Systems for knot-less securing of a suture thread

Abstract

The present disclosure provides systems and methods for securing a suture thread after suturing, more-particularly knot-less securing of a suture thread for securing a suturing thread in a suture location of a tubular organ.

Description

[0001] Systems and methods for knot-less securing of a suture thread

[0002] TECHNOLOGICAL FIELD

[0003] The present disclosure provides systems and methods for securing a suture thread after suturing, more-particularly knot-less securing of a suture thread.

[0004] BACKGROUND ART

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

[0006] [1] WO 2019 / 142185

[0007] [2] WO 2020 / 157753

[0008] [3] WO 2024 / 047653

[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] Suturing of tubular organs one to the other, e.g. arteries, veins, bile ducts, nerve ducts, etc., is typically carried out by utilizing thin sutures - either by manual suturing or by utilization of dedicated suturing tools. Typically, after the suture thread is inserted into the tissue and the two ends of the tubular organ are brought into proximity, the suture is knotted by the practitioner in order to secure the suture in location and maintain the ends of the tubular organ in proximity one to the other, to permit growth of connective tissue and restoration of the integrity of the organ.

[0012] Knotting of the sutures is a lengthy and delicate procedure during the medical operation, and can often result in tearing or breaking of the suture thread in case excessive tensile force is applied by the practitioner. Furthermore, as knotting is typically carried out manually by the practitioner, it is difficult to assess the forces applied onto the tissue during such procedure, as loose sutures cannot maintain the two ends of the organ in sufficient proximity to promote healing, while overly tense sutures apply undesired stresses to the tissue that can result in local damage to the tissue, such as tearing, excessive scar formation, or even local necrosis.

[0013] GENERAL DESCRIPTION

[0014] The present disclosure provides systems and methods for securing a suture thread during suturing, e.g. of tubular organs, without requiring knotting. The systems and methods disclosed herein aim at simplifying the thread-securing stage of a surgical operation, particularly, albeit not exclusively, in micro-surgical procedures, to permit better control over the stresses applied on the thread and the tissue at the suturing site during such securing, and to streamline the suturing process without requiring complicated knotting of the threads.

[0015] The systems and methods of this disclosure are particularly suitable for surgical procedures in which fine suturing threads are utilized, e.g. for suturing small blood vessels, nerve ducts, biliary ducts, etc., for example by utilizing suturing threads of about size 7-0 to about size 13-0.

[0016] In one of its aspects, to be referred to herein as the "double-ring aspect” , the disclosure provides a system for securing a suturing thread in a suture location of a tubular organ, the system comprising: at least one first tubular element, configured for fitting over a tubular organ, the first tubular element having a plurality of suture-receiving openings, each suturereceiving opening in said plurality of suture-receiving openings being configured for receiving a suture thread; and at least one second tubular element, configured for fitting over said first tubular element, and configured for sliding over an external face of the first tubular element over the plurality of suture-receiving openings, and clamping the suture threads between said external face of the first tubular element and an internal face of said second tubular element.

[0017] In other words, in the double-ring aspect, the end of the suture is held fixed in location by the interaction between the first tubular element applied over the tissue at the site of suturing, and the second tubular element applied over the first tubular element, such that the thread is securely clamped between the two tubular elements.

[0018] According to some embodiments, the system comprises a pair of said first tubular elements, one of said first tubular elements for fitting over a first end segment of said tubular organ and the other of said first tubular elements for fitting over a second end segment of said tubular organ, and a corresponding pair of second tubular elements. In such embodiments, each suturing thread extends between a pair of suture-receiving openings, one suture-receiving opening defined in one of the first tubular elements and the other suture-receiving opening defined in the other of the first tubular elements.

[0019] The first tubular element defines a proximal-distal longitudinal directionality, such that once fitted over the end of the tubular organ, the proximal end of the first tubular element is located closer to the end of the tubular organ than its distal end.

[0020] According to some embodiments, the suture -receiving openings are located at a proximal end of the first tubular element. During the suturing process, the practitioner passes a needle through the wall of the tubular organ, in the directionality from the internal face of the tubular organ towards its external face, and then passes the needle through one of the suture-receiving openings in the first tubular element. One end of the suturing thread is pulled by the needle through the wall of the tubular organ and through the suture-receiving opening. The other end of the suturing thread is pulled by another needle through the wall of the second tubular organ in a similar manner, to be received in a suture-receiving opening defined in the other first tubular element fitted over the second end of the tubular organ. In such a manner, the thread links between the first and second ends of the tubular organ.

