Anastomosis devices

Abstract

The disclosure concerns systems for use in anastomosis of tubular organs within the body, particularly suitable for small tubular organs, such as blood vessels, bile ducts, lymph ducts, epididymis, and others. The anastomosis devices include first and second fitting members, a plurality of suturing units each including first and second needles that are connected to one another by a suturing thread, and defining together needle packs that are fitted within the fitting members, and actuated to displace between a restrained position and a deployed position.

Description

[0001] Anastomosis Devices

[0002] TECHNOLOGICAL FIELD

[0003] The present disclosure concerns systems for use in anastomosis of tubular organs within the body, particularly suitable for small tubular organs, such as blood vessels, bile ducts, lymph ducts, epididymis, etc.

[0004] BACKGROUND ART

[0005] References considered to be relevant as background to the presently disclosed subject matter are listed below:

[0006] - WO2016 / 128961

[0007] - WO2019 / 142185

[0008] - W02020 / 157753

[0009] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0010] BACKGROUND

[0011] Various techniques are known in medical practice for the anastomosis of several tubular organs, including blood vessels and other organs. WO2016 / 128961, WO2019 / 142185 and WO2020 / 157753, for example, make use of pairs of needles for joining cut stumps of tubular organs by a plurality of suturing threads.

[0012] GENERAL DESCRIPTION

[0013] Provided by this disclosure is an anastomosis device that provides a solution for suturing together tubular organs, particularly small tubular organs, such as small arteries, veins, or lymph ducts. However, this disclosure is not limited to such tubular organs, and the solution provided herein may also apply to other tubular organs, such as bile ducts, epididymis, etc.A number of embodiments will be described, these include embodiments intended to suture together two ends of cut stumps of a tubular organ (namely “end-to-end” anastomosis). However, the disclosure is not limited to such suturing, and may also be used for suturing an end of one vessel to the side of another vessel, to be referred to herein as “end-to-side” anastomosis or to attach two vessels side to side (“side-to-side” anastomosis).

[0014] In devices of this disclosure, unlike other anastomosis devices where the needles penetration direction into the tissue is from a center of the device to its periphery, the devices of this disclosure are configured to drive suturing needles in the opposite trajectory, i.e. in a peripheral -to-central direction. The driving of the needles in the peripheral-to-central direction assists in minimizing the vessels’ displacement and / or slippage from the device during the anastomosis procedure, as the direction of the movement of the needles are towards the center of the device, rather than to its peripheral direction. Hence, the action of driving the needles into the walls of the vessel operates a force onto the vessel in the direction of the center of the device, thereby preventing the needles from pushing the vessel in the peripheral direction and off the device.

[0015] Further, as the movement of the needles is in the peripheral to central direction, the two vessels to be joint are brought closer to one another (i.e. one vessel with respect to the other) during the penetration of the needles through the vessel walls, thereby reducing the overall space required for carrying out the anastomosis procedure. This enables the device to be operated through small incisions or in smaller operation sites.

[0016] As will also be shown herein, this peripheral-to-central directionality enables the usage of the device not only in end-to-end anastomosis, but also in end-to-side or side-to-side anastomosis procedures.

[0017] Each needle is part of a suturing unit that includes two needles and a suturing thread that connects the two needles.

[0018] For ease of description and definition, the needles in each suturing unit are defined as “first” and “second”, this however does not imply any hierarchy of importance or order of use.

