WO2020053860A1

WO2020053860A1 - Device for tissue suturing

Info

Publication number: WO2020053860A1
Application number: PCT/IL2019/051021
Authority: WO
Inventors: Yoav Tikochinsky; Nir Lilach; Amit SEGAL; Eviatar NESHER; Shmuel SEGAL; Yair Spanier
Original assignee: Epic M.D Ltd
Priority date: 2018-09-12
Filing date: 2019-09-12
Publication date: 2020-03-19
Also published as: IL261719A

Abstract

The present disclosure provides systems and devices for suturing tissue sections, for example two sections of a tissue, by using at least one suturing unit (100) that comprises tissue anchoring elements (102, 104) and a thread (106) coupled thereto. The disclosure also concerns cassettes and kits comprising at least one suturing unit.

Description

Device for tissue suturing

TECHNOUOGICAU FIEUD

The present disclosure provides systems and devices for suturing tissue sections, for example two sections of a tissue, by using at least one suturing unit that comprises tissue anchoring element(s) and a thread coupled thereto.

BACKGROUND ART

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

[1] WO 2011/039732

[2] WO 2014/033692

[3] WO 2014/039651

[4] US 6,500,184

[5] WO 2017/006321

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.

BACKGROUND

Suturing is used in many surgical operations to close, i.e. bring together, tissue sections which have been separated, e.g. by cutting. For example, during hernia repair or C-section surgical operations, the abdominal fascia tissue is surgically cut, and then needs to be sutured in order to restore tissue integrity. Sutures are used in order to maintain the cut tissue sections proximal to one another during the healing period of the tissue. A growing number of post-surgical complications, typically relating to suture slaking due to tension unevenly distributed in the suture thread, due to tearing of the thread and/or disengagement of the thread from the sutured tissue, pose significant risks to the patients' health and often require additional surgical involvement. Such post-surgical complications are also of great concern to care-takers and medical insurance organizations due to the costs associated with such secondary surgical involvement and post-surgical treatments.

Traditional suturing involves using a needle threaded with a suitable suturing thread, that is operated by the surgeon by hand or by using forceps. The needle is passed through both tissues sections, and the thread is pulled to bring the tissue sections into proximity. During traditional fascia suturing procedure, a single, continuous thread is used and the needle is consecutively passed through both tissue sections in order to obtain a single, continuous suture. The suture is secured at both ends, typically by a knot. Such traditional suturing procedures often require the involvement of at least two surgical staff members, one member for holding the tissue sections to be sutured in proper orientation with respect to one another, and the other staff member for performing the suturing procedure. As a single thread is used, there is a risk of the suture tearing during the procedure. In addition, due to the thickness of the fascia tissue and the relatively high force required to pass the needle through it, surgeons often suffer from needle pricks during surgery that may pose a health risk and exposure to contaminations to both the surgeon and the patient. Further, uneven tensioning or slaking of the thread may cause formation of ischemic damage in vicinity to the suture.

Some alternative devices and suturing methods have been proposed in the art. One of the common techniques used is stapling, in which the tissue sections are held in proximity to one another by metal staples. Although stapling is a procedure that is quicker than traditional suturing, it is unsuitable for holding together thick tissues or for closing wide gaps of the tissue, and is, thus, used in cosmetic or superficial skin incisions (i.e. incisions that are not carried out in the deep-tissue).

Another technique involves using multiple single stitches instead of a continuous suture. This may be accomplished by passing the needle through the first and second tissue sections, and tying (or locking) the thread to form a single, individual, suture after each such passing. The thread is then cut, and other such single sutures are similarly applied until the tissue sections are stitched together. Such application of a plurality of single stitches may be carried out manually by the surgeon, or applied by using a dedicated device, such as that described in [1] In this suturing technique ( e.g . a plurality of single stiches formed only by using a thread) it is difficult to obtain uniformity in the size of sutures and/or an even distribution of stresses along the sutured tissue. Moreover, the individual knots are often bulky, causing inconvenience to the patient. In addition, the plurality of exposed thread edges (resulting from the multiple cutting of the thread to form individual sutures) may cause local irritation and/or sites of infection in the tissue.

A similar procedure involves applying anchoring members, passing through the tissue sections, such that the anchoring members are fixed within the tissue and the thread is passed between pairs of anchoring members, the first being fixed to one section of the tissue and the other being fixed to the opposite tissue section. The thread is then tied or locked in position, to form singular sutures, each constituted by a pair of anchoring members and a respective thread linking between them. Typically, the thread is locked in the tensioned position out of the tissue (on the outer surface of the tissue) or in portions of the anchors that protrude out of the tissue. Various devices are disclosed, for example in [2-5].

GENERAL DESCRIPTION

The present disclosure provides a tissue suturing unit for suturing tissue sections, in particular, but not limited to, two sections of fascia, thoracic wall, thick muscular tissue, closing of tissue in laparoscopic procedures, etc. The disclosure also provides a device for deployment of such units, cassettes with a plurality of such units and a kit comprising said device and at least one such cassette.

The suturing units, systems and devices described herein are designed to significantly simplify and/or reduce the duration of the suturing procedure, as well as increasing surgeon safety ( e.g . avoiding unintentional pricking).

The present disclosure, by its first aspect, provides a tissue suturing unit that comprises one or more tissue-anchoring elements and at least one suturing thread coupled thereto. In use, each element is anchored in a tissue section and by tensioning the suturing thread, that extends over the outer face of the tissue, after anchoring, the tissue sections are pulled into proximity and are held in this state by the thread.

In the description below, the term " tissue section " may be used to refer to a part of a tissue that is intended for suturing. Tissue sections may, for example, be sections of the fascia that are surgically cut or perforated in abdominal or chest surgery and are then sutured together.

