阅读说明：本技术 吻合术的组件 (Anastomosis assembly ) 是由 迪安·阿德-埃尔 卡迈尔·达斯 穆哈马德·曼苏尔 于 2019-01-16 设计创作，主要内容包括：本发明公开一种用于吻合术的装置,特别(但是非排他地)适用于体内管状器官的吻合术,特别是小的管状器官(如血管、胆管、淋巴管、神经管、附睾等)。(The present invention discloses a device for anastomosis, particularly (but not exclusively) suitable for anastomosis of tubular organs in vivo, in particular small tubular organs (e.g. blood vessels, bile ducts, lymphatic vessels, neural tubes, epididymis, etc.).)

1. An anastomosis assembly for joining a stump of an incised tubular organ to another stump, comprising: the assembly comprises:

a device having a body with two opposing axial projections, each of said axial projections being configured for insertion into a stub for connection with another stub and for allowing walls of said stub to be pulled over a stub engagement of an outer surface of said axial projection; and

a plurality of curved guide channels, each said guide channel extending in a generally axial direction between a first end and a second end defined on said stump junction of one of said axial projections, each said guide channel configured to receive a suture needle and guide said suture needle to pierce through walls of said stump, said suture needle having a pointed head and a tail, said tail being connected to a suture thread.

2. The assembly of claim 1, wherein: the assembly includes a plurality of suture needles pre-received within the plurality of guide channels.

3. The assembly of claim 1 or 2, wherein: each of the guide channels extends between a stub engaging portion of one of the axial projections and a stub engaging portion of the other of the axial projections.

4. The assembly of claim 1 or 2, wherein: each of the guide channels extends between the body and a stub junction.

5. The assembly of claim 4, wherein: each of the guide channels accommodates a suture needle.

6. The assembly of any one of the preceding claims, wherein: the device has an axial symmetry.

7. The assembly of any one of the preceding claims, wherein: the device has a mirror symmetry in a plane perpendicular to the axis.

8. The assembly of claim 7, wherein: each of the guide channels extends between the body and a butt seam and receives a needle having a suture extending between two needles in two opposing guide channels.

9. The assembly of any one of the preceding claims, wherein: each of the guide channels is a hole.

10. The assembly of any one of claims 1 to 8, wherein: each of the guide channels constitutes an open channel.

11. The assembly of claim 10, wherein: the assembly includes a retaining assembly configured to retain the suture needle within the open channel.

12. The assembly of claim 11, wherein: the securing assembly is removable to allow release of the suture needle.

13. The assembly of claim 11, wherein: the open channel is configured to retain the suture needle, but allow release of the suture.

14. The assembly of any one of the preceding claims, wherein: the axial projection is substantially cylindrical.

15. The assembly of any one of the preceding claims, wherein: the axial projection is tapered.

16. An anastomosis assembly for joining a stump of an incised tubular organ to another stump, comprising: the assembly comprises:

an axisymmetric device having two opposing axial projections extending from a central body, each of said projections being configured for insertion into one of said stubs to connect with the other stub and for allowing walls of said stub to be pulled over a stub engaging portion of the outer surface of said axial projection;

the axisymmetric device is formed with a plurality of axially extending, radially open channels defined between sidewalls and a curved bottom wall, each open channel extending from an end of the central body to a second end of a stub junction of a projection;

a plurality of suture units, each unit including a pair of suture needles having their tails connected to each other by a suture thread, each suture needle having a sharpened head; and

each needle of a suturing unit is received within one of the open channels, the open channels being opposite one another in a plane of mirror symmetry with the pointed head of each needle facing in the direction of the second end, each needle being slidable within the open channel and each needle being guided by the bottom wall so as to pierce through the walls of the stump once pulled over the stump junction.

17. The assembly of claim 16, wherein: the tail of the needle passes out of the first end and the needle can be slid in a generally axial direction by pushing on the tail.

18. The assembly of claim 16, wherein: the sliding of the needle is accomplished by a sliding insert insertable into the open channel.

19. An anastomosis assembly according to any of claims 16 to 18, wherein: the assembly includes a retaining assembly configured to retain the suture needle within the open channel.

20. The assembly of claim 19, wherein: the securing assembly is removable to allow release of the needle or suture.

21. The assembly of any one of claims 16 to 20, wherein: the open channel is configured to retain the suture needle, but allow release of the suture.

