Suturing systems and their components

Abstract

The drive mechanism for operating the suturing mechanism includes a user input displaceable through a range of motion and a linkage mechanically coupled to the user input and a shuttle receiver of the suturing mechanism, the linkage converting displacement of the user input into a sequence of operation of the shuttle receiver, either unidirectionally or bidirectionally, to effect a sequence of operation of the suturing mechanism to apply successive bidirectional stitches, the shuttle receiver alternately penetrating tissue with and without a shuttle needle attached.

Description

[Technical field]

[0001] The present invention relates to suturing systems, and more particularly to suturing systems for suturing applications such as closing an incision, joining tissue or tissue regions, and / or changing the shape of tissue.

[0002] Suturing is a common surgical technique for closing incisions, joining tissues or tissue regions, and / or changing the shape of tissue. In the context of minimally invasive procedures or in small confined surgical spaces, suturing poses particular challenges and requires a high level of skill from the surgeon. In the context of vascular occlusion devices, certain dedicated tools are currently available to facilitate suturing. However, these devices have various limitations and typically cannot sew continuously and bidirectionally back and forth through the thickness of tissue. Summary of the Invention

[0003] The present invention relates to a suturing system and components thereof.

[0004] In accordance with teachings of embodiments of the present invention, a drive mechanism for operating a suturing mechanism is provided, the suturing mechanism having a shuttle for holding a suture, the movement of the shuttle being controlled by a shuttle delivery part displaceable along a longitudinal axis between a withdrawal position and a penetration position, the shuttle delivery part being reconfigurable between a shuttle-holding state and a shuttle-released state, the drive mechanism including: (a) a user input part displaceable through a range of motion; and (b) a linkage part mechanically coupled to the user input part and the shuttle delivery part, the linkage part configured to translate displacement of the user input part into a sequence of operation of the shuttle delivery part, in one or both directions, the sequence of operation of the shuttle delivery part including: (i) axially moving the shuttle delivery part from the withdrawal position to the penetration position to penetrate material at a first location. (ii) reconfiguring the shuttle delivery portion from a shuttle holding state to a shuttle releasing state; (iii) axially displacing the shuttle delivery portion from the piercing position to the withdrawal position to withdraw the shuttle from the material while leaving a first suture stitch at the first position; and after repositioning the shuttle delivery portion and the shuttle so that they are aligned at the second position, (iv) axially displacing the shuttle delivery portion from the withdrawal position to the piercing position to penetrate the material at the second position; (v) reconfiguring the shuttle delivery portion from the shuttle releasing state to the shuttle holding state to hold the shuttle; and (vi) axially displacing the shuttle delivery portion from the piercing position to the withdrawal position to withdraw the shuttle from the material while forming a second suture stitch at the second position.

[0005] According to a further feature of an embodiment of the invention, reconfiguring the shuttle delivery portion from a shuttle holding state to a shuttle releasing state generates a tissue penetrating configuration of the shuttle delivery portion without the shuttle, and reconfiguring the shuttle delivery portion from a shuttle releasing state to a shuttle holding state generates a tissue penetrating configuration of the shuttle delivery portion together with the shuttle.

[0006] According to a further feature of an embodiment of the invention, repositioning of the shuttle transfer section is also performed unidirectionally or bidirectionally by a linkage driven by a displacement of a user input section.

[0007] According to a further feature of an embodiment of the present invention, when aligned with the third and fourth positions, the linkage portion is configured to convert further displacement of the user input portion, in one direction or two directions, into a repeated sequence of operations of the shuttle transfer portion to form a running stitch suture in the material.

[0008] According to a further feature of an embodiment of the invention, the user input is manually displaceable in a first direction and is spring-loaded to return to the opposite direction upon release.

[0009] According to a further feature of an embodiment of the invention, the shuttle delivery portion includes a shuttle holding portion and a shuttle pushing portion, and reconfiguration of the shuttle delivery portion between a shuttle holding state and a shuttle releasing state is achieved by axial movement of the shuttle pushing portion relative to the shuttle holding portion.

[0010] According to a further feature of one embodiment of the present invention, the linking unit includes a first transmission unit that determines a first timing profile for operating the shuttle holding unit in response to a displacement of the user input unit, and a second transmission unit that determines a second timing profile for operating the shuttle pushing unit in response to a displacement of the user input unit.

[0011] According to a further feature of one embodiment of the present invention, the second timing profile defines the operation of the shuttle pusher in response to the displacement of the user input over two cycles of displacing the shuttle transfer section from the withdrawal position to the penetration position and back to the withdrawal position, the operation over a first of the two cycles being non-identical to the operation over a second of the two cycles.

[0012] According to a further feature of an embodiment of the present invention, the shuttle pusher and the shuttle holder are attached to a common slide, and the linking portion includes a first transmission portion defining a first timing profile for operating the slide in response to a displacement of the user input portion, and a second transmission portion defining a second timing profile for operating the shuttle pusher and / or the shuttle holder in response to a displacement of the slide.

[0013] According to a further feature of an embodiment of the present invention, the second timing profile defines the operation of the shuttle pusher and / or the shuttle holder in response to the displacement of the user input over two cycles of displacing the shuttle transfer section from the withdrawal position to the penetration position and back to the withdrawal position, the operation over a first of the two cycles being non-identical to the operation over a second of the two cycles.

[0014] According to a further feature of an embodiment of the present invention, the suturing device is a minimally invasive suturing device including an elongate body for percutaneous insertion, and the user input portion and the linkage portion are implemented as part of a handle coupled to a proximal end of the elongate body.

[0015] According to a further feature of an embodiment of the invention, the suturing device further includes a shuttle receiver for receiving the shuttle on the second side of the material, the shuttle receiver being retractable to a retracted position relative to the elongate body and selectively deployable to a deployed position to receive the shuttle, and the drive mechanism further includes a manually operated actuator associated with the shuttle receiver for deploying the shuttle receiver from the retracted position to the deployed position, the actuator being coupled to the handle at a location distal to the user input.

[0016] According to a further feature of an embodiment of the invention, the elongate body is rotatable about its longitudinal axis relative to the handle for applying stitches at successive angular positions about the elongate body, and the handle further includes a mechanical indicator coupled to the elongate body and configured to provide a visual indicator as to a current rotational position of the elongate body relative to the handle.

[0017] According to a further feature of an embodiment of the invention, the mechanical indicator is further coupled to the linkage and configured to provide a visual indication when passage of the suture through the material is completed at the current rotational position.

[0018] In accordance with a further feature of an embodiment of the invention, a suture feeding device is also provided, coupled to the handle, for feeding the suture along the elongate body to the shuttle, the suture feeding device configured to provide tactile and / or audio feedback to a user as the suture is dispensed.

[0019] According to a further feature of an embodiment of the invention, the elongate body is rotatable about its longitudinal axis relative to the handle to apply stitches at successive angular positions around the elongate body, and the elongate body further includes an air bleed pipe extending from an air bleed inlet along said elongate body to an outlet connected to the handle, the air bleed pipe comprising an unsupported loop of pipe positioned to accommodate relative rotation between the elongate body and the handle.

[0020] According to a further feature of an embodiment of the invention, a pinch valve is also provided, the pinch valve being coupled to the handle and deployed to selectively obstruct the bleed tube.

[0021] According to a further feature of an embodiment of the invention, there is also provided: (a) a shuttle receiving portion for receiving the shuttle on a second side of the material; (b) a pressing portion coupled to the shuttle delivery portion, the pressing portion at least partially surrounding the shuttle delivery portion and deployable to press the material between the pressing portion and the shuttle receiving portion; and (c) at least one sensor coupled to the pressing portion and generating an output indicative of a thickness of the material between the pressing portion and the shuttle receiving portion.

[0022] According to a further feature of an embodiment of the invention, the user input portion includes a first portion of a magnetic snap and the handle includes a second portion of the magnetic snap, the first portion and the second portion of the magnetic snap being deployed such that when the user input portion reaches a fully displaced position, the first portion and the second portion of the magnetic snap abruptly close together to generate tactile and / or auditory feedback.

[0023] According to a further feature of an embodiment of the invention, the user input portion is spring-biased to return from the fully displaced position to the initial position, and the magnetic snap has insufficient retaining force to keep the user input portion in the fully displaced position against the spring bias.

[0024] According to a further feature of an embodiment of the invention, the magnetic snap has sufficient holding force to keep the user input in the fully displaced position until more aggressively displaced back toward the initial position by the user.

[0025] Unless otherwise defined herein, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs.Although similar or equivalent methods and materials as described herein may be used to carry out or test embodiments of the present invention, exemplary methods and / or materials are described below.In case of conflict, this patent specification, including definitions, will prevail.In addition, materials, methods and examples are illustrative only and are not necessarily intended to be limiting. [Brief description of the drawings]

[0026] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings, in which: While particular reference is made in detail to the drawings, it is stressed that the particulars shown are by way of example only and for illustrative discussion of embodiments of the present invention, and in this connection the description taken together with the drawings will make apparent to those skilled in the art how embodiments of the present invention may be practiced.

