Suturing device and method of using the same

Abstract

A suturing device includes a shuttle for holding sutures, a shuttle launcher, and a shuttle receiver. The shuttle launcher includes a shuttle holder for holding the shuttle and a shuttle release movable relative to the shuttle holder for releasing the shuttle from the shuttle holder. The shuttle holder advances through material at a first position while holding the shuttle until the shuttle engages the shuttle receiver. The shuttle release then releases the shuttle from the shuttle holder so that the shuttle launcher can be withdrawn from the material, allowing the shuttle to engage the shuttle receiver. The shuttle launcher penetrates the material and retrieves the shuttle at a second position opposite the shuttle receiver, retaining the shuttle while withdrawing it through the material at the second position. This sequence can be repeated to form a variety of multi-needle suturing patterns for vascular closure and a wide range of other applications.

Description

Technical Field

[0001] The present invention relates to a plurality of suturing devices, and in particular to a plurality of suturing devices for use in suturing applications, such as closing an incision, joining tissue or tissue regions, and / or changing the shape of tissue. Background Art

[0002] Suturing is a common technique used to close incisions in tissues and blood vessels, often performed during surgery and other medical procedures. Surgeons must use different suturing devices when various suturing patterns are required. Furthermore, depending on the suturing operation, especially within confined spaces such as blood vessels, suturing must be performed using a variety of different tools or manually, requiring a high level of skill from the surgeon. Summary of the Invention

[0003] The presently disclosed subject matter relates to a suturing device that performs precise suturing operations of various sutures in narrow surgical spaces, such as blood vessels.

[0004] Therefore, according to one embodiment of the present invention, a suturing device is provided for passing a suture from a first side of a material to a second side of the material at a first position, and returning from the second side of the material to the first side of the material at a second position, the suturing device comprising: (a) a shuttle for clamping a suture; (b) a shuttle launcher comprising: a shuttle holder for clamping the shuttle; and a shuttle releaser movable relative to the shuttle holder for releasing the shuttle from the shuttle holder; and (c) a shuttle receiver for receiving the shuttle on the second side of the material; the shuttle holder clamps the shuttle so that the shuttle The shuttle and the shuttle launcher together form a movable first penetration configuration for advancing the shuttle through the material in the first position until the shuttle engages the shuttle receiver; the shuttle releaser releases the shuttle from the shuttle holder so as to retract the shuttle launcher through the material in the first position so that the shuttle engages the shuttle receiver; the shuttle launcher presents a second penetration configuration for penetrating the material in the second position with a movable penetration tip when aligned in the second position relative to the shuttle receiver; the shuttle holder clamps the shuttle for retracting the shuttle through the material in the second position.

[0005] According to further features in embodiments of the present invention, the shuttle has a pointed distal end, the pointed distal end being adapted for the first penetrating configuration.

[0006] According to further features of embodiments of the present invention, the shuttle has a middle region and a proximal region, the middle region being adapted to connect the suture and the proximal region being adapted to engage with the shuttle support.

[0007] According to another feature in embodiments of the present invention, the intermediate region has at least one recess configured to accommodate a suture throughout the diameter of the shuttle.

[0008] According to further features in embodiments of the present invention, the intermediate region has a transverse opening for receiving a portion of a suture.

[0009] According to further features in embodiments of the present invention, the proximal region has an at least partially conical outer surface and an axial notch.

[0010] According to further features of an embodiment of the present invention, the proximal region has a bonding surface, which includes: a partially cylindrical surface with a first diameter D1; and at least one chamfered surface, so that the circumference of the bonding surface is less than πD1.

[0011] According to further features of embodiments of the present invention, the shuttle holder includes a tubular component having a diameter D2, wherein D2 is smaller than D1, and the tubular component is elastically deformable to fit on the engagement surface.

[0012] According to further features of embodiments of the present invention, the shuttle support comprises a tubular component.

[0013] According to further features in embodiments of the present invention, the tubular component is formed of a superelastic alloy.

[0014] According to another feature of an embodiment of the invention, the shuttle launcher bracket is formed with at least one resilient feature for engaging a proximal region of the shuttle.

[0015] According to another feature in an embodiment of the invention, the at least one resilient feature cooperates with a proximal region of the shuttle to provide a snap-fit ​​engagement of the bracket with the shuttle.

[0016] According to another feature in embodiments of the present invention, the release is movable relative to the bracket to disengage the at least one resilient feature from the shuttle.

[0017] According to further features of embodiments of the present invention, the suturing device further includes a bridge portion in mechanical communication with the shuttle launcher and the shuttle receiver to maintain alignment of the shuttle launcher with the shuttle receiver.

[0018] According to another feature in an embodiment of the invention, the shuttle receiver is telescopically mounted to the bridge portion.

[0019] According to another feature of an embodiment of the present invention, extension of the shuttle receiver from a retracted position to an extended position is achieved by displacement of an actuator assembly within a first range of motion, and further displacement of the actuator assembly beyond the first range of motion locks the shuttle receiver to prevent retraction.

[0020] According to further features of embodiments of the present invention, the suturing device further comprises a dilator, the dilator being deployed toward the distal end of the bridging portion, the dilator being interconnected with the bridging portion via a rotatable, i.e., deflectable, joint.

[0021] According to further features of an embodiment of the present invention, the suturing device further includes a shaft, a discharge port and a discharge tube, wherein the shaft extends from the bridging portion toward the proximal end, the discharge port opens in the bridging portion, and the discharge tube extends from the discharge port along the proximal end opening of the shaft to a discharge tube outlet.

[0022] According to further features of an embodiment of the present invention, the suturing device also includes a suture feeding space and a suture, the suture feeding space is connected to a suture release hole, the suture portion is located in the suture feeding space, and extends from the suture release hole to the shuttle, and the suture is connected to the shuttle; wherein the shuttle launcher and the shuttle receiver are aligned along a first axis, at least a portion of the bridging portion is offset from the first axis in a first direction, and the suture release hole is oriented to face away from the first axis and open toward the first direction.

[0023] According to further features of embodiments of the present invention, the shuttle launcher has a penetration portion having a penetration length for penetrating the material at the first position and the second position, the penetration length being greater than a length of the shuttle.

[0024] According to further features in embodiments of the present invention, the shuttle launcher is associated with a flexible shaft.

[0025] According to further features of embodiments of the present invention, the shuttle receiver includes a pocket for receiving the shuttle.

[0026] According to further features of embodiments of the present invention, the suturing device further includes an elastic retaining assembly associated with the pocket and configured to releasably retain the shuttle within the pocket.

[0027] According to a further feature of an embodiment of the present invention, the shuttle launcher is axially movable within a shaft, and the shaft further includes a shuttle lock, which is effective to clamp the shuttle lock within the shaft when the shuttle is withdrawn from the shaft after the suturing process is completed.

[0028] According to further features of embodiments of the present invention, the shuttle launcher further includes a preload member selectively movable to clamp the material between the preload member and the shuttle receiver before the shuttle launcher passes through the material.

[0029] According to further features in embodiments of the present invention, the preload member is concentrically deployed around the shuttle support.

[0030] According to one embodiment of the present invention, there is also provided a suturing method for suturing a material, characterized in that: the suturing method comprises: (a) providing: (i) a shuttle, clamping a suture; (ii) a shuttle launcher, configured to selectively clamp and release the shuttle, the shuttle launcher forming a first penetration configuration when clamping the shuttle, and the shuttle launcher presenting a second penetration configuration after releasing the shuttle; and (iii) a shuttle receiver, receiving the shuttle; (b) advancing the shuttle launcher in the first penetration configuration so that the shuttle penetrates the material at least at a first position and engages the shuttle receiver; (c) removing the shuttle from the shuttle launcher (c) releasing the shuttle launcher and removing the shuttle launcher from the material without the shuttle; (d) repositioning the shuttle launcher and the shuttle receiver so that the shuttle launcher and the shuttle are aligned with two opposite sides of the material in a second position; (e) advancing the shuttle launcher in a second penetration configuration so as to penetrate the material in a direction toward the shuttle at the second position; and (f) clamping the shuttle with the shuttle launcher and retracting the shuttle at a second position to penetrate the material, the shuttle pulling the suture together with the material so that the suture extends into the material at the first position and extends out of the material at the second position.

[0031] According to another feature of an embodiment of the present invention, the suturing method further comprises: repeating steps (b) and (c) at at least one additional suture entry position on the material, and repeating steps (d) and (e) at at least one additional suture exit position on the material, thereby forming a multi-needle pattern.

[0032] According to further features in embodiments of the present invention, the multi-needle pattern substantially surrounds an opening in the material.

[0033] According to further features in embodiments of the present invention, the multi-stitch pattern is a purse string stitch substantially surrounding an opening in the material.

[0034] According to further features in embodiments of the present invention, the multi-stitch pattern is a spiral suture.

[0035] Unless otherwise defined herein, all technical and / or scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein may be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In the event of a conflict, the patent specification, including definitions, shall prevail. In addition, these materials, methods, and examples are illustrative only and are not necessarily intended to be limiting. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Some embodiments of the present invention are described herein by way of example only with reference to the accompanying drawings. With specific detailed reference to the drawings, it is emphasized that the details shown are exemplary and are intended to provide an illustrative discussion of the embodiments of the present invention. In this regard, the description taken in conjunction with the drawings will make it apparent to those skilled in the art how the embodiments of the present invention may be practiced.

[0037] Attention is now directed to the drawings, wherein like reference numerals or characters designate corresponding or similar components.

[0038] In the attached figure:

[0039] Figure 1A is a perspective view of a suturing device according to an embodiment of the presently disclosed subject matter for use in a vessel sealing application.

[0040] Figure 1B yes Figure 1A An enlarged perspective view of the distal portion of the suturing device.

[0041] Figure 2A and 2B yes Figure 1A A perspective view of a suturing module of a suturing device.

