore, it is advantageous to use a suture passer as shown in fig. 5, such as suture passer (100), which is configured to capture and release a suture (60) to facilitate closing of the tissue opening (58) after removal of the trocar assembly (10). For example, after the suture (60) has been inserted through the fascia (56) on one side of the tissue opening (58), the suture passer (100) captures the suture (60) to facilitate upward redirection and selective repositioning of the suture (60) toward the fascia (56) on the other side of the tissue opening (58), as discussed in more detail below.

The following description provides various examples of a suture passer (100) having various needles (132, 232, 332, 432) in fig. 5-15C configured to capture and securely hold a suture (60) within a patient. Each needle (132, 232, 332, 432) is configured to capture and release a suture (60). In addition, the suture passer (100) also includes various actuation mechanisms for covering and uncovering the needle (132, 232, 332, 432) in use. The suture passer (100) and needle (132, 232, 332, 432) described below may be used with any of the various trocar assemblies (10) described above and any of the various procedures described in the various references described herein. While the following examples are provided in the context of the trocar assembly (10) described above, the teachings below may be readily incorporated into any other surgical access device and instrument. Other suitable ways in which the suture passers (100) described below may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

A. Exemplary suture passer with biasing member

As shown in fig. 5-6, an exemplary suture passer (100) includes an outer sheath (110) and an inner needle (130). The inner needle (130) is substantially enclosed within the outer sheath (110) such that a longitudinal length of the inner needle (130) extends within the bore (112) of the outer sheath (110). The inner needle (130) includes a first needle tip (132), a longitudinal axis (140), and a driver (142). The longitudinal shaft (140) has a longitudinal length that separates a needle (132) positioned on a distal end of the longitudinal shaft (140) from a driver (142) positioned on an opposite proximal end of the longitudinal shaft (140). The needle tip (132) of the inner needle (130) includes a proximal recess (133) and a distal recess (136). The outer sheath (110) includes a bore (112), a housing (114), a radial wall (115) having a distal opening (116) (see fig. 7A), and a proximal opening (118) (see fig. 7A). The bore (112) has a longitudinal length separating a distal opening (116) (see fig. 7A) from the housing (114) and a proximal opening (118) (see fig. 7A). The openings (116, 118) (see fig. 7A) communicate with the bore (112) and are axially aligned with the longitudinal length of the bore (112). The inner needle (130) is inserted into the outer sheath (110) by directing the needle tip (132) toward the proximal opening (118) and slidably advancing the inner needle (130) through the bore (112). As further shown in fig. 6, the inner needle (130) further includes a latch (144) configured to engage the biasing member (120) of the outer sheath (110) and be received within the housing (114).

As merely an illustrative example, the inner needle (130) is formed of hardened stainless steel, while the molded features on the inner needle (130), particularly the driver (142) and latch (144), are formed of plastic, such as polycarbonate. In the present example, the recesses (133, 136) are machined into the inner needle (130), but alternatively may be moulded with the inner needle (130), for example by injection moulding. In another example, the inner needle (130) may be in the form of a plastic material and metal coated for additional surface hardness similar to stainless steel and bending strength similar to aluminum. The inner needle (130) has a diameter smaller than the diameter of the outer sheath (110) such that the inner needle (130) is slidably received within the outer sheath (110). For example, the inner needle (130) has a diameter in the range of about 2 millimeters to about 3 millimeters and the outer sheath (110) has a correspondingly larger diameter with sufficient clearance configured to receive a usp (u.s.p.) designation class 2 suture (60). The outer sheath (110) is formed from a seamless stainless steel pipe. As will be apparent to those of ordinary skill in the art, the outer sheath (110) and the inner needle (130) may be formed from a variety of other suitable materials that will maintain durability when inserted into the patient's cavity.