[0021] By some embodiments, the first tubular element comprises a distal rim, the distal rim having a plurality of suture-receiving channels, each suture-receiving channel in said plurality of suture-receiving channels corresponds to a suture-receiving opening in said plurality of suture-receiving openings. The suture -receiving channels are configured to hold the end segments of each suturing thread in a dedicated channel, thereby preventing the threads from entangling during the suturing procedure.

[0022] According to some embodiments, the external face of the first tubular element is inclining in said proximal-to-distal direction, and the internal face of the second tubular element has a corresponding inclination to the inclination of the external face of the first tubular element. This arrangement permits a unidirectional sliding directionality of the second tubular element vis-a-vis the first tubular element, to ensure no excessive forces are applied onto the suturing thread as it is clamped between the first and second tubular elements to prevent its rupturing.

[0023] According to some embodiments, the suturing thread is held between said external face and said internal face by forces of friction.

[0024] By another aspect, the disclosure provides a method of suturing two ends of a tubular organ one to the other, utilizing the system of the double-ring aspect, the method comprises: fitting said first tubular element over a first end segment of the tubular organ; fitting another first tubular element over a second end segment of the tubular organ to be joined to said first end segment of the tubular organ; passing suturing threads through the first and second end segments of the tubular organ, such that a first end of each suturing thread is received within a suture-receiving opening of the first tubular element fitted over the first end segment of the tubular organ, and a second end of each suturing thread is received within a corresponding suturereceiving opening of the first tubular element fitted over the second end segment of the tubular organ; bringing the first and second end segments of the tubular organ into proximity while pulling onto the first and second ends of the suturing threads; and fitting said second tubular elements over the first tubular elements, such that the suturing threads are securely clamped between an external face of the first tubular element and an internal face of said second tubular element.

[0025] By another aspect, to be referred to herein as the "ratchet aspect”, the disclosure provides a system for securing a suturing thread in a suture location of a tubular organ, the system comprising: a plurality of suture-tensioning units, each suture-tensioning unit in said plurality of suture-tensioning units comprises a rotatable spool defining a longitudinal axis and rotatable thereabout, and having a pair of sets of teeth projecting from an external surface of the rotatable spool, the pair of sets of teeth being spaced apart along said longitudinal axis, to define therebetween a thread spooling space, a pivoting, spring-loaded pawl, configured for engaging said teeth during rotation of the rotatable spool about the longitudinal axis to permit unidirectional rotation of the rotatable spool, a suture receiving through-bore defined at said rotatable spool in a direction normal to said longitudinal axis, for slidingly receiving an end portion of a suturing thread; and a tensioning tool, configured for engagement with an engageable portion of said rotatable spool for rotation of the rotatable spool and spooling the thread within said thread spooling space.

[0026] In other words, after the threads have been passed through the first and second end segments of the tubular organ, and the ends of the tubular organ have been brought into proximity one to the other, the suture -tensioning unit is positioned at the suture location, and the two ends of each suturing thread are threaded through the through-bore defined in the rotatable spool. The tensioning tool is then engaged with an engageable portion of the rotatable spool, and by rotation of the rotatable spool, the portions of the suturing thread that extend out of the tissue can be spooled onto the rotatable spool. As the interaction between the teeth projecting from the surface of the rotatable spool and the spring-loaded pawl limit the rotation of the spool in a single direction, tension can be built in the suturing thread in an incremental manner, thereby controlling the tightening of the suturing thread at the suture location.

[0027] By another aspect, the disclosure provides a method of suturing two ends of a tubular organ one to the other, utilizing the system of the ratchet aspect, the method comprises: fitting a first end of the suturing thread through said suture receiving through-bore of said rotatable spool; fitting a second end of the suturing thread through said suture receiving through- bore of said rotatable spool; engaging the tensioning tool with an engageable portion of said rotatable spool and rotating the rotatable spool by said tensioning tool to spooling the thread within said thread spooling space. By another aspect, to be referred to herein as the “adhesive aspect”, the disclosure provides a system for securing a suturing thread in a suture location of a tubular organ, the system comprising: an adhesive reservoir; a longitudinal hollow shaft associated with said adhesive reservoir at a proximal end of said shaft, and having an adhesive-depositing opening at a distal end of said shaft; a suture-retrieving element configured for engaging a suturing thread at said suture location, the suture -retrieving element being slidably received through a side through-bore defined in a distal end portion of the longitudinal hollow shaft and said adhesive-depositing opening, and configured to engage the suturing thread and retrieve an end portion thereof through the adhesive-depositing opening and the side through-bore to displace surplus of suturing thread from the suture location; and a trigger handle, configured to induce deposition of adhesive from said adhesive reservoir, through the longitudinal hollow shaft and out of the adhesive-depositing opening, onto a portion of the suturing thread at the suture location to adhere the thread to the tubular organ at the suture location.

