EA040079B1 - SYSTEM FOR LINING HUMAN OR ANIMAL TISSUES - Google Patents

Description

The field of technology to which the invention belongs

The present invention relates to devices and systems for repairing human or animal soft tissue. More specifically, the invention relates to a surgical suture, in particular to an intermittent suture, a suture needle for use with said suture, and a suture device (stapling device) for handling the suture needle.

Prior Art

A surgical suture is used to hold body tissues together after injury or surgery. Sutures or stitches are usually applied using a needle with a piece of thread attached and secured with surgical knots. The interrupted suture method is the most commonly used wound closure method and is characterized by the fact that the individual stitches are not connected, but each stitch is secured with a separate knot. The process of making a knot for each stitch is very time consuming.

The prior art includes CA 2125839 A1 by Feagin et al., which discloses a soft tissue repair system and method that includes a self-locking (barbed) suture anchor attached to at least one seam element. The suture retainer engages with the suture so that the length and tension of the suture can be selectively adjusted before the suture is permanently engaged in the retainer. In use, the self-locking suture anchor and suture are inserted into the soft tissue repair site and across the tear. The suture extends back through the original upstream side of the tear. The retainer is applied to the suture, followed by tension on the suture to draw the sides of the tear into reposition (bring it into contact). Once tensioned, the retainer is permanently attached to the suture to maintain the selected tension and length of the suture.

The prior art also includes WO 2006/079469 A1 by Wohlert et al., which discloses a surgical suture system having a needle-shaped applicator with a tip in its anterior end region, with a surgical suture provided with spikes, which, on the one hand, are preferably directed in the same direction of action from the reference point, and on the other hand, are directed in the opposite direction of action from the reference point and are intended to block the movement of body tissue away from the reference point, and with a casing, the area of the front end of which starts from the region of the posterior end of the applicator, and which surrounds the surgical suture.

The prior art also includes CA 2661709 A1 by Cohen which discloses a suture having a proximal end defining a first outside diameter and a distal end configured to accommodate the proximal end of the suture to form a closed loop stitch (outline).

The prior art also includes Yoon's patent document WO 90/14795 A2 which discloses a suture device consisting of a bioabsorbable material having an elongated body element that has a pointed distal end for tissue penetration and a means of securing said suture. devices in tissues to prevent forward and backward movement, wherein the suture device is made of bioabsorbable material and has a hinge-like loop to fold the distal portion into a precise location adjacent to the proximal portion, allowing for adjustable fixation.

Accordingly, there is still a need to improve the intermittent suture method.

The essence of the invention

An invention that solves the above problems is set forth and characterized in independent claims, while dependent claims describe other characteristics of the invention.

According to one aspect, the invention provides a discontinuous suture that can be easily secured and tightened without the use of a knot, thereby reducing the time it takes to place each stitch.

According to another aspect, the invention provides for a combination of an intermittent suture and a needle, wherein the suture can be easily connected to a surgical needle without crimping.

According to another aspect, the invention provides a suture device (stapling device) that is easy to handle.

According to yet another aspect, the invention provides a suture device for performing interrupted suture stitches that operates in an area with limited space, limited mobility, and limited visualization.

List of figures

These and other characteristics of the invention will become apparent from the following description of various embodiments of the invention, given as non-limiting examples, with reference to the accompanying schematic drawings.

In FIG. 1a and 1b show a perspective view and a side view, respectively, of a suture according to a first embodiment of the invention;

in fig. 2a is a side view of the first end of the suture shown in FIG. 1a, b showing the hook in the unfolded position, while in FIG. 2b and 2c show the hook in the stowed, retracted position;

in fig. 2d-2f are detailed perspective views of alternative embodiments of a suture hook according to the invention;

in fig. 3a is a side view of the first end of an embodiment of a suture according to the invention and shows an alternative embodiment of the hook in the unfolded position, while FIG. 3b shows the hook in the retracted position wrapped around the shaft of the suture;

in fig. 4a-d are side views of alternative embodiments of the second end of the intermittent suture according to the invention;

in fig. 5a, b are end views of alternative embodiments of the movable locking element located at the second end of the discontinuous suture element according to the invention;

in fig. 6a-c are side views of alternative embodiments of the movable locking element located at the second end of the discontinuous suture element according to the invention;

in fig. 7 is a side view of a portion of an intermittent suture according to the invention, illustrating a method of manufacturing a movable locking element and a suture shaft;

