Anastomosis equipment

Abstract

The present disclosure provides an anastomotic device for connecting two opposite stumps of a tubular organ in a simplified anastomotic procedure. The device comprises a pair of axisymmetric stump coupling members, which accommodate paired suture needles, which are connected together by a common suture thread and can be manipulated by a needle manipulation element to remove the tip of the needle from the stump coupling member for piercing the wall of the stump.

Description

Technical Field

[0001] The present disclosure relates to components and instruments for anastomosis of tubular organs, particularly small tubular organs, in the body (eg, blood vessels, bile ducts, lymphatic vessels, neural tubes, epididymis, etc.). Background Art

[0002] Listed below are references that are believed to be relevant to the background of the presently disclosed subject matter:

[0003] WO 2016 / 128961

[0004] US 4,744,362

[0005] US 2006 / 0167485

[0006] US 2004 / 0199185

[0007] US 5,330,503

[0008] US 2005 / 0288697

[0009] US 5,746,757

[0010] US 5,417,699

[0011] US 3,265,069

[0012] Acknowledgment of the above references herein should not be inferred as meaning that these references are in any way relevant to the patentability of the presently disclosed subject matter.

[0013] background

[0014] In medical practice, various techniques are known for anastomosing severed tubular organs, including blood vessels and other organs. WO 2016 / 128961 discloses, among other things, an anastomotic device for connecting two tubular organs, which utilizes a plurality of threads, each of which has needles at both ends, and discloses a device that simplifies the suturing procedure intended to connect two blood vessel portions to each other.

[0015] General Description

[0016] The present disclosure provides an anastomotic device (i.e., one or a combination of two or more parts or elements used in conjunction in an anastomotic procedure) for joining two opposing stumps of a tubular organ. The two stumps can be stumps of a tubular organ, such as stumps of a blood vessel or lymphatic vessel (e.g., cut during surgery or accidentally), stumps of a blood vessel transplanted to a donor site, etc.

[0017] In the anastomosis procedure, it is necessary to suture multiple times between the relative stumps. In the case of small blood vessels, this may be a complicated and time-consuming procedure. The arrangement of the present disclosure is intended to simplify the process. The device includes a pair of axially symmetrical stump coupling members, which can be separate or connected to each other through an integrated axial connection body or auxiliary unit, which axially connects the coupling members in pairs, and the pair of coupling members has a relative axial stump coupling projection, which is configured to be connected to the stump by pulling the wall of the stump onto the outer surface of these projections. Paired matching (and oppositely oriented) suture needles that are linked together by a common suture are part of the device and are assembled in the coupling member, and the tip of the suture needle is accommodated in the needle receiving channel. By the axial displacement of the needle manipulation element associated with the stump coupling member, the tip of the needle is extracted to pierce the wall of the stump assembled on the outer surface of the stump coupling projection, and the needle manipulation element is usually in the form of a sleeve assembled on the outer surface of the stump coupling member.

[0018] In the following description, the term suturing unit will be used to refer to a pair of needles linked together by a suture; and the term needle set will be used to refer to all suturing needles associated with one stump coupling member.

[0019] A suture needle of the suture unit is associated with a stump coupling member and thus forms part of a group of needles intended to pierce the wall of one of the stumps to be joined together in the procedure; while its counterpart is associated with another stump coupling member and forms part of another group of needles intended to pierce the wall of the opposite stump. All needles in a group of needles are manipulated together in a manner to be explained, and as a result, in a relatively simple process, one group of needles is pierced through one stump and another group of needles is pierced through another stump. After the tip of the needle pierces the stump, each needle can be pulled so as to completely pass through the wall of the stump, and then the suture (which couples the needle to the paired needle) is pulled through the wall of the stump. In this way, the two stumps are joined together by a plurality of sutures, and then, after the stumps are pulled apart from the stump coupling member, the sutures can approach each other and suture.