[0028] In other words, in the adhesive aspect, after the threads have been passed through the first and second end segments of the tubular organ, and the ends of the tubular organ have been brought into proximity one to the other, the first and second end portions of each suturing thread that extend out of the tissue are first captured and retrieved with the suture-retrieving element, to remove the surplus of suturing thread from the suture location. Then, a drop of adhesive is deposited over the suturing thread at the suture location, to adhere the suturing thread to the tubular organ at the suture location. The surplus thread is then removed by cutting.

[0029] According to some embodiments, the adhesive is a biocompatible adhesive. According to other embodiments, the adhesive is a biocompatible biodegradable adhesive.

[0030] In some embodiments, the suture-retrieving element is a grip.

[0031] In other embodiments, the suture-retrieving element is a loop wire.

[0032] By another aspect, the disclosure provides a method of suturing two ends of a tubular organ one to the other, utilizing the system of the adhesive aspect, the method comprises: passing suturing threads through a first end segment and a second end segment of the tubular organ, such that a first end portion of each suturing thread extends out of said first end segment of the tubular organ, and a second end portion of each suturing thread extends out of said second end segment of the tubular organ; bringing the first and second end segments of the tubular organ into proximity while pulling onto the first and second end portions of the suturing threads; bringing the distal end of the longitudinal hollow shaft into proximity with said first and second end portions of a suturing thread; operating said suture-retrieving element to capture said first and second end portions of said suturing thread and slidably retrieving the first and second end portions of said suturing thread through the adhesive-depositing opening and the side through-bore to displace surplus of suturing thread from the suture location; and operating the trigger handle to induce deposition of adhesive from said adhesive reservoir, through said longitudinal hollow shaft and out of the adhesive-depositing opening, onto the suturing thread at the suture location to adhere the thread to the tubular organ at the suture location.

[0033] By another one of its aspect, to be referred to herein as the “clipping aspect”, the disclosure provides a system for securing a suturing thread in a suture location of a tubular organ, the system comprising: a central body having two oppositely oriented axial protrusions, each configured for insertion into an end segment of a tubular organ, the central body being configured with two axially spaced apart rings extending normal to an external surface of the central body, each of the rings being configured with a plurality of clip-receiving slits, each of the axial protrusions comprises a plurality of open axial needle channels, corresponding to and aligned with the plurality of clip-receiving slits; a plurality of suturing units, each suturing unit comprising a pair of suturing needles connected at their rear end by a suturing thread, one needle of a pair being accommodated in one of the axial needle channels configured at one of the axial protrusions and the other needle of the pair being accommodated in one of the axial needle channels configured at the other of the axial protrusions; a plurality of needle clips, each releasably received in a clip-receiving slit of said plurality of clip-receiving slits, and each configured for receiving and holding a suturing needle after the needle is extracted from the axial needle channel; and a plurality of fasteners, each fastener configured for fastening the ends of the suturing thread over the suture location after removal of the central body from the suture location.

[0034] By some embodiments, each of the needle clips comprises a needle receiving rigid track for slidingly receiving at least a front portion of said needle therein, and an elastic arm angled with respect to the rigid rack, and configured to clamp said front portion of the needle against the rigid track.

[0035] In operation of the system of the clipping aspect, a central body of the system is first positioned such that the end segments of the tubular organ to be joined one to the other are fitted over the axial protrusions. Then, suturing needles that are located within axial needle channels are displaced into the tissue, thereby piercing the walls of the end segments of the tubular organ. As the needles are arranged in pairs, with a suturing thread linking between the two needles in a pair, the threads extend between the two end segments of the tubular organ after passing of the needles through the walls of the tubular organ. After their extraction through the wall of the tubular organ, each needle is slidingly inserted into its respective needle clip, in which at least a front portion of the needle (i.e. the portion that terminates with a sharp tip) is received within the rigid track and held in position against the rigid track by the force applied thereto by the elastic arm. In such a manner, each needle is secured after its extraction through the tissue, and entanglement of the threads is prevented. After securing all the needles, the needle clips are slidingly removed from the clip-receiving slits that are defined in the rings of the central body, such that the central body can be removed, and release the suturing threads from the central body through the open axial needle channels. After removal of the central body, the needle clips can be pulled and manipulated in order to tighten the suturing threads and bring the first and second end segments of the tubular organ into proximity one to the other. After positioning the end segments of the tubular organ in proximity, the end portions of each suturing thread are fastened over the suture location by applying a fastener to hold the suturing thread in position and apply the proper tension on the tissue.