in fig. 8a-e are side views, and FIG. 8f is a perspective view illustrating alternative embodiments of an intermittent suture according to the invention;

in fig. 9 is a perspective view illustrating alternative embodiments of a suture according to the invention;

in fig. 10 is a perspective view of a stapler in accordance with one embodiment of the invention;

in fig. 11 is an enlarged view of the area marked A in FIG. 10;

in fig. 12 is a transparent perspective view of a stapler in accordance with one embodiment of the invention;

in fig. 13 is an axial view, seen from the first end, of the stapling device shown in FIG. 10 and 12;

in fig. 14a is a perspective view of a portion of the handle block, and FIG. 14b is a perspective view of an embodiment of the stapler, schematically illustrating the drive connection interface between the handle assembly and the stapler;

in fig. 15 is a perspective view of the assembled handle assembly and the stapling device performing the stapling procedure;

in fig. 16 is a schematic side view of a plurality of stapling devices arranged in a rack and a handle assembly capable of being connected to said stapling devices;

in fig. 17 is a perspective view of a plurality of discontinuous suture members positioned in a clip for insertion into a stapler;

in fig. 18 is a schematic side view of a mechanically operated unified handle unit and stapling device;

in fig. 19 is a perspective sketch of an embodiment of a stapler;

in fig. 20 is an illustration of the operation of an embodiment of a stapling device, showing the three steps of the stapling procedure;

in fig. 21 is a side view of a stapling needle according to one embodiment of the invention, including enlarged views of both ends of the needle;

in fig. 22 is a side view of a stapling needle according to another embodiment of the invention, also showing a cross section of a portion of the needle;

in fig. 23 is a side view of a stapling needle in accordance with yet another embodiment of the invention;

in fig. 24a-c show various cross sections of the stapling needles, FIG. 24a illustrates a solid needle, FIG. 24b illustrates a hollow needle and FIG. 24c - a hollow needle with a slot;

in fig. 25a-b are perspective views of alternative stapling needles in accordance with other embodiments of the invention;

in fig. 26 is a perspective view of a stapling needle according to another embodiment of the invention, also showing a top view of the needle and an exploded view of the tip;

in fig. 27 is a perspective view of a stapling needle in accordance with yet another embodiment of the invention, also showing a perspective view of the needle from below and exploded

- 2 040079 tip view;

in fig. 28 shows the sequence of insertion of the stapling needle according to the first embodiment of the invention into soft tissue;

in fig. 29 shows the sequence of insertion of the stapling needle according to the second embodiment of the invention into soft tissue;

in fig. 30 shows the sequence of insertion of the stapling needle into soft tissue, with the stapling needle then retracted;

in fig. 31a is a side view of an embodiment of an intermittent suture according to the invention, and FIG. 31b, c shows the sequence of closing a gap in soft tissue with a suture;

in fig. 32a is a side view of an embodiment of an intermittent suture according to the invention, and FIG. 32b shows a suture placed in preparation for closing a gap in soft tissue;

in fig. 33a is a side view of an embodiment of an intermittent suture according to the invention, and FIG. 33bc shows the soft tissue gap closure sequence with a suture;

in fig. 34a is a side view of an embodiment of an intermittent suture according to the invention, and FIG. 34b-d illustrate the soft tissue gap closure sequence with a suture;

in fig. 35a is a side view of an embodiment of an intermittent suture according to the invention, and FIG. 35b-d illustrate the soft tissue gap closure sequence with a suture;

in fig. 36a shows a plurality of embodiments of an intermittent suture according to the invention in plan and sectional views, installed in soft tissue prior to gap closure, and FIG. 36b shows, in plan and sectional views, that the gap has been closed by actuating the movable locking element;

in fig. 37 is a side view of a portion of an embodiment of an intermittent suture according to the invention, illustrating the unidirectional movement of the movable locking element;

in fig. 38, 39 and 40 show soft tissue gap closure sequences with alternative fixation devices, methods and element;

in fig. 41 is a sketch of a side view of an alternative suture device, the device being manually operated and configured to insert one discontinuous suture at a time into tissue;

in fig. 42 is a sketch of a side view of yet another alternative suture device, the device being manually operated and configured to be connected to a discontinuous suture clamp;

in fig. 43 is a side view sketch of yet another alternative suture device, the device being manually operated and configured to insert one discontinuous suture at a time into tissue, or manually operated and configured to insert more than one suture at a time, with different sutures connected head to tail, as shown in Fig. 46a;

