Suturing device and mechanism for operating such a device

Abstract

The suturing device (10) uses a displaceable bistable mechanism to enable a user to perform continuous bidirectional suture passes of continuous stitches by successive presses of a single actuation button (14) when the device is rotated. The displaceable bistable mechanism can also be used in other medical and non-medical applications. Aspects of a suture shuttle holder and a distal shuttle receiver having a retention structure that generates a retention force profile optimized for a suturing sequence are also disclosed.

Description

Technical Field

[0001] The present invention relates to medical devices, and more specifically, to suturing devices. Further, the present invention provides various mechanisms for operating medical devices suitable for operating the disclosed suturing devices, but can also be advantageously used with various other suturing devices and other medical devices.

[0002] Various aspects of the present invention are presented herein in the context of a non-limiting type of suturing device similar to those described in co-owned co-pending patent applications published as WO2021 / 024236A1 and WO2021 / 111429A1, which patent applications are hereby incorporated by reference in their entirety as if fully set forth herein.

Summary of the Invention

[0003] The present invention provides mechanisms for operating medical devices such as suturing devices and various details of such devices.

[0004] According to the teachings of embodiments of the present invention, a mechanism for operating a medical device is provided, the mechanism comprising: (a) a handle; and (b) an effector assembly attached to the handle so as to be axially displaceable 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 device comprising at least a first spring element and a second spring element, the biasing device biasing each of the first effector and the second effector distally relative to the bistable element, the bistable element assuming a first axial state in which the second effector is biased toward a first axial relative position relative to the first effector, and a second axial state in which the second effector is biased toward a second axial relative position relative to the first effector, the effector assembly comprising the biasing device; and (c) a force input portion deployed to selectively apply an input force to the bistable mechanism, the force applied in a first direction by the force input portion being: (i) axially displacing the effector assembly distally without changing the state of the bistable mechanism; and (ii) sequentially effective to toggle the bistable element between the first axial state and the second axial state when at least a portion of the effector assembly encounters an obstacle to further distal displacement, the biasing device being configured such that the bistable mechanism is toggleable from the first axial state to the second axial state without requiring the second effector to have reached the second axial relative 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 a further feature of an embodiment of the present invention, there is further provided a bistable mechanism and a return spring deployed to axially return the first effector and the second effector in the proximal direction.

[0008] According to a further feature of an embodiment of the present invention, the first effector is a holder for holding a suture needle, and the second effector is an ejector effective to push the suture needle out of the holder when displaced from the first axial relative position to the second axial relative position.

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

[0010] According to a further feature of an embodiment of the present invention, at least one spring of the first spring element and the second spring element is deployed with a preload force that defines the minimum force required to change the length of the at least one spring.

[0011] According to a further feature of an embodiment of the present invention, in the first axial state of the bistable element, the first spring element is deployed with a first preload force and the second spring element 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 such that the ratio between the first preload force and the second preload force is different between the first axial state and the second axial state.

[0012] Also, according to the teachings of embodiments of the present invention, a stitching mechanism is provided, the stitching mechanism comprising: (a) a needle having a pointed distal tip, an intermediate portion configured to receive a suture, and a proximal engagement portion, the proximal engagement portion comprising a first portion adjacent to the intermediate portion and a second portion proximal to the first portion, the first portion having a circumscribing cylinder with a diameter D1 and a length L1, and the second portion having a circumscribing cylinder with a diameter D2 greater than D1 and a length L2; and (b) a holder for releasably holding the needle, the holder comprising a tube formed from a superelastic material, the tube having a distal segment of length less than or equal to L1 with an inner diameter matching D1, and a second segment having a length greater than L2 and an inner diameter matching D2, such that when the tube is pressed against the proximal end of the needle, the second portion passes through the distal segment of the tube, causing elastic deformation of the distal segment, and when the second portion is fully inserted into the second segment, the tube is substantially undeformed.

[0013] According to a further feature of embodiments of the present invention, the shape of the proximal engagement portion of the needle and the design of the tube are such that the force required to withdraw the needle from the holder when fully inserted is greater than the force required to insert the needle into the holder.

[0014] According to a further feature of embodiments of the present invention, the portion of the tube proximal to the second segment has the same inner diameter as the distal segment of the tube.

[0015] According to a further feature of embodiments of the present invention, the tube continues proximally to the second segment with an inner diameter equal to the inner diameter of the second segment.

[0016] According to a further feature of embodiments of the present invention, an ejector element is further provided that is displaceable along the tube to push the needle out of the holder, deployed within the tube.

[0017] Also, according to the teachings of embodiments of the present invention, a needle receiver for passively holding the needle of a suturing device is provided, the needle receiver comprising: (a) a receiver body having a needle receiving bore extending parallel to a bore axis for receiving the needle, and a retaining element slot extending from a side surface of the receiver body and intersecting the needle receiving bore; and (b) an elastic snap retainer deployed within the retaining element slot such that the elastic snap retainer is aligned within the needle receiving bore for elastically holding the needle.

[0018] According to further features of embodiments of the present invention, the receiver body further comprises a locking element channel intersecting the retaining element slot, the elastic snap retainer is interconnected with a fixed configuration having an opening aligned with the locking element channel, and the needle receiver further comprises a locking element deployed within the locking element channel for engaging the opening, thereby fixing the elastic snap retainer in alignment with the needle receiving bore.

[0019] According to further features of embodiments of the present invention, the elastic snap retainer and the fixed configuration are interconnected via a flexible connection element to facilitate self-alignment of the elastic snap retainer with the needle inserted into the needle receiving bore.

[0020] According to further features of embodiments of the present invention, the elastic snap retainer, the flexible connection element, and the fixed configuration are integrally formed as one flat element made of a superelastic material.

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

[0022] According to further features of embodiments of the present invention, the needle receiving bore has an inner stepped bore defining a fully inserted position of the needle.

[0023] According to a further feature of an embodiment of the present invention, a needle for introduction into a needle receiver is further provided, the needle having an outer peripheral groove for receiving an elastic snap retainer, the outer peripheral groove and the elastic snap retainer being configured such that the force required to release the needle from the needle receiver is greater than the force required to engage the needle with the needle receiver.

[0024] Also, according to the teachings of an embodiment of the present invention, a sewing mechanism is provided, the sewing mechanism comprising: (a) a shuttle having an intermediate portion configured to receive a sewing thread and a proximal engagement portion, the proximal engagement portion having an axial opening surrounded by a rim having a radius R2 from the central axis of the shuttle; (b) a shuttle receiver having a bore for receiving the shuttle at an insertion position and releasably holding the shuttle, the bore having a radius R1 and having an opening located at an axial height H from the rim of the axial opening of the shuttle when in the insertion position; and (c) a shuttle transmitter configuration for engaging the shuttle within the bore, the shuttle transmitter presenting a through configuration that terminates at a through point, the through configuration having a gradually increasing radius such that at an axial distance H from the through point, the through configuration has a radius R3 and R3 is greater than (R1 - 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, will make apparent to those skilled in the art how some embodiments may be implemented. The drawings are for illustrative purposes only and do not attempt to show structural details of the embodiments in more detail than is necessary for a basic understanding of the present disclosure. For clarity, some of the objects depicted in the figures are not to scale. In the drawings:

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DETAILED DESCRIPTION OF THE INVENTION

[0026] The present invention provides a mechanism for operating medical devices such as suturing devices and various details of such devices.

[0027] As an introduction, the present invention introduces a class of mechanisms that are useful for operating devices in a wide range of medical and other applications whenever the compound movement of two elements, referred to as a first effector and a second effector, is required. Specifically, the mechanism needs to perform a compound movement in which the two effectors move together, and in addition, it needs to accommodate switching between two states in which relative movement occurs between the two effectors. An exemplary application that requires such movement is a suturing mechanism, where a first displacement may cause a needle to penetrate tissue and remain in a distal needle receiver (or "pocket"), and a subsequent shift between the two elements may release the needle so that it remains in the pocket and may retract. Additionally, or alternatively, the compound displacement may engage a needle holder with a needle held on the distal side of the tissue, and the relative shift between the two elements may cause the needle holder to grip the needle for pulling it through the tissue. However, the mechanism is not limited to any particular implementation of the suturing mechanism itself and may be adapted to various other applications in the medical field and other fields. Accordingly, FIGS. 1A - 3B schematically present the features of various implementations of this mechanism, are applicable to a wide range of application examples, and encompass multiple possible implementations.

[0028] Next, as one specific example, with reference to FIGS. 4A - 7G, the implementation of the mechanism will be described in the context of one particularly preferred embodiment, and with reference to FIGS. 8A - 20C, some complementary features that are advantageously implemented in a particularly preferred suturing device according to various further aspects of the present invention will be described.

[0029] Universal actuator having a displaceable bistable mechanism Referring now to FIGS. 1A-3B generally, there is shown a mechanism generally designated 100 constructed and operative in accordance with aspects of the present invention for manipulating a device such as a medical device and a suturing device in some particularly preferred embodiments. The details of the device are not shown in these drawings but are shown later in this document as non-limiting examples. Mechanism 100 generates motion relative to an external reference, shown here as an external housing or handle 102. Effector assembly 104 is mounted to handle 102 such that it is displaceable axially (arrow 106) relative to the handle. Effector assembly 104 includes a first effector 184 and a second effector 182. An effector is an element that interacts with or forms part of the device being actuated. In the particularly preferred but non-limiting examples shown below, the first effector 184 is a holder for holding a suture needle and the second effector 182 is an ejector for releasing the suture needle from the holder. Thus, throughout this document, these elements may be referred to as holder 184 and ejector 182, but it should be noted that these terms apply only to a non-limiting subgroup of exemplary embodiments of the present invention.

[0030] Effector assembly 104 further includes a bistable mechanism 170 including a bistable element 172 and a biasing device including at least a first spring element 180B and a second spring element 180A. The biasing device biases each of the first effector and the second effector 184 and 182 distally relative to the bistable element 172. As is most readily seen in the pairs of bistable states shown in FIGS. 2A(i)-2D(ii), the bistable element 172 has a first axial state (FIGS. 2A(i), 2B(i), 2C(i), and 2D(i)) in which the second effector 182 is biased toward a first axial relative position relative to the first effector 184, and a second axial state (FIGS. 2A(ii), 2B(ii), 2C(ii), and 2D(ii)) in which the second effector 182 is biased toward a second axial relative position relative to the first effector 184.

[0031] Optionally, all components of the effector assembly 104 are preferably integrated to move the first effector 184 together, defining two axial positions of the bistable mechanism 170, and may be contained within the inner housing 185, providing a feature (shown schematically as stops 108 in FIGS. 2A(ii), 2B(ii), 2C(ii), and 2D(ii)).

[0032] The mechanism 100 also includes a force input that is deployed to selectively apply an input force to the bistable mechanism 170. The force input may be manual or may be actuated by any form of electromechanical or other actuator. Additionally, the manually or otherwise actuated force input may be unidirectional (e.g., by a reverse movement provided by a return spring) or the input may actively provide force bidirectionally. In the preferred but non-limiting example shown herein, the force input is implemented as a push button, knob, or plunger 114, the force is manually applied in only one direction, causing distal displacement of the effector assembly 104 relative to the handle 102, while the return movement is governed by the return spring 140.

[0033] Figures 1A - 1C show different configurations of the biasing device, and in particular, show whether the first spring element 180B and the second spring element 180A are deployed in parallel or in series. Thus, in the example of FIG. 1A, the first spring element 180B acts between the first effector 184 and the bistable element 172, and the second spring element 180A acts between the second effector 182 and the bistable element 172, such that the two springs define a parallel biasing device. In FIG. 1B, the first spring element 180B acts between the first effector 184 and the second effector 182, and the second spring element 180A acts between the second effector 182 and the bistable element 172, thereby defining a series biasing device. FIG. 1C shows a hybrid device where the first and second spring elements 180B, 180A are deployed as in FIG. 1B, but they are complemented by an additional spring 120 that acts directly between the first effector 184 and the bistable element 172. Additionally, in certain preferred implementations, at least one, typically both, of the first and second springs 180B and 180A are deployed with a preload force that defines the minimum force required to change the length of at least one spring. The ratio between the preload forces of the first and second spring elements 180B, 180A typically differs between the first and second axial states of the bistable mechanism.

[0034] Devices for providing these preload forces are schematically shown in FIGS. 1A - 1C by providing corresponding spring enclosures 181A and 181B for springs 180A and 180B, respectively, along with an input to each spring delivered via corresponding compression rods 186A and 186B. This depiction of each spring within a dedicated enclosure is for clarity of explanation, but it will be understood that there are many ways in which the springs can be confined so as to have a preload force. Some alternative implementations will become apparent from the subsequent examples.