[0036] The open axial needle channels are typically formed as open axial tranches on the surface of the external surface of the central body. In some embodiments, each of the axial protrusions comprises an O-ring, fitted over the open axial needle channels to prevent extraction of the needles from the channels in the direction normal to the axis of the central body. After securing all needles in the needle clips, the O-rings can be cut and removed in order to release the suturing threads from the channels.

[0037] By another aspect, there is provides a method of suturing two ends of a tubular organ one to the other, utilizing the system of the clipping aspect, the method comprises: fitting a first end segment of the tubular organ over one of the axial protrusions and a second end segment of the tubular organ over the other of the axial protrusions; displacing a first suturing needle and a second suturing needle in a suturing unit through the walls of the first end segment and the second end segment of the tubular organ, respectively, such that the front portion of each suturing needle protrudes out of the needle channel and through the wall of the respective end segment of the tubular organ; sliding said front portion of each of the suturing needle into a respective rigid track of a respective needle clip against the elasticity of the elastic arm, to thereby clamp the front portion of the suturing needle between the rigid track and the elastic arm; sliding the needle clips out of the clip-receiving slits defined in the rings of the central body; removing the central body from the suture location; pulling onto the needle clips to tension the suturing threads and bring the first and second end segments of the tubular organ into proximity; and applying a fastener of said plurality of fasteners over the end portions of each suturing thread to fasten the suturing thread against the organ at the suture location.

[0038] In any of the aspects described herein, the piercing of the walls of the tubular organ by the needles to connect the two ends of the tubular organ by the suturing thread during the suturing procedure can be carried out manually (z. e. by manually passing the needles through the tissue walls) or by use of a dedicated piercing apparatus. Such piercing apparatus can be, for example, those described in Applicant’s PCT applications publication no. WO 2019 / 142185, WO 2020 / 157753, and / or WO 2024 / 047653, the content of which being incorporated herein by reference. In each of the aspects above, elements that come into contact with the tissue, e.g. the first and second tubular elements of the double-ring aspect, the suture-tensioning units of the ratchet aspect, the fasteners of the clipping aspect, etc. are preferably made of biocompatible materials. According to some embodiments, such elements are made of biocompatible and biodegradable materials.

[0039] As used herein, the singular form a, an and the include plural references unless the context clearly dictates otherwise. For example, the term "a binder" or "at least one binder" may independently include a plurality of binders, including mixtures thereof.

[0040] As used herein, the term about is meant to encompass deviation of ±10% from the specifically mentioned value of a parameter.

[0041] Throughout this disclosure, 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.

[0042] Generally it is noted that the term ... at least one... as applied to any component of a formulation or a composition of this disclosure should be read to encompass one, two, three, four, five, six, seven, eight, nine or ten different occurrences of said component in a formulation or a composition disclosed herein.

[0043] 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.

[0044] BRIEF DESCRIPTION OF THE DRAWINGS

[0045] 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:

[0046] Fig. 1A is a perspective view of a system according to an embodiment of the doble-ring aspect.

[0047] Fig. IB is a longitudinal cross section along line I-I of the system of Fig. 1A.

[0048] Figs. 2A-2E demonstrate operational steps in utilizing the system of Fig. 1A.

[0049] Figs. 3A-3G demonstrate an alternative set of operational steps utilizing the system of Fig. 1A.

[0050] Figs. 4A-4E demonstrate operational steps in utilizing a system according to an embodiment of the ratchet aspect.

[0051] Fig. 5A is a side view of a system according to an embodiment of the adhesive aspect.

[0052] Fig. 5B shows a close-up view of the suture -retrieving element of the system of Fig. 5A.

[0053] Figs. 5C-5H demonstrate operational steps in utilizing the system of Figs. 5A-5B.

[0054] Figs. 6A-6G demonstrate operational steps in utilizing a system according to an embodiment of the clipping aspect.

[0055] DETAILED DESCRIPTION OF EMBODIMENTS

[0056] Turning first to Figs. 1A-3G, shown in a system according to an embodiment of the double-ring aspect. System 100 comprises first tubular elements 102 that are configured for fitting over end segments a tubular organ.

[0057] In a first step of the suturing procedure, seen in Fig. 2A, one first tubular element 102 that is fitted over the first end segment 104 of the tubular organ, while another first tubular element 102 is fitted over the second, opposite end segment 106 of the tubular organ.