in fig. 44a and b are perspective views of an alternative embodiment of the invention illustrating an intermittent suture in combination with a surgical needle, the needle being hollow and slit in accordance with the needles of FIG. 24c and 26, in FIG. 44c and d also show two cross-sectional views of the suture-needle combination;

in fig. 45a is a side view of an alternative embodiment of the invention illustrating three discontinuous sutures connected head to tail, in FIG. 45b is a side view of two successive discontinuous sutures connected head to tail and in combination with a suture needle that is hollow and slotted in accordance with the needles of FIG. 24c and 27;

in fig. 46a-d show a combination of an interrupted suture and a needle according to an alternative embodiment of the invention, wherein the needle is positioned within a hollow interrupted suture with the tip of the needle protruding from the tip of the suture. In FIG. 46a and b are perspective views of the combination of suture and needle, and FIG. 46c and d are cross-sectional views of the same suture-needle combination. The stapling needle is solid as shown in FIG. 46d and fig. 24a;

in fig. 47a-c are perspective views of alternative intermittent suture and needle combinations in accordance with alternative embodiments of the invention, the needle tip having a recess further comprising an opening to grip and hold the suture tip in place during insertion of the needle into the skin. In FIG. 47d shows part of the intermittent suture/needle combination in which the movable anchor has a recess to hold the suture in place during insertion of the needle into the skin. In FIG. 47e is a cross-sectional view of the combination of suture and needle at point c;

In FIG. 48a-b are perspective views of an intermittent suture and needle combination in accordance with one embodiment of the invention.

Information confirming the possibility of carrying out the invention

In order to provide the skilled person with a more complete understanding of the invention, the following description provides various examples and embodiments of the invention. The specific details described in the context of various embodiments and with reference to the accompanying drawings should not be construed as limitations. Rather, the scope of the invention is defined by the appended claims.

In the following description, terms such as horizontal, vertical, side, front-back, up-down, top, bottom, inside, outside, front, rear, etc. may be used. These terms generally refer to the views and orientations shown in drawings and related to the normal use of the invention. These terms are used for the convenience of the reader only and are not limiting.

In addition, the term tissue includes, but is not limited to, tissues such as skin, fat, fascia, bones, muscles, organs, nerves or blood vessels, or fibrous tissues such as tendons or ligaments.

The term discontinuous suture is a suture according to the accompanying drawings of FIGS. 1-9, said suture being suitable for use in a suture technique in which the individual stitches are not connected. The simple interrupted stitch is a suture technique often used to close wounds and is most commonly used in skin closure.

The embodiments described below are numbered. In addition, dependent embodiments defined with respect to the numbered embodiments are described. Unless otherwise indicated, any embodiment that can be combined with one or more numbered embodiments may also be directly combined with any of the dependent embodiments of said numbered embodiment(s).

The first embodiment of the invention is a combination of an intermittent suture element and a needle for connecting human or animal tissue, comprising:

a) a discontinuous suture element (10) containing a flexible elongated element (11) having a proximal tip (12) and a distal end (13); while the tip contains two or more anchor hooks (14, 14a, 14b, 14c, 14d) made to secure the suture element in soft tissue, and the second end contains a movable locking element (17, 17a, 17b, 17c, 17d, 17e), wherein the force exerted on the fabric by the hook and the anchor can be adjusted by moving the anchor along at least a portion of the suture, and

b) a stapling needle containing a straight or arcuate body and having a tip (61, 61a, 61b, 61c), additionally containing a sharp cutting edge (63).

In a first appropriate embodiment, the suture consists of a biocompatible, eg, sterilizable, medical grade plastic material, polypropylene, polyester, or polyamide.

In an appropriate embodiment, the suture element may have a shaft (11) containing toothed elements (16) on the entire shaft or at least on a part of the shaft.

In an appropriate embodiment, the suture may have on the head portion (13) a gripping portion shaped to be held and pulled by the user.

In a suitable embodiment, the suture may comprise a recess at one of the hooks suitable for holding the discontinuous suture in its position in the needle during insertion of the suture into tissue.

In an alternative embodiment, two or more sutures may be connected in a head-to-tail configuration.

In an alternative embodiment, the needle may be hollow and have a slit that is sufficiently long and wide, or the needle may be slit along the entire length, or at least a portion of the total length of the needle, for easy insertion of the suture into the needle and for guiding the suture into tissue.