[0027] Attention is now directed to the drawings, in which like reference numbers or characters indicate corresponding or similar elements. [Figure 1A] FIG. 1 is a schematic perspective view of a suturing system according to one embodiment of the disclosed subject matter for use in vascular occlusion applications. [Figure 1B] FIG. 1B is an enlarged perspective view of a distal portion of the suture instrument of FIG. 1A. [Figure 2A] FIG. 1B is a perspective view of a suturing module of the suturing instrument of FIG. 1A. [Figure 2B] FIG. 1B is a perspective view of a suturing module of the suturing instrument of FIG. 1A. [Figure 2C] FIG. 1B is a side view of the suturing module of the suturing instrument of FIG. 1A. [Figure 3A] FIG. 1B is a side view of the needle delivery module of the device of FIG. 1A. [Figure 3B] FIG. 1B is a side view of the needle delivery module of the device of FIG. 1A. [Figure 3C] FIG. 1B is a side view of the needle delivery module of the device of FIG. 1A. [Figure 4A] FIG. 1B is a diagram of a shuttle including a shuttle needle for the suture instrument of FIG. 1A. [Figure 4B] FIG. 1B is a diagram of a shuttle including a shuttle needle for the suture instrument of FIG. 1A. [Figure 4C] FIG. 1B is a diagram of a shuttle including a shuttle needle for the suture instrument of FIG. 1A. [Figure 5A] 1B is a cross-sectional view of a shuttle receiver and actuation mechanism for the suturing instrument of FIG. 1A. [Figure 5B] 1B is a cross-sectional view of a shuttle receiver and actuation mechanism for the suturing instrument of FIG. 1A. [Figure 6] FIG. 1B is a cutaway view of the shaft of the suturing instrument of FIG. 1A. [Figure 7A] FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 7B] FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 7C] FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 7D]FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 7E] FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 7F] FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 7G] FIG. 1 is a diagram of the shuttle (needle) insertion sequence. [Figure 8A] 11A-11C are a series of schematic partial axial cross-sectional views through the sewing mechanism illustrating the operation of the shuttle handoff components during sewing of a series of sutures. [Figure 8B] 11A-11C are a series of schematic partial axial cross-sectional views through the sewing mechanism illustrating the operation of the shuttle handoff components during sewing of a series of sutures. [Figure 8C] 11A-11C are a series of schematic partial axial cross-sectional views through the sewing mechanism illustrating the operation of the shuttle handoff components during sewing of a series of sutures. [Figure 8D] 11A-11C are a series of schematic partial axial cross-sectional views through the sewing mechanism illustrating the operation of the shuttle handoff components during sewing of a series of sutures. [Figure 8E] 11A-11C are a series of schematic partial axial cross-sectional views through the sewing mechanism illustrating the operation of the shuttle handoff components during sewing of a series of sutures. [Figure 9A] A diagram of the shuttle (needle) retraction sequence. [Figure 9B] A diagram of the shuttle (needle) retraction sequence. [Figure 9C] A diagram of the shuttle (needle) retraction sequence. [Figure 9D] A diagram of the shuttle (needle) retraction sequence. [Figure 9E] A diagram of the shuttle (needle) retraction sequence. [Figure 9F] A diagram of the shuttle (needle) retraction sequence. [Figure 9G] A diagram of the shuttle (needle) retraction sequence. [Figure 10A] FIG. 1B is a diagram of a preload member for the device of FIG. 1A. [Figure 10B]FIG. 1B is a diagram of a preload member for the device of FIG. 1A. [Figure 10C] FIG. 1B is a diagram of a preload member for the device of FIG. 1A. [Figure 11A] FIG. 1 is a schematic block diagram of a suturing system including a human machine interface (HMI) module. [Figure 11B] FIG. 11B is a simplified schematic diagram similar to FIG. 11A showing further options for a pivot connection between the machine shaft and the HMI module. [Figure 11C] FIG. 11B is a simplified schematic diagram similar to FIG. 11A showing further options for a pivot connection between the machine shaft and the HMI module. [Figure 12A] 13A-13C are schematic diagrams of options for a full or partial pivot connection between the machine shaft and the HMI module. [Figure 12B] 13A-13C are schematic diagrams of options for a full or partial pivot connection between the machine shaft and the HMI module. [Figure 12C] 13A-13C are schematic diagrams of options for a full or partial pivot connection between the machine shaft and the HMI module. [Figure 12D] 13A-13C are schematic diagrams of options for a full or partial pivot connection between the machine shaft and the HMI module. [Figure 13A] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 13B] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 14A] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 14B]13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 15A] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 15B] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 16A] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 16B] 13A, 13B, 14A, 14B, 15A, 15B, 16A and 16B are schematic axial cross-sectional views showing more detailed implementation options corresponding to FIGS. 12A to 12D. [Figure 17] 13 is a schematic diagram of a configuration of notches for indexing the rotational position of a suturing mechanism. [Figure 18] 1 is a state diagram illustrating modes of operation of a suturing system, according to an aspect of the present invention. [Figure 19A] 1 is a schematic diagram of a drive mechanism for operating a suturing mechanism, according to an aspect of the present invention. [Figure 19B] FIG. 19B is a schematic diagram of a variation of the drive mechanism of FIG. 19A. [Figure 20] FIG. 19B is a schematic diagram of a further variation of the drive mechanism of FIG. 19A. [Figure 21A] FIG. 19B is a schematic diagram of a further variation of the drive mechanism of FIG. 19A. [Figure 21B] FIG. 21B is an enlarged view of the shaped cam element of the drive mechanism of FIG. [Figure 22A] FIG. 21B is a schematic diagram of a partial view of further components of the mechanism of FIG. 21A. [Figure 22B] FIG. 22B is an enlarged view of the sector gear element of FIG. 22A. [Figure 23A] 21B is a sequence of states of the main slide of the mechanism of FIG. 21A illustrating the sequence of operation of the mechanism. [Figure 23B] 21B is a sequence of states of the main slide of the mechanism of FIG. 21A illustrating the sequence of operation of the mechanism. [Figure 23C] 21B is a sequence of states of the main slide of the mechanism of FIG. 21A illustrating the sequence of operation of the mechanism. [Figure 23D] 21B is a sequence of states of the main slide of the mechanism of FIG. 21A illustrating the sequence of operation of the mechanism. [Figure 23E] 21B is a sequence of states of the main slide of the mechanism of FIG. 21A illustrating the sequence of operation of the mechanism. [Figure 24A] FIG. 19B is a schematic diagram of a further variation of the drive mechanism of FIG. 19A utilizing a lever as the user input. [Figure 24B] FIG. 19B is a schematic diagram of a further variation of the drive mechanism of FIG. 19A utilizing a lever as the user input. [Diagram 25] 2 is a partial axial cross-sectional view of the handle of the suturing system of FIG. 1 showing an actuator for selectively deploying the shuttle receiver according to a further embodiment of the present invention. [Figure 26A] 26A-26C are side views showing three positions of the actuator of FIG. [Figure 26B] 26A-26C are side views showing three positions of the actuator of FIG. [Figure 26C] 26A-26C are side views showing three positions of the actuator of FIG. [Figure 27A] 27A-27C are isometric, close-up, and side views, respectively, of an HMI module according to a further embodiment of the invention showing progress indicators for indicating the position and operational status of a suturing mechanism during suturing of a string of sutures. [Figure 27B]27A-27C are isometric, close-up, and side views, respectively, of an HMI module according to a further embodiment of the invention showing progress indicators for indicating the position and operational status of a suturing mechanism during suturing of a string of sutures. [Figure 27C] 27A-27C are isometric, close-up, and side views, respectively, of an HMI module according to a further embodiment of the invention showing progress indicators for indicating the position and operational status of a suturing mechanism during suturing of a string of sutures. [Figure 28A] FIG. 27B is an end view of the HMI module of FIG. 27A showing a series of states of the indicator. [Figure 28B] FIG. 27B is an end view of the HMI module of FIG. 27A showing a series of states of the indicator. [Figure 28C] FIG. 27B is an end view of the HMI module of FIG. 27A showing a series of states of the indicator. [Figure 28D] FIG. 27B is an end view of the HMI module of FIG. 27A showing a series of states of the indicator. [Figure 29A] FIG. 27B is a partial schematic diagram of a mechanism for actuating the indicator of FIG. 27A. [Figure 29B] FIG. 29B is an isometric view of a spirally split disk for use with the indicator of FIG. 29A. [Figure 30A] FIG. 13 is an exploded isometric view of an HMI module according to a further embodiment of the invention including a suture filament dispenser that provides feedback during dispensing of the suture filament. [Figure 30B] FIG. 30B is a schematic plan view of the spool of the dispenser of FIG. 30A. [Figure 31A] 1A-1C are schematic diagrams of various positions of the suturing device of the present invention relative to a blood vessel illustrating the function of the bleed tube. [Figure 31B] 1A-1C are schematic diagrams of various positions of the suturing device of the present invention relative to a blood vessel illustrating the function of the bleed tube. [Figure 31C] 1A-1C are schematic diagrams of various positions of the suturing device of the present invention relative to a blood vessel illustrating the function of the bleed tube. [Figure 32A]32A and 32B are partial isometric views showing two possible deployments of the bleed tube relative to the shaft of the suturing device. [Figure 32B] 32A and 32B are partial isometric views showing two possible deployments of the bleed tube relative to the shaft of the suturing device. [Figure 33A] 13A-13C show schematic diagrams of bleed pipe connection configurations for kink-free accommodation of relative rotation between the shaft and the HMI module according to a further aspect of the invention; [Figure 33B] 13A-13C show schematic diagrams of bleed pipe connection configurations for kink-free accommodation of relative rotation between the shaft and the HMI module according to a further aspect of the invention; [Diagram 34] 11 is a schematic diagram of a pinch valve arrangement for selectively obstructing an air bleed tube of a suturing device, in accordance with a further aspect of the present invention. FIG. [Figure 35A] 11A-11C are schematic cross-sectional views showing successive positions of a preload member for bearing against the tissue area to be punctured. [Figure 35B] 11A-11C are schematic cross-sectional views showing successive positions of a preload member for bearing against the tissue area to be punctured. [Figure 35C] 11A-11C are schematic cross-sectional views showing successive positions of a preload member for bearing against the tissue area to be punctured. [Figure 36A] 1 is a schematic side view showing measurement of blood vessel wall thickness by use of a preload member; [Figure 36B] 1A-1C are schematic isometric views showing possible deployments of sensors connected to preload members; [Figure 37A] 11A-11C are schematic cross-sectional views illustrating the operation of a magnet-based arrangement for providing tactile and / or auditory feedback on movement of a user input according to a further aspect of the invention; [Figure 37B] 11A-11C are schematic cross-sectional views illustrating the operation of a magnet-based arrangement for providing tactile and / or auditory feedback on movement of a user input according to a further aspect of the invention; [Figure 37C]11A-11C are schematic cross-sectional views illustrating the operation of a magnet-based arrangement for providing tactile and / or auditory feedback on movement of a user input according to a further aspect of the invention; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0028] Before describing at least one embodiment of the disclosed subject matter in detail, it is to be understood that the disclosed subject matter is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings, as the disclosed subject matter is capable of other embodiments or of being practiced or carried out in various ways.

[0029] Throughout this document, references are made to directions, such as proximal, distal, inward, outward, internal, external, superior, inferior, up, below, up, down, right, left, forward, rearward, etc. These directional references, including their derivatives, refer to the general orientation of the instrument (100) and / or its components as shown in the drawings (figures), which are exemplary only and are not limiting in any way, but are intended for purposes of description and illustration.

[0030] By way of preamble, aspects of the present invention relate to systems for suturing, and in particular to systems including a suturing mechanism as described in co-pending PCT patent application PCT / IB2020 / 057513. Said document was not published as of the effective filing date of this application and does not constitute prior art. The present invention relates to various aspects of a human machine interface (HMI) that is particularly suitable for use with suturing mechanisms such as, but not necessarily limited to, those described in the aforementioned application and variations thereof. To facilitate an understanding of certain aspects of the present invention, a brief description of the suturing mechanism itself will now be provided with reference to FIGS. 1A-10C. Further details of the suturing mechanism, and implementations of variations thereof, may be found in the aforementioned application.

[0031] Before referring to the drawings, by way of introduction, one aspect of the present invention relates to an apparatus and method for suturing a material(s), such as in vivo biological tissue, as part of a surgical procedure. In general terms, the apparatus and method employ a shuttle, typically in the form of a sharpened shuttle needle, which holds the suture, and a shuttle receiver which selectively holds and releases the shuttle. When holding the shuttle, the shuttle receiver forms a first piercing configuration, and after releasing the shuttle, the shuttle receiver assumes a second piercing configuration. In this second piercing configuration, the shuttle receiver is typically configured to present a sharpened needle-like end.

[0032] The shuttle receiver operates the shuttle from one side of the material (arbitrarily referred to as the proximal side) to pass the suture from the proximal side to the distal side and from the distal side to the proximal side, thereby facilitating a wide range of running stitch patterns. Specifically, passing from the proximal side to the distal side is performed by advancing the shuttle receiver in a first piercing configuration, i.e., while the shuttle is being gripped, whereby at least the shuttle penetrates the material at a first location, after which the shuttle is released from the shuttle receiver and, preferably, temporarily held by the shuttle receiver to withdraw the shuttle receiver without the shuttle from the material. Passing the suture from the distal side to the proximal side is performed by advancing the shuttle receiver in a second piercing configuration, i.e., without the shuttle, to collect and retrieve the shuttle through the material to be sutured. The shuttle delivery portion penetrates the material at a second position aligned with the shuttle temporarily retained in the shuttle receiver, engages and retains the shuttle, and draws the shuttle through the material at the second position, During each pass, the shuttles together draw the suture so that the suture extends into the material at the first position and out of the material at the second position.

[0033] Thus, the shuttle needle transfer section functions as a "push-pull mechanism" (PPM) for the corresponding shuttle needle to perform the following operations: 1. The needle is pushed through the medium to be sutured. 2. Push the needle out to the other side of the medium or inside the medium and retract without the needle. 3. Reconfigure to provide a through end. 4. Re-penetrate the medium, re-engage / collect the needle, and withdraw / retract with the needle.

[0034] This process of passing the shuttle through the material in alternating directions may be repeated at a series of locations, thereby creating a wide range of running stitch stitch configurations for a wide range of different applications.

[0035] To facilitate collection of the shuttle by passing the shuttle receiver from distal to proximal, both the shuttle and the shuttle receiver are preferably arranged to be aligned with the material at the second position. The shuttle is advantageously arranged to be held by the shuttle receiver while released from the shuttle receiver, which is configured to receive and hold the shuttle. The alignment of the shuttle receiver and the shuttle receiver on either side of the material to be sutured may be maintained by a bridging portion, which forms a mechanical interconnection between the shuttle receiver and the shuttle receiver. Various non-limiting examples of each of these structures are described in detail below.

[0036] Aspects of the present invention find a wide range of 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 shallow incisions, minimally invasive procedures, or traditional surgical procedures. As a non-limiting set of exemplary preferred implementations, the present invention is illustrated herein primarily in terms of a vascular occlusion device. As will be apparent to those skilled in the art, it will be understood that this example is only one of many suitable applications of the technology. Many other non-limiting examples of further applications are briefly mentioned below.