[0035] All of the springs shown in this specification are schematically represented as helical compression springs, but it will be understood by those skilled in the art that the present invention may be implemented using any and all types of springs or other elastic elements, including but not limited to compression springs and tension springs. Torsion springs and any other form of mechanical spring may be formed from an elastic or other elastic material as discrete spring elements, or integrally formed with other components, and are formed from metal, metal alloy, superplastic alloy, polymeric material, or any other material exhibiting properties suitable for forming a spring, as well as pneumatic springs, magnetic or electromagnetic devices that emulate or replace a spring, and any other element or device that provides the biasing characteristics described herein.

[0036] According to one aspect of some implementations of the present invention, the overall effect of the structure described herein is that a force applied in a first direction by a force input portion is first effective to axially displace the effector assembly distally along the axis without first changing the state of the bistable mechanism, and then is effective when at least a portion of the effector assembly encounters an obstacle to further distal displacement. The bistable element is switched between a first axial state and a second axial state. This aspect of a particular implementation of the present invention will be illustrated with reference to FIGS. 2A-2D.

[0037] According to a second aspect of some implementations of the present invention, the biasing device is configured to be able to switch the bistable mechanism from a first state to a second state without requiring that a second effector has reached a second axial relative position. This will be described with reference to FIGS. 3A-3B.

[0038] Referring now to FIGS. 2A(i) - 2A(iv), these figures schematically illustrate an implementation of the mechanism 100 in the "parallel" implementation form of FIG. 1A. The first effector 184 is shown here as a holder in the form of a tube, and the second effector 182 is shown here as an ejector in the form of a pointed rod. The second spring 180A is enclosed here within an enclosure 181A. One side of the enclosure 181A abuts, is attached to, or is 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. Thus, the second spring 180A acts between the bistable element 172 and the second effector 182. Parenthetically, throughout this specification and this document, the phrase "acts on" relates to the functional relationship between a biasing element and the corresponding component on which the biasing element acts, and does not limit the deployment of the elements to spatially intervening between those components. The first spring 180B is housed (preferably preloaded) between the outer surface of the spring enclosure 181A and the inner shoulder of the first effector 184 such that the first spring 180B acts between the first effector 184 and the bistable element 172.

[0039] The spring constants and preloads of the first spring and the second springs 180B and 180A are such that the force applied to the plunger 114 is effective to first axially displace the effector assembly distally along the retraction spring 140 without changing the state of the bistable mechanism corresponding to the movement from FIG. 2A(i) to FIG. 2A(ii). This movement ends when an obstacle is encountered that provides resistance to further movement that overcomes the preload of the associated spring of the biasing device. Typically, such resistance occurs when the effector encounters a needle, a needle retaining pocket, or other similar structure when the suturing device is being operated. Optionally, as shown herein, step and shoulder configurations may also be provided between the outer housing or handle 102 and the inner housing 185 that define the maximum displacement of the effector assembly relative to the handle. In either case, when an obstacle to further distal displacement is reached, the additional force applied to the plunger 114 compresses 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 occurs by compressing the mechanism beyond the states shown herein such that a transition state is reached and subsequently the mechanism retracts to the second state. Here, only the final state of the bistable mechanism when not subject to external strain is shown. Further details of the transition process and the system's response to external forces will be addressed below. Preferably, under the action of the retraction spring 140 (or in an alternative implementation, when a reverse operating force is applied to the force input), the effector assembly then retracts relative to the handle 102 while maintaining the new state of the bistable mechanism and reaches the state of FIG. 2A(iv). This process is reversible, and when the force input is next actuated, the process is repeated, this time returning from the second state of FIG. 2A(iii) to the first state of FIG. 2A(ii), then to the state of FIG. 2A(i), and thereafter the entire process may be repeated.

[0040] The bistable mechanism 170 is shown here schematically and can be implemented as substantially any bistable mechanism that is actuated by an axial force to alternate between two states corresponding to two axial positions of the bistable element 172 relative to the internal housing 185. For example, various bistable mechanisms having a rotating cam, pin-in-slot or ball-in-slot bistable mechanisms, and rocker-based bistable mechanisms, among others, are known in the context of a retractable pen. There are numerous variations of such mechanisms and their designs themselves are well-known, so in the interest of brevity of presentation, it is not necessary to describe in detail multiple examples of the bistable mechanism. One particularly preferred subgroup of bistable mechanisms uses a rotating cam having an axially-directed inclined surface with a protrusion that is slightly rotated by the actuating surface of a sliding actuator and that continuously settles into slots within the housing 185 that define two different axial positions. One such non-limiting example will be described in detail below.

[0041] Particularly preferred bistable mechanisms are often referred to as “click mechanisms” due to a distinctive audible and / or tactile feedback (“clicking”) that is typically generated twice during each transition.

[0042] Optionally, some portions of the bistable mechanism may be attached to the end of the plunger 114. However, it should be noted that such attachment is not necessary. FIG. 2A(iv)’ shows a state similar to FIG. 2A(iv) in which a portion of the bistable mechanism 170 can move independently of both the bistable element 172 and the plunger 114, which state is indicated by the space on either side of the element labeled 170.

[0043] The bistable mechanism itself is similar to mechanisms used in other positions, but the manner in which the bistable mechanism is used in accordance with embodiments of the present invention differs in many respects from the general use of bistable mechanisms. The bistable mechanism 170 is used herein to generate a relative displacement between two effectors that are themselves displaceable as a unit relative to the handle 102. Most preferably, a single force input is used to sequentially generate both the composite motion of the effectors and the toggling of their relative positions. The biasing device also provides unique functionality that is not normally present in bistable mechanisms, as will be described in more detail below.

[0044] Referring now to FIGS. 2B(i)-2B(iv), which are similar to FIGS. 2A(i)-2A(iv) but show the serial deployment of the biasing device. 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 attaching (or integrally forming) the second effector 182 to the second spring enclosure 181A and providing an actuator rod 186A that associates the bistable element 172, thereby providing an input to the second spring 180A. The first spring 180B is captured between the spring enclosure 181A and an internal shoulder of the first effector 184. Both springs 180A and 180B are preferably preloaded such that the force applied in addition to the force input (plunger 114) generates a displacement of the entire effector assembly without changing the state of the bistable mechanism (FIGS. 2B(i)-2B(ii)), and then, after encountering an obstacle (either an external obstacle such as a step or a needle receiving pocket in the outer housing / handle 102), further force causes the toggling of the bistable mechanism (FIGS. 2B(ii)-2B(iii)) through a transition state not shown. The withdrawal is then effected in accordance with the details of a particular implementation, either under the influence of the retraction spring 140 in the state of FIG. 2B(iv) or by the positive application of a withdrawal force.

[0045] Figures 2C(i) to 2C(ii) are structurally more similar to the implementation forms of Figures 2A(i) to 2A(iv), but show an alternative implementation form involving a series expansion of a biasing device that is functionally equivalent to the implementation forms of Figures 2B(i) to 2B(iv). For the sake of brevity, only the states before and after the toggling of the bistable mechanism corresponding to Figures 2B(ii) and 2B(iii) are shown here. The structure shown here is almost the same as the structure of Figures 2A(i) to 2A(iv), except that the first spring 180 is delimited on one side by a flange 110 protruding from the second effector (ejector) 182 here, so that the spring acts between the first effector 184 and the second effector 182. This defines the biasing device as a series expansion that is functionally similar to Figures 1B and 2B(i) to 2B(iv).

[0046] Figures 2D(i) to 2D(ii) show a further alternative implementation form that adopts a hybrid implementation form of the biasing device, in which a series structure similar to that of Figures 2B(i) to 2B(iv) is complemented by an additional spring 120 acting directly between the first effector 184 and the bistable element 172.

[0047] The differences between the various options of parallel expansion, series expansion, or hybrid expansion of the biasing device typically do not significantly affect the operation of the device as experienced by the user, but can be important in defining the characteristics required for each spring, how sensitive the design is to manufacturing tolerances, and how much force the user needs to apply to toggle the state of the bistable mechanism. Further design considerations for achieving the required device functions in a particular application are discussed further below.

[0048] Figure 3A shows the operation of the device of Figure 2A in the scenario of a suturing device (suture not shown), in which scenario the mechanism delivers the needle 800 into the pocket 1000, releases the needle before withdrawal (sequence steps 1-7), and then extends to engage the needle and withdraw it from the pocket (sequence steps 8-14). All parts of the structure including the needle and the pocket are shown here only schematically. Particularly preferred non-limiting examples of specific implementations of these elements are discussed below.

[0049] First, referring to FIG. 3A(i), the transition from stage 1 to stage 2 is similar to the transition from FIG. 2A(i) to FIG. 2A(ii), but in this case, the movement is effective to place the needle 800 within the pocket 1000, and then the pocket provides an obstacle to further movement of at least the first effector (holder) 184. The additional force applied 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 effector and the second effector are prevented from further movement, and as a result, the additional force applied to the input plunger forces the plunger to transition the bistable mechanism to a transitional state (stage 4, typically generating a first "click"), and when the force on the plunger is partially released, the bistable element 172 remains in the position displaced distally relative to the holder 184 (stage 5, typically generating a second "click"), causing compression of both the first spring 180B and the second spring 180A until the bistable mechanism stabilizes in the second state. Different from the conventional use of the bistable mechanism, due to the presence of the second spring 180A, the bistable mechanism can transition to its second state here even though the second effector (ejector) 182 has not yet reached its forward displacement position relative to the first effector (holder) 184. In this state, the second spring 180A biases the ejector 182 forward relative to the holder 184, and as a result, the ejector 182 pushes the needle 800 out of the holder 184 simultaneously with a slight rearward movement of the holder 184 (stage 6). Then, the ejector 182 assumes its fully extended position, and the retraction of the effector assembly is completed (stage 7). This completes the process of moving the needle from the holder to the needle receiver and withdrawing the holder. This process is effective for performing proximal-to-distal suturing through tissue when using a needle carrying suture through one or more layers of tissue.

[0050] To complete a continuous stitch, both the needle receiver holding the needle and the effector assembly are preferably repositioned to align with each other on both sides of the second position of the tissue for the distal-to-proximal stitch process shown in stages 8 - 14.

[0051] From stage 8, by pushing the plunger 114, the effector assembly is advanced while the ejector 182 protrudes and the bistable mechanism is in its second state. In this state, the ejector most preferably provides a penetration point that enables the effector assembly to penetrate the tissue and reach the needle and needle receiver. (The mechanism is also applicable to other implementations where the double-ended needle penetrates the tissue from the distal side, in which case a penetration point is not required on the effector assembly.) When the ejector 182 contacts the needle and thus impedes the advancement, the additional force applied to the force input compresses the second spring 180A (stage 9), and the holder 184 continues to move forward via the force transmitted through the first spring 180B until the holder 184 engages the needle 800 (stage 10). The further forward force at this stage forces the plunger to transition the bistable mechanism (stage 11, typically generating a "click"), and when the force on the plunger is partially released, the bistable mechanism returns to its first state, enabling the bistable element 172 to be retracted relative to the holder 184 (stage 12 typically generates a further "click" and subsequent further retraction in stage 13), compressing the first spring and the second spring 180B, 180A. The engagement of the holder 184 with the needle 800 is effective for the retreat of the effector assembly to then release the needle 800 from the needle receiver 1000 and pull the needle through the tissue (not shown), thereby completing a distal-to-proximal suture stitch (stage 14).

[0052] By repositioning the mechanism 100 and the needle receiver 1000 to successive positions and repeating sequence 1 - 7 at one position and then repeating sequence 8 - 14 at another position, it is possible to form continuous suture stitches through the tissue.

[0053] Based on the desired sequence of operations described in FIG. 3A, it is possible to define various characteristics of the spring and other force-related components to ensure proper operation of the sequence. For example, in this implementation, it is preferable that at least some, and preferably all, of the following criteria are met. · The retraction spring 140 must be strong enough to pull the effector assembly (in either configuration, with or without the needle) through any tissue that may be encountered during use. · The first spring and the second springs 180B, 180A must have a preload force sufficient to allow penetration of any soft or semi-rigid tissue that may be encountered during penetration to avoid toggling the bistable mechanism before reaching the needle receiver (it must be possible to avoid encountering bone or other hard tissue through the use of appropriate pre-operative planning and / or intra-operative imaging techniques). · The force exerted by the first spring 180B must be sufficient to engage the holder 184 with the needle 800. · The force exerted by the second spring 180A must be sufficient to release the needle from the holder 184. · The needle holding force of the holder 184 must be greater than the needle holding force within the needle receiver ("pocket") 1000.