[0020] As will be further explained below, manipulation of the suture needle from its initial state (in which the tip of the suture needle is contained within the stump connecting member) to a piercing state (in which the tip of the suture needle is biased to pierce the wall of the stump placed on the outer surface of the stump connecting member) is performed by pivoting the needle about a pivot point located within the stump connecting member, and the suture needle is typically curved.

[0021] The stump coupling member and the device can be formed in different sizes to suit different anastomotic procedures. For example, the stump coupling member can have different diameters or different geometric shapes to accommodate different stump diameters or different anastomotic procedures.

[0022] One embodiment of the present disclosure provides an anastomotic device for connecting two stumps of a tubular organ, comprising a coupling assembly and a suturing unit incorporated in the coupling assembly. The coupling assembly comprises a pair of axially symmetrical stump coupling members, the stump coupling members defining two opposite axially extending stump coupling projections, each projection being configured to be coupled to one of the stumps by pulling the wall of the stump on the outer surface of the projection to a suturing state. In the suturing state, the wall of the stump covers the stump engagement portion of the stump coupling projection.

[0023] Each stump coupling member has a group of open channels, and this group of open channels is arranged in a manner symmetrical about the longitudinal axis of the stump coupling member. Each channel (i) extends between the front channel end in the stump joint portion of the rear channel end and the protrusion in the described stump coupling member to define a channel axis, (ii) is limited between the side wall and the bottom wall, and this bottom wall is configured to have a pivot point in the middle channel portion to define the front channel portion and the rear channel portion, and (iii) has a counterpart in the relative channel group (formed in the relative stump coupling member), and this counterpart extends in opposite directions toward the relative stump coupling portion along the same channel axis. Each channel in a stump coupling member has a counterpart in another described member.

[0024] Each of the stump coupling members has a needle handling element axially displaceable between a forward position closer to the stump coupling projection and a rearward needle withdrawal position.

[0025] Each suturing unit comprises a suture thread and two curved suture needles, each needle having a pointed front portion and a thread-connected rear portion connected to the thread. Each suture needle is accommodated in a channel, a suture needle of each unit is accommodated in a channel of a described stump connecting member, and another suture needle of the unit is accommodated in a paired channel of another described stump connecting member. The front end of each needle is completely accommodated in the channel near the front channel end, the middle part of the needle rests on the pivot point, and the rear end of the needle extends out of the channel near the rear channel end. The rear end of the needle is connected to the needle operating element of the corresponding stump connecting member, so that when the needle operating element is axially displaced to the needle withdrawal position, the needle pivots around the pivot point, whereby when in the described suturing state, the pointed front portion of the needle pivotally moves out of the described front channel end to pierce the wall of the stump.

[0026] In one embodiment, two stump coupling members are connected to each other by a central connecting body, thereby forming an integral anastomotic device with each other. In another embodiment, two stump coupling members are formed separately and are kept together by an auxiliary unit, such as a support, a frame, a jig, a bridge, etc. The auxiliary unit maintains integrity and generally maintains the stump coupling member in a coaxial configuration. The auxiliary unit can also be a part of an actuating device configured to displace a needle manipulation element.

[0027] The needle manipulation element can be formed as a sleeve or annular body, which is assembled on a part of the outside of the stump coupling member and can slide axially along the outer surface of the stump coupling member and rotate on the outer surface of the stump coupling member. The needle manipulation element is configured to engage the rear end of the suture needle, for example, through an opening in the element, through which the rear end of the needle protrudes. This opening can be formed to have a general L-shape, and one arm of the L-shaped opening extends from the distal edge of the needle manipulation element, so that the rear end of the needle can be captured in the opening by the push-turn manipulation of the element.

[0028] The coupling assembly typically has a mirror symmetry about a plane of symmetry between the two coupling members, for example a plane of symmetry in the middle portion integrating the two stump coupling members into a central body of an instrument.

[0029] The stump coupling projection can have a variety of geometric shapes to adapt to different purposes. Although other cross sections (e.g., hexagons, heptagons, octagons, enneagons, decagons, etc.) may also be possible, it generally has a circular cross section in the entire distal portion at least coupled to the tubular organ stump. It may generally be cylindrical, conical or truncated conical. In order to facilitate or simplify the coupling with the stump, the distal end of the stump coupling member may be tapered.