[0042] Figure 2C yes Figure 1A Side view of the suturing module of the suturing device.

[0043] Figure 3A 、 3B and 3C is Figure 1A Side view of the needle launcher module of the device.

[0044] Figure 4A and 4B is used for Figure 1A A perspective view of an alternative suturing module for a suturing device.

[0045] Figure 5A 、 5B and 5C is used for Figure 1A A perspective view of another alternative suturing module for a suturing device.

[0046] Figure 6A 、 6B , 6C and 6D are used for Figure 1A A perspective view of another alternative suturing module for a suturing device.

[0047] Figure 7A and 7B is used for Figure 1A A perspective view of another alternative suturing module for a suturing device.

[0048] Figure 8A 、 8B and 8C is used for Figure 1A A perspective view of another alternative suturing module for a suturing device.

[0049] Figure 9A 、 9B and 9C is used for Figure 1A Schematic diagram of the shuttle of the suturing device, including the shuttle needle.

[0050] Figure 10 is used for Figure 1A Perspective view of a shuttle needle of a suturing device.

[0051] Figure 11 is used for Figure 1A A perspective view of another shuttle needle of a suturing device.

[0052] Figure 12A and 12B Suture is shown attached to an example shuttle needle, e.g. Figure 11 shuttle needle.

[0053] Figure 13 is used for Figure 1A A perspective view of another shuttle needle of a suturing device.

[0054] Figure 14A 、 14B , 14C and 14D are used for Figure 1A A perspective view of another shuttle needle of a suturing device.

[0055] Figure 15A and 15B is used for Figure 1A Cross-sectional view of the shuttle receiver and actuation mechanism of a suturing device.

[0056] Figure 15C and 15C is used for Figure 1A A cross-sectional view of the shuttle receiver and actuation and locking mechanism of a suturing device.

[0057] Figure 15E and 15F is used for Figure 1A Cross-sectional view of an alternative shuttle receiver and actuation and locking mechanism of a suturing device.

[0058] Figure 16A yes Figure 1A A cross-sectional view of a shuttle receiver of a suturing device including a pocket.

[0059] Figure 16B is a cross-sectional view of the shuttle receiver, including the Figure 16A pocket.

[0060] Figure 16C is used for Figure 1A A perspective view of another shuttle receiver of a suturing device having a snap assembly in a pocket.

[0061] Figure 16D Including shuttle needle entry and engagement Figure 16C A cutaway view of the receiver pocket.

[0062] Figure 16E is used for Figure 1A A perspective view of an alternative shuttle receiver for a suturing device, including the pocket.

[0063] Figure 17 yes Figure 1A A cross-sectional view of the shaft of a suturing device.

[0064] Figure 18 yes Figure 1A Cross-sectional view of the bridging portion, flexible joint and expander of the suturing device.

[0065] Figure 19A 、 19B , 19C, 19D and 19E are schematic diagrams of the rotation mechanism of the flexible joint relative to the bridging portion of the suturing device.

[0066] Figure 20 and 21 It passes through Figure 1A A cross-sectional view of the handle of a suturing device is shown in two operating states corresponding to a clamping state and a releasing state of the shuttle launcher, respectively.

[0067] Figure 22A is used for Figure 1A A perspective view of a suturing module of a suturing device including an integrated needle receiver;

[0068] Figure 22B is a perspective view of another suturing device.

[0069] Figures 23A-23G This is a diagram of the operation sequence for inserting the shuttle (needle).

[0070] 24 is a perspective view of a shuttle during a suture anchoring operation.

[0071] Figures 25A-25G This is the operation sequence diagram for retracting the shuttle (needle).

[0072] Figure 25H is in Figure 25G Partial cross-sectional view of the suturing device in position.

[0073] Figures 26A-26E is Figure 1A Schematic diagram of the suture pattern produced by the device.

[0074] Figure 26F It is used Figure 1A A diagram of a device producing a running stitch.

[0075] Figures 27A-27C is used for Figure 1A Schematic diagram of the preload component of the device.

[0076] Figure 28 It is a needle insertion diagram showing the action of the clamping assembly, including a detailed diagram.

[0077] Figures 29A-29E is a schematic diagram of a device having a preload member for performing a suturing operation.

[0078] Figures 30A-30C is a schematic diagram of the device with a preload member showing the movement of the suture during the suturing operation.

[0079] Figures 31A-31C is a schematic diagram of the device in which the preload member retrieves the needle from the needle receiver with the suture. DETAILED DESCRIPTION

[0080] Before explaining in detail at least one embodiment of the subject matter disclosed herein, it should be understood that the subject matter disclosed is not necessarily limited in its application to the details of construction and arrangement of components and / or methods set forth in the following description and / or illustrated in the accompanying drawings. The subject matter disclosed is capable of other embodiments or of being practiced or carried out in various ways.

[0081] Throughout this document, references are made to directions such as proximal, distal, inward, outward, inside, outside, up, down, upper, lower, right, left, front, and back. These directional references, including their extensions, are for typical orientations of the device 100 as shown in the accompanying drawings (Figures) and / or its components. They are exemplary only and are not limiting in any way as they are used for purposes of description and explanation.

[0082] Before referring to the accompanying drawings, by way of introduction, one aspect of the present invention relates to an apparatus and method for suturing one or more materials, such as biological tissue, within a body as part of a surgical procedure. Generally speaking, the apparatus and method utilize a shuttle, typically in the form of a pointed shuttle needle, to hold a suture, and a shuttle launcher to selectively grasp and release the shuttle. The shuttle launcher assumes a first penetrating configuration when the shuttle is grasped, and a second penetrating configuration after the shuttle is released. In the second penetrating configuration, the shuttle launcher is typically configured to present a pointed, needle-like end.

[0083] A shuttle launcher manipulates the shuttle from one side of the material (arbitrarily referred to as the proximal side) to perform both proximal-to-distal and distal-to-proximal suture transfers, thereby facilitating a wide range of stitch patterns. Specifically, proximal-to-distal transfers are performed by advancing the shuttle launcher in a first penetration configuration, i.e., while the shuttle is clamped, the shuttle penetrates the material at least at a first position, then releasing the shuttle from the shuttle launcher, preferably temporarily held by a shuttle receiver, and removing the shuttle launcher from the material without the shuttle. Suture transfers from the distal side to the proximal side are performed by advancing the shuttle launcher in a second penetration configuration, i.e., without the shuttle, to collect and retrieve the shuttle that has passed through the suture material. The shuttle launcher penetrates the material at a second position aligned with the shuttle temporarily held in the shuttle receiver, engages and clamps the shuttle, and withdraws the shuttle through the material at the second position. During each pass, the shuttle pulls the suture along with it, causing the suture to extend into the material at the first position and out of the material at the second position.

[0084] Therefore, the shuttle needle launcher acts as a "push-pull mechanism (PPM)" for the corresponding shuttle needle to perform the following operations:

[0085] 1. Push the needle through the suture medium.

[0086] 2. Pop the needle on the other side of the media or inside the media and exit without it.

[0087] 3. Reconfigure to provide a penetration end.

[0088] 4. Re-penetrate the media to re-engage / collect the needle and pull / withdraw with the needle.

[0089] This process of passing the shuttle through the material in alternating directions can be repeated at a series of locations and allows for the formation of a variety of running stitch suture configurations for a variety of different applications.

[0090] To facilitate the shuttle launcher to collect the shuttle for transfer from far to near, both the shuttle and the shuttle launcher are preferably displaced so as to align with the material in the second position. The shuttle can advantageously be held and displaced by a shuttle receiver when released from the shuttle launcher, the shuttle receiver being configured to receive and clamp the shuttle. The alignment of the shuttle launcher and the shuttle receiver on opposite sides of the material to be stitched can be maintained by a bridge portion that forms a mechanical interconnection between the shuttle launcher and the shuttle receiver. Various non-limiting examples of each of these structures will be described in detail below.

[0091] Aspects of the present invention have broad applications in both non-medical and medical fields. Within the medical field, aspects of the present invention are applicable to a wide range of procedures, whether external / superficial, superficial incision, minimally invasive, or conventional surgical. The present invention will be described primarily in the context of vascular closure devices, by way of a non-limiting set of exemplary preferred embodiments. It should be understood that the illustrated example is but one of numerous suitable applications of the technology, as will be apparent to one of ordinary skill in the art. Numerous other non-limiting examples of additional applications will be briefly referenced below.

[0092] Now as Figure 1A By way of non-limiting example, this diagram illustrates a suturing device 100 that is particularly suitable for vessel closure applications according to an embodiment of the disclosed subject matter. The suturing device 100 includes a suturing module 102 formed by an optional shaft 110 having a proximal end 110p and a distal end 110d, and a bridging portion 120 extending laterally from the distal end 110d of the shaft 110. The bridging portion 120 includes a proximal end 120p and a distal end 120d and is connected to the shaft 110 at the proximal end 120p. An optional handle 130 is located at the proximal end 110p of the shaft 110 for manipulating the components of the suturing module 102. A flexible connector 140 extends from the distal end 120d of the bridging portion 120, and an optional dilator 150 extends distally from the flexible connector 140. The bridging portion 120 is, for example, connected to the flexible connector 140 so as to be rotatable relative to the flexible connector 140.

[0093] Figure 1B 1 is an enlarged view of the distal portion of the suturing device 100, showing an exemplary embodiment of the suturing module 102 and the dilator 150, which is used to dilate a blood vessel during preparation for a suturing procedure and / or another procedure performed through a vascular access point. The dilator 150 has a distal tapered portion 150a that facilitates dilation of the blood vessel during insertion. An internal channel extends from a lateral entry point 150b to an aperture at the hollow tip 150c of the dilator. The internal channel is used for over-the-wire insertion of the device in a manner known in the art.