[0037] Reference is now made to the non-limiting example of FIG. 1A, which shows a suturing system (100) according to an embodiment of the disclosed subject matter, particularly adapted for vascular occlusion applications. The suturing instrument (100) includes a suturing module (102) optionally formed of a 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 connects to the shaft (110) at the proximal end (120p). A handle portion (130) is at the proximal end (110p) of the shaft (110) and is used to manipulate the components of the suturing module (102). A flexible link (140) extends from a distal end (120d) of the bridging portion (120), and an optional dilator (150) extends distally from the flexible link (140). The bridging portion (120) is connected to the flexible link (140), for example, such that the bridging portion (120) is rotatable relative to the flexible link (140).

[0038] 1B is a close-up view of the distal portion of the suturing instrument (100), showing the suturing module (102) and an exemplary implementation of a dilator (150) used to dilate a blood vessel in preparation for a suturing procedure and / or another procedure performed through a vascular access point. The dilator (150) has a distal cone-shaped portion (150a) that facilitates dilating the blood vessel when inserted. An internal channel extends from a side entry point (150b) to an opening at the hollow tip (150c) of the dilator. This internal channel aids in over-the-wire insertion of the device, a method known in the art.

[0039] Attention is also directed to Figures 2A-2C, which show the suturing module (102) of the suturing instrument (100) (Figure 1A). The suturing module or suturing mechanism (102) (these terms are used interchangeably herein) includes a shuttle receiver (200), a shuttle, typically implemented as a shuttle needle (210) (optionally engaged with a suture (212) or suture filament), and a shuttle (needle) receiver (220). The suturing module (102) may be designed and configured to suture media that is much thicker than the length of the needle (210), as will become apparent from the structure and function of the module as described in more detail below. The shaft (110) supports a shuttle or needle receiver (200) that is movable proximally and distally within the shaft (110), the movement of which is controllable by a handle portion (130) as described in more detail herein below. The shuttle or needle receiver (200) may be configured to push and pull the needle (210) through the medium (eg, tissue) being sutured.

[0040] The shuttle (210) is illustrated herein primarily in an implementation in which the shuttle has a piercing point and functions as a needle. Thus, the shuttle (210) is interchangeably referred to as "shuttle needle (210)" or sometimes simply as "needle (210)". Similarly, the "shuttle delivery portion (200)" and the "shuttle receiver (220)" may alternatively be referred to as the needle delivery portion (200) and the needle receiver (220), respectively. However, it should be noted that the invention may also be practiced with a shuttle without a piercing point, e.g., as described below with reference to FIG. 9C, and all features described herein are equally applicable to such embodiments unless expressly stated otherwise.

[0041] Functionally, the needle receiving portion (200) includes a shuttle holding portion for holding the shuttle (210) and a shuttle release portion displaceable relative to the shuttle holding portion for releasing the shuttle (210) from the shuttle holding portion. In the non-limiting example illustrated here, the shuttle holding portion is implemented as a tubular element (e.g., tube (204)) that engages with an external engagement surface of the shuttle (210), while the release portion is implemented as a rod portion (206) that is inwardly displaceable within the tubular element, as further described below with reference to FIG. 3C. The term "tubular element" is used herein to refer to any hollow element having a generally cylindrical appearance, including, but not limited to, general tubes of circular, polygonal or other cross-sectional shapes, such tubes with a shaped internal contour for positive engagement, as well as tubes with notched grooves or other features for increased flexibility or to provide an engagement configuration. It should be noted that, although these implementations of the shuttle retainer and shuttle release are believed to be advantageous as they are particularly simple and compact, virtually any retention configuration may be used to retain the shuttle (210), whether externally, internally, or via any other suitable mechanical engagement, by friction, by mechanical engagement, or regardless of any other form or retention. In each case, a corresponding release is provided. The release may be implemented either as an element that interacts with the retainer to remove (release) the retaining or gripping action, or as an element that can interact directly with the shuttle to push it out by overcoming the retaining force applied by the retainer, or as any combination of the above.

[0042] In the implementation illustrated here, the shuttle delivery portion (200) includes a tube (204) and a rod portion (206) arranged, e.g., coaxially with respect to one another and, e.g., axially displaceable with respect to one another. The tube (204) is movable proximally and distally on the shaft (110), the movement being controlled, e.g., by the handle portion (130), as described in more detail below. The rod portion (206) is movable proximally and distally in and out of the tube (204), the movement being controlled, e.g., by the handle portion (130), as described in more detail below.

[0043] In this example, rod portion (206) includes a sharp tip (206a) at its distal end (206d) for piercing tissue in various applications detailed herein. Rod portion (206) also functions as a pusher (or "releaser") for shuttle (210). Rod portion (206) pushes needle (210) out of delivery portion (200), for example, after needle (210) has been moved through the medium to be sutured. Pushing needle (210) is performed, for example, after needle (210) is securely positioned inside needle receiver portion (220) (pocket (224)). As the needle receiver (200) disengages and, optionally, retracts through the medium to be sutured, the rod portion (206) may hold the needle (210) inside the receiver (220) and prevent the needle (210) from being released from the needle receiver (220) during this process. Thus, due to the relative movement of the rod portion (206) and the tube (204), the rod portion (206) may release the shuttle needle (210) while the shuttle needle (210) is stationary. In this example, the rod portion (206) has a pointed suture needle-like shape (206a) at its distal end. Prior to actuation of the needle receiver (200), the pusher portion (206) is advanced relative to the distal end of the tube (204) to engage the needle (210) located in the needle receiver (220), e.g., through the medium to be sutured without the needle (210), resulting in the second piercing configuration described above. Further uses of the rod portion (206) are described in more detail below.

[0044] At least the through length (229) (FIG. 3B) of the needle receiving portion (200) typically includes the rod portion (pushing member) (206) and the tube (204), and possibly additional elements, which typically have a cross-section no larger than the shuttle needle (210). In some applications, the cross-section may have dimensions corresponding to USP #4-0 or a similar range.

[0045] Distal end (204d) of tube (204) mates with pointed tip (206a) of rod portion (206) to form a retention or engagement mechanism for shuttle (210), which is shown retained or engaged by tube (204). Additionally, distal end (204d) of tube (204) mates with pointed tip (206a) of rod portion (206) to form a release or push-out portion of shuttle (210) (into pocket (224) of shuttle receiver (220)) as part of the push-out and insert operations of shuttle (210), as shown in Figures 7A-7G, as well as a mechanism for gripping and engaging shuttle (210) and removing shuttle (210) from pocket (224) as part of the reconnection and retraction operations of shuttle (210), as shown in Figures 8A-8G.

[0046] The shuttle (210) may be, for example, a shuttle needle, as shown in Figures 4A and 4B and described in more detail below, or may be a shuttle without its own piercing point, as shown in Figure 4C. The shuttle (210) receives and holds, for example, a suture (212) extending from an opening (suture release opening) (214) in the shaft (110), where the suture (212) is fed along a lumen or contained in a suture feed volume. The opening (214) is, for example, located in the shaft (110) on the opposite side of the suture line of action (230) (Figure 2C). As an alternative geometric definition of this feature, the shuttle delivery portion (200) and the shuttle receiving portion (220) are preferably aligned along a first axis (230) corresponding to the "suture line of action". At least a portion of the bridge portion is offset in a first direction (233) from this first axis. The suture release opening (214) is preferably oriented to face away from the first axis and preferably opens toward a first direction, i.e., in intuitive terms, the suture release opening is "rear" of the device relative to the current suture line of action and is typically optimized for feeding sutures away from the current suture line of action.

[0047] Shuttle delivery portion (200) includes an outer tube (202), a tube (204), and a rod portion (206) to which is attached a shuttle (210), which is preferably fully retractable within shaft (110), for example as shown in Figure 2B, and extendable from shaft (110), as shown by double arrow (211) in Figure 2C. For medical applications, both tube (204) and rod portion (206) are typically made of surgical grade metals, including superelastic and shape memory alloys, and materials such as Nitinol, although other metallic or non-metallic materials may be used.

[0048] The bridge portion (120) supports a receiver (220), also known as a shuttle receiver (these terms are used interchangeably herein), which is, for example, pivotally mounted in a slot (222) in the bridge portion (120) and retractable into (FIG. 2B) and out of (FIGS. 2A and 2C) the slot (222), as shown by the curved double arrow (223) in FIG. 2C. The receiver (220) includes a pocket (224) for receiving the shuttle (210), for example, in a frictional or snap-lock engagement. The frictional engagement is such that the shuttle (210) can be placed and held in the pocket (224), as well as removed from the pocket (222) by the shuttle delivery portion (200). Deployment of the receiver (220) is controlled by an actuator (226), e.g., a wire acting like a spring, preferably pre-shaped to return to a deflected shape when advanced, thereby biasing the receiver (220) toward a retracted position inside the slot (222) of the bridging portion (120), and operable to move the receiver (220) to an extended position, protruding outside the slot (222) of the bridging portion (120), when the actuator (226) is withdrawn. The actuator (226) is controlled, e.g., by manipulating the handle portion (130), as described in more detail below. The actuator (226) may be made of surgical grade metals, including superelastic and shape memory alloys, as well as materials such as Nitinol.

[0049] Bridging portion (120) also preferably includes an opening or port (227a) for an air bleed tube (228). The air bleed tube extends into shaft (110) and into port (227b), through which blood can be detected. Based on the detection of blood, the user can determine that the bridging portion is inside tissue, such as a blood vessel, at the appropriate surgical site (location).

[0050] 2C, the bridging portion (120) includes a deflection portion (120x) at a proximal end (120p) that creates a lateral offset from the axis of the suturing action (230) in a direction (233) following the bridging portion (120), here implemented as a planar portion (120y). This configuration results in a suturing straight line with a predetermined offset between the suturing line of action (230) and the centerline of the rotating member.

[0051] Attention is also directed to Figures 3A-3C, which show one embodiment of the shuttle delivery portion (200). As shown in Figure 3A, the outer tube (202) supports a tube (204). The tube (204) is made of a superelastic alloy, such as Nitinol, for example, and grips and engages a shuttle (210), such as a shuttle needle (210). The rod portion (206) is moved distally into contact with the shuttle needle (210), such that its sharp distal tip (206a) seats in a recess (302) of the shuttle needle (210), as shown in Figure 3C. As a result of further distal movement from this position, the rod portion (206) functions as a pusher or release portion to release the shuttle needle (210).

[0052] FIG. 3B, for example, shows a tube (204) extending from the outer tube (202) a length that is typically greater than the thickness of the medium to be sutured, thereby defining the penetration length of the shuttle interface (200), as represented by the square bracket (229). Note that it is this penetration length that primarily defines the thickness of the material (e.g., tissue) that can be sutured using the suturing module (102). Thus, this penetration length (229) is typically selected to be greater than the length of the shuttle needle (210), and in some preferred cases, at least twice as long, more preferably at least three times as long, and often more than five times as long as the length of the shuttle needle. Thus, some implementations of the present invention can achieve bidirectional suturing of material having a thickness greater than the length of the shuttle needle (210).

[0053] The elongated portion of tube (204), designated by numeral (229), and the overall structure of the suturing mechanism with its line of action parallel to the bridging portion as depicted in FIG. 2C, allows for flexible axial positioning of the suturing device relative to the medium being sutured, allowing for suturing at access points in thinner vessels or any suture material, even when the material is thicker than the length of the shuttle needle (229) that is passed back and forth (hence the term "shuttle").

[0054] 3C shows the shuttle needle (210) being gripped or engaged by the shuttle receiver (200) prior to being pushed into the shuttle receiver (220). In this embodiment, the shuttle needle (210) includes an oversized diameter portion (304) at its proximal end (210p), which is of a larger diameter than the diameter of the tube (204). Tube (204) is preferably made of Nitinol, and when rod portion (206) is moved distally (as indicated by arrow (305)) with tip (206a) seated in recess (302) of shuttle needle (210), it pushes shuttle needle (210) distally, causing oversized diameter portion (304) of shuttle needle (210) to push tube (204) outward, deforming tube (204) and creating an engagement force that can withdraw shuttle needle (210) during suturing.

[0055] 4A-4C show a typical example of a shuttle (210) (e.g., as shown in FIG. 2A). FIGS. 4A and 4B show shuttles in the form of needles (shuttle needles) (402), (404), while FIG. 4C shows a shuttle (406). For example, in FIG. 4A, the shuttle needle (402) is female, since it is frictionally engaged by a rod portion (206) that is movable within the tube (204). For example, in FIG. 4B, the shuttle needle (404) is male, since it is frictionally engaged by the tube (204) and pushed distally by the rod portion (206) when it is desired to disengage the shuttle needle (404).