[0054] FIG. 3B is equivalent to FIG. 3A(i) but shows the series biasing device of FIG. 2B. This sequence is essentially the same as the sequence described above, but the specific interrelationships required between the preload force and the spring constant of each spring are different to provide the required operations. These different options provide different degrees of freedom in system design, which can relax certain design constraints, thereby facilitating manufacturing and / or ensuring improved reliability of the device.

[0055] Suture device application The remaining description relates to a particularly preferred but non-limiting example of the application of the above mechanism as applied to a particularly advantageous suturing device. The present disclosure also relates to various features of a suturing device that are considered to have patentable significance in their own right, regardless of the actuating mechanism used in the suturing device.

[0056] According to some embodiments, the present disclosure relates to various aspects of the components of a suturing device, including, among other things, an operating handle (user interface handle), a needle (shuttle), a displacement module, a bleeder, and a transmitter module, which are particularly suitable for use with a suturing mechanism as described in PCT patent application No. PCT / IB2020 / 057513 and PCT application No. PCT / IB2020 / 061610, although not necessarily limited thereto.

[0057] According to some embodiments, the suturing devices and methods disclosed herein relate to suturing tissue (such as a blood vessel wall) as part of a surgical procedure. According to some embodiments, the devices and methods disclosed herein are applicable to a variety of medical procedures, including, for example, 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 for use in vascular occlusion procedures.

[0058] According to some embodiments, as detailed herein, the suture device includes an operating handle and a shuttle (also referred to herein as a "needle") that can have various shapes / morphologies as detailed below, but generally has a pointed sagittal morphology at its distal end and a proximal truncated arrowhead-shaped end with an axial kink / hole. The suture device also includes a shuttle transmitter module (also referred to herein as a "needle transmitter module", "push-pull mechanism" or "PPM"), which is configured to selectively displace, hold, and release the shuttle. The shuttle transmitter is configured to manipulate the shuttle from a first side of the tissue (e.g., the vessel wall) and allow passage of the suture from the first side to the second side and from the second side to the first side. The shuttle transmitter module may include at least two of the following elements: a shuttle ejector (also referred to herein as a "releaser element", "shuttle releaser", "needle ejector" or "needle releaser") corresponding to the second effector 182 described above, and a shuttle holder (also referred to herein as a "needle holder" or "tube") corresponding to the first effector 184 described above, where the shuttle holder is configured to hold / relate to the shuttle and the shuttle ejector is capable of releasing the shuttle from the holder. In some embodiments, the shuttle holder may be implemented as a tubular or essentially tubular element that can engage an outer region / surface of the shuttle. The releaser element may, in some embodiments, be implemented as a rod that can be displaced inwardly within the tubular element. The releaser element preferably has a pointed distal end and optimally has a distal penetrating end shaped to penetrate the tissue when protruding from the shuttle holder (PPM tube).

[0059] According to some embodiments, as further detailed herein, the shuttle may be held and / or displaced by a shuttle receiver module (also referred to herein as a "needle receiver module" or "pocket") that 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, and the transition between states may be controlled by a user via an operating handle, as further detailed herein. In some embodiments, the shuttle transmitter module and the pocket are positioned on opposing sides of the tissue to be sutured (e.g., when the pocket is inside a blood vessel and the shuttle transmitter module is outside the blood vessel), and they may be aligned on such opposing sides by a mechanical interconnection between the two modules.

[0060] In some embodiments, a shuttle, typically in the form of a pointed needle, is configured to hold a suture, and a shuttle transmitter module is configured to selectively hold and release the shuttle. When holding the shuttle, the transmitter module forms a first penetration configuration and, after releasing the shuttle (held by a pocket), presents a second penetration configuration. In this second penetration configuration, the shuttle transmitter is configured to present a pointed needle-like distal end (in particular, an ejector element). Thus, the shuttle transmitter module can manipulate the shuttle from one side of the material to be sutured (e.g., a blood vessel or other tissue), through the tissue from one side of the tissue to the opposite side of the tissue, and vice versa, for the passage of the suture. For this purpose, the passage from the first side to the other (second) side is effected by advancing the shuttle transmitter in the first penetration configuration and then facilitating the release of the shuttle from the shuttle transmitter, being passively and temporarily held by a shuttle receiver (located on the opposite side of the tissue), and withdrawing the shuttle transmitter from the tissue with the shuttle removed. The passage of the suture from the second side to the first side is effected by advancing the shuttle transmitter in the second penetration configuration (i.e., without the shuttle) to collect and retrieve the shuttle through the sutured tissue. The shuttle transmitter is configured to penetrate the material at a second position aligned with the shuttle temporarily held in a pocket, engage and hold the shuttle, and withdraw the shuttle through the tissue at the second position. During each passage, the shuttle draws the suture with it such that the suture extends into the tissue at the first position and out of the material at the second position.Accordingly, such a suturing process can be used in, for example, but not limited to, closing external superficial incisions, closing superficial surface incisions, minimally invasive procedures, conventional surgical procedures, coronary artery procedures, cardiovascular procedures, vascular ostium / hole closure, closing openings between tissues (e.g., openings in the wall between the right upper and left upper ventricles (PFO), etc.), closing incisions, closing wounds, attaching two or more materials arranged in an overlapping relationship by suturing through both layers; joining two edges of two regions of a material, fixing a suture to a material by forming stitches in an overlapping relationship by closely adjacent repeated passes through the material, suturing an artificial device or material for interconnecting with natural tissue, where the material can be natural biological tissue or any other material, patent foramen ovale specific (PFO), atrial septal defect (ASD), suturing, left atrial appendage occlusion (LAAO), left atrial appendage closure (LAAC), aneurysm repair, transcatheter valve repair, minimally invasive apical closure, minimally invasive repair of the left ventricle, endoscopic procedures, laparoscopic procedures, gastroscopic procedures, otoscopic procedures, and minimally invasive gynecological procedures, etc., or combinations thereof, and can be used in various procedures including these or combinations thereof. Each possibility is a separate embodiment.

[0061] Referring now to FIG. 4A, which schematically shows a perspective view of a suturing device according to some embodiments. As shown in FIG. 4A, the suturing device 10 includes, at its proximal end, a handle portion 12 having an operating button (also referred to herein as a “suturing button”) 14 and a rotational interface 16 that facilitates axial rotation of the handle by a user (e.g., by the user gripping with the palm). The rotational interface 16 may optionally include one or more indicators 18 for the purpose of guiding and assisting the user when operating the device, for example, by indicating a pocket operation (its deployment or retraction), the radial positioning of the device in accordance with the suturing operation, etc. In some cases, the rotational interface 16 may simply be a flange for facilitating manual gripping and operation, as shown in FIG. 4C. FIG. 4A further shows a removable safety catch 20, which is configured to lock / prevent actuation of the operating button 14 when in the closed position and to enable such actuation when released to the open position (e.g., only when the pocket is deployed as will be detailed hereinbelow). Further shown is an intermediate handle portion body / casing / housing 22 that surrounds, among other things, an operating module (click mechanism). As illustratively shown in FIG. 4A, the interface 16 preferably has a flat toroidal geometry, forming a rounded flange around the handle portion, enabling one-handed operation of the button 14 while allowing rotation of the handle within the user's palm. The suturing device 10 may further include one or more indicators indicating the positioning of the suture needle within tissue, more specifically within a blood vessel. FIG. 4A further shows indicators 24A - 24B, illustrated in the form of a bleeding portion, configured to allow blood flow from the suturing area towards the bleeding portion.One of the bleeders (e.g., 24A) can function as a "GO" bleeder (i.e., when blood flows through the bleeding site, the distal end of the suture device is properly positioned (fully inserted) into the target tissue), while the other bleeder (e.g., 24B) can function as a "NO-GO" bleeder (i.e., when blood flows through the bleeding site, the distal end of the suture device is not properly positioned and, specifically, is not over-inserted). Additionally, in its distal region, the handle 12 further comprises a pocket deployment mechanism (cam) 26 configured to enable the opening (deployment) or closing of a pocket (needle receiver module) of the suture mechanism 30, which is located in a more distal region of the shaft 32 that interconnects the distal end of the handle portion 12 and the suture mechanism 30. The suture device 10 may optionally further comprise a dilator 34 connected to the distal end of the shaft via an optional fixed-angle swivel connector 36, which may be used to assist in dilating the target tissue and to enable the insertion or removal of the shaft, the suture mechanism, or any other medical tool used during a medical procedure.

[0062] Refer to FIG. 4B, which schematically shows an enlarged perspective view of a cross-section of the handle according to some embodiments. As shown in FIG. 4B, the handle 12 includes an operation button 14 configured to move longitudinally (vertically) so as to be started by a user pressing (pushing) the button. Each press / push of the button actuates a mechanism such as those described above with reference to FIGS. 1A - 3B, generates displacement of the shuttle transmitter, toggles between different internal states, and ultimately drives the stitching mechanism as will be described in detail below herein. An internal retraction (return) element 40 is further shown, which in some exemplary embodiments may be a retraction spring configured to allow retraction of the operation button and associated click mechanism during its operation. As exemplarily shown in FIG. 2, an interface 16 is further shown, which has an essentially flat toroidal geometry and which may allow one-handed operation of the button 14 while facilitating rotation of the handle 12 within the user's palm, as shown in FIG. 4C. Additionally, an operation module (also referred to as a click mechanism module) 50 corresponding to the effector assembly described above is disposed within the internal casing of the handle 12. The click mechanism module, the specific embodiments of which will be discussed in detail below, includes a combination of internal springs / spring-like elements and elements of a bistable mechanism (linear and / or circular), and is used to enable stitching state machine steps while advantageously providing tactile feedback to the user while preventing overloading of the needle receiver module (i.e., preventing excessive force from acting on the pocket and preventing distortion or breakage of the pocket). A tube and ejector rod 52 of the shuttle transmitter module are further shown, which are connected to the click mechanism module at the proximal end and extend longitudinally along the distal end of the handle through the shaft 34 to the stitching mechanism. FIG. 2 further shows bleeders 24A - 24B, and a pocket deployment mechanism 56 actuated by the pocket deployment mechanism knob 26 (shown in FIG. 4A).

[0063] FIG. 4C schematically shows a perspective view of the handle 2 of the suture device held in the palm (15) of a user's hand, according to some embodiments.

[0064] Now, refer to FIGS. 5A - 5C which show additional details of an exemplary click mechanism module according to some embodiments. FIG. 5A shows the interior of one side of the housing 22 and the click mechanism module 50 removed therefrom. The housing 22 includes one or more elongated axial slots 23, while the click mechanism module 50 features corresponding protrusions 25 for sliding engagement within the slots 23, whereby it can be seen that the click mechanism module 50 can slide axially within the housing 22 without rotating about an axis. As shown in the partial cutaway view of FIG. 5B, the click mechanism module 50 can be composed of at least two parts (60A - B) made of a housing (envelope) and integrally, transiently or permanently coupled by any suitable means (e.g., screws, adhesives, attachment elements, welding, etc.). The housing can be made of any suitable material including, for example, plastic, metal, aluminum, etc. The housing may include one or more structures that can be used in the operation of the click mechanism module, such as openings 62A and fixed guide surfaces 64 that can interact with one or more internal elements of a bistable mechanism, as detailed below. The bistable mechanism is also referred to herein as a "toggle mechanism" due to its ability to toggle between two stable states. The click mechanism module 50 includes a combination of internal elements and a combination of springs that enable switching between different stable states upon pressing of the operation button. FIG. 5B shows a reciprocating toggle shaft 70 which includes or is attached to a bistable mechanism actuator element (toggle teeth) 72 configured to interact with a rotatable bistable element (cam) 74 at its distal end and connected to an operation button (not shown) at its proximal end. Next, the rotatable bistable element 74 can define different internal states (e.g., state A and state B) of the stitching mechanism by its relative position and the change of an internal flexible element (such as a spring) configured to drive the movement of elements of the stitching mechanism (particularly, shuttle transmitter module elements).As shown in FIG. 5B, the click mechanism module includes a combination of flexible elements, such as springs, that can operate in series or in parallel (as detailed above), and each set of flexible elements can interact with, or actuate / control the movement of, different elements of the stitching mechanism, particularly elements of the shuttle transmitter module. For example, the flexible element (spring) 80A is configured to interact / actuate / control the movement of the shuttle ejector element (shuttle releaser) of the shuttle transmitter module, and the flexible element (spring) 80B is configured to interact / actuate / control the movement of the shuttle holder element (shuttle releaser) of the needle transmitter module that is directly associated with / connected to the toggle mechanism envelope (casing). In some embodiments, the relative size, diameter, force, flexibility, and / or any other characteristic of the flexible elements can affect the respective relative movement of the stitching mechanism elements, and the interaction between the flexible elements facilitates such control. In some embodiments, the relative position between the toggle element (of the reciprocating and rotatable toggle mechanism) and the fixed toggle element (of the click mechanism envelope) can affect the force exerted on the insertion module elements. FIG. 5B further shows a shuttle ejector collet 82 and a shuttle releaser collet 84. Thus, as shown in FIG. 5B, the click mechanism 50 can enable smooth and reliable operation of the stitching mechanism.

