Suturing device and mechanism for operating same

Abstract

A suturing device (10) employs a displaceable bi-stable mechanism allowing a user to perform continuous bi-directional suturing by continuously pressing a single actuation button (14) as the device rotates. The displaceable bistable mechanism may also be used in other medical and non-medical applications. Also disclosed are various configurations of the suture shuttle stent and the distal shuttle receiver having a retention structure that produces a retention force profile that is optimized for the suture sequence.

Description

Technical Field

[0001] The present invention relates to medical devices, in particular suturing devices. In addition, the present invention provides various mechanisms for operating medical devices, which are suitable for operating the disclosed suturing devices, but can also be used with a range of other suturing devices and other medical devices. Background Art

[0002] Various aspects of the present invention will be described herein in the non-limiting context of suturing devices of similar types to those described in co-applied, commonly assigned patent applications (published as WO2021 / 024236A1 and WO2021 / 111429A1), which are hereby incorporated by reference as if set forth in their entirety herein. Summary of the invention

[0003] The present invention provides mechanisms for operating medical devices (eg, suturing devices) and various details of such devices.

[0004] According to the teachings of an embodiment of the present invention, a mechanism for operating a medical device is provided, which comprises: (a) a handle; (b) an effector assembly, which is mounted on the handle so as to be displaceable in an axial direction relative to the handle, the effector assembly comprising: (i) a first effector; (ii) a second effector; (iii) a bistable mechanism, including a bistable element; and (iv) a biasing assembly, which comprises at least one first spring element and at least one second spring element, wherein the biasing assembly biases each of the first effector and the second effector toward a distal direction relative to the bistable element; the bistable element is in a first axial state and a second axial state, and in the first axial state, the second effector is biased toward a first relative axial direction relative to the first effector. position, in which, in the second axial state, the second effector is biased to a second relative axial position relative to the first effector; and (c) a force input end, arranged to selectively apply an input force to the bistable mechanism; wherein the force applied to the force input end in a first direction is effective, in sequence: (i) displacing the effector assembly distally along the axial direction without changing the state of the bistable mechanism; and (ii) switching the bistable element between the first axial state and the second axial state when at least a portion of the effector assembly is further displaced distally and encounters an obstacle; wherein the biasing assembly is configured to enable the bistable mechanism to switch from the first axial state to the second axial state without requiring the second effector to reach the second relative axial position.

[0005] According to further features of embodiments of the present invention, the first spring element acts between the first effector and the second effector, and the second spring element acts between the second effector and the bistable element.

[0006] According to further features of embodiments of the present invention, the first spring element acts between the first effector and the bistable element, and the second spring element acts between the second effector and the bistable element.

[0007] According to further features of embodiments of the present invention, the mechanism further comprises a retraction spring, the retraction spring being deployed to return the bistable mechanism, the first effector and the second effector along the axial direction toward a proximal direction.

[0008] According to further features of an embodiment of the present invention, the first effector is a bracket for holding a suture needle, and the second effector is an ejector. When the second effector moves from the first relative axial position to the second relative axial position, the second effector ejects the suture needle from the bracket.

[0009] According to further features of embodiments of the present invention, in the second relative axial position, the ejector has a penetrating tip.

[0010] According to further features of embodiments of the present invention, at least one of the first spring and the second spring is deployed with a preload force, the preload force defining a minimum force required to change the length of at least one spring.

[0011] According to further features of the embodiments of the present invention, in the first axial state of the bistable element, the first spring is expanded with a first preload force, and the second spring is expanded with a second preload force, and in the second axial state of the bistable element, at least one of the first preload force and the second preload force changes, so that a ratio between the first preload force and the second preload force is different between the first axial state and the second axial state.

[0012] According to the teachings of an embodiment of the present invention, a suturing mechanism is also provided, which comprises: (a) a needle having a sharp distal tip, a middle portion configured to receive a suture thread, and a proximal engagement portion, wherein the proximal engagement portion comprises a first portion adjacent to the middle portion and a second portion close to the first portion, wherein the first portion has a circumscribed cylinder with a diameter (D1) and a length (L1), and the second portion has a circumscribed cylinder with a diameter (D2) greater than the diameter (D1) and a length (L2); and (b) a bracket for releasing the suture thread. The support comprises a tube made of a superelastic material, the tube having a tip section and a second section, the tip section having a length no greater than the length (L1) and an inner diameter matching the diameter (D1), the second section having a length greater than the length (L2) and an inner diameter matching the diameter (D2); when the tube is forced against a proximal end of the needle, the second section passes through the tip section of the tube, thereby causing elastic deformation of the tip section, and when the second section is fully inserted into the second section, the tube is substantially not deformed.

[0013] According to further features of an embodiment of the present invention, a shape of the proximal engagement portion of the needle and a design of the tube are such that when fully inserted, the force required to remove the needle from the stent is greater than the force required to insert the needle into the stent.

[0014] According to further features of embodiments of the present invention, a portion of the tube proximate the second section has the same inner diameter as the tip section of the tube.

[0015] According to further features of an embodiment of the present invention, the tube extends proximally to the second section, and an inner diameter of the tube is equal to an inner diameter of the second section.

[0016] According to further features of an embodiment of the present invention, the suturing mechanism further comprises an ejection element, which is disposed in the tube and can move along the tube so as to eject the needle from the bracket.

[0017] According to the teachings of an embodiment of the present invention, a needle receiver for passively holding the needle of a suturing device is also provided, which includes: (a) a receiver body having: a needle receiving hole extending parallel to a hole axis and for receiving the needle; and a retaining element groove extending from one side of the receiver body and intersecting with the needle receiving hole; and (b) an elastic snap fastener fixture disposed in the retaining element groove so that the elastic snap fastener fixture is aligned in the needle receiving hole to elastically hold the needle.

[0018] According to further features of an embodiment of the present invention, the receiver body also includes a locking element channel intersecting with the retaining element groove, and the elastic snap fastener retainer is interconnected with an anchoring structure, the anchoring structure having a hole aligned with the locking element channel, and the needle receiver also includes a locking element, which is deployed in the locking element channel so as to engage the hole, thereby anchoring the elastic snap fastener retainer in a position aligned with the needle receiving hole.

[0019] According to further features of embodiments of the present invention, the resilient snap fastener and the anchoring structure are connected to each other via a flexible connecting element to facilitate self-alignment of the resilient snap fastener with the needle inserted into the needle receiving hole.

[0020] According to further features of embodiments of the present invention, the elastic snap fastener, the flexible connecting element and the anchoring structure are integrally formed as a unitary flat element made of superelastic material.

[0021] According to further features of the embodiment of the present invention, the elastic snap fastener is a snap ring.

[0022] According to further features of an embodiment of the present invention, the needle receiving hole has an internal stepped hole, and the internal stepped hole is used to define a fully inserted position of the needle.

[0023] According to further features of an embodiment of the present invention, the needle receiver also includes a needle for inserting into the needle receiver, the needle having a peripheral groove for receiving the elastic snap fastener retainer, and the peripheral groove and the elastic snap fastener retainer are configured so that the force required to release the needle from the needle receiver is greater than the force required to engage the needle in the needle receiver.

[0024] According to the teachings of an embodiment of the present invention, a suturing mechanism is also provided, which includes: (a) a shuttle having a middle portion configured to receive a suture and a proximal engagement portion, the proximal engagement portion having an axial hole, the axial hole being surrounded by an edge having a radius (R2) from a central axis of the shuttle; (b) a shuttle receiver having a hole for receiving and releasably holding the shuttle in an inserted position, the hole having an opening, the opening having a radius (R1), and when in the inserted position, the opening is located at an axial height (H) from the edge of the axial hole of the shuttle; and (c) a shuttle ejector configured to engage the shuttle in the hole, the shuttle ejector using a penetration structure in which the shuttle ejector terminates at a penetration point, the penetration structure having a gradually increasing radius so that at an axial distance (H) from the penetration point, the penetration structure has a radius (R3), wherein the radius (R3) is greater than the difference (R1-R2) of the radius (R1) minus the radius (R2). BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Some embodiments of the present disclosure are described herein with reference to the accompanying drawings. The description together with the drawings makes it clear to one of ordinary skill in the art how some embodiments may be practiced. The drawings are for illustrative purposes only and are not intended to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present disclosure. For clarity, some objects depicted in the drawings are not drawn to scale. In the drawings:

[0026] Figures 1A to 1C 1 is a schematic diagram of a mechanism for operating a device, such as a suturing device, constructed and operated in accordance with one aspect of the present invention, the mechanism being illustrated using a parallel biasing device, a series biasing device, and a hybrid biasing device, respectively.

[0027] FIG. 2A(i) to FIG. 2A(iv) is based on Figure 1A A mechanical schematic diagram of a mechanism in a first retracted state, a first deployed state, a second deployed state, and a second retracted state, respectively.

[0028] FIG. 2A(iv)′ is a view similar to FIG. 2A(iv) showing a bistable mechanism with separable elements.

[0029] Figure 2B(i) to Figure 2B(iv) They are Figure 1B Mechanical schematic diagram of the mechanism shown in a first retracted state, a first deployed state, a second deployed state and a second retracted state.

[0030] Figure 2C(i) and Figure 2C(ii) are Figure 1B A mechanical schematic diagram of an alternative mechanism in a first deployed state and a second deployed state.

[0031] Figure 2D(i) and Figure 2D(ii) are Figure 1C Mechanical schematic diagram of the mechanism shown in a first deployed state and a second deployed state.

[0032] 3A(i) and 3A(ii) are schematic diagrams showing, respectively, various stages of the operating sequence of the mechanism of FIG. 2A for use in a suturing device for delivering a needle into a needle receiver and retrieving a needle from a needle receiver.

[0033] Figure 3B is a schematic diagram showing various stages of the operating sequence of the mechanism of FIG. 2B for transferring a needle to a needle receiver in a suturing device.

[0034] Figure 4A A perspective view of a suturing device according to some embodiments is schematically shown.

[0035] Figure 4B A cross-sectional view of a handle according to some embodiments is schematically shown.

[0036] Figure 4C A perspective view schematically illustrates a handle of a suturing device being operated by a user according to some embodiments.

[0037] Figure 5A is a cutaway perspective view of a portion of the interior of a handle, and an exemplary click mechanism module removed from the handle.

[0038] Figure 5B A schematic cross-sectional view of an exemplary click mechanism module is shown according to some embodiments.

[0039] Figure 5C A partial cross-sectional view of a handle including a click mechanism is shown according to some embodiments.

[0040] Figure 6 Schematically illustrates an axial cross-sectional view of an operating stage of a suturing mechanism during a suturing process according to some embodiments.

[0041] FIG. 7A to FIG. 7G Schematic cross-sectional views of a portion of a handle including a click mechanism module in different states according to some embodiments are shown, wherein: Fig. 7A The initial position of the click mechanism is shown (state 1, initial position); Figure 7B State 2 is shown (the shuttle is in the receiving module (pocket)); Figure 7C State 3 is shown (the ejector of the shuttle ejector module contacts the proximal end of the shuttle); Fig.7D State 4 is shown (click action switches from state A to state B and vice versa); Fig. 7E Display state 5 (locked after clicking); Figure 7F State 6 is shown (PPM reply and shuttle ejected); Figure 7G The final position (state 7) is shown.

[0042] Fig. 8A Schematically illustrates a perspective exterior view of a pocket deployment module located in a handle of a suturing device, according to some embodiments.

[0043] Figure 8B Show Fig. 8A A cutaway perspective view of a pocket deployment module.

[0044] Figure 8C A schematic cross-sectional view of a pocket deployment mechanism in a handle of a suturing mechanism is shown in accordance with some embodiments.

[0045] FIG. 8D(i) to FIG. 8D(ii) According to some embodiments, the center position of the pocket retracted and pocket expanded states is displayed.

[0046] FIG. 8E(i) to FIG. 8E(ii) An exemplary visual indication of pocket position is shown with respect to rotation of a knob of a pocket deployment mechanism (PDM) in accordance with some embodiments.

[0047] Figure 8F An exemplary arrangement for defining the end of rotational motion of a cam of a PDM is shown in accordance with some embodiments.

[0048] Figure 8G Schematic diagram showing a connecting element and corresponding support tube of a pocket deployment mechanism according to some embodiments.

[0049] Fig.9A Schematic diagram showing an exemplary cam and follower module allowing for tactile feedback in accordance with some embodiments.

[0050] Fig. 9B yes Fig.9A A three-dimensional view of the middle cam.

[0051] FIG. 10A to FIG. 10C is a partial perspective cutaway view of an exemplary pocket deployment module according to some embodiments.

[0052] Fig.11A is a perspective cutaway view of a drain assembly according to some embodiments showing an external drain tube extending from a handle of a suturing device connected / routed to an internal drain tube via a manifold.

[0053] Fig. 11B yes Fig.11A An enlarged schematic diagram of the flow path within the manifold of the exhaust assembly.

[0054] Fig. 11C yes Fig.11A A perspective view of the manifold of the exhaust assembly.

[0055] Fig.11D and Fig.11E An enlarged perspective view of the discharge drip plug is shown with a view of a drop of blood dripping therefrom.

[0056] Fig.11F is an enlarged partial cross-sectional view of the suturing mechanism area of ​​the suturing device, showing the distal components of the discharge assembly, including the internal discharge tubes and their respective discharge openings.

[0057] FIG. 12A to FIG. 12C is a partial cross-sectional view showing the path of the suture tube passing through the handle of the suturing device according to some embodiments, respectively showing a cut-away stereoscopic view of the proximal flat circular ring element, a stereoscopic view of the interior of the handle housing, and a top view of the cut-away flat circular ring element.

[0058] FIG. 13A to FIG. 13B is an isometric view showing a safety latch mechanism in an engaged state and a disengaged state, respectively, according to some embodiments.

[0059] Fig. 13C A partial cross-sectional view of a flat ring element is shown, illustrating the interior portion of the internal safety catch engagement mechanism.

[0060] Fig.14A A perspective view of an exemplary shuttle is shown in accordance with some embodiments.

[0061] Fig. 14B It is a partial three-dimensional cross-sectional view of the shuttle and the proximal region of the stent (tube).