The term " suturing thread" is used to denote any type of cord or thread that can be linked to the tissue-anchoring elements of the suturing units. It may be made of any one of a variety of suitable materials (e.g., biodegradable or not biodegradable), of any thickness or cross-section, may be smooth, structured or textured (e.g. textured such as to permit unidirectional relative movement of the thread in a direction that increases tension in the thread due to the pulling of two opposite tissue portions towards each other), etc. The suturing thread may be uniform throughout or may be non-uniform, e.g. having one or more bulging portions in one or more portions thereof.

The term "suture" or " suturing " is used herein to refer to the surgical operation of closing and bringing together tissue sections that have been surgically cut or otherwise ruptured or perforated. This term encompasses, in particular, the method of tissue closing, which may be carried out by using the units in accordance with the disclosure, although it may not fall within the classical meaning of the term "suturing".

The suturing unit of said first aspect comprises, as noted above, one or more tissue-anchoring elements. In the text below an arbitrary directionality is used in reference to the tissue-anchoring element. The term“top” is arbitrarily applied to the side through which the suturing thread engages the element. Consistent therewith an element-relating frame of reference includes a vertical direction that extends between the top side and the opposite, bottom side of the element and lateral sides that extend between the top and bottom sides of the element.

These tissue-anchoring elements are typically elongated along a horizontal, front- rear axis, and are inserted by pushing them axially into the tissue, typically essentially in a direction normal to the surface of the tissue, with the front end first, penetrating the tissue. The anchoring elements may have rounded edges. However, in another embodiment, the tissue-anchoring elements may have axially-oriented tapered front ends that facilitate the elements' penetration into the tissue.

The thread is typically coupled with each of the tissue-anchoring elements in a cavity defined within the element through an opening at a mid-portion of an upper end thereof. When inserted into the tissue, the thread extends from a top side of the element through the passage of insertion of the elements into the tissue and a pulling force on the thread induces the elements to orient themselves in a direction transverse to that of the passage; and, in this manner, become anchored in the tissue. The suturing thread, extending from these elements out through said passage, extends to the other element of the pair on the external face of the tissue. By tensioning the thread, the tissue sections come together through proximation of the tissue-anchoring elements one to the other.

The configuration of the elements and their coupling with the suturing thread permits, on the one hand, pulling a free end of the thread to tension it and thereby bringing the elements and the tissue sections in which they are anchored into proximity; and, on the other hand, inherent arrest of the thread from sliding in a tension-releasing direction.

The suturing thread has at least one leading free end and is slidably coupled to at least a first of the tissue-anchoring elements such that the thread can be slid relative the tissue-anchoring element by pulling the leading end in a tensioning direction, and resisting displacement in an opposite direction.

The resistance to displacement in a direction opposite to the tensioning direction may be obtained, by an embodiment, by arranging the suturing thread to follow a tortuous path within at least one of the tissue-anchoring elements, whereby a first section of the thread bears against a second section of the thread, such that once the thread is tensioned the friction between the two sections of the thread arrests displacement in the direction opposite to the tensioning direction.

In accordance with this disclosure, through a sliding and tensioning arrangement of the thread in its coupling with at least one of the tissue-anchoring elements, in which the thread loops about a looping surface formed within the element and the sections of the thread adjacent the loop are in close contact with one another. Thus, when the thread is pulled one section slides against the other. Once a tension is built in the thread, the tensioned thread section is forced against the opposite thread section and the friction between the two prevents movement of the thread in a tension-releasing direction. Thus, this arresting arrangement is inherent to the coupling configuration and caused by the thread itself, without requiring any knotting or other mechanical locking arrangement, devices, units or elements. Also, the entire tension-release arrest happens within the elements, fully embedded within the tissue, while visible on the surface are only thread sections that extend between the elements and free ends of the threads that are pulled to tension the thread.

In the description below the term“ leading section” will denote the thread section that extends between the looping surface and the free end; and the term“ trailing section” will denote the thread section extending between the looping surface and the opposite end of the thread. As can be readily understood, during pulling of the thread to induce tension, portions of the thread that are initially part of the trailing section become part of the leading section. Also, the respective portions of the leading section and the trailing section that are in contact with one another and move in opposite directions when the thread is pulled, will be referred to herein as“ overlapping leading segment” and“ overlapping trailing segment”. As can be readily understood, it is the friction between the overlapping segments and the applied force upon tension build-up that gives rise to the tension-release arrest.

There are a number of alternative configurations. In one of these configurations, to be referred to herein as the“first configuration” the unit includes two or more tissue anchoring elements, at least one of which being distinct from the others. While the two or more elements are configured for anchoring in the tissue in a similar manner, at least one of which differs from the others in its function and structure in the overall arrangement that permits tensioning but arrests release. The suturing thread has one end that is fixed to one of the elements, referred to below as“ second element” and is extended through the other element, referred to below as“first elemen in which it is engaged in the manner permitting tensioning but arresting release, to be defined and described below. Typically, the suturing unit includes a pair of tissue-anchoring elements, one being a first element and the other being a second element. The free end section of the thread extends back to the second element and is engaged with it in a slidable manner that permits pulling of the free end to tension the thread. The tension is built in the trailing section of the thread and through this tension the overlapping trailing segment applies a force to thereby enhance friction onto the overlapping leading segment.

In another arrangement of the first configuration, the suturing unit may comprise more than two tissue-anchoring elements, typically one of which is a first element, another being a second element, and the rest being relay elements which are coupled to the thread in a manner permitting its relatively free sliding therethrough. Such arrangements may be applied to irregular cut sections, such as in a procedure for closing a perforation or an irregularly-shaped cut.