[0094] Figures 2A-2C Also referenced, there is shown a suturing device 100 ( Figure 1A ) of a suturing module 102. The suturing module or suturing mechanism 102 (these terms are used interchangeably herein) includes a shuttle launcher 200, a shuttle, typically implemented as a shuttle needle 210 (optionally engaged with a suture 212 or suture thread), and a shuttle (needle) receiver 220. The suturing module 102 can be designed and constructed to suture media that is much thicker than the length of the needle 210, as will become clear from the structure and function of the module described in detail below. The shaft 110 supports the shuttle or needle launcher 200, which can move proximally and distally within the shaft 110, and the movement can be controlled by a handle 130, as described in detail below. The shuttle or needle launcher 200 can be configured to push and pull the needle 210 through the suturing medium (e.g., tissue).

[0095] The shuttle 210 is exemplified herein primarily in embodiments in which the shuttle has a penetration point and functions as a needle. The shuttle 210 is therefore interchangeably referred to as a "shuttle needle 210," and in some cases simply as a "needle 210." Similarly, the "shuttle launcher 200" and the "shuttle receiver 220" may alternatively be referred to as a needle launcher 200 and a needle receiver 220, respectively. However, it should be noted that the present invention may also be implemented using a shuttle without a penetration point, such as will be described below with reference to a shuttle. Figure 9C All features discussed, and unless explicitly stated otherwise, described herein also apply to these embodiments.

[0096] Functionally, the needle launcher 200 includes a shuttle holder for holding the shuttle 210 and a shuttle releaser movable relative to the shuttle holder for releasing the shuttle 210 from the shuttle holder. Figures 3C-8C As further described, the shuttle holder is implemented as a tubular component (e.g., tube 204) that engages the external engagement surface of shuttle 210, while the release is implemented as a rod 206 that is movable within the tubular component. The term "tubular component" is used herein to refer to any hollow component having a generally tubular appearance, including but not limited to regular tubes of circular, polygonal, or other cross-sectional shapes, such tubes having a shaped internal profile for positive engagement, and tubes having cutout grooves or other features to increase flexibility or provide an engagement configuration. It should be noted that these embodiments of the shuttle holder and shuttle release are considered advantageous because they are particularly simple and compact, however, essentially any holder arrangement for retaining shuttle 210 externally, internally, or through any other suitable mechanical engagement (whether through friction, mechanical engagement, or any other form or retention) may be used. In each case, a corresponding release is provided. The release can be implemented as a component that interacts with the holder to counteract (release) the grip or grip, or can interact directly with the shuttle to eject the shuttle by overcoming the retaining force applied by the holder, or some combination thereof.

[0097] In the embodiment shown here, the shuttle launcher 200 includes a tube 204 and a rod 206, for example, arranged coaxially relative to each other and, for example, axially displaceable. The tube 204 can be moved proximally and distally within the shaft 110, such as by control of the handle 130, as described in detail below. The rod 206 can be moved proximally and distally within and outside the tube 204, such as by control of the handle 130, as described in detail below.

[0098] The tube 204 may advantageously have regions of different sizes, a first size near its distal end, and a region of increasing diameter (or, if not circular, increasing transverse dimension) away from its distal end. This facilitates clearance around the shuttle 210 when withdrawn within the guide channel, so as to leave room for the suture alongside the tube (as shown below). Figure 25H In the embodiment shown here, the increased diameter is achieved by providing an additional outer tube 202 outside the tube 204. In some embodiments, the outer tube 204 is in a fixed relationship with the tube 202, in which case they can alternatively be implemented as a single component formed with a variable outer diameter. Alternatively, as described below with reference to Figures 6A-6D As mentioned, outer tube 202 is displaceable along tube 204 to provide additional functionality associated with locking the stent.

[0099] In the illustrated example, the rod 206 includes a pointed tip 206a at its distal end 206d for piercing tissue in various applications described in detail herein. The rod 206 also serves as an ejector (or "releaser") for the shuttle 210. The rod 206 ejects the needle 210 from the launcher 200, for example, after the needle 210 has been transferred through the suture medium. For example, the ejection of the needle 210 occurs after the needle 210 is securely positioned within the interior (pocket 224) of the needle receiver 220. The rod 206 can retain the needle 210 within the receiver 220 when the needle launcher 200 is disengaged, optionally retracting through the suture medium to prevent the needle 210 from being released from the needle receiver 220 during this process. Due to the relative motion of the rod 206 and the tube 204, the rod 206 can thus release the shuttle needle 210 when it is stationary. The rod 206 in the illustrated example has a sharp, suture-needle-like shape 206a at its distal end. Prior to the needle launcher 200 being activated, the ejector 206 is advanced relative to the distal end of the tube 204 to provide the aforementioned second penetration configuration without the needle 210 passing through the suture medium, such as by engaging the needle 210 located in the needle receiver 220. Other applications of the rod 206 are described in detail below.

[0100] At least one penetration length 229 ( Figure 3B ), typically comprising a rod (ejector member) 206 and a tube 204, possibly with additional components, typically having a cross-section no larger than that of a shuttle needle 210. In some applications, the size of the cross-section may correspond to USP #4-0 or a similar range.

[0101] The distal end 204d of the tube 204 is coupled to the tip 206a of the rod 206 to form a holder or engagement mechanism for the shuttle 210, which is shown being held or engaged by the tube 204. In addition, the distal end 204d of the tube 204 is coupled to the tip 206a of the rod 206 to form a releaser or ejector for the shuttle 210 (into the pocket 224 of the shuttle receiver 220) as part of the ejection and insertion operation of the shuttle 210, as shown. Figures 23A-23G and 24, and described in detail below, and a mechanism for grasping and engaging the shuttle 210 to remove the shuttle 210 from the pocket 224, as part of a reconnection and retraction operation of the shuttle 210, as shown in FIG. Figures 25A-25G shown and described in detail below.

[0102] The shuttle 210 is, for example, a shuttle needle, for example Figure 9A and 9B As shown in and described in detail below, and is a shuttle, such as Figure 9C Shuttle 210 receives and holds suture 212, for example, extending from an opening (suture release hole) 214 in shaft 110, where the suture is fed along the internal lumen or otherwise stored in a suture feeding volume. Opening 214 is located, for example, on the opposite side of the suture action line ( Figure 2C 230 in). As an alternative geometric definition of this feature, the shuttle launcher 200 and the shuttle receiver 220 are preferably aligned along a first axis 230, corresponding to the "suture action line". At least a portion of the bridging portion is offset from this first axis in a first direction 233. The suture release hole 214 is preferably oriented away from the first axis and preferably opens toward the first direction. In other words, intuitively speaking, the suture release hole is located at the "back" of the device, relative to the current suture action line, and is optimized for the action of feeding suture in a direction generally away from the current suture. This preferred positioning of the suture release hole plays an important role in certain applications and certain suturing modes to minimize the risk of suture becoming tangled around the device when the device is turned during operation. See below Figures 30A-30C This feature will be better understood.

[0103] The shuttle launcher 200, comprising an outer tube 202, a tube 204 and a rod 206, has a shuttle 210 attached, and is preferably fully retractable into the shaft 110, e.g. Figure 2B As shown, and can be extended from the shaft, as shown in Figure 110, as shown Figure 2C 211. For medical applications, both the tube 204 and the rod 206 are typically made of surgical grade metals, including superelastic and shape memory alloys and materials such as Nitinol, although other metallic and non-metallic materials may also be used.

[0104] The bridge portion 120 supports a receiver 220, also referred to as a shuttle receiver, these terms being used interchangeably herein, which is pivotally mounted in a slot 222 of the bridge portion 120 for retractable ( Figure 2B ) and retract as Figure 2C As shown by the double-headed curved arrow 223, ( Figure 2A and 2C ) The receiver 220 is pulled out at the position indicated by the arrow 222 of the corner 222 of the slot 222. The receiver 220 includes a pocket 224 for receiving the shuttle 210, for example, with a friction or spring lock engagement. The friction engagement allows the shuttle 210 to be placed into the pocket 224 and held therein, as well as removed from the pocket 222 by the shuttle launcher 200. The deployment of the receiver 220 is controlled by an actuator 226, which is, for example, a wire that operates in a spring-like manner and is preferably preformed to return to a deflected form when advanced so as to bias the receiver 220 toward a retracted position within the slot 222 of the bridge portion 120, and is operable to move the receiver 220 to an extended position, where the receiver 220 protrudes out of the slot 222 of the bridge portion 120 when the actuator 226 is pulled. The actuator 226 is controlled, for example, by a joystick 130, as described in detail below. The actuator 226 may be made of surgical grade metals, including superelastic and shape memory alloys, and materials such as Nitinol.

[0105] The bridge portion 120 also preferably includes an opening or port 227a for a drain tube 228. The drain tube extends to the shaft 110 and the port 227b through which blood can be detected. Based on the detected blood, the user can determine that the bridge portion is within tissue, such as within a blood vessel, and at the appropriate surgical site (position).

[0106] In addition, if Figure 2C As shown, the bridge portion 120 includes a deflection portion 120x at the proximal end 120p that is laterally offset from the suturing motion axis 230 in a direction 233 for a continuation of the bridge portion 120, here implemented as a linear portion 120y. This configuration results in a linear suture line having a predetermined offset between the suturing action line 230 and the centerline of the rotating member.

[0107] Also note Figures 3A-3C , which shows an embodiment of a reciprocating transmitter 200. Figure 3A As shown, the outer tube 202 supports the tube 204. The tube 204 is made of a superelastic alloy such as Nitinol, for example, and holds the shuttle 210 to engage the shuttle 210, such as a shuttle needle. The rod 206 moves distally to contact the shuttle needle 210 so that its distal tip 206a is located in the groove 302 of the shuttle needle 210, as shown in FIG. Figure 3CFurther distal movement from this position causes the rod 206 to act as an ejector or release for releasing the shuttle needle 210.