[0062] Fig. 14C is a partial perspective cutaway view of the shuttle-to-shuttle ejector module interface associated with the shuttle receiver module.

[0063] Fig.15A is a partial perspective sectional view showing the engagement of the shuttle needle with the shuttle support according to another aspect of the present invention.

[0064] Fig. 15B yes Fig.15A Axial cross-section of the arrangement.

[0065] Fig. 15C and Fig.15D They are similar to Fig.15A and Fig. 15B , for a variant embodiment of a shuttle support tube.

[0066] Fig.16A is a perspective view of an exemplary configuration of a distal region of a shuttle holder (PPM) tube for interfacing with a shuttle, having two enlarged openings, according to some embodiments.

[0067] Fig. 16B yes Fig.16A A stereoscopic view of the shuttle support tube associated with the shuttle.

[0068] Fig. 16C and Fig.16D They are respectively Fig.16A and Fig. 16B A similar view showing the distal end of the PPM tube, with two partial openings.

[0069] Fig.16E is a partial perspective cutaway view showing the distal end of the PPM tube, having an opening.

[0070] Fig.16F and Figure 16G They are respectively Fig.16A and 16B A similar view showing the distal end of the PPM tube, with the slot opening.

[0071] Fig.16H Additional exemplary configuration diagrams of the distal region of the PPM tube for interfacing with a shuttle are schematically shown.

[0072] Fig.17A is a perspective view of a receiver module according to some embodiments.

[0073] Fig. 17B is with Fig.17A Similar partial cross-section.

[0074] Fig. 17C Show Fig.17A A perspective view of the engagement elements of a receiver module.

[0075] Fig.17D Show Fig.17A A cross-section taken axially through the receiver module interface with the shuttle.

[0076] Fig.18A and Fig.18C is a perspective view of an alternative embodiment of a shuttle engagement element according to a variant embodiment of the present invention.

[0077] Fig.18B and Fig.18D They are respectively Fig.18A and Fig.18C A partial perspective cutaway view of a receiver module of a shuttle engagement element.

[0078] FIG. 19A to FIG. 19D is a schematic cross-sectional view of a shuttle ejector approaching a shuttle within a bore of a shuttle receiver in an off-axis manner, showing successive stages of a self-alignment process according to another aspect of an embodiment of the present invention.

[0079] Fig. 20 yes Fig.19A Magnified view of the area marked with box XX in FIG.

[0080] FIG. 21A(i) to FIG. 21A(iii) is a side view of a rotary connector according to some embodiments, showing three different fixed-angle rotary connectors providing different deflection angles.

[0081] Fig.21B It is a partial cross-sectional side view similar to Figure 21A(i).

[0082] Fig. 21C is an axial cross-sectional view of the distal end of the suturing mechanism connected to the dilator via the rotary connector of Figure 21A(i).

[0083] Fig.21D yes Fig. 21C A stereoscopic view of the distal end of the shaft of the suturing mechanism module.

[0084] Fig.21E 21A(i) is an enlarged axial cross-sectional view of the connection between the rotary connector and the distal end of the insert. DETAILED DESCRIPTION

[0085] The present invention provides mechanisms for operating medical devices (eg, suturing devices) and various details of such devices.

[0086] By way of introduction, the present invention describes a class of mechanisms that can be used to operate devices in various medical and other applications in which a combined motion of two elements (referred to as a first effector and a second effector) is required. Specifically, the mechanism addresses the situation in which it is necessary for the two effectors to perform a combined motion (move together), and it is also necessary to switch between two states in which relative motion occurs between the two effectors. An exemplary application requiring such motion is a suturing mechanism, in which a first displacement may cause the needle to penetrate the tissue and become stuck in a distal needle receiver (or "pocket"), and a subsequent movement between the two elements may release the needle to remain in the pocket and retract. In addition, or alternatively, the combination of displacements may cause the needle holder to engage the needle held on the distal side of the tissue, and the relative movement between the two elements may cause the needle holder to grasp the needle for extraction through the tissue. However, the mechanism itself is not limited to any particular implementation of a suturing mechanism, and may also be applicable to a variety of other applications in the medical field and other fields. Therefore, Figures 1A to 3B Features of various implementations of the mechanism will be presented in a schematic manner, suitable for a wide range of applications, and covering a variety of possible implementations.

[0087] Then, through a specific example, reference Figures 4A to 7G In the context of a particularly preferred embodiment, the implementation of the mechanism is described and reference will be made to FIG. 8A to FIG. 20 C describes a number of complementary features that are advantageously implemented in a particularly preferred suturing device according to various further aspects of the present invention.

[0088] Universal actuator with displaceable bistable mechanism

[0089] Now generally refer to Figures 1A to 3B , wherein a mechanism, generally designated as 100, is shown, which is constructed and operated according to one aspect of the present invention for operating a device, such as a medical device, and according to some particularly preferred embodiments, for operating a suturing device. Details of the device are not shown in these figures, but will be described by non-limiting examples later in this article. The mechanism 100 produces motion relative to an external reference, shown here as an external housing or handle 102. The effector assembly 104 is mounted relative to the handle 102 so that it can move relative to the handle in an axial direction (arrow 106). The effector assembly 104 includes a first effector 184 and a second effector 182. An effector is an element that interacts with or constitutes a part of the actuated device. In the particularly preferred but non-limiting example shown below, the first effector 184 is a bracket for holding a suturing needle, and the second effector 182 is an ejector for releasing the suturing needle from the bracket. Therefore, throughout the document, these elements may be referred to as brackets 184 and ejectors 182, but it should be noted that these terms only apply to non-limiting subgroups of exemplary embodiments of the present invention.

[0090] The effector assembly 104 also includes a bistable mechanism 170, which includes a bistable element 172, and a biasing device, which includes at least a first spring element 180B and a second spring element 180A. The biasing device biases each of the first and second effectors 184 and 182 in a distal direction relative to the bistable element 172. FIG. 2A (i) to FIG. 2D (ii) In the bistable state shown in the figure, the bistable element 172 presents a first axial state (Figures 2A(i), 2B(i), 2C(i) and 2D(i)), in which the second effector 182 is biased to a first relative axial position relative to the first effector 184, and presents a second axial state (Figures 2A(ii), 2B(ii), 2C(ii) and 2D(ii)), in which the second effector 182 is biased to a second relative axial position relative to the first effector 184.

[0091] Optionally, the elements of the effector assembly 104 can be entirely contained within an inner shell 185, which is preferably integrated together so as to move the first effector 184 together and provide a feature (schematically shown as a stop 108 in Figures 2A(ii), 2B(ii), 2C(ii), and 2D(ii)) relative to which the two axial positions of the bistable mechanism 170 are defined.

[0092] The mechanism 100 also includes a force input end for selectively applying an input force to the bistable mechanism 170. The force input can be manual or actuated by any form of electromechanical or other actuator. In addition, the manual or other actuated force input can be unidirectional (for example, providing reverse motion through a return spring), or the input can actively provide force in both directions. In the preferred but non-limiting example shown herein, the force input is implemented as a button, knob or plunger 114, and the force is manually applied to the button, knob or plunger 114 in only one direction, thereby causing the effector assembly 104 to be distally displaced relative to the handle 102, and the return motion is controlled by the return spring 140.

[0093] Figures 1A to 1C Different arrangements of the biasing means are shown, in particular whether the first spring element 180B and the second spring element 180A are arranged in parallel or in series. Figure 1A In the example of , the first spring element 180B acts between the first effector 184 and the bistable element 172, while the second spring element 180A acts between the second effector 182 and the bistable element 172, so that the two springs thereby define a parallel biased arrangement. Figure 1B , the first spring element 180B acts between the first effector 184 and the second effector 182, while the second spring element 180A acts between the second effector 182 and the bistable element 172, thereby defining a series biasing arrangement. Figure 1C A hybrid arrangement is shown, wherein the first and second spring elements 180B, 180A are arranged in a manner similar to Figure 1B 180A, but supplemented by another spring 120, which acts directly between the first effector 184 and the bistable element 172. In addition, in certain preferred embodiments, at least one (typically both) of the first and second springs 180B and 180A is deployed with a preload force, which defines the minimum force required to change the length of at least one of the springs. The ratio between the preload forces of the first and second spring elements 180B, 180A is typically different between the first axial state and the second axial state of the bistable mechanism.

[0094] Figures 1A to 1C The arrangement for providing these preload forces is schematically shown by providing springs 180A and 180B with respective spring housings 181A and 181B, respectively, with the input of each spring being transmitted through respective compression rods 186A and 186B, respectively. Each spring is placed in a dedicated housing here for ease of illustration, but it will be appreciated that there are many ways to constrain the springs to provide them with preload forces. Certain alternative embodiments will become clear from the subsequent examples.

[0095] All springs shown herein are schematically represented as helical compression springs, but one of ordinary skill in the art will understand that the present invention may be implemented using any and all types of springs or other resilient elements, including but not limited to compression springs, extension springs, torsion springs and any other form of mechanical springs made of elastic or other resilient materials, formed as discrete spring elements or integrally with other components, formed of metals, metal alloys, superplastic alloys, polymeric materials or any other material exhibiting properties suitable for forming a spring, as well as pneumatic springs, magnetic or electromagnetic devices that simulate or replace springs, and any other elements or devices that provide the biasing characteristics described herein.

[0096] According to one aspect of certain embodiments of the present invention, the overall effect of the structure described herein is that the force applied by the force input end in the first direction first effectively moves the effector assembly axially toward the distal end without changing the state of the bistable mechanism, and then, when at least a portion of the effector assembly is further displaced toward the distal end and encounters an obstacle, the bistable element is switched between the first axial state and the second axial state. This aspect of certain embodiments of the present invention will be described with reference to Figures 2A to 2D.

[0097] According to a second aspect of some embodiments of the present invention, the biasing device is configured so that the bistable mechanism can switch from the first state to the second state without requiring the second effector to reach the second relative axial position. Figure 3B Provide explanation.

[0098] Reference now FIG. 2A(i) to FIG. 2A(iv) , these views schematically show the Figure 1A 1. The embodiment of the present invention is an implementation of the mechanism 100 of a "parallel" implementation. The first effector 184 is shown here as a tubular bracket, and the second effector 182 is shown here as a pointed rod-shaped ejector. The second spring 180A is confined within the housing 181A. One side of the housing 181A is adjacent to, attached to, or integrally formed with the bistable element 172, and the rear end of the second effector 182 is formed as a compression rod that acts on the second spring 180A. Therefore, the second spring 180A acts between the bistable element 172 and the second effector 182. By the way, here and throughout the document, the term "acting between..." refers to the functional relationship between the biasing element and the corresponding element it acts on, but does not limit the deployment of the element to be spatially between these elements. The first spring 180B is contained (and preferably preloaded) between an outer surface of the spring housing 181A and an inner shoulder of the first effector 184 , such that the first spring 180B acts between the first effector 184 and the bistable element 172 .

[0099] The spring constants and preloads of the first and second springs 180B and 180A are such that the force applied to the plunger 114 is first effective to move the effector assembly axially distally to resist the retraction spring 140 without changing the state of the bistable mechanism, corresponding to the change from Figure 2A(i) to Figure 2A(ii) Movement. When encountering an obstacle, the movement terminates, and the obstacle creates resistance to further movement, thereby overcoming the preload of the spring associated with the biasing device. Typically, when used to operate a suturing device, the effector will generate this resistance when encountering a needle, a needle holder pocket or other similar structures, as described below. Optionally, as shown in the figure, a step and shoulder configuration can also be provided between the outer shell or handle 102 and the inner shell 185, which limits the maximum displacement of the effector assembly relative to the handle. In either case, when reaching an obstacle to further distal displacement, a further force applied to the plunger 114 will compress at least the first spring 180B until the bistable mechanism switches between the first axial state (Fig. 2A (ii)) and the second axial state (Fig. 2A (iii)). This transition is achieved by compressing the mechanism to exceed the state shown here to reach a transition state and then retract to the second state. Only the final state of the bistable mechanism when not subject to external strain is shown here. The transition process and the response of the system to external forces will be described in detail below. Preferably, under the action of the retraction spring 140 (or in an alternative embodiment, when a reverse actuation force is applied to the force input), the effector assembly is then retracted relative to the handle 102 while maintaining the new state of the bistable mechanism, reaching the state of Figure 2A (iv). The process is reversible, so that when the force input is next initiated, the process will repeat, this time switching from the second state of Figure 2A (iii) back to the first state of Figure 2A (ii), and then retracting the state of Figure 2A (i), after which the entire process can be repeated.

[0100] The bistable mechanism 170 is shown schematically here, and can be implemented as essentially any bistable mechanism that is actuated by an axial force to alternately switch between two states corresponding to two axial positions of the bistable element 172 relative to the internal housing 185. A variety of such mechanisms are known, for example in the context of retractable pens, including but not limited to various bistable mechanisms with rotating cams, pin-slot or ball-slot bistable mechanisms, and rocker-based bistable mechanisms. There are many variations of such mechanisms, and their designs are well known per se, so for the sake of brevity, it is not necessary to introduce the details of multiple examples of bistable mechanisms. A particularly preferred subgroup of bistable mechanisms is a mechanism that employs a rotating cam with an axially inclined surface, the rotating cam being slightly rotated by the actuation surface of a sliding actuator, and the rotating cam having protrusions that are in turn seated in slots in the housing 185, thereby defining two different axial positions. One such non-limiting example will be described in detail below.

[0101] Particularly preferred bi-stable mechanisms are often referred to as "click mechanisms" because two distinct audible and / or tactile feedbacks ("clicks") are typically produced during each transition.

[0102] Optionally, some portion of the bistable mechanism may be attached to the end of the plunger 114. However, it should be noted that such attachment is not required. FIG. 2A(iv)′ shows a state similar to FIG. 2A(iv) where a portion of the bistable mechanism 170 can move independently of the bistable element 172 and the plunger 114, as shown by the space on either side of the element labeled 170.

[0103] Although the bistable mechanism itself is similar to mechanisms employed elsewhere, the manner in which it is used, according to embodiments of the present invention, differs in many respects from the common application of such mechanisms. The bistable mechanism 170 is used here to produce a relative displacement between two effectors, which themselves can be displaced relative to the handle 102 as a unit. Most preferably, a single force input end is used to sequentially produce the combined motion of the effectors and the switching of their relative positions. The biasing device also provides unique functionality not typically found in bistable mechanisms, as further described below.