[0058] Each of the first tubular elements 102 includes a plurality of suture-receiving openings 110, that is configured to receiving a suture thread 112. Generally, when in operation, a plurality of suturing units are used, each suturing unit comprises a pair of suturing needles (not shown), that are linked at their rear, non-pointed ends by a suturing thread. In operation, the practitioner pierces one of the end segments of the tubular organ with one needle of the pair, and the other one of the end segments of the tubular organ with the other needle of the pair, passing the needles through the wall of the tissue in a direction from the inner face of the tubular organ towards the tubular organ’s outer face. When the two needles of the pair are extracted from the tissue, the suturing thread 112 links between the two end segments of the tubular organ. During such piercing, the practitioner passes the needles through the suture-receiving openings 110, thereby causing the thread trailing the needles to pass through the suture-receiving openings 110, as shown in Fig. 2B.

[0059] As can be seen, in this example the suture -receiving openings 110 are located at proximal portions 102p of the first tubular elements 102. In order to minimize entanglement of the end portions of the suturing threads, the first tubular elements 102 comprise distal rims 114 at the distal portions 102D thereof. Each distal rim 114 has a plurality of suture -receiving channels 116, each such suture-receiving channel 116 corresponds to one of the suture-receiving openings 110. Thus, when the suturing threads 112 are passed through the tissue, each end portion of the suturing thread is received in a respective suture-receiving channel 116, thereby preventing the threads from entangling during the suturing procedure.

[0060] After all the needles have been passed through the tissue and the suturing threads sorted, the suturing threads can be pulled in order to bring the first and second end segments of the tubular organ into proximity one to the other. Then, a second tubular element 118 is fitted over a first tubular element 102, such that the suturing threads 112 are securely clamped between an external face 120 of the first tubular element 102 and an internal face 122 of said second tubular element 118, as seen in Fig. 2C. As the second tubular element 118 is slid over the first tubular element 102 (Fig. 2D), friction is applied onto the end portion of the suturing thread 112, to hold the suturing thread in location and apply the proper tension onto the suture location and the first and second end segments of the tubular organ one against the other (Fig. 2E).

[0061] While the system can be used in a manual suturing procedure, various suturing devices for positioning and manipulating the needles through the tissue can be used, such as those described in Applicant’s PCT applications publication no. WO 2019 / 142185, WO 2020 / 157753, and / or WO 2024 / 047653, the content of which is incorporated herein by reference.

[0062] An example of a process utilizing such a device is shown in Figs. 3A-3G. After positioning the first tubular elements 102 over the end segments 104 and 106 of the tubular organ (Fig. 3A), a suturing device 130 is brough into contact with the end segments 104 and 106 of the tubular organ (Fig. 3B). As better seen in Fig. 3C (which is a longitudinal cross section of detail 3C in Fig. 3B), an axial protrusion 132 of the suturing device 130 is inserted into the end segment of the tubular organ. Needle channels 134 are defined in the axial protrusion 132, each needle channel 134 accommodating one suturing needle 136 of a suturing unit. The device 130 is configured to displace the needles 136 for piercing the walls of the tubular organ, as seen in Fig. 3C. The first tubular element 102 is positioned such that the openings 110 are located over the terminus of channels 134, such that the needle 136 passes out of the channel, through the wall of the tubular organ, and through the suture-receiving openings 110, with the suturing thread 112 trailing thereafter. The threads are then arranged within the suture -receiving channels 116 defined at the distal rim of the first tubular element 102, as seen in Fig. 3D, and then device 130 can be removed from the suture location (Fig. 3E), leaving the threads sorted over the first tubular element 102. The second tubular element 118 is then fitted over the first tubular element 102 (Fig. 3F), and slid into a locking position to secure the thread end portions in position (Fig. 3G).

[0063] Turning to Figs. 4A-4E, shown is a sequence of operation of system 200 according to an embodiment of the ratchet aspect. After passing the threads through the first and second end segments 104 and 106 of the tubular organ and bringing the segments into proximity (Fig. 4A), a suture-tensioning unit 202 is applied to the suture location. Better seen in isolation in Fig. 4D, the suture -tensioning unit 202 comprises a frame 204, which holds a rotatable spool 206, rotatable about a longitudinal axis 208. The rotatable spool 206 defines a suture receiving through-bore 210 extending in a direction normal to the longitudinal axis, and configured to slidingly receive the end portions of the suturing thread 112 (as seen in Fig. 4B). Spool 206 has a pair of sets of teeth 212 projecting from an external surface of the spool, the pair of sets of teeth are spaced apart along the longitudinal axis to define between them a thread spooling space 214.