By another arrangement of the first configuration, the suturing unit comprises at least one first tissue-anchoring element and the thread has a terminal free end, that may be fixedly coupled to a tissue section. In such an arrangement, the first tissue-anchoring element is inserted and anchored within a section of the tissue, while the terminal free end is fixed to the opposite tissue section, for example by traditional fixing techniques as knot tying.

By another configuration, to be referred to herein as the“ second configuration the elements are similar in function, or similar in both function and structure, often being identical. In this configuration the thread has a mid-portion that extends between two tissue-anchoring elements and two free ends, one extending from each of the elements. The thread can be tensioned by pulling one or both of these free ends. Said mid-portion functions, in fact, as the trailing section including an overlapping trailing segment in each of the elements that overlaps an overlapping leading segment that is in between the loop formed by the thread and the leading section ending in said free end.

The arrangement that permits tensioning but arrests release, by one embodiment, comprises looping surface formed within an element (which is the first element in the first configuration or each of the elements in the second configuration) about which the threads loops, whereby said first section, being a leading section of the thread, that extends between the looping surface and the free end, is in contact with a second section that is a trailing section of the thread, and upon pulling the leading free end the two thread sections slide in opposite directions one against the other. As noted above, once tension develops in the trailing section, the overlapping trailing segment applies pressure onto the overlapping leading section and the strong friction between the two segments thereby arrests movement and prevents relative sliding of the two sections to consequently inhibit tension-release.

By one embodiment, to be referred to herein as the " parallel embodiment ", the first and second sections of the thread are disposed parallel to one another, and the arrangement may be such that displacement of the first section in the tensioning direction causes displacement of the second section in the opposite direction.

By another embodiment, in addition to the looping surface, the respective element comprises also a strain-inducing member with a curved edge and both the overlapping leading and trailing segments of the thread are bent about this member and strained against the curved edge. In this embodiment the overlapping leading segment is positioned between the overlapping trailing segment and the curved edge.

Typically, the looping surface and the strain-inducing member span between the two lateral sides of a cavity formed within the element and are spaced (vertically or horizontally) from one another to define a channel or a passage between them. This channel or passage accommodates a portion of the leading section of the thread. Thus, the portion of the thread accommodated within the cavity, defines a serpentine path in which the trailing section extends downward from an opening at a top side of the element, about the strain-inducing member and then loops around the looping surface, with the leading section extending from the looping surface, passing through the channel curving about the strain-inducing member and then out of the opening. Typically, the looping surface is positioned above the strain-inducing member. By some embodiments the looping surface and the strain-inducing member are differently shaped, while in other embodiments they have a similar cross-sectional shape and may be mirror images of one another.

The distance between the two lateral sides of the cavity are typically dimensioned such that the leading and trailing sections of the thread cannot be accommodated horizontally side-by-side within the cavity.

By another embodiment, to be referred to herein as the "angled embodiment" , the thread may be arranged within the tissue anchoring element such that the first and second sections of the thread have respective first and second portions that are angled and in contact with respect to one another; tensioning of the second section causes the second portion to bear against the first portion to lock the first section in a tensioned state.

In the angled embodiment, the first tissue-anchoring element has a cavity that is defined between two opposite lateral sides and has an opening at a top side thereof. The second section of the thread is disposed within the cavity in a direction essentially parallel to the two sides, and the first section of the thread is disposed, at least partially, so as to pass through one or more bores in the lateral sides to form an angle with the second section of the thread. The first thread portion may, by one exemplary configuration, pass through the cavity along an axis extending between two lateral openings formed in the two lateral sides, and tensioning of the second section causes the second thread portion to press on the first thread portion in a direction normal to said axis ( e.g . causing it to bend off-axis).

By one example, the tissue-anchoring elements, which is elongated along a front- rear axis has four lateral bores formed in the lateral sides between the element's exterior and in the internal cavity. These four lateral bores include a front bore in one side proximal an upper edge of the element, two opposite central bores in the two opposite sides proximal a bottom edge of the element and a rear bore in the other side than the front bore proximal the upper edge. The first thread section extends from a cavity opening at the upper edge into the cavity, out through the front bore, then through the two central bores with a segment defining said first thread portion spanning the cavity and enters the cavity again through the rear bore. The second thread section extends from the rear bore, through the cavity under the first thread portion and out of the cavity through the cavity opening.

By a further embodiment, to be referred to herein as the " ratchet embodiment ", at least one of the tissue-anchoring elements (typically both) may comprise a thread- engaging arrangement permitting a displacement of the thread with respect to the element in one direction and arresting it to move in the opposite direction. The arrangement may, by one embodiment, comprise thread-engaging flaps that are inclined from a base in said one direction toward a peripheral, thread-engaging end of the flaps. The inclination of the flaps permit displacement of the thread in said one direction (the pulling direction) by permitting sliding of the thread through a gap formed between the flaps' thread-engaging ends; while displacement of the thread in an opposite direction will cause the thread- engaging ends to be anchored in the thread, thus preventing its retraction in said opposite direction. The thread may also have a plurality of bulges ( e.g . knots or sections with a large diameter distributed at predetermined intervals along the thread), such that the bulges are wider than the gap between the thread-engaging ends. Due to the inclination of the flaps, displacement of the thread in the tensioning direction will be permitted, while displacement of the thread in the opposite direction will be prevented by an engagement of the thread-engaging ends with the bulges.

After the tissue-anchoring elements of the unit are inserted into their respective tissue sections, a free end of the thread may be pulled and this causes tension and thereby proximation of the elements and hence of the respective tissue sections, one against the other. The trailing section of the thread then plays the main role in holding the elements in proximity and the tension in it also functions to inhibit the tension release.

The tissue anchoring elements may be made of any suitable material, e.g. metal, plastic or other polymeric material. In some embodiments, the anchoring elements are made of or comprise a biodegradable material or composition.

