KR20090027188A - Medical closure clip system and method - Google Patents

Abstract

A medical closure screen device for a separation of first and second tissue portions is provided, which includes a mesh screen comprising tubular vertical risers, vertical strands with barbed filaments, and horizontal spacers connecting the risers and strands in a grid-like configuration. An optional perimeter member partly surrounds the screen and can comprise a perimeter tube fluidically coupled with the vertical risers to form a tubing assembly. Various input/output devices can optionally be connected to the perimeter tube ends for irrigating and/or draining the separation according to methodologies of the present invention. Separation closure, irrigation and drainage methodologies are disclosed utilizing various combinations of closure screens, tubing, sutures, fluid transfer elements and gradient force sources. The use of mechanical forces associated with barbed strands for repositionably securing separated tissues together is disclosed. The use of same for eliminating or reducing the formation of subcutaneous voids or pockets, which can potentially form hematoma and seroma effects, is also disclosed. The device can be fabricated and the method practiced with clips having various configurations.

Description

MEDICAL CLOSURE CLIP SYSTEM AND METHOD

BACKGROUND OF THE INVENTION Field of the Invention The present invention generally relates to medical (including dental, veterinary, etc.) suture and fluid management devices, and more particularly to screen closure members for suturing tissue separations such as incisions and wounds, and optionally bioabsorbable suture members. . The closure member can be combined with other components selected due to its function and material affinity characteristics.

In a broadly defined medical field, including dentistry, veterinary medicine, and the like, skin incisions are commonly performed in surgery to provide access to underlying tissues, organs, joints, skeletal structures, and the like. Incisions and sutures are generally an important part of surgery. This tends to occupy surgical teams and other resources for important parts of numerous surgical procedures.

Surgeons typically employ a variety of sutures that minimize the incision and reduce postoperative edema, bleeding, serous edema, infections and other undesirable postoperative side effects. try to minimize scarring effects. For example, the fields of endoscopic-assisted surgery, submicroscopic microsurgery, and computer-enhanced instrumentation (e.g., DaVinci System, available from Intuitive Surgical, Inc., Sunyvale, CA) are generally becoming increasingly popular. It is associated with proven minimally invasive surgery ("MIS") procedures and techniques. Such popularity is due, at least in part, to the smallest sized wounds left by such techniques, as well as minimal trauma to the fascia and muscle layers and thereby faster recovery. However, surgeons must balance such considerations with the provision of an appropriate access route to perform the various surgical procedures. Conventional surgical procedures include cutting or dissecting steps and suture steps. Recently, significant progress has been made in minimizing surgical cutting, dissection and shaping. Surgical sutures include sutures, clips, staples, and adhesives. However, sutures can be a time consuming and tedious task. In addition, the combined tissue structures may not be favorable to other sutures. MIS often restricts access to separate tissue structures, making them more difficult to access and suture.

Unlike MIS, some surgical procedures must include long incisions by their nature. Examples thereof include skin lift procedures such as "lifts" and reduction procedures, flap procedures for closure of defects, and numerous bariatric procedures. In these widespread deficiencies the suture process can be a time consuming and tedious task.

The "first intention (primary intention healing)" in surgical operations is to "suture" the incision. For load-bearing tissues such as bone, fascia, and muscle, this requires substantial material, whether suture material, staples or plates and screws. The epithelial layer must be sealed in order for the wound to be closed. To achieve this, the "load bearing" areas of the skin and subcutaneous layers (ie, the deep elastic and superficial fascia or fibrous layers of adipose tissue, respectively) must also be at least in close proximity. Important considerations include controlling infection and bleeding, reducing wound incidence, eliminating the possibility of hematoma, serous serous and "dead-space" formation, and pain management. The problem of dead space occurrence occurs more frequently in subcutaneous sutures. Relatively shallow incisions may be closed primarily with surface applied sutures such as sutures, staples, surgical pastes, and adhesive tape strips. Deeper incisions, however, require time-consuming arrangement of multiple layers of sutures in the load bearing planes, as well as skin surface closure. Absorbable sutures are commonly used for this purpose and include an important class of surgical sutures. According to various factors, the absorbent sutures typically dissolve over a period of days to months. Commercially available examples include Mococryl.RTM, which is a monofilament absorbent synthetic suture comprising polyglecaprone. And PDS.RTM (polydrioxanone) and Vicryl.RTM. (Polyglactin), all of which are available from Ethicon, Inc., Somerville, NJ.

Surgical meshes are commonly used to fill or reinforce load-bearing planes or defects in them. When combined with sutures or fasteners, surgical meshes occupy another important class of surgical suture tools. The applications include reconstruction, hernia repair and organ repair. In such a procedure, surgical mesh fabric protheses are inserted into the patient through any of the published surgical or endoscopy (MIS) procedures. Surgical meshes woven for repairing hernias are disclosed in US Pat. No. 6,287,316 to Agarwal et al. Assigned to Ethicon, Inc. Other Ethicon, Inc. Patent Duncan US Pat. No. 4,548,202 discloses mesh tissue fixtures including various fixtures with isolated legs for use through tissue portions. Another suture procedure is a worm screw device that can fill the wound after placement of pins or rods through skin edges or bones and may be gradually tightened over time, often to be sutured, stabilized or distracted. Followed by the placement of an external clamp or fixture comprising a.

Fluid management occupies other important aspects of both open and minimally invasive surgery. Postoperative fluid drainage can be achieved with various combinations of tubes, sponges and porous materials adapted to collect and drain body fluids. The prior art includes techniques and methods to assist drainage. See, eg, US Pat. No. 4,969,880 to Zamierowski; No. 5,100,396; 5,261,893; 5,527,293; And 6,071,267 disclose the use of pressure gradients, ie vacuum and positive pressure, to assist fluid drainage from a wound comprising surgical incision sites. Such pressure hardness can be achieved by applying a porous foam material internally or externally to the window, covering it with a permeable, semi-permeable or impermeable membrane and connecting a suction vacuum source thereto. The sap drawn from the patient is collected for treatment. Such fluid control methods are considered to have achieved significant improvements in patient healing. Other aspects, such as fluid management, after surgery, relate to the application of fluid to wound sites for purposes of washing, infection control, pain control, growth factor application, and the like. Wound drainage devices are also used to achieve fixation and immobility of tissues to aid healing and closure. This can be accomplished by both internal closure wound drainage and external vacuum devices. The fixation of the tissues in attachment can also be achieved by bolus suture bandages (stent bandages), taping and (contact) gypsum bandages.

To date, there has been no available medical suture screen assembly with the advantages and features of the present invention, including the combination of negative pressure wound therapy (“NPWT”) and the present invention.

