CN115192108A

CN115192108A - Wound closure system and method

Info

Publication number: CN115192108A
Application number: CN202210404114.7A
Authority: CN
Inventors: 薛利刚; 刘德鹏
Original assignee: Huarong Kechuang Biotechnology Tianjin Co ltd
Current assignee: Huarong Kechuang Biotechnology Tianjin Co ltd
Priority date: 2022-04-18
Filing date: 2022-04-18
Publication date: 2022-10-18

Abstract

The present invention provides a wound closure system and a method of reducing an open wound. In particular, sutures are used to pass through body tissue adjacent an open wound, and the suture may be passed into and out of the body tissue and include a plurality of outwardly extending barbs that are at an acute angle to the suture surface. The force applying member applies continuous tension on the suture to stretch the body tissue toward the open wound, and is characterized in that during stretching, the force applying member tightens the suture with evidence of loosening to maintain the suture in a taut state.

Description

Wound closure system and method

Technical Field

The present invention relates to the field of skin repair. And more particularly to a wound closure system and method that can facilitate stretching of body tissue adjacent a wound with continuous or dynamic force to effect wound closure.

Background

Surgical operations such as tumor resection or fasciotomy can cause extensive skin trauma, and chronic wounds such as diabetic ulcers generally cannot heal, and medical techniques for promoting closure of extensive skin defects and closure of chronic wounds have been developed.

Wounds and skin defects are often progressively closed by skin graft closure, flap closure, and by tissue dilation. Medium-thickness skin graft involves removing a portion of the skin layer from the donor area (usually the thigh) and leaving the dermis at the donor area to regenerate the epithelium. Such a suitable patch of repair skin may be placed over the wound area by transfer or implantation. The implanted flap is typically a mesh-like (comprising cutting the skin in a series of offset longitudinal cross-cuts) and stretchable flap to cover an area two to three times larger than the wound and to ensure wound drainage while healing. Normal biological function of the skin promotes wound healing after transplantation. This type of reticulated graft requires a smaller donor area than conventional non-reticulated or full-thickness grafts. Flap closure refers to the transfer of skin from adjacent areas to the wound and is therefore only effective for anatomical areas suitable for transferring adjacent skin. Flap closure is a more complex surgical procedure that adds to the cost and risk of the procedure. Both methods do not achieve optimal cosmetic results and the skin coverage quality is not high. At the same time, they can also cause pain in the donor area, causing new disfigurement, with complications resulting from incomplete "resorption" of the graft. In addition, skin grafting generally requires immobilization of the limb, increasing the possibility of contracture, and additional surgery and prolonged hospital stay also impose additional economic burdens on the subject.

Another method of closing a wound is a gradual or progressive closure method. This technique may require suturing the vascular rings to the wound margins and pulling them together with large sutures in a manner similar to tying laces. In addition, the wound edges can be gradually pulled close with sutures or sterile paper tape. The progressive technique has the advantages of no need of obtaining graft skin from donor parts, keeping limb mobility, achieving satisfactory beautifying effect, realizing more durable skin coverage and the like. Meanwhile, the technology adopts full-thickness skin sheets, so that the skin can be better protected, and normal skin feeling is realized.

However, there are a number of disadvantages with existing devices for achieving progressive closure. Current methods and devices require the use of static or elastic surgical tape or suture material, and the relatively small area of skin movement essentially eliminates most of the closing force, which necessitates repeated adjustments of the tape or suture material to draw the wound edges together. However, even with constant readjustment, it is difficult to maintain an almost constant tension over time. Current popular closure techniques use relatively inelastic materials such as sutures, medical tape, and the like. Thus, these materials exert a large pulling force on the wound edges when periodically adjusted, so that the necessary closing force is obtained. Excessive tension has problems of cutting the skin or causing necrosis due to point loading of the tissue.

There is a need in the art for a progressive wound closure technique that uses continuous or dynamic tension to draw the wound edges together and which can be automatically adjusted and adjusted without the need for constant adjustment of a static system.

Disclosure of Invention

The present invention overcomes the deficiencies of the prior art and provides a wound closure system and method.

The purpose of the invention is realized by the following technical scheme.

A wound closure system comprising a suture for suturing body tissue adjacent an open wound, the suture being passable into the body tissue and passable out through the body tissue, the suture comprising a plurality of outwardly extending barbs, the barbs being at an acute angle to the suture surface; and a force applying member for applying a continuous pulling force on the suture to stretch the body tissue towards the open wound, characterised in that during the stretching process the force applying member tightens the suture with evidence of loosening to maintain the suture in a taut condition.

The suture includes a force applying member.

The force applying member comprises a spring.

Also included is a housing containing the spring, the housing including a spool rotatably connected thereto, the spool being connected to the spring, the wound spring exerting a continuous pulling force on the suture.

The housing and spring include cooperating structure for winding the spring that slides relative to one another when the spring is fully wound, thereby indicating that the spring is fully wound.

The engagement structure includes radially aligned vertical grooves in the housing and a radially outwardly projecting tab of the spring.

The housing includes a second thread wound on the spool that is removably coupled to the suture to apply a continuous pulling force to the suture.

The suture is removably connected to a second thread by a ball/socket joint.

The housing includes a button that can be pushed in the longitudinal direction of the spool to release the continuous pulling force.

A method of reducing the size of an open wound by drawing body tissue adjacent the open wound toward or into the open wound, comprising passing a suture through the body tissue adjacent the open wound, into the body tissue and out, the suture having a plurality of outwardly extending barbs, the barbs being at an acute angle to the suture surface; and a force applying member for applying a continuous pulling force on the suture to stretch the body tissue toward the open wound, the force applying member automatically applying a continuous pulling force during the stretching of the body tissue.

Also included is threading the suture through the body tissue around the entire circumference of the open wound.

No portion of the force applying member is around the open wound.

Also included is passing the suture through the body tissue to suture in a manner similar to lacing, wherein a portion of the suture is passed through the open wound at least twice.