It is also of note that, compared to the suture thread passing through the tissue in classic suturing techniques, the anchoring elements have a larger surface in contact with the tissue (as compared to the surface contacted by the suturing thread in classic techniques), which may reduce the likelihood of the development of ischemic damage and/or the risk to hernia formation in the scar area.

Provided by another aspect of this disclosure is a system or a device for suturing together tissue sections. The device comprises an arrangement of a plurality of tissue suturing units of the kind described herein, intended for insertion and deployment into a tissue to be sutured. In the device, such an arrangement is held in a suitably -configured holder (which is typically, but not exclusively, in the form of a cassette described hereinbelow). As noted above, each suturing unit comprises one or more tissue anchoring elements of the kind described herein, and a suturing thread coupled thereto that, once tensioned after anchoring, holds the tissue section in proximity.

The device also comprises an actuation arrangement that is configured for inserting each of the tissue anchoring elements into respective tissue sections. The actuation arrangement also permits manipulation of the thread to bring the tissue anchoring elements into proximity after their insertion into the tissue.

In one example, the actuation arrangement may comprise a displacing member axially reciprocating in a forward-rearward direction (forward direction being toward the tissue and rearward being away from the tissue) and configured to thereby displace one tissue anchoring element at a time and insert it into the tissue section by pushing in the axial direction (i.e. with the anchoring element's longitudinal axis being substantially normal to the surface of the tissue).

Once a suturing unit, namely the tissue anchoring elements, is inserted into the tissue, the free end of the thread may be pulled in order to bring the elements into proximity one with the other. Such pulling may be carried out manually, for example by using forceps. Alternatively, the actuation arrangement may be configured for pulling the free end of the suturing thread to proximate the tissue anchoring elements once inserted into the tissue. The pulling arrangement may be any type of suitable mechanism, e.g. mechanical or electrical. The pulling arrangement may further comprise a tension controlling or tension-limiting utility or mechanism, to limit the tension applied onto the thread to reduce risk of over-tensioning or undesired tearing of the thread. The tension controlling or tension-limiting utility may, at times, be user-calibrated, such that the practitioner can calibrate the limiting tension to a desired upper threshold value. Further, the actuation arrangement may also comprise a cutting utility for cutting the free end of the thread after proximating the two tissue-anchoring elements to shorten the free end section that protrudes out of the tissue.

By some embodiments, the device may further comprise a displacing member, activatable by the actuation arrangement, and configured to axially reciprocate in a forward-rearward direction (forward direction being toward the tissue and rearward being away from the tissue) to thereby displace the tissue-anchoring element to a position in which the anchoring element is fixed within the tissue. Said displacing member has typically an elongated forward portion, that has a tapered tissue-penetrating end. The tissue-anchoring element may be detachably attached to the displacement member, permitting the displacing member to forwardly displace the tissue-anchoring member and causing it to penetrate the tissue. The tissue-anchoring elements, by some embodiments, are configured to define a tissue penetration axis between a front, tapered end portion forwardly directed toward the tissue and a rear, opposite end. The displacing member in such a case is thus configured for axial, forward displacement of the tissue-anchoring element into the tissue. In other configurations, where the front end of the tissue anchoring element is not tapered, the displacing member may be configured with a tapered end that is configured for penetrating the tissue prior to the tissue-anchoring element, thus forming a lead puncture through which the tissue-anchoring element may be inserted into the tissue.

The device may be preloaded with a predefined number of suturing units, and provided as such. Such a preloaded device may, by one embodiment, be disposable and intended for use in a single suturing procedure. In such embodiments, the device may be made of a recyclable or degradable material. In other embodiments, the device may be designed for multiple uses, and may be made out of construction materials that permit sterilization (for example by an autoclave). When configured for multiple uses, the device's holder is typically designed to hold a replaceable, cassette, or cartridge that holds the arrangement of the suturing units, such that once such a cassette is inserted into the receptacle, the actuation arrangement can controllably drive the tissue anchoring elements from the cassette one at a time upon actuation into the tissue.

Such a cassette constitutes an independent aspect of this disclosure. The cassette comprises a plurality of suturing units of the kind described above. The suturing units are arranged in said cassette to permit extraction of a first-in-line tissue anchoring element and axially displacing the element into the tissue.

Tissues to be sutured by utilizing the suturing units of this disclosure may vary. For example, the tissue may vary in thickness from patient to patient, or various areas of tissue may have various thickness, strength or integrity, it may be useful to provide suturing units having different dimensions. Thus, the suturing units may vary in the dimensions of the tissue anchoring elements, the type and length of thread, etc. Once assessing the thickness and/or quality of the tissue to be sutured, the practitioner may then load the proper suturing units into the device or choose the proper device or cassette with properly dimensioned pre-loaded suturing units.

According to another aspect, provided is a kit, comprising the device or system of this disclosure and one or more cassettes ( e.g . a plurality of cassettes each holding suturing units of different dimensions) as herein defined.

BRIEF DESCRIPTION OF THE DRAWINGS

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:

Figs. 1A-1B are schematic representations of a suturing unit comprising a pair of tissue anchoring element linked by a suturing thread, according to the first configuration of the parallel embodiment of this disclosure: in a perspective view (Fig. 1A) and in an exploded view (Fig. 1B).

Figs. 2A-2B are schematic representations of the suturing unit of Figs. 1A-1B after being proximated to one another: in a perspective view (Fig. 2A), and in an exploded view (Fig. 2B).

Fig. 3A is a schematic representation of a suturing unit according to an embodiment of the second configuration of the parallel embodiment of this disclosure.

Fig. 3B is a schematic representation of another suturing unit according to the parallel embodiment of the second configuration of this disclosure.