[0019] According to an aspect of this disclosure, there is provided an anastomosis device comprising:first and second fitting members axially extending in opposite directions from a central body along a central-peripheral axis and configured for fitting into first and second tubular organs;

[0020] a plurality of suturing units, each consisting of a first and a second needle connected to a suturing thread, each of the needles has a curvature defined between a needle end portion and a tip-terminated front portion;

[0021] the first needles defining together a first needle pack fitted within the first fitting member and being held at the needles’ ends by a first needles actuator and being restrained in a restrained position by a first restraining element configured for restraining the needles at the front portion, all the first needles tips point in the general central direction, the first needle actuator being associated with a first displacing element configured for displacing the first needle actuator in the central direction causing the first needles to slide with respect to the first restraining element and thereby enable their gradual switch into a piercing position, in which the tips of the needles pierce walls of the first tubular organ fitted thereon; and

[0022] the second needles defining together a second needle pack fitted within the second fitting member and being held at their ends by a second needles actuator and being restrained in a restrained position by a second restraining element configured for restraining the needles at the front portion, all the second needles tips point in the general central direction, the second needle actuator being associated with a second displacing element configured for displacing the second needle actuator in the central direction causing the second needles to slide with respect to the second restraining element and thereby enable their gradual switch into a piercing position in which the tips of the needles pierce walls of the second tubular organ fitted thereon.

[0023] In other words, the needles are arranged in two packs, with a corresponding definition of a “first pack" and a “second pack" and are contained within the fitting members. Each of the first and second packs are displaced by the, respective, first and second needles actuator. By displacing the pack in a peripheral-to-central direction, the needles gradually switch from a restrained position, in which they are held within the device with their tips embedded within the device (i.e. the tips do not protrude out of the fitting members), into a piercing position in which the needles extend out of openings defined in the fitting members, to thereby substantially cause simultaneous penetration ofthe needles’ tipped portions through the walls of the tubular organ mounted on the fitting members.

[0024] This can be, as already noted above, in an end-to-end anastomosis, in an end-to-side anastomosis, or in a side-to-side anastomosis. In the end-to-end anastomosis, two stumps of a tubular organ are mounted on the fitting members (each stump on one member). In the case of end-to-side anastomosis, one tubular organ is mounted onto one of the fitting members (the “end”), while the other fitting member is inserted through an opening formed in a sidewall of another tubular organ (the “side”). In the side-to-side anastomosis, two side walls of tubular organs are connected one to the other.

[0025] By some embodiments, the needles maintain their shape throughout their switch from the restrained position to the piercing position.

[0026] Alternatively, the needles can have some degree of flexibility, such that the needles are elastically deformed when held at the restrained position. Thus, according to other embodiments, each of the first and second needles is strained by the first and second restraining elements, respectively, into a strained curvature when in the restrained position, the strained curvature being larger than the curvature of the first and second needles in their non-strained state. In other words, in such embodiments, the restraining element applies a force onto the needles to slightly elastically deform the needles when in the restrained position, thereby increasing their curvature to maintain the needles in a tensioned state. When displacing the needles to the piercing position, the needles’ tips pass beyond the restraining element, and the needles are forced to slide in the peripheral-to-central axial direction, freeing the needles’ tips and reducing the straining exerted by the restraining element on the needles. This permits the needles to return to their nonstrained curvature during their displacement. Such return to non-strained curvature can further assist in driving the needles into the tissue.

[0027] By one embodiment, the first fitting member has a plurality of first openings, one for each needle of the first pack such that the tips of the first needles extend out through the first opening during said displacing, and the second fitting member has a plurality of second openings, one for each needle of the second pack such that the tips of the second needles extend out through the second opening during displacing.

[0028] The first and second restraining elements may be O-rings that are fitted in respective first and second annular grooves defined on external surfaces of the respective first and second fitting members. The grooves are positioned as to permit the first andsecond restraining elements to be directly over the needles, thereby restraining the needles in the restrained position, stabilizing the needles’ displacement through the first and second openings, and directing the needles’ tips to enter the walls of the tubular organ at an obtuse angle (the needle being in obtuse angle with respect to the projection directionality of the fitting member from the central body). Such an obtuse angle assist in preventing the tubular organ from slipping off the fitting member during penetration of the needles therethrough.

[0029] The restraining elements can also function to provide further support to the tubular organ fitted over the fitting members, and to increase the friction between the end of the tubular organ and the fitting member as to further hold the tubular organ in position over the fitting member during operation.