Fig. 7A-7B illustrate the transition of the suture passer (100) from the retracted position to the extended position, respectively, when the clinician exerts a distal force on the driver (142). Specifically, fig. 7A shows the suture passer (100) in an initial retracted position in which the inner needle (130) is slidably inserted into the bore (112) of the outer sheath (110). Due to the natural expansion of the biasing member (120) captured in compression, the suture passer (100) is generally maintained in the retracted position unless the clinician maneuvers toward the extended position. When in the retracted position, a needle tip (132) of the inner needle (130) is substantially received at the distal opening (116) within the bore (112). Further, the proximal recess (133) and the distal recess (136) are fully covered within the bore (112) by the outer sheath (110) in the retracted position, and the driver (142) is fully extended from the proximal opening (118). When the suture passer (100) is in the retracted position, the likelihood of the notch (133, 136) contacting a tissue opening (58) or other portion of the patient's body in use is reduced because the notch (133, 136) remains covered within the outer sheath (110). A biasing member (120) within the housing (114) is similarly in a fully extended state and securely engages a latch (144) of the inner needle (130). The latch (144) is configured to movably secure the inner needle (130) to the outer sheath (110) such that the inner needle (130) has limited translational movement that does not slide distally out of the outer sheath (110) from the distal opening (116).

In this example, the clinician grasps the suture passer (100) at the housing (114) to selectively position the needle (132) within the cavity of the patient adjacent the suture (60) (see fig. 4A). When the clinician applies a predetermined force to the driver (142) to overcome the resilient bias created by the biasing member (120), the inner needle (130) slidably translates in the distal direction within the bore (112), as shown in fig. 7B. The biasing member (120) is compressed to a compressed state when the suture passer (100) is in the extended position and the driver (142) is held distally toward the housing (114). As merely an illustrative example, the biasing member (120) has a spring rate in the range of about 2.3 lbs/inch to about 2.8 lbs/inch, but other spring rates configured to provide relatively smooth translation of the inner needle (130) within the outer sheath (110) may similarly be used. When the suture passer (100) is in the extended position, a needle tip (132) of the inner needle (130) extends distally through the distal opening (116) such that the recesses (133, 136) extend beyond the bore (112) of the outer sheath (110). In this case, the inner needle (130) and notches (133, 136) are configured to be physically manipulated within the tissue opening (58) to capture and subsequently release the suture (60) (see fig. 4A).

Fig. 8 shows the needle tip (132) of the inner needle (130) exposed outside the bore (112) of the outer sheath (110) when the suture passer (100) is in the extended position. In addition to the notches (133, 136), the needle (132) includes a dome-shaped pointer (131) that is geometrically configured to provide a smooth, low-force impact to the inner needle (130) when the inner needle (130) is inserted into the tissue opening (58) (see fig. 4A). With the unsharpened point, the dome-shaped pointer (131) is configured to inhibit accidental damage to tissue when inserting the suture passer (100) into a patient.

A proximal notch (133) extends through the inner needle (130) and includes a proximal catch undercut (134) and a proximal release cam surface (135). The proximal catch undercut (134) has a hooked surface (139) and is configured to receive and retain a suture (60) (see fig. 4A) radially inward toward the inner needle (130) when the inner needle (130) is selectively manipulated to capture the suture (60) (see fig. 4A). A proximal release cam surface (135) is positioned between the proximal catch undercut (134) and an outer radial surface (141) of the inner needle (130). A proximal release cam surface (135) extends proximally and radially outward from a hooked surface (139) of the proximal catch undercut (134) until flush with an outer radial surface (141) of the inner needle (130). The proximal release cam surface (135) is configured to push the suture (60) (see fig. 4A) radially outward from the proximal buckle undercut (134) to remove the suture (60) (see fig. 4A) from the proximal recess (133) when the inner needle (130) is selectively manipulated to release the suture (60) (see fig. 4A).

Similarly, a distal notch (136) extends through the inner needle (130) and includes a distal catch undercut (137) and a distal release cam surface (138). The distal clasp undercut (137) has a hooked surface (139') and is configured to receive and retain a suture (60) radially inward toward the inner needle (130) (see fig. 4A) when the inner needle (130) is selectively manipulated in a clasp direction to capture the suture (60) (see fig. 4A). A distal release cam surface (138) is positioned between a distal catch undercut (137) and an outer radial surface (141) of the inner needle (130). Distal release cam surface (138) extends distally and radially outward from hook surface (139') of distal catch undercut (137) until it is planar with outer radial surface (141) of inner needle (130). The distal release cam surface (138) is configured to push the suture (60) (see fig. 4A) radially outward from the distal snap-fit undercut (137) to remove the suture (60) (see fig. 4A) from the distal recess (135) when the inner needle (130) is selectively manipulated in a release direction to release the suture (60) (see fig. 4A).