No portion of the force applying member is around the open wound.

The force applying member is separate from the suture.

The force applying member is a spring.

Further comprising providing a continuous pulling force on the suture in the direction of the barbs to thread the suture through the body tissue with the barbs passing through the body tissue.

Further comprising providing a continuous pulling force on the suture in a direction opposite the barbs, causing the barbs to hook into the body tissue and pull the body tissue toward or into the open wound.

The barbs are resilient and can flex toward the suture surface as the barbs enter body tissue and can flex outward away from the suture surface as the barbs exit body tissue.

The barbs are resilient and can flex toward the suture surface when the barbs enter body tissue and flex outward away from the suture surface when the barbs exit the body tissue.

The beneficial effects of the invention are as follows: sutures are used to suture through body tissue adjacent an open wound, and the sutures may be passed through the body tissue and threaded out of the body tissue, which includes a plurality of outwardly extending barbs oriented at an acute angle to the suture surface. The force applying member applies continuous tension on the suture to stretch the body tissue toward the open wound, and is characterized in that during stretching, the force applying member tightens the suture with evidence of loosening to maintain the suture in a taut state.

Drawings

FIG. 1 is a perspective view of a wound closure system according to the principles of the present disclosure;

FIG. 2 illustrates operation of the wound closure system of FIG. 1 in the vicinity of a wound;

FIG. 2A illustrates the operation of the staggered wound closure system of FIG. 1 in the vicinity of a wound;

FIG. 3 is an exploded perspective view of the tensioning device of the wound closure system of FIG. 1;

FIG. 4 is a cross-sectional view of the tensioning device of FIG. 3, taken along line 4-4 of FIG. 3, showing the knob in the tensioning device in a fully ejected position;

FIG. 5 is a cross-sectional view similar to FIG. 4 showing the knob with the tensioning device in a fully depressed position;

FIG. 6 is a side view of the tensioner reel of FIG. 3;

FIG. 7 is a top view of the spool of FIG. 6;

FIG. 8 is a bottom view of the spool of FIG. 6;

FIG. 9 is a cross-sectional view taken along line 9-9 of FIG. 7;

FIG. 10 is a cross-sectional view taken along line 10-10 of FIG. 8;

FIG. 11 is a top perspective view of the lower cover of the tensioning device of FIG. 3;

FIG. 12 is a bottom perspective view of the lower cover of FIG. 11;

FIG. 13 is a top view of the lower cover of FIG. 11;

FIG. 14 is a bottom view of the lower cover of FIG. 11;

FIG. 15 is a side view of the lower cover of FIG. 11;

FIG. 16 is a cross-sectional view taken along line 16-16 of FIG. 13;

FIG. 17 is a top perspective view of a force applying member of the tensioning device of FIG. 3;

FIG. 18 is a top plan view of the biasing member of FIG. 17;

FIG. 19 is a side elevational view of the force applying member of FIG. 17;

FIG. 20 is a top perspective view of the knob of the tensioning device of FIG. 3;

FIG. 21 is a bottom perspective view of the knob of FIG. 20;

FIG. 22 is a top view of the knob of FIG. 20;

FIG. 23 is a bottom view of the knob of FIG. 20;

FIG. 24 is a cross-sectional view taken along line 24-24 of FIG. 22;

FIG. 25 is a top perspective view of the tensioning device cover of FIG. 3;

FIG. 26 is a bottom perspective view of the cover of FIG. 25;

FIG. 27 is a top view of the cover of FIG. 25;

FIG. 28 is a bottom view of the cover of FIG. 25;

FIG. 29 is a cross-sectional view taken along line 29-29 of FIG. 28;

FIG. 30 is a front view of the cover of FIG. 25;

FIG. 31 is a top perspective view of the locking button of the tensioning device of FIG. 3;

FIG. 32 is a bottom perspective view of the locking button of FIG. 31;

FIG. 33 is a rear elevational view of the lock button of FIG. 31;

FIG. 34 is a bottom view of the locking button of FIG. 31;

FIG. 35 is a cross-sectional view taken along line 35-35 of FIG. 34;

FIG. 36 is a side view of a locating pin placed between the knob and spool of the tensioning device of FIG. 3;

FIG. 37 is a side elevational view of a linear spring disposed around the alignment pin of FIG. 36 and disposed between the knob and the spool of the tensioning device of FIG. 3;

FIG. 38 is a top perspective view of a skin anchor which can secure the tensioning device of FIG. 3 to body tissue surrounding a wound;

FIG. 39 is a top perspective view of another embodiment of a skin anchor that can secure the tensioning device of FIG. 3 to body tissue surrounding a wound;

fig. 40-42 are exemplary illustrations of one attachment method showing how the barbed suture of the wound closure system of fig. 1-2 is attached to a tensile cord. This tension wire is wound around the take-up spool in figure 3;

FIG. 43 is a schematic view of a knob with indicating marks;

FIG. 44 is a rear elevational view of the indicating identification knob;

FIG. 45 is a top view of the knob with the indicator markings;

FIG. 46 is a side view of a knob with indicator markings.

Detailed Description

The technical solution of the present invention is further illustrated by the following specific examples.

The principles disclosed herein relate to closing a wound by promoting stretching of body tissue. The present invention relates to a system and method that can facilitate stretching/expanding body tissue in the vicinity of a wound by using dynamic or continuous forces.

According to the present invention, "body tissue" may refer to human or animal tissue, including internal and external tissues, such as skin tissue (epidermis and dermis), subcutaneous tissue, fascial tissue, organ tissue, and the like.

The present invention relates to a wound closure system that includes a means for applying dynamic or continuous tension to sutures of body tissue surrounding a wound. The dynamic tension pulls the suture toward the wound closure system, helping to stretch the body tissue in the wound area.