[0104] Reference now Figure 2B(i) to Figure 2B(iv) , these drawings and FIG. 2A(i) to FIG. 2A(iv) 180A and 180B are similar, but a series of deployments of the biasing device are shown. Thus, in this case, the first spring 180B acts between the first effector 184 and the second effector 182, while the second spring 180A acts between the second effector 182 and the bistable element 172. Structurally, in this non-limiting example, this is achieved by rigidly connecting (or integrally forming) the second effector 182 to the second spring housing 181A and providing an actuator rod 186A connected to the bistable element 172 to provide input to the second spring 180A. The first spring 180B is clamped between the spring housing 181A and the internal shoulder of the first effector 184. Both springs 180A and 180B are preferably preloaded so that, as before, a force applied to the force input end (plunger 114) will initially produce a displacement of the entire effector assembly without changing the state of the bistable mechanism ( Figure 2B(i) to Figure 2B(ii) ), then, upon encountering an obstruction (a step in the housing / handle 102 or an external obstacle such as a needle receiver pocket), further force causes the bistable mechanism to switch ( Figure 2B(ii) to Figure 2B(iii) ). Then, according to the details of the specific implementation, under the action of the retraction spring 140 or by actively applying a pulling force, it is pulled out to the state of FIG. 2B (iv).

[0105] Figure 2C(i) to Figure 2C(ii) An alternative embodiment is shown in which the series deployment of the biasing means is functionally equivalent to Figure 2B(i) to Figure 2B(iv), but is more similar in structure to FIG. 2A(i) to FIG. 2A(iv) For simplicity, only the states before and after the bistable mechanism is switched are shown here, corresponding to FIG. 2B (ii) and FIG. 2B (iii). The structure shown here is similar to FIG. 2A(i) to FIG. 2A(iv) The structure in is almost the same, except that one side of the first spring 180 is bounded by a flange 110 extending from the second effector (ejector) 182, so the spring acts between the first effector 184 and the second effector 182.

[0106] Figure 2D(i) to Figure 2D(ii) Another alternative implementation using a hybrid implementation of a biasing device is shown, wherein Figure 2B(i) to Figure 2B(iv) A similar series arrangement is supplemented by an additional spring 120 acting directly between the first effector 184 and the bistable element 172 .

[0107] The distinction between the various options for parallel, series, or hybrid deployment of the biasing device will not typically have a large impact on the device operation experienced by the user, but may be important in defining the characteristics required of each spring, how sensitive the design is to manufacturing tolerances, and how much force the user needs to apply to switch the state of the bistable mechanism. Additional design considerations for achieving desired device functionality in certain applications are discussed further below.

[0108] FIG. 3A illustrates in more detail the operation of the device of FIG. 2A in a suturing device (suture not shown) scenario, where the mechanism delivers needle 800 into pocket 1000 and releases the needle before withdrawal (in order of multiple stages 1 to 7), then extends to engage the needle and withdraw it from the pocket (in order of multiple stages 8 to 14). All parts of the structure, including the needle and pocket, are only schematically shown here. Particularly preferred non-limiting examples of specific implementations of these elements will be discussed below.

[0109] First, referring to FIG. 3A(i), the transition from phase 1 to phase 2 is similar to the transition from Figure 2A(i) to 2A(ii)800 into the pocket 1000, which then provides a barrier to further movement of at least the first effector (cradle) 184. Further applied force overcomes the preload force of the first spring 180B, which compresses until the second effector (ejector) 182 contacts the needle 800 (stage 3). At this point, both the first and second effectors are blocked from further movement, so further force applied to the input plunger causes the first and second springs 180B, 180A to compress until the plunger forces the bistable mechanism into the transition state (stage 4, typically producing the first "click"), and upon partial release of the force on the plunger, the bistable mechanism stabilizes in the second state with the bistable element 172 in a distally displaced position relative to the cradle 184 (stage 5, typically producing the second "click"). Unlike conventional bistable mechanism applications, the bistable mechanism is able to switch to its second state here due to the presence of the second spring 180A, even though the second effector (ejector) 182 has not yet reached a forward displacement position relative to the first effector (support) 184. In this state, the second spring 180A biases the ejector 182 forward relative to the support 184, so that the ejector 182 ejects the needle 800 from the support 184 while the support moves slightly backward (stage 6). The ejector 182 is then in a fully extended position and the retraction of the effector assembly is completed (stage 7). This completes the process of moving the needle from the support to the needle receiver and removing the support. This process can effectively suture the tissue from the proximal end to the distal end when a needle with sutures is used to pass through one or more layers of tissue.

[0110] To complete the running suturing, it is desirable to reposition the needle receiver and effector assembly of the fixed needle so that they are aligned with each other on opposite sides of the tissue at a second location to perform the distal to proximal suturing process shown in stages 8 to 14.

[0111] Starting from stage 8, the effector assembly is advanced by depressing the plunger 114 while the bistable mechanism is in its second state and the ejector 182 is protruding. In this state, the ejector most preferably provides a penetration point, allowing the effector assembly to penetrate the tissue to reach the needle and needle receiver (the mechanism is also applicable to other embodiments where the double-ended needle penetrates the tissue from the distal end, in which case no penetration point is required on the effector assembly). Once the ejector 182 contacts the needle and is unable to advance, further force applied to the force input end compresses the second spring 180A (stage 9), and the bracket 184 continues to move forward through the force transmitted by the first spring 180B until the bracket 184 engages the needle 800 (stage 10). At this stage, further forward force compresses the first and second springs 180B, 180A until the plunger forces the bistable mechanism into a transition state (stage 11, typically producing a "click"), and upon partial release of the force on the plunger, the bistable mechanism returns to the first state, thereby allowing the bistable element 172 to retract relative to the bracket 184 (stage 12, typically producing a further "click", and then further retracting in stage 13). The engagement of the bracket 184 with the needle 800 causes the retraction of the effector assembly to effectively release the needle 800 from the needle receiver 1000 and pull the needle through the tissue (not shown), thereby completing the distal to proximal suture (stage 14).

[0112] By repositioning the mechanism 100 and needle receiver 1000 to successive locations and repeating sequence 1 through 7 in one location and then repeating sequence 8 through 14 in another location, a continuous line of suture may be formed through tissue.

[0113] Based on the desired sequence of operations described in FIG. 3A , various properties of the spring and other force-related components may be defined to ensure proper operation of the sequence. For example, in this embodiment, at least some of the following criteria are preferably met, preferably all of them are met:

[0114] • The retraction spring 140 should be strong enough, when in use, to pull the effector assembly (in whatever configuration, with or without a needle) through any tissue that may be encountered.

[0115] The first and second springs 180B, 180A should have sufficient preload force to allow penetration of any soft or semi-hard tissue that may be encountered during the penetration process to avoid switching the bistable mechanism before reaching the needle receiver. (Bone or other hard tissue should be avoided through proper preoperative planning and / or use of intraoperative imaging techniques.)

[0116] The force applied by the first spring 180B should be sufficient to engage the support 184 with the needle 800 .

[0117] The force applied by the second spring 180A should be sufficient to eject the needle from the bracket 184.

[0118] The needle retention force of the bracket 184 should be greater than the needle retention force within the needle receiver ("pocket") 1000.

[0119] Figure 3B Equivalent to FIG. 3A(i), but showing the series biasing arrangement of FIG. 2B. The sequence is substantially similar to that described above, but differs in the specific interrelationships required between the preload force and the spring constant of each spring to provide the desired operation. These different options provide different degrees of freedom in the system design, which can relax certain design constraints to facilitate manufacturing and / or ensure enhanced device reliability.

[0120] Suture device application

[0121] The remainder of the specification relates to a particularly preferred but non-limiting example of application of the above mechanism to a particularly advantageous suturing device. The present disclosure will also relate to various features of the suturing device that are considered to have patentable significance in their own right, independent of the actuating mechanism used in the device.

[0122] According to some embodiments, the present disclosure relates, in particular, to various aspects of components of a suturing device, including an operating handle (user interface handle), a needle (shuttle), a displacement module, an ejector module, and a ejector module, which are particularly suitable for (but not necessarily limited to) use with a suturing mechanism, such as the suturing mechanisms described in PCT Patent Application No. PCT / IB2020 / 057513 and PCT Application No. PCT / IB2020 / 061610.

[0123] According to some embodiments, the suturing devices and methods disclosed herein relate to suturing tissue (e.g., a blood vessel wall) as part of a surgical procedure. According to some embodiments, the devices and methods disclosed herein are applicable to various medical procedures, including but not limited to external, surface, shallow incisions, minimally invasive procedures, surgical procedures, and structural heart-related procedures, such as patent foramen ovale (PFO). In some exemplary embodiments, the devices and methods disclosed herein are used in vascular closure surgery.

[0124] According to some embodiments described herein, the suturing device includes an operating handle, a shuttle (also referred to herein as a "needle"), which can have various shapes / forms, as described below, but generally has a distal end in the form of a pointed arrow and a proximal end in the form of a truncated arrow with an axial notch / hole, and a shuttle ejector module (also referred to herein as a "needle ejector module", "push-pull mechanism" or "PPM"), which is configured to selectively move, hold and release the shuttle. The shuttle ejector is configured to manipulate the shuttle from a first side of a tissue (e.g., a vessel wall) to allow the suture to pass from the first side to the second side and from the second side to the first side. The shuttle ejector module may include at least two elements: a shuttle ejector (also referred to herein as a "releaser element", "shuttle releaser", "needle ejector" or "needle releaser"), corresponding to the above-mentioned second effector 182, and a shuttle holder (also referred to herein as a "needle holder" or "tube"), corresponding to the above-mentioned first effector 184, wherein the shuttle holder is configured to hold / associated with the shuttle, and the shuttle ejector can release the shuttle from the holder. In some embodiments, the shuttle holder can be implemented as a tubular or substantially tubular element that can engage with the outer region / surface of the shuttle, and the releaser element can be implemented as a rod that can be moved internally within the tubular element in some embodiments. The releaser element is preferably sharp at its distal end, preferably having a distal penetrating end that is shaped to penetrate tissue when extended from the shuttle holder (PPM tube).

[0125] According to some embodiments, as further detailed herein, the shuttle can be held and / or displaced by a shuttle receiver module (also referred to herein as a "needle receiver module" or "pocket"), which is passively configured to receive, hold, and release the shuttle. In some embodiments, the pocket is configured to reversibly retract from a "closed" position to an "open" position, wherein the transition between states can be controlled by a user via an operating handle, as further detailed herein. In some embodiments, the shuttle ejector module and the pocket are located on opposite sides of the tissue to be sutured (e.g., when the pocket is located within a blood vessel and the shuttle ejector module is located outside the blood vessel), and can be aligned on these opposite sides by a mechanical interconnection between the two modules.

[0126] In some embodiments, the shuttle is generally in the form of a sharp needle, configured to hold the suture, and the shuttle ejector module is configured to selectively hold and release the shuttle. When the shuttle is held, the ejector module forms a first penetration configuration, and presents a second penetration configuration after releasing the shuttle (held by the pocket). Under this second penetration configuration, the shuttle ejector is configured to present a sharp needle-like distal end (particularly an ejection element). Therefore, the shuttle ejector module can manipulate the shuttle from one side of the material to be sutured (for example, a blood vessel or other tissue) to transfer the suture from one side of the tissue to the other side of the tissue, and vice versa. To this end, by advancing the shuttle ejector (while being held) in the first penetration configuration, it is then convenient to release the shuttle from the shuttle ejector, so that it is passively and temporarily held by the shuttle receiver (located on the opposite side of the tissue), and withdrawing the shuttle ejector (without the shuttle) from the tissue. By advancing the shuttle ejector (that is, without the shuttle) in the second penetration configuration, the suture is transferred from the second side to the first side so that the shuttle is collected and retrieved by the sutured tissue. The shuttle ejector is configured to penetrate the material at the second position, align with the shuttle temporarily retained in the pocket, engage and hold the shuttle, and pull the shuttle through the tissue at the second position. During each pass, the shuttle pulls the suture so that the suture extends into the tissue at the first position and extends out of the material at the second position. Thus, this suturing process can be used for a variety of procedures, including but not limited to: external superficial incision closure, superficial superficial incision closure, minimally invasive surgery, conventional surgery, coronary artery surgery, cardiovascular surgery, closure of vascular openings / holes, closure of intertissue openings (e.g., an opening in the wall between the right upper heart chamber and the left upper heart chamber (PFO)), incision closure, wound closure, connection of two or more materials arranged in overlapping relationship by suturing two layers; joining two edges of two material areas together, anchoring a suture in a material by repeatedly and closely passing stitches through the material to form an overlapping relationship, suturing to interconnect a prosthetic device or material with a natural tissue, wherein the material can be a natural biological tissue or any other material, patent foramen ovale (PFO), atrial septal defect (ASD), left atrial appendage closure (LAAO), left atrial appendage closure (LAAC), aneurysm repair, transcatheter valve repair, minimally invasive apical closure, minimally invasive left ventricular repair, endoscopic surgery, laparoscopic surgery, gastroscopic surgery, otoscope surgery, and suturing in minimally invasive gynecological surgery, etc., or a combination thereof. Each possibility is a separate embodiment.