In an alternative embodiment, the tip of the needle may have a structure comprising two or more suture anchor cavities and two or more ridges, the ridges having sharp cutting edges for optimal penetration into the skin.

In an alternative embodiment, the suture element may have an anchor (anchor) structure with two hooks.

In an alternative embodiment, the needle may include a cutting edge (63) on the tip (61), and the tail (69) of the needle has a notch (62) to capture and hold the suture on the hooks of the suture structure to draw the suture into the tissue.

- 4 040079

In an alternative embodiment, the needle may include a notch (64) in close proximity to the tip (61) configured to capture and hold the suture on the hooks of the suture anchor structure and push it into tissue.

In an alternative embodiment, the suture anchor structure may have a T-shape, and the anchor structure additionally contains a protrusion, while the specified T-shaped anchor structure containing the specified additional protrusion is made so that it fits in the specified needle containing a recess, wherein the recess additionally contains an opening for accommodating the protrusion of the suture element.

In an alternative embodiment, one of the hooks of the anchor structure may be configured to fit in said needle containing a recess, the recess further comprising an opening for accommodating a protrusion of the suture.

The second embodiment of the invention is a combination of an intermittent suture element and a needle for connecting human or animal tissue, comprising:

a) a discontinuous suture element (10) containing a flexible elongated element (11) having a proximal tip (12) and a distal end (13); while the tip contains two or more anchor hooks (14, 14a, 14b, 14c, 14d) made to secure the suture element in soft tissue, and the second end contains a movable locking element (17, 17a, 17b, 17c, 17d, 17e), wherein the force exerted on the fabric by the hook and the locking element can be adjusted by moving the locking element along at least a portion of the suture element,

b) a suture needle comprising a straight or arcuate body and having a tip (61, 61a, 61b, 61c) further containing a sharp cutting edge (63), and wherein the suture element is hollow and structured so as to hold the suture needle within the body suture, wherein the tip of the needle protrudes from the tip of the hollow suture.

In the third embodiment of the invention, which can be combined with any of the above embodiments, two handles (54) are additionally provided, mounted on the end portion (69) of the needle, for gripping and holding the stapling needle by the user.

In the fourth embodiment of the invention, the stapling device comprises a combination of an intermittent suture element and a needle, wherein the needle is an arcuate stapling needle rotatably located in the body of the device, a cavity for holding a plurality of suture elements according to the invention, and a drive means for selectively rotating said stapling needle.

In a further embodiment, the stapling device comprises a feeding means by which the suture element can be moved into contact with at least a portion of said stapling needle.

In a further embodiment, the stapling device further comprises a handle portion for detachable connection to the body of the device.

1. Seam

Various embodiments of the discontinuous suture according to the invention will now be described, primarily with reference to FIGS. 1-9.

The suture element 10 according to the invention comprises an elongated element having a shaft 11 and first 12 and second 13 ends. The first end may also be referred to as the tip 12 and the second end as the head 13. As seen in FIG. 1a, b, the tip forms a T-shape formed by a beam element 14 located transversely to the rod. In the future, the beam element may also be referred to as the hook 14 or the anchor 14.

The suture 10, which is intended to be inserted into human or animal soft tissue, consists of a flexible or semi-rigid material that is biocompatible and inherently sterile. A non-limiting example of materials includes polypropylene, polyester, polyamide (nylon), polytetrafluoroethylene, polyester (polyester containing ester groups), medical grade sterilizable plastic material. The suture 10 may be partially made from bioabsorbable materials, including, but not limited to, polydioxanone, polyactide, polyglycolide, polycaprolactone, and their copolymers.