In a particular aspect, the present invention relates to a wound closure system including a force applying member that applies a dynamic or continuous pulling force to a suture of body tissue surrounding a wound, and the suture is used with a plurality of barbs to hook the body tissue. One embodiment shows that the barbed suture extends substantially around the entire perimeter of the wound and that application of force to the suture pulls the body tissue toward the wound and stretches it. Another example shows that when using a wound closure system, sutures may also be used in a lace-like fashion across the wound to suture body tissue surrounding the wound.

In another particular aspect, the force applying member providing tension to the barbed suture may be part of a single tensioning device that may be fixedly attached near the wound area. In other embodiments, the tensioning device may be fixedly attached at a region slightly distal to the wound while dynamic tension is directed to the wound area.

In a particular aspect, the wound closure system is not provided with a separate tensioning device, but rather is attached to the barbed suture using a thread comprising an elastic material, or the barbed suture itself is elastic, thereby providing dynamic tension to the body tissue surrounding the wound. Furthermore, the elastic threads or elastic sutures may be used in conjunction with a separate tensioning device.

In another particular aspect, the invention relates to a method of wound closure comprising the steps of: the body tissue surrounding the wound is closed using a barbed suture and a dynamic or continuous pulling force is applied to the suture, thereby stretching the body tissue in the direction of the wound.

In yet another particular aspect, the present invention relates to a wound closure kit including a barbed suture for attachment to body tissue surrounding a wound and a force applying member that provides continuous or dynamic tension to the suture to stretch the body tissue.

Wound closure system

Fig. 1-2 illustrate one embodiment of a wound closure system 10, the wound closure system 10 may represent an innovative feature of the present disclosure. The wound closure system 10 includes a suture 12 with a plurality of barbs 13 distributed around the suture 12. As shown in FIG. 2, the barbed suture 12 is used to suture body tissue around a wound 14. The barbed suture 12 is provided with a needle 16 at the end, which allows suturing of the suture 12 to body tissue. After being sutured around the wound area 14 with suture 12, the needle 16 may be removed and the two ends brought together to form a closed loop around the wound area 14, as shown in fig. 2.

The wound closure system 10 shown in fig. 1-2 is provided with a tensioning device 18 that applies a dynamic or continuous pulling force to the barbed suture after the body tissue surrounding the wound 14 has been sutured with the suture 12. At this point, the body tissue stretches toward or covers the wound area 14 to reduce the size of the area.

One embodiment of the wound closure system 18 suture shows that the barbs 13 of the suture 12 may be unidirectional such that all of the barbs 13 are at an acute angle to the longitudinal axis of the suture 12 and extend in the same direction.

As described below, suture 12 may have two lengths of barbs 13, with all barbs 13 in a first length extending at an acute angle in a first direction and all barbs 13 in a second length extending at an acute angle in a second direction that is opposite the first direction. For example, such sutures may be used to suture body tissue contralateral to the wound 14 from the same point to the opposite end of the wound 14. If the tensioning device 18 is illustrated as a single line with the barbed suture 12, as shown in FIG. 1, the suture may include two barbs as described above. However, the embodiment shown in FIG. 1 includes two separate sutures 12 attached to a spool within the tensioning device 18 and separately wound within the tensioning device 18, as will be discussed in further detail below.

The barbs 13 of the barbed suture 12 may be resilient so as to flex toward the surface of the thread when sutured, thereby passing through body tissue. When barbs 13 pass through the body tissue and exit the other side of the body tissue, if suture 12 is pulled in the opposite direction, barbs 13 will again bend outward from the suture surface and hook into the body tissue. In this manner, the barbed suture 12 may be used to suture body tissue like a conventional suture, and may prevent the suture 12 from backing out while passing through body tissue.

It should be noted that the wound closure system 10 may apply tension on the suture 12 in either direction relative to the barbs 13. For example, if tension is applied in the direction of the barbs 13, the barbed suture 12 operates in a manner similar to a conventional suture-pulling or pulling both sides of the body tissue through the body tissue to the open wound area 14. However, as noted above, barbs 13 may still prevent suture 12 from backing out during initial suturing of body tissue. If the pulling force exerted by the wound closure system 10 is in the opposite direction of the barbs 13, body tissue may be grasped by the barbs 13 and stretched or pulled toward the open wound area 14. The embodiment illustrates that the tensioning device 18 of the wound closure system 10 may further comprise a single wire 22 wound within the tensioning device 18 and connectable to the barbed suture 12. In the present disclosure, the wire is a tension wire 22. Fig. 40-42 demonstrate the method of attaching the barbed suture 12 to the tension wire 22 that has been wound within the tensioning device 18. As shown in one embodiment in fig. 40-42, one end of the barbed suture 12 may include a crimp 24. The end containing the crimp structure may be the end with the needle 16 or the opposite end. The crimp 24 is inserted into a socket 26, which socket 26 is connected to one end of the tension wire 22 wound within the tensioning device 18. Further details of such a connection system will be discussed further below. Other methods of attaching the barbed suture 12 to the tension wire 22 (wound on the spool 20 in the tensioning device 18 of fig. 3-5) may also be used, such as tying knots in the barbed suture 12 and the tension wire.

Although the embodiment of the wound closure system 10 shown in fig. 1-2 includes a separate tensioning device 18, the wound closure system may use only elastic threads attached to the barbed sutures 12. In other embodiments, the barbed suture 12 is elastic and may be used directly as an elastic thread to provide a pulling force that exerts a dynamic pulling force on the body tissue surrounding the wound 14. The elastic thread or elastic suture may also be used in combination with a separate tensioning device 18 as shown in fig. 1-5.

Since the tensioning device 18 is provided with a force applying member that can provide the dynamic or continuous force required for wound closure, the body tissue can be pulled toward the wound 14 with a separate tensioning device 18, either with the inelastic thread 22 attached to the barbed suture 12 or with only the inelastic barbed suture 12.