[0127] Reference now Figure 4A , schematically depicts a perspective view of a suturing device according to some embodiments. Figure 4AAs shown, the suturing device 10 includes a handle portion 12 having an operating button (also referred to herein as a "suturing button") 14 at its proximal end, and a rotation interface 16 for facilitating the user (e.g., by the user's gripping palm) to axially rotate the handle. The rotation interface 16 may optionally include one or more indicators 18 intended to guide and assist the user in operating the device, for example, by indicating pocket operation (its expansion or retraction), radial positioning of the device according to the suturing operation, etc. In some cases, the rotation interface 16 may simply be a flange to facilitate manual grasping and operation, such as Figure 4C shown. Figure 4A Also shown is a removable safety lock 20 configured to lock / prevent activation of the operating button 14 when in the closed position and allow such operation when released to the open position (e.g., only when the pocket has been deployed, as described below). Also shown is an intermediate handle portion body / housing / casing 22, which includes the operating module (click mechanism), etc. Figure 4A As shown in the example, the interface 16 can preferably have a flat ring-shaped geometry, forming a circular flange around the handle portion, allowing one-handed operation of the button 14 while allowing the handle to rotate in the palm of the user. The suturing device 10 can also include one or more indicators for indicating the positioning of the suturing needle with the tissue (more specifically, within the blood vessel). Figure 4A Also shown are indicators 24A-B, which are in the form of a bleeder, for example, configured to allow blood to flow from the suture area to the bleeder. One of the dischargers (e.g., 24A) can be used as a "GO" discharger (i.e., when blood flows through the discharger, the distal end of the suturing device is correctly positioned with the target tissue (fully inserted); and the other discharge (e.g., 24B) can be used as a "NO-GO" discharger (i.e., when blood flows through the discharger, the distal end of the suturing device is not correctly positioned, specifically, over-inserted). In addition, in its distal region, the handle 12 also includes a pocket expansion mechanism (cam) 26, which is configured to allow the pocket (needle receiver module) of the suturing mechanism 30 to be opened (expanded) or closed, and the suturing mechanism is located in the more distal region of the shaft 32, connecting the distal end of the handle portion 12 to the suturing mechanism 30. The suturing device 10 may also optionally include an expander 34, which is connected to the distal end of the shaft by an optional fixed-angle rotation connector 36 and can be used to help expand the target tissue, thereby allowing the insertion or removal of the shaft, suturing mechanism, or any other medical tool used in the medical procedure.

[0128] Reference now Figure 4B , schematically shows a partial stereoscopic view of a handle section according to some embodiments. Figure 4B As shown, the handle 12 includes an operating button 14, which is configured to move longitudinally (up and down) and is activated by the user pressing (pushing) the button. Each time the button is pressed / pushed, a mechanism is activated, such as the above reference Figures 1A to 3B The mechanism described herein produces displacement of the shuttle ejector and switches between different internal states, ultimately driving the suturing mechanism, as will be described in detail below. Further shown is an internal retraction (return) element 40, which in some exemplary embodiments can be a retraction spring, which is configured to allow the operating button and its associated click mechanism to retract during its operation. Further shown is the interface 16, which can have a substantially flat donut-shaped geometry, as shown in Figure 2, to allow one-handed operation of the button 14 while facilitating rotation of the handle 12 within the palm of the user, such as Figure 4C As shown. In addition, an operating module (also referred to as a click mechanism module) 50 corresponding to the above-mentioned effector assembly is located within the internal housing of the handle 12. The click mechanism module (specific embodiments of which will be discussed in detail below) includes a combination of internal spring / spring-like elements and bistable mechanism (linear and / or circular) elements, and is used to enable the suturing state machine steps while preventing the needle receiver module from being overloaded (i.e., preventing excessive force from being applied to the pocket to prevent the pocket from being deformed or ruptured), and advantageously providing tactile feedback to the user at the same time. Also shown is the tube and ejector rod 52 of the shuttle ejector module, which is connected at its proximal end to the click mechanism module and extends longitudinally along the distal end of the handle, through the shaft 34, and reaches the suturing mechanism. Also shown in Figure 2 is the ejector 24A-B and the pocket deployment mechanism 56, which are controlled by the pocket deployment mechanism knob 26 (as shown in Figure 2). Figure 4A as shown) to start.

[0129] Figure 4C A perspective view of the handle 2 of the suturing device is schematically shown according to some embodiments, being held in the palm (15) of a user.

[0130] Reference now FIG. 5A to FIG. 5C , showing additional details of an exemplary click mechanism module according to some embodiments. Figure 5A The interior of one side of the housing 22 and the click mechanism module 50 removed therefrom are shown. It can be seen that the housing 22 includes one or more elongated axial slots 23, and the click mechanism module 50 has corresponding protrusions 25 for sliding engagement in the slots 23, thereby allowing the click mechanism module 50 to slide axially in the housing 22 without rotating about the axis. Figure 5BAs shown in the partial cross-sectional view of , the click mechanism module 50 is made of a shell (housing) and can be composed of at least two parts (60A-B), which can be temporarily or permanently connected together by any suitable means (e.g., screws, adhesives, connecting elements, welding, etc.). The shell can be made of any suitable material, including, for example, plastic, metal, aluminum, etc. The shell may include one or more structures that can be used for the operation of the click mechanism module, such as an opening 62A and a fixed guide surface 64, which can interact with one or more internal elements of a bistable mechanism, as described below. The bistable mechanism is also referred to herein as a "switching mechanism" because it can switch between two stable states. The click mechanism module 50 includes a combination of internal elements and a combination of springs, which allows switching between different stable states when an operating button is pressed. Figure 5B A reciprocating switching shaft 70 is shown, the proximal end of which is connected to an operating button (not shown), and the distal end of which includes or is associated with a bistable mechanism actuator element (switching tooth) 72, which is configured to interact with a rotatable bistable element (cam) 74. The rotatable bistable element 74 in turn can define different internal states (e.g., state A and state B) of the suturing mechanism by changes in its relative position and an internal flexible element (e.g., a spring), the internal flexible element being configured to drive the movement of elements of the suturing mechanism (particularly, the shuttle ejector module element). As shown Figure 5B As shown, the click mechanism module includes a combination of flexible elements (e.g., springs) that can operate in series or in parallel (as described above), wherein each set of flexible elements can interact or activate / control the movement of different elements of the suturing mechanism (particularly elements of the shuttle ejector module). For example, flexible element (spring) 80A is configured to interact / activate / control the movement of the shuttle ejection element (shuttle releaser) of the shuttle ejector module, and flexible element (spring) 80B is configured to interact / activate / control the movement of the shuttle support element (shuttle releaser) of the needle ejector module, which is directly associated / connected to the toggle mechanism housing (housing). In some embodiments, the relative size, diameter, force, flexibility, and / or any other characteristics of the flexible elements can affect the relative movement of each associated suturing mechanism element, and the interaction between the flexible elements facilitates such control. In some embodiments, the relative position between the toggle element (the toggle element of the reciprocating and rotatable toggle mechanism) and the fixed toggle element (the toggle element of the housing of the pawl mechanism) affects the force applied to the insertion module element. Figure 5B Also shown are the shuttle ejector chuck 82 and the shuttle release chuck 84. Thus, as shown in FIG. Figure 5B As shown, the click mechanism 50 allows the suturing mechanism to operate smoothly and reliably.

[0131] According to some embodiments, the bistable mechanism is configured to provide tactile and / or audible feedback to the user at the end of each compression (inward movement), for example, for inserting or retrieving the PPM and shuttle. This advantageously allows the user to determine that the mechanism has correctly changed state at each stage of the suturing process.

[0132] Reference now Figure 5C , showing a cross-section of a handle with a click mechanism according to some embodiments. Figure 5C As shown, the handle 12 includes a click mechanism module 50. The click mechanism module 50 includes a combination of a toggle element and a combination of a spring, which allows switching between different states when the operating button 14 is pressed. Figure 5C A reciprocating toggle shaft 70 is shown, the proximal end of which is connected to the operating button 14 and the distal end of which is associated with a sliding bistable mechanism actuator element (toggle tooth) 72, which is configured to interact with a rotatable bistable element (cam) 74 and drive a rotating bistable mechanism that can move axially between different states.

[0133] According to some embodiments, an advantageous click mechanism can be converted between states A and B according to the action of a switching mechanism. As described herein, state A is configured to implement a state sequence of transferring the shuttle from the ejector module to the receiving module (pocket). As described herein, the transfer of the shuttle from the ejector module to the pocket is performed through the suture material. State B is configured to implement a state sequence of transferring the needle from the receiver module (pocket) to the ejector module (insertion module) while the ejection element protrudes from the bracket (tube) and is configured to present a sharp needle-like distal end capable of penetrating the material. In order to better understand the states and steps involved, now refer to Figure 6 , schematically illustrating the state of a suturing mechanism during a suturing process according to some embodiments. Figure 6 The general states of the suturing mechanism are shown (0 to 7), showing the position of the shuttle in each state of its insertion (through the ejector module) and passive reception (through the pocket). Figure 6Elements of the shuttle ejector module (ejector and bracket) and receiving module are shown. In state 0 (before insertion or after the suturing cycle is completed), the shuttle 200 is maintained in a retracted position within the ejector module, ready to be deployed. The pocket 202 is in a closed (retracted) position. In state 1, i.e., after the suturing mechanism is positioned in the target tissue, the pocket is deployed / opened (e.g., within a blood vessel) while the needle is still in the retracted position. The ejector 212 and bracket 214 of the ejector module 210 are also shown. In state 2, the needle is inserted through the lateral movement of the transmission module (PPM-push-pull mechanism) module, passes through the tissue (not shown) and interacts with the pocket (deployed on the second side of the tissue). In state 3, the ejector element 212 is associated with the shuttle (more specifically, its proximal end) as described herein. In states 4 to 6, the relative position of the shuttle does not change, but the switching mechanism (located in the handle) is configured to change the position / state (from state A to state B), and the insertion mechanism is retracted and the needle is ejected therefrom. In the terminal position of state 7, the shuttle, which has been released from the insertion mechanism, is connected to the pocket and the ejector module is retracted, ready for another suturing cycle. When reactivated, the click mechanism in state B can affect state 7 to 0 (in reverse order) to enable the ejector module to move from the retracted (proximal) position to allow the ejection element to protrude out of the tube, penetrate the tissue, and associate the shuttle with the ejector module's retaining element (tube) and release it from the pocket (pull).

[0134] Reference now 7A to 7E , according to some embodiments, a schematic cross-sectional view of a handle including a click mechanism module is shown in 7 different states, corresponding to Figure 6 and states 1 to 7 of the schematic diagram of FIG. 3A(i). Now referring to Fig. 7A , a cross-sectional view of the handle in the initial position of the click mechanism state machine is shown, which shows the handle 12, with the operating button 14, which can be moved longitudinally to activate the click mechanism module, and the return element (retraction spring) 40. The click mechanism is shown in the state position of the click mechanism 50. A flexible element (second spring) 80A is also shown, which is configured to interact with the ejection element 82 of the insertion module and cause its movement. A flexible element 80B (in the form of a spring) is also shown, which is configured to interact with the retaining element 84 of the ejector module, which is associated with the housing 85 of the click mechanism. As described above, pressing the operating button (suturing button) 14 will execute the state sequence from 1 to 7. Figure 7B State 2 is shown, in which the shuttle (not shown) is associated with (retained within) a pocket (not shown). Figure 7C State 3 is shown, in which the distal end (not shown) of the ejection element 82 interacts (impacts) with the needle (at its proximal end). Fig.7DState 4 is shown in FIG. 4 , which triggers a switching action, wherein the switch switches from state A to state B ( 50 ′). In this state, the user can release the pressure on the operating button 14 to complete the switching action. The switching action is completed. Next, Fig. 7E State 5 is shown in FIG. 1 , in which the click mechanism is locked by the locking engagement 360 . Figure 7F State 6 is shown in FIG, in which the insertion module is restored and the needle (not shown) is fully ejected therefrom while maintaining interaction with the pocket (not shown). Figure 7G State 7 is shown in the end position, in which the insertion module is fully retrieved (retracted), the click mechanism (and associated operating button) is returned to the starting position by the retraction spring 40, and the ejection element is in the penetration position, protruding from the bracket. In this position, the click mechanism is in state B, and pressing the operating button again will allow activation of state 7 to 1 (i.e., in reverse order) to allow the ejector module to be pushed toward the shuttle through the tissue with the help of the ejection element (as described herein) acting as the penetration portion, while allowing the sharp distal end of the ejection element to interact with the corresponding opening in the proximal end of the shuttle to promote the interaction / retention of the bracket element with the proximal end region of the shuttle, pull the needle out of the pocket, and return to the starting position.

[0135] According to some embodiments, the advantageous click mechanism disclosed herein can implement a state machine for implementing repeated suturing using a suturing mechanism. According to some embodiments, the click mechanism disclosed herein includes multiple flexible elements, such as springs, and one or more toggle modules. In some exemplary embodiments, the click mechanism can include multiple springs, preferably 3 springs, such as a launch spring, a retainer spring, and a retraction spring, wherein the springs are affected by the linear toggle module.

[0136] According to some embodiments, the switching module of the click mechanism can also provide / generate tactile feedback when switching between states (e.g., between states A and B and vice versa).

[0137] According to some embodiments, as described herein, the click mechanism is configured to acquire two states: an A state and a B state, which are interchanged by a switching module. The A state is configured to implement a sub-state sequence for transferring the shuttle from the ejector module to the receiver module, and the B state is configured to implement a sub-state sequence for transferring the shuttle needle from the receiver module to the ejector module. According to some embodiments, the linear switching module is configured to switch from the A state to the B state, or vice versa, from the B state to the A state, at each final movement of the ejector module from the proximal position to the distal position (i.e., when inserted or retrieved).

[0138] Pocket deployment mechanism

[0139] According to some embodiments, the suturing device disclosed herein includes a pocket deployment mechanism that facilitates the deployment (i.e., opening) of a needle receiver ("pocket") at a distal region of a shaft, while controlling the deployment via a handle of the suturing device. According to some embodiments, the pocket deployment mechanism may include a cam and a closing cam follower that can generate tactile feedback and preferably provide a locking action at both ends of its rotation. The cam may be activated by an attached knob or any other suitable element.

[0140] Reference now Fig. 8A , schematically illustrates an external stereoscopic view of a pocket deployment module located in a handle of a suturing device according to some embodiments. Fig. 8A As shown, the pocket deployment module 400 is located within the distal region of the handle. The pocket deployment module includes an external operating knob 402 configured to allow operation of internal components of the pocket deployment module to allow the pocket to transition from a retracted position to a deployed position, and vice versa, as described below.