[0030] Each of the front channel portion and the rear channel portion typically has a curvature that matches the curvature of the suture needle. Axial displacement of the needle manipulation element into the needle withdrawal position causes the suture needle to pivot about a pivot point between a first stationary state in which the portion of the needle in front of the middle portion rests on the front channel portion and a second stationary state in which the portion of the needle behind the middle portion rests on the rear channel portion. The curve of each of the rear channel portion and the front channel portion can be arched around a respective rear and front curvature center, the rear curvature center being offset rearwardly relative to the front curvature center.

[0031] The suturing needles may each have a pointed tip that is angled relative to a trajectory defined by the curve of the needle, such as in a generally inward radial direction.

[0032] The anastomotic assembly generally includes a retaining element for retaining the suture needle in the passage. The retaining element may be integrally formed with the stump coupling member, or may be a separate element mounted on the open passage, such as an elastic ring contained in a circumferential groove formed at the rear end of the stump coupling member.

[0033] The present disclosure also provides a connecting assembly for the above-mentioned anastomotic device.

[0034] By one embodiment, the coupling assembly includes a pair of axisymmetric stump coupling members, the stump coupling members defining two opposing axially extending stump coupling projections, each of the projections being configured to couple with one of the stumps by pulling the wall of the stump over the outer surface of the projection to a sutured state, in which the wall of the stump covers the stump engaging portion of the projection; two sets of opposing open channels, which are arranged in an axisymmetric manner about the axis, each channel (i) extending between a rear channel end in the stump coupling member and a front channel end in the stump engaging portion of the projection to define a channel axis, and (ii) being defined between a side wall and a bottom wall, the bottom wall being configured to have a pivot point in a middle channel portion to define a front channel portion. and a rear channel portion, (iii) having a counterpart in an opposing group extending in opposite directions along the same channel axis toward an opposing stump coupling portion, and (iv) the channels are each configured to receive and accommodate a suture needle, each needle having a pointed front portion and a thread-connected rear portion coupled to a thread, such that when each needle is received in the channel, the front end of each needle is fully accommodated in the channel near the front channel end, the middle portion of the needle rests on the pivot point, and the rear end of the needle extends out of the channel near the rear channel end; and two needle manipulation elements, one in each stump coupling member, each needle manipulation element being axially displaceable between a front position closer to the stump coupling protrusion and a rear needle withdrawal position.

[0035] An actuator instrument for operating the device is also an aspect of the present disclosure. The actuator instrument may include a handle and two arms, each arm being configured to couple to one of the needle manipulation elements at a distal portion; and an actuator configured to displace the arms to move each distal portion toward the other, thereby axially displacing the needle manipulation element to a needle withdrawal position.

[0036] In an embodiment, the actuator instrument may comprise two retaining members, each retaining member for releasably retaining one stump coupling member in a pair of separate stump coupling members.

[0037] By way of example, the actuator instrument includes a wire retainer for releasably associating with a suture, such as being held near or at a mid-position of the suture. The wire retainer may be designed to maintain tension in the wire when associated with the wire retainer.

[0038] The actuator instrument may include a selector that allows selective displacement of one of the arms, thereby allowing selective displacement of one of the needle manipulation elements. Each of the two arms may have a coupling end that fits into a groove formed on an outer face of the needle manipulation element.

[0039] Once the needle has penetrated the wall of the stump, it is necessary to grasp the tip of the needle so that the needle can be pulled through the wall, pulling the suture behind the needle. To do this, the surgeon needs to be able to access the tips of all needles. Some of the wall portions penetrated by the needles are located on the side of the stump opposite to the side facing the surgeon, and access to the tips of such needles may be difficult. To overcome this difficulty, the actuator instrument may include a rotating device for rotating the device around an axis. Once so rotated, this device causes the coupled stump to rotate with it, so that the opposite side of the stump faces the surgeon; the surgeon can then easily access the corresponding tip and pull the needle through the wall of the stump.