[0108] Figure 3B The tube 204 is shown, for example, extending from the outer tube 202 to a length that is generally longer than the thickness of the suture medium, thereby defining the penetration length of the shuttle launcher 200 as represented by square bracket 229. It should be noted that it is primarily the penetration length that defines the thickness of the material (e.g., tissue) that can be sutured using the suturing module 102. Therefore, the penetration length 229 is generally selected to be longer than the length of the shuttle needle 210, and in certain preferred cases, the length of the shuttle needle is at least twice the length of the shuttle needle, more preferably at least three times, and in many cases, more than five times. Therefore, certain embodiments of the present invention are capable of achieving bidirectional suturing through materials with a thickness greater than the length of the shuttle needle 210.

[0109] The elongated portion of the tube 204, indicated by numeral 229, together with the elongated portion having a Figure 2C The overall suturing mechanism configuration of the parallel lines of action of the bridge portion described in the present invention provides a flexible axial position of the suturing device relative to the suturing medium. This allows suturing of access holes in blood vessels or any suture material thinner than 229, even if the material is thicker than the length of the shuttle needle passing back and forth (hence the name "shuttle").

[0110] Figure 3C The shuttle needle 210 is shown captured or engaged by the shuttle launcher 200 before being ejected into the shuttle receiver 220. In the depicted embodiment, the shuttle needle 210 includes an oversized diameter portion 304 at its proximal end 210p, the oversized diameter portion 304 having a diameter greater than the diameter of the tube 204. Because the tube 204 is preferably made of nitinol, distal movement of the rod 206 (as indicated by arrow 305), with its tip 206a positioned in the recess 302 of the shuttle needle 210, pushes the shuttle needle 210 distally, such that the oversized diameter portion 304 of the shuttle needle 210 pushes outward against the tube 204, deforming the tube 204 and generating an engagement force that allows the shuttle needle 210 to be pulled during suturing.

[0111] Figure 4A and 4BAnother embodiment of a tube 204 is shown for holding (also referred to as engaging or retaining) a shuttle 210, such as a shuttle needle. Here, the tube 204, for example, at the distal end 204d, may optionally include a preformed internal recess 231, for example, in the form of an annular band where the tube is made wider. The internal recess 231 forms a capture chamber for engaging a correspondingly shaped ridge 306 around the shuttle needle 210 to retain the shuttle needle 210 in engagement with the tube 204. The ridge 306 may advantageously be formed at the transition between an intermediate region for attaching a suture and a proximal region for engaging with a shuttle holder, wherein the proximal region has an at least partially tapered outer surface, and the ridge 306 is formed at the larger diameter edge of the tapered outer surface. For example, because the diameter of the shuttle needle 210 at the spine 306 is greater than the diameter of the tube 204, and most preferably, the tube 204 is a superelastic alloy, such as Nitinol, distal movement of the reciprocating needle 210 pushes the tube 204 outward, deforming the tube 204 and generating an engagement force that allows the reciprocating needle 210 to be withdrawn during suturing.

[0112] These figures, as well as subsequent views of various embodiments of the shuttle needle, illustrate a number of additional particularly preferred, but non-limiting, features and characteristics of the shuttle needle. Specifically, the middle region of the shuttle is preferably provided with at least one side notch, generally allowing the suture to trail alongside the needle without enlarging the overall size of the shuttle plus suture cross-section. Preferably, a transverse opening 506, optionally having more than one diameter, is provided in the middle region of the shuttle for attachment of suture, as described below with reference to Figure 12A and 12B As further described. The proximal region of the shuttle needle preferably has an outer surface that is at least partially conical and a central recess. The tapered outer surface helps align the shuttle launcher with the shuttle needle when the launcher collects the shuttle needle from the bag. In certain embodiments, a radially inward step behind the tapered surface provides an arrow-shaped head (without a tip in the case of an axial recess) with a narrowed neck portion in the middle region. In the case of a shuttle holder in the form of a tubular component (e.g., tube 204), the tubular component preferably has a size and / or shape that is small enough to engage the widest area of ​​the at least partially tapered surface while being larger than the narrow neck portion.

[0113] Figures 5A-5C Another embodiment of a shuttle launcher 200-1 is shown, including a tube 204 for clamping (engaging) a shuttle 210, such as a shuttle needle, through a mechanical holding interface 235. For example, the shuttle needle 210 can be the one described in detail above. Figures 3A-3CHere, the tube 204 includes a bead 240 at its distal end 204d, which has a gap 240a and communicates with the groove 242, and a slit 244 extending proximally. The slit 244 includes a distal narrow width portion 244a that tapers proximally and outwardly to a proximal portion 244b having a wider width. The slit 244 is designed to accommodate the protrusion 246 on the rod 206.

[0114] like Figure 5B As shown, the protrusion 246 on the rod 206 is initially located in the wide width portion 244b of the slit 244, so that the shuttle needle 210 is engaged (held) by the curling edge 240. When the shuttle needle 210 is released, the rod 206 moves distally (arrow 247), causing the protrusion 246 to enter and move distally in the narrow width portion 244a of the slit 244, as shown in FIG. Figure 5C As shown. Figure 5C , the distal movement forces the portion of the tube 204 including the curl 240 outward (as shown by arrow 249), widening the gap 240a of the curl 240 and coupling with the tube 204, for example, made of a shape memory alloy of Nitinol, causing the shuttle needle 210 to be released from the tube 204.

[0115] In an alternative embodiment, the crimping portion 240 can be replaced by mechanical fingers with gaps between each finger. This allows the outer tube 202 to be spread apart, as shown above. Figure 5A - as detailed in 5D.

[0116] Figures 6A-6D A shuttle launcher 200-2 is shown including a collet-like interface. Figure 6A and 6B As shown, the tube 204 includes a slit 260 that is coupled to the tube 204 of a shape memory alloy, such as Nitinol, to allow the tube 204 to expand radially outward, releasing the shuttle needle 210 from its clamping engagement with the tube 204. Figure 6A As shown, outer tube 202 is above tube 204, locking shuttle needle 210 in place. Figure 6B In the embodiment of the present invention, outer tube 202 moves proximally (as indicated by arrow 262) to expose tube 204, allowing tube 204 to extend outward (as indicated by arrow 264) and, in combination with distal movement of rod 206 (arrow 266), releases shuttle needle 210 from the clamping engagement of tube 204, as shown in FIG. Figure 6C shown.

[0117] Figure 6DA detailed view of an embodiment of a shuttle launcher 200-2 is shown in which the tube 204 includes inwardly directed gripping teeth 270 (single or in a ring) that engage notches 310 in the shuttle needle 210 for additional friction and / or mechanical engagement. The shape of these gripping teeth 270 is selected so that they bend outward to release the shuttle needle 210 when an axial force above a certain threshold is applied, but such outward bending is prevented when the outer tube 202 is advanced around the tube 204, thereby providing a positive lock. As with the other movable components, the movement of the outer tube 202 is preferably also controlled by the handle of the device. The tube 260 can preferably be made of a superelastic preformed alloy such as Nitinol.

[0118] Figure 7A and 7B A threading needle 200-3 is shown that includes a snap-on gripping interface. Here, the tube 204 includes one or more notches 276 that fit between notches 314 formed at the junction of the proximal inward middle portion 316 of the needle and the shoulder 318 of the proximal neck 320. A similar effect can be achieved by forming an opening or "window" in the tube 204 where the widest portion of the needle tends to seat. Figure 7A As shown, the rod 206 located in the groove 302 of the shuttle needle 210 moves distally to overcome the retaining force applied by the notch in the tube 204, ejecting the shuttle needle 210 distally to be released from the clamping engagement of the tube 204. In this case, the tube 204 can be made of any suitable elastically deformable material, optionally grooved to provide enhanced flexibility, and / or by using a superelastic alloy such as Nitinol.

[0119] Figure 7B An alternative embodiment of a shuttle launcher 200-3 is shown in which the tube 204 includes one or more slits 278 extending proximally from the distal end 204d of the tube 204. These slits 278 facilitate outward flexing of the tube 204 when the shuttle needle 210 is pushed distally by the rod 206.

[0120] Inwardly directed gripping teeth 270 (single or in a ring) which engage notches 310 in shuttle needle 210 for additional frictional engagement.

[0121] Figures 8A-8C Shuttle launcher 200-4 is shown, wherein tube 204 frictionally engages shuttle needle 210 ( Figure 8A) of the engagement surface (neck) 330. The engagement surface comprises a partially cylindrical surface 330a having a first diameter D-1 and at least one chamfered surface 330b such that the circumference of the engagement surface is less than its circumference if it were fully cylindrical (i.e., less than πD1). The tube 204 has at least one internal dimension, typically its diameter D-2, which is less than D-1, i.e., it cannot be fitted on the engagement surface without undergoing deformation, but is typically achieved by using a superelastic material, such as Nitinol, which can be elastically deformed to fit on the engagement surface. The solution can be clearly implemented by a series of geometries of the engagement surface and the end of the tube, which are formed into incompatible shapes that cannot fit together without deforming the tube, but can be elastically deformed to fit together, thereby producing frictional retention of the shuttle needle. The frictional retention can be overcome by a releaser, such as a rod 206, which advances relative to the tube 204 to overcome the frictional retention force and eject the shuttle needle.

[0122] Figures 9A-9C A general example of a shuttle 210 is shown (e.g., as Figure 2A shown). Figure 9A and 9B A shuttle in the form of needles 402, 404 is shown, and Figure 9C Shuttle 406 is shown. For example, Figure 9A In FIG, the shuttle needle 402 is female because it is frictionally engaged with the rod 206, which is movable within the tube 204. For example, in Figure 9B In the embodiment shown, the shuttle needle 404 is of male type because when the shuttle needle 404 needs to be disengaged, it is frictionally engaged with the tube 204 and is pushed distally by the rod 206.