[0064] The suture -tensioning unit 202 also includes a pivoting, spring-loaded pawl 216, that is configured for engaging teeth 212 during rotation of the rotatable spool 206 about the longitudinal axis to permit unidirectional rotation of the rotatable spool. As the interaction between the teeth projecting from the surface of the rotatable spool and the spring -loaded pawl limit the rotation of the spool in a single direction, tension can be built in the suturing thread in an incremental manner, thereby controlling the tightening of the suturing thread at the suture location.

[0065] Once the end portions of the suturing thread 112 are inserted into through-bore 210 (Fig. 4B), a tensioning tool 230 is engaged with an end portion 218 of spool 206, to permit rotation of the spool and spooling the thread 112 within the thread spooling space 214 (Fig. 4C), to thereby apply tension on the thread and hold the thread and the suturetensioning unit at the suture location and the two end segments of the tubular organ held fast one against the other.

[0066] A plurality of suture -tensioning units 202 can be applied in such a manner (Fig. 4E), to hold each of the suturing threads in location.

[0067] Figs. 5A-5H show steps of operation of a system according to an embodiment of the adhesive aspect. In system 300, an applicator 302 includes an adhesive reservoir 304, from which drops of bio-compatible adhesive can be deposited at the suture location to secure the suturing thread in position.

[0068] However, as the threads used for suturing are typically long, a mechanism for removing surplus of thread from the suture location is required. For this purpose, applicator 302 comprises a longitudinal hollow shaft 306, that is associated with the adhesive reservoir 304 at a proximal end 308 of the shaft, and also having an adhesivedepositing opening 312 at a distal end 310 of the shaft. Also defined at the distal end 310 of the shaft is a side through-bore 314. The side through-bore 314 permits a sutureretrieving element 316, in this case a loop wire, to be inserted into the shaft, and to exit through the adhesive-depositing opening 312, as best seen in Fig. 5B. When the distal end 310 is brought into proximity with the thread end portions extending out of the tissue at the suture location, as seen in Figs. 5C-5E, the suture-retrieving element 316 can capture the end portions of the suturing thread 112, and by pulling onto the suture-retrieving element 316, the surplus of suturing thread 112 can be removed from the suture location, as seen in Fig. 5F, through opening 312 and then through side through-bore 314.

[0069] After the surplus of thread has been removed from the suture location, handle 318 of applicator 302 can be pulled to deposit a drop of adhesive 320 from the reservoir, through the shaft 306, onto the suture location (Fig. 5G), to hold the threads at the suture location in position. In such a manner, all suturing threads can be adhered to the external surface of the tissue (Fig. 5H), holding the first and second end segments of the tubular organ in proximity to one another. A system according to an embodiment of the clipping aspect is shown in Figs. 6A- 6G. System 400 includes a central body 402, that has two oppositely oriented axial protrusions (not shown, however similar to protrusions 132 in Fig. 3C), each configured for insertion into one of end segments 104 and 106 of the tubular organ. The central body 402 has two axially spaced apart rings 404, each extending normal to an external surface of the central body. Each of the rings 404 includes a plurality of clip-receiving slits 406, each of which releasably receives a needle clip 408, the function of which will be described below.

[0070] In operation of system 400, the central body 402 is first positioned such that the end segments 104 and 106 of the tubular organ to be joined one to the other are fitted over the axial protrusions. Then, suturing needles 136 that are located within open axial needle channels 410 (best seen in Fig. 6B) are displaced into the tissue, thereby piercing the walls of the end segments of the tubular organ. As the needles 136 are arranged in opposite pairs, with a suturing thread 112 linking between the two needles in a pair, the threads extend between the two end segments of the tubular organ after passing of the needles through the walls of the tubular organ. After their extraction through the wall of the tubular organ, each needle is slidingly inserted into its respective needle clip 408, in which at least a front portion of the needle (i.e. the portion that terminates with a sharp tip) is received within a rigid track 412 and held in position against the rigid track by the force applied thereto by an elastic arm 414. In such a manner, each needle 136 is secured after its extraction through the tissue, and entanglement of the threads 112 is prevented.

[0071] After securing all the needles, the needle clips 408 are slidingly removed from the clip-receiving slits 406, such that the central body 402 can be removed from the operation site, and release the suturing threads 112 from the central body through the open axial needle channels 410, as seen in Fig. 6C.

[0072] After removal of the central body, the needle clips 408 are pulled and manipulated in order to tighten the suturing threads 112 and bring the first and second end segments 104 and 106 of the tubular organ into proximity one to the other, as seen in Fig. 6D.