The embodiment shows that the tensioning device 18 includes a force applying member 30 (shown in FIGS. 3, 17-19) mounted within it that can provide dynamic or continuous tension on the barbed suture 12. Body tissue stretches and grows around the wound 14, moving toward the wound area, reducing the size of the open wound area 14, while also reducing the tension on the barbed suture 12, causing the suture 12 to "relax". The force applying member 30 may provide tension to tighten the slack suture 12. Although the biasing member 30 is shown in a coil spring configuration in fig. 3 and 17-19, it may have other configurations. The force applying member 30 may be designed as a constant force spring that provides a constant level of tension on the

wires

12, 22 when under load. The force applying member 30 may also be designed as a non-constant force spring, providing different amounts of force to the

wires

12, 22 depending on how tightly the spring is wound.

Those skilled in the art will recognize that the force characteristics of such springs depend on such factors as the mechanical properties of the spring.

In certain embodiments, the pulling force exerted on the barbed suture 12 is generally at least 0.3N and no more than 18N, and is typically between 8.5 and 14N.

If a separate tensioning device 18 is used in the wound closure system, the tensioning device may be secured to the patient by mechanical attachment means (e.g., adhesive, sutures, or other means), as will be discussed in more detail below. The tensioning device 18 may also be placed near the wound area 14 or away from the patient's body, but the tension is still directed to the wound area 14.

The wound closure system 10 may be used to close wounds of almost any size, depending on the wound placement (e.g., using multiple tensioning devices) and the use of barbed sutures.

Tension device

Fig. 3 shows an exploded perspective view of the tensioning device 18 of the wound closure system 10. The take-up device 18 includes a lower cover 40, a cover 50, a spool 20 on the lower cover 40, a force applying member 30 disposed around the spool 20, a knob 60 for winding the force applying member 30 to apply a pulling force, and a linear spring 70 disposed around a positioning pin 80, the positioning pin 80 being located between the knob 60 and the spool 20. The linear spring 70 provides an upward pulling force and allows the knob 60 to be pushed downward relative to the cover 50, disengaging the knob 60 from the cover 50 and rotating in a counterclockwise direction so that the suture 12 can be drawn out of the tensioning device. This will be discussed in further detail below. This may be advantageous during initial setup or during removal of the system from the wound area 14. Fig. 4-5 illustrate the operation of the linear spring 70 and the interaction between the knob 60 and the cover 50.

Fig. 6-10 generally illustrate the spool 20 of the take-up device 18. The bobbin 20 includes an upper spring seat 21, a lower bobbin 23, and a main plate 25 separating the two parts. In this embodiment, all of the portions of the spool 20 are formed from one unitary piece, but it should be understood that in other embodiments, the spool may be formed from multiple separate pieces that are connected together.

Upper spring seat 21 is generally cylindrical and includes a slot 27 adapted to receive one end of a force applying member 30, which will be discussed in further detail below. Upper spring seat 21 also includes a bore 19 for receiving linear spring 70 (see fig. 4-5 and 37). The bore 19 is not a through-hole structure and includes a closed bottom within the upper spring seat. When the linear spring 70 is placed within the bore 19, a portion of the spring 70 may extend upwardly out of the bore 19.

The lower tension wire frame 23 defines two winding

slots

9 and 11. The lower winding groove 9 is defined between two seat plates, i.e., the lower seat plate 1 and the upper seat plate 3. The upper winding groove 11 is fixed between the main plate 25 and the upper seat plate 3. The seat plates 1, 3 provide a structure for seating the spool 20 in the lower cover 40 of the take-up device 18. The bobbin 20 also defines an upper opening 5 through the upper seat plate 3 and a lower opening 7 through the lower seat plate 1. The openings 5, 7 of the seat plates are aligned to define a large opening through the plates 1, 3 and to guide one or

more wires

12, 22 for use between the upper and lower winding

slots

11, 9 of the reel 20.

After inserting the

wires

12, 22 into the 5, 7 openings, the sutures can be tied or a crimp tube of sufficient size can be used so that the tied or crimped ends of the

wires

12, 22 do not slip out of the openings. The other end of the other thread or the same thread may be passed through an opening in another seat plate and a similar knotting or crimping tube used to connect the single or

multiple threads

12, 22 to the spool 20 to be wound. If a single wire is used, the two ends of the wire are preferably each connected to an opening in the seat plate 1 or 3, respectively, to facilitate the winding of the

wires

12, 22 and to keep the wires from tangling during the winding process. It will be appreciated that there are many ways to connect one or more wires to the bobbin 20 using the winding

slots

9, 11 and openings 5, 7 provided in the base plates 1, 3 of the bobbin 20.

Fig. 11-16 generally illustrate the lower cover 40 of the tensioning device 18. The lower cap 40 includes a generally circular body 41 and an elongated nose 42. Fastener mounting openings, generally indicated at 43, are provided around the body 41 for mounting the lower cover 40 to the cover 50 with fasteners.

The lower cover 40 has a convex circumferential wall 44. Wall 44 is divided into an outer wall 45 and an inner wall 46. The inner wall 46 defines an interior cavity 47, the interior cavity 47 being shaped to receive the lower tension wire rack 23 of the spool 20. The wall 44 of the base 40 also defines a slot 48 for directing the cord 22 outwardly of the tensioning device 18 and toward the wound 14. As described above, the line 22 may be attached to the barbed suture 12 once it exits the tensioning device 18.

The nose 42 of the lower cap 40 is elongated in shape to match the contour of the cover 50 of the wound closure system 10 and can be used to guide the cord 22 out of the tensioning device.

Fig. 17-19 generally illustrate the force applying member 30 of the tensioning device 18. The force applying member 30 in the figure is a spring formed by coiling a tape 31. The embodiment shows that the coiled strip 31 can be made of metal or other materials. As previously described, spring 31 may be a constant force spring, providing a constant level of tension regardless of how tightly it is wound, or it may be a non-constant force spring, providing different levels of tension at different levels of tension. One embodiment shows that the coiled strip 31 is made of type 301 high yield strength stainless steel. In certain embodiments, the force applying member 30 may provide a load force of approximately 18N. In the art, the load force of the force applying member 30 may vary with certain characteristic changes, such as the thickness, diameter or material of the coiled strip 31.