[0065] According to some embodiments, the bistable mechanism is configured to provide tactile and / or audible feedback to the user at the end of each press (inward movement), for example, for the insertion or retrieval of the PPM and the shuttle. Thereby, advantageously, the user can confirm that the state of the mechanism has changed appropriately at each stage of the stitching process.

[0066] Referring now to FIG. 5C, which shows a cross-section of a handle having a click mechanism according to some embodiments. As shown in FIG. 5C, the handle 12 includes a click mechanism module 50. The click mechanism module 50 includes a combination of toggle elements and a combination of springs that enable toggling between different states upon pressing of the operation button 14. FIG. 5C shows a reciprocating toggle shaft 70, which is connected to the operation button 14 at its proximal end and is associated at its distal end with a sliding bistable mechanism actuator element (toggle teeth) 72, which interacts with a rotating bistable element (cam) 74 and is configured to drive a rotating bistable mechanism, which can move axially between different states.

[0067] According to some embodiments, the advantageous click mechanism can transition between state A and state B according to the toggle mechanism operation. As detailed herein, state A is configured to perform a series of states for transferring the shuttle from the transmitter module to the receiver module (pocket). As detailed herein, the movement of the shuttle from the transmitter module to the pocket is performed through the material to be sutured, and state B is configured to realize a series of states for transferring the needle from the receiver module (pocket) to the transmitter module (insertion module), and the ejector element protrudes from the holder (tube) but is configured to present a pointed needle-like distal end that can penetrate the material. To better understand the states and steps involved, reference is made to FIG. 6, which schematically shows the state of the suture mechanism during suture implementation according to some embodiments. FIG. 6 shows the overall state (0-7) of the suture mechanism, showing the position of the shuttle in each of the insertion states of the shuttle (by the transmitter module) and the passive reception of the shuttle (by the pocket). FIG. 6 shows the elements of the shuttle transmitter module (ejector and holder) and the receiver module. In state 0 (before insertion or after the end of the suture cycle), the shuttle 200 is held within the transmitter module in a retracted position ready to be deployed. The pocket 202 is in the closed (retracted) position. In state 1, i.e., after the suture mechanism is placed within the target tissue, the pocket is deployed / opened while the needle is still in the retracted position (e.g., within a blood vessel). Further, the ejector 212 and holder 214 of the transmitter module 210 are shown. In state 2, the needle is inserted by the lateral movement of the transmission module (PPM - push-pull mechanism) module, traverses 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 detailed herein.In states 4 to 6, the shuttle relative position does not change, but the toggle mechanism (located within the handle) is configured to change the position / state (from state A to state B), the insertion mechanism retracts, and the needle is pushed out therefrom. At the end position of state 7, the shuttle released from the insertion mechanism is associated with the pocket, the transmitter module retracts, and preparations are made for another cycle of stitching. When restarted, the click mechanism in state B affects states 7 to 0 (in reverse order), enabling the movement of the transmitter module from the retracted (proximal) position, enabling the ejector element to protrude from the tube and penetrate the tissue, enabling the association of the shuttle with the holder element (tube) of the transmitter module and its release (withdrawal) from the pocket.

[0068] Referring now to FIGS. 7A - E, which show schematic cross - sectional views of a handle including a click mechanism module in seven different states corresponding to states 1 - 7 of the schematic diagrams of FIGS. 6 and 3A(i) according to some embodiments. Referring now to FIG. 7A, which shows a cross - section of the handle at the starting position of the click mechanism state machine. The handle 12 has an operating button 14 that is longitudinally movable to actuate the click mechanism module and a return element (return spring) 40. The click mechanism is shown in the state position A of the toggle mechanism 50. Further, a flexible element (second spring) 80A is shown that interacts with the ejector element 82 of the insertion module and is configured to induce its movement. Also shown is a flexible element 80B (in the form of a spring) that is configured to interact with the holder element 84 of the transmitter module associated with the envelope 85 of the click mechanism. As detailed above herein, when the operating button (stitching button) 14 is pressed, a state machine sequence of 1 - 7 is implemented. FIG. 7B shows state 2 in which a shuttle (not shown) is associated with (held within) a pocket (not shown). FIG. 7C shows state 3 in which the distal end (not shown) of the ejector element 82 interacts (hits) the needle at its proximal end. FIG. 7D shows state 4 that induces a toggle operation in which the toggle switches from state A to state B (50'). In this state, the user can end the toggle operation by releasing the pressure on the operating button 14. Next, FIG. 7E shows state 5 in which the click mechanism is locked by a locking engagement 360. FIG. 7F shows state 6 in which the insertion module is retracted and the needle (not shown) is fully pushed out of the pocket while still interacting with it. FIG. 7G shows state 7 at the end position where the insertion module is fully retracted (retreated) by the return spring 40 returning the click mechanism (and associated operating button) to the starting position while the ejector element is in the penetrating position protruding from the holder.At this position, the click mechanism is in state B, and by pressing the operation button again, it becomes possible to activate states 7 to 1 (i.e., in reverse order), and an ejector element acting as a through portion (as detailed herein) can push the transmitter module through the tissue towards the shuttle, while allowing the pointed distal end of the ejector element to interact with the corresponding opening at the proximal end of the shuttle, facilitating the interaction / holding of the holder element with the shuttle proximal region, pulling the needle out of the pocket and returning it to the starting position.

[0069] According to some embodiments, the advantageous click mechanism disclosed herein can implement a state machine for implementing repetitive stitches using a stitching mechanism. According to some embodiments, the click mechanism disclosed herein comprises a plurality of flexible elements such as springs and one or more toggle modules. In some exemplary embodiments, the click mechanism can comprise a plurality of springs, preferably three springs such as an ejector spring, a holder spring, and a retraction spring, and the springs are affected by a linear toggle module.

[0070] According to some embodiments, the toggle module of the click mechanism can further provide / generate a tactile feedback when toggling between states (e.g., between state A and B and vice versa).

[0071] According to some embodiments, as detailed herein, the click mechanism is configured to acquire two states, a state A and a state B, which are exchanged by a toggle module. The state A is configured to implement a sequence of sub-states for moving the shuttle from the transmitter module to the receiver module, and the state B is configured to implement a sequence of sub-states for moving the shuttle needle from the receiver module to the transmitter module. According to some embodiments, the linear toggle module is configured to switch from state A to state B, or vice versa, from state B to state A, and vice versa, in each of the end operations of the transmitter module from the proximal position to the distal position (i.e., when inserted or retrieved).

[0072] Pocket deployment mechanism According to some embodiments, the suture device disclosed herein includes a pocket deployment mechanism that facilitates the deployment (i.e., opening) of a needle receiver (the "pocket") in the distal region of the shaft while controlling the deployment via the handle of the suture device. According to some embodiments, the pocket deployment mechanism may comprise a cam and a closing cam follower that generates a tactile feedback and preferably provides a locking action at both end points of its rotation. The cam may be actuated by a connected knob or any other suitable element.

[0073] Now refer to FIG. 8A, which schematically shows a perspective view of a pocket deployment module disposed within the handle of a suture device according to some embodiments. As shown in FIG. 8A, the pocket deployment module 400 is located within the distal region of the handle. The pocket deployment module is configured to enable operation of the internal components of the pocket deployment module to enable movement of the pocket from a retracted position to a deployed position, as detailed below, and includes an external operating knob 402.

[0074] Now, refer to FIG. 8B, which shows a cutaway view of the pocket deployment module of FIG. 8A. As shown in FIG. 8B, a rotatable cam 404 configured to connect to the knob 402 (FIG. 8A) is configured to drive, by its rotation, a connection element that is connected at its proximal end to a pivot point and at its distal end to the pocket. Also further shown in FIG. 8B is a preload spring 408, which is configured to retract or extend in accordance with the movement of the cam, thereby providing tension to the connection element. Also shown is a part of the insertion module 440 of the sewing mechanism. Preferably, the cam and the connected knob are connected such that no relative movement (sliding between them) occurs.

[0075] Next, refer to FIG. 8C, which shows a schematic cross-section of the pocket deployment mechanism in the handle of a suturing device according to some embodiments. The deployment mechanism 400 includes a rotatable knob 402 connected to a cam 404. The cam 404 can rotate between two end positions to facilitate the movement of a corresponding cam follower 420, and the end points are determined / delineated by a groove / slot in the knob and a corresponding protrusion on the handle housing / case (as will be described below). The deployment mechanism further includes a preloaded spring connected to a spool element (clamp block) 414. The clamp block 414 includes a core 416A and a face 416B. The core may include a slit or channel that allows the passage of a connection element 406. In some preferred embodiments, the connection element may be realized from a superelastic alloy, preferably a nitinol wire. The clamp block holds the connection element and can be used to further adjust its length, preferably by tightening a clamp screw 422 that is accessible from the outside of the handle, locking the length after device-specific calibration, and allowing calibration adjustment after assembly. The core may be disposed in the hollow space of the spring 408, and the face may be connected to the upper region of the spring, whereby a change in spring tension causes axial movement of the clamp block, inducing movement of the connection element 406 (e.g., by elongation or release), thereby inducing movement of the pocket (deployment or retraction). Such an advantageous configuration allows controlling / limiting the tensile force of the pocket during deployment. In some embodiments, the clamping block structure may be assembled with the deployment module using screws, snaps, clips, and the like. In some embodiments, the clamp block may be fixed by two separate portions of a cam follower configured to connect / close around the clamp block. In some embodiments, the clamp block may be assembled by a snap, a circlip, or by splitting / separating the cam follower into two portions and closing the two portions over the clamp block.Figure 8C further shows, in some embodiments, optional attachment elements 424 used to attach / fix the spool structure and / or spring to the deployment mechanism body. Figure 8C further shows the ejector element 442 and the holder element 444 of the insertion module.

[0076] Accordingly, according to some embodiments, the pocket deployment mechanism can provide two locked over the center (OTC) positions at the end of its rotational movement, such that the reaction force tends to bias the cam towards its end position rather than reverse its movement. One OTC position is for pocket deployment and the other OTC position is for pocket retraction. According to some embodiments, the preloaded spring associated with the clamp block structure can be used as compensation for connection element tensile function and assembly tolerances. Such OTC positions are shown in FIGS. 8D(i) - 8D(ii), showing the OTC position 480A for pocket retraction (spring 408 in relaxed state) and the OTC position 480B for pocket deployment (spring 408 in contracted state).

[0077] Accordingly, in some embodiments, the pocket can be deployed or retracted (concealed) by rotating the deployment knob, for example, by 90 degrees. In some embodiments, rotation of the knob induces rotation of a cam, and the cam can be translated between different positions, thereby enabling movement of a connection element. In some embodiments, the deployment knob may provide a tactile or visual indication regarding its position and thus the position of the pocket. For example, as shown in FIGS. 8E(i)-8E(ii), the knob 402 may include openings 411A-B in its face, and the color identified within the openings may vary according to the closed (concealed) (411A-B) or open (retracted) position of the pocket (411A'-B'). In some embodiments, as shown in FIG. 8F, the end of the cam rotation movement may be defined by a groove / slot 413 within the knob 402, and a corresponding protrusion 415 on the handle housing / housing, or some other mechanical engagement for limiting the range of rotation.

[0078] According to some preferred embodiments, the connection element for pocket deployment can include a superelastic material such as a wire, preferably a Nitinol wire, that can translate between a pulled state and a pushed state (in accordance with the OTC state). In some embodiments, to prevent buckling, the connection element (such as a wire) may be at least partially supported by a support tube that is typically screwed along the wire section passing through the deployment module. Such a support tube may be made of any suitable material such as plastic, metal, etc. In some embodiments, the use of the support tube may be particularly important when in a lower OTC position, which typically involves pushing the connection element (such as Nitinol). Thus, the use of the support tube can assist and improve the pushing process. Referring now to FIG. 8G, which shows such an embodiment. As shown in FIG. 8G, the connection element 404 shown as a Nitinol wire is positioned within a support tube 410. The support tube may extend parallel and adjacent to the stitching mechanism 210.