[0030] According to some embodiments, the first and second fitting members comprise, respective, first and second circumferential bulges, located adjacent to the first and second openings, respectively, in the central-peripheral axial direction. The bulges can function to further guide the needles during their displacement to enter the walls of the tubular organ in said obtuse angle, and / or to further prevent slippage of the tubular organs from the fitting members.

[0031] The suturing threads can extend over the surface of the central body between the two fitting members. However, in other arrangements, the suturing threads may be held within open axial channels, extending along the central member.

[0032] In order to hold the suturing threads in location during anastomosis and minimize their entanglement, the suturing threads can be held against the surface of the central body by two thread holders. The thread holders are, in some embodiments, cuttable or breakable, e.g. in the form of elastic O-rings.

[0033] By an embodiment, the first and second displacing elements comprise, respective, first and seconds manipulation members. Each of the manipulation members may have a portion extending laterally out of the central body, permitting the use to manipulate the actuators to displace the needles.

[0034] The first and second displacing elements are, by some embodiments, axially slidable in respective first and second guiding lumens defined within the device. However, other displacement arrangements are also possible.

[0035] As noted above, the needles are displaced to protrude out of openings when displaced by the displacement element. These first and second openings can be definedrespectively in walls of the first and second guiding lumens. For example, the first and second openings may be configured as ducts in said walls, e.g. being angular with respect to the axis and extending in a general peripheral-to-central direction.

[0036] By some embodiments, there may be suturing threads-guiding slits formed in first and second peripheral segments of the central body opening into the first and second guiding lumens, respectively.

[0037] The anastomosis device typically comprises a handle, that may be firmly associated or integral with the central body, facilitating manipulation by a medical practitioner during the anastomosis procedure. According to some embodiments, the device comprises a ball joint, that connects the central body to a user-gripping portion to be held by the user during operation of the device. The ball joint permits rotation of the gripping portion in relatively broad angular range with respect to the central body for ease of operation during the anastomosis procedure. The handle may comprise one or more locking arrangements, that are configured to selectively lock the ball joint with respect to the gripping portion, thereby enabling the practitioner to lock the central body at various angles with respect to the gripping portion during the anastomosis procedure.

[0038] As noted, in the anastomosis devices of this disclosure, the needles are driven from their restrained position to their piercing position along a peripheral-to-central direction of the device. The needles of each pack, as also noted, are held and driven together by a needles’ actuator, in which the needles are held and pushed from their end non-tipped end. Thus, the actuator is designed to interface with the needle’s end portion through a flat terminal face thereof. While the anastomosis devices of this disclosure can be used with standard needles in which the suturing thread protrudes out of the terminal face of the needle, the inventors have also envisaged newly designed suturing needles, to reduce the risk of undesired folding of the suturing thread.

[0039] Thus, according to some embodiments, the suturing thread is connected to each of the first and second needles at a thread-connecting portion defined at the needle’s curvature. In other words, in such embodiments, unlike standard suture-needle connection, the thread is not connected to the non-tipped end of the needle, but rather to a portion of the needle defined along the needle, remote from the non-tipped end of the needle.According to other embodiments, the suturing thread is connected to the end portions of the first and second needles, however not through their terminal end faces. According to such embodiments, the suturing thread in each suturing unit is defined between a first suture terminus and a second suture terminus, the first suture terminus is encased within the end portion of the first needle and the second suture terminus is encased within the end portion of the second needle. Each of the end portions of said first and second needles comprises a side opening, that is defined in a side wall of the end portion, such that the suturing thread protrudes out the end portion through the side opening. This permits secure anchoring of the thread terminus within the end portion on the one hand, and permits the thread to protrude out of the end portion through a side opening on the other hand, such that the needle can interface with the needles’ actuator through its flat terminal face without damaging the suturing thread.

[0040] According to some embodiments, the side opening is formed as a recess.

[0041] According to other embodiments, the side opening is formed as a radial bore, i.e. a bore that is normal to the longitudinal axis of the needle.