Coiled strap 31 defines an inner end 32 and an outer tab 33, coiled strap 31 being positioned about upper spring seat 21 of spool 20. When placed therein, the position of the inner end 32 of the coiled strip 31 is defined within the slot 27 in the upper spring seat 21 of the spool 20, and the outer tab 33 thereof cooperates with the knob 60 of the tensioning device 18 for winding. The winding of the force application member 30 will be described in further detail below.

20-24 generally illustrate the knob 60 of the take-up device 18 for loading and unloading the apply member 30. Knob 60 includes a generally cylindrical body 61, body 61 including an outer surface 62 and an inner cavity 63 defined by an inner surface 64. The lumen 63 is shaped and dimensioned to seamlessly receive the force applying member 30. The inner surface 64 comprises a radially arranged vertical notch 65 which, together with the outer tab 33 of the force application member 30, serves for winding the force application member. The inner surface 64 also includes a slot 67 (fig. 4-5, 36) adapted to receive a portion of the locating pin 80. As previously described, the locating pin 80 may receive the linear spring 70 between the knob 60 and the spool 20, and when the knob 60 is pushed downward relative to the cover 50, the knob 60 may be pushed upward by the linear spring 70. (see FIGS. 4-5, FIGS. 36-37 for details).

As shown in fig. 20-24, the outer surface 62 of the knob 60 defines a radial array of gripping features 66 that allow the knob to be rotated during winding. The gripping structure 66 is shown as a generally vertical groove, but may be other structures that facilitate rotation of the force applying member 30.

The outer surface 62 of the knob 60 also includes a flange 68 having horizontal tabs 69 radially aligned along the circumference of the knob 60. The tab 69 includes a ramp 71 that slopes upward in a counterclockwise direction and defines a square face 72 at the end of the ramp 71. The tabs 69 are spaced apart and define a gap 73 therebetween. The tab 69 cooperates with the cover 50 of the tensioning device 18 to perform the following functions: 1. for winding the force application member 30;2. locking the force application member 30 at the time of loading; 3. the force applying member 30 is released when needed, as will be described in detail below.

Fig. 25-30 generally show the cover 50 of the tensioning device 18. The cover 50 generally includes an internal shape that fits over the exterior of the lower cover 40. The cover includes a body 51 and an elongated nose 52. The body 51 is fitted on the body 41 of the lower cover 40, and the nose 52 is fitted on the nose 42 of the lower cover 40. The cover 50 includes an inner wall 53, the inner wall 53 being shaped and dimensioned to fit snugly against the wall 44 of the lower cover 40.

Near the rear side, the cover 50 defines an aperture 54 for suturing the tensioning device 18 to body tissue. As previously mentioned, although the cover 50 is described as being adapted for mounting to the body by stitching, it need not be provided with stitching holes 54 and the tensioning device 18 may be secured to the patient by other means, such as by adhesive, tape, bandages, straps, wound dressings and the like. As also previously described, the tensioning device 18 may also be located outside of the patient and away from the wound area 14, if desired.

The elongated nose portion 52 of the cover 50 defines a pair of channels 55 for directing the tensile strands 22 or barbed sutures 12 toward the wound 14. Thus, as shown in FIG. 2, the tension threads 22 or barbed suture 12 exiting the tensioning device 18 may be in line with the remaining barbed suture that is sutured to the body tissue around the wound 14. This maintains an even distribution of tension on the body tissue surrounding the wound 14. The nose 52 of the cover 50 may be placed in different locations depending on the morphology of the wound 14, and where force concentration is desired. The nose 52 provides structural support for the

sutures

12, 22 so that the tensioning device 18 can be placed at a location remote from the wound 14. This may facilitate the operation of inspecting and dressing the wound 14.

The tensioning device may also be secured to the patient's body by an extended nose 52 of the cover 50. As shown in fig. 25, 27, 29 and 30, the forward end of nose 52 includes a ramp 56. The ramp 56 is used in conjunction with a skin anchor 100 (see fig. 38) that is attached to the body near the wound 14, and another embodiment of a skin anchor 200 that is used in conjunction with the tensioning device 18 is shown in fig. 39. The tension tab 101 of the skin anchor 100 may be used to secure the cap 50 to the skin anchor 100. Ramp 56 is inserted into a pull slot 102 formed by a pull tab 101 of skin anchor 100, with pull tab 100 abutting the forward end of nose 52. Thus, the cover 50 may be mounted on the skin anchor 100 adjacent the wound 14, and the tensioning device 18 may move with the skin anchor 100 as the body tissue is drawn toward the wound 14. The method of attachment of the tensioning device 18 is shown in figure 2.

As shown in the bottom view of the lower cover 40 in FIG. 12, the bottom surface of the lower cover 40 includes notches 57, the notches 57 accommodating the thickness of the staples mounted on the skin anchor 100 for securing the skin anchor 100 to the body.

As shown in bottom perspective view of the cover 50 in fig. 26 and bottom plan view of the cover 50 in fig. 28, the inner wall 53 of the cover 50 defines a flange 58 around the inner periphery of the main body portion 51. The flange 58 is adapted to capture the flange 68 of the knob 60 to capture the knob 60 between the lower cover 40 and the cover 50 of the tensioning device 18. The flange 58 of the cover 50 defines edge tabs 59 that slide over the ramps 71 of the horizontal tabs 69 of the knob 60 and snap into the rectangular slots 73 between the horizontal tabs 69 when the knob 60 is rotated clockwise, as will be described in further detail below. Although the cover 50 is attached to the base 40 by fasteners, it may be attached to the base 40 by a variety of other methods, including the use of interference fits, adhesives, snaps, and the like.

The rear of the cover 50 includes an opening 91 for receiving a locking button 90 for locking and preventing relative rotation of the knob 60 and the cover 50, as will be described in further detail below.

The locking button 90 of the tensioning device 18 is seen in fig. 31-35. The lock button 90 is used to lock the lock knob 60 relative to the rest of the tensioning device 18 to prevent inadvertent rotation of the knob 60. The lock button 90 is located in an opening 91 between the cover 50 and the knob 60 and is linearly slidable between a forward locked position and a rearward unlocked position.