[0056] It should be noted that in each case of shuttle needles with a piercing tip, the piercing tip may have any shape suitable for piercing the corresponding material to be sutured, and is not limited to a conical tip. Alternative shapes include various shapes having beveled and / or pointed ridges, having three-fold, four-fold or other symmetries, or having an asymmetric tip.

[0057] In FIG. 4C , the shuttle (406) includes a centrally open core (408) through which the piercing tip (206a) of the rod portion (206) extends to function as the piercing tip of the shuttle (406). The rod portion (206) is of a diameter at least equal to, and typically greater than, the diameter of the core (408) so as to frictionally engage the shuttle (406). When it is desired to release the shuttle (406) from engagement with the rod portion (206), the tube (204) is moved distally to push the shuttle (406) off the rod portion (206), or the rod portion (206) is moved proximally to release the shuttle (406) from engagement with the rod portion by contacting the shuttle (406) with the tube (204), or a combination of both of the aforementioned movements.

[0058] In each of the options of Figures 4A-4C, the needle receiving portion may be configured to present a needle-like pointed end even though no shuttle or shuttle needle is present.

[0059] In many cases, the suture (212) will emerge laterally from the intermediate region of the shuttle, especially when it is desirable to provide a penetrating distal tip and a proximal portion that is grasped by the shuttle retainer.

[0060] 5A and 5B show in detail an exemplary implementation of the receiver (shuttle receiver) (220). The receiver (220) is attached to the bridge portion (120) by a pin (600) or other structure that defines a hinge axis or otherwise guides the deploying or retracting motion of the receiver (220), thereby allowing rotational movement of the receiver (220). The receiver (220) is rotated by an actuator (226) that moves the receiver between a deployed or extended position, shown in FIG. 5A, and a non-deployed or retracted position, shown in FIG. 5B. When the actuator (226) is pulled proximally (per arrow (602)), the receiver (220) moves outwardly into a deployed or extended position (FIG. 5A) to receive and engage the shuttle (210), and when the actuator (226) is pushed distally (per arrow (604)), the receiver (220) moves into slot (222) (FIG. 5B) (undeployed or retracted position). The actuator (226) is made of a shape memory alloy, such as, for example, Nitinol, and preferably includes a preformed bend (226x) that acts as a spring to retract the receiver (220) into the slot (222) and to its retracted position. The actuator (226) is attached to the channel (220x) of the receiver (220) by one or more of welding, adhesive, or mechanical fasteners, such as folds (605). Additionally or alternatively, a locking pin (220y) holds the actuator (226) in place.

[0061] The end of receiver 220 that extends out of slot 222 includes a pocket 224 for receiving and engaging shuttle 210, e.g., any of shuttle needles 210-201-7 detailed above. Pocket 224 is typically shaped to correspond to the shape of shuttle 210. In the illustrated example, flexible element 224r, which may be ring- or tubular-shaped, is positioned and configured to receive and engage the shuttle when pressed into the pocket, and to allow the shuttle to be withdrawn by shuttle delivery portion 200, as described herein. In the illustrated implementation, flexible element 224r is carried by locking pin 224x that extends laterally across at least a portion of receiver 220.

[0062] 6 shows an exemplary implementation of shaft (110). In this example, shaft (110) includes shaft envelope (110x) that supports shaft insert (110y) that includes axial envelope (110x), which may be implemented as a multi-lumen tube housing suture conveyor lumens and a bleed tube. Shaft insert (110y) includes channel (110y-1) that supports outer tube (202) and thereby shuttle delivery (200) such that actuator (226) is movable proximally and distally (as indicated by double arrow (652)) along shaft insert (110y). The suture tubular conveyor (110y-2) facilitates passage therethrough of the suture (212). An air bleed tube (228) is also supported by the shaft insert (110y).

[0063] According to one particularly preferred implementation in which the present invention is practiced, for example, in terms of a vascular occlusion device, the device is advantageously integrated with a dilator (150), which serves to expand the access site into the vessel for the shaft (110) and the bridging portion (120). As shown here, the dilator (150) is a tubular structure joined to a flexible connector (140). When inserted into the vessel, the dilator (150) is aligned with the vessel direction, typically at about 45 degrees to the longitudinal axis of the suturing device. Preferably, one or both ends of the flexible connector (140) are provided with a rotatable connection, so that rotation of the suturing device facilitates the formation of a circular suturing pattern while the dilator remains aligned with the vessel, typically without rotation. However, the flexible connector 140 should transmit axial forces from the bridging portion 120 to pull or push the dilator 150 during insertion into and removal from the vessel, while at the same time allowing the flexible connector 140 to rotate the bridging portion 120 about its line of action, for example, without rotating the dilator 150, preferably after the dilator 150 is positioned within the vessel.

[0064] The surfaces of the bridging portion (120), the flexible connector (140), and the dilator (150) are flush with one another and have a smooth tubular surface in this example. The dilator (150) is connected to the suturing module (102) via the flexible connector (140), which allows, for example, the dilator (150) to line itself up in the vessel, typically at about 45 degrees to the bridging portion (120). The flexible connector (140) transmits, for example, an axial force from the bridging portion (120) to push or pull the dilator (150) into or out of the vessel. Once the dilator (150) and the bridging portion (120) are positioned in the vessel, the flexible connector (140) preferably allows the suturing module (102) to rotate about the dilator (150) without rotating the dilator (150).

[0065] Treatment: Suturing process 1. Push in the shuttle (1st and subsequent odd-numbered suture stitches) Attention is now directed to Figures 7A-7G, which illustrate the shuttle insertion (distal movement or "pushing") process. In describing the shuttle insertion process, which is the first part of the suturing operation, forming a stitch, reference is made to the elements of Figures 1A-6 of the drawings, in conjunction with the descriptions of those elements provided above.

[0066] FIG 7A is a first sub-step of the shuttle insertion and suture insertion steps. As shown in FIG 2B, the suture (212) is joined to the shuttle needle (210) and the shuttle receiver (200) is retracted into the shaft (110). A portion of the bridge portion (120) is inserted into tissue, e.g., the blood vessel (1002), e.g., including at least the shuttle receiver (220) and the port (227a) of the air bleed tube (228). When blood exits the port (227a) of the air bleed tube (228) in the shaft (110), the position of the bridge portion (120) in the blood vessel (1002) can be confirmed. When the shuttle receiver (220) is in the deployed or extended position, it receives the shuttle needle (210). Using a conventional insertion procedure, the bridging portion (120), the flexible coupling (140) and the dilator (150) are inserted into the blood vessel (1002).

[0067] 7B and 8A show the next sub-step, in which the shuttle needle (210) engaged with the shuttle delivery portion (200), e.g., tube (204) (and rod portion (206)), is advanced distally (along with the suture (212)) toward the shuttle receiving portion (220).

[0068] The shuttle needle (210) continues to advance by moving at least the tube (204) distally, so that the sharp tip at the distal end (210d) of the shuttle needle (210) contacts tissue, as shown in FIG. 7C, and eventually pierces and penetrates tissue, e.g., the blood vessel wall (1002), as shown in FIG. 7D. Further in FIG. 7D, the shuttle needle (210) is inserted into the pocket (224) of the shuttle receiver (220) and as the shuttle needle (210) continues to be moved distally to the tip of the distal end (210d), it encounters a smaller diameter section of the pocket (224) that acts as a "stop" for the shuttle needle (210) to be moved distally. The shuttle needle (210) is now engaged within the pocket (224) of the shuttle receiver (220), e.g., by frictional forces. This corresponds to the state of FIG. 8B. At this point, the shuttle is released by the shuttle receiver. In the example illustrated here, this is accomplished by advancing the rod portion (206) until it engages the proximal portion of the shuttle needle (210) (FIG. 8C), and then withdrawing the tube (204) while the rod portion (206) pushes distally to hold the shuttle needle (210) in its pocket (FIG. 8D). The shuttle delivery portion (200) can then be withdrawn, leaving the shuttle needle in the pocket of the shuttle receiver. It should be noted that this description also applies to the specific, non-limiting implementation of the holding and releasing portions of the shuttle delivery portion (200). Corresponding steps according to alternative implementations will be apparent to those skilled in the art.

[0069] The tube (204) and rod portion (206) continue to be retracted proximally until they exit the vessel (1002) and tissue, as shown in Figure 7F, and are fully retracted into the outer tube (202) and shaft (110), as shown in Figure 8G. As shown in Figures 7E, 7F, and 7G, the shuttle needle (210) holding the suture (212) is engaged (held or grasped) within the pocket (224) of the shuttle (needle) receiver (220) by frictional forces, as described above.

[0070] 2. Pull out the shuttle (2nd and subsequent even-numbered suture stitches) Attention is now directed to Figures 9A-9G, which illustrate the shuttle retraction (proximal translation or "pulling") process. The corresponding operations of rod portion (206) and tube (204) can be understood to correspond to those of Figures 8A-8E, but in reverse. In describing the second portion of the suturing operation, the shuttle retraction process, which is forming a stitch, reference is made to the elements of Figures 1A-6 of the drawings, in conjunction with the descriptions of those elements provided above.

[0071] In Figure 9A, suture (212) has been removed from shaft (110) and bridging portion (120) and shaft (110) have been rotated (from the position shown in Figure 7G) so that shuttle delivery portion (200), outer tube (202), tube (204) and rod portion (206) are aligned with pocket (224) in shuttle receiving portion (220), which engages (holds or grips) shuttle needle (210) to retain suture (212).

[0072] The shuttle delivery portion (200), i.e., outer tube (202), tube (204) and rod portion (206), are now retracted by being moved distally out of the shaft (110) as shown in Figure 9B. Distal movement continues while the piercing tip of rod portion (206) pierces tissue or blood vessel (1002), and as shown in Figure 9C, tube (204) is also moved distally, followed by rod portion (206).

[0073] As shown in Figure 9D, rod portion (206) and tube (204) enter pocket (224), rod portion (206) contacts shuttle needle (210) at recess (302), and tube (204) frictionally engages shuttle needle (210). This frictional engagement between tube (204) and shuttle needle (210) provides a force sufficient to cause shuttle needle (210) to be gripped and engaged by tube (204) when tube (204) and rod portion (206) are retracted by being moved proximally, causing shuttle needle (210) to disengage from pocket (224).

[0074] In Figure 9E, the tube (204) and rod portion (206) are moved proximally, for example with the shuttle needle gripped (engaged) to the tube by frictional forces, thereby causing the shuttle needle (210) to be retracted along with the suture (212). As shown in Figure 9F, the shuttle needle (210) engaged to the tube (204), tube (204), rod portion (206), and optionally the outer tube (202) continues to be retracted as it is moved proximally. As shown in Figure 9G, the proximal movement of the shuttle needle (210) engaged to the tube (204), tube (204), rod portion (206), and optionally the outer tube (202) is now complete when all of those elements are inside the shaft (110).

[0075] The instrument (100) may now be returned to a position and orientation similar to that shown in FIG. 7A to perform the next or subsequent suture.

[0076] A series of suture stitches applied according to the sequence of Figures 7A-9G may be used to form a wide range of suture patterns, which preferably include an even number of suture (penetration) points. Examples include, but are not limited to, purse-string suture patterns (PSS), which preferably have an even number of suture points, usually at least four suture points, and most preferably six or eight suture points. Other running stitch patterns, particularly spiral sutures, may also be formed, where some or all of the stitches cross between two sides of an incision or wound, or between adjacent edges of two materials side-by-side, and the relative motion between successive stitches causes the device to advance along the edge of the material. One or both ends of the suture may be secured by applying multiple overlapping stitches by repeated penetrations at closely spaced locations on the material, thereby achieving self-locking or knot securing of the suture ends. This technique may be used at either the distal or distal ends of the suture, or both.

[0077] 10A-10C show an alternative embodiment, where the instrument (100) includes a preload member (1102) as part of the needle receiver (200). The preload member (1102) may be actuated prior to inserting or retracting the needle (210) through the medium to be sutured. The distal end (1102a) of the preload member (1102) has a bulbous shape that allows for clamping forces to be applied at different angles to a tubular surface, such as a vessel wall. In FIG. 10A, a cross section of a vessel (1002) is shown with the suturing module in an initial position. In FIG. 10B, the vessel (1002) wall is clamped, thereby immobilizing the tissue for clean penetration. In FIG. 10C, the suturing is performed.