[0123] In each case of a shuttle needle with a piercing tip, it should be noted that the piercing tip can have any form suitable for piercing the corresponding material to be sutured and is not limited to a tapered tip. Alternative forms include various forms with bevels and / or sharpened ridges, with triple, quadruple or other symmetries, or with asymmetrical tips.

[0124] exist Figure 9C 2, the shuttle 406 includes an open central core 408 through which the piercing tip 206a of the rod 206 extends to serve as the piercing tip of the shuttle 406. The diameter of the rod 206 is at least equal to, and typically greater than, the diameter of the core 408 to frictionally engage the shuttle 406. When it is desired to release the shuttle 406 from engagement with the rod 206, the tube 204 is moved distally, pushing the shuttle 406 away from the rod 206, or the rod 206 is moved proximally such that contact between the shuttle 406 and the tube 204 allows the shuttle 406 to disengage from the rod, or a combination of both movements.

[0125] exist Figures 9A-9CIn each of the options, the needle launcher can be configured to present a needle tip without a shuttle or shuttle needle.

[0126] Figure 10 An embodiment of a shuttle needle 210-1 is shown. A shuttle needle generally includes a distal end configured for tissue penetration, a central (middle) portion generally configured as an interface for suture / filament engagement, and a proximal end generally configured as an interface with a needle launcher module. Thus, in the example shown here, shuttle needle 210-1 includes a distal end 502d and a proximal end 502p, with distal end 502d having a tip 504 for tissue puncture. Near point 504 at distal end 502d is a suture interface 506, which includes a hole 508 for receiving a suture and securing it to shuttle needle 210-1. The shuttle needle may include one or more side notches, preferably two, optionally positioned relative to each other. The notch may be located only in the central (middle) portion of the needle, but may also be located in other portions of the needle. In some embodiments, there is more than one notch, each notch may have a different shape and form. The central portion of the shuttle needle may include a hole for receiving a suture or filament. The hole may have a slotted shape, preferably circular, with a constant diameter, or alternatively, a tapered shape. In yet another embodiment, the aperture may comprise several diameters, each diameter for a different, finite depth of the aperture.

[0127] An inner tapered neck portion 512a, which tapers proximally and inwardly, is connected to a proximally tapered proximal end portion 512b. The inner tapered neck portion 512a is connected to a flat, circular base 514 of the proximal end portion 512b. The circular base 516 has a larger diameter than the proximal end of the inner neck portion 512a, forming a shoulder 518. The proximal end of the proximal end portion 512b terminates in a groove 516. As described above, the groove 516 receives the piercing tip 206a of the shaft 206 of the shuttle launcher 200.

[0128] Figure 11 Shown is another embodiment of the shuttle needle 210-2. The shuttle needle 210-2 is similar to Figure 10 The shuttle needle 210-1, the same or the same components as above Figure 10 The same numbering and description are used, except that the inner tapered neck 512a is replaced by an inner cylindrical neck 512a' having a diameter smaller than that of the base 514, forming a shoulder 518a. A second shoulder 518b is formed at the junction of the distal end 502d and the inner cylindrical neck 512a'. An undercut or flat surface 519 may be on the lateral side of the shuttle needle 210-2 at the distal end 502d.

[0129] Figure 12A and 12B Show Figure 11The shuttle needle 210-2 holds the suture 212. The hole 506 is, for example, circular (round) and has two different diameter portions 506q, 506r, wherein the suture 212 extends through the smaller diameter portion 506q to the larger diameter portion 506r, the larger diameter portion 506r receives the suture 212 as a knot 212a and is filled with an adhesive 520, such as an ultraviolet (UV) type adhesive, etc. Figure 12A Alternatively, Figure 12B As shown, it is similar to Figure 12A , the suture 212 (enlarged monofilament 212b) is modified to have a spherical or cylindrical cutout 522 to create a "living hinge" and a small bend radius for the suture 212 (monofilament). Although shown here as being attached near the end of the suture, attaching the suture to the shuttle needle can also be done at any location along the length of the suture, including attachment to a loop passing through a hole in the suture.

[0130] Incidentally, it will be noted that in many cases, the suture 212 emerges laterally from the middle region of the shuttle, particularly when it is desired to provide a distal penetrating tip and a proximal portion to be grasped by the shuttle holder. The aforementioned difference in outer diameter between the outer tube 202 and the tube 204 helps to accommodate the suture next to the shuttle needle and / or tube 204 when the shuttle launcher is retracted into a guide channel sized to fit within the outer tube 202.

[0131] Figure 13 Another embodiment of the shuttle needle 210-3 is shown. The shuttle needle 210-3 is similar to Figure 11 The shuttle needle 210-2, the same or the same components as above Figure 11 Needle 210-3 differs from needle 210-2 in that the proximal portion 512b may include one or more indentations, flats, or polygonal parameters 523, for example, two of these components 523, disposed opposite each other.

[0132] Figures 14A-14D Alternating shuttle needles 210-4, 210-5, 210-6, 210-7 are shown. Figure 14A The shuttle needle 210-4 includes a similar Figure 10 The distal end 502d has a gap 530 between the distal end 502d and the proximal end 502p. The proximal end 502p includes an inner cylindrical neck 532 that meets a tapered portion 534 that tapers toward the proximal side and terminates in a groove 516. Figure 14B The shuttle needle 210-5 is similar to Figure 14A The shuttle needle 210-4 is different in that the gap 530 is not present, and the neck 532 is longer and the tapered portion 534 is shorter. Figure 14C Shows something like Figure 11Needle 210 - 2 is similar to needle 210 - 6 , except that the inner cylindrical neck 512 a ′ includes a tapered portion 538 extending proximally from the distal end 502 d to form an inwardly tapered collar around the inner cylindrical neck 512 a ′. Figure 14D The display shows the shuttle needle 210-7, which is Figure 8A The shuttle needle 210 is provided, and as described above, the description applies here.

[0133] Figure 15A and 15B An exemplary embodiment of a receiver (shuttle receiver) 220 is shown in detail. The receiver 220 is attached to the bridge portion 120 by a pin 600 or other structure that defines a hinge axis, or guides the expansion and retraction movement of the receiver 220, which allows for rotational movement of the receiver 220. The receiver 220 is rotationally moved by an actuator 226, which is Figure 15A The expanded or extended position shown and Figure 15B When the actuator 226 is pulled proximally (according to arrow 602), the receiver 220 moves outward into the deployed or extended position ( Figure 15A ) to receive and engage shuttle 210, and when pushed distally (according to arrow 604), moves receiver 220 into slot 222 ( Figure 15B ) (non-deployed or retracted position). Actuator 226 is made, for example, of a shape memory alloy such as Nitinol and preferably includes a pre-formed bend 226x that acts as a spring to retract receiver 220 into slot 222 to its retracted position. Actuator 226 is attached to channel 220x in receiver 220 by one or more of welding, adhesive, or mechanical fasteners (e.g., crimp 605). Additionally or alternatively, a locking pin 220y holds actuator 226 in place.

[0134] The end of the receiver 220 extending from the slot 222 includes a pocket 224 for receiving and engaging the shuttle 210, such as any of the shuttle needles 210 through 201-7 described in detail above. The shape of the pocket 224 generally corresponds to the shape of the shuttle 210. In the example shown here, a flexible member 224r in the form of a ring or tube is positioned and configured to receive and engage the shuttle when pushed into the pocket and also to allow the shuttle launcher 200 to extract the shuttle, as described herein. In the embodiment shown here, the flexible member 224r is retained by a locking pin 224x that extends transversely through at least a portion of the receiver 220.

[0135] Figure 15C and 15D Show Figure 15A and 15BThe receiver (shuttle receiver) 220 has a locking member 610 added thereto. The locking member 610 is a wire or the like that fills the space 612 between the mounting end of the receiver 220 and the wall 222x of the slot 222 to hold the receiver 220 in the deployed or extended position, as shown. Figure 15C For example, once the receiver 220 is in the deployed position (as indicated by the proximal movement of the actuator 226, as indicated by arrow 614a), the locking member 610 moves distally (according to arrow 614b) into the space 612, retaining the receiver in the deployed position. Figure 15D As shown, locking member 610 moves proximally (according to arrow 618a), and once clear of receiver 220, actuator 226 moves distally (according to arrow 618b), causing receiver 220 to retract into slot 222 (via pivotal or rotational movement about pin 600, as indicated by double arrow 619). Lock 610 extends, for example, from bridge 120 through shaft 110 and is controlled by handle 130. Engagement of locking member 610 ensures that receiver 220 is continuously and reliably deployed in its deployed position without requiring constant tension on actuator 226 during the procedure.

[0136] Figure 15E and 15F An alternative receiver (shuttle receiver) 220-1 is shown in which an actuator assembly 620 serves as both a locking member and an actuator. The locking member 620 extends, for example, from the bridge 120 through the shaft 110 and is controlled by the handle 130. The actuator assembly 620 is, for example, an electrical wire that is attached to the receiver 220 within the channel 220c of the receiver 220, for example, by a mechanical pin 220q (e.g., Figure 15F 22x of the slot 222, so as to secure the receiver 220 in place. The actuator assembly 620 includes a preformed bend 620x that acts as a spring to deploy the receiver 220 when the actuator assembly 620 is pushed distally. When the receiver 220 is no longer required to be deployed, as shown, the actuator assembly 620 moves the receiver 220 to the deployed position (as per arrow 622a). Further displacement of the actuator assembly 620 causes the thickened portion of the actuator assembly corresponding to the locking member 610 to enter the locked position, filling the space 612 between the mounting end of the receiver 220 and the wall 222x of the slot 222 to secure the receiver 220 in place. The actuator assembly 620 includes a preformed bend 620x that acts as a spring to deploy the receiver 220 when the actuator assembly 620 is pushed distally. When the receiver 220 is no longer required to be deployed, as shown Figure 15F As shown, the actuator assembly 620 moves proximally (as per arrow 618b) such that the locking member 610 disengages and subsequent further movement of the actuator assembly 620 returns the receiver 220 to its retracted position in the slot 222 (via pivotal or rotational movement about the pin 600 as indicated by double arrow 619) in the non-deployed or retracted position.