[0073] After positioning the end segments of the tubular organ in proximity, the end portions of each suturing thread 112 can be fastened over the suture location by applying a fastener 420 to hold the suturing thread in position and apply the proper tension on the tissue, and cutting off the surplus thread attached to the needle clip 408. After applying a fastener 420 on each of the threads, the two segments of tubular organ are fixedly held one against the other.

[0074] An example of a suitable fastener is shown in Fig. 6G. Fastener 420 comprises an annular fastener body 422, through which the end portions of the suturing thread 112 can be threaded. Once threaded, a cap 424 is inserted into the fastener body 422. The outer surface of the cap is dimensioned to snugly fit within the annular opening of the fastener body, thereby tightly holding thread 112 between the outer surface of the cap and the inner surface of the fastener body.

Claims

CLAIMS:

1. A system for securing a suturing thread in a suture location of a tubular organ, the system comprising: at least one first tubular element, configured for fitting over a tubular organ, the first tubular element having a plurality of suture-receiving openings, each suturereceiving opening in said plurality of suture-receiving openings being configured for receiving a suture thread; and at least one second tubular element, configured for fitting over said first tubular element, and configured for sliding over an external face of the first tubular element over the plurality of suture-receiving openings, and clamping the suture threads between said external face of the first tubular element and an internal face of said second tubular element.

2. The system of claim 1, comprising: a pair of said first tubular elements, one of said first tubular elements for fitting over a first end segment of said tubular organ and the other of said first tubular elements for fitting over a second end segment of said tubular organ, and a corresponding pair of second tubular elements.

3. The system of claim 1 or 2, wherein the suture-receiving openings are located at a proximal end of the first tubular element.

4. The system of claim 3, wherein the first tubular element comprises a distal rim, the distal rim having a plurality of suture-receiving channels, each suture -receiving channel in said plurality of suture-receiving channels corresponds to a suture-receiving opening in said plurality of suture-receiving openings.

5. The system of any one of claims 1 to 4, wherein the external face of the first tubular element is inclining in a proximal-to-distal direction.

6. The system of claim 5, wherein the internal face of the second tubular element has a corresponding inclination to the inclination of the external face of the first tubular element.

7. The system of any one of claims 1 to 7, wherein the suturing thread is held between said external face and said internal face by forces of friction.

8. A method of suturing two ends of a tubular organ one to the other, utilizing the system of any one of claims 1 to 7, the method comprises: fitting said first tubular element over a first end segment of the tubular organ;fiting another first tubular element over a second end segment of the tubular organ to be joined to said first end segment of the tubular organ; passing suturing threads through the first and second end segments of the tubular organ, such that a first end of each suturing thread is received within a suture-receiving opening of the first tubular element fited over the first end portion of the tubular organ, and a second end of each suturing thread is received within a corresponding suturereceiving opening of the first tubular element fited over the second end portion of the tubular organ; bringing the first and second end portions of the tubular organ into proximity while pulling onto the first and second ends of the suturing threads; and fiting said second tubular elements over the first tubular elements, such that the suturing threads are securely clamped between an external face of the first tubular element and an internal face of said second tubular element.

9. A system for securing a suturing thread in a suture location of a tubular organ, the system comprising: a plurality of suture-tensioning units, each suture-tensioning unit in said plurality of suture-tensioning units comprises a rotatable spool defining a longitudinal axis and rotatable thereabout, and having a pair of sets of teeth projecting from an external surface of the rotatable spool, the pair of sets of teeth being spaced apart along said longitudinal axis, to define therebetween a thread spooling space, a pivoting, spring-loaded pawl, configured for engaging said teeth during rotation of the rotatable spool about the longitudinal axis to permit unidirectional rotation of the rotatable spool, a suture receiving through-bore defined at said rotatable spool in a direction normal to said longitudinal axis, for slidingly receiving end portions of a suturing thread; and a tensioning tool, configured for engagement with an engageable portion of said rotatable spool for rotation of the rotatable spool and spooling the thread within said thread spooling space.

10. A method of suturing two ends of a tubular organ one to the other, utilizing the system of claim 9, the method comprises:fitting a first end of the suturing thread through said suture receiving through-bore of said rotatable spool; fitting a second end of the suturing thread through said suture receiving through- bore of said rotatable spool; engaging the tensioning tool with an engageable portion of said rotatable spool and rotating the rotatable spool by said tensioning tool to spooling the thread within said thread spooling space.