22. An anastomosis assembly for joining two stumps of a severed tubular organ, comprising: the assembly comprises:

a central body having two opposing axial projections, each configured for insertion into a stub for connection with another stub and for allowing walls of the stub to be pulled over a stub engagement of the outer surface of the axial projection;

two or more first tunnels extending in a generally axial direction between openings at opposite sides of said central body, one opening being formed at said stub junction of one of said axial projections and the other opening being formed at said stub junction of the opposite other of said axial projections;

each of the tunnels is configured for receiving and guiding a suture needle of a suture unit, each suture unit comprising the suture needle and a suture thread connected thereto, allowing a suture needle to pierce the walls of two opposing stubs once mounted on the stub junctions; and

the assembly is configured to disintegrate, thereby exposing the full length of the first tunnel.

23. An anastomosis assembly for joining two stumps of a severed tubular organ, comprising: the assembly comprises:

a generally axial core member having a central section between two opposing axial projections, each axial projection being sized for insertion into an opening in one of the two stubs and allowing walls of the stub to be pulled over a stub engaging portion of the outer surface of the axial projection;

an outer body formed around and closely connected to the central section; a plurality of tunnel pairs, each tunnel pair comprising:

a first passage defined between said central section and said outer body and extending between a first inlet and a first outlet axially separated from one another, said first inlet being formed on a stub junction of one of said axial projections and said first outlet being formed on a stub junction of the opposite other of said axial projections; and comprises the following steps:

a second channel formed in the outer body and extending between a second inlet and a second outlet, the second tunnel being configured to receive a suture needle of a suture unit, the suture unit including the suture needle and a suture thread to allow the suture needle to be withdrawn from the second outlet along a trajectory such that the suture needle will be penetrated from the first inlet;

the outer body is configured to disintegrate from the core member, thereby exposing the full length of the second tunnel.

24. The anastomosis assembly of claim 23, wherein: one or more of the second tunnels pre-houses a suture needle.

25. An anastomosis assembly according to claim 23 or 24, wherein: the needle has a non-binding arcuate shape that is presented by withdrawal of the needle from the second tunnel to define an arcuate trajectory that directs the needle tip into the first inlet.

26. An anastomosis assembly according to any of claims 23 to 25, wherein: each of the first tunnels and the corresponding second tunnel define an arch of a common circle.

27. An anastomosis assembly according to any of claims 23 to 26, wherein: the outer body includes a unified securing member that maintains the integrity of the outer body and can be removed, broken or disassembled to allow disassembly of the outer body.

28. The anastomosis assembly of claim 27, wherein: the outer body includes a plurality of sub-units held together by a fixing member of the united body.

Technical Field

The present invention discloses a device for anastomosis, particularly (but not exclusively) suitable for anastomosis of tubular organs in vivo, in particular small tubular organs (e.g. blood vessels, bile ducts, lymphatic vessels, neural tubes, epididymis, etc.).

Background of the invention

References believed to be relevant to the presently disclosed subject matter are listed below:

-WO 2016/128961

-US 4,744,362

-US 2006/0167485

-US 2004/0199185

-US 5,330,503

-US 2005/0288697

-US 5,746,757

-US 5,417,699

-US 3,265,069

the admission herein of the various references mentioned above should not be inferred to mean that these references are in any way relevant to the patentability of the presently disclosed subject matter.

Disclosure of Invention

The present invention provides an assembly for use in an anastomosis procedure (referred to herein as an "anastomosis assembly") for joining together a plurality of cut ends of a plurality of tubular organs. Hereinafter, the plurality of cutting ends may each also be referred to as a "stub" and the end walls of the stub are referred to as "walls of the stub". Such various tubular organs may be various blood vessels, various lymphatic vessels, various bile ducts, etc. The terms "stub" and "cut end" may be used interchangeably.

The assembly of the present invention comprises a combination of components that are intended to simplify an anastomosis procedure and to allow the anastomosis procedure to be performed relatively quickly and efficiently. In particular, the assembly of the invention is intended to guide the needle to pierce the walls of the stump, pulling the suture with it. In some embodiments of the invention, each needle is guided to sequentially pierce through the walls of two opposing stubs, pulling a common suture through the opposing walls. In other embodiments, the plurality of suture needles are arranged in pairs to form a suture unit together with a suture thread, and the two tails of the plurality of suture needles are connected by the suture thread. One of the needles in the pair is guided through the wall of one stub and the other needle through the walls of the opposite stub, pulling the suture through the walls of the stub. Once the two opposing stubs are so threaded, the two stubs can be effectively joined together. The assembly of the invention thus comprises a device configured for such guidance and a plurality of suture needles connected at their tails to a plurality of sutures, which may either be pre-merged and accommodated in a plurality of guide channels formed in the device or provided separately, e.g. as part of a kit comprising the device, and a plurality of suture needles connected to a plurality of sutures or a plurality of such suture units, and configured for insertion into a plurality of guide channels in the device. The plurality of guide channels are generally curved and the plurality of suture needles may be curved in a corresponding manner. The plurality of needles may also be made resilient to allow the curvature of the plurality of needles to match the curvature of the guide channel.