[0040] The present disclosure also provides an actuator device for operating an anastomotic assembly, which is configured to guide or manipulate the needle of a suturing unit during an anastomotic procedure. The suturing unit includes two needles located at opposite ends of a suture. During the anastomotic procedure, the opposite needle of the suturing unit pierces and passes through so that the suture engages the wall of the opposite stump. The device uniquely includes at least one magnetic element for magnetically retaining the needle after the needle passes through the wall of the stump. The magnetic element may also be included in any actuator device described in the preceding paragraphs. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In order to better understand the subject matter disclosed herein and to illustrate how it may be implemented in practice, embodiments will now be described by way of non-limiting examples only, with reference to the accompanying drawings, in which:

[0042] Figure 1A and Figure 1B 1 and 2 are a side view and a longitudinal cross-sectional view through an anastomotic device according to an embodiment of the present disclosure, respectively, wherein the coupling components are connected to each other via a central connecting body in a deployed state.

[0043] Figure 2A and Figure 2B They are in a sutured state. Figure 1A to Figure 1B A side view of an anastomotic device and a longitudinal cross-sectional view through it.

[0044] FIG. 3A to FIG. 3Cis a schematic longitudinal cross-sectional view of one end of a centrally connected body and through an open channel, showing the body without a suture needle in the channel ( Figure 3A ), the needle in the channel is in the deployed position ( Figure 3B ) and the needle in the channel is in the suturing position ( Figure 3C ); FIG. 3B to FIG. 3C Corresponding to Figure 1A to Figure 1B and FIG. 2A to FIG. 2B status.

[0045] FIG. 4A to FIG. 4C Another embodiment of the present disclosure is shown of a stapling device coupled to an actuator instrument for operating the stapling device during a stapling procedure, wherein Figure 4A It is an overall perspective view. Figure 4B An enlarged view of a distal portion of an actuating instrument is shown, wherein a stapling device is associated with the distal portion, and Figure 4C A longitudinal section and a perspective view of the distal portion are shown.

[0046] Figure 5A A perspective view of a stapling device is shown, the stapling device including two separate coupling assemblies according to another embodiment of the present disclosure coupled to an actuator instrument for operating the stapling device.

[0047] FIG. 5B to FIG. 5E is from Figure 5A A perspective view of the sequence of withdrawing the needle from the coupling assembly of the device. DETAILED DESCRIPTION

[0048] In the following description, the present invention will be explained with reference to three embodiments, one of which is Figures 1A to 3C In the figure, another embodiment is FIG. 4A to FIG. 4C There is another embodiment shown in FIG. 5A to FIG. 5E . It will be appreciated that these embodiments are intended to illustrate the general principles of the devices, assemblies, and apparatus disclosed herein and are not limited to the details of these embodiments. When discussing some elements, some potential modifications may be mentioned. However, as will be appreciated by those skilled in the art, modifications may also be possible in elements related to modifications not specifically discussed herein, all of which are within the general teachings of the present disclosure.

[0049] First reference Figures 1A to 2B , an anastomotic device is shown, wherein the stump coupling member is integral with the central connecting body. Figure 1A to Figure 1B shows the device in an initial deployment state, while FIG. 2A to FIG. 2B The instrument is shown with the device in its piercing state.

[0050] The device 100 includes a coupling assembly 102 and a plurality of suturing units 104, each of which includes a suture thread 106 and two curved suture needles 108, each needle having a pointed front end 110 (at FIG. 2A to FIG. 2B ) and connected to the rear end 112 of the suture 106. It should be noted that in FIG. 2A to FIG. 2B , sutures have been omitted for ease of viewing. The coupling assembly 102 has a central coupling body 120 that is symmetrical about the axis X and extends between two opposing body ends 124A and 124B at opposite sides of a middle portion 126 of the central coupling body 120. Two opposing axially extending stump coupling members 128A and 128B are integral with the central coupling body and extend axially from the central coupling body, each stump coupling member having a generally circular cross-section, the stump coupling members having generally cylindrical axially extending stump coupling protrusions 130A and 130B, the stump coupling protrusions 130A and 130B having tapered distal ends 132A and 132B, so that the stump coupling protrusions 130A and 130B have a generally frustoconical shape. Each stump connecting protrusion is configured, by its shape, to connect to one of the stumps, which is intended to be joined together during a stumping procedure by drawing the walls of the stumps (not shown) over the outer surface of the protrusion to a sutured state, in which the walls of the stumps cover the stump engaging portions 134A, 134B of the protrusions 130A, 130B, respectively.