In an embodiment of the present invention, a medical suture includes a mesh screen having tubular vertical risers, barbed filaments and horizontal spacers therebetween. A screen device is provided. Integrated or separate sutures may be provided. An optional perimeter member may comprise a perimeter tube that partially surrounds the screen member and is fluidically coupled to the vertical risers to form a tubing assembly. The tubing assembly works with the vertical risers to extract sap from tissue separation in drainage mode and introduce the sap therein in wash mode. In one embodiment of the invention, the tubing assembly is fluidly coupled with a vacuum source to facilitate drainage. In another embodiment of the present invention, the perimeter tube passes through surrounding tissue to secure the screen member in place. Sap delivery components, such as sponges, foams, absorbent meshes, microtubular materials, etc., are optionally adjacent to and above the extension of the screen for fluid delivery, for example with a vacuum or pump source. Is placed. Another embodiment of the invention includes a suture adapted to connect to and secure the screen in tissue separation.

Other embodiments vertical risers are also disclosed and may use the patient's body dynamics to provide active fluid delivery. Another embodiment of the present invention uses screen thorns for mechanical fixation in the separation for sealing of the separation. Separation closure, cleaning, and drainage methods are disclosed using various combinations of closure screens, tubing, sutures, sap delivery components, and hardness sources. The suture screen of the present invention has screens and spines to fix or reduce the formation of subcutaneous voids or pockets that can hold separate tissues together and potentially form hematoma and serousoma effects. Use the strands and mechanical forces and other forces involved. Other embodiments of the present invention include assemblies of clips that may include a relatively rigid material and flexible, elastic or foldable connecting filaments that form composite material screens.

1 is a measurement side view of a medical suture screen device according to the present invention.

FIG. 2 is an enlarged fragmentary view of its measurement, generally taken inside circle 2 in FIG. 1.

FIG. 3 is an enlarged fragmentary measurement view thereof showing, in particular, the prickly strand taken generally along the 3-3 line in FIG. 2.

4A-4F show other perimeter tube end closure closures including: 4a) subdermal termination; 4b) knotted end; 4c) Leur lock; 4d) delivery components (ie, sponges); 4e) a vacuum source; And 4f) clamped ends.

5A-5E illustrate tissue detachment suture procedures for practicing the methods of the present invention.

FIG. 6A is an enlarged fragmentary cross-sectional view of the tissue separation of the suture screen with skin hooks shown in phantom to locate separated tissue portions along the suture screen. FIG.

6B is an enlarged fragmentary cross-sectional view of the suture screen in substantially sewn tissue detachment.

7A-7F illustrate a tissue detachment closure procedure using the method of the present invention and using optional sponge or foamed sap delivery components and tubing placement tools.

8 is a cross-sectional view of tissue detachable sutures using tubing to secure the suture screen with the fluid delivery subassembly connected to the top edge of the suture screen.

9 shows a needle mounted to fit a portion of drainage tubing and penetrate it through tissue.

10 is a measurement side view of a suture screen incorporating another embodiment of the present invention with a perimeter suture.

FIG. 11A is an enlarged fragmentary view of its measurement generally taken inside circle 11a in FIG. 10.

FIG. 11B is an enlarged fragmentary measurement surface view of the modified vertical risers. FIG.

12 is a measurement side view of a screen-only suture screen incorporating another embodiment of the present invention.

FIG. 13A is an enlarged fragmentary view of its measurement generally taken inside circle 13a in FIG. 12.

FIG. 13B is an enlarged fragmentary measurement side view thereof showing modified vertical risers. FIG.

14A-14G illustrate a tissue detachment closure procedure using an embodiment where only a screen of closure screen is present.

FIG. 15A is a side view of a modified vertical riser with flexible multi-tube riser forming an infusion passage. FIG.

FIG. 15B is a cross-sectional view thereof generally taken along line 15b-15b of FIG. 15A.

16A is a fragmentary view of its measurement, shown in a compressed arrangement.

FIG. 16B is a cross-sectional view thereof generally taken along the line 16B-16B in FIG. 16A.

FIG. 17 is a cross-sectional view of another modified vertical riser configuration with thorns with risers gathered in different arrangements.

18 is a cross-sectional view of a modified vertical riser or perimeter component with a fluted tube.

19 is an enlarged fragmentary view of the measurement of a modified spiny strand arrangement.

20 is an enlarged fragmentary view of the measurement of another modified barbed strand arrangement.

21 is an enlarged cross-sectional view of a suture screen incorporating another embodiment of the present invention with a spine formed by cutting the ends of looped filaments.

FIG. 22 is an enlarged cross-sectional view of a suture screen incorporating another embodiment of the present invention constructed by cutting out the spiny and looped filaments forming hooks.

FIG. 23 is an enlarged cross-sectional view of a suture screen incorporating another embodiment of the present invention with a spine formed by cutting the ends of looped filaments that lie in a common orientation or orientation.

FIG. 24 is an enlarged cross-sectional view of a suture screen including another embodiment of the present invention constructed by cutting looped filaments that are laid out in a common direction or orientation to form hooks.

25 is a perspective view of a suture screen incorporating another embodiment or aspect of the present invention having individual links forming flexible strands.

25A is a front view of its link.

FIG. 26 is a measurement side view of another alignment link for the suture screen shown in FIG. 25.

27 is a front view thereof.

FIG. 27A is a front view of another arrangement link to the suture screen shown in FIG. 25.

28 is a measuring side view of its strands.

Fig. 29 is a measured side view of the strand shown by compression.

30 is a fragmentary view of an enlarged cross section of a strand proximate the separated tissue portions.

31 is a measurement side view of a link of a strand of another embodiment suture screen system.

32 is a front view thereof.

33 is a fragmentary measurement side view of its strands.

34 is a perspective view of another embodiment of a closure screen system that includes individual clips mounted on flexible strips.

34A shows perspective views of other clip arrangements.

FIG. 35 is a measurement side view showing a clip proximate the opposing tissue portion edges generally taken along line 35 in FIG. 34A.

36 is a perspective view of another embodiment of a suture screen system including individual clips.

FIG. 37 is a side front view of its individual clip, generally taken along line 37 in FIG.

38 shows perspective views of other tightening clip configurations for use with the present invention.

39 shows another tightening clip configuration attached to the mesh.

40-43 are measurement side views of various clipped closure screens.

44-46 are perspective views of wire tightening clips for use with the present invention.

47 to 49 are measurement side views of the clips shown in FIGS. 44 to 46, respectively.

50 is a top view of another embodiment clip arrangement.

51A-51C show different peak orientations for the clip arrangements shown in FIG. 50.

52A-52C are measurement side views of the clips shown in FIGS. 51A-51C.

FIG. 53 is a measurement side view of yet another embodiment clip with bent peaks. FIG.

FIG. 53A is a measured side view of a clip proximate the isolated tissue shown in FIG. 53.