Fig. 3C is a schematic cross section of elements of the suturing unit of Fig. 3B. Fig. 4 is a schematic representation of a suturing unit according to another embodiment of the first configuration of the parallel embodiment according to this disclosure.

Figs. 5A-5B are schematic representation of a suturing unit according to the angled embodiment of this disclosure: in a sliding-permitting state (Fig. 5A) and in a locked state (Fig. 5B).

Fig. 6 is a schematic representation of a suturing unit according to the ratchet embodiment of according to this disclosure.

Figs. 7A-7B are longitudinal cross-sections of other suturing units according to the ratchet embodiment of according to this disclosure.

Figs. 8A-8C are schematic representations of a sequence of a fascia suturing procedure using suturing units of this disclosure.

Fig. 9 is a schematic illustration of an exemplary suturing device utilizing the suturing units of this disclosure.

Figs. 10A-10E are schematic representations of a sequence of a suturing procedure of a laparoscopic opening using suturing units of this disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

The invention will now be described with reference to some embodiments of this disclosure, which are schematically illustrated in the annexed drawings. Various embodiments are illustrated of a first configuration of this disclosure, in which the two anchoring elements have a different structure and function one with respect to the other, and jointly embodying the characterizing features of this disclosure; and the others being of the second configuration of this disclosure, in which the two anchoring elements have similar function (and at times also similar structure). As can be understood these are but examples of the broad aspects of this disclosure, as described herein.

Although the embodiments to be described exemplify suturing units which comprise a pair of tissue-anchoring elements, it is appreciated that the suturing unit may comprise one or more tissue-anchoring elements as described hereinabove.

Reference is first being made to Figs. 1A and IB showing a suturing unit according to the first configuration of the parallel embodiment, generally designated 100. The suturing unit consists of two tissue-anchoring elements 102, 104 and a suturing thread 106. The suturing thread has a free end 108, the pulling of which causes tensioning of the thread and proximation of the two anchoring elements, in the manner to be described below.

The two anchoring elements are elongated along respective axes Xi and X2, and in use are axially inserted into a tissue in a direction generally normal to the surface of the tissue. Once the anchoring units are fully within the tissue, portions of the thread that extend out of the tissue cause the anchoring units to re-orientate in a position essentially parallel to the surface of the tissue and in this way become anchored in the tissue.

The suturing thread has a circlet 110 at its other end (the end of the thread opposite the free end 108), that passes through bore 112 and is thereby fixed to anchoring element 104. Anchoring element 104 has an internal cavity 114 with a spool member 116 defined therein, spanning the distance between the two lateral walls of the cavity, the cavity having two openings at the top side of the element 118, 120 (at time these are unified into a single opening) through which the thread enters and exits anchoring element 104, respectively, after looping about spool member 116. This coupling of the thread to anchoring element 104 permits pulling the free end 108 to thereby tension the thread.

Anchoring element 102 has a cavity 122, defined between opposite lateral sides and has two members defined therein - a pivot member 124 that defines a looping surface, and strain-inducing member 126. The pivot member and the strain-inducing member extend between the lateral sides of the cavity, such that a channel (or passage) 128 is formed between the two members. Anchoring element 102 also has an opening 130 at the top side thereof, throughwhich the thread enters and exits element 102.

The thread has two sections that extend between the two anchoring elements, one section is a leading section 132 and the other is trailing section 134, both sections spanning the distance between the elements. The leading section 132 is bent about the curved edge 136 of the strain-inducing member 126, extending through channel 128 to loop-about pivot member 124, extending into the trailing section 134 that bends about the curved edge 136, and from there through opening 130 to anchoring element 104. The leading section 132 and the trailing section 134 have respective overlapping segments, i.e. overlapping leading segment 132A and overlapping trailing segment 134A, such that the overlapping leading segment 132A being positioned between the overlapping trailing segment 134A and the curved edged 136. When free end 108 is pulled for example in the direction of arrow 140 in Figs. 2A and 2B; the leading section 132 then slides in the direction of arrow 142, causing the two overlapping segments 132A, 134A to displace in sliding opposite directions one against the other. When the suturing unit is positioned within the tissue, such pulling causes development of a strong strain in trailing section 134, inducing a strong friction force on the overlapping leading segment 132A, to thereby arrest it from sliding in a tension releasing direction.

In this embodiment, members 124 and 126 have a different cross-sectional shape. However, it is also contemplated that these will have the same cross-sectional shape, albeit having different orientation within the cavity, similar to that shown in the embodiment of Fig. 3A. Also of note is the fact that the cavity 122 in anchoring element 102 is formed with a slanted leading edge 144 for guiding the trailing section 134 into the anchoring element to avoid formation of undesired friction in the thread at the point of entry into element 102 (that may be formed during the sliding motion of the thread and/or during tensioning thereof). It is noted that edge 144 may have any suitable shape that prevents formation of undesired friction between the thread and element 104.

A schematic illustration of another embodiment, according to a second configuration of the parallel embodiment of this disclosure, is shown in Figs. 3A-3B. In Fig. 3A, suturing unit 200 has two identical anchoring elements 202 and a thread 206, with a segment extending between the two anchoring elements, and constitutes the trailing section 234 consistent with the above definition, for each of elements 202. Each of anchoring elements 202 has a structure similar to element 102 in Figs. 1A-2B (accordingly, like parts were given like reference numerals, shifted by a hundred, for example, part 202 in Fig. 3A is identical in function to part 102 in Fig. 1A to 2B). The reader is thus referred to the description of Figs. 1A-2B for full understanding of their function.