The invention also provides a plurality of such devices, a plurality of suturing needles and a plurality of suturing units for use in a plurality of assemblies of the invention.

The invention also provides a kit of parts for assembling an assembly for an anastomosis of the invention, possibly including said assembly and/or said stapling unit, the parts of said assembly being intended to be put together prior to said anastomosis procedure. The present invention also provides a suturing unit configured for use in the assembly of the present invention.

The anastomosis assembly for connecting a stump of a severed tubular organ to another stump includes a device having a body with two opposing axial projections extending therefrom. Each axial projection is configured for coupling with the stub such that the walls of the stub can be pulled over the surface of the projection to cover a stub engagement thereof.

The engagement state in which the stub rests on the stub engagement portion will sometimes be referred to herein as a "stitched state". The terms "axis" or "axial" will be used to refer to an axis defined by and extending between the projections, and also, depending on the context, to a direction generally parallel to the projections.

A plurality of curved guide channels (e.g., 2, 3, 4, 5, 6, 7, 8, or even more) are formed in the device, each guide channel extending in a generally axial direction between a first end thereof and a second end defined in a stub junction of one of the axial projections. The guide channel is configured to receive a needle and guide the needle through the walls of the stump, the needle having a pointed head and a tail, the tail being connected to a suture.

In some embodiments, the plurality of suture needles may be pre-incorporated into the plurality of guide channels. In other embodiments, the plurality of suture needles are provided separately, e.g., as part of a kit, and introduced into the plurality of guide channels prior to or during the anastomosis procedure.

In one embodiment, each of the guide channels extends between a stub engaging portion of one axial projection and a stub engaging portion of the other axial projection. In another embodiment, each of the plurality of guide channels extends between the body and a stub junction. In the case of the one embodiment, a suturing member is used and the suturing member is guided to pierce through the walls of one of the stubs from the exterior of the stub and then through the guide passage to pierce through the walls of the opposite stub from the interior of the opposite stub; the suturing assembly includes a single needle attached to a suture. In the case of the further embodiment, a suturing unit (comprising, as defined above, two suturing needles connected by a common suture) is used, both guided by the guide channel to pierce the wall of the stump of one of the two opposite stumps, and then to cause the suture to extend between the stumps.

The device in the assembly of the invention is generally axisymmetric, having two opposite axial projections extending from a central body. The device may also have a mirror symmetry in a plane perpendicular to the axis. However, said mirror symmetry is not essential and other configurations of the device without a mirror symmetry are also possible, for example a device having two different axial projections whose diameters are different from each other and which is therefore intended for anastomosis of stumps of vessels of different diameters. The two axial projections are generally cylindrical, conical or frustoconical and may also have a tapered end.

Each axial passage has an opposing corresponding passage extending into one of the two axial projections, the opposing corresponding passage extending from the body into the other of the axial projections. One of the two needles of a suturing unit is then merged into one of the channels and the other needle is merged into the opposite corresponding channel.

In one exemplary embodiment, when the two stubs have substantially the same diameter, the two axial projections may be the same; although in some embodiments the two axial projections may have different diameters or lengths. The two axial projections are generally of generally cylindrical configuration and may have a tapered end to facilitate engagement of the axial projections with the ends. It should be noted that within the framework of an anastomosis procedure, as described above, the walls of the stump are drawn over the axial projection, and the tapered ends provide guide surfaces for the walls of the tubular organ, which are drawn over the outer surface of the axial projection. As described below, the walls of the stub are pulled over the axial projection until the tails of the walls of the stub overlie the openings of the first passage (defined above as the sutured state), one stub wall overlying the first inlet and the other opposite stub wall overlying the first outlet.

Two non-limiting embodiments of the general teachings of the present invention are generally described below. One of which is referred to as the "open channel embodiment" and the other as the "pore embodiment". It is to be understood that some features described in one of these embodiments may be applied to another embodiment, and may also be applied to further embodiments employing the general teachings of the present invention.

Open channel embodiment:

according to the open channel embodiment, the plurality of guide channels may be a plurality of open guide channels formed as axially open channels or a plurality of slits extending downwardly from the surface of the device between the side walls to a bottom surface. The plurality of guide channels may receive and accommodate the suture needle and guide the displacement of the suture needle therethrough during the anastomosis procedure. An assembly of the invention having such a plurality of open channels is referred to as an "open channel assembly" and the device of such an assembly is referred to as an "open channel device". The bottom of a plurality of such channels is formed with a bend for guiding the needle in the manner described above. An open channel assembly also typically includes a retaining assembly configured to retain the plurality of suture needles within the open channel to allow the suture needles to slide within the channel without leaking out of the open surface of the channel. The fixation assembly is configured for removal to ultimately allow release of the suture. The open channel embodiments are particularly, but not exclusively, suitable for anastomosis of a plurality of narrow blood vessels, for example, a plurality of small blood vessels or lymphatic vessels.