[0137] Figure 16A The pocket 224 of the receiver 220 is shown, and Figure 16B A shuttle needle 210 is shown, which is engaged in the pocket 224. For example, the pocket 224 includes three parts 224a, 224b, 224c to receive and engage (hold) a shuttle, such as a shuttle needle. The first part is the large diameter or upper part 224a. The diameter of the part 224a allows the tube 204 and rod 206 of the shuttle launcher 200 to enter, as well as the radial expansion of the tube 204 in the part, and provides clearance to accommodate sutures or filaments next to the shuttle. The size of the middle or medium diameter part 224b is preferably set to accommodate the largest shuttle needle 210 diameter, and, for example, is shaped to correspond to the shape of the largest diameter part of the shuttle needle 210, and is preferably provided with features for gripping or otherwise holding the shuttle needle 210 in place and engaged in the pocket 224. The small diameter or lower portion 224c of the pocket 224 receives the distal-most end, including the tip, of the shuttle needle 210, and a shoulder formed at the transition between portions 224b and 224c acts as a stop for distal movement of the shuttle needle 210 when it is placed in the pocket 224. The stop feature can obviously be implemented in a variety of different forms, and the pocket can be open or closed at its lower end.

[0138] FIG16 shows a bag 224-1 with a snap or clamp assembly 224e. The shuttle receiver 220 is here made of a flexible material, possibly a polymer, and preferably has a central slot 225 that separates the bag into two parts to allow a spring-like motion to unfold and spring inward, so that the snap 224e engages the shuttle needle 210. The distal end of the snap (clamp assembly) 224e is preferably tapered inward to allow the retraction force on the shuttle needle 210 to cause the two parts of the bag to unfold and thereby cause the snap (flange) 224e to separate and move proximally to retract when the shuttle needle 210 is separated.

[0139] These snaps 224e can be part of the wall of the bag 224-1 itself (e.g., integral with them). This "snap-on" structure preferably allows the shuttle needle 210, with or without a concave side, to be retained in any rotational orientation radial position. In addition, the tube 204 of the shuttle launcher 200 can be designed to expand outward while being inserted into the bag 224-1, allowing the shuttle needle 210 to be retrieved.

[0140] Figure 16DThe three positions of the shuttle needle 210 when entering the pocket 224-1 are shown. These positions include "position 1", in which the shuttle needle 210 is inserted into the pocket. The movement continues until the shuttle needle 210 is engaged in the pocket 224-1 at "position 2" (indicated by arrow 624), at which time the releaser is actuated to release the shuttle needle's shuttle launcher. This allows the shuttle launcher to be withdrawn to temporarily retain the shuttle needle 210 in the pocket 224-1, as shown in "position 3", where it is temporarily retained for the suturing step.

[0141] As an alternative to flexibility of the entire pocket, temporary retention of the shuttle needle within the pocket may also be achieved with a relatively rigid pocket by providing one or more resilient components to engage or grip the shuttle needle. Figure 16E In the example of the embodiment, the pocket 224 includes an elastic component 224f. The elastic component 224f provides additional force for the engagement of the shuttle needle 210. The spring 224f can be an O-ring, typically formed of an elastomeric material or a superelastic shape memory alloy, a metal C-ring, or any other metal or polymer component to ensure the engagement of the shuttle needle 210 inside the pocket 224. Depending on the material of the shuttle 220 to be received, one or more elastic components can be formed integrally with the material of the bag, such as Figure 16F A variant embodiment is shown by an integrated spring piece 224g.

[0142] Figure 17 An exemplary embodiment of the shaft 110 is shown. In the example, the shaft 110 includes a shaft housing 110x supporting a shaft insert 110y, which can be implemented as a multi-lumen tube that accommodates a suture conveyor lumen and a discharge tube. The shaft insert 110y includes a channel 110y-1 that supports the shuttle launcher 200 by supporting the outer tube 202 so that it can move proximally and distally (as shown by the double-headed arrow 650). Like the actuator 226, it can move proximally and distally along the shaft insert 110y (according to the double-headed arrow 652). The suture tube conveyor 110y-2 facilitates the passage of the suture 212. The discharge tube 228 is also supported by the shaft insert 110y.

[0143] Figure 18A flexible connector 140 is shown, which preferably also forms part of a rotatable joint, rotatably connected at its proximal end 140p to the bridge portion 120 and at its distal end 140d to the dilator 150. In the embodiment shown here, the flexible connector 140 includes a tube connector 702 that is attached to the distal end of the bridge portion 120. The tube connector 702 is also attached to an outer tube 704. The tube connector 702 receives a central flexible member 706, which is typically made of a superelastic wire such as nitinol or other flexible metal or plastic. In a non-limiting example, the central flexible member 706 forms the primary mechanical connection across the connection, while the tube connector 702 provides a continuous, smooth tubular form between the bridge portion 120 and the dilator 150. The central flexible member 706 extends centrally into the dilator 150. A rotational bearing 708 between the tube connector 702 and the central flexible member 706 allows the handle 130 and suturing module 102 (shaft 110 and bridging portion 120) to rotate about the flexible connector 140 and dilator 150 in order to reposition the suturing module for shuttle retraction (from initial shuttle engagement into pocket 224) and subsequent shuttle engagement of the shuttle 210 into pocket 224.

[0144] According to certain particularly preferred embodiments of the present invention, for example, when implemented in the context of a vessel closure device, the device is advantageously integrated with a dilator 150, which is used to dilate the access site into the vessel for the shaft 110 and the bridge portion 120. The dilator 150 shown here is a tubular structure including a central connector 720 for connecting the dilator 150 to a flexible connector 140. Within the dilator 150, a rotational bearing 708 is optionally located between the central connector 720 and the dilator outer tube 722. The dilator 150 is aligned with the direction of the vessel when inserted into the vessel, typically at an angle of approximately 45 degrees to the longitudinal axis of the suturing device. The rotatable connection at one or both ends of the flexible connector 140 facilitates rotation of the suturing device to form a circular suturing pattern, while the dilator remains aligned with the vessel and generally does not rotate. However, the flexible connector 140 should transmit axial forces from the bridge portion 120 to pull or push the dilator 150 during insertion and removal from the vessel. At the same time, for example, preferably, after the dilator 150 is positioned in the blood vessel, the flexible member 140 allows the bridging portion 120 to rotate about its line of action, for example, the dilator 150 does not rotate.

[0145] For example, the bridging portion 120 and the outer tube 704 of the flexible connector 140 are axially aligned relative to each other. In an example, the surfaces of the bridging portion 120, the outer tube 704 of the flexible connector 140, and the outer tube 722 of the dilator 150 are flush with each other to have smooth tubular surfaces. The connection of the dilator 150 to the suturing module 102 is achieved through the flexible connector 140, which allows the dilator 150 to align itself within the blood vessel, typically at an angle of approximately 45 degrees to the bridging portion 120. For example, the flexible connector 140 transmits axial force from the bridging portion 120 to push or pull the dilator 150 into the blood vessel. While the dilator 150 and the bridging portion 120 are placed in the blood vessel, the flexible connector 140 allows the suturing module 102 to rotate about the dilator 150 without the dilator 150 rotating.

[0146] Figures 19A-19E Schematic diagram showing various rotatable connections between the bridge portion 120 and the expander 150 via the flexible connector 140. Various rotations and Figures 19A-19E The arrows in each of the are consistent.

[0147] Figure 19A The flexible connector 140 is shown as a flexible member having fixed connections to the bridge portion 120 and the expander 150. The flexible member is made of, for example, a shape memory alloy such as Nitinol, and is used to transmit radial forces and radial torques.

[0148] Figure 19B A flexible connector 140 is shown which comprises a flexible joint 140 having a central spherical ball and socket bearing 140f. This arrangement allows the bridge portion 120 to rotate while the expander 150 remains stationary.

[0149] Figure 19C A rotational bearing mount 708 is shown between the flexible connector and the expander 150, while the connection between the bridge portion 120 and the flexible connector is "fixed" (ie, non-rotatable).

[0150] Figure 19D The swivel bearing mount 708' in the bridge portion 120 is shown, along with a fixed connection to the expander 150, allowing the bridge portion 120 to rotate while the expander 150 remains stationary. Figure 19C and 19D Each corresponds to Figure 18 A simplified (partial) embodiment of a flexible joint arrangement comprising rotary joints at both ends of a flexible connector.

[0151] Figure 19EA flexible joint 140 is shown with central spherical bearings 752, 754 on the bridge portion 120 and the expander 150. The connection between the spherical bearings 752 and 754 can be flexible or rigid. In this arrangement, rotation of the bridge portion 120 relative to the expander 150 can be accommodated by one or both of the spherical bearings 752 and 754.

[0152] Figure 20 and 21 Shown is a handle 130. The handle 130 serves as a control mechanism for shuttle (needle) insertion and retraction, as well as movement of the actuator 226 for moving the shuttle receiver 220 out of the slot 222 of the bridge portion 120 when deployment and retraction of the receiver 220 is desired.

[0153] The handle 130 includes a body 802 that receives and is attached to the shaft 110 (not shown). For embodiments in which the shuttle receiver is retractable, the handle 130 typically has a lockable slider (not shown) or other actuator for controlling the deployment and retraction of the shuttle receiver. A main knob 804 is preferably associated with the shuttle launcher for displacing the shuttle launcher distally and proximally, while an auxiliary knob (or button) 806 drives the relative movement of the shuttle support and the shuttle release to achieve release or reengagement of the shuttle launcher from the shuttle. The rotation or other movement of the suturing module 102 between the passages of the shuttle can be achieved by the movement of the handle 130 as a whole. The handle 130 has been described herein to the extent required to achieve control of the suturing module 102 and can be easily implemented by one of ordinary skill in the art.