[0051] It can be seen that the central connecting body 120 is mirror-symmetrical about a plane located at and perpendicular to the middle portion of the body. However, it should be noted that this is only an example, for example, in the case where the assembly is intended to connect two stumps with different diameters, the body is configured to be connected to a stump with a relatively large diameter at one end and to a narrower stump at the other end.

[0052] Two sets of open channels 136A, 136B are formed in the protrusion, and the two sets of open channels are arranged in a manner symmetrical about the axis X. Figure 3A As best seen in FIG. 1 , each channel 136 extends between a rear channel end 140 in the stump coupling member 128 and a front channel end 142 in the stump engaging portion 134, defining a channel axis; the channel 136 has a counterpart (not shown) extending along the same channel axis at the opposite end of the body 120. Each channel is defined between side walls and a bottom wall 146, Figure 3AIn the cross-sectional view of FIG. 1 , one of the side walls 144 is seen, and the bottom wall 146 has a pivot point 148 defined in the middle channel portion. In this particular embodiment, the pivot point 148 divides the channel into a front channel portion 150 and a rear channel portion 152, and the curvature of each channel portion matches the curvature of the suture needle, such as Figure 3B and Figure 3C Can be seen in.

[0053] Each rear end 112 of the needle 108 engages in an opening 154 formed at the front end of the needle manipulation element 156. Figure 1A and Figure 2A The opening 154 has a generally L-shaped shape with one arm of the opening 154 extending from the distal edge 158 of the element 156, allowing the needle to be captured within the opening by pushing and turning the element. The manipulation element 156 is assembled to the central body, one at each end of the body, and each manipulation element is removable. Figure 1A to Figure 1B Its initial position is seen to be axially displaced inwardly toward the middle body portion to FIG. 2A to FIG. 2B Position shown.

[0054] Figure 3B Suture needles 108 are shown, each of which is received within a channel 138, wherein the front portion of the needle is completely received within the channel, resting against the bottom wall of the front channel portion 150. The pointed front end 110 of the suture needle 108 is angled relative to the trajectory defined by the curve of the needle. By way of example, FIG. 3B to FIG. 3C As shown, the tip of the needle points in a generally inward radial direction. However, it will be appreciated that the tip of the needle may have some other configuration and is not limited to such an angled or radial direction.

[0055] The curve of the bottom wall of the front part of the channel and the rear part of the channel (and therefore the curve of the needle) is generally circular, i.e., arched, and along a portion of an imaginary curve (e.g., a circle) defined around a center of curvature (not shown), the bottom wall of the front part of the channel is arched around an imaginary front center of curvature, and the rear part of the channel is arched around an imaginary rear center of curvature, which is offset rearwardly relative to the front center of curvature. It should be noted that the arched bottom wall along a portion of an imaginary circle is only an example, and the curve may have other trajectories, such as a hyperbola, a parabola, etc.

[0056] like Figure 3B As can be seen in FIG. 1 , in the initial or deployed state, the front portion of the needle rests on the bottom wall of the front portion 150 of the channel, and the tip 110 of the needle is completely contained within the channel. The middle portion of the needle rests on the pivot point 148, and once the needle manipulation element 156 is moved from the pivot point 148 to the pivot point 148, the needle manipulation element 156 is moved from the pivot point 148 to the pivot point 148. Figure 1A to Figure 1B and Figure 3BIts initial distal position as seen in FIG. 1 is axially displaced inwardly toward the middle body portion to a position at FIG. 2A to FIG. 2B and Figure 3C 14, the needle is pivoted about pivot point 148 so that its rear portion 112 rests against the bottom wall of channel rear portion 152. Once so pivoted, tip 110 is transferred to a piercing position in which tip 110 can pierce a wall (not shown) of a stump placed on stump engagement portion 134. The needle can then be pulled through the stump wall, for example by using forceps, the suture is pulled through the needle, and after removal of coupling device 102, the two stumps can be sutured to each other.