[0078] Although not limited to such implementation, the suturing device is most preferably implemented as a minimally invasive suturing device including an elongate body for percutaneous insertion, with the user input and linkage (described below) implemented as part of a handle coupled to the proximal end of the elongate body. The phrase "elongate body" is used herein to refer broadly and collectively to the dilator, bridge portion and shaft of the suturing mechanism described thus far. Thus, the shuttle delivery portion extends either medially or laterally along the proximal portion of the elongate body.

[0079] Overview of HMI modules and implementation options Certain aspects of the invention relate to features of a human machine interface (HMI) module, which is typically at least partially integrated with a handle (130) or other holder that can be grasped by a user and connected to an elongate body to which a suturing mechanism (102) is coupled. In Figure 11A, a schematic functional representation of an HMI module (500) is illustrated, in which the HMI module (500) is illustrated as including one or more of the following subsystems: a suture control mechanism (502) for controlling the operation of the suturing mechanism (102), a suture dispenser (504), an air bleed tube outlet and control valve (506), and a mechanism (508) for controlling the deployment of the shuttle receiver (220). Each of these subsystems is described in further detail below. For simplicity of presentation, HMI module (500) is shown generally as a simple rectangle in other figures herein without detailing these subsystems, although it should be understood that in each case it may include all or some of the subsystems shown in FIG. 11A.

[0080] The HMI (and stitching control) module may be implemented in a range of different embodiments. The unit may include mechanical elements such as gear trains, cams and cam followers, levers, and combinations thereof, electromechanical elements and actuators such as DC motors, brushless motors, piezoelectric actuators, and others, and sensors such as force sensors, position sensors, pressure sensors, and others, and may optionally include connection elements to an external power source, preferably to an internal power source. In an embodiment, the HMI module may include an electrical circuit with logic components such as a PLC, memory, motion controller, wired or wireless components, and the like. The electrical circuit may be external to the HMI module. Connections may be provided to facilitate operation and control of the HMI module using external modules, such as by robotic control, and a variety of different interface elements may be utilized to provide user inputs to the HMI module, such as mechanical elements such as levers and knobs, and electromechanical elements such as switches, touch sensors, force sensors, and others.

[0081] 12A-12D, it is noted that various suturing applications of the present invention require motion of the suturing mechanism between successive stitches relative to the material (e.g., tissue) being sutured. In a first particularly preferred but non-limiting set of applications, the relative motion is achieved by rotating the suturing mechanism about its longitudinal axis, particularly in the region of the bridging portion (120), thereby achieving a stitch pattern around the opening through which the elongate body is inserted. FIGS. 12A-12D diagrammatically illustrate a number of options as to how this motion is generated using different implementations of the HMI module (500).

[0082] 12A illustrates an HMI implementation with one unit, where the suturing pattern is applied by repeatable, typically axial, actuation of the suturing mechanism (through a control located on the body of the unit) followed by rotation of the unit to reposition the suturing mechanism to different puncture points.

[0083] 12B illustrates an HMI implementation with two units. In this case, a first stationary unit (optionally a lower unit as shown) can position the HMI module relative to the suturing site and remains stationary throughout the suturing procedure. A second unit (optionally an upper unit as shown) is displaceable to perform a normally axial suturing action (through a control located on the unit body) and a second rotational movement to reposition the suturing mechanism to a different puncture point. The control for actuating the suturing mechanism is preferably located on the second unit.

[0084] FIG. 12C illustrates a schematic of an HMI implementation with two units, where the first unit (preferably the lower one) is rotatable to position the HMI module relative to the suture site. This unit may be directly connected to the shaft to rotate the device or reposition the suturing mechanism to different puncture points. The second unit, preferably the upper unit as illustrated here, controls the displacement of the suturing mechanism, usually in the axial direction, preferably through a corresponding control located on the unit body, to achieve suture stitches at the respective positions. The combination of the second unit operations at a sequence of positions selected by the first unit positions results in the desired suturing pattern.

[0085] 12D illustrates diagrammatically an HMI with a single unit, with external functionality to facilitate positioning the HMI module relative to the suture site, and optionally internal mechanisms for actuating the suturing mechanism to achieve suture stitches and for rotating the suturing mechanism to new puncture points thereby generating a desired suturing pattern, preferably also with externally accessible input functionality. In this embodiment, the suturing controls may be preferably located in an external unit or remote module (not shown) that has an electromechanical interface with the HMI module.

[0086] Depending on which of these form factors is selected, various different types of mechanical interfaces may be implemented between the HMI module (500) and the shaft (110), as illustrated in Figures 11A-11C. In the case of Figure 12A, as illustrated diagrammatically in Figure 11A, the HMI module (500) is advantageously rigidly attached to the shaft (110), whereby rotation of the HMI module / handle rotates the suturing mechanism between the desired positions. The same may be true for the lower module of Figure 12C. In other cases, the shaft (110) may advantageously be connected to the HMI module (500) via a pivotable (rotatable) connection, whereby part or all of the HMI module (500) can remain stationary while the device shaft is rotated to the desired suturing position for applying the next stitch. This type of connection is illustrated diagrammatically in Figures 11B and 11C, where a bearing (510) provides a pivotal connection between the shaft (110) and at least a portion of the HMI module (500). Optionally, as illustrated in Figure 11C, at least a portion of the pivotable shaft (110) may be surrounded by a tubular member (sleeve) (512) that is rigidly connected to the HMI module (500).

[0087] Also, as will now be described with reference to Figures 13A-16B, the form of interconnection between the various portions of the HMI module (500) varies between the different configurations of Figures 12A-12D. Specifically, Figures 13A and 13B illustrate a rigid connection between the HMI module and the shaft. In this case, the HMI module is rotated to move the suturing mechanism to a new puncture point, while axial actuation of the suturing mechanism is actuated by a control located in the HMI module.

[0088] 14A and 14B illustrate a semi-pivotable connection between the HMI module and the shaft. In this case, a first unit, preferably the lower part, may contain some of the control elements of the HMI module and is connected directly to the shaft to rotate the device and reposition the suturing mechanism at different puncture points. A second unit, preferably the upper part, used to actuate the suturing mechanism to achieve the suturing pattern, may contain the other controls of the HMI module, as well as display.

[0089] 15A and 15B illustrate an inverted semi-pivotable connection between the HMI module and the shaft. Again, the first unit (preferably the lower part) is for utilizing actuation of the suturing mechanism (through a control located on the unit body), which is usually axial, to achieve the suturing pattern. The second unit (preferably the upper part) is used to rotate (reposition) the suturing mechanism at different puncture points. The upper unit is preferably directly connected to the shaft.

[0090] 16A and 16B illustrate an implementation with a pivotable connection between the HMI module and the shaft. In this scenario, the HMI module is stationary while axial and rotational movement of the sewing mechanism is performed by the HMI module or a remotely located control to achieve the sewing pattern. The HMI module may also include a sub-unit connected to the shaft such that the rotation of the shaft is displayed.

[0091] Insofar as the rotational movement between the two suturing positions is controlled by relative rotation between a rotatable element (connected to the shaft) and a stationary (non-rotating) element, it may be advantageous to provide an index using index marks and / or positive tactile feedback. This may be accomplished using a spring-loaded element, such as a ball bearing, that engages with a series of corresponding recesses, thereby defining well-defined index positions at predefined positions or angular intervals. This is illustrated in FIG.

[0092] HMI module operation sequence As described in more detail above with particular reference to Figures 8A-8E, operation of the suturing mechanism requires a specific sequence of operation of the shuttle receiver coordinated with repositioning of the device to apply a series of bidirectional suture stitches together to form a running stitch back and forth through the tissue (or other material being sutured).

[0093] Specifically, after initially deploying the sewing mechanism and positioning the first sewing stitch, the HMI module (500) shall generate the following series of operations: 1st stitch - proximal to distal ("PUSH" or "PUT"): i. Axial displacement of the shuttle delivery portion from a withdrawal position to a penetration position to penetrate the material at a first location (hereinafter referred to as "penetrating the material"). ii. Reconfiguring the shuttle delivery section from a shuttle-holding state to a shuttle-releasing state (hereinafter referred to as "releasing the shuttle"). iii. Axial displacement of the shuttle delivery portion from the penetration position to a withdrawal position to withdraw the first suture stitch from the material while leaving the first suture stitch in the first position (hereinafter referred to as "withdrawing"). iv. As part of reconfiguring to release the shuttle or as a separate action, forming a pierce configuration of the shuttle delivery section without the shuttle, ready for piercing as part of a subsequent "PULL" stitching cycle (typically included in "Release Shuttle"). Position change 1: v. Reposition the shuttle transfer section and the shuttle so that they are lined up at the position of the second stitch or the position of the next even-numbered stitch (hereinafter referred to as "displacing to the next position"). Second stitch - distal to proximal ("PULL" or "GET"): vi. Axial displacement of the shuttle delivery portion from the withdrawn position to a penetrating position to penetrate the material at the second location (hereinafter referred to as "penetrating the material"). vii. Reconfiguring the shuttle delivery section from a shuttle releasing state to a shuttle holding state to hold the shuttle (hereinafter referred to as "holding the shaft"). viii. Axial displacement of the shuttle delivery portion from the penetration position to a withdrawal position to withdraw the shuttle from the material while forming a second suture stitch at the second location (hereinafter referred to as "withdrawing"). ix. As part of reconfiguring to hold the shuttle or as a separate action, taking the shuttle together to form the shuttle transfer section piercing configuration and preparing it for piercing as part of a subsequent "PUSH" sewing cycle (typically included in "holding the shuttle"). Position change 2: x. Reposition the shuttle transfer station and shuttle to line up with the next odd numbered stitch on every cycle except the last stitch (hereafter referred to as "displace to next position").

[0094] According to one non-limiting aspect of the invention, although it is possible to implement a number of separate user controls / inputs to perform these different operations, a simplified interface is provided in which some or all of these operations are actuated, unidirectionally or bidirectionally, by displacing the user input. Appropriately designed linkages are used to convert the displacement of the user input, unidirectionally or bidirectionally, into the required sequence of operations, optionally including repositioning or where the repositioning is performed through a separate operation. Below are described a number of non-limiting exemplary mechanisms for providing this functionality.

[0095] The term "linkage" as used in the specification and claims refers to any combination of elements that defines a causal relationship between the movement of a user input and the various outputs required to achieve a required operation. The "linkage" defined thus may include multiple mechanisms operated in parallel, and may include solely mechanical components, or various electrical machines, or otherwise powered or power assisted components. Most preferably, the linkage is a mechanical linkage.

[0096] The user input may be any suitable input. Examples include, but are not limited to, a button, a slider, a lever, and a rotatable knob. The actuation of the user input may be unidirectional, such as a button, slider or lever that springs back to its original position, or a rotatable knob that completes a sequence of operations by returning to its starting position. In the case of a spring-back user input, the return action may be a neutral action that does not perform any operation of the suturing mechanism, or may be coupled through a linkage to perform one or more further operations of the suturing mechanism.

[0097] Alternatively, the user input may be bidirectionally actuated, such as a slider or lever that is actively displaced linearly, pivotally, or otherwise, first in one direction and then in the opposite direction, or a pair of opposing buttons that are alternately depressed to produce bidirectional movement of a single user input, etc. In the case of two opposing buttons, these are considered herein to be bidirectional operation of a single user input if they act in both directions on the same input element of the linkage, as illustrated by the example of Figure 22 described below.

[0098] According to a first particularly preferred subset of implementations of the invention, the user input is a machine-operated user input, where a mechanical force is provided by the user, which is converted by the linkage to perform various operations of the suturing mechanism. However, implementations in which the user input force is supplemented or replaced by a force from another source when performing one or more operations of the suturing mechanism also fall within the scope of this aspect of the invention. Such a force source may be a pre-tensioned arrangement of one or more springs, or an actuator driven by any suitable energy source, either built-in or external, such as electrical power or fluid pressure.

[0099] In certain non-limiting but preferred implementations of the suture mechanism described above, the operations of "release shuttle" and "hold shaft" and the corresponding operations of reconfiguring to the first and second piercing configurations are accomplished by differential axial displacement of the shuttle holder (204) and shuttle pusher (206). This aspect of the invention is illustrated below with reference to a linkage that achieves the corresponding required relative axial displacement and operates this exemplary mechanism. However, it should be noted that alternative implementations of the shuttle receiver that perform the functions of "release shuttle" and "hold shaft" by some other mechanism, such as a mechanism that utilizes relative axial rotation between the two elements, also fall within the scope of this aspect of the invention.