54 is a measurement side view of yet another embodiment clip with a bent body.

FIG. 54A is a measurement side view of the clip shown in FIG. 54, shown to be stuck to tissue. FIG.

FIG. 55 is a measurement side view of another embodiment suture screen having clip peaks and a backing material located on both sides of the suture screen, shown to fold substantially flat relative to the clip bodies. FIG.

FIG. 55A is a measurement side view of the suture screen shown in FIG. 55 with clip peaks extending along one side and secured to tissue.

56-58 show other embodiment peaks.

59 shows another embodiment closure system with external adjuncts and an optional negative pressure source.

FIG. 60 is a graph showing a load strain curve (tension to stretch) for a test including a screen embodying the present invention with a plurality of clips.

FIG. 61 is a graph showing another load deformation curve (compression for extension) for another test including a plurality of clip screens.

1. Overview and Environment

As required, detailed embodiments of the invention are disclosed herein; It should be understood, however, that the disclosed embodiments are merely representative of the invention, which can be embodied in various forms. Accordingly, the specific structures and functional details disclosed herein are not to be interpreted as limiting, only as a basis for the claims and as a representative basis for advising the person skilled in the art to variously use the invention in virtually all appropriately detailed structures. Should be interpreted.

Specific terminology will be used in the following description for the convenience of reference only and will not be limiting. For example, the words “upwards”, “downwards”, “rightwards” and “leftwards” will refer to directions in the figures to which reference is made. The words “inwardly” and “outwardly” will refer to directions toward and away from the geometric center of the described embodiment and its designated portions, respectively. The words "horizontal" and "vertical" generally mean side-to-side and top-to-bottom, respectively. The term will include specifically mentioned words, derivatives thereof and words of similar purpose.

Referring to the drawings in more detail, reference numeral 2 generally denotes a medical suture screen or system embodying the present invention. Without being limited to the generality of useful applications of the closure screen system 2, the primary application disclosed herein assists in the closure, drainage, washing and healing of the separation of the first and second tissue portions, such as a wound or incision 4. To do this. As shown in FIG. 5A, the wound 4 extends from the dermis 6 and opens from the dermis 6 to the fascia 10 via the deep dermal layer 7 and the subcutaneous layer 8. The wound 4 reveals edges 12a and 12b corresponding to the first and second tissue portions. The closure screen device 2 generally includes a screen 14, a screen perimeter member 16 and an input / output (I / O) subsystem 18.

II. Screen (14)

Screen 14 has top and bottom 20a, 20b; First and second ends 22a, 22b; And first and second faces 24a and 24b. The screen 14 generally forms a lattice arrangement with vertical hollow perforated tubular risers 26 intersected by horizontal spacer members 28. A plurality of barbed strands 30 are located between the risers 26. The risers 26, spacers 28 and strands 30 are preferably connected at their respective intersections. As shown in FIG. 3, each strand 30 includes a filament 32 having a plurality of pointed spines 34 extending upward and outward on both sides of a staggered spaced relationship. The thorns 34 generally project outwardly from the screen faces 24a and 24b for the purpose of describing in more detail below.

The screen or mesh 14 material may be soluble (absorbent) or insoluble (non-absorbent) and may be selected from numerous commercially available biocompatible products commonly used in medical applications for sutures, implantable mesh and similar medical devices. Can be.

Examples of absorbent materials include lactide, epsilon-caprolactone, para-dioxanone, alkyl derivatives of trimethylene carbonate, delta-hydroxyvalerate, 1,4-dioxepan-2-one ( Homopolymers and copolymers of 1,4-dioxepan-2-one), 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one and polymer mixtures thereof It includes, but is not limited to this. Examples of nonabsorbent materials include, but are not limited to, cotton, linen, silk, polyamides, polyesters, fluoropolymers, polyolefins, polyethylene, metals, and combinations thereof.

III. Screen Perimeter Member (16)

Optional screen perimeter member 16 may include, for example, a flexible perforated hollow tube 35 having a plurality of openings 36. As shown in FIG. 1, tube 35 includes first and second legs 38, 40 and screen bottom 20b that generally extend along screen first and second ends 22a, 22b. A base leg 41 generally extending along. The tubing first and second legs 38, 40 end at the first and second ends 38a, 40a, respectively. Tube 35 may be secured to screen 14 by a plurality of ties 42, which may have extensions of horizontal spacer members 28 and strands 30. By providing the soluble tiees 42, the tube 35 can be designed to separate from the rest of the closure screen 2 after a relatively short period of time. For example, the soluble material may dissolve into the patient's body after a few days, after which the tube 35 may be removed.

Optionally, portions of the tube 35 may be cut out of the screen 14. For example, screen 14 may be separated along respective screen ends 22a and 22b or may be completely separate from tube 35. In this manner, screen 14 and tube 35 may be arranged to accommodate various conditions and tissue separation arrangements.

Vertical risers 26 may optionally be fluidly coupled to the tube at respective T intersections 44. In this arrangement the tube 35 and the vertical risers 26 together provide a manifold for fluid treatment, ie extraction or washing, as indicated by fluid flow arrows 45.

IV. Input / Output Subsystem (18)

The input / output subsystem 18 is designed for the extraction and / or cleaning of body fluids and / or external fluids in a patient. As shown in FIG. 1, the input / output subsystem 18 is attached to tubing first and second leg ends 38a, 38b, which are considered the “port” ends of the tube 35 in this arrangement. First and second I / O devices 18a and 18b. One or both of the I / O devices 18a and 18b may include a pressure differential source such as an NPWT device. V.A.C..RTM. System.TM. Is available from Kinetic Concepts, Inc., San Antonio, Texas. The use of such devices for wound treatment and fluid management is described in Zamierowski, US Pat. No. 4,969,880; No. 5,100,396; 5,261,893; 5,527,293; And 6,071,267.

Alternatively, the tubing port ends 38a, 38b may be connected to various other pressure differential sources and various drainage and cleaning devices. For example, they can be cut shorter than the dermis 6 and left in the separation 4 to be sealed by adjacent tissue portions 12a and 12b. 4A shows the cut tubing end 38b. Tubing ends 38a, 40a may be knotted (as shown in 48 of FIG. 4B), scraped off, bundled (eg, using a suture) or otherwise sutured above and below the dermis 6. . 4C shows a Leur lock coupling 46 mounted on the tubing ends 38a / 40a. In addition, a delivery component with a portion of foam or sponge 50 may be coupled to the tube at the ends 38a / 40a (FIG. 4D). Examples of such foaming and sponge materials and arrangements are addressed in Zamierowski's US patents identified above. A differential pressure source, such as vacuum source 51, can be connected to tube ends 38a / 40a and fluid receptacle 66 as shown in FIG. 4E. Clamp 62 is shown in FIG. 4F and seals the tube ends 38a / 40a. Clamp 62 may be selected from several suitable clamps commonly used in medical applications.