Thread 206 has a section 234 that extends between the two elements 202 having the function of the trailing section, which is akin to section 134 in Figs. 1A-2B, and accordingly is designated by reference numeral 234. The coupling of thread 206 with each of anchoring elements 202 is functionally similar to that of the thread to element 102, the difference being that the leading section 232 does not extend between the anchoring elements, but rather directly terminates at the free ends 208. Thus, in this configuration, section 234 may be strained by pulling on one or both of free ends 208 in the direction of arrows 240.

Another exemplary embodiment of the second configuration of the parallel embodiment is schematically shown in Fig. 3B. In this embodiment, the suturing unit 1200 has two anchoring elements, one of which being element 1202 (identical to element 202 of Fig. 3A) and the other 1250 having the same function as element 1202 (the cross- section thereof is shown in Fig. 3C) however having somewhat different shape. The thread 1206 has a segment extending between the two anchoring elements, and constitutes the trailing section 1234 consistent with the above definition, for each of elements 1202 and 1250.

Anchoring element 1250 is also elongated and has a tapered front end 1252 to facilitate insertion into the tissue. Similar to element 1202, anchoring element 1252 also has a pivot member 1254 and strain-inducing member 1256, however in element 1252 the pivot member and the strain-inducing member extend and link between a front-portion of element 1252 and a back-portion thereof, which a channel 1528 is formed between the two members. Similarly to Fig. 3A, leading section 1232 directly terminates at the free ends 1208, that may be pulled to strain the thread and bring the anchoring elements into proximity.

Fig. 4 shows another embodiment of the first configuration of the parallel embodiment. In this embodiment, the suturing unit 2200 has two anchoring elements, one of which being element 2202 (identical to element 202 of Fig. 3A) and the other being tissue-anchoring element 2270, with the thread 2206 having a segment extending between the two anchoring elements, and constitutes the trailing section 2234 consistent with the above definition. The end 2272 of trailing second 2234 is fixedly coupled to anchoring element 2270, such that sliding of the thread within element 2270 is prevented. Once inserted into the tissue, element 2270 serves as a fixed anchoring point for the end 2272 of the trailing section, such that when the free end 2208 of the leading portion 2232 is pulled in the direction of arrow 2240, element 2270 serves as a fixed point for tensioning the thread.

Referring now to Figs. 5A and 5B, shown is a tissue-anchoring element 3000 of the angled embodiment in two respective states: a sliding-permitting state shown in Fig. 5A in which there is a slack in the thread and, therefore, sliding of the thread is permitted; and a sliding-arresting state shown in Fig. 5B, in which one portion of the thread bears on the other, arresting sliding movement, as will be explained below. The element is drawn to be transparent as to illustrate internal structure. As can be appreciated, in reality this may not be the case.

Element 3000, which is elongated in a front-rear direction between a front end 3002 and a rear end 3004 (the former being tapered to permit tissue penetration) has one or more lateral bores at its two sides 3006 and 3008, leading from the element's exterior into an internal cavity 3010. In this particular example, these bores include a front bore 3012 in one side proximal the upper edge 3014 of the element, two opposite central bores 3016 and 3018 proximal the bottom edge 3020 of the element, and a rear bore 3022 proximal the upper edge 3014 and being in a side opposite that of bore 3012.

A first thread section 3024 extends through a cavity opening 3026 out through bore 3012, then through the two central bores 3016 and 3018, and out at the other side and entering the cavity again through rear bore 3022. The second thread section 3028 extends from rear bore 3022, through cavity 3010 and under the two central bores 3016, 3018, to exist the element through the cavity opening 3026.

The thread segment extending between the central bores 3016, 3018 defines a first, lateral thread portion 3030 which is angled, in essentially a right angle, to a second portion 3032 of the second thread section 3028 that passes underneath. When there is no tension in the second thread section, there is slack between the first portion 3030 and the second portion 3032, permitting sliding of the thread within the element. However, upon pulling the first thread section 3024 in the direction of arrow 3025 a tension forms in the second section 3028, as shown in Fig. 5B, whereupon said second portion bears on said first portion, and the friction between the two would resist sliding to thereby lock the thread in a tensioned state within the element 3000. By some embodiments, said first portion 3030 spans through free space and thus the tension causes some bending in said first portion, which in turn presses the first portion against the two lateral bores 3016, 3018; in other embodiments, the first portion 3030 lies against a wall portion (not shown) within the element and the tension causes the second portion 3032 to press the first portion against such wall portion.

Reference is now made to Fig. 6, which also has been drawn transparent to show its internal structure. Element 4000, which embodies the principles of the ratchet embodiment, has an internal cavity 4002 with two cavity openings - a first cavity opening 4004 and a second cavity opening 4006, with an internal thread portion 4008 extending internally between the first thread section 4010 and the second thread section 4012, and looping about a looping surface 4014. The first section has a free end, and pulling the first section in the direction of arrow 4016 slides the thread in a first direction to thereby tension the thread. Formed inside the element 4000 is a thread engaging element 4018, and comprising two flaps 4020, that are inclined from a base 4022 in the first direction. The peripheral ends 4024 of flaps 4020 engage the thread and as a result of their angled orientation, permitting the thread to slide in said first direction and arresting the thread from sliding in the opposite direction.

Another example of the ratchet embodiment is shown in Figs. 7A and 7B. In these figures, like parts to those of Fig. 6 have been given like reference numeral, however shifted by 1000 and 2000, respectively (for example, part 5006 in Fig. 7A and part 6006 in Fig. 7B, correspond to part 4006 in Fig. 6). In these examples, bulges 5050 and 6050 are formed in the thread portions 5052, 6052 that pass through and engage elements 5000, 6000, the flaps 5020, 6020 which have a different design in these two examples, function similarly to permit the thread with the bulges to slide in the first direction and arrest sliding in the second direction.