[0079] In some embodiments, the cam follower assembly may include a cam having a recess, groove, or slot configured to interact with a corresponding engagement element (e.g., bump, ramp, etc.) located on the cam follower proximate the end of possible end rotation (OTC). Such an arrangement facilitates providing the user with improved tactile feedback at the end of rotation of the cam for deployment and retraction of the pocket. Referring now to FIG. 9A, which illustrates an exemplary cam and follower enabling tactile feedback according to some embodiments. As shown in FIG. 9A, cam 500 includes slot 502 and follower 504 includes ramps 506A - B, which are located slightly in front of the tip of the rotation range. The shape of cam 500 itself is more clearly seen in the isometric view of FIG. 9B.

[0080] According to some embodiments, the cam follower assembly of the pocket deployment module may be in direct contact with the connection element (as shown, for example, in FIG. 8C). As detailed above, the connection element may be in the form of a wire that can behave like a spring and may be made of a superelastic alloy such as Nitinol, for example. In such a setting, the connection element can function as a spring element to compensate for OTC tolerances and / or other tolerances (e.g., assembly tolerances). Here, refer to FIGS. 10A - 10C, which show an exemplary pocket deployment module according to some embodiments. As shown in FIG. 10A, the deployment module 550 (housed within the handle of the suturing device) includes at least a cam 552 and a follower 554. The follower 554 is directly connected to the connection element 556, and by the movement of the cam between end positions and the corresponding linear movement of the follower, the connection element is configured to enable the corresponding retraction / expansion of a pocket (not shown) by being pulled / pushed. As detailed above, the rotation of the cam may be controlled by a corresponding control knob 558. FIGS. 10B - 10C show a perspective view (FIG. 10B) and a cutaway view (FIG. 10C) of the pocket deployment mechanism showing the cam 552, the follower 554, the connection element 556 (in the form of a superelastic material such as Nitinol), and the PPM shaft 560. Also shown is a screw 562 configured to enable a direct connection / association between the follower 554 and the connection element 556. In some embodiments, the screw may further be used to calibrate the push - pull mechanism of the pocket. In other embodiments, other suitable connection forms for connecting various elements may be used, including, but not limited to, adhering, gluing, molding, overmolding, snap - fitting, etc., or any combination thereof.

[0081] Go / No bleeder configuration According to a further embodiment, the suturing device may comprise at least two bleeder assemblies configured to provide user indication regarding the correct / incorrect position of the suturing device with respect to the tissue (e.g., blood vessel) in which the suturing device is deployed, particularly where the portion of the suturing mechanism is in its distal region. In some embodiments, the bleeder assembly may comprise two separate assemblies, each comprising a separate bleeder tube and a distal opening (exit) and a proximal opening (exit) that can be further connected to the external bleeder tube (via a routing element (manifold)). In some embodiments, the bleeding assembly is sent into the handle of the suturing device via a corresponding manifold and connected to a corresponding external blood vessel. In some embodiments, each of the bleeder assemblies may further include a drip stop element at or very close to the end of the external drip tube to enable control / aiming / direction of blood dripping. In some embodiments, the drip stopper functions as a drip edge, drip prevention element, or shunt tooth. In some embodiments, one bleeder assembly is a "go bleeder" that indicates to the user that the suturing mechanism is accurately positioned (fully inserted) within the target tissue when blood is dripping from the external proximal opening, and the second bleeder assembly is a "no-go bleeder" that indicates to the user when blood is dripping from the external proximal opening. The suture mechanism is not correctly positioned (over-inserted) with respect to the target tissue. In some embodiments, the go bleeder assembly extends from an opening in the bridge portion in the distal region of the suturing device, along the shaft proximally from the distal port opening, towards a proximal opening (exit) located within the handle of the suturing device via a corresponding bleeder tube. In some embodiments, the "no-go" bleeder assembly extends from the distal opening of the PPM guide tube within the shaft of the suturing device, and the guide tube can optionally also serve as a no-go bleeder guide tube that extends from the distal bleeder opening to the proximal opening and can be further connected to the external bleeder tube (via a manifold).

[0082] Referring now to FIGS. 11A - 11F, which show different parts of a bleeder assembly according to several embodiments. FIG. 11A shows external bleeder tubes 602A - B extending from a handle 600 (with a portion of the housing (cover) removed for illustrative purposes), and the tubes are connected / routed via a manifold 604 from internal bleeder tubes (configured to allow passage of blood from their respective distal openings towards the proximal openings of the tubes), as shown in the following figures. Further, as will be described in more detail herein, drip stoppers 606A - B are shown, which are configured to enable control of the blood dripping through the external tubes. Also shown are connection element 556, PPM tube 560, and shaft 610. FIG. 11B shows a perspective view of the manifold 604 showing the internal openings 608A - B of the external tubes 602A - B, each being connected to a respective internal bleeder tube that conveys blood from a distal opening (in the bridge portion or within the PPM guide tube) and allowing fluid communication therebetween. Also further shown for illustrative purposes is connection element 556 (which can be at least partially housed within the tube / guide tube and prevent buckling of the tube / guide tube while retracting the pocket to a (hidden position)), PPM tube 560, tube 620 for suture routing (described in more detail below), and shaft 610. FIG. 11C shows an enlarged perspective view of the bleeder manifold 604. As shown in FIG. 11C, the manifold 604 is connected to the shaft 610 at its distal end, and extending proximally through the manifold are connection element 556 and PPM tube 560. Within the manifold (as shown in FIG. 11B), internal bleeder tubes (i.e., a "go bleeder" tube having a distal opening in the bridge portion and a "no - go" bleeder tube which is also the guide tube of the PPM) are connected / routed to the external bleeder tubes 602A - B. At each end of the external tubes, dedicated drip stoppers (i.e., drip stoppers 606A - B) are disposed.The drip stopper is configured to prevent cross - flow between bleeders during operation of the device (especially during its rotation), and further configured to prevent or impede the bleeder flow from reaching other parts of the handle. In some embodiments, the drip stopper is bidirectional. Figures 11D - 11E show enlarged perspective views of exemplary drip stoppers 606A - B. As shown, drip stoppers 606A and 606B enable control of blood flow, prevent the dripped blood from reaching the surgical area, thereby interfering with or otherwise affecting the suturing procedure, especially while rotating the handle during treatment or while holding the device (typically, the exemplary angle α is about 45 degrees). Refer to Figure 11F, which schematically shows the distal opening of the internal bleeder tube according to some embodiments. As shown in Figure 11F, the first internal bleeder tube 630 includes a distal bleeder opening (exit, port) 632 located in the bridge portion 640 of the suturing device. In some embodiments, the pocket is located within the insertion portion (e.g., shown in Figure 19C), including, among other things, the connecting conduit tube between the bleeder tube and the inlet port of the "GO" bleeder. In some embodiments, the proximal end of this insertion portion is filled with a flexible material to prevent the entry of blood from the pocket opening into the shaft. The bleeder opening and the corresponding tube function as a "go bleeder", indicating that when blood flows through it, the suturing device is accurately positioned within the tissue, e.g., within a blood vessel. The second internal bleeder tube 634, which also functions as a PPM conduit tube (the shuttle assembly 210 is shown), has a corresponding distal opening (exit) 636 that allows blood flow therefrom when the suturing device is not properly positioned (e.g., when it is over - inserted into the tissue, more specifically, into the space / volume of the tissue, such as a blood vessel). Thus, the second tube (PPM conduit tube) and the opening function as a "no" bleeder, providing a visual indication that the user should re - position the device before attempting to perform the suturing operation (or the next step).

[0083] Suture storage arrangement According to some embodiments, the handle disclosed herein may further include an internal tube / channel / conduit for routing a suture (suture filament) from its proximal region to the distal end of the handle. When operating a suturing device, each successive stitch requires the dispensing of an additional length of suture. As an alternative to various reels or other dispensing devices, it has been found to be particularly effective and reliable to provide a pre-loaded length of suture filament in a thread tube and at least partially accommodate the thread tube within the internal volume of the handle of the device. The rounded flange (“torus”) 16 described above with reference to FIGS. 4A-4C provides a convenient internal volume for accommodating a length of such a thread tube wound around the axis of the device that is ready to dispense suture through the suture tube as the stitching process proceeds. Referring now to FIGS. 12A-12C, there is shown the routing of a suture tube through the handle, according to some embodiments. FIG. 12A shows a partial cutaway perspective view of the handle 22 showing the proximal flat torus element 16. Further shown is the hollow chamber 704 of the flat torus element, which provides a space for the suture tube (particularly its coiled proximal portion). Further shown is a portion of the suture tube 706 extending along the handle (partially hidden by passing through a channel formed in the molded plastic). FIG. 12B shows a cutaway view of the handle 22 showing the flat torus element 16 having a hollow chamber space 704 that can accommodate and route the coiled section 708 of the suture tube 706. FIG. 12B shows the flat torus element 16 in the proximal region of the handle and shows the suture tube routing in region 708. FIG. 12C shows a top view of a cross-section of the flat torus element 16 and shows the routing of the suture tube 708 along the hollow chamber of the flat torus element 16.In summary, FIGS. 12B and 12C show a device handle cover (shell), which includes a central section having a longitudinally embedded conduit 705 for accommodating a portion of the suture tube, and a proximal end section having a hollow flat toroidal shape with a peripheral channel-like conduit therearound. The peripheral channel can accommodate at least one coiled suture tube portion and an intermediate section having a three-dimensional progressive helical-to-spiral curvature. The intermediate section connects the first (central) section to the second (proximal) section to form a continuous conduit for accommodating the suture tube, while maintaining a state above a given minimum radius of curvature, thereby avoiding twisting of the tube and minimizing friction that can resist pulling of the suture as needed.

[0084] Safety capture mechanism According to some embodiments, as described above herein, the handle proximal region can include safety capture elements and mechanisms configured to prevent inadvertent activation of the device (in particular, caused by pressing the activation (suturing) button), and can further be used to prevent activation of the operation button (i.e., prevent the operation button from being pressed) unless the pocket mechanism is deployed. Such a safety capture mechanism enhances the safety in using the suturing device by preventing inadvertent or improper operation of the suturing device. According to some embodiments, the safety capture element can physically obstruct / prevent the activation button (suturing) from being pressed and can be positioned / arranged such that it can perform the operation button function (i.e., activate the suturing mechanism) only once removed / released. In some embodiments, for improving safety and accuracy, the safety capture element may be locked in place and can be removed / released only after the pocket is deployed (via activation of the pocket deployment mechanism).

[0085] Referring now to FIGS. 13A - 13D showing a safety catch mechanism according to some embodiments. FIG. 13A shows a safety catch 20 having a pull tab 760 attached to a block element 762 configured to fit in / around a cylindrical portion 754 of a guide stem for operating button 14 so as to physically prevent pressing / moving button 14. Clearly, depending on the particular structure used to operate button 14, blocking element 762 may alternatively be clipped directly to the stem of the button or adapted to any other form of force input used. Safety catch 20 is further engaged with a flat torus element (hollow flange) 18 via a corresponding internal safety engagement (snap) mechanism as detailed hereinbelow. FIG. 13B shows the safety catch 20 after being disengaged from the handle. Further, FIG. 13B shows an engagement (snap) element 764 of the safety catch, which is configured to be associated with the internal safety engagement mechanism via a corresponding opening 766 in the flat torus 18.

[0086] Referring now to FIG. 13C, which shows a partial cross-section of the flat torus element 18 showing a portion of the internal safety engagement mechanism according to some embodiments. As shown in FIG. 13C, the safety catch 20 is engaged with the handle. Further, an engagement (snap) element 764 having a corresponding edge 776 provided by the hollow flange 18. Further shown is an internal safety release mechanism 770 including at least a lever 774 associated with a push rod (not shown). The push rod is preferably associated / connected in its distal region to the aforementioned pocket deployment mechanism 400 or 550, for example, to its cam follower. The push rod can be made of any suitable material having sufficient rigidity to physically push the lever. As a result, when the pocket deployment mechanism is activated (e.g., by turning an external knob as detailed above, thereby moving an internal cam follower), the movement of the pocket deployment mechanism induces upward movement of the push rod, and the upward movement of the push rod, in turn, induces upward movement of the pivot lever 774 (e.g., by pushing the lever upward), thereby releasing the snap element 764. In some embodiments, the rod may include a proximal bend to improve the surface area interaction with the lever and is configured to push the lever upward (proximally), thereby releasing the snap of the safety catch from a corresponding engagement area within the handle cover. In some embodiments, the lever has an inclined lower (distal) surface that collides with the rod and further, immediately after the catch is released, laterally moves (rotates) it, resulting in a proximal lever lock. Thus, the safety catch can be released and removed from that position only when the lever is repositioned (e.g., by being pushed upward as detailed above). In some embodiments, the lever is a pivot lever and can be pushed up and down to transition between an engaged position and a released position with respect to a corresponding snap element of the safety catch. In some embodiments, when the lever is pivoted upward, in addition to releasing the engagement element of the safety catch from the stopper, an outward push from that position of the safety catch can also be induced. Such outward movement can indicate to the user that the safety catch is ready to be moved.