Either of the tube ends 38a / 40a may function as either an inlet or outlet to the system 2. For example, suction may be applied to draw the sap from the patient through the system 2 via either of the end tubes 38a / 40a. The fluid can also be drawn in both directions via the system 2 by applying suction to the tube ends 38a / 40a alternately or together. For example, suction can be applied to both tube ends 38a / 40a simultaneously.

V. Surgery and Suture Methods

5A-5E illustrate an installation method using the system of the present invention. In FIG. 5A, the closure screen 2 is disposed in the separation 4 and the tubing base 41 located at the bottom of the separation (eg, wound or incision) and proximal to the fascia layer 10. As shown, tissue portions or wound / incision edges 12a and 12b are spaced apart. The top of the screen 20a may protrude outward from the dermis 6. 5B shows the tissue separation edges 12 gathered together as indicated by arrows 52 representing the force. FIG. 5C shows the separating edges 12 connected in the dermis 6 and some spatial separation within the subcutaneous layer 8. The edges 12 can be gathered together as indicated by arrows 52 representing forces. In addition, the screen 2 may be held or positioned inward to advance the thorns 34 at the separating edges 12 as indicated by arrows 54a representing inward or outward force. have. 5D shows the separation edges 12a, 12b substantially sealed on the screen 2. Pulling on the screen 14 in the general direction of the arrow 54b representing the outward force will fix the mesh thorns 34.

FIG. 5E shows the separation 4 sealed on the sealing screen 2 with the tubing 35 removed from the screen 14. The tubing 35 may be removed before installation by cutting the ties 42 or after the ties 42 are installed by dissolving the tubing 35, after which the non-fixed tubing 35 may be extracted.

6A shows the compressed spines 34 in connection with the separating edges 12a, 12b. As shown, the separating edges 12 may be manually sealed by compressing along the horizontal force arrows 52. The thorns 34 allow the separating edges 12a, 12b to slide up or out along the screen 14. This process can be repeated until separation 4 is closed as shown in FIG. 6B. Any protruding portion of the screen 14 may be cut close to the dermis. In the final arrangement (FIGS. 5E and 6B), the thorns 34 are lodged in tissue adjacent the separation edges 12a, 12b to secure the separation 4 in the closed position. The sap inverting the properties of the screen 14 facilitates sap extraction. Arrows 54b representing the outward or upward force indicate the direction of the force, with the screen thorns 34 fixed in adjacent tissue. The screen 14 may be positioned in a fixed position with the thorns 34, but the separating edges 12a, 12b may be used to remove the thorns 34 using a force acting in the horizontal direction as shown in FIG. 6A. It will be appreciated that it will be possible to slide on the screen 14. Skin hooks 55 may be used to connect and pull tissue portions 12a, 12b outward as shown in FIG. 6A. Skin hooks 55 may facilitate positional arrangement and rearrangement of screen 14.

VI. Other Embodiments Sealing Screen Systems and Methods

7A-7F illustrate another procedure for mounting the closure screen 2 in a wound drainage application using pressure differential. As shown in FIG. 7A, the tubing 35 may pass through the tissue adjacent the wound 4 and exit the dermis 6 for the end of the tubing ends 38a / 40a as described above. A suitable biocompatible adhesive 64 is shown applied to secure the closure screen first face 24a to the first wound edge 12a. FIG. 7B shows the screen 14 extending upward from the dermis 6 with the wound edges 12a, 12b contacted together in a manner similar to that described above.

The input / output subsystem 18 is an optional pair of foam or sponge members 56a, 56b disposed on the dermis 6 on either side of the protruding portion 14a of the screen 14. Infusion solution components. Screen 14 is then cut to a level generally equal to the top surfaces of sponges 56a and 56b as shown in FIG. 7C. An optional sponge bridge 58 is located above the sponge members 56a and 56b (FIG. 7D). Examples of suitable delivery component materials are covered in the Zamierowski patents mentioned above and include open porous foam materials (eg, polyurethane esters (PUE)) selected due to their hydrophobic nature and liquid passage. Polyvinyl acetate (PVA) materials can be used due to their hydrophilic properties. The delivery component subassembly 59 formed by the sponge members 56a, 56b, and 58 may be connected to a vacuum source, an infusion cleaner, and the like. In addition, it may be connected to other fluid delivery components and covered with various flexible membranes and drapes, which may be semi-invasive or non-invasive, as indicated for the closure and treatment of specific separations and wounds. .

FIG. 7E shows a tubing placement tool 120 having a handle 122, a shaft 124, and a hook 126 that terminates at a pointed, round, or bullet shaped tip 128. FIG. 7F shows the tool 120 penetrating the tubing 35 adjacent the dermis 6 via tissue in the subcutaneous layer 8. The tip 128 is received in the blocking portion 134 of the tubing 35 via a notch 136 formed therein. The thrust of the tool 120 causes the dermis 6 to protrude convexly, as shown at 138, where the dermis 6 can be opened with a surgical scalpel 140 and the tubing 35 The patient may be displaced for proper termination as shown in FIGS. 4A-4F.

8 illustrates a modified embodiment closure system 202 having a pair of screens 14 generally positioned end-to-end in separation 204. Delivery component subassembly 59 is disposed above separation 204 and membrane drape 205 is disposed thereon. Tube 35 penetrates tissue on either side of separation 204 (eg, using the procedure and tubing placement tool 120 described above) and dermis 6 on either side of delivery component subassembly 59. ) Is off. Portions of the tube 35 are knotted at 206. Thus, the tube 35 portions function as sutures or retainers that secure suture system 202 at separation 204. Tube ends 38a or 40a can be used for this purpose, making other tubing ends available for fluid communication with one or more of the input / output subsystems 18 described above.

The tube 35 may be secured by suitable fixtures such as clips positioned over the dermis 6. In addition, the screens 14 are overlapped, abutted, slightly spaced and otherwise arranged and positioned as needed for specific tissue separations. The screens 14 are also cut out and trimmed if necessary.

9 illustrates a modified embodiment tubing / suture subassembly having a trocar instrument 222 that includes a proximal end 226 having a pointed distal end 224 and a plurality of annular ridges 226a. 220 is shown. The portion of flexible tubing 228 combines the functions of the screen perimeter member and sutures. The flexible tubing 228 terminates at the distal end 228a fitted for removable mounting on the needle proximal end 226 and is held in place by the ridges 226a. Tubing 228 is optionally connected to screen 14 as described above and also includes perforation holes 228b for fluid drainage and / or cleaning with input / output subsystems 18 as described above. can do. The tubing / suture subassembly 220 is adapted to secure the screen 14 in place and to seal the separation 4 through the tubing 228 through adjacent tissue. Tubing / suture subassembly 220 and screen 14 may be prepackaged and presterilized to suture and treat separations that may include wounds and incisions.