[0057] An annular groove 160 accommodating an elastic O-ring 162 is formed at the rear end of the stump coupling member 128. The elastic O-ring serves to hold the needle in the open channel 138, and in particular to ensure that the needle is Figure 3B Its resting state and deployed position are shown pivotally moved to Figure 3C The piercing state is seen during the period of the channel. Once the needle and suture have been pulled through the wall of the stump, the elastic O-ring can be removed, for example, by cutting or severing.

[0058] The needle manipulation element may be axially displaced by direct manipulation, such as by using forceps. FIG. 4A to FIG. 4C In the embodiment of the present disclosure shown, such displacement can be achieved by using an actuator device. Figure 4A and Figure 4B In the embodiments of the present invention, elements similar to those of the previously described embodiments will be given similar reference numerals of translation 100, for example, FIG. 4A to FIG. 4C The needle operating element 256 and Figures 1A to 3C The same functional element 156 in the embodiment has the same function. Figures 1A to 3C The description is provided to explain any elements shown but not specifically described below.

[0059] FIG. 4A to FIG. 4C The actuator instrument 1000 shown in can be used for two independent functions: one is to manipulate the needle manipulation element 256, and the other is to rotate the entire device about its axis to enable access to the tip of the needle on the side opposite to the side facing the surgeon (i.e., the hidden side), thereby allowing the surgeon to grasp the tip of the needle in order to pull the tip of the needle through the wall of the stump.

[0060] In this particular example, the needle manipulation element 256 has an annular outer recess 271 that is configured to engage with the end portion 1002 of the arm 1004 of the actuator device 1000. The arm 1004 is configured to be axially displaced inwardly, thereby displacing the needle manipulation element 256 axially inwardly toward the middle portion 226 of the body. This can be achieved by the actuating element 1006, which in some embodiments allows for selectable inward displacement of only one or both arms. As in FIG. 4A to FIG. 4C As can be further seen in the drawings, the middle portion 226 of the body is constructed with an integral cogwheel 273 which is coupled to the cogwheel 1008 of the actuator instrument 1000. The body 226 is securely coupled to the actuator instrument 1000 via a drilled extension 1010 with an axial bore 1012 which accommodates a portion of the middle portion of the body between the cogwheel 273 and the needle manipulation element 256.

[0061] Once all the pins are in Figure 4C In the state seen, in which the tips of the needles pierce the wall of the stump, the surgeon can first grasp and pull the needles on the side facing the surgeon, and then can turn cog 1008 to rotate the entire assembly 200 about the axis and bring the tips of the needles from the hidden side to the front, allowing them to be grasped and pulled in the same manner.

[0062] By another embodiment, FIG. 5A to FIG. 5E As shown, the anastomotic device 300 includes two separate coupling assemblies 302, each coupled to an actuator instrument 3000. FIG. 5A to FIG. 5E In the embodiment, combined with Figures 1A to 3C Elements similar to those described will be given similar reference numerals of the translation 200, for example, FIG. 5A to FIG. 5E The needle operating element 356 and Figures 1A to 3C The same functional element 156 in the embodiment has the same function. Figures 1A to 3C The description is provided to explain any elements shown but not specifically described below.

[0063] Figure 5AThe device 300 includes a pair of coupling assemblies 302 connected by a plurality of suturing units 304, each suturing unit including a suture 306 and a pair of curved suture needles 308. The use of a pair of separate coupling assemblies provides a higher degree of flexibility and adaptability to various conditions in the stump coupling procedure, such as separate and independent manipulation of each coupling assembly, positioning one assembly at different angles relative to the other, using assemblies of different sizes, etc. In an exemplary embodiment, the coupling assemblies 302 are held together by an actuation device 3000. However, it is also contemplated that the coupling assemblies can be held together by an auxiliary unit (not shown) that does not have an actuation function, such as a bridge, a frame, a rigid, semi-flexible or flexible swivel (gig), etc.