[0100] A particularly preferred feature of certain implementations of this aspect of the invention is that a drive mechanism for operating a suturing mechanism having a shuttle carrying a suture that is driven bidirectionally through a material by a shuttle receiver is provided, the drive mechanism including a user input displaceable through a range of motion and a linkage mechanically coupled to the user input and the shuttle receiver, the linkage configured to translate displacement of the user input, unidirectionally or bidirectionally, into a sequence of operations of the shuttle receiver, the sequence of operations comprising: A. The operations for applying the first (or odd-numbered) suture stitch, including the operations defined above as penetrating the material (with the shuttle), releasing the shuttle, and withdrawing (without the shuttle); Then, the shuttle transfer section and the shuttle are repositioned so that they are aligned in the second position, B. The operations for applying the second (or even-numbered) suture stitch, including the operations defined above as penetrating the material (without the shuttle), holding the shuttle, and withdrawing (with the shuttle).

[0101] By further repositioning the shuttle transfer section at subsequent locations and repeating the above sequence, further stitches can be applied, preferably in pairs, to form a running stitch stitch at any desired series of piercing locations and with a corresponding stitch pattern.

[0102] Resizing may be done manually or may be accomplished by coordination as a result of user input, as exemplified below.

[0103] The operation for forming each sewing stitch may be performed by one complete operating cycle of the user input (e.g., a back and forth operation), by a part of a cycle (e.g., a unidirectional displacement without a return operation), or by several operating cycles of the user input. In any case, the operating cycle of at least a part of the linkage preferably occurs over the operations corresponding to the two sewing stitches, since the operation of the sewing mechanism to be performed, as all described above in detail, necessarily distinguishes between successive stitches, with odd-numbered stitches performing a PUT operation of the shuttle and even-numbered stitches performing a GET operation of the shuttle.

[0104] Example behavior changes In the case of a reciprocating motion between endpoints "A" and "B", such as the linear displacement of a button or slider, or the angular displacement of a lever, the operation performed by the linkage may be mapped to any desired combination of user input motions, and may be by any of the following, as non-limiting examples:

[0105] [Table 1]

[0106] [Table 2]

[0107] For a rotary input, such as a rotatable knob, the range of options is typically similar to the examples above, with the motion from A to B, or the full cycle of ABA, typically mapped to rotations by a full or half rotation. Two non-limiting examples are:

[0108] [Table 3]

[0109] Referring now to FIG. 18, it may be useful to describe the operation of the suturing mechanism by the drive mechanism in terms of a logical "state machine" for applying N stitches (usually an even number). FIG. 18 illustrates such a description, where "PUT NEEDLE" and "GET NEEDLE" each represent a corresponding set of operations of the needle receiver, as detailed above (in examples where the shuttle has a piercing tip, the shuttle is interchangeably referred to as a "needle"). As with the various examples described above, the operation of "ROTATE SHAFT" (one example of displacing to the next stitch position) may be performed by the drive mechanism or may be a manual operation by a user. The stopped state may be based on a user decision as the stitching process progresses, or may be a mechanical "brake". N is typically 6 or 8, but other numbers may be used.

[0110] A number of possible implementations of the drive mechanism are described at a schematic level with reference to Figures 19A-24B. These examples are presented here in schematic terms only, in order to illustrate the principles of operation to a degree sufficient to practically practice the invention, without taking into account dimensions, gear tooth details, and numerous other details which would be readily determined by one of ordinary skill in the art when implementing such mechanisms.

[0111] Reference is now made to Figure 19A, which illustrates a drive mechanism (700) for synchronizing the operation of a suturing mechanism such as those described above based on the unidirectional displacement of a user input in the form of a push button (701). The dimensions of the different gear wheels, cams and other elements are not to scale and do not represent actual gear ratios.

[0112] Pressing the push button (701) activates either the PUT or GET needle action as per FIG. 18, respectively, and then axially rotates the device shaft and suturing mechanism through a pre-determined angle to the new puncture point (e.g., 60 degrees for six stitches surrounding the opening). One-way bearings (702) and (703) operate the mechanism only while the button is pressed. The bearings are each geared with an externally toothed gear wheel. Activation of the one-way bearings is accomplished by gear racks (202) and (709), respectively.

[0113] The gear ratio between gear wheels (704) and (705) allows cam (706) to rotate 360 ​​degrees, while the gear ratio between gear wheels (704) and (707) allows cam (708) to rotate only 180 degrees per depression of button (701).

[0114] Cam (706) may have a simple eccentric profile with an eccentric amplitude as a motion function f1() corresponding to the required back and forth movement of the shuttle retainer. Cam (706) engages an opening in slider (710) and acts as a double-sided flat cam follower. Cam (708) may have a profile with function f2() corresponding to the required shuttle pusher movement with the cam profile projected over 180 degrees. Slider (711) has a similar opening for cam (708).

[0115] Another gear rack (709) is also connected to the button (701), but in a position and length designed to rotate the one-way bearing (702) only after the cam (706) has rotated 360 degrees and the cam (708) has rotated 180 degrees. The one-way bearing (702) preferably rotates both the needle-transport tube (204) and rod member (206) of the suturing mechanism and the device shaft (110) together. The cam (706) actuates the axial movement of the slide (710), and the cam (708) actuates the axial movement of the slide (711). Advantageously, the slide (710) is connected to the tube member (204) through a swivel joint (712), and the slide (711) is connected to the extruder (rod) member (206) through a swivel joint (713). As a result of one-way bearings (702) and (703), spring (714) returns button (701) to its initial position and does not allow further movement to be produced.

[0116] Figure 19B illustrates an alternative implementation of the drive mechanism (700) generally similar to that of Figure 19A with like elements labeled similarly. This implementation differs from Figure 19A in that the location of the gear portion of the rack (709) is now located closer to the distal end of the rack and the direction of rotation of the one-way bearing (702) is reversed. In this case, rotation of the device shaft (110) together with the suturing mechanism occurs during the return motion of the button (701) after completing a needle PUT or GET sequence while the button (701) is pressed inward.

[0117] 20, which is a partial view of a further variation implementation of the drive mechanism of the present invention, in which the HMI module is implemented using a pair of opposing buttons (721) and (722) that are alternately pressed to activate PUT and GET needle actions, respectively. These buttons may be arranged and used in several non-limiting embodiments, including: Two separate buttons, each biased by a spring (723), each with its own gear rack (724) and (725) and, optionally, separate linking elements such as gear wheels (726), (727) and (728). Two buttons, connected together by gear racks (725) and (724) which cooperate as a single bidirectional shuttle member carrying the gear rack. Two separate buttons, each biased by a spring (723), acting against a single separate shuttle slide (729) combining both gear rack (724) and gear rack (725) into a single element.

[0118] The device may be fitted with a shuttle slider (729) arranged to urge the first button inwardly and away from the second button. Left-right movement of the shuttle slider from one button to the other by the user typically accomplishes a PUT or GET needle action.

[0119] Optionally, two shuttle slides (729) may be arranged on either side of the one-way bearing (728) so that the suturing mechanism rotates only when the PUT or GET needle action is completed. Advantageously, the gap between the racks may be longer than the length of the rack parts. Advantageously, depending on the implementation of the mechanism, the gear wheel (727) may transmit the motion to the gear wheel (726) in both directions. The remaining parts of the linkage are not shown in FIG. 20, but may be generally similar to the linkage described with reference to FIG. 19A or may be generally similar to the one described below with reference to FIG. 21A, and the gear wheel (727) in FIG. 20 may be considered as the gear wheel (704) in FIG. 19A or the gear wheel (733) in FIG. 21A. Other elements not shown in this figure may be similar to the elements described in FIG. 19A or FIG. 21A.

[0120] It should be noted that the linkage in the drive mechanism of Figures 19A and 19B includes a first transmission (gear wheels (704) and (705), eccentric cam (706) and slider (710)) that defines a first timing profile for operating the shuttle holder (204) in response to the displacement of the user input (701), and a second transmission (gear wheels (704) and (707), shaped timing cam (708) and slider (711)) that defines a second timing profile for operating the shuttle pusher (206) in response to the displacement of the user input (701). At least the second timing profile defines the operation of the shuttle pusher (206) in response to the displacement of the user input (701) over two cycles of displacing the shuttle transfer section from the withdrawn position to the through position and back to the withdrawn position, the operation over the first of the two cycles being non-identical to the operation over the second of the two cycles.

[0121] 21A and 21B, which illustrate an alternative approach to the implementation of the linkage, where the shuttle pusher (206) and the shuttle holder (204) are attached to a common slide, the main slide (735). In this case, the linkage preferably includes a first transmission defining a first timing profile for operating the slide in response to the displacement of the user input, and a second transmission defining a second timing profile for operating the shuttle pusher and / or the shuttle holder in response to the displacement of the slide. The overall motion of the shuttle pusher is then the sum of the motion of the main slide and the differential motion of the shuttle pusher relative to the main slide. At least this differential action defined by the second timing profile defines the action of the shuttle pusher and / or shuttle holder in response to the displacement of the user input over two cycles of displacing the shuttle transfer section from the withdrawal position to the penetration position and back to the withdrawal position, and the action over the first of the two cycles (e.g., the "PUT" process) is non-identical to the action over the second of the two cycles (e.g., the "GET" process).

[0122] Preferably, either the PUT or GET needle action is activated by pressing (and releasing) the push button button (731), respectively, and then the device shaft and suturing mechanism are rotated (e.g., 60 degrees per step) to the new puncture point.

[0123] Pressing the button (731) displaces the gear rack (732), which in turn rotates the gear wheel (733) 180 degrees together with the eccentric cam (734). The cam (734) has a simple eccentric profile with an eccentric amplitude as motion function f1 per one push and release action, and may force linear motion of the primary slide (735) through engagement with an opening (743) in the primary slide (735) and function as a double-sided flat cam follower. A similar opening (744) in the secondary slide (737) engages with a piggyback secondary cam (736). A preferred exemplary form of the cam (736) is shown enlarged in FIG. 21B.

[0124] The axis of cam (736) is connected to the main slide for movement therewith. Gear wheel (745) is axially interconnected to cam (736) for rotation therewith. Gear rack (742) is also connected to button (731) which has a position and length selected to operate one-way bearing (738) only after cam (734) has rotated 180 degrees back and forth (completing a needle PUT or GET action). One-way bearing (738) rotates both device shaft (110) and the tube (204) and rod portion (206) of the needle receiving portion of the suturing mechanism.

[0125] The primary slide 735 is connected to the tube 204 through a swivel joint 739, and the secondary slide 737 is connected to the pusher (rod) member 206 through a swivel joint 740. A spring 741 biases the button 731 back to its initial position.

[0126] Figure 22A illustrates the same structure as Figure 21A, but shows other components on another layer of the mechanism not visible in Figure 21A, according to one preferred implementation. Specifically, a slotted frame (750) is shown with two gear racks (746), one on each side, axial to the main slide (735) and aligned along the direction of motion. The slotted frame (750) is rigidly connected to the enclosure (747) of the suture drive mechanism. The gear racks may each have one tooth (748) at one rack end located on each side, which may optionally be slightly longer (protruding).

[0127] The sector gear wheel (749) is shaped to fully engage only one of the gear racks (746) at any angular position, and when the geared portion of the wheel is perpendicular to the gear racks on both sides (Figures 23A or 34B), the ends of its teeth are just outside the line defining the ends of the gear teeth on both sides. Only in this position can the protruding teeth (748) mesh with the sector gear teeth.

[0128] Sector gear wheel (749) (FIG. 22B) is axially interconnected for co-rotation with gear wheel (751), their common axis of rotation being attached to main slide (735). Gear wheel (751) typically meshes with gear wheel (745) with a gear ratio of 2:1 (one rotation of wheel (751) typically rotates wheel (745) 180 degrees).

[0129] When the apex of the cam (734) and the cam apex (752) are aligned upward with the line of motion of the main slide (735), the sector gear wheel (749) is normally positioned in the position of FIG. 23A so as to be driven by the gear racks (746) on both sides.