10, 11A and 11B show modified embodiment suture screen systems 302 with first and second suture subassemblies 304, 306 having a screen perimeter member. Suture line subassemblies 304 and 306 include respective bent needles 304a and 306a swaged or glued to opposing distal ends 304b and 306b of a common portion of suture 307. Suture 307 may be absorbent or nonabsorbent. As shown in FIG. 10, screen closure system 302 may be preassembled with suture portion 307 detachably secured to perimeter 308a of screen 308. Prior to the installation of the screen 308, the suture 307 may be partially or completely broken or cut therefrom. For example, suture 307 may be separated along screen end portions 310a and 310b such that the suture portions are secured only along screen bottom 312.

During surgery, suture subassemblies 304 and 306 provide for a preassembled device that includes the necessary components to facilitate installation of suture / screen suture system 302 and secure to separation 4. For example, screen 308 may be secured solely at the bottom by penetrating suture subassemblies 304 and 306 via tissue portions located at the bottom of separation 4. In addition, suture subassemblies 304 and 306 can penetrate adjacent tissue and escape the surface of dermis 6, and suture subassemblies 304 and 306 suture separation 4 in the dermis 6. Can be used. Spiny strands 320 may interact with tissue portions 12a and 12b as described above, and screen 308 may provide a relatively strong mechanical connection between separate tissue portions 12a and 12b. to provide. Suture line subassemblies 304 and 306 may be used for a variety of purposes in separation 4 including addition and fixation of dermis 6, deep dermal layer 7, subcutaneous layer 8 and fascia 10. In addition, all or some of the suture subassemblies 304 and 306 may be removed, and other suture subassemblies may be mounted on the screen 308 or sutured to the screen 308.

11A shows screen 308 attached to suture 307. FIG. 11B shows separation (4) and sap via open tube ends 324a and perforations 324b, all connected by spacers 322 and opened as indicated by sap flow arrows 326. FIG. A screen 318 of another configuration is shown having hollow tubular vertical risers 324 positioned between each adjacent vertical strands 320 that are adapted to contact. All or part of the screen / seam line system 302 may have an absorbent material.

12, 13A and 13B illustrate a suture screen system 402 and application method in which only the screen of the modified embodiment is present. A screen or mesh 404, similar to the screen 14 with the prickly strands 30 described above, is disposed in the separation 4 abutting the first tissue portion 12a. The second tissue portion 12b is then placed in contact with the screen 404 and the separation 4 can be sealed and secured by the mechanical action of the screen 404. The screen 404 sutures the wound edges 12, sutures the interior of the tissue separation 4, prevents infection, and pain management, as discussed above with sutures, drainage tubing, input / output devices, and elsewhere. And other auxiliary components for the purpose of all other functions related to the present invention. For example, screen 404 may be secured with sutures at subcutaneous level 8. Various infusion interconnect devices can be used as needed and can be designed to be removed after they have performed their initial purpose. External drainage may also be achieved at the dermal level 6, designated 59 and using delivery component subassemblies such as the example described above (FIG. 7D). In addition, drainage and wash tubing may be installed along the screen 404 or inside the window 4 adjacent the screen 404. The version in which only the screen of the present invention is present may include various suitable biocompatible absorbent and nonabsorbent materials, including the aforementioned materials.

FIG. 13A is an enlarged view of the screen 404 and in particular shows the visible strands 406 and the horizontal spaces 408 connected together in a lattice pattern forming the screen 404. FIG. 13B shows another embodiment with a modified screen 410 comprising vertical risers 412 connected to horizontal spacers 408 and having hollow tubing spaced by the horizontal spacers. The sap flows into and out of the vertical risers 412 through the open riser ends 412a and the puncture holes 412b, as indicated by sap flow arrows 420.

14A-14G illustrate a screen 404 installed in tissue detachment 4 and the closure of this using the method of the present invention. The methods shown in FIGS. 14A-14G are similar to the methods shown in FIGS. 5A-5E and 6A and 6B. 14C shows an arrow 54a representing a downward / inward force indicating the direction in which the screen 404 is pushed or guided towards the separation.

15A and 15B and 16A and 16B show a modified vertical riser 502 having a bundle of tubes 504 secured together by connectors 506 at spaced intervals. Due to the normal movement of the patient, there is also a tendency to compress and expand the vertical risers 502, thus "pumping" the fluid from the wound 4 as the sap flow arrows 510 indicate. Provide action. 15A and 15B show riser tube 502 in an extended arrangement. Compressing the screen 14 longitudinally (ie, end-to-end) compresses the bundle of risers 504 in the arrangement shown in FIGS. 16A and 16B, where the risers 502 extend. The sap is drawn into the inter-organization space 508 and pumped from there.

FIG. 17 shows another arrangement of a vertical riser 602 with a bundle of tubes 604 defining a tightly bundled and transit passageway 606. Such fluid delivery can be enhanced by the normal movements of the patient and the pumping action involved. The thorns 608 protrude outward from the tubes 604. It will be appreciated that various other bundles of tube arrangements, such as twisted and twisted, may be used.

18 shows another embodiment arrangement of another vertical riser / perimeter member 702. The member 702 has an arrangement, which is often referred to as a "fluted" outlet and includes longitudinally extending passages 704. This arrangement may replace the above-described perimeter members and may function to deliver fluids into and out of the wound 4 with the input / output subsystem 18.

As still other embodiment arrangements for the vertical risers, they may have either one of the spiny monofilament strands or the non-thorny monofilament strands similar to the strand 30 shown in FIG. 3. Such monofilament vertical risers function as passive discharge tubes so that sap can flow along them. They may be adjacent or connected to the delivery components formed in various arrangements extending above the dermis 6 and having suitable absorbent materials. Examples thereof include gauze dressings and delivery component subassemblies, such as (59) shown in FIG. 7D.

19 illustrates another embodiment strand 802 constructed by twisting and twisting a plurality of individual filaments 804. The thorns 805 are formed by respective individual filaments 804a ending at blunt ends 806. Thorns 805 generally protrude outward from strand 802 to form an acute angle with respect to its longitudinal axis. These are tailored to penetrate the tissue within the separation 4 as described above. In use, the thorns 805 will mainly be oriented in a generally outward direction from the patient and tissue separation 4.

20 illustrates another embodiment strand 902 that includes a plurality of twisted and twisted filaments 904. Thorns 905 are formed from individual filaments 904a and have notches 908 and pointed ends 910. Notches 908 and distal ends 910 are arranged such that the spines 905 are easily extracted from the separating edge tissues, and the screen is adapted to slide along the separating edges to achieve a proper position.