[0042] According to some other embodiments, the side opening is formed as an angular bore, defining an angle with respect to a longitudinal axis of the needle. The angular bore can define an angle ranging between about 10° and about 170° with the needle’s longitudinal axis, preferably between about 10° and about 60°.

[0043] A suturing unit and a suturing needle also form distinct aspects of the present disclosure.

[0044] Thus, by another aspect of this disclosure, there is provided a suturing unit comprise a first needle and a second needle, each having a curvature defined between a needle end portion and a tip-terminated front portion; and a suturing thread defined between a first suture terminus and a second suture terminus, the first suture terminus being encased within the end portion of the first needle and the second suture terminus being encased within the end portion of the second needle; each of the end portions of said first and second having a flat terminal face, and comprising a side opening define in a side wall of said end portion, the suturing thread protruding out the end portion through said side opening.

[0045] According to some embodiments, the suturing unit disclosed herein is for use in an anastomosis device of this disclosure.By another aspect, there is provided a suturing needle each having a curvature defined between a needle end portion and a tip-terminated front portion, the end portion being configured to encase a terminus of a suturing thread,

[0046] having a flat terminal face, and

[0047] comprises a side opening defined in a side wall of said end portion, configured to permit a suturing thread, when connected to the needle, to protrude out the end portion through said side opening.

[0048] According to some embodiments, wherein the side opening is formed as a recess. According to other embodiments, the side opening is formed as a radial bore. According to some other embodiments, the side opening is formed as an angular bore, defining an angle with respect to a longitudinal axis of the needle.

[0049] According to some embodiments, the suturing needle disclosed herein is for use in an anastomosis device and / or a suturing unit of this disclosure.

[0050] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise.

[0051] As used herein, the term "about" is meant to encompass deviation of ±10% from the specifically mentioned value of a parameter, such as temperature, pressure, concentration, etc.

[0052] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases "ranging / ranges between" a first indicate number and a second indicate number and "ranging / ranges from" a first indicate number "to" a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0053] Unless the context requires otherwise, the word ''comprise' / and variations such as "comprises" and ''comprising' will be understood to imply the inclusion of a stated integer or step or group of integers or steps but not the exclusion of any integer or step or group of integers and steps.

[0054] Generally it is noted that the term “ ...at least one... ” as applied to any component of the device of this disclosure should be read to encompass one, two, three, four, five, six, or more different occurrences of said component in the device.It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0055] BRIEF DESCRIPTION OF THE DRAWINGS

[0056] In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

[0057] Fig- 1 is an isometric view of an anastomosis device according to an embodiment of this disclosure.

[0058] Figs 2A-2B are close-up views of the device of Fig. 1 with the needles being in their restrained position and fully accommodated with the fitting members; in Fig. 2B some outer parts of the central body are removed to permit view of internal elements.

[0059] Figs. 2C-2D show the device of Figs. 2A-2B, respectively, after mounting of a stump of a tubular organ on one of the fitting members.

[0060] Figs. 3A-3B show the device of Fig. 1, with the needles penetrating the stump of a tubular organ; in Fig. 3B some outer parts of the central body are removed to permit view of internal elements.

[0061] Figs 3C-3D are close-up views of the devices of Figs. 3 A-3B with the needle being displaced into their piercing position.

[0062] Fig. 4 shows an end-to-end configuration of the anastomosis procedure.

[0063] Fig. 5 shows the two stumps and the sutures that pass through them after removal of the device in the end-to-end configuration.

[0064] Fig. 6 shows the device of Fig. 1 used in an end-to-side anastomosis procedure, with one of the fitting members inserted into a side wall of a tubular organ.Fig. 7A shows the device of Fig. 6, after extraction of the needles in the “side” fitting member and mounting of the “end” of another tubular organ on the other fitting member.

[0065] Fig. 7B is a view from the direction of arrow Ai in Fig. 7A.