As described above, the open channel means is formed with a plurality of open channels extending axially and oriented radially, the plurality of open channels being defined between side walls and a curved bottom wall, each open channel extending between an end on the central body and a second end of the stub engagement portion of a projection. The open channel assembly also includes a plurality of suturing units, each of which includes a pair of suturing needles connected to each other at their tails by a suture thread, each of the suturing needles having a sharpened head. Each needle of a suturing unit is received in an opposed channel that is opposed to each other in a mirror-symmetrical plane. The pointed head of each suture needle is directed toward the second end, each of the plurality of suture needles is slidable within the channel, guided by the plurality of bottom walls, so as to pierce the wall of the stump once pulled over the stump junction.

In one embodiment of the open channel assembly, a tail portion of the needle extends from the first end and, by manipulation of this portion, the needle may be pushed to slide the needle in a generally axial direction (referred to as "forward") in the direction of the first end. In another embodiment, the assembly includes a sliding insert configured to be removably inserted into the plurality of channels and engage the suture needle received therein and cause the suture needle to slide forward. The sliding insert may have a generally disc shape having a needle engaging edge with a curvature that matches the curvature of the bottom wall of the channel. The needle engaging edge of the sliding insert causes the forward sliding of the suture needle by frictional engagement and may be provided with a friction-increasing material or may be treated to increase friction, for example, by texturing the surface.

The plurality of suture needles are typically retained within the plurality of channels by a securing component, which is a ring or band, such as an elastic band, disposed about the device above the plurality of channels, and which is typically configured for removal, such as cutting or breaking, to allow the plurality of sutures to be released from the device.

The plurality of channels may be configured to retain the suture needle but allow the suture to be released once the suture needle is pulled into the channels by the advancing suture needle. In addition to some of the inherent elasticity of the suture, the suture needle typically also has a diameter that exceeds the suture. Thus, the open channel may be provided with a plurality of protrusions provided at a distance above the bottom surface of the channel, leaving an opening between the protrusions, which opening is narrower than the diameter of the suture needle, thus holding the suture needle at or near the bottom of the channel between the walls and such protrusions. Another configuration is that the overall width of the channel is wider than the diameter of the needle, and the bottom of the channel includes a wider portion, e.g., a portion of generally circular cross-section, that is capable of receiving the needle, which in this manner is ready to remain at the bottom of the channel. However, as the case may be, the suture has a smaller diameter than the distance between the plurality of projections or than the general width of the channel and may therefore be released from the channel. In some embodiments, when the suture has the same diameter as the needle, the suture may still be released from the channel by its own elasticity.

Well example:

according to the well embodiment, the plurality of guide channels are defined in the device in the form of a plurality of wells. In some embodiments, the plurality of holes may be formed by mating a plurality of recesses defined on opposing faces of a plurality of components that are connected together to form the device in a manner that allows the plurality of components to be disassembled to release the suture that is received in the hole after being pulled through the suture needle. The present invention has a plurality of orifices as the plurality of guide channels, referred to herein as an "orifice assembly", and the assembly of such assemblies is referred to as an "orifice assembly".

The bore assembly includes a central body having two opposing axial projections of the type described above with respect to the multiple open channel embodiments. Tunnels are formed in said central body and these tunnels comprise two or more first tunnels (typically 4, 5, 6, 7, 8 or sometimes even more) extending in a substantially axial direction between two opposite openings of a plurality of said central bodies, one opening being formed on said stub engaging portion of one of said plurality of projections and the other opening being formed on said stub engaging portion of said opposite projection. Each of the plurality of tunnels is configured to receive and guide a suture needle of a suture unit including the suture needle and suture coupled to a tail of the suture needle to pierce through walls of opposing stubs mounted on the stub junctions. The component is configured to disintegrate, thereby exposing the full length of the plurality of first tunnels. Each of the first tunnels is generally curved such that two openings of the first tunnel are present in a respective radial configuration, each opening being on an opposite face of the central portion. When the walls of the stub are pulled over the stub junctions of the two axial projections and when in their sutured state, the tails of the walls of the stub overlie the openings and the suture needle can be guided to penetrate into one of the openings of the first tunnel, referred to herein as the "first entrance". The suture needle is then guided through the first tunnel to be withdrawn from the opening at the other end of the tunnel, referred to herein as the "first exit". When in the suturing state, the plurality of guiding actions of the suturing needle cause the suturing needle to penetrate the plurality of tails of the plurality of walls of the stump. The device is configured for disassembly, and after disassembly, the plurality of sutures pulled by the plurality of needles may then form a plurality of sutures for connecting the two stumps to each other. A plurality of such stitches may be formed by guiding a plurality of stitch units in this manner or by guiding a needle successively through a series of such first plurality of tunnels (see definition below for pairs of tunnels), thereby connecting the two cut ends to each other.