As will be explained later, the anchor 14 is retracted (ie folded or bent) during the insertion of the suture into the tissue. Thus, the suture will pass through the skin and dermis (pierced by the suture needle described below) without causing undue trauma. Examples of such retracted anchor positions are shown in FIG. 2b, c, d, e and f, and in FIG. 2a shows the unfolded position of the anchor. Fig. 2d illustrates an alternative embodiment of the anchor of FIG. 2a and b, with the T-anchor in FIG. 2d has an additional notch 19 designed to keep the anchor connected to the tip 61 of the stapling needle when the needle penetrates the skin or tissue. Fig. 2e illustrates another alternative embodiment of FIG. 2c, in which the anchor has two or three hooks or arms that are used to hold the suture in its position in the needle during skin penetration, as shown in FIG. 45b&c; fig. 2f illustrates another alternative embodiment of the anchor of FIG. 2a and b, in which the T-anchor has an additional protrusion A designed to fit into the hole in the stapling needle as shown in FIG. 47a and b. The protrusion A is located at an acute angle away from the needle tip 61 in order to reduce the diameter of the needle-suture assembly. In FIG. 47c and d show yet another alternative embodiment of the anchor 14, wherein the anchor is in the form of an arrow, on which two hooks forming the head (tip) of the arrow are located at acute angles in the direction from the needle tip, and one of the hooks is made so that it placed in the hole in the stapling needle. Fig. 3a, 3b illustrate an alternative embodiment of the armature 14. In FIG. 3b, the anchor 14d is removed, i.e. wound around part of the stem 11, while in FIG. 3a shows the unfolded position. Once the suture is positioned within the tissue, the deployed anchor 14, 14a, 14b, 14c and 14d can be fixed against the tissue or skin.

The second end of the suture, or head 13, in the embodiment shown in FIG. 1a, b is provided with a gripping part 15 with a hole in it. The gripping portion 15 is shaped to be held and pulled by a person (user) to tighten the fixing plate, as will be described below. The gripping part 15, as well as any excess part of the rod, can be cut off after the installation of the suture element. In FIG. 4a shows an embodiment with a head without any gripping part. However, the head of this embodiment can be grasped and pulled out with tweezers or other suitable tool. In FIG. 4b shows an embodiment having a tapered grip portion 15a. In FIG. 4c shows an embodiment having a flat grip portion 15b. In FIG. 4d shows an embodiment having a flat, tapered grip portion 15c.

Referring again to FIG. 1a, b, it can be seen that the movable locking element 17 is located around the rod 11 near the second end 13 and is configured to interact with the teeth 16 on the rod. This feature is illustrated in Fig. 37, and such a unidirectional locking device is known per se in the art, although not as applied to a suture. Thus, the locking element 17 can move along the rod towards the first end 12, but not in the opposite direction. In FIG. 5a, b and 6a, b show alternative embodiments of such movable locking elements 17a-d. In FIG. 6c shows another embodiment in which the teeth have been replaced by threads 16a and the movable locking element 17c is also threaded. Thus, the movable locking element 17c can move back and forth along the threaded part of the rod 11.

The complete suture 10, including the movable anchor, can be manufactured (eg, molded) in one piece in a manner that is known per se in the art. The seam may, for example, be molded with a crack 18 (or low strength zone) as shown in FIG. 7, and the locking element can subsequently be separated along this crack, after which it can be moved along the rod 11.

It should be understood that the suture 10 illustrated in FIG. 1a, b is just one example of possible embodiments. For example, the entire stem 11 of suture 10a may include barbs (FIG. 8a), or the tip 12 of suture 10b may include one or more hooks 14d (eg, multiple hooks at sharp angles as shown in FIG. 8b). The suture 10c may also have a symmetrical configuration in which the gripping portion 15 and the locking member 17 are located at opposite ends of the suture (FIG. 8c). The stem of the suture member 10d may include serrations on the head portion only, as shown in FIG. 8b, 8d and 8e. Referring to FIG. 9, it can be seen that the seam member 10e need not have a circular cross section, but may have a rectangular cross section (eg with teeth 16b on opposite sides of the step and the rectangular retainer 17e) or any other cross sectional shape. The locking element 17 may also have a recess, as shown in FIG. 8f.

It should be understood that these various features may be used interchangeably, depending on the particular application of the suture. However, a common key feature is the locking/tightening mechanism in the form of a movable locking element 17 whereby the suture can be installed and re-tightened if necessary.

2. Stapler

Various embodiments of the stapling device according to the invention will now be described, mainly with reference to FIGS. 10-20.

The stapler and the fastener cartridge 40 are comprised in the embodiment shown in FIG. 10-13, an outer housing 41 and a drive unit 42. A clip 20 (see also FIG. 17) holding a plurality of seam members 10 (in principle any of the embodiments described above) is located within the housing and biased by a spring element 44 (FIG. . 12) which will try to push the suture clamp against the opening 47 of the body. Drive unit 42 drives (via shafts 46) a plurality of drums 43 located in or near housing opening 47, where

Also located is a curved stapling needle 60. The stapling needle 60 forms part of a circle in the illustrated embodiment and is rotated by the drums 43. Thus, the stapling needle 60 can be rotated around the longitudinal axis of the stapler by the drive unit and the drums.