[0087] Configuration of the needle and the holder According to some embodiments, the shuttle (needle) disclosed herein has several regions, each configured to facilitate its operation and / or interaction with various components of the suturing mechanism during the suturing process. In some embodiments, the shuttle typically includes a distal end configured for tissue penetration (thereby defining it as a "needle"), a central (intermediate) section typically configured as an interface for suture engagement and pocket engagement interfaces, and a proximal end typically configured as an interface to a needle transmitter module (specifically, a PPM tube and a PPM ejector). Here, refer to FIG. 14A showing an exemplary shuttle according to some embodiments. As shown in FIG. 14A, the shuttle 800 includes at its distal end 802 a sharp or other sharp tip 804 for piercing / puncturing tissue. Its intermediate (central) section 806 includes a suture interface that includes at least an opening 809 for engaging / receiving a suture and preferably side recesses for accommodating the suture on both sides of the shuttle. The recesses may be only in the central section of the shuttle, but optionally may be in other sections of the shuttle. In some embodiments, the thread opening may have a slot shape, a circular shape, a constant diameter, or a tapered shape. As further shown in FIG. 14A, a pocket interface slot 810 is present proximal to the tip 804 and distal to the suture interface 809. The pocket interface 810 may be in the form of a slot, a circular slot, or a partially circular slot within the body of the shuttle and is configured to releasably engage a corresponding engagement element of the pocket (e.g., a snap ring). In some embodiments, the pocket interface may have an angled profile along the entire surface of the slot or at least a portion thereof in its lower (distal) portion. As will be described in further detail below, the pocket interface (e.g., in the form of an angled circular slot in its distal region) enables receiving a corresponding engagement element of the pocket (e.g., in the form of a flexible ring) and facilitates holding of the needle by the pocket with a limited axial holding force (e.g., a snap force).As further shown in FIG. 14A, in its proximal region 812, the shuttle includes a proximal end 814 configured to interface with a needle transmitter module (i.e., the PPM tube and the PPM ejector). The proximal end 814 of the needle may be in the form of a truncated arrow having an outer diameter that is typically larger than the inner diameter of at least the end of the PPM tube. The proximal end 814 may include two inclined portions 815A - B, and the distal portion 815A has a diameter that is slightly larger than that of the proximal chamfered portion 815B. Further, the proximal end may include a hole or recess, for example, an axially extending hole 816 that may preferably be chamfered, thereby enabling an improved interaction with the needle ejector element of the needle transmitter module, as will be described in further detail below.

[0088] As detailed above herein, the shuttle (needle) transmitter module (PPM) includes a shuttle (needle) holder (e.g., in the form of a tube) configured to releasably hold the shuttle (needle) (by engaging, in particular, its proximal region), and a shuttle (needle) releaser / ejector element (e.g., in the form of a rod). For example, it is configured to interface with the proximal end of the shuttle by centering itself within a hole at the proximal end of the shuttle and releasing the shuttle from the holder (tube). The shuttle holder may be made of any suitable material and may be rigid, semi-rigid, or flexible. In some embodiments, the tube may be made of a superelastic alloy (e.g., nitinol, etc.), plastic, metal, and the like. In some embodiments, the ejector element is most preferably configured to move internally (from the proximal direction to the distal direction) reciprocally within the tube so as to be able to engage the proximal region of the shuttle under the control of a mechanism as described above with reference to FIGS. 1A-7G. According to some embodiments, the shuttle transmitter may have any desired shape that conforms to the shape and / or size of the corresponding engaging proximal region / surface of the shuttle in order to facilitate the fixed reversible engagement (holding) and release of the shuttle, as required, in accordance with the suturing steps. In some embodiments, the holding of the shuttle by the shuttle transmitter may be with sufficient force to prevent its unintended or premature release, yet still allow the ejector to release the shuttle from the transmitter module.

[0089] Accordingly, according to some embodiments, the shuttle-shuttle transmitter module interface may be adjusted to ensure an optimal interaction between the needle ejector and the shuttle. More specifically, such optimization can facilitate the ejector engagement with the shuttle even under various degrees of eccentric positions of the ejector. For this purpose, the proximal end of the shuttle may be sized to fit as closely as possible within the shuttle holder and may further include an engagement opening / hole / depression configured to allow for a maximum surface area for interaction with the distal end of the ejector element.

[0090] Referring now to FIGS. 14B and 14C, which show diagrams of a shuttle-shuttle transmitter module interface according to some embodiments. Shown in FIG. 14B is shuttle 800, the proximal end 814 of which is configured to interface with the distal region 852 of the transmitter module, specifically with shuttle holder (PPM tube) 850, such that the proximal end of the shuttle can fit into the internal cavity of shuttle holder 850. As shown in FIG. 14B, the diameter (DI) of the opening (hole) 816 at the proximal end 814 of the shuttle is substantially the same as / identical to the inner diameter (D2) 858 of holder 850. Advantageously, therefore, the chamfered regions at the distal end of the tube and the proximal end of the shuttle allow engagement therebetween even when DI is greater than D2. Thus, in some embodiments, by having a chamfered region at the distal end of the tube, the shuttle proximal end can interact / engage even if the proximal end is not chamfered or if the diameter of the proximal end hole (configured to relate / engage with the ejector of the transmitter module) is substantially the same as or larger than the inner diameter of the tube. Now referring to FIG. 14C, which shows a cross-section of the shuttle-shuttle transmitter module interface associated with shuttle receiver module 870. As shown in FIG. 14C, shuttle 800 is interfaced and connected at its proximal end 814 to shuttle transmitter module 870 (including shuttle holder (PPM tube) 850 and ejector 860), and is also associated with (and thereby held by) shuttle receiver module 870. The interface between the shuttle and the receiver module includes a snap fit between circular slot 867 having an angled profile in the lower distal section of the shuttle and corresponding flexible / elastic snap ring 865 within the receiver module, as will be described in detail below herein. As shown in FIG. 14C, the distal end 864 of ejector 860 (which may be pointed or otherwise have a through shape) can interface with chamfered opening 816 at the proximal end of shuttle 800.Accordingly, the size and / or shape of the opening 816 facilitates engagement with the distal end (tip) of the ejector under various conditions (e.g., various degrees of eccentric positions of the ejector), thereby enhancing the shuttle release efficiency from the shuttle transmitter module. Accordingly, as shown in FIG. 14C, the shuttle is configured to reversibly engage both the transmitter module and the receiver module via their respective corresponding engagement elements of the modules.

[0091] As an introduction to FIGS. 15A - 15D, various embodiments of the suture device according to the present invention impose requirements corresponding to the relative forces that should be required to engage and disengage the shuttle. For example, in certain implementations, it is desirable that the force required to engage and grip the shuttle be relatively small and the force required to pull the shuttle out of the holder be greater so that the holder can reliably pull the shuttle out of the shuttle receiver. At the same time, in certain implementations, the dimensions of the needle and the holder may be such that the diameter may be sub - millimeter and, in some cases, even less than half. Presented here is a particularly advantageous form of engagement that is effective over a wide range of dimensions and has been found to be well - suited particularly for applications where the diameter is less than a millimeter.

[0092] As described above, the needle 800 is shown as having a pointed distal tip 804, an intermediate portion 806 configured to receive suture, and a proximal engagement portion 812. The proximal engagement portion 812 has a first section 813 adjacent to the intermediate portion and a second portion 814 proximal to the first portion. The first portion 813 has a circumscribing cylinder of diameter D1 and length L1, and the second portion 814 has a circumscribing cylinder of diameter D2 greater than D1 and length L2. In the non-limiting example shown here, portions 813 and 814 are essentially cylindrical, and the "circumscribing cylinder" corresponds to the outer surface of these portions (and thus is not shown separately). However, also encompassed by these definitions are cases where these portions (particularly the second portion 814) have a shape that deviates from a cylinder, such as a cylinder modified by one or more flat chamfered surfaces, or a hexagonal or other prismatic shape. In such cases, the "circumscribing cylinder" is the smallest virtual cylindrical construct that completely surrounds the corresponding portion of the needle.

[0093] The corresponding holder design according to this aspect of the invention is implemented as a tube 880 formed from a superelastic material, the tube having a tip segment 882 of length no greater than L1 with an inner diameter that matches diameter D1, and a second segment 884 of length greater than L2 and an inner diameter that matches diameter D2. The term "matching" in this context refers to the diameter of the tube segment that is essentially stress-free to accommodate the corresponding diameter of the engagement portion 812. This may correspond to what is referred to in engineering terms as a "tight fit" where the dimensions are substantially equal according to normal engineering tolerances for a tight fit or "slip fit" where the dimensions of the tube 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 field of engineering. In all cases, the fit is preferably selected to be close enough to ensure stable axial alignment of the needle and the tube during operation.

[0094] As a result of 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 elastic deformation of the tip segment. When the second portion 814 is fully inserted into the second segment 884, the tube 880 does not substantially deform. Since the fully inserted state of the needle corresponds to the non-deformed state of the tube 880, releasing the needle from the holder encounters resistance to deform the tip segment 882 from the non-deformed state to the deformed state, which is basically a transition similar to the insertion of the needle, and thus tends to improve the resistance to removing the needle from the holder.

[0095] Furthermore, 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 withdraw the needle from the holder when fully inserted is greater than the force required to insert the needle into the holder. This is typically achieved by appropriate selection of the shape and angle of the outer surface at the transition between the needle portions 812 and 814, as well as the shape of the chamfered conical 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, which will be apparent to those skilled in the art.

[0096] In the case of FIGS. 15A and 15B, the portion of the tube 880 proximal to the second segment has the same inner diameter as the tip segment of the tube. In this case, the enlarged second segment 884 can conveniently be formed by insertion of a mandrel of appropriate shape followed by heat treatment to fix the superelastic shape memory of the tube material, all of which are well known in the art.

[0097] In the case of FIGS. 15C and 15D, the proximal portion of the tube 880 continues proximally with an inner diameter equal to the inner diameter of the second segment 884. In this case, the manufacturing technique starts with a tube of larger dimensions, and the narrower tip segment 882 is formed by use of an external template, with or without an internal mandrel, followed by heat treatment, all of which are well known in the art.

[0098] As described above, the device also preferably includes an ejector element 860 that is deployed within the tube 880 and displaceable along the tube 880 to release the needle from the holder, such as under the control of a mechanism such as that described above with reference to FIGS. 1A-7G.

[0099] Referring to FIGS. 16A-16H, which show alternative exemplary configurations of the distal region of a PPM tube for interfacing with a shuttle according to further embodiments. FIG. 16A shows the distal end of a PPM tube 900 having two openings (902A-B) on the tube. The openings may be positioned opposite each other and may be the same or different in size and / or shape. In some embodiments, any number of openings, such as 1-4 openings, may be present. The openings, which may have any desired shape or size, are formed to fit into the proximal region of the shuttle, allowing for a snap action with the proximal end of the shuttle and facilitating engagement therebetween, thereby improving the holding force therebetween. This is particularly important when pulling the shuttle out of the receiver pocket. In some embodiments, as shown in FIG. 16A, the openings may have a substantially elongated rectangular shape and may be positioned at a specified distance from the distal tip of the tube to fit and engage with the corresponding proximal portion 814 of the shuttle, which has a truncated arrow shape with a larger diameter. Referring to 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 may be chamfered and the inner diameter of the tube may be smaller than the diameter of the proximal end portion 814 of the shuttle, thereby strengthening the snap engagement between the tube (specifically, its openings) and the shuttle. In some embodiments, the entire proximal region 814 of the shuttle (including sections 815A-B) is snap-fitted / engaged with the openings of the tube.

[0100] FIG. 16C shows an exemplary distal end of a PPM tube 910 having partial openings 912A - B on the outer surface of the PPM tube 910. The openings may be tooth - shaped and may be positioned opposite each other. The openings may be the same, similar, or different in size and / or shape. In some embodiments, any number, for example, 1 to 6 openings may be present. In some embodiments, the openings are sized to fit into the proximal region of the shuttle and allow for radial flexibility of the distal region of the tube to receive the proximal end of the shuttle, enabling a partial snap - action with the shuttle and facilitating a reversible engagement therebetween. FIG. 16D shows a shuttle 800 engaged with the distal region of the PPM tube 910, and the openings in the wall of the tube allow for its slight radial opening and enable engagement with the proximal region 814 of the shuttle. In such an apparatus, the axial stability of the shuttle is enhanced and wear of the proximal end shape of the shuttle is reduced (the wear is caused by repeated cycles of holding / engagement between the tube and the shuttle). FIG. 16E shows a shuttle 800 engaged with the distal region of a PPM tube 920 having at least one opening 922A on the PPM tube 920. The opening is located at a distance from the distal end of the tube to allow for engagement with the proximal region of the shuttle and is optionally square.