[0066] Fig- 8 shows the tubular organs sutured in a side-to-end configuration after removal of the device.

[0067] Figs. 9A-9B show an exemplary configuration of a needle according to an embodiment of this disclosure, in a perspective view (Fig. 9A) and cross-sectional view (Fig. 9B) of the end portion along line IX-IX in Fig. 9A in close up of the end portion.

[0068] Figs. 10A-10B show another exemplary configuration of a needle according to another embodiment of this disclosure, in a perspective view (Fig. 10A) and cross-sectional view (Fig. 10B) of the end portion along line X-X in Fig. 10A in close up of the end portion.

[0069] DETAILED DESCRIPTION OF EMBODIMENTS

[0070] In the following description, various orientations may be referred to as “up”, “down”, “upwards”, “downwards”, “sideways”, etc. this is made in reference to the manner in which the device is shown in the figures and has no functional operational significance. For example, two elements where one is above the other may be oppositely oriented during the anastomosis procedure or parts thereof.

[0071] Reference is first being made to Fig. 1, showing an anastomosis device generally designated 100, that includes a central body 102, and first and second fitting members 104A,104B, axially extending in opposite directions from the central body 102, and define co-linear central -to-peripheral axes XA and XB, each extending from a center point of the central body to the periphery of the device. The central body is firmly associated or integral with a handle 106, with a grip 108, that permits the practitioner to manipulate the device during the anastomosis procedure. The central body 102 is connected by a ball joint 105 to grip 108, to permit rotation of the grip vis-a-vis the central body during the anastomosis procedure. The handle is provided with a locking arrangement, in this example with a locking nut 107, that can selectively lock the ball joint at various operational angles of the central body 102.As can better be seen in Figs. 2A-2B, the fitting members 104A,104B are generally tapered to permit mounting of an end of a tubular organ thereonto. Each of the fitting members comprises a respective leading tip member 103A,103B, that, in operation, assists the practitioner in locating the opening in the tubular organ and to lead the fitting member thereinto. Housed within each of the fitting members 104A,104B are packs 110A,110B of, respective, first and second needles 112A,112B. Each pack is held together by a respective needle actuator 114A,114B, each actuator being integral with rods 116A,116B of respective manipulation elements 118A,118B, with respective portions 120A,120B laterally extending out of the central body 102, substantially parallel to the handle 106.

[0072] As can be seen in Fig. 2B, the handle 106 is integral with a chassis member 122, fitted within the central body 102.

[0073] Needles 112A,112B form parts of suturing unit, that include once needle 112A and its counterpart 112B connected by a suturing thread 124. Suturing threads 124 in this embodiment extend between the two packs over the external surface of the central body 102. The central body has two peripheral skirt portions 126A,126B each comprise a plurality of suture-guiding slits 128, that guide the threads 124 through openings 130A,130B respectively defined in fitting members 104A,104B, into respective lumens 132A,132B, that house the needle packs 110A,110B. The slits also facilitate easier manual pulling of the needles out of the walls of the tubular organ by the practitioner after their penetration through the walls of the organ.

[0074] Fitted, respectively, over depressions 134A,134B defined by skirt portions 126A,126B, are two thread-holding O-rings 136A,136B that hold the threads over the central body. Towards the end of the anastomosis procedure, these O-rings 136A,136B can be cut to permit freeing of the suturing threads 124 and removal of the device.

[0075] Also seen in Figs. 2A-2B are needle-restraining elements 138A,138B, which may be configured as O-rings, that are fitted over respective annular grooves 140A,140B formed in the fitting members 104A,104B, and hold the needles in a restrained position. As noted above, O-rings 138A,138B can also assist in holding the tubular organ onto the fitting members during the displacement of the needles into the walls of the tubular organ due to the friction that is formed between the tubular organ and the O-rings.