As described above, the aperture assembly is configured for disassembly. After the guided suturing (in the manner mentioned above, and as further explained and exemplified in connection with some embodiments below), the hole assembly is disassembled, thereby completely exposing the plurality of tunnels and the portions of the plurality of suturing units located within the tunnels, and the two stumps can be manipulated close to and sutured to each other by pulling on the plurality of sutures.

With embodiments of the hole assembly of the present invention, such a suture needle guidance procedure is possible through a combination of multiple tunnels, including multiple first tunnels as defined above, and multiple corresponding tunnels referred to herein as "second tunnels". Each first tunnel and the corresponding second tunnel together form a pair of tunnels, i.e., a "tunnel pair".

Each of the first and second tunnels has an opening, referred to herein as an "inlet" with respect to the entry point of the suture needle and the passage through the tunnel, while the other is referred to as an "outlet" (the suture needle passes through the tunnel in a direction from the inlet to the outlet). In some embodiments, the assembly has mirror symmetry in a plane perpendicular to the axis, and the entrance and exit of the tunnel are indistinguishable from each other, one serving as the entrance and the other as the exit, depending on the orientation of the needle. Throughout the specification, the terms inlet and outlet will be used for convenience of implementation, it being understood that these terms may, but generally do not, represent any structural differences.

The device of this embodiment generally includes a generally axial core member and an outer body. The core member is an elongated member having a central section defined between two peripheral sections forming the two axial projections.

The outer body is formed around and closely associated with the central section, together forming a central portion from which the two axial projections project axially.

In some embodiments, a plurality of first tunnels are defined between the central section and the outer body peripheral portion, each tunnel extending between the first inlet and the first outlet. The first inlet and first outlet are axially separated from each other, one at the interface between an axial projection and the central section, and the other at the interface between the central section and the other axial projection. Each of the first tunnels may be formed by a groove on the surface of the central section or a groove on the inner surface of the outer body covering the central section. The first plurality of tunnels is formed between such a plurality of grooves and the opposing surface, or a plurality of grooves may be formed on both of these opposing surfaces, and the first plurality of tunnels is formed at the junction of the two grooves and is also properly aligned in the case of two opposing grooves.

Where the plurality of tunnels are part of a tunnel pair, formed within the outer body is a plurality of second tunnels, each second tunnel extending between two openings, referred to herein as a "second inlet" and a "second outlet". As described above, each first tunnel has a respective second tunnel, together forming the tunnel pair. Each of the second tunnels is configured to receive a suture needle of a suture unit in a manner allowing the suture needle to be withdrawn from the second outlet along a trajectory that directs a pointed end of the suture needle to penetrate the respective first tunnel of the tunnel pair through the first inlet for eventual withdrawal from the first outlet. Thus, a needle passing through a pair of tunnels continues within at least the second tunnel or the first tunnel until the needle is withdrawn from the first outlet.

The outer body is configured to disintegrate from the core member, and such disintegration results in exposing the full length of the plurality of first tunnels, thereby releasing the portion of the suturing unit housed therein.

The tunnel pairs, which may comprise 3, 4, 5, 6, 7, 8, 9, 10, etc., are typically arranged in a radially symmetrical manner in the assembly. This ensures that the final suture is substantially radially symmetrical.

Multiple stitching units may be used, typically one per tunnel pair. Thus, for example, when the assembly comprises 4, 5, 6, 7, 8, 9 or 10 tunnel pairs, a corresponding number of multiple stitching units may be used. The plurality of suture needles may be pre-received in the plurality of second tunnels or may be inserted into the plurality of second tunnels immediately prior to or during the anastomosis procedure using the assembly of the present invention.

In another embodiment of the invention, a plurality of blind holes are formed in the outer body instead of the plurality of through tunnels, each blind hole functioning similarly to the plurality of second tunnels (and thus also having a second inlet and a second outlet defined at opposite ends of the blind hole). Each blind hole is configured to receive the suturing unit having the suturing needle protruding through the second outlet of the plurality of blind holes. The plurality of suture units may be previously received in the blind holes, or may be reversely inserted through the plurality of second outlet ports before or during the anastomosis procedure.