As will be described in more detail below, a stapling needle suitable for use with the device described above includes a recess 64, in the illustrated embodiment, proximate the needle tip 61. Thus, during operation, the recess 64 in the rotating needle captures the hook (or anchor) 14; 14c on the suture 10 pushed into the hole 47 and pulls the suture out of its clamp (and into the tissue, as will be described below).

It should be understood that other means than those described and illustrated may be used to rotate the stapling needle. The device can be configured and controlled to rotate the needle (ie so that the needle makes a full turn) or move back and forth along its circular path.

It should also be understood that the drive unit may be powered by any known and suitable power source such as a pneumatic device or an electric motor (not shown). The electric motor can be powered by a battery or contain a cable for connection to the electrical network. In one embodiment, the power supply may be housed in separate, removable units, such as the handle unit 45, see FIG. 14 and 15.

In FIG. 14a, b show the drive connection interface between the handle unit 45 and the stapler 40. The switches, push buttons, etc. necessary to control and adjust the stapler are not illustrated as they are well known in the art.

In FIG. 16 shows that this modular design allows a user to store multiple stapler clip-on cartridges 40, for example, in a rack 48. The staplers can be disposable and the handle (including the power pack) can be reused.

In another embodiment, illustrated in FIG. 18, the handle unit 45 and the stapling fastener cartridge 40 can be made as one single unit and, for example, be mechanically controlled by the trigger 49.

In FIG. 19 shows an embodiment of a stapling device comprising a gap closing device 51 which is connected to the body 41 via a hinge loop or other flexible articulation 50. In the inactivated state, a distance d is formed between the gap closing device 51 and the body part, which is greater than the tissue gap to be closed. Therefore, in use, the body is placed on the gap or scar to be sutured, and the gap closing device 51 is pressed against the body (reducing the distance d) and thereby pinching the skin to keep the gap closed while the suturing procedure continues.

3. Stapling needle

Various embodiments of the stapling needle 60 according to the invention will now be described, primarily with reference to FIGS. 21-27. An embodiment of a needle 60 comprising an arcuate needle with a tip 61 is shown in FIG. 21-23 and 25. The tip 61 may have a sharp cutting edge 63 for optimal skin penetration. Both needle embodiments shown in FIG. 21 and FIG. 22 include a notch 62 at the opposite end of the ferrule that is configured to grip the suture and draw it out of the stapler and into tissue. It should be understood that the notch may be located elsewhere on the needle 60. The needle embodiment shown in FIG. 22 further comprises a cutting edge 65 along an outer convex curvature.

The needle embodiment shown in FIG. 23 and 25 includes a notch 64 proximate the tip, configured to grip the suture and push it out of the stapler and into tissue. The needle embodiments shown in FIG. 25a and b further include an opening 64a to retain the suture when the needle is penetrating the skin. An embodiment showing the combination of needle and suture is further illustrated in FIG. 47. The needle in FIG. 25b has a recess 64, the recess having an inclination towards the opening 64a, or an appropriate angle of inclination.

It should be understood that the needle may be straight or curved, and that the entire or partial cross section of the needle may be solid, hollow, or slotted 66 as shown in FIG. 24a-c, respectively.

Embodiments of hollow needles are illustrated in FIG. 26 and 27 and contain a slot 66 along the entire length or at least part of the total length of the needle and have a tip 61a or 61b. The tip 61a or 61b includes a retaining structure consisting of depressions between ridges to hold the suture. The combs contain sharp cutting edges 63a for optimal penetration into the skin. The needle tip embodiment of FIG. 26 includes two troughs 67 and three ridges 68 for holding the suture with the anchor structure of FIG. 8e, having three arms. The needle tip embodiment of FIG. 27 contains one depression 67 between two ridges 68

- 7 040079 for holding the T-shaped suture in FIG. 8d, having two arms and a notch. The number of ridges and valleys on the tip of the needle may vary according to the invention and depends on the design and number of hooks on the anchor structure.

4. Ways of working inventions

Various uses of the inventions will now be described, mainly with reference to FIGS. 28-40.

In FIG. 28 shows the sequence of insertion of the suture needle 60, having a recess near the rear end of the needle (see Fig. 21 or 22), that is, by pulling the suture 10 from the stapler (not shown in Fig. 28), into the soft tissue T to close the gap G. The figure also shows how the needle 60 completes a full turn and is positioned to pick up the next suture in the clip after completing the turn.