[0101] FIG. 16F shows an exemplary distal end of the PPM tube 930, which has slotted openings (exemplary slotted openings 932A-E are shown) along the perimeter of the surface of the tube. Each of the openings may be in the form of a narrow rectangular slot, and the openings may be distributed substantially homogeneously along the perimeter of the tube. The slots may be the same, similar, or different in size and / or shape. In some embodiments, the slots are sized and positioned to fit into the proximal region of the shuttle, allow a snap action therewith, and facilitate a reversible engagement therebetween. FIG. 16G shows a shuttle 800 that engages the distal region of the PPM tube 930, and the slots in the wall of the tube collectively form snap engagement elements with the proximal region of the shuttle. In such an apparatus, enhanced axial stability of the shuttle may be facilitated to allow sufficient interaction with the shuttle holder, and less degradation of the outer diameter of the proximal end shape thereof may be required. FIG. 16H shows additional exemplary openings 942A-B on the distal region of the PPM tube end according to some embodiments.

[0102] Pocket needle retention feature As detailed above, the receiver module (also referred to as the pocket module) is configured to passively receive and securely hold the shuttle in accordance with the stitching step and, when pushed out from the shuttle transmitter, to passively release the shuttle to the shuttle transmitter. Here, reference is made to FIGS. 17A - 17C, which show diagrams of the receiver module according to some embodiments. FIGS. 17A - 17B show a complete partial cutaway isometric view of pocket 1000 associated with / attached to the distal end of connection element 1002 (configured to enable retraction / expansion of the pocket under the control of the pocket deployment mechanism, corresponding to element 556 as detailed above and disposed within the handle of the stitching device). As better seen in the cross-sectional view of FIG. 17D, connection element 1002 may have a flat (or ball-shaped, not shown) distal end 1008 that enables securing / anchoring of the connection element to the body of the pocket by any suitable means such as pins, screws, rings, etc. In some embodiments, ring or sleeve 1009 may be screwed on the connection element as a bead and function as a strain releaser / distributor at the fixed interface of the connection element located within the stepped hole in the pocket.

[0103] Furthermore, a shuttle receiving portion 1004 is shown that is shaped to receive a corresponding shuttle 800. Further shown is an engagement element 1006 that interacts with a corresponding groove 810 of the shuttle and is configured to facilitate retention of the shuttle within the receiving portion 1004 by an axially retaining force (i.e., a snap force) of limited magnitude, as further shown below. The engagement element 1006 includes a forward region of a ring or other circular shape corresponding to the shape of a corresponding groove within the engaged shuttle, and a rearward region configured to enable securing / engaging / anchoring the engagement element to the body of the pocket using any suitable means such as pins, screws, rings, etc. In some embodiments, the engagement element is fitted into a corresponding slot / aperture 1014. FIG. 17C shows a perspective view of an exemplary engagement element 1006. As shown in FIG. 17C, the engagement element 1006 (configured to fit into slot 1014) includes a shuttle engagement portion 1012A configured to be associated with a shuttle (particularly having a corresponding engagement groove 810 of the shuttle as shown, for example, in FIG. 14A), and a pocket engagement portion 1012B configured to enable association with the pocket body. In the example shown in FIG. 17B, different portions of the engagement element 1006 may be integrally formed as part of a substantially flat single element. In some embodiments, the engagement element is flexible and may be made of, for example, but not limited to, plastic, nylon, silicon, rubber, or preferably a superelastic alloy such as nitinol. In some embodiments, the size and / or shape of the engagement element may be adjusted / pre-determined according to the size, form, and / or shape of the engaged shuttle. In some embodiments, the shuttle engagement portion 1012A may be in the form of a ring and may optionally include an opening / slot 1015 (i.e., an incomplete ring form) to enable flexibility in retention (snapping) and release of the shuttle. In some embodiments, portion 1012A is connected to portion 1012B via a beam-like or otherwise flexible element 1013 to facilitate centering and expansion of the ring during pin engagement.The tolerance of the pocket engagement portion 1012B and / or the flexibility of the flexible connection element 1013 that interconnects the pocket engagement portion with the shuttle engagement portion 1012A is preferably such that the shuttle engagement portion is effectively "floating" in the sense that it can move freely within a sufficient range of positions in the slot 1014 so as to self-align with the shuttle 800 when the shuttle is inserted into the shuttle receiving portion. This degree of freedom of movement should be sufficiently restricted to ensure that the tip of the shuttle will be successfully positioned within the opening of the shuttle engagement portion when inserted.

[0104] Refer to FIG. 17D showing a cross-section of a pocket assembly according to some embodiments. FIG. 17D shows a pocket 1000 associated with a shuttle 800 received in a pocket receiving portion 1004 of the pocket. As shown in FIG. 17D, the engagement element 1006 (in particular, its ring portion) is associated with the body of the shuttle 800, in particular, with the pocket interface slot 810 of the shuttle. The slot / groove 810 along the periphery of the intermediate region / lower distal section of the shuttle fits into and is thereby retained by the ring portion of the engagement element 1006. Such a limited axial retaining force (snap retention) by the ring secures the needle in the pocket when retained by the pocket. As further shown in FIG. 17D, the shuttle receiving portion 1004 includes an upper (proximal) section 1017A, an intermediate section 1017B, and a lower (distal) section 1017C. The proximal region 1017A has a relatively large diameter to allow entry / reception of the shuttle even if it is off-center, as well as to provide space for suture threads associated with the shuttle (on its side), enabling the distal end of the tube to expand at least partially radially and allowing release of the shuttle therefrom. The intermediate region 1017B allows for axial stabilization of the shuttle within the receiver and includes a slot 1014 for receiving the engagement element 1006. The distal region 1017C includes a bore of gradually or otherwise decreasing diameter for halting / stopping the axial movement of the shuttle.

[0105] Refer to FIGS. 18A - 18D, which show further exemplary preferred embodiments of a receiver module having shuttle engagement elements. Similar to the previous embodiments, the receiver body (pocket) has a needle receiving bore extending parallel to the bore axis for receiving the needle, and a retaining element slot extending from the side surface of the receiver body and intersecting the needle receiving bore. An elastic snap retainer is deployed within the retaining element slot such that the elastic snap retainer is aligned within the needle receiving bore to elastically hold the needle.

[0106] In the case of FIGS. 18A - 18B, the receiver module (pocket) 1050 has a shuttle receiving portion (needle receiving bore) 1054 shaped to accommodate a corresponding shuttle. Additionally, an engagement element 1056 is shown, and its inner ring (elastic snap retainer) 1060 is configured to interact with a corresponding groove of the shuttle to facilitate retention of the shuttle within the receiving portion 1054. As shown in FIG. 18A, the inner ring 1060 may be slotted and is preferably positioned within a housing / body portion 1062 such that it "floats" to self - align with the shuttle while leaving sufficient clearance for the elastic snap retainer to be captured in the required range of positions when inserted into the needle receiving bore. The housing is configured to fit into a corresponding front opening (slot) within the body of the pocket 1050 and may be fixed there using fixed geometries 1064A - B. The fixed geometries 1064A - B may be in the form of flexible extensions (elastic locking tabs or "wings") that project slightly upward and are configured to snap / lock with corresponding openings 1067 within the pocket 1050.

[0107] The implementation forms of FIGS. 18C to 18D are the same as those of FIGS. 18A to 18B, but use the same fixing configuration as that of FIGS. 17A to 17D. Specifically, in this case, the receiver body further includes a locking element channel that intersects with the holding element slot, and the elastic snap retainer is interconnected with a fixing configuration having an opening aligned with the locking element channel. The locking element (pin) 1110 is deployed within the locking element channel so as to engage with the opening, thereby fixing the elastic snap retainer in alignment with the needle receiving bore.

[0108] Accordingly, the receiver module (pocket) 1100 has a shuttle receiving portion (cavity) 1104 that is shaped to accommodate the corresponding shuttle. Further, an engagement element 1106 is shown, which includes an inner ring 1112 that may be slotted and is disposed within the housing / body 1114. The housing 1114 further includes a slotted slot 1117 at its rear end (1119), separating the end of the housing into two end sections 1115A - B. The engagement module is configured to fit into a corresponding (slot) within the body of the pocket 1110 and may be fixed thereto using a pin 1110 attached to the pocket. The engagement element (particularly its housing) is configured to snap - fit around the pin by the chamfered slot 1117 and slide over the pin 1110 while spreading the open end sections 1115A - B of the housing. In some embodiments, the engagement element (housing and / or ring) may be flexible or semi - flexible and may be made of any suitable material, such as, but not limited to, plastic, rubber, silicon, superelastic alloy (such as nitinol), or any combination thereof.

[0109] In each of the non-limiting examples of FIGS. 17A-18D, the elastic snap retainer is a snap ring that extends around the entire circumference of the shuttle. This is particularly beneficial for shuttle designs such as the needle 800 shown in FIG. 14A where the peripheral groove 810 does not extend around the entire circumference of the needle. In this case, the use of a ring surrounding the shuttle ensures snap retention of the shuttle regardless of the rotational orientation in which the shuttle reaches the pocket. In other implementations, for example, if the peripheral groove surrounds the shuttle, other snap retainers such as leaf spring wires on one or both sides of the needle receiving bore may be used.

[0110] In certain particularly preferred implementations, the shape and mechanical design of the peripheral groove and the elastic snap retainer are such that the force required to release the needle from the needle receiver is greater than the force required for the needle receiver to engage the needle.

[0111] Self-alignment of the shuttle transmitter in the shuttle receiver Further particularly preferred features of a particular embodiment of the suturing device according to an aspect of the present invention are shown in FIGS. 19A-19D and FIG. 20. According to this aspect of the present invention, the geometric shapes of the shuttle receiver 1000, the shuttle 800, and the shuttle transmitter 210 are such that when the shuttle seats within the bore 1004 of the shuttle receiver, the shuttle transmitter self-aligns coaxially with the shuttle as long as the initial approach of the shuttle transmitter axis is anywhere within the shuttle receiver bore, ensuring the correct operation of the shuttle holder for engaging the shuttle and pulling it out of the receiver bore. This process is shown in FIGS. 19A-19D, where FIG. 19D shows the initial approach of the shuttle transmitter, which is significantly off-axis with respect to the receiver bore but just within its outer perimeter. FIG. 19B shows how the shuttle transmitter is guided by sliding its surface along the peripheral surface of the bore until the tip of the shuttle transmitter is positioned within the rim of the axial opening 816 of the shuttle before reaching the shuttle, thereby showing how further movement of the shuttle transmitter self-aligns with that opening as seen in FIG. 19C. The shuttle transmitter is then precisely aligned for engagement with the shuttle holder as shown in FIG. 19D.

[0112] The main geometric requirement for ensuring this self-alignment process is schematically shown in FIG. 20, which is an enlarged partial view with annotations of FIG. 19A. The proximal engagement portion of the shuttle presents an axial opening surrounded by a rim having a radius R2 from the central axis of the shuttle. The bore of the shuttle receiver has an opening with a radius R1 and is positioned at an axial height H from the rim of the axial opening of the shuttle when the shuttle is in the inserted position. Using this terminology, when the shuttle transmitter configuration presents a through configuration that terminates at a through point, this self-centering function is provided by ensuring that the radius of the through configuration gradually increases such that at the axial distance H from the through point, the through configuration has a radius R3, where R3 is greater than (R1 - R2).

[0113] Expander swivel configuration As described above, the suture device can optionally further include an expander connected to the distal end of the shaft via a dedicated connector. Such a flexible expander is deployed distally with respect to the shaft of the suturing mechanism (the cross-linking portion of the device) and interconnected therewith via a swivel connector. In some embodiments, the dedicated expander connector is a swivel connector having a fixed angle.