In other embodiments, a number of stitching units may be used that is less than the number of tunnel pairs, e.g., one stitching unit may be used. Such a stitching unit successively passes through the second tunnel and the first tunnels of the first tunnel pair, then through another successive tunnel pair, and so on. The plurality of suture needles generally have a non-binding arcuate shape presented by withdrawal of the suture needles from the second exit port of the second tunnel and define an arcuate trajectory that directs the pointed ends of the suture needles into the first entry port of the first tunnel of the same tunnel pair. The second tunnel may be designed to have the same curvature as the arcuate shape of the needle and, as such, the needle passes through the second tunnel in a non-binding manner. However, it is also possible for the second tunnel to be straight or have a different curvature than the arcuate shape of the needle, and then the needle assumes its unconstrained arcuate curvature by its internal offset once it exits from the second outlet.

Each first tunnel and second tunnel of the same tunnel pair may be configured to collectively define an arch of a common circle. Thus, in this manner, the needle passes through the second tunnel and then the first tunnel of the pair of tunnels in an overall trajectory that follows the circumference of the circle.

The central section of the core member typically has a biconcave cross-sectional shape.

The outer body generally has a generally annular shape with an inner surface surrounding a void that receives the central section. Thus, the inner surfaces of the outer body have an overall shape that matches the inner surface of the central section. Where the central section has a biconcave cross-sectional shape, the cross-sectional shape of the inner surface of the outer body will be convex, matching the curvature.

The anastomosis assembly of this embodiment may include a conformable securement member which maintains the integrity of the outer body and which may be removed, broken or disassembled to allow disassembly. The securing member of such a combination may be, for example, a rigid or flexible ring held within a groove formed in the outer peripheral surface of the outer body. The outer body may be composed of a plurality (e.g., 2, 3, 4, 5, 6, etc.) of complementary sub-units that together form the outer body and upon removal, breakage or rupture of the securing member, the securing member of the unitizing body holds the plurality of sub-units together, the plurality of sub-units being separated from one another, thereby disassembling the outer body.

The subunits of the outer body each constitute a radial section of the body and, therefore, upon disassembly, each form a unit separated from each other on another radial section of the axis.

In an embodiment, the plurality of second tunnels extend in a substantially axial direction between the plurality of opposing faces of the outer body, between the second inlet on one face and the second outlet on the other face. In these embodiments, the plurality of second tunnels extends in a generally axial direction. According to another embodiment, the plurality of second tunnels extends between a second inlet in the peripheral portion of the outer body and a second outlet on the proximal core member, whereby the plurality of second tunnels extends in an overall radial direction.

Typically, although not exclusively, the assembly comprises a radially directed diverging surface formed at the interface between the axial projection and the outer body. In one embodiment, the diverging surface is an inclined surface that diverges in a peripheral-to-central direction and is defined by one or both of a portion of the core member and a portion of the outer body. Typically, such an inclined surface is formed by a combination of a portion of the core member and a portion of the outer body, whereby openings of the first tunnel are defined in a middle portion of the inclined surface.

Drawings

For a better understanding of the subject matter of the invention and to show by way of illustration how it may be carried into effect in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

FIG. 1 is a schematic isometric view of an exemplary anastomosis assembly in accordance with the aperture embodiment of the present invention. In this figure, the assembly is shown between the two stumps of a severed tubular organ.

Figures 2A-2H are schematic illustrations of sequences of operations for joining together stumps of a severed tubular organ using the assembly of figure 1 of these figures. Fig. 2A to 2D are isometric longitudinal sectional views; and figures 2E-2H are isometric views.

Figures 3A and 3B are isometric schematic views of an anastomosis assembly in accordance with another aperture embodiment of the present invention.

Fig. 4 is a longitudinal cross-sectional view through the anastomosis of fig. 3A and 3B.

Figure 5 is a schematic isometric view of an anastomosis assembly coupled with a plurality of sliding inserts, in accordance with the open channel embodiment of the invention.

FIG. 6A shows one half of the device of FIG. 5, wherein all of the plurality of suture needles are fully received within the plurality of channels.

FIG. 6B shows the device of FIG. 6A coupled with a sliding insert, wherein one of the plurality of suture needles is partially withdrawn.

Fig. 6C is a longitudinal cross-section of fig. 6B.

Fig. 7A-7B are schematic radial cross-sectional views of a portion of the device shown in various exemplary embodiments of the plurality of open channels configured to retain the suture needle within the channel while allowing the suture to be released from the channel in an unimpeded manner.