[0141] Reference now Figure 8B ,show Fig. 8A A cross-sectional view of the pocket deployment module. Figure 8B As shown, the rotatable cam 404 is configured to be connected to the knob 402 ( Fig. 8A ), which is configured to drive a connecting element by its rotation, the connecting element being connected to a pivot point at its proximal end and to a pocket at its distal end. Figure 8B Also shown in the figure is a preload spring 408, which is configured to retract or extend according to the movement of the cam, thereby providing tension to the connecting element. Also shown is a portion of the insertion module 440 of the suturing mechanism. Preferably, the cam and the connected knob are connected so that no relative movement (slippage between the two) occurs.

[0142] Reference now Figure 8C, showing a schematic cross-section of a pocket deployment mechanism in a handle of a suturing device according to some embodiments. The deployment mechanism 400 includes a rotatable knob 402, which is connected to a cam 404. The cam 404 can be rotated between two end positions to facilitate the movement of a corresponding cam follower 420, wherein the end points are determined / defined by a groove / slot in the knob and a corresponding protrusion on the housing / shell of the handle (as shown below). The deployment mechanism also includes a preload spring, which is connected to a spool element (clamping block) 414. The clamping block 414 includes a core 416A and a face 416B. The core may include a slit or channel to allow the connection element 406 to pass therethrough. In some preferred embodiments, the connection element may be implemented by a superelastic alloy, preferably by a nitinol wire. The clamping block can be used to secure the connection element and further adjust its length, locking the length by tightening a clamping screw 422 after a specific calibration of the device, and the screw is preferably accessible from the outside of the handle to allow calibration adjustment after assembly. The core can be placed with the hollow space of the spring 408, and the surface can be connected to the top area of ​​the spring so that changes in the spring tension cause axial movement of the clamping block to cause movement of the connecting element 406 (for example, by stretching or releasing), thereby causing movement of the pocket (expansion or retraction). This advantageous arrangement allows the tension of the pocket to be controlled / limited when unfolding. In some embodiments, the clamping block structure can be assembled with the unfolding module using screws, snaps, clips, etc. In some embodiments, the clamping block can be fixed by two independent parts of a cam follower, which is configured to be connected / closed around the clamping block. In some embodiments, the clamping block can be assembled by snaps, spring retaining rings, or by dividing the cam follower into two parts and closing the two parts on the clamping block. Figure 8C Also shown are optional connection elements 424, which in some embodiments are used to connect / secure the spool structure and / or spring to the deployment mechanism body. Figure 8C Also shown are an ejection element 442 and a retaining element 444 of the insertion module.

[0143] According to some embodiments, the pocket deployment mechanism can therefore provide two locking over the center (OTC) positions at the end of its rotational movement, so that the reaction force tends to push the cam towards its end position rather than reverse its movement. One OTC position is for pocket deployment and the other is for pocket retraction. According to some embodiments, the preload spring associated with the clamping block structure can be used as a connection element pulling function and compensation for assembly tolerances. Such OTC positions are as follows FIG. 8D(i) to FIG. 8D(ii) , which shows an OTC position 480A for pocket retraction (spring 408 in a relaxed state) and an OTC position 480B for pocket deployment (spring 408 in a contracted state).

[0144] According to some embodiments, the pocket can be deployed or retracted (hidden) by rotating the deployment knob (e.g., 90 degrees). In some embodiments, rotation of the knob causes rotation of a cam, which can translate between different positions, thereby allowing the connection element to move. In some embodiments, the deployment knob can provide a tactile or visual indication of its position, thereby providing the position of the pocket. For example, as FIG. 8E(i) to FIG. 8E(ii) As shown, the knob 402 may include openings 411A-B on its surface so that the color of the markings in the openings may change depending on the closed (hidden) (411A-B) or open (retracted) position (411A'-B') of the pocket. Figure 8F As shown, the end of the cam's rotational motion may be defined by a recess / slot 413 in the knob 402 and a corresponding protrusion 415 on the housing / casing of the handle or some other mechanical engagement for limiting the range of rotation.

[0145] According to some preferred embodiments, the connecting element for pocket deployment may include a superelastic material, such as a wire, preferably a Nitinol wire, which can be converted between a pulling state and a pushing state (depending on the OTC state). In some embodiments, to prevent buckling, the connecting element (e.g., a wire) may be at least partially supported by a support tube, which typically passes through the portion of the wire that passes through the deployment module. Such a support tube can be made of any suitable material, such as plastic, metal, etc. In some embodiments, the use of a support tube may be particularly important when in the lower OTC position, which typically includes pushing the connecting element (e.g., Nitinol). Therefore, the use of a support tube can assist and improve the pushing process. Now refer to Figure 8G , showing such an embodiment. Figure 8G As shown, the connecting element 404 (shown as a nitinol wire) is located within the support tube 410. The support tube can extend parallel to the suturing mechanism 210 and be adjacent to the suturing mechanism 210.

[0146] In some embodiments, the cam follower assembly may include a cam having a notch, groove, or slot configured to interact with a corresponding engagement element (e.g., a bump, ramp, etc.) located on the cam follower near the end of possible end rotation (OTC). Such an arrangement helps provide the user with improved tactile feedback at the end of the cam rotation for the deployment and retraction of the pocket. Now referring to Fig.9A , which shows an exemplary cam and follower that allows tactile feedback according to some embodiments. Fig.9A As shown, cam 500 includes slot 502 and follower 504 includes ramps 506A-B that are located slightly forward of the end of the rotational range. Fig. 9B The form of the cam 500 itself can be seen more clearly in the isometric view of FIG.

[0147] According to some embodiments, the cam follower assembly of the pocket deployment module may be in direct contact with the connecting element (e.g., Figure 8C As described above, the connecting element can be in the form of a wire that can behave like a spring and can be made of a superelastic alloy, such as Nitinol. In such an arrangement, the connecting element can act as a spring element to compensate for OTC tolerances and / or other tolerances (e.g., assembly tolerances). Now referring to FIG. 10A to FIG. 10C , showing an exemplary pocket deployment module according to some embodiments. Fig. 10A As shown, the deployment module 550 (housed in the handle of the suturing device) includes at least a cam 552 and a follower 554. The follower 554 is directly connected to the connecting element 556, and the connecting element is configured to be pulled / pushed by virtue of the movement of the cam between the end positions and the corresponding linear movement of the follower, thereby allowing the corresponding retraction / deployment of the pocket (not shown). As described above, the rotation of the cam can be controlled by a corresponding control knob 558. Figures 10B-10C A perspective view showing a pocket deployment mechanism ( Fig. 10B ) and Section View ( Fig. 10C ), showing a cam 552, a follower 554, a connecting element 556 (e.g., in the form of a superelastic material, such as Nitinol), and a PPM shaft 560. Also shown is a screw 562, which is configured to allow a direct connection / association between the follower 554 and the connecting element 556. In some embodiments, the screw can also be used to calibrate the push-pull mechanism of the pocket. In other embodiments, other suitable connection forms for connecting various elements can be used, including but not limited to, bonding, gluing, molding, mold-covering, snap-fitting, etc., or any combination thereof.

[0148] Go (GO) / No-GO emission configuration

[0149] According to further embodiments, the suturing device may include at least two discharge assemblies configured to provide a user with an indication of the go / no-go position of the suturing device (particularly the portion of the suturing mechanism in its distal region) relative to the tissue (e.g., blood vessel) in which it is deployed. In some embodiments, the discharge assembly may include two discrete assemblies, each of which includes a discrete discharge tube, a distal opening (outlet) and a proximal opening (outlet), which may be further connected (via a routing element (manifold)) to an external discharge tube. In some embodiments, the discharge assembly is routed to the handle of the suturing device via a corresponding manifold to be connected to a corresponding external discharge tube. In some embodiments, each discharge assembly may also include a drip stop element located at or near the end of an external dropper to allow control / aiming / guiding blood dripping. In some embodiments, a drip stopper is used as a drip edge, a drip protection element, or a diverter tooth. In some embodiments, one drain assembly is a "go drain assembly" that indicates to the user that the suturing mechanism is correctly positioned (fully inserted) in the target tissue if blood drips from the external proximal opening, while the second drain assembly is a "no go drain assembly" that indicates to the user that the suturing mechanism is incorrectly positioned (over-inserted) relative to the target tissue if blood drips from the external proximal opening. In some embodiments, the go drain assembly extends from an opening in a bridging portion of a distal region of the suturing device, extending axially proximally from the distal port opening through a corresponding drain tube to a proximal opening (outlet) located in a handle of the suturing device. In some embodiments, the "no go" drain assembly extends from the distal opening of a PPM catheter in the suturing device shaft, and the catheter may also optionally be used as a no go drain catheter, extending from the distal drain opening to the proximal opening, which may be further connected (via a manifold) to an external drain tube.

[0150] Reference now FIG. 11A to FIG. 11F , according to some embodiments, different portions of an exhaust assembly are shown. Fig.11A 602A-B are shown extending from the handle 600 (a portion of the housing (cover) is removed for ease of illustration), wherein the tubes are connected / routed from the internal discharge tubes (configured to allow blood to flow from the respective distal openings of the tubes to the proximal openings) through the manifold 604, as shown below. Further shown are drip stoppers 606A-B configured to allow control of blood dripping through the external tubes, as further described herein. Also shown are the connecting element 556, the PPM tube 560, and the shaft 610. Fig. 11BA transparent view of manifold 604 is shown showing the internal openings 608A-B of the outer tubes 602A-B, each connected to a respective internal drain tube that delivers blood from a distal opening (in the bridge portion or in the PPM catheter) to allow fluid communication therebetween. Also shown for illustration purposes are connection element 556 (which may be at least partially contained within the tube / catheter to prevent it from bending when retracted into the pocket (to a hidden position)), PPM tube 560, tube 620 for suture routing (as further described below), and shaft 610. Fig. 11C An enlarged perspective view of the exhaust manifold 604 is shown. Fig. 11C As shown, the manifold 604 is connected to the shaft 610 at its distal end, and the connecting element 556 and the PPM tube 560 extend proximally through the manifold. Fig. 11B ), the internal drain tubes (i.e., the "go drain" tube having a distal opening in the bridge portion and the "no go" drain tube which is also a conduit (tube) of the PPM) are connected / routed to the external drain tubes 602A-B. At the end of each external tube, a dedicated drip stopper (i.e., drip stopper 606A-B) is provided. The drip stopper is configured to prevent cross flow between the outlet tubes during operation of the device (particularly during rotation thereof), and is also configured to prevent or obstruct outlet tube flow from reaching other parts of the handle. In some embodiments, the drip stopper is bidirectional. FIG. 11D to FIG. 11E , a close-up perspective view of exemplary drip stops 606A-B is shown, as shown, drip stops 606A and 606B allow for control of blood flow and prevent dripping blood from reaching the operating area and thereby obstructing or otherwise affecting the suturing process, particularly when the handle is rotated or the device is held during the process (generally indicated by an exemplary angle α of about 45 degrees). Fig.11F , which schematically illustrates the distal opening of an internal outlet blood vessel according to some embodiments. Fig.11F As shown, the first internal discharge tube 630 includes a distal discharge opening (outlet, port) 632, which is located in the bridge portion 640 of the suturing device. In some embodiments, the pocket is located within the insert (e.g., Fig.19C), the insert includes a connecting conduit between a drain tube and an inlet port of a "going" drain, etc. In some embodiments, the proximal end of the insert is filled with a flexible material to prevent blood from entering the shaft from the pocket opening. The drain opening and corresponding tube serve as a "going drain", indicating that if blood flows therethrough, the suturing device is properly positioned in the tissue, such as within a blood vessel. A second internal drain tube 634, which also serves as a PPM conduit (shuttle assembly 210 is shown in the figure), has a corresponding distal opening (outlet) 636, allowing blood to flow out if the suturing device is not properly positioned (for example, if it is over-inserted into the tissue, more specifically, into a space / volume of tissue, such as a blood vessel). Thus, the second tube (PPM conduit) and opening serve as a "dead" drain, providing a visual indication that the device should be repositioned before the user attempts to perform the suturing operation (or the next stage thereof).

[0151] Suture storage arrangement

[0152] According to some embodiments, the handle disclosed herein may also include an internal tube / channel / conduit for guiding the suture (suture filament) from the proximal region of the handle to the distal end of the handle. When operating the suturing device, each consecutive suture requires the dispensing of an additional length of suture. As an alternative to various reels or other dispensing devices, it has been found that providing the desired length of suture filament preloaded into a wire tube and at least partially containing the wire tube within the internal volume of the device handle is particularly effective and reliable. It has been found that the above reference FIG. 4A to FIG. 4C The depicted circular flange ("ring") 16 provides a convenient internal volume for housing a length of such tube coiled about the axis of the device, ready to dispense suture through the suture tube as the suturing procedure proceeds. FIG. 12A to FIG. 12C , which shows the routing of suture tubes through the handle according to some embodiments. Fig. 12A A partial cutaway perspective view of the handle 22 is shown in FIG. 1 , showing the proximal flat ring element 16. Also shown is the cavity 704 of the flat ring element, which provides space for the suture tube (particularly the proximal portion of its coil). Also shown is a portion of the suture tube 706, which extends along the handle (partially hidden due to passing through a channel formed in the molded plastic). Fig. 12B A cross-sectional view of the handle 22 is shown, illustrating the flat annular element 16 having a cavity space 704 that can accommodate and guide a coiled portion 708 of a suture tube 706 . Fig. 12B The flat ring element 16 is shown in the proximal region of the handle, and suture tube guidance at region 708 is shown. Fig. 12C A top view of a cross section of the flat ring element 16 is shown, showing the suture tube 708 being guided along the lumen of the flat ring element 16. In summary, Fig. 12B and Fig. 12CThe device handle cover (housing) is shown to include: a central portion having a longitudinally embedded catheter 705 to accommodate a portion of a suture tube; a proximal portion having a hollow flat ring shape, with a peripheral channel similar to a catheter at its periphery. The peripheral channel is capable of accommodating at least one coiled suture tube portion; and a middle portion having a channel-like catheter with a three-dimensional progressive spiral to spiral curvature. The middle portion connects the first (central) portion with the second (proximal) portion to form a continuous catheter for accommodating a suture tube while maintaining a given minimum radius of curvature above, thereby avoiding tube kinking and minimizing friction that may hinder the pulling of the suture as needed.