[0130] The size of cam (734), sector gear wheel (749), and gear wheels (751) and (745) may be adjusted to rotate cam (736) from the position in FIG. 23A to the position in FIG. 23C, or vice versa, during a 360 degree rotation of cam (734) (or two 180 degree rotations back and forth).

[0131] The profile of the cam (736) is typically a symmetrical combination of surfaces (755) that correspond to the differential motion of the shuttle pusher (206) required for the motion of the shuttle retainer (204) (Figure 21B), which itself corresponds to the motion of the main slide (735) as determined by the cam (734). The sequence of motion of the overall drive mechanism is illustrated in Figures 23A-23E.

[0132] As mentioned above, in various implementations (not shown), the displacement of the primary cam (734) may be generated by two opposing buttons similar to those described above with reference to FIG.

[0133] Referring now to FIG. 24A, it is noted that the user input of the present invention may utilize linear motion, rotational motion, or any other desired motion. As a further non-limiting example, FIG. 24A illustrates a drive mechanism in which PUT or GET needle action is achieved by operation of a lever input (770) against the bias of a spring (777). The lever input may be connected to both the main slide (771) and a gear rack (772) that is part of member (778) via a gear train that combines gear wheels such as gear wheels (773), (774) and a double gear wheel (775). The main slide (771) may include a gear rack (776), preferably on its side, for engagement with the gear train. Member (778) may include a second gear rack (779) for rotating a geared one-way bearing (738) connected to the device shaft (110) along with the suturing mechanism. Typically, the rotational action is accomplished upon return of the lever after completion of the needle GET or PUT action.

[0134] Other aspects of the suturing control mechanism may be similar to those described above with reference to Figures 19A-23E.

[0135] 24B illustrates a further variation implementation of the user input employing a dual lever input (780), where the PUT and GET needle actions may each be accomplished by operation of the dual lever (780), optionally without a return spring.

[0136] The gear train connecting the dual lever input to the linkage may be adjusted to achieve a "full" GET or PUT needle operation and then rotate the device shaft and suturing mechanism to a new puncture point. For example, by pressing lever end A, a PUT needle action is achieved, and then by pressing lever end B, a GET needle action is achieved. The device may be fitted with a dual lever button, with one side already pressed, usually side B. The lever gear (780a) may be directly meshed with the main slide presented in the previous figures, such as FIG. 24A.

[0137] Needle Receptacle Actuator Position A feature of preferred examples of the suturing mechanisms described herein, and many others otherwise known in the art, is the use of a selectively deployable shuttle receiver to receive and / or hold a shuttle distal to the material to be suturing during one or more stages of the suturing process. The shuttle receiver is preferably retractable to a retracted position relative to the elongate body and selectively deployable to a deployed position to receive the shuttle. A further feature of the invention, while not necessarily limited to the particular details of the suturing or drive mechanism sequence for the suturing process, relates to the positioning of an actuator (781) associated with the shuttle receiver to deploy the shuttle receiver from a retracted position to its deployed position. Specifically, according to an embodiment of the invention, the actuator (781) is coupled to the handle (130) at a location distal to the user input for the suturing operation, as shown in FIG. 1. This distal positioning ensures that the mechanism does not obstruct user access to the suturing control mechanism during the subsequent suturing sequence.

[0138] Non-limiting examples of actuators for deploying the shuttle receiver are illustrated in Figure 25 and Figures 26A-C. Specifically, Figure 25 illustrates an axial cross section of the lower end of the HMI module (handle) showing the rotation mechanism and gripper components for deploying the needle receiver.

[0139] As illustrated here, a rotating gripper (781) at the bottom end of the HMI handle (782) engages with an interior space used as a partially linear, partially rotational track or slot for the rotating gripper. A connecting member (783), preferably made of a superelastic alloy such as Nitinol, is preferably hidden inside the device shaft (784) and engages the rotating gripper at (785). To deploy the needle receiver, the rotating gripper is pulled proximally (arrow (786)), after which the gripper is rotated to lock (arrow (787)). The locking action may be configured to be a clockwise or counterclockwise rotation.

[0140] To release the needle receiver at the end of the procedure, the rotating gripper is disengaged by rotating it in the opposite direction to the locking. Optionally, a spring (788) may then force the rotating gripper back to its initial position, releasing tension and pushing the connecting member (783) distally. Releasing tension on the connecting member allows the needle receiver to retract to its undeployed position.

[0141] It should be noted that, while distal positioning of the actuator (781) is believed to have certain advantages in certain implementations, further considerations may in some cases lead to alternative preferred implementations of the actuator for the shuttle receiver. For example, in the alternative embodiment illustrated in FIG. 27A, deployment of the shuttle receiver is controlled by a lever (781') that is configured to mechanically impede operation of the user input (701) of the suturing mechanism when the shuttle receiver is in its retracted position (FIG. 27C). This prevents inadvertent reversal of the sequence of operations required when using the device.

[0142] Stitching progress indicator A further aspect of the present invention, while not necessarily limited to the particular details of the suturing mechanism described above, is the provision of an indicator that provides a visual indication as to the current position and / or status of the suturing device for applying a series of running stitches. Non-limiting examples of implementations of this functionality are illustrated herein with reference to Figures 27A-29B.

[0143] Referring to Figures 27A and 27B, in all cases where rotation of the stitching mechanism between stitches occurs relative to at least a portion of the HMI module (such as by the options of Figures 12B, 12C and 12D), the non-rotating portion of the HMI module may advantageously include an indicator, illustrated here as a stitching progress dial (801).

[0144] The dial (800) preferably includes a pointer (802) that indicates the angular position of the current puncture, which may be the angular position relative to the first initial puncture point about the axis of the device insert (803).

[0145] Most preferably, the dial also provides a visual indication of the suturing (puncturing) progress at the current location. For example, all of the dial marks may have an initial color (804), which changes to color B (as shown at (806)) after completing a local suturing (puncturing) cycle at the "active mark" (805) (current location). Thus, when the suturing procedure is completed, all of the dial marks are changed to color B. Figures 28A-28D illustrate a number of stages in the progress of a suturing procedure using a device designed to apply six consecutive stitches. At each stage, the operator can immediately see where the suturing device is currently deployed and whether a suturing stitch has already been completed at that location.

[0146] The indicator may be mechanical, electromechanical, or any combination thereof. The indicator may be located directly on the device or may be located at a remote location on the device using a wired or wireless connection. The dial markings or display information may be alphanumeric. The suturing progress and status, such as the pointer and color (804) or (806), may be displayed through the use of an LED or LCD. Advantageously, the indicator may include a display of additional indicators such as blood pressure, progress of the suture during suturing, a bar code, and others.

[0147] Mechanical dial embodiments may include a pointer directly connected to the device shaft or a geared connection such that rotation of the shaft rotates the pointer. The color of the dial markings may change depending on the completion of the user input.

[0148] 29A and 29B illustrate diagrammatically possible implementations of a mechanism for providing a dial display having the characteristics described above. The device utilizes an indicator arm to indicate the current rotational state of the suturing mechanism and a spirally split disk to gradually change the apparent color of the colored state indicator at each position.

[0149] After depressing the suture button (731) and releasing it, the one-way bearing (738) rotates both the device shaft (110) and the gear wheel (817), thus rotating the dial shaft (810) and the pointer (802) to the next puncture point and dial mark.

[0150] A one-way rotating lever (812) is deployed to rotate a spiral disk (813) of a second color B through an angular step by the action of button (731), thereby changing the apparent color of the current puncture point from color A to color B. The color of the disk may be visible through a marking slot on the dial floor (814).

[0151] Both spiral discs (813) and (815) have radial slots (816) that overlap during rotation of disc (813).

[0152] Suture feeder with feedback A further aspect of the present invention, although not necessarily limited to the particular details of the suturing mechanism described above, provides audio and / or tactile feedback to indicate that suture is being dispensed from the dispenser. When operating a suturing system capable of applying a series of suture stitches, each successive stitch requires the dispensing of an additional length of suture. As the suture is dispensed, a series of "clicks" or other audio, tactile and / or visual feedback is generated, providing intuitive feedback to the operator that the successive suture stitches (applied percutaneously and therefore invisible) are progressing well.

[0153] One example of a suture dispenser according to this aspect of the invention is illustrated in Figures 30A and 30B. In this case, a spool (820) is incorporated into the HMI module, and may optionally be part of a disposable cassette. A supply of suture filament (821) is provided and wound around the spool.

[0154] The cover of the spool may include one or more openings (822) to confirm rotation of the spool as the filament is fed into the suturing mechanism. The sidewall of the spool may include markings (823) that are visible through the openings (822) as the spool rotates, providing visual confirmation that the filament is exiting.

[0155] Additionally or alternatively, one or more of the sidewalls of the spool are implemented with a plurality of peripheral protrusions or recesses, optionally resembling teeth (824), on the exterior or underside of the sidewall. The teeth preferably engage a flexible member (825). The flexible member may prevent unwanted free rotation of the spool when filament is not being fed to the suturing mechanism. This also preferably produces clicking sounds and tactile vibrations during rotation of the spool.

[0156] Bleed pipe management Further aspects of the present invention, while not necessarily limited to the particular details of the suturing mechanism described above, allow for management of the bleed tube to accommodate relative rotation between a shaft and a portion of the HMI module, allowing for selective occlusion and re-opening of the bleed tube.

[0157] As mentioned above, a bleed tube is advantageously provided, extending from the bleed inlet (132) along the elongate body to an outlet connected to the handle, to allow confirmation of correct positioning of the device within the blood vessel.

[0158] The principle of operation of the bleed tube is illustrated in Figures 31A-31C. In Figure 31A, the inlet access hole (132) is outside the blood vessel (131) and blood cannot flow. In Figure 31B, the device is inserted further into the blood vessel to the point where the access hole is exposed to blood flow (135), which can reach the device HMI module through a conduit in the device shaft (133). Correct positioning of the device is thus confirmed by the release of a drop of blood from the bleed tube outlet. In Figure 31C, the needle receiver (134) of the suturing mechanism has been deployed. Blood may still flow to the HMI module.

[0159] The bleed pipe may be implemented either externally (FIG. 32A) or internally (FIG. 32B) to the equipment shaft. In either case, the bleed line is most preferably implemented as a continuous pipe without couplings or connectors.

[0160] In the case of an elongate body that is rotatable about its longitudinal axis relative to the handle to apply stitches at successive angular positions around the elongate body, the bleed pipe connection preferably accommodates relative rotation of the shaft with respect to the handle without bending of the bleed pipe.

[0161] To avoid the complexity of any kind of swivel connection incorporated into the bleed tube, aspects of the present invention provide a particularly elegant and simple solution for accommodating this relative rotation. In particular, it has been found sufficient to provide an unsupported loop of tubing positioned to accommodate relative rotation between the elongate body and the handle for the range of rotation typically required for the suturing device of the present invention (typically 360 degrees or less). Optionally, the unsupported loop may be provided with a braided or otherwise kink-resistant sleeve or other reinforcement to further inhibit bending of the tubing during rotation.

[0162] This aspect of the invention is illustrated in Figures 33A and 33B, where the bleed line (840), preferably a flexible microtube, optionally made of a flexible material such as silicone, may be turned within the HMI module (136) to allow the device shaft (133) and suturing mechanism to rotate at least 360 degrees relative to the HMI module without bending. Preferably, the turning tubing includes a loop of tubing (841) to provide rotational flexibility (842).

[0163] Additionally or alternatively, a pinch valve is preferably coupled to the handle and deployed to selectively block the bleed tube. This option is illustrated in FIG. 34, where a normally closed pinch valve is shown. Alternatively, the valve may be implemented as a toggle valve, and the device may be pumped, preferably with the valve set to open and flow. Alternatively, an electromechanical valve may be used.

[0164] In the example illustrated here, the pinch valve is enclosed inside the HMI module (136). A flexible blood line (840) passes through the valve body (843). The tubing is clamped between the valve anvil (844) and a pinching element (845), which is optionally part of the valve spool (846). The spool is acted upon by a flexible element (847), typically a spring, which clamps the tubing and stops blood flow unless the protruding end (848) of the spool is pressed in.

[0165] Sensor-equipped clamping member As already described above with reference to Figures 10A-10C, certain particularly preferred implementations of the suturing device of the present invention utilize a preload member (or clamping member or pusher) (1102) to press against the tissue prior to penetration, thereby stabilizing the tissue. According to further features of certain particularly preferred implementations of the present invention, at least one sensor is coupled to the pusher to generate an output indicative of a thickness of material between the pusher and the shuttle receiver, and / or to provide, in some cases, other important information regarding the characteristics of the tissue faced by the pusher.