[0076] In Figs. 2C and 2D, the device is shown after the mounting of an end of a tubular organ 142A over fitting member 104A.Referring now to Figs. 3A-3D, when the manipulation element 118A is displaced in the peripheral-to-central direction, as represented by arrow A2 in Figs. 3A-3B, the actuator 114A is axially displaced in the direction of arrow A3, and the needles are simultaneously displaced toward the center of the device, to gradually slide past the needle-restraining element 138A, switching into their piercing position in which the tips of the needles extend out of the openings 130A to thereby penetrate the walls of the mounted tubular organ 142A.

[0077] As can be seen, particularly in Figs. 3C-3D, the opening 130A are configured as angular ducts with respect of the axis, and extend in a general peripheral-to-central direction, thereby matching the general trajectory of the needles, and assist in maintaining their trajectory.

[0078] Fig. 4 shows the device 100 after the needles 112A having fully passed through the walls of tubular organ 142A, causing threads 124 to follow, and with the other tubular organ 142B mounted onto the second fitting member 104B. A similar process can then follow.

[0079] It should be, however, noted that his sequence is exemplary. By another example, the two ends of the tubular organs 142A,142B are both mounted and then the device may be operated to cause the needles in both sides to pass through the walls of the organs, or operate one side and then the other side of the device.

[0080] After the needles have been fully extracted out of the device, thread-holding firings 136A,136B and needle-restraining elements 138A,138B can be cut and removed, and the entire device can be removed, leaving the two ends of tubular organs 142A,142B linked by suturing threads 124. At one point of the procedure the needles may be cut from the threads, and the opposite ends of the threads can then be tied to bring the two ends of the organs together.

[0081] Reference is now being made to Figs. 6-8, in which the same device is used in an end-to-side anastomosis procedure. To this end, fitting member 104B is inserted through a side-opening in a wall segment in tubular organ 152, which may be formed by surgical incision of by the tapered tip 150B of fitting member 104B. Then, needles 112B can be extracted in the manner described above to penetrate the wall segment, as seen in Figs.

[0082] 7A-7B. A tubular organ 154 can then be mounted over fitting member 114A, as seen in Figs. 7A-7B, and needles 112A made to pass through the walls of organ 154.In some embodiments, the needles 112B may be different than needles 112 A (e.g. in length, curvature, material, tip angle, etc.); at other embodiments, needles 112A and 112B may be the same.

[0083] It should also be noted that the sequence of first associating with the side of one tubular organ and then with the end of the other tubular organ may also be reversed.

[0084] After removal of the device in a manner similar to that described above, the ends of the suturing threads 124 can then be tied to one another to bring the organs together.

[0085] A similar procedure can be carried out to join two tubular organs in a side-to-side configuration (not shown).

[0086] In the anastomosis devices of this disclosure, the needles are driven from their restrained position to their piercing position along the peripheral-to-central direction of the device. As also explained, the needles of each pack are held within and driven together by the needles’ actuator, that interfaces with the needle’s terminal face.

[0087] While standard suturing needles, in which the suturing thread protrudes out of the terminal face of the needle, can be used in the disclosed devices, the inventors have envisaged newly designed needles that can, potentially, reduce undesired folding of the suturing thread. While such folding can be compensated for in devices utilizing large needles - in the devices of this disclosure, which are designed for delicate operation procedures in very small tubular organs, the newly designed needles aim at mitigating such risk.

[0088] Various exemplary configurations of needles that may be suitable for anastomosis devices according to this disclosure are shown in Figs. 9A-9B and Figs. 10A-10B. As noted above, while the exemplified needles can be used in devices of this disclosure, it is to be understood that such needles also constitute a separate aspect of the present disclosure.

[0089] Fig. 9A shows an example for a suitable needle configuration. Needle 1112 (which can be used as needle 112) has an end portion 1160 and a tip-terminated front portion 1162, with a needle curvature defined therebetween. The end portion 1160 has a terminal flat face 1164, that permits engagement with the needles’ actuator 114 of the anastomosis device, and through such engagement the actuator can push the needle to displace from the restrained position to the piercing position, as described above.