FIG. 21 shows spines 1104 formed by looping individual filaments 1006 and cutting them at cut locations 1010 spaced inwardly from respective vertices 1008 of the filament loops. Another modified screen 1102 is shown. During surgery, the thorns 1004 slightly penetrate the tissue and become lodged therein. It will be appreciated that the filaments 1006 are relatively thin in diameter, similar to microfibers, thereby optimizing patient comfort.

22 loops individual filaments 1106 so that respective hooks 1112 are formed and cut at cut locations 1110 spaced inward from vertices 1108 of the filament loops. And another modified screen 1102 with the spines 1104 formed therein. The hooks 1112 operate in a similar manner to hook-and-loop fixtures with adjacent tissue forming the loop portions of the connection. During surgery, the hooks 1112 slightly penetrate the tissue and get lodged therein. Arrangements of hooks 1112 tend to hold them in tissue adjacent to separation 4 such that separated first and second tissue portions 12a, 12b can be sealed.

FIG. 23 shows a screen 1202 having a similar arrangement as the screen 1002 described above and having other fiber components or filaments 1204. The other filaments 1204 tend to place the filament thorns 1206 thereon, such that the screen 1202 can be oriented in the direction within the wound separation 4 and in a similar manner to the screen 14 described above. Works. The thorns 1206 are formed by cutting the vertices 1208 at the cutting positions 1210.

Similarly, FIG. 24 shows a screen 1302 with other filaments 1304 sandwiching the filament loops 1306 and orienting it in the right direction as shown in FIG. 24. The inclined orientation of the filament loops 1306 is pulled out on the screen 1302 to facilitate securing it to the tissue portions 12a, 12b adjacent to the separation 4. Repositioning of the screen 1302 is also possible as described above. The filament loops 1306 may be cut at cutting locations 1310 spaced inwardly from the filament loop vertices 1308.

It will be appreciated that FIGS. 21-24 disclose screens with thorns and hooks extending from one side thereof. The present invention also includes screens having thorns and hooks extending from both sides.

Suture screens comprising more modified aspects or embodiments of the present invention are shown in FIGS. 25-30 and generally designated by reference numeral 1402. Screen 1402 is generally a semi-unique of a plurality of individual clips having links 1440 sewn together at respective strands 1408 by suitable flexible filaments or lines 1446. By action (FIG. 25B) it comprises a highly flexible panel 1404 that sandwiches and closes adjacent tissue portions across separation. As shown in FIG. 25B, each link 1440 includes a pair of peaks 1442 bounded in the middle by a loop 1444 in which the filament 1446 is tied or secured. Thus, the loop 1444 forms a pivot center or support point with the filament 1446 to facilitate rocking action of the link 1440. For example, due to the relative motion of the screen 1402 and surrounding tissue, torque forces may be imparted as indicated by arrows 1424 representing torque. The torque force rotates the clip 1440 to an inclined position, as indicated by the broken lines in FIG. 25B. Such rocking action pushes the peaks into the surrounding tissue, enhancing sutures. In addition, the relative motion of the surrounding tissue can be accommodated by a combination of screen flexibility and peak motion. The fixation and tissue movement can be controlled to some extent by modifying the design of screen 1402 and clips 1440.

26 and 27 terminate at pointed first and second peak ends 1414 and 1416, respectively, with a first peak 1410 and a second peak 1412 connected by a link body 1413. Another arrangement link 1406 is shown. A link 1417 with a slightly different and more open arrangement is shown in FIG. 27A. As shown in FIG. 28, the peaks 1410, 1412 of the link 1406 generally extend outwardly from the body 1413 and longitudinally with respect to the longitudinal axis 1418 of the strand 1408, opposite the acute angle thereof. To form. The angular orientation of the peaks 1410, 1412 provides one direction orientation for engagement in the first direction and departure orientation in the opposite direction. Each link 1406 may be integrally formed from a single portion of a suitable suture-like material having suitable shape memory, flexibility / rigidity, and biocompatible features.

As also shown in FIG. 28, each loop 1420 is an adjacent link 1406 in a flexible bond that may be formed by thermal fusing, ultrasonic welding, adhesive, or any other suitable clamping device or method. Each of which receives a long peak 1410. For example, link peaks 1410 and loops 1420 provide a tongue-and-groove or snap-fit mobility interconnect without the need to physically bond the links 1406. Can be arranged to.

The strands 1408 are generally fastened together in forming the panel 1404 by a plurality of diagonal filaments 1422 extending laterally, horizontally, longitudinally or preferably diagonally relative to the panel 1404. Can be. Like the links 1406, 1417, and 1440, the filaments 1422 may comprise a bioabsorbable or other biocompatible material. The filaments 1422 are preferably highly flexible and thin. FIG. 29 illustrates a screen arrangement 1404 in a compressed arrangement, in which first long elongated peaks 1410 are pivotally received within respective loops 1406 of adjacent links 1406. 30 illustrates such pivoting action of links 1406 (dashed line) to accommodate relative tissue movement on either side of tissue separation.

Screen 1402 includes a pre-installed closure assembly 1424 having front and rear support sheets 1426, 1428 that can be provided with a suitable removable adhesive 1429. The support sheets 1426 and 1428 are preferably made of paper or relatively stiff (relatively soft panels) to maintain the flat shape of the closure screen 1402 and protect it from sharp tip tips during handling and placement to the patient. Other materials (eg, Styrofoam. RTM. Material). The outer edge steering strip 1430 is mounted on the upper edge of the perimeter 1432 of the panel 1404 (FIG. 25) and is adapted to be slid manually or using instruments to facilitate handling, arrangement and placement. have.

Another embodiment or aspect of the present invention is shown in FIGS. 31-33 and includes a modified clip having a double-loop link 1556. Each link 1556 includes first and second peaks 1560 and 1562 terminating at respective first and second ends 1564 and 1566. Near-end and far-end loops 1570, 1571 are provided adjacent to first and second peaks 1560, 1562, respectively.

34 illustrates a modified suture screen configuration 1624 using clips 1604 mounted on a flexible matrix 1626 having flexible strips 1628 flexibly interconnected in parallel by cross strands 1630. To show. The strips 1628 can be penetrated by the peaks 1614, 1616, and both clips 1604 can be mounted on one side of the double-sided closure screen 1624. Clips 1604 may also be mounted on either side of the strips 1628 or on one side where all of the peaks protrude toward the single side closure screen in the double side closure screen.

34A shows other clip configurations. Clip 1632 includes inner peaks 1614 and edge peaks 1616 extending from one side at the vertex and the other at the bottom. Clip 1634 includes upper peaks 1614 and 1616 extending from opposite sides and lower peaks 1614 and 1616 extending in similar manner from opposite sides. The clip 1636 includes only each inner tip 1614 and edge tip 1616 that can extend outwardly from the same face (as shown) or extend outwardly from opposite faces.