In FIG. 29 shows the sequence of inserting the suture needle 60, which has a recess near the tip of the needle (see FIG. 23), that is, by pushing the suture 10 out of the stapler (not shown in FIG. 26), into the soft tissue T to close the gap G. The figure also shows how the needle 60 completes a full turn and is positioned to pick up the next suture in the clamp after completing the turn.

In FIG. 30 shows the sequence of insertion of the suture needle into soft tissue, with the suture needle not completing a full turn but retracting (as indicated by arrows) after the suture is placed in the tissue.

As mentioned above, the suture is designed to be inserted into the soft tissue T of the animal and is made of a flexible material that is biocompatible and inherently sterile. The entire suture, or portions thereof, may be made of an absorbable material.

In FIG. 31b, an embodiment of the suture according to the invention has been inserted into the tissue spanning gap G. In FIG. 31c, the movable locking device has been moved along the suture 10 to tighten the tissue and close the gap G. The hooks 14d are in the unfolded state and are inside the soft tissue T. The corresponding setting is illustrated in FIG. 32b, in which the suture was placed in preparation for closing the tissue gap.

In FIG. 33a-35d show other embodiments of a suture according to the invention installed in tissue. In FIG. 36a shows a plurality of sutures placed in soft tissue prior to closing gap G, and FIG. 36b shows that the gap has been closed by actuating the movable locking elements 17.

In FIG. 34, 35, 36, 38, 39, and 40 show soft tissue gap closure sequences with alternative fixation devices, methods, and element. In FIG. 38, a cable tie-like version of the suture is inserted into the tissue and then tightened to close the tissue gap. In FIG. 39, a twisted version of the suture is inserted into the fabric and the ends are twisted together to close the gap. In FIG. 40, a locking device 52 is used to secure the suture and close the gap. It should be understood that these suture variants can be placed using the stapler and needle described above.

5. Other suture devices

In FIG. 41 shows an alternative embodiment of the suture device, the device being manually operated and configured to insert one suture at a time into tissue.

In FIG. 42 shows an alternative suture device in which the suture is pushed through a hollow needle by an inner shaft (not shown) connected to a trigger 53 in the handle. A spring (not shown) resets the trigger and stem and pulls the next suture out of the clip and into the tubular needle.

In FIG. 43 shows an alternative suture device, the device being manually operated and configured to insert one suture or more than one suture (illustrated in FIG. 45) into tissue at a time. The suture 10 is placed in a hollow needle having a slot along the entire length of the needle, as shown further in FIG. 44. The device is controlled by the user holding the two handles 54 and inserting the needle into the tissue. The two handles 54 are grasped by the user and moved towards each other to obtain a good and easy grip when manipulating the stapler. When the needle is pulled out of the tissue, the suture stays in the tissue due to its hooks (or anchor).

6. Alternative combinations of suture and needle

A common feature of the alternative suture and needle combinations shown in FIG. 44-47 is that the anchor 14 on the tip 12 of the suture is designed to fit a particular needle design to facilitate assembly of the suture and needle and to reduce the diameter of the suture and needle combination.

In FIG. 44-47 show preferred combinations of intermittent sutures and needles. The suture and needle combinations shown in FIG. 44 and 45 can be used with the stapler shown in FIG. 43. In FIG. 44 shows an embodiment containing

- 8 040079 combination of a suture and a needle, in which the needle 60 is hollow and contains a slot 66 along the entire length or at least part of the total length of the needle. The slot can be used to easily insert the suture into the needle and to guide the suture when the combination of the suture and needle is inserted into human or animal tissue. The needles in Fig. 44 and 45 may further comprise two or more needle tip cavities 68 which, together with the formed ridges 67, engage to hold the suture anchor in place during insertion of the needle into tissue. In FIG. 45a shows an alternative embodiment in which two or more discontinuous sutures are joined head to tail to insert two or more successive sutures into a cannula having slot 66, FIG. 45b.

In FIG. 46 shows an alternative combination of suture and needle, wherein the suture 10e is hollow and surrounds the suture needle 60, with the tip of the needle protruding from the tip of the suture and the tip of the suture containing hooks that are deployed when the suture is placed in tissue.