Reference is now being made to Figs. 8A-8C showing schematic illustrations of use of a suturing unit, according to the disclosure, in surgery. Anchoring element 102 is inserted through fascia portion 302A in a direction essentially perpendicular to the surface of the tissue (as represented by arrow 304); similarly, anchoring element 104 is inserted through opposite fascia portion 302B, with thread sections extending therebetween, and free end 108 extending from anchoring element 104 out of the tissue. The anchoring elements 102, 104 assume a horizontal position when the thread is being pulled, thus anchoring the elements within the tissue, as seen in Fig. 8A.

The suturing unit specifically illustrated in Figs. 8A-8C is that of the first configuration; applied for the purpose of suturing together two parts of the fascia. It should be understood that in an analogous manner, suturing units of other embodiments described herein may be employed in bringing together sections of tissue. It is further to be appreciated that, although the description herein refers to suturing together two sections of fascia tissue, other tissues may also be sutured by using the suturing units of this disclosure ( e.g . thoracic wall, thick muscular tissue, etc.).

As noted above and seen in Fig. 8A, the first step would be to anchor two elements of the unit below the surface of the tissue, which is done by inserting each of the elements by forcing it through the tissue, in the general direction represented by arrow 304. Once fully within the tissue, pulling the free end 108 causes the anchoring elements 102,104 to proximate in the mechanism of thread- sliding described above, thus bringing the two tissue portions 302A, 302B into contact with one another, as can be seen in Figs. 8B and 8C.

The coupling of the thread 106 with anchoring element 102 ensures that the suturing unit is locked in this strained position, as coupling of the thread in with element 102 in the manner described above, prevents sliding of the thread in a tension-releasing direction.

A similar exemplary suturing sequence to that of Figs. 8A-8C is shown in Figs. 10A-10E for closing a tissue opening formed during laparoscopic procedures. In this sequence, the tissue suturing units may be applied to the tissue by a suturing device during the procedure or after extraction of trocar 500 from the tissue opening 502.

The suturing units may be inserted into the tissue manually. However, fascia and other fibrous tissues are relatively tough and require a deployment device for inserting the suturing units into the tissue. An exemplary suturing device for deploying the suturing units of this disclosure is schematically shown in Fig. 9. It is appreciated that this device is merely an example and other devices, configurations or arrangements may be utilized.

Device 400 has a body 402 with an actuation lever 404 that can be pressed in the direction represented by arrow 406. The device also comprises a tissue guide 408 which, while suturing, is positioned against the tissue's inner part to provide support permitting axial insertion of the anchoring elements into the tissue. A plurality of anchoring elements 410 is housed in an appropriate receptacle 412 (for example a cassette or a cartridge) within the body of the device. Pressing lever 404 actuates reciprocating member 414 to push an anchoring element out of the device and axially drive it through an underlying tissue portion.

The anchoring elements 410 are typically arranged within the device in pairs, each pair including two tissue anchoring elements (at least one of which being an anchoring element designated above as element 102), linked together by a suturing thread. The pairs are arranged within the device such that a first element of the pair is deployed into one section of the tissue, following by deployment of the other element of the pair into the opposite section of the tissue, with the suturing thread extending between the elements in the pair. Insertion of the anchoring elements is facilitated, for example, by axial displacement of reciprocating member 414 that can reciprocate in a forward-rearward direction, as represented by arrow 406 ("forward." being the downward direction of arrow 406), thus pushing a first-in-line anchoring element into the tissue.

In case the anchoring elements have a tapered front end, their insertion into the tissue may be facilitated by merely pushing the elements into the tissue by the reciprocating member 414. In an alternative arrangement, the device may comprise a reciprocating puncturing needle or pointed shaft (not shown), which is used to form a puncture through the tissue prior to insertion of the anchoring elements, thus facilitating the insertion of round-edged anchoring elements into the tissue.

As noted above, the actuation arrangement may also permit manipulation of the thread to bring the anchoring elements into proximity one with the other. Thus, the actuation arrangement may be configured for pulling the free end of the suturing thread to proximate the tissue anchoring elements once inserted into the tissue.

Further, the actuation arrangement may also comprise a cutting utility for cutting the free end of the thread after proximating the two tissue anchoring elements to shorten the free end section that protrudes out of the tissue.

Claims

CLAIMS:

1. A tissue suturing unit comprising one or more tissue-anchoring elements and at least one suturing thread coupled thereto, said one or more elements being configured for anchoring in a tissue section to be sutured to another tissues section and said thread being manipulable to proximate the coupled anchoring element to the other tissue section; wherein

the suturing thread has at least one leading free end and is slidably coupled to at least a first of the tissue-anchoring elements such that it can be slid relative the element in a tensioning direction by pulling the leading end thereof and resists displacement in an opposite direction.

2. The tissue suturing unit of claim 1, wherein

the suturing thread follows a tortuous path within at least one of the elements, whereby a first section of the thread bears against a second section of the thread such that once the thread is tensioned the friction between the two sections arrests displacement in the opposite direction.

3. The tissue suturing unit of claim 1 or 2, wherein the elements are elongated along a front-rear axis and the thread is coupled with each of the elements in a cavity within the element through an opening at a mid-portion of an upper end thereof.

4. The tissue suturing unit of claim 1 or 2, wherein

the suturing thread has at least one leading free end and is slidably coupled to at least a first of the tissue-anchoring elements such that it loops about a looping surface formed within the element (e.g. a pivot member), whereby said first section, being a leading section of the thread, that extends between the looping surface and the free end, is in contact with a second section that is a trailing section of the thread, and upon pulling the leading free end the two sections slide in opposite directions one against the other; and wherein

tension in the trailing section pressures the contacted leading section to arrest movement and prevent relative movement of the opposite and contacting thread sections and thereby inhibit tension-release.