11. A system for securing a suturing thread in a suture location of a tubular organ, the system comprising: an adhesive reservoir; a longitudinal hollow shaft associated with said adhesive reservoir at a proximal end of said shaft, and having an adhesive-depositing opening at a distal end of said shaft; a suture-retrieving element configured for engaging a suturing thread at said suture location, the suture -retrieving element being slidably received through a side through-bore defined in a distal end portion of the longitudinal hollow shaft and said adhesive-depositing opening, and configured to engage the suturing thread and retrieve an end portion thereof through the adhesive-depositing opening and the side through-bore to displace surplus of suturing thread from the suture location; and a trigger handle, configured to induce deposition of adhesive from said adhesive reservoir, through the longitudinal hollow shaft and out of the adhesive-depositing opening, onto a portion of the suturing thread at the suture location to adhere the thread to the tubular organ at the suture location.

12. The system of claim 11, wherein the adhesive is a biocompatible adhesive.

13. The system of claim 11 or 12, wherein the suture-retrieving element is a grip.

14. The system of claim 11 or 12, wherein the suture-retrieving element is a loop wire.

15. A method of suturing two ends of a tubular organ one to the other, utilizing the system of any one of claims 11 to 14, the method comprises: passing suturing threads through a first end segment and a second end segment of the tubular organ, such that a first end portion of each suturing thread extends out of said first end segment of the tubular organ, and a second end portion of each suturing thread extends out of said second end segment of the tubular organ; bringing the first and second end segments of the tubular organ into proximity while pulling onto the first and second end portions of the suturing threads;bringing the distal end of the longitudinal hollow shaft into proximity with said first and second end portions of a suturing thread; operating said suture-retrieving element to capture said first and second end portions of said suturing thread and slidably retrieving the first and second end portions of said suturing thread through the adhesive-depositing opening and the side through-bore to displace surplus of suturing thread from the suture location; and operating the trigger handle to induce deposition of adhesive from said adhesive reservoir, through said longitudinal hollow shaft and out of the adhesive-depositing opening, onto the suturing thread at the suture location to adhere the thread to the tubular organ at the suture location.

16. A system for securing a suturing thread in a suture location of a tubular organ, the system comprising: a central body having two oppositely oriented axial protrusions, each configured for insertion into an end segment of a tubular organ, the central body being configured with two axially spaced apart rings extending normal to an external surface of the central body, each of the rings being configured with a plurality of clip-receiving slits, each of the axial protrusions comprises a plurality of open axial needle channels, corresponding to and aligned with the plurality of clip-receiving slits; a plurality of suturing units, each suturing unit comprising a pair of suturing needles connected at their rear end by a suturing thread, one needle of a pair being accommodated in one of the axial needle channels configured at one of the axial protrusions and the other needle of the pair being accommodated in one of the axial needle channels configured at the other of the axial protrusions; a plurality of needle clips, each releasably received in a clip-receiving slit of said plurality of clip-receiving slits, and each configured for receiving and holding a suturing needle after the needle is extracted from the axial needle channel; and a plurality of fasteners, each fastener configured for fastening the ends of the suturing thread over the suture location after removal of the central body from the suture location.

17. The system of claim 16, wherein each of the axial protrusions comprises an Ciring, fitted over the open axial needle channels to prevent extraction of the needles from the channels in the direction normal to the axis of the central body.

18. The system of claim 16 or 17, wherein each of the needle clips comprises a needle receiving rigid track for slidingly receiving at least a front portion of said needle therein, and an elastic arm angled with respect to the rigid rack, and configured to clamp said front portion of the needle against the rigid track.

19. A method of suturing two ends of a tubular organ one to the other, utilizing the system of any one of claims 16 to 18, the method comprises: fitting a first end segment of the tubular organ over one of the axial protrusions and a second end segment of the tubular organ over the other of the axial protrusions; displacing a first suturing needle and a second suturing needle in a suturing unit through the walls of the first end segment and the second end segment of the tubular organ, respectively, such that the front portion of each suturing needle protrudes out of the needle channel and through the wall of the respective end segment of the tubular organ; sliding said front portion of each of the suturing needle into a respective rigid track of a respective needle clip against the elasticity of the elastic arm, to thereby clamp the front portion of the suturing needle between the rigid track and the elastic arm; sliding the needle clips out of the clip-receiving slits defined in the rings of the central body; removing the central body from the suture location; pulling onto the needle clips to tension the suturing threads and bring the first and second end segments of the tubular organ into proximity; and applying a fastener of said plurality of fasteners over the end portions of each suturing thread to fasten the suturing thread against the organ at the suture location.

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