[0166] 35A to 35C are cross-sectional views of the needle passing section including preload members corresponding to the positions in FIGS. 10A to 10C, respectively.

[0167] In full stock, the force on jaws (1102) may be exerted through a buckled spring (852) or directly by a "step" (853) on the needle delivery shaft.

[0168] According to the implementation shown in Figures 36A and 36B, the clamping member (1102) extends along the device shaft (856) to the sensor (857), preferably in the HMI module (858), and may optionally be integrated directly into the tubular element (855).

[0169] The sensor, which may be mechanical or electromechanical, may obtain measurements such as obtaining (859) the thickness of the vessel wall (860) and may advantageously provide additional information, such as an indication of the stiffness of the vessel wall during the clamping action.

[0170] Tactile feedback using magnetic elements Further aspects of the invention, without necessarily being limited to the particular details of the suturing mechanism described above, utilize magnetic elements to provide tactile and / or auditory feedback. Thus, in one implementation, the user input (876) includes a first portion of a magnetic snap and the handle includes a second portion of the magnetic snap. The first and second portions of the magnetic snap are deployed such that when the user input reaches a fully displaced position, the first and second portions of the magnetic snap suddenly close together to generate tactile and / or auditory feedback. This feature may be implemented using any of the buttons and / or levers of the HMI module for any suturing system.

[0171] 37A-37C, which illustrate an HMI module (875) having a button (876) biased outwardly by a spring (877), and a tactile feedback module including a magnet (828) integrated into the button, a spring (879), and a reciprocating member (880) rigidly connected to the spring, or other flexible member. The reciprocating member (880) is a complementary part of a "magnetic snap" for operation with a magnet (878), which may itself be a magnet, or more preferably is made of a ferritic material or alloy. Both members (879) and (880) may move in a limited, predefined manner, in this case axially, toward the magnet (878) in the button.

[0172] As shown in FIG. 37B, when button (876) is pressed inward, ferrite member (880) is pulled by the magnetic force achieved by magnet (876), which results in stretching of spring (879). The magnetic force exerted by magnet (876) on ferrite member (880) is non-linear with the distance between them. As a result, ferrite member (880) accelerates as it moves toward magnet (876) until its motion is stopped by its surroundings. The cessation of accelerated motion results in sound and vibration.

[0173] As shown in Figure 37C, when button (876) is released, the greater pushing force generated by spring (877) causes the button to return, thereby releasing ferrite member (880). Spring (879) then pulls it backwards to its initial position. The strength of spring (879) and ferrite member (880) may be optionally selected to also generate vibrations and sounds during the backward movement of the ferrite member.

[0174] The described structure may also be used as a toggle mechanism: if the magnetic force is strong enough to overcome the force of the spring (877), the button will be locked in its depressed position until another element, such as an internal member or an opposing button, actively pushes it back outward.

[0175] Although the suturing mechanism of the present invention has been illustrated above in terms of a vaso-occlusion device, the suturing mechanism of the present invention can be readily implemented in other terms and for other procedures, including, but not limited to, closing an incision, wound or lesion in one material, changing the shape or other properties of one material, attaching two or more materials placed in an overlapping manner by suturing through both layers, joining two edges of two regions of material, which may be of the same type or body of different material, and securing the suture to the material by repeatedly passing the suture through the material intimately to form an overlapping stitch. Any and all of the above materials may be natural biological tissue or any other material. The device and method may perform suturing to interconnect artificial or man-made materials and biological tissue.

[0176] Another set of procedures suitable for performance using the suturing device of the present invention are coronary artery procedures, including, but not limited to, patent foramen ovale (PFO), atrial septal defect (ASD), and other types of structural heart disease.

[0177] The subject matter of the present disclosure is also applicable to a variety of cardiovascular procedures, including, but not limited to, left atrial appendage closure (LAAO), left atrial appendage closure (LAAC), (AAA or EVAR) aneurysm repair, and more generally, transcatheter aortic valve repair, and minimally invasive apical occlusion or minimally invasive left ventricular repair.

[0178] The disclosed subject matter is also applicable to a wide range of minimally invasive procedures, including, but not limited to, endoscopic procedures, laparoscopic procedures, gastroscopic procedures, otoscopic procedures, and minimally invasive gynecological procedures. It will be recognized that the above description is intended to serve as an example only, and that many other embodiments are possible within the scope of the invention as defined in the appended claims.

[0179] It will be appreciated that the above description is intended to serve as an example only, and that many other embodiments are possible within the scope of the invention as defined in the appended claims.

Claims

1. A drive mechanism for operating a suturing mechanism mounted on a shaft connected to a handle, the suturing mechanism having a shuttle for holding a suture thread, movement of the shuttle being controlled by a shuttle delivery section displaceable along a longitudinal axis between a withdrawal position and a penetration position, the shuttle delivery section being reconfigurable between a shuttle holding state and a shuttle released state, the drive mechanism comprising: (a) a user input portion displaceable relative to the handle through a range of motion; (b) a linking unit mechanically connected to the user input unit and the shuttle transfer unit, the linking unit being configured to convert a displacement of the user input unit into a series of operations of the shuttle transfer unit in one direction or two directions, the series of operations of the shuttle transfer unit including: (i) axially displacing the shuttle delivery portion relative to the handle from the withdrawal position to the penetration position to penetrate material at a first location; (ii) reconfiguring the shuttle delivery section from the shuttle holding state to the shuttle releasing state; (iii) axially displacing the shuttle delivery portion relative to the handle from the penetration position to the withdrawal position to withdraw the shuttle delivery portion from the material while leaving a first suture stitch in the first position; Next, after changing the position of the shuttle delivery section and the shuttle so that they are aligned at a second position, (iv) axially displacing the shuttle delivery portion relative to the handle from the withdrawn position to the penetrating position to penetrate the material at the second location; (v) reconfiguring the shuttle transfer section from the shuttle releasing state to the shuttle holding state to hold the shuttle; (vi) axially displacing the shuttle delivery portion relative to the handle from the penetration position to the withdrawal position to withdraw the shuttle from the material while forming a second suture stitch at the second position; unidirectional or bidirectional displacement of the user input relative to the handle causes a sequence of operations (i)-(iii) of the shuttle delivery part to be performed such that both the shuttle and the shuttle delivery part are released from the substance without requiring axial displacement of the handle or the shaft; a drive mechanism, wherein further displacement of the user input relative to the handle in one or both directions performs a series of operations (iv)-(vi) of the shuttle delivery part, causing both the shuttle and the shuttle delivery part to move away from the substance without requiring axial displacement of the handle or the shaft.

2. 2. The drive mechanism of claim 1, wherein reconfiguring the shuttle handset from the shuttle holding state to the shuttle release state generates a tissue penetrating configuration of the shuttle handset without the shuttle, and reconfiguring the shuttle handset from the shuttle release state to the shuttle holding state generates a tissue penetrating configuration of the shuttle handset together with the shuttle.

3. The drive mechanism according to claim 1 , wherein the repositioning of the shuttle transfer section is also performed unidirectionally or bidirectionally by the linkage section driven by the displacement of the user input section.

4. 2. The drive mechanism of claim 1, wherein the linkage is configured to translate further displacement of the user input into a repetition of the sequence of operations of the shuttle interface, in one direction or two directions, when aligned with a third position and a fourth position to form a running stitch stitch in the material.

5. The drive mechanism of claim 1 , wherein the user input is manually displaceable in a first direction and is spring-loaded to return in the opposite direction upon release.

6. 2. The drive mechanism of claim 1, wherein the shuttle delivery section includes a shuttle holding section and a shuttle pushing section, and reconfiguring the shuttle delivery section between the shuttle holding state and the shuttle releasing state is accomplished by axial movement of the shuttle pushing section relative to the shuttle holding section.

7. 7. The drive mechanism of claim 6, wherein the linking unit includes: a first transmission unit that determines a first timing profile for operating the shuttle holding unit in response to a displacement of the user input unit; and a second transmission unit that determines a second timing profile for operating the shuttle pushing unit in response to a displacement of the user input unit.

8. 8. The drive mechanism of claim 7, wherein the second timing profile defines an operation of the shuttle pusher in response to a displacement of the user input over two cycles of displacing the shuttle transfer portion from the withdrawn position to the through position and back to the withdrawn position, and the operation over a first of the two cycles is non-identical to the operation over a second of the two cycles.

9. 7. The drive mechanism of claim 6, wherein the shuttle pusher and the shuttle holder are attached to a common sliding part, and the linking part includes a first transmission part that defines a first timing profile for operating the sliding part in response to a displacement of the user input part, and a second transmission part that defines a second timing profile for operating the shuttle pusher and / or the shuttle holder in response to a displacement of the sliding part.

10. 10. The drive mechanism of claim 9, wherein the second timing profile defines operation of the shuttle pusher and / or the shuttle holder in response to displacement of the user input over two cycles of displacing the shuttle transfer portion from the withdrawn position to the through position and back to the withdrawn position, and the operation over a first of the two cycles is non-identical to the operation over a second of the two cycles.

11. 2. The drive mechanism of claim 1, wherein the suturing device is a minimally invasive suturing device in which the shaft is part of an elongate body for percutaneous insertion, and the user input portion and the linkage portion are implemented as part of the handle coupled to a proximal end of the elongate body.

12. 12. The drive mechanism of claim 11, wherein the suturing device further includes a shuttle receiver for receiving the shuttle on the second side of the material, the shuttle receiver retractable relative to the elongate body to a retracted position and selectively deployable to a deployed position to receive the shuttle, and the drive mechanism further includes a manually operated actuator associated with the shuttle receiver for deploying the shuttle receiver from the retracted position to the deployed position, the actuator being coupled to the handle at a location distal to the user input.

13. 12. The drive mechanism of claim 11, wherein the elongate body is rotatable about its longitudinal axis relative to the handle to apply stitches at successive angular positions about the elongate body, the handle further including a mechanical indicator coupled to the elongate body and configured to provide a visual indication as to a current rotational position of the elongate body relative to the handle.

14. 14. The drive mechanism of claim 13, wherein the mechanical indicator is further coupled to the linkage and configured to provide a visual indication when the suture has completed passing through the material at the current rotational position.

15. 12. The drive mechanism of claim 11, further comprising a suture feeder coupled to the handle for feeding a suture along the elongate body to the shuttle, the suture feeder configured to provide tactile and / or auditory feedback to a user as the suture is dispensed.

16. 12. The drive mechanism of claim 11, wherein the elongated body is rotatable about its longitudinal axis relative to the handle to apply stitches at successive angular positions around the elongated body, the elongated body further including an air bleed pipe extending from an air bleed inlet along the elongated body to an outlet connected to the handle, the air bleed pipe including an unsupported loop of pipe positioned to accommodate relative rotation between the elongated body and the handle.

17. 17. The drive mechanism of claim 16, further comprising a pinch valve coupled to the handle and deployed to selectively obstruct the air bleed tube.

18. The drive mechanism includes: (a) a shuttle receiver for receiving the shuttle on a second side of the material; (b) a pressing portion coupled to the shuttle delivery portion, the pressing portion being deployable to at least partially surround the shuttle delivery portion and to press the substance between the pressing portion and the shuttle receiving portion; and 12. The drive mechanism of claim 11, further comprising: (c) at least one sensor coupled to the pusher and configured to generate an output indicative of a thickness of the material between the pusher and the shuttle receiver.

19. 12. The drive mechanism of claim 11, wherein the user input portion includes a first portion of a magnetic snap and the handle includes a second portion of the magnetic snap, the first and second portions of the magnetic snap being deployed such that when the user input portion reaches a fully displaced position, the first and second portions of the magnetic snap abruptly close together to generate tactile and / or auditory feedback.

20. 20. The drive mechanism of claim 19, wherein the user input portion is spring-biased to return from the fully-displaced position to an initial position, and the magnetic snap has insufficient retaining force against the spring bias to keep the user input portion in the fully-displaced position.

21. 20. The drive mechanism of claim 19, wherein the magnetic snap has sufficient holding force to keep the user input in the fully displaced position until more aggressively displaced back toward an initial position by a user.

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