35 shows a clip 1632 that approximates tissue separation 4. Respective peaks 1614, 1616 are lodged at opposite tissue portion edges 12a, 12b. Due to the relative movement of the tissue, the peaks 1614 and 1616 can be further fixed and the edges 12a and 12b are pulled together for healing.

36 and 37 illustrate a suture screen 1602 with another aspect or embodiment having a plurality of independent rigid clips 1604 on a flexible mesh matrix 1606. Each clip 1604 includes first and second faces 1608, 1610 and a perimeter 1612. Inner peaks 1614 are punched from clip 1604 to form clip openings 1615, and perimeter peaks 1616 are punched adjacent to perimeter 1612, notches 1618. Will form. The suture screen 1602 stitches the mesh material connector strands 1620 through the clip openings 1615 and threades the mesh material connector strands 1620 and crosses the strands 1620 in a cross-shaped pattern as shown in FIG. 36. It is formed by fixing together. The clips 1604 may be alternately oriented such that their respective peaks 1614, 1616 extend from both sides of the screen 1602 for double-sided engagement (shown) or only from one side for cross-sectional engagement. .

FIG. 38 has bases 1854, 1860, 1866, and 1872 with respective pointed peaks 1856, 1862, 1868, and 1874 that are stamped from sheet metal or other suitable material and protrude therefrom. Some configurations of clips 1852, 1858, 1864, and 1870 with respective bodies are shown. FIG. 39 illustrates another clip configuration 1876 disposed on a woven screen or mesh structure 1880 generally coplanar with the clip base 1880, such as the screen or mesh structures described above. Each clip 1876 has a pair of peaks 1882 that project outwardly therefrom. Clips 1852, 1858, 1864, and 1870 are adapted to attach to such screen or mesh structures, making arrangements as shown in FIGS. 40-43.

44-49 illustrate other bent wire clip configurations adapted for mounting on a flexible screen or mesh structures. In general, a clip 1802 having a rectangular base 1804 and a single peak 1806 projecting out therefrom is shown in FIGS. 44 and 47. 45 and 48 generally show another clip 1808 having a rectangular base 1810 and peaks 1812. 46 and 49 generally show another clip 1814 having a U-shaped base 1816 and a pair of peaks 1818 protruding out therefrom. Bases 1804, 1810 and 1818 are generally positioned in a plane formed by a screen or mesh structure with peaks 1806, 1812 and 1818 projecting outward therefrom at suitable acute angles, such as about 30 to 45 degrees. Is tailored to The peaks may include sharp tips as shown.

50 illustrates a clip 1902 that includes another embodiment clip arrangement. As shown in FIGS. 51A-51C, clip configurations 1902a-1902c each have four primary peaks that may extend from one or both sides of the body 1908 of each clip 1902. 1904 and four secondary peaks 1906, respectively. 52A-52C show sides of clip arrangements 1902a-1902c. The central slot 1903 is formed in the body 1908 and the notches 1905 are formed around the perimeter. The center slot 1903 and the notches 1905 are adapted to receive filaments or other flexible members in a sealing screen matrix including a plurality of clips 1902, and the clips 1902 constitute a flexible sealing screen. It can be fixed in place somewhat in place.

53 and 53A show another embodiment clip arrangement 1910 with bent primary peaks 1912 and straight secondary peaks 1914. Due to the curvature of the primary peaks 1912, it is easy to pull together the separated tissue parts 12a, 12b as shown by arrows 1916 shown in FIG. 53A and representing the transverse force. . Such transverse forces are described by V.A.C..RTM. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas. Can be applied using an NPWT device such as System.TM. The secondary peaks 1914 assist to prevent loosening when the suture screen is forced downwardly (ie toward the body), indicated by an arrow 1917 representing the force.

54 and 54A show another embodiment clip arrangement with a bent body 1922. This arrangement causes the subsequent primary tip 1924 to connect and infiltrate tissue for the first time, and then the clip 1920 rotates to immerse the primary primary tip 1926. For example, the torque imparted to the clip 1920 by force pulling along an arrow 1928 representing a force on the enclosing filament 1929 (clockwise as the torque arrow 1927 shows) is There is a tendency to facilitate firm fixation in the tissue 12b.

55 and 55A show another embodiment clip-array 1930 with flexible folding peaks 1932, 1934 that fold when the clips are between the support screens 1936a, 1936b. When the support screens 1936a, 1936b are removed (FIG. 55A), the peaks 1932, 1934 are adapted to penetrate the tissue 12b and protrude in an outwardly extending orientation.

Other arrangement clips 1910, 1920, and 1930 may be formed from a common clip template having extensible bodies and peaks adapted to bend in various desired arrangements, as shown in 1902 of FIG. 50. . In addition, the clips can be mounted to various screen matrices.

FIG. 56 shows another embodiment clip arrangement 1940 with primary and secondary peaks 1942 and 1944 with spines 1942a and 1942b, respectively. FIG. 57 shows another embodiment clip arrangement 1950 with first and second peaks 1952, 1954 having respective spines 1952a, 1952b. 58 shows another embodiment clip arrangement 1960 with quadrilateral primary and secondary peaks 1962, 1964 having respective trocar-shaped ends 1962a, 1964a. Various other clip, base and peak arrangements, combinations and orientations can be used with the present invention.

59 illustrates a suture clip system 1970 that includes another embodiment of the present invention. The system 1970 includes a screen 1972 that may have any of the clip and screen configurations described above. The screen 1972 is disposed inside the tissue detachment 4 and the extension 1974 is folded over the skin surface on one or both sides of the tissue detachment 4. Attaching or attaching a strip comprising the screen assists in supporting the links and the clips in a position abutting downward loads. Adhesive on the screen or strips will not stick to the wet tissue of the separating edges, but will appear on the dry skin surface 6. Screens or strips are located in St. Minnesota. STERI-STRIP.RTM, available from 3M Company in Paul, can be made of rapidly dissolving biodegradable materials reinforced with species strands of slower dissolving material similar to the construction of strand-reinforced tapes. With the extension 1974 folded over the skin surface 6 and the remaining clips on the wound 4 removed or cut off, the extension (s) 1974 may be removed from the skin surface with a STERI-STRIP or other suitable tape 1976. 6) can be attached. In place of or in addition to the tape 1976, surgical staples 1978 may be used to suture tissue detachment and attach the extension (s) 1974 to the skin surface 6. The transverse suture forces are selectively applied to the V.A.C..RTM. NPWT source 1980, such as System.TM., May be added to tissue isolation 4 shown in FIG. A suitable drape 1982 may be applied over the sound pressure source 1980 which is in sealing relationship with the skin around the perimeter.