[0114] Referring now to FIGS. 21A - 21E, which show various views of a swivel connector and related interfaces according to several embodiments. FIGS. 21A(i) - 21A(iii) show three views of a swivel connector 1200 that connects / cross - bridges the distal end of a stitching mechanism (shaft) 1202 and the proximal end of an expander 1204, showing three different fixed - angle connectors that provide a user - selectable angle of action during device assembly. As shown in FIGS. 21A(i) - 21A(iii), the connector 1200 can include one or more openings / holes 1206 for fixing the swivel connector to the stitching mechanism portion (in particular, to its internal insertion portion, as detailed below). Fixing the swivel connector to the stitching mechanism portion / module can be facilitated by any suitable means, including, for example, screws, pins, welding (such as welding by spot welding, laser welding, etc.). In some embodiments, the connector may be fixed to a locking sleeve (locking ring) associated with the distal - most end of the internal insertion portion, which has the shape of a shaft / hinge, as detailed below. FIG. 21B shows a partial cross - sectional view of FIG. 21A(i) in which the connector 1200 and the expander 1204 are shown in cross - section. As seen in FIG. 21B, the distal end of the shaft of the stitching mechanism 1202 includes an insertion distal end 1208, which is configured to connect (hold) to the connector 1200 and further allow the connector to pivot around it. The insertion portion 1208 is fixed to the distal end (also referred to as the mast end) of the stitching mechanism by any suitable means. In some embodiments, the insertion portion may be formed integrally with the shaft of the stitching mechanism. In some embodiments, relative movement between the insertion portion and the shaft is not formed since both of these parts are stationary. As shown in FIG. 21B, the insertion portion 1208 has an elongated body with slip bearings (collars) 1210A - B integrated at its proximal and distal ends. An intermediate section (having a concave diameter) 1212 of the insertion distal end is configured to associate with a locking sleeve (locking ring 1214).The retention ring is configured to snap firmly into a concave intermediate section in the diametrical direction of the insertion distal end and further interact with a corresponding opening 1206 of the connector 1200 (Figs. 21A(i)-21A(iii)) to enable fixing of the connector to the insertion distal end. In some embodiments, the connector may be further fixed to the retention sleeve (retention ring), for example, by welding thereto (e.g., via the opening 1206).

[0115] Figure 21C shows a cross-section of the distal end of a suture mechanism connected to an expander via a swivel connector. The distal end 1202 of the suture mechanism includes a receiver module 1250 (shown in a retracted (hidden) position), a connection element 1252 that connects the receiver module to the proximal PDM, and a shaft 1254 of the transmitter module. An elastomeric seal 1253 preferably prevents leakage of blood along the channel of the connection element 1252. Further shown is an insert 1256 having a distal end (mast end) 1208 that is fixed to and projects from the shaft of the suture mechanism. As detailed above, the insertion distal end 1208 includes slip bearings integrated at its proximal and distal ends and an intermediate section having a concave diameter configured to be associated with a retention sleeve 1214. Further shown is a swivel connector 1200 that is connected to the distal end of the insert portion 1208 (which serves as an axis for rotation of the connector 1200) and is further connected to the expander 1204 via a connection element (shown as a spined connector 1220).

[0116] FIG. 21D shows a perspective view of the distal end of the insertion portion 1256, showing the insertion distal end 1208 and the associated locking sleeve 1214. In some embodiments, the locking sleeve may include slots 1216 to facilitate assembly / disposition of the sleeve over the insertion distal end. In some embodiments, the locking sleeve may be snap - fastened over the insertion portion. In some embodiments, the locking sleeve can rotate around the insertion portion. In some embodiments, the locking sleeve can increase the diameter of the intermediate concave section at the distal end of the insertion portion. In some embodiments, the locking sleeve facilitates axial locking between the insertion distal end and the swivel connector by forming a tight fit between the locking sleeve and the corresponding opening / receiving portion of the swivel connector. FIG. 21E shows a cross - sectional view of the connector 1200 associated with the insertion distal end 1208. As shown, the connector can rotate on two collar slip bearings 1210A - B, and the locking sleeve further provides a freely rotatable interface. Referring again to FIG. 21B, the swivel connector 1200 further includes at its distal end a connection element 1220 configured to connect / attach / fix the expander 1204 thereto. In some embodiments, the distal connection element 1220 may be integrally formed with or attached / associated with the connector 1200. In some embodiments, the connection element 1220 can have an elongated body with one or more engaging elements configured to enhance the interaction / association between the expander and the distal connection element. In some exemplary embodiments, as shown in FIG. 21B, the distal connection element 1220 may be a spined connector having a protruding structure 1222 (shown in the form of small circular teeth, for example) in its distal region. In some embodiments, the distal connection element can fit into a corresponding opening 1224 located in the proximal region of the expander body. In some embodiments, the connection element and the expander may be integrally formed. In some embodiments, the connection element may be embedded in the expander.

[0117] In some embodiments, the connector is a fixed-angle connector, and the fixed-angle connector can be at a selected angle in the range from, for example, a deflection of 0 degrees (right angle) to a maximum deflection of 90 degrees (vertical) between the shaft of the suturing mechanism and the dilator. According to some embodiments, the angle may be predetermined, and thus, the corresponding connector can be defined for various preformed angles. In some embodiments, the selection of the angle of the connector for use may be determined by specific needs such as a medical procedure. A typical set of preferred angles may include some or all of the angles shown in FIGS. 21A(i)-21A(iii), i.e., 20 degrees, 30 degrees, and 40 degrees, and / or additional angle options.

[0118] According to some embodiments, provided herein is a method of suturing a material (such as in-vivo tissue) using the suturing device disclosed herein.

[0119] According to some embodiments, the present disclosure describes devices with some of the components connected by fasteners such as screws and nuts, but it should be understood that in any of these instances, these connections may be achieved by US welding, adhesion, snap, etc.

[0120] For clarity, it should be understood that certain features of the present disclosure described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the present disclosure described in the context of a single embodiment may also be provided separately, or in any suitable partial combination, or as suitable in any other described embodiment of the present disclosure. Any feature described in the context of an embodiment should not be considered an essential feature of that embodiment unless so explicitly specified.

[0121] As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.

[0122] The steps of the method according to some embodiments may be described in a particular order, but the methods of the present disclosure may include some or all of the steps described as being performed in a different order. The methods of the present disclosure may include some of the steps described, or all of the steps described. No particular step in the disclosed methods should be considered an essential step of the method unless so explicitly specified.

[0123] The present disclosure is described in conjunction with its specific embodiments, but it is clear that there may be numerous alternatives, modifications, and variations that will be apparent to those skilled in the art. Accordingly, the present disclosure encompasses all such alternative, modified, and varied forms that fall within the scope of the appended claims. It should be understood that the present disclosure is not necessarily limited in its application to the details of the construction and arrangement of the components and / or methods described herein. Other embodiments may be practiced and the embodiments may be carried out in various ways.

[0124] The expressions and terms used herein are for the purpose of description and should not be regarded as limiting. The citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present disclosure. Section headings are used herein to facilitate understanding of the specification and should not necessarily be construed as limiting.

[0125] As used herein, the term "about" can be used to specify a value of a quantity or parameter (e.g., the length of an element) within a continuous range of values near (and including) a given (stated) value. According to some embodiments, "about" can specify that the value of a parameter is 80% to 120% of a given value. According to some embodiments, "about" can specify that the value of a parameter is 90% to 110% of a given value. According to some embodiments, "about" can specify that the value of a parameter is 95% to 105% of a given value.

[0126] In the description and claims of this application, the terms "comprise", "include", and "have", and their forms are not necessarily limited to the members in the list with which the term may be associated.

Claims

1. A mechanism for operating a medical device, comprising: (a) a handle; (b) an effector assembly attached to the handle so as to be axially displaceable relative to the handle, the effector assembly comprising: (i) a first effector; (ii) a second effector; (iii) a bistable mechanism having a bistable element; and (iv) a biasing device having at least a first spring element and a second spring element, the biasing device biasing each of the first effector and the second effector distally relative to the bistable element, the bistable element presenting a first axial state in which the second effector is biased toward a first axial relative position relative to the first effector, and a second axial state in which the second effector is biased toward a second axial relative position relative to the first effector, the effector assembly comprising a biasing mechanism; (c) a force input portion deployed to selectively apply an input force to the bistable mechanism, wherein a force applied in a first direction by the force input portion: (i) displaces the effector assembly distally along the axial direction without changing the state of the bistable mechanism; (ii) is sequentially effective to toggle the bistable element between the first axial state and the second axial state when at least a portion of the effector assembly encounters an obstacle to further distal displacement; and the biasing device is configured such that the bistable mechanism is toggleable from the first axial state to the second axial state without the second effector needing to have reached the second axial relative position. A mechanism for operating a medical device.

2. The mechanism according to claim 1, wherein 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, wherein 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, further comprising a retraction spring deployed to return the bistable mechanism and the first effector and the second effector proximally along the axial direction.

5. The mechanism according to claim 1, wherein the first effector is a holder for holding a suture needle, and the second effector is an ejector effective to eject the suture needle from the holder when displaced from the first axial relative position to the second axial relative position.

6. The mechanism according to claim 5, wherein at the second axial relative position, the ejector has a penetrating tip.

7. The mechanism according to claim 1, wherein at least one spring of the first spring element and the second spring element is deployed with a preload gravity defining a minimum force required to change the length of the at least one spring.

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

9. A suturing mechanism, a needle having (a) a pointed distal tip, an intermediate portion configured to receive a suture thread, and a proximal engagement portion, the proximal engagement portion comprising a first portion adjacent to the intermediate portion and a second portion proximal to the first portion, the first portion having a circumscribing cylinder with a diameter D1 and a length L1, and the second portion having a circumscribing cylinder with a diameter D2 greater than D1 and a length L2; a needle, (b) A holder for releasably holding the needle, the holder comprising a tube formed of a superelastic material, the tube having a tip segment of length L1 or less with an inner diameter matching diameter D1, and a second segment having a length greater than L2 and an inner diameter matching diameter D2, such that when the tube is pressed against the proximal end of the needle, the second portion causes elastic deformation of the tip segment through the tip segment of the tube, and when the second portion is fully inserted into the second segment, the tube is substantially undeformed; a stitching mechanism comprising a holder. **Claim 10** The stitching mechanism according to claim 9, wherein the shape of the proximal engagement portion of the needle and the design of the tube are such that the force required to pull the needle out of the holder when fully inserted is greater than the force required to insert the needle into the holder. **Claim 11** The stitching mechanism according to claim 9, wherein the portion of the tube proximal to the second segment has the same inner diameter as the tip segment of the tube. **Claim 12** The stitching mechanism according to claim 9, wherein the tube continues proximally to the second segment with an inner diameter equal to the inner diameter of the second segment. **Claim 13** The stitching mechanism according to claim 9, further comprising an ejector element displaceable along the tube to push the needle out of the holder, deployed within the tube. **Claim 14** A needle receiver for passively holding a needle of a stitching device, the needle receiver comprising (a) a receiver body having a needle receiving bore extending parallel to a bore axis for receiving the needle, and a retaining element slot extending from a side surface of the receiver body and intersecting the needle receiving bore; a receiver body; (b) an elastic snap retainer deployed within the retaining element slot such that the elastic snap retainer is aligned within the needle receiving bore to elastically hold the needle; a needle receiver. **Claim 15** The receiver body further comprises a locking element channel that intersects the retaining element slot, the elastic snap retainer is interconnected with a fixed configuration having an opening aligned with the locking element channel, and the needle receiver further comprises a locking element deployed within the locking element channel to engage the opening, thereby fixing the elastic snap retainer in alignment with the needle receiving bore, the needle receiver according to claim 14.

16. The needle receiver according to claim 15, wherein the elastic snap retainer and the fixed configuration are interconnected via a flexible connection element so as to facilitate self-alignment of the elastic snap retainer with the needle inserted into the needle receiving bore.

17. The needle receiver according to claim 16, wherein the elastic snap retainer, the flexible connection element, and the fixed configuration are integrally formed as one flat element made of a superelastic material.

18. The needle receiver according to claim 14, wherein the elastic snap retainer is a snap ring.

19. The needle receiver according to claim 14, wherein the needle receiving bore has an inner stepped bore that defines a fully inserted position of the needle.

20. The needle receiver according to claim 14, further comprising a needle for introduction into the needle receiver, the needle having an outer peripheral groove for receiving the elastic snap retainer, and the outer peripheral groove and the elastic snap retainer are configured such that the force required to release the needle from the needle receiver is greater than the force required to engage the needle with the needle receiver.

21. A sewing mechanism, (a) A shuttle having an intermediate portion configured to receive a sewing thread and a proximal engagement portion, the proximal engagement portion having an axial opening surrounded by a rim having a radius R2 from the central axis of the shuttle, the shuttle; (b) A shuttle receiver having a bore for receiving the shuttle at an insertion position and releasably holding it, the bore having a radius R1 and having an opening located at an axial height H from the rim of the axial opening of the shuttle when in the insertion position, the shuttle receiver; (c) A shuttle transmitter configuration for engaging the shuttle within the bore, the shuttle transmitter presenting a through configuration that terminates at a penetration point, the through configuration having a gradually increasing radius such that at an axial distance H from the penetration point, the through configuration has a radius R3 and R3 is greater than (R1 - R2), comprising a shuttle transmitter configuration, a sewing mechanism.

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