In FIG. 47 shows another intermittent suture and needle combination in which the anchor 14 of the suture 10 is connected to the needle in a recess 64 located in the needle tip during insertion of the needle into tissue. This combination of suture and needle can be used with a stapler as shown in FIG. 10-20. The recess 64 in the needle tip further includes an opening 64a for grasping and holding the suture anchor 14 in place during insertion of the needle into the skin. The movable locking member 17 may include a recess for holding and guiding the head of the suture toward the needle as the needle and suture are inserted into tissue, FIG. 47d. In FIG. 47c and d show an alternative embodiment of the suture and needle combination of FIG. 47a and b, wherein the suture may have an arrow anchor 14, with one of the arrow hooks configured to fit in needle hole 64a to hold the suture attached to the needle during insertion into tissue.

Fig. 48a and 48b illustrate another intermittent suture and needle combination, including a suture 10 and a suture needle 60. FIG. 48a, the interrupted suture 10 and the suture needle 60 are assembled, and in FIG. 48b, the discontinuous suture 10 and the suture needle 60 are disassembled for illustration. The suture 10 includes a proximal tip 12 and an anchor 14. The suture needle 60 includes a tip 61. The tip 61 is capable of being inserted through the proximal tip 12, but the suture needle 60 cannot pass through the proximal tip 12. The locking member 70 may prevent the stapling needle 60 from passing through. through the proximal tip 12. The locking element 70 may be a step, a protrusion, an increase in the thickness of the body part of the needle 70, etc.

In exemplary embodiments, various features and details are shown in combination. The fact that several features are described with respect to a particular example should not be construed as implying that these features must necessarily be included together in all embodiments of the invention. Conversely, features that are described with reference to various embodiments should not be construed as mutually exclusive. As those skilled in the art will readily appreciate, embodiments that include any subset of the features described herein and that are not explicitly interdependent are intended by the present inventor and are part of the intended disclosure. However, an explicit description of all such embodiments would not be helpful in understanding the principles of the invention and therefore some permutations of features have been omitted for the sake of simplicity or brevity.

List of reference designations

- Seam element

- rod

- First end or tip or proximal end

- Second end or head or distal end

- Anchor (anchor)

- gripping part

- teeth

- Movable locking element

- Crack

- notch

- Shop

- Clip-on cartridges

- Outer case

- Drive unit

- Drums

- Handle block

- Housing hole

- Rack

- 9 040079

- Starting device

- Swivel hinge or flexible swivel

- Gap closing device

- fixing device

- Starting device

- Handles

- Stapling needle

- Tip or head

- Notch at the back end of the needle

- cutting edge

- Notch near the tip

64a - Slit

- cutting edge

- slot

- Combs

- depression

- Tail section, end section

- locking element

Claims (7)

CLAIM 1. A system for stitching human or animal tissue, comprising: a) at least one suture element (10) containing a flexible elongated element (11) having a proximal tip (12) and a distal end (13); at the same time, the proximal tip (12) contains two or more anchor hooks (14) made to secure the specified at least one suture element in the tissue, and limits the channel, while the distal end (13) contains a movable fixing element (17, 17a , 17b, 17c, 17d, 17e), configured to abut against the tissue, wherein the force exerted on the tissue by the hook and the locking element is adjustable by moving the locking element along at least a portion of said at least one suture element, and b) a stapling needle (60) containing a straight or arcuate body and having a tip (61) and an end part (69), and the tip (61) additionally contains a sharp cutting edge (63), characterized in that the tip (61) is made with the possibility of insertion through the specified channel in the proximal tip (12) of the specified at least one suture element (10), and at the same time, a locking element (70) is provided, configured to prevent the passage of the stapling needle (60) through the proximal tip (12). 2. The system according to claim 1, in which the locking element (70) contains a step, ledge or increase in the thickness of the body part of the stapling needle. 3. The system according to claim 1 or 2, wherein said at least one suture (10) consists of a biocompatible material, such as medical grade sterilizable plastic material, polypropylene, polyester or polyamide. 4. System according to any one of claims 1 to 3, wherein said at least one seam element (10) having a shaft (11) comprises toothed elements (16) on the entire shaft or only on a part of the shaft. 5. The system according to any one of claims 1 to 4, wherein the distal end (13) of said at least one suture (10) has a gripping portion (15) shaped to be held and pulled by the user. 6. System according to any one of claims 1 to 5, wherein the proximal tip (12) of said at least one suture element (10) has an anchor structure with two anchor hooks (14). 7. The system according to any one of claims 1 to 6, further comprising two handles (54) mounted on the end portion (69) of the stapling needle (60) for gripping and holding the stapling needle by the user.