In the forward locked position, the front portion 92 of the lock button 90 is positioned below the flange 68 of the knob 60, preventing downward sliding of the knob 60 relative to the cover. Rotating the knob 60 clockwise raises the rectangular tab 59 in the cover 50 beyond the ramp 71 of the horizontal tab 69 of the knob 60 so the knob 60 must be moved downward for clockwise rotation. When rectangular tab 59 rises above ramp 71, a "click" is heard, indicating that rectangular tab 59 is stuck into rectangular slot 73. The front portion 92 of the lock button 90 prevents the knob 60 from moving downward, thereby preventing the knob 60 from rotating clockwise.

In the counterclockwise direction, locking of the rectangular tab 59 within the rectangular slot 73 generally prevents counterclockwise rotation of the knob 60. To rotate the knob 60 counterclockwise, the knob 60 is pressed downward relative to the cover 50 so that the rectangular tabs 59 around the periphery of the flange 58 of the cover 50 spring out of the rectangular slots 73 between the horizontal tabs 69 of the knob 60, rotating the knob 60 counterclockwise and releasing the

sutures

12, 22. However, as previously described, the forward portion 92 of the lock button 90 prevents downward movement of the knob 60.

When the lock button 90 is slid rearwardly to the unlocked position, the front portion 92 is moved away from under the flange 68 of the knob 60 so that the knob can be moved downwardly relative to the cover and rotated in either direction.

Tension thread and barbed suture

As previously described, the wound closure system 10 includes a tension wire 22 wound on a spool 20 of the tensioning device 18 and connected to the barbed suture 12, which sutures the body tissue around the wound 14. The tension wires 22 may be nylon or polypropylene wires, ropes, cables, wires, or made of other similar materials. The tension wire 22 is sufficiently flexible and bendable to wind the spool 20 within the tensioning device 18. One embodiment of the tensile strand 22 is made of nylon having a tensile strength of about 2.7 to 4.5Kg. The tension wires 22 have a wire diameter of about 0.5 to 0.6 mm.

As previously shown in fig. 1-2, although the wound closure system 10 includes a separate tensioning device 18, it may simply employ an elastic thread 22 attached to the barbed suture 12 or a barbed suture 12 that is elastic in nature to provide dynamic tension to the body tissue surrounding the wound 14. The elastic threads or elastic sutures may also be used in conjunction with a separate tensioning device, such as tensioning device 18.

Because it is the tensioning device 18 that provides the dynamic or continuous tension required for closure of the wound, the tension wires 22 and/or barbed sutures 12 may not be elastic when a separate tensioning device 18 is used.

As previously described and shown in fig. 1 and 2, the barbed suture 12 includes a plurality of barbs 13 distributed about the suture 12. At both ends of the barbed suture 12 there is a suture 16 for body tissue suturing. After the barbed suture 12 is sutured around the wound area 14, as shown in fig. 2, the needle 16 may be removed, joining the two ends together, forming a closed loop around the wound area 14.

One embodiment of a wound closure system 18 suture shows that the barbs 13 of the suture 12 may be unidirectional such that all of the barbs 13 are at an acute angle to the longitudinal axis of the suture 12 and extend in the same direction. It is also contemplated that suture 12 may have two lengths of barbs 13, with all barbs 13 in a first length extending at an acute angle in a first direction and all barbs 13 in a second length extending at an acute angle in a second direction opposite the first direction. For example, such sutures may be used to suture body tissue contralateral to the wound 14 from the same point to the opposite end of the wound 14.

The barbs 13 of the barbed suture 12 may be resilient so as to flex toward the surface of the thread when sutured, thereby passing through body tissue. When barbs 13 pass through the body tissue and out the other side of the body tissue, barbs 13 may again flex outward from the suture surface and hook into the body tissue if suture 12 is pulled in the opposite direction. In this manner, the barbed suture 12 may suture body tissue like a conventional suture, and may prevent the suture 12 from backing out while passing through body tissue.

Barbs 13 may be individually distributed 360 ° around suture 12 with gaps between individual barbs 13. According to other embodiments of barbed sutures, the barbs 13 may be combined together, rather than distributed individually around the suture, where a first set of barbs 13 may be located at a first radial location of the suture 12, a second set of barbs 13 may be located at a second radial location of the suture 12 (e.g., where the suture 12 is on the opposite side of the first set), and so on.

As previously described, the wound closure system 10 and the barbed suture 12 may apply a pulling force in either direction relative to the barbs 13. If tension is applied in the direction of the barbs 13, the barbed suture 12 operates in a manner similar to a conventional suture-pulling or pulling both sides of the body tissue through the body tissue to the open wound area 14. In this suturing operation, barbs 13 may still prevent suture 12 from backing out during initial suturing of body tissue. If the wound closure system 100 applies a pulling force in the opposite direction to the barbs 13, body tissue can be grasped by the barbs 13 and stretched or pulled toward the open wound area 14.

An exemplary embodiment of a barbed suture 12 suitable for use with the wound closure system 10 of the present disclosure is manufactured by Covidien, marketed under the product designation V-Loc ^TM Absorbable wound closure devices. Angio-tech pharmaceuticals may provide another exemplary barbed suture 12 suitable for use with the present wound closure system 10Example, model number "

SRS self-fixing system ".

As previously described, the barb sutures 12 may be attached directly to the tensioning device 18 of the wound closure system 10, or may be attached by a separate tension wire 22 that is pre-wound on the spool 20 of the tensioning device 18. 40-42 illustrate one example method of connecting a barbed suture 12 to a tension wire 22 that has been wound within a tensioning device 18. As shown in fig. 40-42, according to one embodiment, the barbed suture 12 includes a crimp 24 at its distal end. One end of the crimp 24 may be the end of the needle 16 or the other end. The tension line 22 pre-wound on the tensioner spool includes a socket 26 pressed against the end of the tension line 22. The socket structure 26 is responsible for receiving the crimp 24 to quickly and easily connect the barbed suture 12 to the tension wire 22. As shown in fig. 3-5, other attachment methods may be used to attach the barbed suture 12 to the tension wire 22 wound on the spool 20 of the tensioning device 18.