[0090] The suturing thread 124 is defined between two suture termini 1124 (one of which is shown in Fig. 9B). The suture terminus 1124 is encased within the end portion 1160 ofthe needle, within a longitudinal bore 1166. The walls of bore 1166 are crimped about the suture terminus 1124, preventing the suture terminus to disengage from the end portion of the needle. Defined in the side wall 1168 of the end portion 1160 is a side opening in the form of a recess 1170, through which a non-encased portion of the suturing thread 124 protrudes. Therefore, the configuration of the needle allows the terminus of the suturing thread to be held fast within the end portion of the needle, however also permit another portion of the suturing thread, adjacent to the terminus, to exit the needle’s end portion through the side opening. In this manner, the needle can be pushed by the needles’ actuator through the terminal flat face 1164 of the end portion 1160 without damaging the suturing thread 124. The recess 1170 can have chamfered faces to minimize friction with the suture thread 124 during displacement of the needle in the anastomosis procedure.

[0091] Another exemplary configuration of a suitable needle is shown in Figs. 10A-10B. Needle 1112’ comprises an angular bore 1172 in which the terminus 1124 of the suture is encased. The angular bore extends from a terminal bore end 1174 defined in the flat terminal surface 1164’ of the end portion 1160’, to a side opening 1170’ defined in the side wall 1168’ of the end portion 1160’. The angular bore defines an angle with the longitudinal axis Y of the needle 1112’.

[0092] While the configuration shown in Figs. 10A-10B demonstrates an angular bore that defines an acute angle with axis Y, it is also contemplated that the bore can, alternatively, comprise two segments (not shown): a longitudinal bore segment extending from the terminal flat surface 1164’ into the end portion 1160’, and a radial bore segment continuous therewith and extending from the longitudinal axis through the side wall 1168’, terminating in side opening 1164’.

[0093] Pairs of such needles connected to one another by the suturing thread form together a suturing unit (not shown) that can be used in the anastomosis devices of this disclosure.

Claims

CLAIMS:

1. An anastomosis device comprising:first and second fitting members axially extending in opposite directions from a central body along a central-peripheral axis and configured for fitting into first and second tubular organs;a plurality of suturing units each consisting of a first and a second needle connected to one another by a suturing thread, each of the needles has a curvature defined between a needle end portion and a tip-terminated front portion;the first needles defining together a first needle pack fitted within the first fitting member and being held at the needles‘ ends by a first needles actuator and being restrained in a restrained position by a first restraining element configured for restraining the needles at the front portion, all the first needles tips point in the general central direction, the first needle actuator being associated with a first displacing element configured for displacing the first needle actuator in the central direction causing the first needles to slide with respect to the first restraining element and thereby enable their gradual switch into a piercing position in which the tip-terminated front portions pierce walls of the first tubular organ fitted thereon; andthe second needles defining together a second needle pack fitted within the second fitting member and being held at the needles’ ends by a second needles actuator and being restrained in a restrained position by a second restraining element configured for restraining the needles at the front portion, all the second needles tips point in the general central direction, the second needle actuator being associated with a second displacing element configured for displacing the second needle actuator in the central direction causing the second needles to slide with respect to the second restraining element and thereby enable their gradual switch into a piercing position in which the tip-terminated front portions pierce walls of the second tubular organ fitted thereon.

2. The device of claim 1, wherein each of the first and second needles is strained by the, respective, first and second restraining elements to a strained curvature when in the restrained position, the strained curvature being larger than the curvature of the first and second needles in the piercing position.

3. The device of claim 1 or 2, whereinthe first fitting member has a plurality of first openings, one for each needle of the first pack such that the tips of the first needles extend out through the first opening during said displacing, andthe second fitting member has a plurality of second openings, one for each needle of the second pack such that the tips of the second needles extend out through the second opening during said displacing.