[0154] Figure 22A An alternative suturing module 102-1 for suturing apparatus 100 is shown. The module 102-1 includes an integrated shuttle (needle) receiver 220', which is similar to the shuttle (needle) receiver 220, but is integrated with module 102-1. The shuttle launcher module 200 is integrated with the modified bridge portion 120 and aligned with the integrated needle receiver 220', thereby providing a similar suturing module to the above. Figure 2C The improved bridging portion 120 serves as a mechanism for defining the center of rotation of the suturing module and is rotatable relative to the flexible joint 140 or at least relative to the dilator, as described in detail above. The described and other embodiments of the device can also be used for suturing in a mode that employs a displacement component, with or without rotation.

[0155] Figure 22B Another suturing device 100-1 is shown. The suturing device 100-1 includes a suturing module 102, as described above for the above Figure 1AThe present invention relates to a device for suturing a patient's body, comprising a short, straight shaft segment 110x1 extending from a bridging portion. The segment 110x1 is constructed and arranged for the linear motion of the internal suturing member, and a shaft 110x2, which includes all actuators, effectors, conduits, etc. The shaft 110x2 is configured as a flexible shaft, for example, suitable for being inserted into a body position by a curved or otherwise convoluted path to perform minimally invasive surgery. As shown, the flexible shaft can be formed of a flexible material, and / or can adopt a structure of segments that are joined or flexibly interconnected to accommodate the bends between the segments. As known in the art, the device can become steerable by including a steering mechanism.

[0156] Surgical suturing process

[0157] 1. Shuttle insertion

[0158] Notice Figures 23A-23G , they show the shuttle insertion process. Figures 24A-24E The movement of the tube 204 and rod 206 can also be seen particularly clearly in the cross-sectional view of FIG. Figure 1A-22B , and the descriptions of the components provided above.

[0159] Figure 23A This is the first sub-process of the shuttle insertion and suture insertion process. Suture 212 is connected to shuttle needle 210, and shuttle launcher 200 is retracted into shaft 110, as shown in FIG. Figure 2B As shown, a portion of the bridging portion 120, including, for example, at least the shuttle receiver 220 and the port 227a for the drain tube 228, has been inserted into tissue, such as the blood vessel 1002. The position of the bridging portion 120 in the blood vessel 1002 can be confirmed by the outflow of blood from the port 227b of the drain tube 228 in the shaft 110. The shuttle receiver 220 is deployed or in an extended position to receive the shuttle needle 210. The bridging portion 120, the flexible joint 140, and the dilator 150 have been inserted into the blood vessel 1002 using a conventional insertion procedure.

[0160] Figure 23B and Figure 24A The next sub-process is shown, wherein the shuttle needle 210 (with suture 212 ) is engaged on the shuttle launcher 200 , eg, the tube 204 (and rod 206 ) are advanced distally toward the shuttle receiver 220 .

[0161] The shuttle needle 210 continues to advance by distal movement of at least the tube 204, so that the tip at the distal end 210d of the shuttle needle 210 contacts the tissue, as shown in FIG. Figure 23C As shown, it eventually pierces and penetrates tissue, for example, a blood vessel wall 1002, as shown Figure 23D In addition, Figure 23D, the shuttle needle 210 enters the pocket 224 of the shuttle receiver 220, and the distal movement of the shuttle needle 210 continues until the tip at the distal end 210d is located in the small diameter portion 224c of the pocket 224, acting as a "stop" for the distal movement of the shuttle needle 210. The shuttle needle 210 has now been engaged in the pocket 224 of the shuttle receiver 220, for example, by friction, e.g., Figure 16A and 16D (Position 2). This corresponds to Figure 24B At this point, the shuttle is released by the shuttle launcher. In the example shown here, this is done by advancing the rod 206 until it engages the proximal portion of the shuttle needle 210 ( Figure 24C ), then pressing distally on the rod 206 to hold the shuttle needle 210 in the pocket ( Figure 24D ) is achieved by withdrawing the tube 204 when the shuttle launcher 200 is released. The shuttle launcher 200 can then be withdrawn, leaving the shuttle needle in the shuttle receiver pocket. It should be noted that the description applies to a specific non-limiting embodiment of the retainer and release of the shuttle launcher 200. It will be apparent to one of ordinary skill in the art that corresponding stages of alternative embodiments, such as those described above with reference to Figures 5A to 5C and Figures 6A to 6D The stages described.

[0162] like Figure 23F As shown in FIG24G , the tube 204 and rod 206 continue to be retracted proximally out of the vessel 1002 and tissue until fully retracted into the outer tube 202 and shaft 110. Figure 23E 、 23F 23G , as described above, shuttle needle 210 holding suture 212 is frictionally engaged (held or clamped) in pocket 224 of shuttle (needle) receiver 220 .

[0163] Figure 24F An alternative process is shown, in which, instead of the shuttle launcher 200 placing the shuttle needle 210 into the pocket 224 of the shuttle receiver 220, the shuttle receiver 220 is not involved in the process. Instead, the shuttle needle 210 with the suture 212 is placed in the material 1003, which can be suture material or some other nearby material. The shuttle needle 210 can then serve as an anchor for the suture 212. This can be used as the final step in the suturing process, in which the shuttle needle will remain in the tissue as an anchor for the end of the suture.

[0164] 2. Shuttle retraction

[0165] Notice Figures 25A-25G , which show the shuttle retraction process. The corresponding operation of the rod 206 and the tube 204 can be understood as Figures 24A-24E When describing the shuttle retraction process as the second part of the suturing operation to perform suturing, refer to the attached Figure 1A-22B, and the descriptions of the components provided above.

[0166] exist Figure 25A , suture 212 has been removed from shaft 110, and bridging portion 120 and shaft 110 have been rotated (from Figure 23G 20) so that the shuttle launcher 200 and outer tube 202, tube 204 and rod 206 are aligned with the pocket 224 of the shuttle receiver 220, which engages (clamps or grasps) the shuttle needle 210, clamping the suture 212.

[0167] The reciprocating transmitter 200, i.e., the outer tube 202, the tube 204, and the rod 206, is now retracted by moving distally out of the shaft 110, as shown. Figure 25B As the piercing tip 206a of the rod 206 pierces the tissue and blood vessel 1002, the distal movement continues, wherein the tube 204 also moves distally following the rod 206, as shown. Figure 25C shown.

[0168] like Figure 25D As shown, the rod 206 and tube 204 enter the pocket 224 and the rod 204 contacts the needle 210 at the recess 302, while the tube 204 frictionally engages the needle 210. This frictional engagement of the tube 204 with the needle 210 is sufficiently strong that when the tube 204 and rod 206 are retracted by moving proximally, the needle 210 is caught and engaged by the tube 204 with a force sufficient to break the engagement of the needle 210 with the pocket 224.

[0169] exist Figure 25E In the embodiment, the tube 204 and the rod 206 are retracted by moving proximally, wherein the shuttle needle 210 is clamped (engaged) by the tube, such as by friction, so that the shuttle needle 210 and the suture 212 are retracted. Figure 25F As shown, retraction continues as the shuttle needle 210, which is engaged with the tube 204, the tube 204, the rod 206, and optionally the outer tube 202, moves proximally. The proximal movement of the shuttle needle 210, which is engaged with the tube 204, the tube 204, the rod 206, and optionally the outer tube 202 is complete, as shown. Figure 25G As shown, their components are now all inside the shaft 110. Figure 25H A detailed view of the completed retraction is displayed.

[0170] The device 100 can now return to Figure 23A Position and orientation shown, or similar Figure 23A The position and direction shown are used to perform the next or subsequent sutures.

[0171] Figures 26A-26E Shows the Figures 23A-25H The various stitching patterns produced by the stitching process preferably include an even number of stitching (penetration) points. Figure 26AA purse-string suture pattern (PSS) is shown, preferably with an even number of suture points, and typically at least 4 suture points.

[0172] Figure 26F The stages of forming a continuous suture, labeled 1-5, are shown, and more particularly, the formation of a spiral suture in which some or all of the sutures are crossed between two sides of an incision or wound, or between adjacent edges of two-sided, side-by-side material, and the relative motion between the continuous stitches advances the device along the edge of the material. Also illustrated herein, but also applicable to other situations, is an optional technique for anchoring one or both ends of the suture by repeatedly penetrating the material in overlapping relationship with multiple sutures, thereby achieving securement of the suture ends by self-locking or knotting. The knot is here labeled 212k. The technique can be used to begin or end a suture, or both.

[0173] 27-27C illustrate an alternative embodiment in which the device 100 includes a preload member 1102 as part of the needle launcher 200. The preload member 1102 can be activated before any needle 210 is inserted or retracted through the suture medium. For example, the distal end 1102a of the preload member 1102 has a spherical shape to allow the clamping force to be applied at different angles on a vessel surface, such as a blood vessel wall. Figure 27A A cross section of a blood vessel 1002 is shown with the suturing module in its initial position. Figure 27B In the , the wall of the blood vessel 1002 is squeezed. Figure 27C In the middle, sutures were implemented.

[0174] For example, Figure 28 As shown, as part of the needle insertion process, the needle 210 is retained within the needle receiver 200 by the ejector rod 206. When the needle launcher 200 (i.e., the tube 204) is retracted, the preload member 1102 operates as a gripping member because it is activated and locks the suture medium in place before the suturing action is initiated.