The use of barbed sutures 12 with the wound closure system 10 provides a number of advantages over prior art systems. There are fewer initial set-up steps for the wound closure system 10. Wound closure system 10 does not require the use of skin anchors 100 and needles. Barbed sutures 12 for stretching of body tissue may also be used to close a wound 14 without the need to re-suture the wound 14 after stretching. After stretching the body tissue surrounding the wound, the surgeon pulls on the barbed suture to close the wound. Because of the barbs, knots at both ends of the suture are also not required. Surgeons are generally familiar with suturing procedures and no redundant paradigm shifts are required in deploying the wound closure system 10.

General use of wound closure systems

According to one example method, the barbed suture 12 may be sutured into the body tissue surrounding the wound region 14 prior to stretching the tissue with dynamic or continuous pulling force. The suturing operation is illustrated in FIG. 2, and is characterized by the passage of a suture 12 through and out of the body tissue surrounding a wound 14. As previously mentioned, there are a number of options in the type of barbed suture and the direction of the suture. One or more barbed sutures 12 may be used and attached directly to the spool 20 of the tensioning device 18. In other embodiments, the barbed suture 12 may be indirectly connected to the tensioning device 18 by a pre-attached tension wire 22. As previously mentioned, a ball/socket joint connection may be used. In suturing the barbed suture 12, a single thread may be used, with one end attached to the tensioning device 18, then sutured into the skin, and the other end tied to the tensioning device 18. According to other methods, two separate barbed sutures 12 connected to the tensioning device 18 may be sutured to the body tissue starting at the same point to the other end of the wound 14, with the two ends of the suture 12 tied to form a closed loop. As previously described, the pulling force may be applied in the direction of barbs 13 or in the opposite direction of barbs 13. Both of these methods effectively stretch the body tissue to effect wound closure. A single barbed suture 12 with bi-directional barbs 13 may also be used. The barbed suture 12 includes needles 16 at both ends of the suture 12, as shown in fig. 1, where the middle portion of the suture 12 (with the barbs 13 changing direction) may be attached to a spool 20 of a tensioning device 18. According to one embodiment, the barbed suture 12 may extend substantially entirely around the wound 14, and applying tension to the suture 12 may draw and stretch the body tissue toward the wound 14 (see FIG. 2). According to another embodiment, the suture 12 may also be sutured to body tissue around the wound 14, passing through the wound 14, i.e., using a "shoelace" type suture with the wound closure system 10 (see fig. 2A). It should also be noted that although the present wound closure system 10 already has one tensioning device 18, it may use multiple tensioning devices 18. For example, two tensioning devices 18 may be used, one on each side of the elongate wound 14. There are also different ways of suturing, for example, the barbed suture 12 of one tensioning device 18 may be sutured in one direction and the barbed suture 12 of the other tensioning device 18 may be sutured in the opposite direction, such that the tension applied by the two tensioning devices 18 may cause the barbs 13 to hook the tissue and pull the tissue on either side inwardly towards the wound 14.

In some embodiments, the wound closure system has two barbed sutures, with one suture entering the deep dermis/subcutaneous layer and a second suture entering the dermis/subcutaneous layer, thereby performing a double layer closure.

It should be noted that the above-described arrangement of the present wound closure system 10 is merely an example, and other arrangements are certainly possible.

In assembling the tensioning device 18, according to one embodiment, after one or two barbed sutures 12 are directly or indirectly connected to the spool 20 through the openings 5 and 7 and wound on the spool 20, the tensioning device 18 may be assembled by loading the spool 20 into the lower cover 40, placing the force applying member 30 on top of the spool 20 after the tension or

barbed sutures

22 or 12 are wound, and placing the securing pin 80 and the linear spring 70 in the hole 19 of the spool 20, and placing the knob 60 on top of the force applying member 30. The cover 50 is then mounted on top of the base 40, the knob 60 is clamped between the base 40 and the cover 50, and the

sutures

12, 22 are passed out of the nose 52 of the cover 50. After assembly is complete, the barbed suture 12 connected to the tensioning device 18 may be sutured to body tissue starting at the same point until the other end of the wound 14, and the two ends of the suture 12 may be tied together to form a closed loop. The suture 12 should be long enough to ensure a suturing operation.

After the body tissue is sutured with the barbed suture 12 and closed, the knob 60 of the tensioning device 18 may be rotated clockwise to wind the force applying member 30 therein and begin pulling on the barbed suture 12.

Rotating the knob 60 clockwise moves the rectangular tab 59 on the inside of the cover 50 up past the ramp 71 of the horizontal tab 69 of the knob 60. A linear spring 70 projecting on the spool 20 is used to apply an upward force to the knob 60 to keep the horizontal tabs 69 of the knob 60 pressed against the flange 58 of the cover 50. A click is heard when the rectangular tab 59 moves up past the ramp 71, indicating that the rectangular tab 59 snaps into the rectangular slot 73. Locking of the rectangular tab 59 within the rectangular slot 73 prevents counterclockwise rotation of the knob 60.

When the knob 60 is rotated clockwise, the outer tab 33 of the coiled strip 31 is caught in one of the vertical grooves 65, so that the force applying member 30 is rotated together with the knob 60, thereby loading the force applying member 30. When the coiled strip 31 starts to be in the unwound state, it is brought into close contact with the inner surface 64 of the knob 60 due to its large diameter, thereby generating a great friction with the inner surface 64 of the knob 60. Thus, the outer tab 33 is always pressed against the inner surface 64 of the knob 60 within the vertical recess 65. After winding has begun, the force applying member 30 becomes smaller and smaller, eventually having a diameter so small that the outer tab 33 no longer creates sufficient friction with the inner surface 64 of the knob 60. At this point, further rotation of the knob 60 causes the outer tab 33 to slide out of the vertical recess 65. A sound is emitted when slipping out, which indicates that the force application member 30 has been fully wound.