4. The device of any one of claims 1 to 3, wherein the first and second restraining elements are O-rings fitted in respective first and second annular grooves defined on external surfaces of the respective first and second fitting members.

5. The device of any one of claims 1 to 4, wherein the suturing threads extend over the surface of the central body between the two fitting members.

6. The device of claim 5, wherein the suture threads are held against the surface of the central body by two thread holders.

7. The device of claim 6, wherein the thread holders are cuttable or breakable.

8. The device of any one of claims 1 to 7, wherein the first and second displacing elements comprise respective first and seconds manipulation members.

9. The device of claim 8, wherein each of the manipulation members has a portion extending laterally out of the central body.

10. The device of any one of claims 1 to 9, wherein the first and second displacing elements are axially slidable in respective first and second guiding lumens defined within the device.

11. The device of claim 10 as depending from claim 3, wherein the first and second openings are defined respectively in walls of the first and second guiding lumens.

12. The device of claim 11, wherein the first and second openings are configured as ducts in said walls.

13. The device of claim 12, wherein the ducts are angular with respect to the axis and extend in a general peripheral-to-central direction.

14. The device of any one of claims 10 to 13, comprising suturing threads-guiding slits formed in first and second peripheral segments of the central body opening into the first and second guiding lumens, respectively.

15. The device of any one of claims 1 to 14, comprising a handle associated or integral with the central body.

16. The device of claim 15, comprising a ball joint connecting between the central body and a user-gripping portion.

17. The device of claim 16, wherein the handle comprises one or more locking arrangements, configured to selectively lock the ball joint with respect to the usergripping portion.

18. The device of any one of claims 1 to 17, wherein the needle end is flat.

19. The device of any one of claims 1 to 18, wherein the suturing thread in a suturing unit is connected to the first and second needles at their respective end portions.

20. The device of claim 19, wherein the suturing thread in each suturing unit is defined between a first suture terminus and a second suture terminus, the first suture terminus being encased within the end portion of the first needle and the second suture terminus being encased within the end portion of the second needle,each of the end portions of said first and second needles comprising a side opening define in a side wall of said end portion, the suturing thread protruding out the end portion through said side opening.

21. The device of claim 20, wherein the side opening is formed as a recess.

22. The device of claim 20, wherein the side opening is formed as a radial bore.

23. The device of claim 20, wherein the side opening is formed as an angular bore, defining an angle with respect to a longitudinal axis of the needle.

24. A suturing unit comprisinga first needle and a second needle, each having a curvature defined between a needle end portion and a tip-terminated front portion; anda suturing thread defined between a first suture terminus and a second suture terminus, the first suture terminus being encased within the end portion of the first needle and the second suture terminus being encased within the end portion of the second needle;each of the end portions of said first and second having a flat terminal face, and comprising a side opening define in a side wall of said end portion, the suturing thread protruding out the end portion through said side opening.

25. The suturing unit of claim 24, wherein the side opening is formed as a recess.

26. The suturing unit of claim 24, wherein the side opening is formed as a radial bore.

27. The suturing unit of claim 24, wherein the side opening is formed as an angular bore, defining an angle with respect to a longitudinal axis of the needle.

28. The suturing unit of any one of claims 24 to 27, for use in an anastomosis device of any one of claims 1 to 23.

29. A suturing needle each having a curvature defined between a needle end portion and a tip-terminated front portion, the end portionbeing configured to encase a terminus of a suturing thread,having a flat terminal face, andcomprises a side opening defined in a side wall of said end portion, configured to permit a suturing thread, when connected to the needle, to protrude out the end portion through said side opening.

30. The suturing needle of claim 29, wherein the side opening is formed as a recess.

31. The suturing needle of claim 29, wherein the side opening is formed as a radial bore.

32. The suturing needle of claim 29, wherein the side opening is formed as an angular bore, defining an angle with respect to a longitudinal axis of the needle.

33. The suturing needle of any one of claims 29 to 32, for use in a suturing unit of any one of claims 24 to 28.

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