[0153] Safety lock mechanism

[0154] According to some embodiments, as described above herein, the proximal region of the handle may include a safety lock element and mechanism that is configured to prevent accidental activation of the device (particularly by pressing the activation (suturing) button), and in addition, can be used to prevent activation of the operating button (i.e., prevent it from being pressed) as long as the pocket mechanism has not yet been deployed. Such a safety lock mechanism improves safety when using the suturing device by preventing accidental or inappropriate operation. According to some embodiments, the safety lock element can be positioned / positioned so that it can physically interfere with / prevent the activation (suturing) button from being pressed, and only once removed / released can the operating button function (i.e., be able to activate the suturing mechanism). In some embodiments, in order to improve safety and accuracy, the safety lock element can be locked in place and can only be removed / released after the pocket is deployed (by activating the pocket deployment mechanism).

[0155] Reference now Fig.13A 13D , a safety latch mechanism is shown, according to some embodiments. Fig.13A A safety catch 20 is shown having a pull tab 760 connected to a blocking element 762 configured to fit over / around the cylindrical portion 754 of the guide rod for the operating button 14 to physically prevent the button from being depressed / moved. Obviously, depending on the specific structure used for the operating button 14, the blocking element 762 may alternatively clip directly onto the rod of the button, or may accommodate any other form of force input used. The safety catch 20 also engages with the planar annular element (hollow flange) 18 via a corresponding internal safety engagement (snap) mechanism, as described below. Fig. 13B The safety lock 20 is shown in a state after being detached from the handle. Fig. 13B Also shown is an engagement (snap) element 764 of the safety catch, which is configured to associate with the internal safety engagement mechanism through a corresponding opening 766 in the flat annular surface 18.

[0156] Reference now Fig. 13C, which shows a partial cross-section of the planar annular element 18, showing a portion of the internal safety engagement mechanism according to some embodiments. Fig. 13C As shown, the safety catch 20 is engaged with the handle. In addition, the engagement (snap) element 764 has a corresponding edge 776 provided by the hollow flange 18. The internal safety release mechanism 770 is further shown, which includes at least one lever 774 associated with a push rod (not shown). The push rod is preferably associated / connected with the pocket deployment mechanism 400 or 550 described above at its distal region, and is associated / connected with its cam follower, for example. The push rod can be made of any suitable material with sufficient rigidity to allow the lever to be physically pushed. Therefore, only when the pocket deployment mechanism is activated (for example, as described above, by turning the external knob and thereby moving the internal cam follower), its movement will cause the push rod to move upward, which in turn causes the pivot lever 774 to move upward (for example, by pushing the lever upward), thereby releasing the snap element 764. In some embodiments, the rod can include a proximal bend to improve the surface area interaction with the lever, and is configured to push the lever upward (proximally) to release the snap of the safety lock from the corresponding engagement area in the handle cover. In some embodiments, the lever has an inclined lower (distal) surface that collides with the lever and further causes it to move sideways (rotate) immediately after releasing the catch, thereby causing the proximal lever to lock. Therefore, the safety lock can only be released and removed from its position when the lever changes position (for example, by pushing upward, as described above). In some embodiments, the lever is a pivoting lever that can be pushed up / down to switch between engaged and released positions relative to the corresponding catch element of the safety lock. In some embodiments, when the lever is pivoted upward, in addition to releasing the engagement element of the safety lock from the stop, it can also cause the safety lock to be pushed outward from its position. This outward movement can indicate to the user that the safety lock pin is ready to move.

[0157] Needle and bracket configuration

[0158] According to some embodiments, the shuttle (needle) disclosed herein has multiple regions, each of which is configured to facilitate its operation and / or interaction with various components of the suturing mechanism during the suturing process. In some embodiments, the shuttle generally includes a distal end configured for tissue penetration (thus defining it as a "needle"), a central (middle) portion generally configured as an interface for suture engagement and pocket engagement interface, and a proximal end generally configured as an interface with a needle ejector module (particularly a PPM tube and a PPM ejector). Now referring to Fig.14A , according to some embodiments, an exemplary shuttle is shown. Fig.14AAs shown, the shuttle 800 includes a pointed or other sharp tip 804 at its distal end 802 for piercing / puncturing tissue. Its middle (center) portion 806 includes a suture interface, which includes at least one hole 809 for engaging / receiving sutures, and side grooves for accommodating sutures, preferably located on both sides of the shuttle. The grooves can be located only in the middle portion of the shuttle, but can also be optionally located in other parts of the shuttle. In some embodiments, the wire hole can have a slot shape, a circle, a constant diameter, or a cone. As shown in FIG. Fig.14A As further shown, at the proximal end of the tip 804 and the distal end of the suture interface 809, there is a pocket interface groove 810. The pocket interface 810 can be in the form of a groove, a circular groove, a partially circular groove in the shuttle body, and is configured to releasably engage a corresponding engagement element (e.g., a snap ring) of the pocket. In some embodiments, the pocket interface can have a beveled profile in its lower (distal) portion, along the entire surface of the groove, or along at least a portion of the groove. As further described in detail below, the pocket interface (e.g., in the form of a circular groove, beveled at its distal region) allows for receiving a corresponding engagement element of the pocket (e.g., in the form of a flexible ring) to facilitate the pocket to retain the needle with a limited axial retention force (e.g., a snap force). As Fig.14A As further shown, at its proximal region 812, the shuttle includes a proximal end 814 that is configured to interface with a needle ejector module (i.e., a PPM tube and a PPM ejector). The proximal end 814 of the needle can be in the form of a truncated arrowhead having an outer diameter that is generally greater than the inner diameter of at least one end of the PPM tube. The proximal end 814 can include two graduated portions 815A-B, wherein the diameter of the distal portion 815A is slightly greater than the proximal chamfered portion 815B. In addition, the proximal end can include a hole or recess, such as an axial hole 816, which can preferably be chamfered to allow for improved interaction with the needle ejector element of the needle ejector module, as further described below.

[0159] As described above, the shuttle (needle) ejector module (PPM) includes a shuttle (needle) support (e.g., tubular) configured to releasably hold the shuttle (particularly by engaging its proximal region), and a shuttle (needle) releaser / ejector element (e.g., rod-shaped) configured to interface with the proximal end of the shuttle, such as by centering itself within a hole at the proximal end of the shuttle, and releasing the shuttle from the support (tube). The shuttle support can be made of any suitable material and can be rigid, semi-rigid, or flexible. In some embodiments, the tube can be made of a superelastic alloy (e.g., nickel-titanium alloy), plastic, metal, etc. In some embodiments, the ejector element is configured to move in a reciprocating manner (in the proximal-distal direction) within the tube so as to be able to engage the proximal region of the shuttle, most preferably in a position as described above with reference to the present invention. Figures 1A to 7GAccording to some embodiments, the shuttle ejector may have any desired shape to conform to the shape and / or size of the corresponding engagement proximal region / surface of the shuttle so as to securely and reversibly engage (hold) and release the shuttle as needed according to the suturing step. In some embodiments, the shuttle ejector may hold the shuttle with sufficient force to prevent its accidental or untimely release, but still allow the ejector to release the shuttle from the ejector module.

[0160] Thus, according to some embodiments, the shuttle-shuttle ejector module interface can be tuned to ensure optimal interaction between the needle ejector and the shuttle. More specifically, such optimization can facilitate ejector engagement with the shuttle even at varying degrees of ejector off-center position. To this end, the proximal end of the shuttle can be sized to fit as tightly as possible within the shuttle holder, and can further include an engagement opening / hole / recess configured to allow maximum surface area to interact with the distal end of the ejector element.

[0161] Reference now Fig. 14B and 14C , according to some embodiments, a view of a shuttle-to-shuttle ejector module interface is shown. Fig. 14B 800 is shown with its proximal end 814 configured to interface with the distal region 852 of the ejector module, and in particular with the shuttle holder (PPM tube) 850, so that the proximal end of the shuttle can be loaded into the internal cavity of the shuttle holder 850. Fig. 14B As shown, the diameter (D1) of the opening (hole) 816 at the proximal end 814 of the shuttle is substantially similar / identical to the inner diameter (D2) 858 of the bracket 850. Therefore, advantageously, the chamfered areas in the distal end of the tube and the proximal end of the shuttle allow engagement therebetween even if D1 is equal to or greater than D2. Therefore, in some embodiments, having a chamfered area at the distal end of the tube allows interaction with / retention of the proximal end of the shuttle even if the proximal end is not chamfered, or the diameter of the proximal end hole (configured to associate / engage with an ejector of an ejector module) is substantially similar to or greater than the inner diameter of the tube. Now referring to Fig. 14C , which shows a cross section of the shuttle-shuttle ejector module interface while associated with the shuttle receiver module 870. Fig. 14C As shown, the shuttle 800 is connected at its proximal end 814 to a shuttle ejector module 870 (including a shuttle holder (PPM tube) 850 and an ejector 860), and is also associated with (retained by) a shuttle receiver module 870. The interface between the shuttle and the receiver module includes a snap-fit ​​connection between a circular groove 867 with a beveled profile at the lower end of the shuttle and a corresponding flexible / elastic snap ring 865 in the receiver module, as described below. Fig. 14CAs shown, the distal end 864 of the ejector 860 (which may be pointed or have a penetrating shape) is capable of engaging with the chamfered opening 816 at the proximal end of the shuttle 800. Thus, the size and / or shape of the opening 816 can facilitate engagement with the distal end (tip) of the ejector under various conditions (e.g., different degrees of eccentricity of the ejector), thereby improving the ejection efficiency of the shuttle from the shuttle ejector module. Fig. 14C As shown, the shuttle is configured to reversibly engage with the ejector module and the receiver module via respective engagement elements of each module.

[0162] Through FIG. 15A to FIG. 15D As introduced, various embodiments of the suturing device according to the present invention impose corresponding requirements on the relative forces required to engage and release the shuttle. For example, in certain embodiments, it is desired that the force required to engage and grasp the shuttle is relatively small, while the force required to pull the shuttle out of the bracket is large so that the bracket can reliably pull the shuttle out of the shuttle receiver. At the same time, in certain embodiments, the size of the needle and bracket can be sub-millimeter diameter, in some cases less than half a millimeter in diameter. A particularly advantageous form of engagement is introduced here that is effective for a variety of sizes, and in particular, it has been found to be well suited for sub-millimeter diameter applications.

[0163] As previously described, needle 800 has a sharp distal tip 804, a middle portion 806 configured to receive a suture, and a proximal engagement portion 812. The proximal engagement portion 812 has a first portion 813 adjacent to the middle portion and a second portion 814 proximal to the first portion. The first portion 813 has a circumscribed cylinder with a diameter of D1 and a length of L1, and the second portion 814 has a circumscribed cylinder with a diameter of D2 and greater than D1 and a length of L2. In the non-limiting example shown here, portions 813 and 814 are substantially cylindrical, so that the "circumscribed cylinder" corresponds to the outer surface of these portions (and therefore not shown separately). However, these definitions also cover the case where these portions (particularly the second portion 814) have a non-cylindrical shape, such as a cylindrical or hexagonal or other polyhedral shape modified by one or more flat chamfered surfaces. In this case, the "circumscribed cylinder" is the smallest virtual cylindrical structure that completely surrounds the corresponding portion of the needle.

[0164] A corresponding stent design according to this aspect of the invention is implemented as a tube 880 formed of a superelastic material, the tube having a tip segment 882 of length no greater than L1, whose inner diameter matches the diameter D1, and a second segment 884 of length greater than L2, whose inner diameter matches the diameter D2. The term "matching" in this context refers to the diameter of the tube segment, which is substantially unstressed, to accommodate the corresponding diameter of the engagement portion 812. This may correspond to what is known in engineering parlance as a "tight fit," where the dimensions are substantially equal, according to normal engineering tolerances for the tight fit, or a "slip fit," where the tube dimensions are slightly larger than the corresponding portion of the engagement portion. The dimensions and tolerances for achieving such a fit are well known in the engineering arts. In all cases, the fit is preferably selected to be close enough to ensure that the needle and tube are stably axially aligned during operation.

[0165] Due to this structure, when the tube 880 is pressed against the proximal end of the needle 800, the second portion 814 passes through the tip segment 882 of the tube, causing the tip segment to elastically deform, and when the second portion 814 is fully inserted into the second segment 884, the tube 880 is substantially not deformed. Since the fully inserted state of the needle corresponds to the undeformed state of the tube 880, ejecting the needle from the bracket encounters the deformation resistance of the tip segment 882 from the undeformed state to the deformed state, which is substantially similar to the insertion transition of the needle, and thus tends to enhance the resistance to pulling the needle out of the bracket.

[0166] In addition, according to certain particularly preferred embodiments, the shape of the proximal engagement portion 812 of the needle and the design of the tube 880 are such that the force required to remove the needle from the holder when fully inserted is greater than the force required to insert the needle into the holder. This is generally achieved by appropriately selecting the shape and angle of the outer surface at the transition between the needle portions 812 and 814, the shape of the tapered chamfered surface at the proximal end of the needle, and the shape of the transition between the tip segment 882 and the second segment 884 of the tube 880, as will be apparent to one of ordinary skill in the art.

[0167] exist Fig.15A and 15B In the case of the tube 880, the portion near the second section has the same inner diameter as the tip section of the tube. In this case, the enlarged second section 884 can be conveniently formed by inserting a mandrel of appropriate shape and then heat treating to fix the superelastic shape memory of the tube material.

[0168] exist Fig. 15C and 15D In the case of the proximal portion of the tube 880 extending proximally, the inner diameter of the tube 880 is equal to the inner diameter of the second segment 884. In this case, the manufacturing techniques start with a larger size tube, use an external template (with or without an internal mandrel) to form the narrower tip segment 882, and then heat treat, all of which are well known in the art.

[0169] As before, the device also includes an ejection element 860 located within the tube 880 and movable along the tube to eject the needle from the bracket, most preferably at the reference Figures 1A to 7G Ejection under the control of the mechanism described above.