As best shown in fig. 8, the notches (133, 136) are positioned at varying angular positions about the longitudinal axis (129) along the inner needle (130) such that the proximal notch (133) is angularly positioned on the inner needle (130) opposite the distal notch (136). While the notches (133, 136) are positioned relative to each other along the inner needle (130), the catch undercuts (134, 137) are oriented distally on the inner needle (130) relative to the release cam surfaces (135, 138), respectively. Although not shown, it is understood that proximal notch (133) and/or distal notch (136) may be oriented in an opposite position along inner needle (130) than shown in fig. 8. In this case, the catch undercuts (134, 137) are oriented proximally on the inner needle (130) relative to the release cam surfaces (135, 138), respectively.

Fig. 9 shows the second needle tip (232) of the inner needle (230). The needle (232) includes a first side notch (233, 236), a second side notch (243, 246), and a dome shaped pointer (231). Like the dome-shaped pointer (131) (see fig. 7A), the dome-shaped pointer (231) is geometrically configured to provide a smooth, low-force impact to the inner needle (230) when the inner needle (230) is inserted into the tissue opening (58) (see fig. 4A) to reduce the likelihood of tissue damage when inserting the suture passer (100) into a patient. The first side notch (233, 236) extends through the inner needle (230) and is positioned angularly opposite the second side notch (243, 246) about a longitudinal axis (229) of the inner needle (230). Like the notches (133, 136) (see fig. 7A) of the inner needle (130) (see fig. 7A), the first side notches (233, 236) and the second side notches (243, 246) include a catch undercut (234, 237, 244, 247) and a release cam surface (235, 238, 245, 248), respectively, that are configured to perform similarly as described above with respect to the catch undercut (134, 137) (see fig. 7A) and the release cam surface (135, 138) (see fig. 7A).

Fig. 10-11 show the third tip (332) of the inner needle (330). In this example, the needle (332) includes a plurality of notches (333) along the inner needle (330) and the dome shaped pointer (331). The plurality of notches (333) are positioned angularly about the longitudinal axis (329) of the inner needle (330) in a helical arrangement along the needle tip (332), as shown by reference numeral (334). Although six notches (333) are shown, it will be apparent to one of ordinary skill in the art that more or fewer notches (333) may be located along the needle (332).

B. Exemplary suture passer with rotating member

Fig. 12 shows another exemplary suture passer (400) including an outer sheath (410) and an inner needle (430) having a fourth needle tip (432). The inner needle (430) is substantially enclosed within the outer sheath (410) such that a longitudinal length of the inner needle (430) extends within the bore (412) of the outer sheath (410). The inner needle (430) includes a needle tip (432), a longitudinal shaft (440), and a driver (442). The longitudinal shaft (440) has a longitudinal length that separates a needle (432) positioned on a distal end of the longitudinal shaft (440) from a driver (442) positioned on an opposite proximal end of the longitudinal shaft (440). The driver (442) includes a knob (446), an externally threaded portion (443), and an engagement mechanism (445). The longitudinal shaft (440) further comprises an engagement coupling (441) configured to movably attach the inner needle (430) to the driver (442) by mating with a corresponding engagement mechanism (445) of the driver (442).