[0175] Figures 29A-29E Details Figures 27A-27CThe suture delivery operation in the device 100 is described in detail. For example, the suture is delivered (fed) to the suturing mechanism 102, typically to a first puncture point hidden in the shaft 110. The delivery route ends with an entry hole 1114 in the shaft 110, which is close to the rotational entry hole of the device 100 when used to make a suture hole, such as a hole in a blood vessel. The thread 212 is typically guided from the entry hole 1114 in the shaft 110 to the needle 210 on the proximal side of the suturing mechanism 102. This is the side opposite to the rotational movement of the device 100 during the implementation of the circular suturing pattern. This arrangement provides for free rotation of the device 100 without having to drag the suture 212 through the shaft 110 of the device 100 to reach the first puncture point. Figure 29A The initial state of the line transfer is shown. Figure 29B An embodiment of a first puncture site is shown, for example, where the needle 210 is transferred into the needle receiver 220 . Figure 29C The suturing mechanism 102 is shown rotated (eg, clockwise) to a new puncture point. Figure 29D Shows the new puncture point being implemented. Figure 29E The needle 210 and attached suture 212 are shown being pulled out at the second puncture site.

[0176] Figures 30A-30C The sequence of suture delivery is shown. For example, a three-dimensional view of the suturing mechanism 102 is shown, which suturing mechanism 102 is used through a circular suture pattern and, optionally, a purse string suture (PSS) pattern. The suture 212 is guided through a centrally located feed hole and fed to a first puncture point to prevent the suture from becoming entangled or twisted around the device 100 (e.g., the shaft 110 and the bridge portion 120) during suturing. Figure 30A The implementation of the first puncture point is shown. Figure 30B The implementation of the third puncture point is shown. Figure 30C The sequence is arbitrarily shown here in the example of a suturing mechanism with a preload member 1102, but is equally applicable to embodiments without such a preload member.

[0177] Alternatively, other components, assemblies, and methods can be used to deliver the suture to the first puncture point. For example, the threads 212 can be freely arranged along the shaft 110. The threads 212 can be temporarily glued to the shaft 110 and usually detach from the shaft 110 during rotation. The threads can pass through a catheter that is not part of the shaft 110. The catheter can be temporarily glued to the shaft 110 and usually detach from the shaft 110 during rotation of the shaft 110. The catheter can be connected to the shaft 110 using a ring hinge.

[0178] Another alternative is to pass through hole 214 ( Figure 2A) passes the suture 212 directly through the shaft 110. During the delivery of circular sutures, the hole in the shaft 110 near the suturing mechanism 102 and near the rotation line of the device 100 will provide a routing line between the shaft 110 and the needle 210.

[0179] Figures 31A-31C 26A-27C shows the device 100 during a suture retrieval process. After completing the suture and before retrieving the shuttle needle 210, the needle launcher 200, along with the needle 210 connected to the suture 212, can be pulled outwardly to a position where an internal locking member, such as a resilient member 1118 hidden in the shaft 110, can expand or otherwise displace and prevent the needle 210 from moving backward. Figure 31A Suture 212 is shown when needle 210 is initially retracted from receiver 220. Figure 31B The suture 210 is shown in the shaft 110 with the needle 210 retracted and a locking member 1118, such as a spring, preventing further distal movement of the needle 210. The locking member 1118 thus acts as a shuttle lock, preventing the shuttle needle 210 from being released from the shaft and allowing the user to apply considerable tension to the suture in the axial direction of the shaft without fearing that the shuttle may become detached from the shuttle launcher 200. Figure 31C Suture 212 connected to needle 210 is shown secured within the interior of shaft 110 by flexible member 1118 (as suture 212 moves proximally in the direction of arrow 1120).

[0180] Alternative embodiments of the apparatus 100 include those comprising a robotically or manually operated shuttle transmitter and a robotically or manually operated shuttle receiver. The respective transmitters / receivers can be aligned relative to each other in a first / second position. This can be achieved, for example, by spatially registering the two robotic subsystems or by using imaging equipment to allow manual alignment of the robotic subsystems relative to the tissue location.

[0181] While described above in the context of a vascular closure device, it should be noted that the suturing mechanism of the present invention can be readily implemented in other settings and procedures, including but not limited to: closing an incision, wound, or defect in a single material; modifying the shape or other properties of a single material; joining two or more materials arranged in an overlapping relationship by suturing the two layers; joining two edges of two regions of material, which may be of the same type or different material bodies; and anchoring a suture in a material by repeatedly passing the suture through the material in an overlapping relationship in close proximity. Any and all of the materials discussed above can be natural biological tissue or any other material. The devices and methods can also perform suturing to interconnect prosthetic devices or materials with natural tissue.

[0182] Another group of procedures suitable for use with the suturing device of the present invention are coronary artery procedures, including but not limited to: patent foramen ovale (PFO), ventricular septal defect (ASD), and other types of structural heart disease.

[0183] The disclosed subject matter is also applicable to a range of cardiovascular procedures including, but not limited to, left atrial appendage occlusion (LAAO), left atrial appendage closure (LAAC), aneurysm repair (AAA or EVAR), and more generally for transcatheter valve repair, and as a minimally invasive apical closure procedure or minimally invasive left ventricular repair procedure.

[0184] The presently disclosed subject matter is also applicable to a wide range of minimally invasive surgeries, including but not limited to suturing procedures during endoscopic, laparoscopic, gastroscopic, otoscopy, and minimally invasive gynecological procedures.

[0185] Although the disclosed subject matter has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. It is therefore intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. A suturing device for passing a suture from a first side of a material to a second side of the material at a first position and returning from the second side of the material to the first side of the material at a second position, characterized in that: The suturing device comprises: (a) a shuttle for holding a suture; (b) a shuttle launcher comprising: a shuttle holder for holding the shuttle; and a shuttle releaser movable relative to the shuttle holder for releasing the shuttle from the shuttle holder; and (c) a shuttle receiver for receiving the shuttle on a second side of the material; the shuttle holder clamping the shuttle so that the shuttle and the shuttle launcher are together movable into a first penetration configuration to advance the shuttle through the material in the first position until the shuttle engages the shuttle receiver; the shuttle release releasing the shuttle from the shuttle holder to retract the shuttle launcher through the material in the first position to engage the shuttle with the shuttle receiver; The shuttle launcher presents a second penetration configuration, and when aligned with the second position relative to the shuttle receiver, penetrates the material with a movable penetration tip at the second position; the shuttle bracket clamps the shuttle for retracting the shuttle through the material at the second position.

2. The suturing device according to claim 1, wherein: The shuttle has: a pointed distal end for the first penetration configuration; a middle region for connecting the suture; and a proximal region for engaging with the shuttle holder, the proximal region of the shuttle having an axial recess for receiving the penetration tip of the shuttle launcher and aligning the penetration tip with the shuttle after penetrating the material in the second penetration configuration at the second position.

3. The suturing device according to claim 2, wherein: The shuttle support includes a tubular component configured to mount and engage a proximal region of the shuttle.

4. The suturing device according to claim 3, wherein: The tubular component is formed from a superelastic alloy.

5. The suturing device according to claim 3, wherein: The tubular assembly is formed with at least one resilient feature for engaging a proximal region of the shuttle.

6. The suturing device according to claim 3, wherein: The release includes a rod disposed within the tubular assembly, the rod providing a penetrating tip for the shuttle launcher, the rod and the tubular assembly being differentially axially displaceable such that advancement of the rod relative to the tubular assembly ejects the shuttle from the shuttle holder and assumes the second penetrating configuration.

7. The suturing device according to claim 1, wherein: The suturing device also includes a bridge portion that mechanically communicates with the shuttle launcher and the shuttle receiver to maintain alignment of the shuttle launcher and the shuttle receiver.

8. The suturing device according to claim 7, wherein: The suturing device also includes a shaft extending proximally from the bridging portion, the shuttle launcher being movable axially within a channel of the shaft and retractable to a position where the shuttle launcher and the shuttle are fully positioned within the channel.

9. The suturing device according to claim 7, wherein: The shuttle receiver is formed with a pocket in which the shuttle is received, and a portion of the shuttle holder is insertable into the pocket for engaging the shuttle and retracting the shuttle from the pocket.

10. The suturing device according to claim 7, wherein: The shuttle receiver is telescopically mounted to the bridge portion.

11. The suturing device according to claim 10, wherein: Extension of the shuttle receiver from a retracted position to an extended position is accomplished by displacement of an actuator assembly formed from a shape memory alloy preformed to facilitate retraction of the shuttle receiver.

12. The suturing device according to claim 10, wherein: Extension of the shuttle receiver from a retracted position to an extended position is accomplished by displacement of an actuator assembly through a first range of motion, and further displacement of the actuator assembly beyond the first range of motion locks the shuttle receiver against retraction.

13. The suturing device according to claim 7, wherein: The suturing device further includes a dilator deployed distally of the bridging portion, the dilator being interconnected with the bridging portion via a deflectable joint.

14. The suturing device according to claim 7, wherein: The suturing device also includes: a shaft extending from the bridging portion toward the proximal end; a drain port opening in the bridge portion; and A discharge pipe extends from the discharge port along the axial proximal opening to a discharge pipe outlet.

15. The suturing device according to claim 7, wherein: The suturing device also includes: a suture feeding space communicating with a suture releasing hole; and a suture partially located within the suture feeding space and extending from the suture release hole to the shuttle, the suture being connected to the shuttle; The shuttle launcher and the shuttle receiver are aligned along a first axis, at least a portion of the bridge portion is offset from the first axis in a first direction, and the suture release aperture is oriented away from the first axis.

16. The suturing device according to claim 1, wherein: The shuttle launcher has a penetration portion having a penetration length for penetrating the material in the first position and the second position, the penetration length being greater than a length of the shuttle.

17. The suturing device according to claim 1, wherein: The shuttle launcher is associated with a flexible shaft.

18. The suturing device according to claim 1, wherein: The shuttle receiver is formed with a pocket for receiving the shuttle, and a resilient retention assembly is associated with the pocket and configured to releasably retain the shuttle within the pocket.

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