[0170] refer to 16A to 16H , according to further embodiments, an alternative exemplary configuration of a distal region of a PPM tube for interfacing with a shuttle is shown. Fig.16A , the distal end of a PPM tube 900 is shown with two openings (902A-B) therein. The openings may be located opposite each other and may be the same or different in size and / or form. In some embodiments, there may be any number of openings, such as 1 to 4 openings. The openings may be of any desired shape or size, formed to fit the proximal region of the shuttle to allow for a snap action with the proximal end of the shuttle to facilitate engagement therebetween, thereby enhancing retention therebetween. This is particularly important when pulling the shuttle from the receiver pocket. In some embodiments, as Fig.16A As shown, the opening may have a substantially elongated rectangular form and may be located at a specified distance from the distal tip of the tube so as to fit and engage a corresponding proximal portion 814 of the shuttle having a truncated arrow shape, which has a larger diameter. Fig. 16B , which shows the shuttle 800 engaged with the distal region of the PPM tube 900. In some embodiments, the proximal end of the tube can be chamfered and the inner diameter of the tube can be smaller than the diameter of the proximal portion 814 of the shuttle, thereby enhancing the snap-fit ​​engagement between the tube (particularly its opening) and the shuttle. In some embodiments, the entire proximal region 814 of the shuttle (including portions 815A-B) snaps / engages with the opening of the tube.

[0171] Fig. 16C An exemplary distal end of a PPM tube 910 is shown having partial openings 912A-B on the outer surface of the tube. The openings may be toothed and may be positioned relative to one another. The openings may be the same, similar, or different in size and / or shape. In some embodiments, there may be any number of openings, such as 1 to 6. In some embodiments, the openings are sized to fit the proximal region of the shuttle to allow for a partial snap-fit ​​action to facilitate reversible engagement therebetween by allowing radial flexibility of the distal region of the tube to receive the proximal end of the shuttle. Fig.16D The shuttle 800 is shown engaged with the distal region of the PPM tube 910, wherein the opening in the tube wall allows it to open slightly radially to allow engagement with the shuttle's proximal region 814. In this arrangement, increased axial stability of the shuttle may be promoted, and the proximal form of the shuttle may experience less wear (said wear being caused by repeated retention / engagement cycles between the tube and the shuttle). Fig.16EShuttle 800 is shown engaged with a distal region of a PPM tube 920 having at least one opening 922A therein, wherein the opening is located a distance from the distal end of the tube and is optionally square shaped to allow engagement with a proximal region of the shuttle.

[0172] Fig.16F An exemplary distal end of a PPM tube 930 is shown having slotted openings along the circumference of the tube surface (exemplary slotted openings 932A-E are shown). Each opening can be in the form of a narrow rectangular slot, and the openings can be substantially evenly distributed about the circumference of the tube. The size and / or shape of the slots can be the same, similar, or different. In some embodiments, the size and location of the slots are designed to fit the proximal region of the shuttle to allow a snap-fit ​​action therewith to facilitate reversible engagement therebetween. Figure 16G The shuttle 800 is shown engaged with the distal region of the PPM tube 930, whereby the grooves in the tube wall together form snap-fit ​​engagement elements with the proximal region of the shuttle. In this arrangement, enhanced axial stability of the shuttle may be promoted, and less reduction in the outer diameter of its proximal shape may be required to allow adequate interaction with the shuttle holder. Fig.16H Additional exemplary openings 942A-B are shown on the distal region of the PPM tube according to some embodiments.

[0173] Pocket needle retention feature

[0174] As described above, the receiver module (also referred to as the pocket module) is configured to passively receive and securely hold the shuttle (once ejected from the shuttle ejector) and passively release the shuttle to the shuttle ejector in accordance with the stitching step. Fig.17A -C, which shows a view of a receiver module according to some embodiments. FIG. 17A to FIG. 17B Isometric views of pocket 1000 are shown in full and partial cutaway, associated / attached to the distal end of connecting element 1002 (corresponding to element 556, which is configured to allow retraction / deployment of the pocket, as controlled by a pocket deployment mechanism located in the handle of the suturing device, as described above). Fig.17D As shown in the cross-sectional view of FIG. 1 , the connecting element 1002 can have a flat (or spherical, not shown) distal end 1008, thereby allowing the connecting element to be fixed / anchored to the body of the pocket by any suitable means (e.g., pins, screws, rings, etc.). In some embodiments, a ring or sleeve 1009 can be screwed onto the connecting element as a bead to act as a strain relief / distributor at the anchoring interface of the connecting element located in the stepped hole in the pocket.

[0175] Also shown is a shuttle receiving portion 1004, which is shaped to accommodate a corresponding shuttle 800. Also shown is an engagement element 1006, which is configured to interact with a corresponding groove 810 of the shuttle to facilitate retaining the shuttle in the receiving portion 1004, for example, by a limited amount of axial retention force (i.e., snap force), as further described below. The engagement element 1006 includes a front region, which is shaped as a ring or other circular shape, corresponding to the shape of the corresponding groove in the shuttle to be engaged, and a rear region, which is configured to allow the engagement element to be fixed / engaged / anchored to the pocket body using any suitable means (e.g., pins, screws, rings, etc.). In some embodiments, the engagement element is mounted to a corresponding slot / opening 1014. Fig. 17C A perspective view of an exemplary engagement element 1006 is shown. Fig. 17C As shown, the engagement element 1006 (which is configured to be mounted into the slot 1014) includes a shuttle engagement portion 1012A, which is configured to be associated with the shuttle (in particular, associated with the corresponding engagement slot 810 of the shuttle, such as Fig.14A ), and a pocket engagement portion 1012B configured to allow association with a pocket body. Fig. 17B In the example shown, the different portions of the engagement element 1006 can be integrally formed as part of a substantially flat single element. In some embodiments, the engagement element is flexible and can be made of a suitable material, such as but not limited to: plastic, nylon, silicone, rubber, or preferably made of a superelastic alloy, such as Nitinol. In some embodiments, the size and / or shape of the engagement element can be adjusted / predetermined according to the size, form and / or shape of the shuttle to be engaged. In some embodiments, the shuttle engagement portion 1012A can be in the form of a ring and can optionally include an opening / slot 1015 (i.e., an incomplete ring form) to allow flexibility in the retention (snap) and release of the shuttle. In some embodiments, portion 1012A is connected to portion 1012B by a beam-like or other flexible element 1013 to facilitate centering and expansion of the ring during needle engagement. The tolerances of the pocket engaging portion 1012B and / or the flexibility of the flexible connecting element 1013 interconnecting the pocket engaging portion with the shuttle engaging portion 1012A are preferably such that the shuttle engaging portion effectively "floats", i.e., is free to move within the slot 1014 within a sufficient range of positions to self-align with the shuttle 800 when the shuttle is inserted into the shuttle receiving portion. This freedom of movement should be sufficiently limited to ensure that the leading end of the shuttle can successfully position itself within the opening of the shuttle engaging portion upon insertion.

[0176] refer to Fig.17D , according to some embodiments, a cross-section of a pocket assembly is shown. Fig.17D The pocket 1000 is shown in FIG. 1 and is associated with the shuttle 800, which is received in the receiving portion 1004 of the pocket. Fig.17D As shown, the engagement element 1006 (particularly its ring portion) is associated with the body of the shuttle 800, and in particular with the pocket interface groove 810 of the shuttle. The groove / recess 810 along the circumference of the middle region / lower distal portion of the shuttle cooperates with and is retained by the ring portion of the engagement element 1006. When the needle is retained by the pocket, this limited axial retention force (snap retention) of the ring secures the needle into the pocket. Fig.17D As further shown, the shuttle receiving portion 1004 includes an upper (proximal) portion 1017A, a middle portion 1017B, and a lower (distal) portion 1017C. The proximal region 1017A has a relatively large diameter to allow the shuttle to enter / receive the shuttle even if the shuttle is not centered, provide space for sutures associated with the shuttle (to the sides thereof), and allow the distal end of the tube to at least partially expand radially to allow the shuttle to be released therefrom.

[0177] refer to 18A to 18D , which shows a further exemplary preferred embodiment of a receiver module with a shuttle engagement element. As with the previous embodiment, the receiver body (pocket) has a needle receiving hole that extends parallel to the hole axis to receive the needle and has a retaining element slot that extends from one side of the receiver body and intersects the needle receiving hole. The elastic snap retainer is deployed in the retaining element slot so that the elastic snap retainer is aligned within the needle receiving hole to elastically retain the needle. The intermediate region 1017B allows the shuttle to be axially stabilized within the receiver and includes a slot 1014 for receiving the engagement element 1006. The distal region 1017C includes a hole that gradually decreases or otherwise reduces in diameter for pausing / stopping the axial movement of the shuttle.

[0178] exist FIG. 18A to FIG. 18B In the case of the embodiment shown in FIG. 1 , the receiver module (pocket) 1050 has a shuttle receiving portion (needle receiving hole) 1054, which is shaped to accommodate a corresponding shuttle. Also shown is an engagement element 1056, wherein its inner ring (elastic snap fastener retainer) 1060 is configured to interact with a corresponding groove of the shuttle to facilitate retaining the shuttle in the receiving portion 1054. Fig.18A As shown, the inner ring 1060 can be slotted and located / positioned within a housing / body portion 1062 that preferably constrains the resilient snap fasteners within a desired range of positions while allowing enough clearance for them to "float" to self-align with the shuttle when inserted into the needle receiving aperture. The housing is configured to fit into a corresponding front opening (slot) in the body of the pocket 1050 and can be secured thereto using securing geometries 1064A-B. The securing geometries 1064A-B can take the form of flexible extensions (elastic locking tabs or "wings") that protrude slightly upward and are configured to snap / lock with corresponding openings 1067 in the pocket 1050.

[0179] FIG. 18C to FIG. 18D The implementation method and FIG. 18A to FIG. 18B is implemented similarly, but with 17A to 17D A similar anchoring arrangement. Specifically, in this case, the receiver body also includes a locking element channel that intersects the retaining element slot, and the resilient snap retainer is interconnected with the anchoring arrangement having a hole aligned with the locking element channel. The locking element (pin) 1110 is deployed in the locking element channel to engage the hole, thereby anchoring the resilient snap retainer in a position aligned with the needle receiving hole.

[0180] Thus, the receiver module (pocket) 1100 has a shuttle receiving portion (cavity) 1104, which is shaped to accommodate a corresponding shuttle. Also shown is an engagement element 1106, which includes an inner ring 1112, which can be slotted and is located within a housing / body 1114. The housing 1114 also includes a slot 1117, which is beveled at its rear end (1119) to separate the end of the housing into two ends 1115A-B. The engagement module is configured to fit into a corresponding (slot) in the body of the pocket 1110 and can be fixed thereto using a pin 1110 attached to the pocket. The engagement element (particularly its housing) is configured to snap around the pin with the aid of the beveled slot 1117, slide on the pin 1110, and simultaneously separate the open ends 1115A-B of the housing. In some embodiments, the coupling element (housing and / or ring) can be flexible or semi-flexible and can be made of any suitable material, such as but not limited to: plastic, rubber, silicon, superelastic alloy (such as Nitinol), etc., or any combination thereof.

[0181] exist FIG. 17A to FIG. 18D In each non-limiting example, the resilient snap-fit ​​retainer is a snap-fit ​​ring extending around the entire periphery of the shuttle. This is useful for shuttle designs (e.g. Fig.14A The needle 800 shown in FIG. 8 is particularly valuable where the peripheral groove 810 does not extend around the entire needle. In this case, the use of a ring around the shuttle ensures snap-on fixation of the shuttle regardless of the rotational direction of the shuttle to the pocket. In other embodiments, for example, when the peripheral groove surrounds the shuttle, other snap-on fixators may be used, such as leaf spring wire on one or both sides of the needle receiving hole.

[0182] In certain particularly preferred embodiments, the shape and mechanical design of the peripheral groove and the resilient snap-fit ​​retainer are such that the force required to release the needle from the needle receiver is greater than the force required to engage the needle in the needle receiver.

[0183] Self-alignment of the shuttle ejector in the shuttle receiver

[0184] FIG. 19A to FIG. 19D and Fig. 20Another particularly preferred feature of certain embodiments of the suturing device according to one aspect of the present invention is shown. According to this aspect of the present invention, the geometry of the shuttle receiver 1000, shuttle 800 and shuttle ejector 210 is such that when the shuttle is positioned in the aperture 1004 of the shuttle receiver, the shuttle ejector will self-align coaxially with the shuttle to ensure that the shuttle holder operates properly to engage the shuttle and pull it out of the receiver aperture, provided that the initial approach of the shuttle ejector axis is at any position within the shuttle receiver aperture. This process is FIG. 19A to FIG. 19D It is shown in Fig.19D The initial approach of the shuttle ejector is shown, significantly off-axis relative to the receiver bore, but just within its perimeter. Fig.19B 816, so that further movement of the shuttle ejector is self-aligned with the hole, as shown in FIG. Fig.19C The shuttle ejector is then properly aligned to engage the shuttle holder, as shown. Fig.19D shown.

[0185] Fig. 20 The main geometrical requirements to ensure this self-alignment process are schematically illustrated. Fig. 20 yes Fig.19A An enlarged and annotated partial view of the shuttle. The proximal engagement portion of the shuttle has an axial bore surrounded by an edge having a radius R2 from the central axis of the shuttle. The bore of the shuttle receiver has an opening having a radius R1 and, when the shuttle is in the inserted position, the opening is located at an axial height H from the edge of the shuttle axial bore. Using this terminology, when the shuttle ejector configuration adopts a penetration configuration that terminates at a penetration point, this self-centering function can be provided by ensuring that the radius of the penetration configuration gradually increases so that at an axial distance H from the penetration point, the penetration configuration has a radius R3, where R3 is greater than (R1–R2).

[0186] Expander Rotation Configuration

[0187] As mentioned above, the suturing device may also optionally include a dilator connected to the distal end of the shaft by a dedicated connector. This flexible dilator is deployed at the distal end of the shaft of the suturing mechanism (the bridging portion of the device) and is interconnected with it by a rotary connector. In certain embodiments, the dedicated dilator connector is a rotary connector with a fixed angle.