Detailed description of the preferred embodiments

Listed below in the various numbered paragraphs are certain embodiments of the invention. The list of embodiments is intended to illustrate and clarify the teachings of the present invention and is not intended to limit the invention in any way, as described above.

1. An anastomosis assembly for joining a stump of an incised tubular organ to another stump, said assembly comprising:

a device having a body with two opposing axial projections, each of said axial projections being configured for insertion into a stub for connection with another stub and for allowing walls of said stub to be pulled over a stub engagement of said outer surface of said axial projection; and

a plurality of curved guide channels, each said guide channel extending in a generally axial direction between a first end and a second end defined on said stump junction of one of said axial projections, each said guide channel configured to receive a suture needle and guide said suture needle to pierce through walls of said stump, said suture needle having a pointed head and a tail, said tail being connected to a suture thread.

2. The assembly of example 1, comprising a plurality of suture needles pre-received within the plurality of guide channels.

3. The assembly of embodiment 1 or 2, wherein each said guide channel extends between a stub engaging portion of one said axial projection and a stub engaging portion of another said axial projection.

4. The assembly of embodiment 1 or 2, wherein each of the guide channels extends between the body and a stub junction.

5. The assembly of embodiment 4, wherein each of said guide channels accommodates a suture needle.

6. The assembly of any preceding embodiment, wherein the device has an axial symmetry.

7. The assembly of any preceding embodiment, wherein the device has a mirror symmetry in a plane perpendicular to the axis.

8. The assembly of embodiment 7, wherein

Each of the guide channels extends between the body and a butt seam and receives a needle having a suture extending between two needles in two opposing guide channels.

9. The assembly of any preceding embodiment, wherein each said guide channel is an aperture.

10. The assembly of any one of embodiments 1 to 8, wherein each of the guide channels constitutes an open channel.

11. The assembly of embodiment 10, wherein the assembly comprises a retaining assembly configured to retain the plurality of suture needles within the open channel.

12. The assembly of embodiment 11, wherein the securing assembly is removable to allow release of the suture needle.

13. The assembly of embodiment 11, wherein the open channel is configured to retain the suture needle but allow release of the suture.

14. The anastomosis assembly of any preceding embodiment, wherein the axial projection is substantially cylindrical.

15. The anastomosis assembly of any preceding embodiment, wherein the axial projection is tapered.

16. An anastomosis assembly for joining a stump of an incised tubular organ to another stump, comprising:

an axisymmetric device having two opposing axial projections extending from a central body, each of said projections being configured for insertion into one of said stubs to connect with the other stub and to allow walls of said stub to be pulled over a stub junction of said outer surfaces of said two axial projections;

said device defining a plurality of axially extending radially open channels defined between side walls and a curved bottom wall, each open channel extending from an end of said central body to a second end of said stub junction at a projection;

a plurality of suture units, each unit including a pair of suture needles, the tail portions of the pair of suture needles being connected to each other by a suture thread, each suture needle having a sharp head portion; and

each needle of a suturing unit is received within one of the open channels, the open channels being opposite one another in a plane of mirror symmetry with the pointed head of each needle facing in the direction of the second end, each needle being slidable within the open channel and each needle being guided by the bottom walls so as to pierce the walls of the stump once pulled over the stump junction.

17. The assembly of embodiment 16, wherein the device has a mirror symmetry in a plane perpendicular to the axis.

18. The assembly of embodiment 16 or 17, wherein the tail of the suture needle passes out of the first end and the suture needle can be slid in a generally axial direction by pushing on the tail.

19. The assembly of embodiment 16 or 17, wherein sliding of the suturing needle is accomplished by a sliding insert insertable into the open channel.

20. The anastomosis assembly of any one of embodiments 16 to 19, wherein the two axial projections are substantially cylindrical.

21. The assembly for an anastomosis of any one of embodiments 16 to 20, in which the two axial projections are tapered.

22. The anastomosis assembly of any one of embodiments 16 to 21, including a fixation assembly configured to retain the plurality of suture needles in the open channel.

23. The assembly of embodiment 22, wherein the securing assembly is removable to allow release of the needle or suture.

24. The assembly of embodiment 23, wherein the securing assembly is an elastic ring or band that is removed by cutting or incising.

25. The assembly of embodiment 22, wherein the open channel is configured to retain the suture needle but allow release of the suture.