[0064] The actuator instrument 3000 includes two retaining members 3002, each retaining member for releasably retaining one stump coupling member 302 so that once deployed, the stump coupling member can be detached from the actuator instrument for removal from the operating site. In order to maintain the suture 306 in an at least partially tensioned state during the stump coupling procedure (e.g., to prevent the line from tangling during the operation), the actuator instrument may include a line retainer 3004 releasably associated with the suture.

[0065] The actuator instrument can also include one or more magnetic elements 3006, which can be an integral part of the instrument, or removably attached to the instrument. Although in this particular example, the magnetic element is shown as being associated with the frame portion of the instrument, this is merely an example, and the magnetic element can be associated with any other suitable part of the actuator instrument (or sometimes associated with an auxiliary frame that holds the instrument). As described above, during the anastomosis procedure, the suture needle 308 is manipulated to pierce and pass through the tissue, and after the suture needle is completely removed from the tissue, the suture needle can be magnetically retained by one or more magnetic elements 3006 until the actuator instrument and / or the anastomosis assembly are removed. This allows the operator of the instrument to temporarily hold a needle that is no longer used during the procedure and reduces the risk of suture entanglement.

[0066] This embodiment (such as FIG. 5B to FIG. 5E The operation of the connection assembly is similar to Figures 1A to 3C The operations of the components in the described embodiments will therefore be described briefly.

[0067] exist FIG. 5B to FIG. 5E 302, for ease of illustration, the coupling assembly contains a suture needle 308 (with the suture removed). The suture needle 308 is contained in one of the plurality of open channels 336. In the first stationary state of the needle, as shown in FIG. FIG. 5B to FIG. 5CAs shown, the tip of the needle is housed in the passage 336. The rear end 312 of the needle is retained by an L-shaped opening 354 formed in a needle manipulation element 356, which is generally in the form of a sleeve element mounted on the body 333 of the coupling assembly in a manner that allows it to be axially displaced along the longitudinal axis X' and rotatable about the longitudinal axis X'.

[0068] After the tissue stump has been assembled on the protrusion 330, the needle operating element 356 is rotated about the axis in the direction of arrow 355 to actuate the coupling assembly, thereby locking the rear end 312 of the suture needle 308 in the opening 354 (such as Figure 5C Then, as Figure 5D As can be seen, axial displacement of the needle manipulation element in the direction of arrow 357 causes the needle to pivot about the pivot point of channel 336 and transition to its second rest state in which the needle tip 310 is exposed and penetrates the wall of the stump (although not shown in this embodiment, the structure of channel 336 is similar to Figure 3A In order to facilitate further penetration of the needle into the tissue stump and enable the physician to better grasp the needle to pass it through the tissue, the needle manipulation element 356 may be axially displaced in the direction of arrow 359 to Figure 5E The position shown thereby pushes the needle tip further through the tissue, providing better access to the needle tip after it penetrates the tissue.