[0188] Now refer to Figures 21A to Fig.21E , various views of a rotary connector and associated interface are shown, according to some embodiments. FIG. 21A(i) to FIG. 21A(iii)Three views of a rotary connector 1200 are shown connecting / bridging the distal end of the suturing mechanism (its shaft) 1202 and the proximal end of the dilator 1204, showing three different fixed angle connectors to provide user selectable working angles when assembling the device. FIG. 21A(i) to FIG. 21A(iii) As shown, the connector 1200 may include one or more openings / holes 1206 for fixing the rotary connector to the suturing mechanism part (particularly its internal insert, as described below). The fixing of the rotary connector to the suturing mechanism part / module may be achieved by any suitable means, including, for example, screws, pins, welding (e.g., by spot welding, laser welding, etc.), etc. In some embodiments, the connector may be fixed to a locking sleeve (locking ring) associated with the distal end of the internal insert, the locking sleeve having the shape of an axis / hinge, as described below. Fig.21B FIG. 21A(i) is a partial cross-sectional view showing the connector 1200 and the expander 1204 in cross-sectional view. Fig.21B As shown, the distal end of the shaft of the suturing mechanism 1202 includes an insert distal end 1208, which is configured to connect to (hold) the connector 1200 and further allow the connector to rotate around it. The insert 1208 is fixed to the distal end (also called the rod end) of the suturing mechanism by any suitable means. In some embodiments, the insert can be integrally formed with the shaft of the suturing mechanism. In some embodiments, there is no relative motion between the insert and the shaft because both parts are stationary. As shown in FIG. Fig.21B As shown, the insert 1208 has an elongated body with integrated sliding bearings (collars) at its proximal and distal ends (1210A-B, respectively). The middle portion (having a recessed diameter) 1212 of the insert distal end is configured to be associated with a locking sleeve (locking ring 1214). The locking ring is configured to fit tightly (snap into) the recessed diameter middle portion of the insert distal end and further engage with a corresponding opening 1206 ( FIG. 21A(i) to FIG. 21A(iii) ) interact to allow the connector to be fixed to the distal end of the insert. In some embodiments, the connector can be further fixed to a locking sleeve (locking ring), such as by welding thereon (e.g., through opening 1206).

[0189] Fig. 21CA cross-section of the distal end of the suturing mechanism is shown, which is connected to the dilator via a rotary connector. The distal end 1202 of the suturing mechanism includes a receiver module 1250 (shown in a retracted (hidden) position), a connecting element 1252 is also shown, connecting the receiver module to the proximal PDM), and the shaft 1254 of the ejector module. The elastic seal 1253 preferably prevents blood from leaking along the channel of the connecting element 1252. An insert 1256 is also shown, which is fixed to the shaft of the suturing mechanism and has a distal end (rod end) 1208 protruding therefrom. As described above, the distal end 1208 of the insert includes integrated sliding bearings located at its proximal and distal ends, and a middle portion having a recessed diameter, which is configured to be associated with a locking sleeve 1214. Further shown is a rotary connector 1200, which is connected to the distal end of the insert 1208 (which serves as the rotation axis of the connector 1200), and is further connected to the dilator 1204 via a connecting element (shown as a barbed connector 1220).

[0190] Fig.21D A perspective view of the distal end of an insert 1256 is shown, showing the distal end 1208 of the insert and a locking sleeve 1214 associated therewith. In some embodiments, the locking sleeve can include a groove 1216 to facilitate assembly / placement of the sleeve on the distal end of the insert. In some embodiments, the locking sleeve can snap onto the insert. In some embodiments, the locking sleeve can rotate around the insert. In some embodiments, the locking sleeve can increase the diameter of a central recessed portion of the distal end of the insert. In some embodiments, the locking sleeve facilitates axial locking of the distal end of the insert with the rotary connector by forming a tight fit between the locking sleeve and a corresponding opening / receiving portion of the rotary connector. Fig.21E A cross-sectional view of the connector 1200 is shown in relation to the distal end 1208 of the insert. As shown, the connector can rotate on two collar plain bearings 1210A-B, and the locking sleeve further provides a freely rotatable interface. Fig.21B , the rotary connector 1200 also includes a connection element 1220 at its distal end, which is configured to connect / attach / fix the expander 1204 thereto. In some embodiments, the distal connection element 1220 can be formed integrally with the connector 1200 or can be attached / associated therewith. In some embodiments, the connection element 1220 can have an elongated body having one or more engagement elements configured to enhance the interaction / association between the expander and the distal connection element. In some exemplary embodiments, as Fig.21BAs shown, the distal connection element 1220 can be a barbed connector having a protruding structure 1222 (e.g., shown in the form of a micro-scallop) at its distal region. In some embodiments, the distal connection element can be loaded into a corresponding opening 1224 located in the proximal region of the expander body. In some embodiments, the connection element and the expander can be formed integrally. In some embodiments, the connection element can be embedded in the expander.

[0191] In some embodiments, the connector is a fixed angle connector that can be at a selected angle between the axis of the suturing mechanism and the dilator, such as ranging from 0 degrees of deflection (straight) to 90 degrees of deflection (vertical). According to some embodiments, the angle can be predetermined, so that corresponding connectors can be defined for various pre-formed angles. In some embodiments, the selection of the angle of use of the connector can be determined based on specific needs (e.g., medical procedures, etc.). A typical set of preferred angles may include FIG. 21A(i) to FIG. 21A(iii) Some or all of the angles shown in , namely 20 degrees, 30 degrees and 40 degrees, and / or other angle options.

[0192] According to some embodiments, provided herein is a method of suturing a material (eg, in vivo tissue) using a suturing device disclosed herein.

[0193] According to some embodiments, although the present disclosure describes a device in which certain components are connected by fasteners such as screws and nuts, it should be understood that in any of these cases, these connections can be achieved by US welding, gluing, snaps, etc.

[0194] It should be understood that, for the sake of clarity, certain features of the present disclosure are described in separate embodiments, but these features may also be provided in combination in a single embodiment. Conversely, for the sake of brevity, various features of the present disclosure are described in a single embodiment, but these features may also be provided separately or in any suitable sub-combination, or in any other embodiment of the present disclosure in an appropriate manner. Unless expressly provided, any feature described in the context of an embodiment should not be considered an essential feature of that embodiment.

[0195] As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more", unless the context clearly indicates otherwise.

[0196] Although the steps of the method according to certain embodiments may be described in a specific order, the method of the present disclosure may include some or all of the steps performed in a different order. The method of the present disclosure may include several or all of the steps. Unless explicitly stated, any specific step in the disclosed method should not be considered a necessary step of the method.

[0197] Although the present disclosure is described in conjunction with its specific embodiments, it is apparent that there may be numerous alternatives, modifications and variations that are apparent to those skilled in the art. Therefore, the present disclosure encompasses all such alternatives, modifications and variations that fall within the scope of the appended claims. It should be understood that the present disclosure is not necessarily limited to the construction details and the arrangement of components and / or methods described herein in its application. Other embodiments may be practiced, and embodiments may be implemented in various ways.

[0198] The wording and terms used herein are for descriptive purposes only and should not be considered as limiting. Any reference cited or identified in this application should not be construed as an admission that such reference can serve as prior art for the present disclosure. Section headings are used herein to facilitate understanding of the specification and should not be construed as necessarily limiting.

[0199] As used herein, the term "about" may be used to specify that a value of a quantity or parameter (e.g., the length of an element) is within a continuous range of values ​​that is in the neighborhood (inclusive) of a given (specified) value. According to some embodiments, "about" may specify that a value of a parameter is between 80% and 120% of a given value. According to some embodiments, "about" may specify that a value of a parameter is between 90% and 110% of a given value. According to some embodiments, "about" may specify that a value of a parameter is between 95% and 105% of a given value.

[0200] In the description and claims of this application, each of the words "including," "comprising," and "having" and forms thereof are not necessarily limited to the members of the list with which these words may be associated.

Claims

1. A mechanism for operating a medical device, characterized in that: The mechanism for operating a medical device comprises: (a) a handle; (b) an effector assembly mounted in response to the handle so as to be displaceable in an axial direction relative to the handle, the effector assembly comprising: (i) a first effector; (ii) a second effector; (iii) a bistable mechanism comprising a bistable element; and (iv) a biasing assembly comprising at least one first spring element and at least one second spring element, the biasing assembly biasing each of the first effector and the second effector in a distal direction relative to the bistable element; The bistable element is in a first axial state and a second axial state, in which the second effector is biased to a first relative axial position relative to the first effector in the first axial state, and in which the second effector is biased to a second relative axial position relative to the first effector in the second axial state; and (c) a force input end configured to selectively apply an input force to the bistable mechanism; The force applied to the force input end in a first direction is effective in the following order: (i) displacing the effector assembly distally along the axial direction without changing the state of the bistable mechanism; and (ii) switching the bistable element between the first axial state and the second axial state when further distal displacement of at least a portion of the effector assembly encounters an obstacle; The biasing assembly is configured to enable the bistable mechanism to switch from the first axial state to the second axial state without requiring the second effector to reach the second relative axial position.

2. The mechanism according to claim 1, characterized in that: The first spring element acts between the first effector and the second effector, and the second spring element acts between the second effector and the bistable element.

3. The mechanism according to claim 1, characterized in that: The first spring element acts between the first effector and the bistable element, and the second spring element acts between the second effector and the bistable element.

4. The mechanism according to claim 1, characterized in that: The mechanism also includes a retraction spring deployed to return the bistable mechanism, the first effector, and the second effector along the axial direction toward a proximal direction.

5. The mechanism according to claim 1, characterized in that: The first effector is a bracket for holding a suture needle, and the second effector is an ejector. When the second effector is moved from the first relative axial position to the second relative axial position, the second effector ejects the suture needle from the bracket.

6. The mechanism according to claim 5, characterized in that: In the second relative axial position, the ejector has a penetrating tip.

7. The mechanism according to claim 1, characterized in that: At least one of the first spring and the second spring is deployed with a preload force that defines a minimum force required to change the length of at least one of the springs.

8. The mechanism according to claim 1, characterized in that: In the first axial state of the bistable element, the first spring is deployed with a first preload force and the second spring is deployed with a second preload force, and in the second axial state of the bistable element, at least one of the first preload force and the second preload force changes so that a ratio between the first preload force and the second preload force is different between the first axial state and the second axial state.

9. A suturing mechanism, characterized in that: The suturing mechanism comprises: (a) a needle having a sharp distal tip, a middle portion configured to receive a suture, and a proximal engagement portion, the proximal engagement portion comprising a first portion adjacent to the middle portion and a second portion proximal to the first portion, the first portion having a circumscribed cylinder of diameter (D1) and length (L1), and the second portion having a circumscribed cylinder of diameter (D2) greater than the diameter (D1) and length (L2); and (b) a support for releasably holding the needle, the support comprising a tube made of a superelastic material, the tube having a tip section and a second section, the tip section having a length no greater than the length (L1) and an inner diameter matching the diameter (D1), the second section having a length greater than the length (L2) and an inner diameter matching the diameter (D2); When the tube is forced against a proximal end of the needle, the second portion passes through the tip section of the tube, thereby causing elastic deformation of the tip section, and when the second portion is fully inserted into the second section, the tube is substantially undeformed.

10. The suturing mechanism according to claim 9, characterized in that: A shape of the proximal engagement portion of the needle and the design of the tube are such that, when fully inserted, the force required to remove the needle from the stent is greater than the force required to insert the needle into the stent.

11. The suturing mechanism according to claim 9, characterized in that: A portion of the tube proximate the second section has the same inner diameter as the tip section of the tube.

12. The suturing mechanism according to claim 9, characterized in that: The tube extends proximally to the second section, and the inner diameter of the tube is equal to the inner diameter of the second section.

13. The suturing mechanism according to claim 9, characterized in that: The suturing mechanism also includes an ejection element disposed within the tube and movable along the tube to eject the needle from the bracket.

14. A needle receiver for passively holding a needle of a suturing device, characterized in that: The needle receiver comprises: (a) a receiver body having: a needle receiving hole extending parallel to a hole axis and for receiving a needle; and a retaining element groove extending from a side of the receiver body and intersecting the needle receiving hole; and (b) a resilient snap retainer disposed in the retaining element slot such that the resilient snap retainer is aligned within the needle receiving aperture to resiliently retain the needle.

15. The needle receiver of claim 14, wherein: The receiver body also includes a locking element channel that intersects with the retaining element groove, and the elastic snap fastener retainer is interconnected with an anchoring structure, the anchoring structure has a hole aligned with the locking element channel, and the needle receiver also includes a locking element, which is deployed in the locking element channel to engage the hole, thereby anchoring the elastic snap fastener retainer in a position aligned with the needle receiving hole.

16. The needle receiver of claim 15, wherein: The resilient snap fastener and the anchoring structure are connected to each other by a flexible connecting element to facilitate self-alignment of the resilient snap fastener with a needle inserted into the needle receiving hole.

17. The needle receiver of claim 16, wherein: The elastic snap fastener, the flexible connecting element and the anchoring structure are integrally formed into a unitary flat element made of superelastic material.

18. The needle receiver of claim 14, wherein: The elastic snap fastener is a clamping ring.

19. The needle receiver of claim 14, wherein: The needle receiving hole has an internal stepped hole for defining a fully inserted position of the needle.

20. The needle receiver of claim 14, wherein: The needle receiver also includes a needle for insertion into the needle receiver, the needle having a peripheral groove for receiving the elastic snap retainer, and the peripheral groove and the elastic snap retainer are configured so that the force required to release the needle from the needle receiver is greater than the force required to engage the needle in the needle receiver.

21. A suturing mechanism, characterized in that: The suturing mechanism comprises: (a) a shuttle having a middle portion configured to receive a suture and a proximal engagement portion having an axial bore surrounded by an edge having a radius (R2) from a central axis of the shuttle; (b) a shuttle receiver having a bore for receiving and releasably retaining said shuttle in an inserted position, said bore having an opening having a radius (R1) and being located at an axial height (H) from said edge of said axial bore of said shuttle when in said inserted position; and (c) a shuttle ejector configured to engage the shuttle within the hole, the shuttle ejector having a penetration structure in which the shuttle ejector terminates at a penetration point, the penetration structure having a gradually increasing radius such that at an axial distance (H) from the penetration point, the penetration structure has a radius (R3), wherein the radius (R3) is greater than the difference between the radius (R1) and the radius (R2).

Images