26. An anastomosis assembly for joining two stumps of a severed tubular organ, comprising:

a central body having two opposing axial projections, each said axial projection configured for insertion into a stub for connection with another stub and for allowing walls of said stub to be pulled over a stub engagement of said outer surface of said axial projection;

two or more first tunnels extending in a substantially axial direction between openings at opposite sides of said central body, one opening being formed at said stub junction of one of said axial projections and the other opening being formed at said stub junction of the opposite other of said axial projections;

each of the tunnels is configured for receiving and guiding a suture needle of a suture unit, each suture unit comprising the suture needle and a suture thread connected thereto, allowing a suture needle to pierce the walls of two opposing stubs once mounted on the stub junctions; and

the assembly is configured to disintegrate, thereby exposing the full length of the first tunnel.

27. The anastomosis assembly of embodiment 26, wherein the two axial projections are substantially cylindrical.

28. The anastomosis assembly of embodiment 26 or 27, wherein the two axial projections are tapered.

29. An anastomosis assembly for joining two stumps of a severed tubular organ, comprising:

a generally axial core member having a central section between two opposing axial projections, each axial projection being sized for insertion into an opening in one of the two stubs and allowing walls of the stub to be pulled over a stub engaging portion of the outer surface of the axial projection;

an outer body formed around and closely connected to the central section;

a plurality of tunnel pairs, each tunnel pair comprising:

a first tunnel defined between said central section and said outer body and extending between a first inlet and a first outlet axially separated from each other, said first inlet being formed on a stub junction of one of said axial projections and said first outlet being formed on a stub junction of the opposite other of said axial projections; and comprises the following steps:

a second tunnel formed in the outer body and extending between a second inlet and a second outlet, the second tunnel configured to receive a suture needle of a suture unit, the suture unit including the suture needle and a suture thread to allow the suture needle to be withdrawn from the second outlet along a trajectory such that the suture needle will be penetrated from the first inlet;

the outer body is configured to disintegrate from the core member, thereby exposing the full length of the second tunnel.

30. The anastomosis assembly of embodiment 29, wherein one or more of the second tunnels is pre-received with a suture needle.

31. The anastomosis assembly of embodiment 29 or 30, wherein the needle has a non-binding arcuate shape presented by withdrawal of the needle from the second tunnel and defines an arcuate trajectory for directing the needle tip into the first inlet.

32. The anastomosis assembly of any one of embodiments 29-31, wherein each of the first and second tunnels defines an arc of a common circle.

33. The anastomosis assembly of any one of embodiments 29-32, wherein the central section of the core member has a biconcave cross-sectional shape.

34. The anastomosis assembly of any one of embodiments 29 to 33, wherein the outer body has a generally annular shape.

35. The anastomosis assembly of any one of embodiments 29 to 34, wherein the outer body includes a conformable securement member that maintains integrity of the outer body and can be removed, broken or detached, thereby allowing disassembly of the outer body.

36. The assembly for an anastomosis of embodiment 35, wherein the outer body includes a plurality of sub-units held together by a fixation member of the fusion body.

37. The anastomosis assembly of embodiment 35 or 36, wherein the conformable body fixation member is an annular member which is mounted on the outer periphery of the outer body and removed by cutting or breaking.

38. The anastomosis assembly of any one of embodiments 35 to 37, wherein the fixation member of the conformable body is an elastic ring received in a peripheral recess.

39. The anastomosis assembly of any one of embodiments 35 to 38, including a peripheral recess configured to allow cutting of the conformable fixation member.

40. The anastomosis assembly of any one of embodiments 29 to 39, wherein the second plurality of tunnels extends between opposing faces of the outer body that are spaced apart in a direction parallel to the axis.

41. The anastomosis assembly of any one of embodiments 29-39, wherein the second plurality of tunnels extends between a peripheral portion of the outer body and a space adjacent the core member.

42. The assembly according to any one of embodiments 29-41, wherein each of the axial projections is cylindrical with a diameter corresponding to a diameter of the respective stump.

43. The anastomosis assembly of any one of embodiments 29 to 42, wherein each of the axial projections has a tapered end.

44. The assembly of embodiment 42 or 43, wherein the diameter of the axial projection is such that the end section fits snugly into the severed tubular organ.

45. The anastomosis assembly of any one of embodiments 42 to 44, wherein the stub junction is a radially-directed diverging surface and is disposed at an interface between the axial projection and the outer body.

46. The anastomosis assembly of embodiment 45, wherein the diverging surface is an angled surface that diverges in a peripheral-to-central direction and is defined on (i) a portion of the core member, (ii) a portion of the outer body, or (iii) a combination of a portion of the core member and the outer split.

47. A kit for assembling the components of an anastomosis of any one of embodiments 1 to 46.

48. The kit of embodiment 47, comprising the assembly of any one of embodiments 1-46, and one or more of the suturing units.

49. A suturing unit configured for use in the assembly of any one of embodiments 1-46.

50. An apparatus configured for use in the assembly of any one of embodiments 1-46.