The spool 20 is connected to the apply member 30 such that turning the knob 60 also causes rotation of the spool 20 to tighten the barbed suture 12 around the breach zone 14. The biasing member 30 applies a dynamic force to the barbed suture 12 to pull the body tissue toward the wound 14, indicating that the biasing member is in place. The nose 52 of the cover 50 concentrates all pulling forces in one area. The tip of the nose 52 aligns the tensioning device 18 with the closed loop of barbed suture 12 around the wound 14, diverting all tension forces in a direction transverse to the closed loop, rather than in the direction of the nose 52 itself, thereby preventing pulling on the tensioning device 18. The force applying member 30 and the spool 20 maintain the barbed suture 12 in a taut state as the tissue is pulled toward the wound 14. It should be noted that if tension is applied in the direction of the barbs 13, the force applying member 30 will cause the barbed suture 12 to pass through the body tissue as the tissue is stretched. If the pulling force is in the direction opposite to the direction of the barbs 13, the force application member 30 grips the body tissue with the barbs 13 and pulls the body tissue with the gripping force.

It may sometimes be necessary to loosen the barbed suture 12 to re-suture or reposition the suture, or to remove the tensioning device 18. Pressing the knob 60 downward tightens the linear spring 70 (see fig. 4, 5) and disengages the rectangular tab 59 inside the cover 50 from the rectangular slot 73 around the knob 60. This allows the knob 60 to be rotated counterclockwise to disengage the barbed suture 12.

In use, the lock button 90 locks the knob 60 relative to the remainder of the tensioning device 18 to prevent unwanted rotation of the knob 60.

As shown in FIGS. 43-46, in contrast to the previous embodiment, the knob 60 is provided with arrow representations to indicate the pointing orientation of the knob 60, and the booster knob 60 is provided with increased force to facilitate twisting.

The embodiments of the present invention have been described in detail, but the description is only for the preferred embodiments of the present invention and should not be construed as limiting the scope of the present invention. All equivalent changes and modifications made within the scope of the present invention shall fall within the scope of the present invention.

Claims

1. A wound closure system, characterized by: comprising a suture for suturing body tissue adjacent an open wound, the suture being capable of passing into the body tissue and out, the suture comprising a plurality of outwardly extending barbs, the barbs being at an acute angle to the suture surface; and a force applying member for applying a continuous pulling force on the suture to stretch the body tissue towards the open wound, characterised in that during the stretching process the force applying member tightens the suture with evidence of loosening to maintain the suture in a taut condition.

2. A wound closure system according to claim 1, wherein: the suture includes a force applying member.

3. A wound closure system according to claim 1, wherein: the force applying member comprises a spring.

4. A wound closure system according to claim 3, wherein: also included is a housing containing the spring, the housing including a spool rotatably connected thereto, the spool being connected to the spring, the wound spring exerting a continuous pulling force on the suture.

5. The wound closure system of claim 4, wherein: the housing and spring include cooperating structure for winding the spring that slides relative to one another when the spring is fully wound, thereby indicating that the spring is fully wound.

6. A wound closure system according to claim 5, wherein: the engagement structure includes radially aligned vertical grooves in the housing and a radially outwardly projecting tab of the spring.

7. A wound closure system according to claim 4, wherein: the housing includes a second thread wound on the spool that is removably attached to the suture to apply a continuous pulling force to the suture.

8. A wound closure system according to claim 7, wherein: the suture is removably connected to a second thread by a ball/socket joint.

9. A wound closure system according to claim 4, wherein: the housing includes a button that can be pushed in the longitudinal direction of the spool to release the continuous pulling force.

10. A method of reducing the size of an open wound by pulling body tissue adjacent the open wound toward or into the open wound, characterized by: comprising passing a suture through body tissue adjacent the open wound, thereby passing into and out of the body tissue, the suture having a plurality of outwardly extending barbs disposed at an acute angle to the surface of the suture; and a force applying member for applying a continuous pulling force on the suture to stretch the body tissue toward the open wound, the force applying member automatically applying a continuous pulling force during the stretching of the body tissue.

11. A method according to claim 10, characterized by: also included is passing a suture through body tissue surrounding the entire open wound.

12. A method according to claim 11, characterized by: no portion of the force applying member is around the open wound.

13. A method according to claim 10, characterized by: also included is threading the suture out of the body tissue to suture in a manner similar to tying a lace, wherein a portion of the suture is threaded through the open wound at least twice.

14. A method according to claim 13, characterized by: no portion of the force applying member is around the open wound.

15. A method according to claim 10, characterized by: the force applying member is separate from the suture.

16. A method according to claim 15, characterized by: the force applying member is a spring.

17. A method according to claim 16, characterized by: also included is a housing containing the spring, the housing including a spool rotatably connected thereto, the spool being connected to the spring, the wound spring exerting a continuous pulling force on the suture.

18. A method according to claim 17, characterized by: the housing and spring include cooperating structure for winding the spring that slides relative to one another when the spring is fully wound, thereby indicating that the spring is fully wound.

19. A method according to claim 10, characterized by: further comprising providing a continuous pulling force on the suture in the direction of the barbs to thread the suture through the body tissue with the barbs passing through the body tissue.

20. A method according to claim 10, characterized by: further comprising providing a continuous pulling force on the suture in a direction opposite the barbs, causing the barbs to hook into the body tissue and pull the body tissue toward or into the open wound.

21. A wound closure system according to claim 1, wherein: the barbs are resilient and can flex toward the suture surface as the barbs enter body tissue and can flex outward away from the suture surface as the barbs exit body tissue.

22. A method according to claim 10, characterized by: the barbs are resilient and can flex toward the suture surface as the barbs enter body tissue and can flex outward away from the suture surface as the barbs exit body tissue.