5. The tissue suturing unit of any one of claims 2 to 4, wherein

the first and second sections are disposed parallel to one another, and

the arrangement is such that displacement of the first section in the tensioning direction causes displacement of the second section in the opposite direction.

6. The tissue suturing unit of claim 4 or 5, comprising a pair of tissue anchoring elements and at least one suturing thread linking the two such that in use each element of the pair is anchored in a tissue section and the suturing thread, tensioned after anchoring, holds the two tissue section in proximity; wherein

the suturing thread has at least one free end and is slidably coupled to at least one first element of the pair such that it loops about the looping surface, whereby the leading section of the thread, extending between the looping surface and the free end, is in contact with the trailing section of the thread, and upon pulling the free end slide in opposite directions one against the other; and wherein

7. The tissue suturing unit of claim 6, wherein the leading section of the thread comprises an overlapping leading segment and the trailing section of the thread comprises an overlapping trailing segment, such that said contact is formed between the segments.

8. The tissue suturing unit of claim 7, wherein

said at least one first element comprises a strain-inducing member with a curved edge, and

the leading and the trailing section are bent about and strained against the curved edge, such the overlapping leading segment is between the overlapping trailing segment and the curved edge.

9. The tissue suturing unit of claim 8, wherein

said at least one first element has a cavity defined between two opposite lateral sides and having an opening at a top side thereof, and

the looping surface and the strain-inducing member span between the two lateral sides and are spaced (e.g. vertically or horizontally) from one another and defining a passage between them accommodating a portion of the leading section of the thread.

10. The tissue suturing unit of claim 9, wherein the distance between the two lateral sides has a dimension such that the leading and trailing sections of thread cannot be accommodated side-by-side within the cavity.

11. The tissue suturing unit of claim 9 or 10, wherein the looping surface is positioned above the strain-inducing member.

12. The tissue suturing unit of claim 2, wherein the first and second sections have respective first and second portions that are angled and in contact with respect to one another, and wherein,

tensioning of the second section causes the second portion to bear against the first portion to lock the first section in a tensioned state.

13. The tissue suturing unit of claim 11, wherein

said at least one first element has a cavity defined between two opposite lateral sides and having an opening at a top side thereof,

the second thread section is disposed within the cavity in a direction essentially parallel to the two sides, and

the first thread section is disposed, at least partially, so as to pass through one or more bores in the lateral sides.

14. The tissue suturing unit of claim 13, wherein

said first portion passes through said cavity along an axis extending between two lateral openings in the two lateral sides,

tensioning of the second section causes said second portion to press on said first portion in a direction normal to said axis (e.g. causing it to bend off axis).

15. The tissue suturing unit of claim 14, wherein

at least one of the elements is elongated along a front-rear axis and has four lateral bores formed in the lateral sides between the element's exterior and in the internal cavity, including a front bore in one side proximal an upper edge of the element, two opposite central bores in the two opposite sides proximal a bottom edge of the element and a rear bore in the other side than the front bore proximal the upper edge;

said first section extending from a cavity opening at the upper edge into the cavity, out through the front bore, then through the two central bores with a segment defining said first portion spanning the cavity and entering the cavity again through the rear bore; the second section extending from said rear bore, through the cavity under said first portion and out of the cavity through the cavity opening.

16. The tissue suturing unit of any one of claims 6 to 15, wherein the two elements are each coupled to the thread in a slidable and strain-induced movement arresting manner.

17. The tissue suturing unit of claim 16, wherein the two elements are identical.

18. The tissue suturing unit of claim 17, wherein

each of the elements, comprises a cavity defined between two opposite lateral sides and having an opening at a top side thereof, and

a looping surface and a strain-inducing member formed within the cavity and span between the two lateral sides and are spaced from one another to define a passage between them accommodating a portion of the leading section of the thread; and wherein

the thread has a mid-portion that extends between the two elements and two free ends with a leading sections and a trailing sections of the thread defined between the mid portion and each of the free ends.

19. The tissue suturing unit of any one of claims 1 to 18, wherein a second of the two elements is fixedly coupled to an end of a second section of the thread (e.g. a trailing section of the thread).

20. The tissue suturing unit of claim 19, wherein said second of the two elements accommodates and being slidably coupled to a free end section of the thread in a manner permitting tensioning the thread by pulling the free end to thereby proximate the two elements.

21. The tissue suturing unit of claim or 1 or 2, wherein at least one of the elements (typically both) comprise a thread-engaging arrangement permitting a displacement of the thread with respect to the element in one direction and arresting it to move in the opposite direction.

22. The tissue suturing unit of claim 21, wherein the arrangement comprise thread- engaging flaps inclined from a base in said one direction toward a peripheral, thread- engaging end.

23. The tissue suturing unit of claim 22, wherein the thread has a plurality of bulges.

24. The tissue suturing unit of any one of claims 1 to 23, wherein each of the tissue anchoring elements is elongated.

25. The tissue suturing unit of any one of claims 1 to 24, wherein the tissue-anchoring elements are made of a biodegradable material or a biodegradable composition.

26. A device for suturing together two tissue sections, comprising:

a holder holding a plurality of tissue suturing units according to any one of claims 1 to 25; and an actuation arrangement configured for inserting each of the tissue-anchoring elements into a tissue section.

27. The device of claim 26, wherein the actuation arrangement is configured for pulling the free end of the suturing thread to proximate the tissue anchoring elements once inserted into the tissue.

28. The device of claim 27, wherein the actuation arrangement comprises a cutting utility for cutting the free end of the thread after proximating the tissue anchoring elements.

29. A cassette comprising a plurality of tissue suturing units of any one of claims 1 to 25.

30. The cassette of claim 29, for use in a device of any one of claims 26 to 28.

31. A kit comprising the device of any one of claims 26 to 28 and at least one cassette according to claim 29 or 30.