The needle tip (432) of the inner needle (430) has an upper recess (433) and a lower recess (436) that are positioned angularly opposite one another along the inner needle (430). The upper recess (433) includes an upper curved surface (434) and an upper hooked surface (435). The upper surfaces (434, 435) are positioned longitudinally opposite each other such that the upper surfaces (434, 435) face each other along the inner needle (430). The upper curved surface (434) is positioned distally relative to the upper hooked surface (435). As will be described in more detail below, the upper curved surface (434) is configured to direct the layer of suture (60) (see fig. 14A) toward the upper release cam surface (455) (see fig. 13A) such that the upper curved surface (434) pushes the suture (60) (see fig. 14A) out of the upper recess (433) and the upper hooked surface (435) is configured to capture and retain the suture (60) (see fig. 14A) against the upper snap undercut (454) (see fig. 13A). Similarly, the lower recess (436) includes a lower hook surface (437) and a lower curved surface (438). The lower surfaces (437, 438) are positioned longitudinally opposite each other such that the lower surfaces (437, 438) face each other along the inner needle (430). The lower hook surface (437) is positioned distally relative to the lower curved surface (438). As will be described further below, lower curved surface (438) is configured to urge suture thread (60) (see fig. 15A) toward lower release cam surface (458) (see fig. 13A) such that lower curved surface (438) pushes suture thread (60) (see fig. 15A) out of lower recess (436), while lower hooked surface (437) is configured to capture and retain suture thread (60) (see fig. 15A) against lower snap undercut (457) (see fig. 13A). Although not shown, it is understood that the needle (432) may include more or less notches (433, 436) along the inner needle (430) than shown.

The outer sheath (410) includes a bore (412), a housing (414), a radial wall (415), and a distal end (416). The distal end (416) is a corner having a cutting edge configured to pierce tissue (17). The bore (412) has a longitudinal length that separates the distal end (416) from a housing (414) positioned on its proximal end. The inner needle (430) is configured to be slidably translatable within the bore (412) of the outer sheath (410) by rotation of the driver (442). In other words, inner needle (430) and driver (442) are translatably coupled at engagement mechanism (445), but rotatably decoupled such that rotation and translation of driver (442) will only translate inner needle (430) without rotating inner needle (430). To this end, the housing (414) includes an internally threaded portion (420) and a slot (422) to allow the inner needle (430) to slidably translate within the bore (412).

The internally threaded portion (420) is configured to engage the externally threaded portion (443) of the driver (442) such that rotation of the driver (442) in a clockwise direction translates the inner needle (430) in a distal direction when viewed from the proximal end. Conversely, counter-rotation of the driver (442) in a counter-clockwise direction translates the inner needle (430) in a proximal direction when viewed from the proximal end. As further shown in fig. 12, the slot (422) extends inwardly into the housing (414) and has a longitudinal length parallel to the longitudinal axis (429) of the inner needle (430). The inner needle (430) also includes a latch (444) that projects laterally from the shaft (440) along a portion of the inner needle (430) that is housed within the housing (414). The latch (444) is configured to engage the slot (422) configured to inhibit rotation of the inner needle (430) and to constrain longitudinally translating inner needle (430) to a longitudinal length of the slot (422).

As best seen in fig. 13A-13C, the outer sheath (410) further includes an upper aperture (453) and a lower aperture (456) adjacent the end (416). The aperture (453, 456) is configured to provide communication between an outer radial surface (451) of the outer sheath (410) and the bore (412) such that the aperture (453, 456) exposes the needle (432) when the inner needle (430) is slidably inserted within the bore (412). Specifically, an upper aperture (453) is positioned along the outer sheath (410) to correspond with an upper recess (433) on the tip segment (432), and a lower aperture (456) is positioned along the outer sheath (410) to correspond with a lower recess (436). Apertures (453, 456) extend through the outer sheath (410) and include snap-in undercuts (454, 457) and release cam surfaces (455, 458). The capture undercut (454, 457) has a hooked surface (459) and is configured to receive and retain a suture (60) (see fig. 14A) radially outward toward the outer sheath (410) when the suture passer (400) is selectively manipulated in a fastening direction to capture the suture layer (60).

Release cam surfaces (455, 458) are positioned between catch undercuts (454, 457) and outer radial surface (451) of outer sheath (410), respectively. The release cam surface (455, 458) extends distally and radially outward from the hook surface (459) of the catch undercut (454, 457) until flush with the outer radial surface (451) of the outer sheath (410). The release cam surface (455, 458) is configured to urge suture (60) radially outward from the catch undercut (454, 457) to remove suture (60) from the recess (433, 436) upon selective manipulation of the suture passer (400) in a release direction to release suture (60).