Claims

1. An anastomotic device for connecting two stumps of a tubular organ, comprising: A coupling assembly and a suturing unit incorporated in said assembly; The connection assembly comprises: - a pair of axisymmetric coupling members defining two opposed axially extending stump coupling projections, each of said projections being configured to couple with one of the stumps by drawing a wall of the stump over an outer surface of said projection into a sutured state in which the wall of the stump covers a stump engaging portion of said projection, - two opposed sets of open channels, one set of said open channels in each said stump coupling member, said open channels in each said stump coupling member being arranged in an axisymmetric manner about an axis, each of said channels (i) extending between a rear channel end in said member and a front channel end in said stump engaging portion of said projection to define a channel axis, (ii) being defined between side walls and a bottom wall, said bottom wall being configured with a pivot point in a mid-channel portion to define a front channel portion and a rear channel portion, and (iii) having a counterpart in an opposing set extending in opposite directions along the same channel axis towards opposing stump coupling portions, and comprising: - two needle handling elements, one in each stump coupling member, each needle handling element being axially displaceable between a forward position closer to the stump coupling projection and a rearward needle withdrawal position; Each of the stitching units comprises: - a suture thread and two curved suture needles, each suture needle having a pointed front portion and a thread-connecting rear portion connected to the thread, - the suture needles are each accommodated in one of the channels, one of the suture needles of each unit is accommodated in a channel of one of the stump coupling members, the other suture needle of the unit is accommodated in a mating channel of the other of the stump coupling members, - the front end of each needle is completely received within the channel near the front channel end, the middle portion of the needle rests on the pivot point, and the rear end of the needle extends out of the channel near the rear channel end, and -The rear end of the needle is connected to the needle manipulation element of the corresponding stump coupling member so that when the needle manipulation element is axially displaced to the needle withdrawal position, the needle pivots about the pivot point, whereby when in the suturing state, the front part of the needle tip pivotally moves out of the front channel end to pierce the wall of the stump.

2. The anastomotic device according to claim 1, wherein the two stump coupling members are connected to each other via a central connecting body.

3. The anastomotic device according to claim 1, wherein the two stump coupling members are separate members and are held together by an auxiliary unit.

4. The anastomotic device according to claim 3, wherein the auxiliary unit is part of an assembly actuation instrument.

5. The anastomotic device according to claim 1, wherein the coupling assembly has mirror symmetry about a symmetry plane therebetween. The anastomotic device according to claim 1 , wherein the stump coupling protrusion has a circular cross-section.

7. The anastomotic device according to claim 6, wherein the stump coupling protrusion is substantially cylindrical, conical or substantially frustoconical. The anastomotic device according to claim 1 , wherein the stump coupling protrusion is tapered.

9. The anastomotic device according to claim 1, wherein the needle manipulation element is formed as a sleeve on a portion of the stump coupling member and is axially slidable along an outer surface of the portion and rotatable around an outer surface of the portion.

10. The anastomotic device according to claim 1, wherein Each of the front channel portion and the rear channel portion has a curvature that matches the curvature of the suture needle, and wherein Axial displacement of the needle manipulation element into the needle withdrawal position causes the suture needle to pivot about the pivot point between a first stationary state in which a portion of the needle in front of the middle portion rests on the front channel portion and a second stationary state in which a portion of the needle behind the middle portion rests on the rear channel portion.

11. The anastomotic device according to claim 10, wherein the curve of each of the rear channel portion and the front channel portion is arcuate about a rear curvature center and a front curvature center, respectively, and the rear curvature center is offset posteriorly relative to the front curvature center.

12. The anastomotic device of claim 1, wherein the suturing needles each have a pointed end that is angled in a generally inward radial direction relative to a trajectory defined by the curve of the needle.

13. The anastomotic device according to claim 1, comprising a retaining element for retaining the suturing needle in the channel.

14. The anastomotic device according to claim 13, wherein the retaining element is an elastic ring received in a circumferential groove.

15. An actuator device for operating the anastomotic device according to any one of claims 1 to 14, comprising: a handle and two arms, each arm being configured to couple at a distal portion to one of the needle manipulation elements; and An actuator is configured to displace the arms to move each distal portion toward the other to axially displace the needle manipulation element to the needle withdrawal position.

16. An actuator instrument according to claim 15, for operating a pair of separate stump coupling members, the actuator instrument comprising: Two retaining members, each retaining member is used to releasably retain one of the stump coupling members.

17. The actuator device according to claim 15, comprising: A thread retainer is for releasably associating with the intermediate portion of the suture.

18. The actuator instrument of claim 15, comprising a selector allowing selective displacement of one of the arms.

19. The actuator instrument of claim 15, wherein the two arms have coupling ends that fit into grooves formed on an exterior face of the needle manipulation element.

20. The actuator instrument of claim 15, comprising at least one magnet configured to magnetically retain the suture needle after the suture needle is withdrawn from the wall of the stump.

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