The upper aperture (453) is positioned along the outer jacket (410) angularly opposite the lower aperture (456) about a longitudinal axis (429) of the outer jacket (410). The upper snap-in undercut (454) is oriented on the outer sheath (410) distally relative to the upper release camming surface (455) such that the upper snap-in undercut (454) is positioned proximal to the distal end (416) and the upper release camming surface (455) is positioned distal to the distal end (416). In contrast, lower snap-fit undercut (457) is oriented proximally on outer sheath (410) relative to lower release camming surface (458) such that lower snap-fit undercut (457) is positioned distal to distal end (416) and lower release camming surface (458) is positioned proximal to distal end (416).

In this example, the suture passer (400) transitions to a series of positions as the clinician rotates the driver (442). In particular, rotation of the driver (442) slidably advances the inner needle (430) into the bore (412) through threaded engagement of the inner threaded portion (420) and the outer threaded portion (443) until the latch (444) encounters a defined limit of the slot (422). As seen in fig. 13A, the driver (442) is rotated until the notches (433, 436) are substantially aligned with the apertures (453, 456). Fig. 13B shows the inner needle (430) in a distal translated position, wherein the recess (433, 436) is not substantially aligned with the aperture (453, 456), but is substantially covered by the bore (412) at a location proximal to the distal end (416). Finally, as shown in fig. 13C, driver (442) is counter-rotated until inner needle (430) is in a proximally translated position in which notches (433, 436) are not substantially aligned with apertures 453, 456), but are substantially covered by bore (412) at a location distal to distal end (416).

Fig. 14A-14C show a suture passer (400) capturing and releasing a suture (60) within an upper aperture (453) and an upper recess (433). Specifically, fig. 14A shows recesses (433, 436) substantially aligned with apertures (453, 456) (in the position previously shown in fig. 13A) and suture (60) releasably secured at upper snap undercut (454) of upper aperture (453). By rotating the driver (442), the inner needle (430) is translated distally within the bore (412) of the outer sheath (410), causing the recesses (433, 436) to be translated distally. In this case, as shown in fig. 14B, the upper hook surface (435) of the upper recess (433) securely captures the suture (60) against the upper fastening undercut (454), thereby preventing the suture (60) from slipping out of the grasp of the suture passer (400). The clinician may then selectively manipulate the suture passer (400) with the suture (60) securely grasped for placement into a preferred location. By rotating the driver (442) in a direction opposite to that shown in fig. 14B, the upper recess (433) translates proximally and simultaneously releases the suture (60) from the upper snap undercut (454), as shown in fig. 14C. As the upper notch (433) translates proximally, the upper curved surface (434) guides the suture (60) proximally along the upper release cam surface (455) until the suture (60) is free to release from the upper aperture (453).

As seen in fig. 15A-15C, suture passer (400) may similarly capture and release suture (60) within lower aperture (456) and lower recess (436). However, the same rotation of driver (442) may produce different interactions between suture passer (400) and suture (60) due to the opposite orientation of lower aperture (456), particularly lower catch undercut (457) and lower release cam surface (458). For example, lower curved surface (438) is used to release suture (60) from lower fastening undercut (457) by rotating driver (442) in a direction similar to that shown in fig. 14B, as shown in fig. 15B. Thus, the same rotation of the driver (442) produces an opposite interaction between the suture (60) and either the upper recess (433) or the lower recess (436). In this case, the lower curved surface (438) guides the suture (60) distally along the lower release cam surface (458) until the suture (60) is free to release from the lower aperture (456). Further, by rotating driver (442) in the direction shown in fig. 14C, wherein lower recess (436) translates in the proximal direction, upper hook surface (437) securely captures suture (60) against upper catch undercut (457), as shown in fig. 15C.

Exemplary combinations

The following examples relate to various non-exhaustive ways in which the teachings herein may be combined or applied. The following examples are not intended to limit the coverage of any claims that may be presented at any time in this patent application or in subsequent filing of this patent application. Disclaimer is not intended. The following examples are provided for illustrative purposes only. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following embodiments. Thus, none of the aspects or features mentioned below should be considered critical unless explicitly indicated otherwise, e.g., by the inventors or successors to the inventors at a later date. If any claim made in this patent application or in a subsequent filing document related to this patent application includes additional features beyond those mentioned below, then these additional features should not be assumed to be added for any reason related to patentability.