FIG. 60 is an illustration of the elongation of the system measured in tenths of an inch and tension measured in pounds per prong using a plurality of clip screens similar to suture screen 1602 shown in FIG. 36. A load strain curve showing the relationship is shown. The screen was held between two pieces of raw beef steak subjected to varying shear stress (tensile) forces plotted on the Y axis of the graph of FIG. 60. Compressive force equal to 0.341 pounds per peak was applied to the beef steak pieces with the suture screen clamped in between. Such compressive forces were applied mechanically to derive the load deformation curve shown in FIG. 61 shows a load-strain curve that changes the compressive force at a constant tension of 0.341 pounds per peak. Theoretical points derived from the load-strain curves of FIG. 61 indicate that V.A.C..RTM. Vacuum compression of 100 mmHg is shown as applied using System.TM. 60 shows that increasing the tensile load increases the elongation of the model (definition relationship). Fig. 61 shows that the compressive loads and the elongation have an inverse relationship in which a greater elongation occurs with a smaller compressive load.

While specific forms of the invention are illustrated and described herein, it should be understood that they are not limited to the specific forms or arrangement of parts described and illustrated.

Claims (39)

A clip body having a face; And And a prong that protrudes from the face, is adapted to penetrate the tissue, and has a tissue-suture arrangement. The method according to claim 1, And an acute angled tissue-suture arrangement defined by the body face and the tip. The method according to claim 1, And a tissue-sealed array having the peak flexure. The method according to claim 1, The clip body surface having a first surface; A second clip body face; The clip body having a first concave concave and a second convex convex curvature; And And a peak projecting from the first concave surface and forming an acute angle therewith. The method according to claim 1, And wherein the body and the tip comprise a portion of a linear perforated material. The method according to claim 5, A peak having a first peak and ending at the first point; A second peak projecting from the clip body and ending at a second point; And And a body defining a receiver adapted to move and attach the clip to another clip. The method according to claim 6, A receiver having a first receiver; A body surrounding the first receiver and adapted to link with a second loop of an adjacent clip to form a first loop and a second loop to which the clips are linked in an articulated connection; And And a second receiver surrounded by the second loop. The method according to claim 1, A clip body generally having a planar arrangement, a perimeter and an inner portion; A peak having a first peak and positioned at the perimeter; An opening in the inner portion; And And a second peak protruding outwardly from said body adjacent said opening. The method according to claim 8, And first and second spines positioned on ends of each of said first and second peaks. The method according to claim 8, A clip, characterized in that it has a quadrangular arrangement and includes each peak ending at the trocar-shaped end. The method according to claim 8, A notch in the clip body perimeter; A first peak positioned adjacent the notch and having a first primary peak oriented in a first direction with respect to the clip body; A second peak having a second primary peak oriented in the first direction; And A first secondary and a second secondary peak projecting outwardly from the clip body and oriented in a second direction with respect to the clip body and positioned adjacent the notch and the opening, respectively. Clip. The method according to claim 1, A clip comprising a bioabsorbable material. A plurality of clips each having a peak adapted to penetrate tissue; And And a flexible linkage for flexibly linking the clips. A medical suture clip system for suspending separation between first and second tissue portions. The method according to claim 13, And said flexible chain comprises a flexible material screen for mounting said clips and having a plurality of filaments connected to said clips. The method according to claim 14, And a respective clip having a portion of the bent wire forming each peak and a connecting portion flexibly connected to the other clip forming the flexible chain. The method according to claim 13, A first set of clips having a first orientation and having peaks adapted to connect the first tissue portion; And And a second set of clips having a second orientation and having peaks adapted to join the second tissue portion. The method according to claim 16, A flexible screen having first and second sides opposing each other; Peaks of the first set of clips extending from the first screen surface; And And a peak of said second set of clips extending from said second screen surface. The method according to claim 16, A screen having a first portion for mounting said first set of clips; A screen having a second portion for mounting said second set of clips; And A clip system comprising respective peaks of a first set and a second set oriented in opposite directions with respect to each other to tension across tissue separation. The method according to claim 13, Clips each having links having loops; And A plurality of articulated strands of interconnected links in their respective loops, And wherein said plurality of articulated strands are flexibly interconnected. The method according to claim 18, A clip having first and second loops and first and second peaks, respectively; A plurality of flexible strands formed by interconnecting adjacent clips with respective first and second loops linked by articulated connections; And And a screen having said strands and a plurality of flexible filaments connected across and extending across said strands. The method according to claim 17, A clip system having a clip body with each tip protruding outward from the clip body, the clip system comprising respective clips that are independently flexibly mounted on the screen. The method according to claim 17, Each said clip body having an opening; And And a screen having a plurality of filaments through the clip body openings. The method according to claim 22, A screen having a plurality of flexible support strips; A plurality of clips mounted on each support strip having respective clip peaks extending through the support strip; And And a plurality of screen filaments extending between the support strips and flexibly interconnecting the support strips in a generally spaced apart relationship. The method according to claim 13, Wherein each clip comprises first and second faces and first and second peaks extending from each of the first and second faces. The method of claim 24, Each clip is In general, a perimeter surrounding the clip body and having a notch; An opening in the clip body; An inner tip located in a spaced apart relationship within the perimeter adjacent to the opening of the clip body; And A clip system positioned at said clip perimeter adjacent said notch. The method according to claim 25, Each clip is A clip body having first and second faces; First and second inner peaks protruding outwardly from the first and second clip body faces, respectively; And And first and second edge peaks protruding outwardly from said first and second clip body faces, respectively, in opposite directions. The method according to claim 13, Negative pressure source; Means for distributing a sound pressure connected to the sound pressure source; And And means for fluidly coupling the dispensing means to the tissue separation. The method of claim 27, A negative pressure source having a vacuum source; And And dispensing means having foam material located within or in proximity to the tissue separation. The method according to claim 13, A flexible medical closure screen with the clips; A screen extension adapted to extend beyond the detachment tissue; And Clip means adapted to attach the screen extension to a skin surface. The method of claim 29, Attachment means having one of a group comprising an adhesive, staples and sutures; An infusion delivery component having a hydrophobic foam material adapted to engage said screen extension on a skin surface; A drape positioned on the fluid delivery component and adapted to adhere to the skin surface; And And a sound pressure source fluidly connected to the infusion delivery component. A ferrule having a clip body and a clip body perimeter, each having a first and second faces, each having an inner peak that is punched from the clip body portion in a spaced apart relationship from the perimeter to form an opening therein; A plurality of clips each having an edge peak punching from a portion of the clip body adjacent to the meter to form a notch there; Peaks projecting outwardly from opposite sides of each of the clip bodies and generally oriented in a common direction with respect to the clip; And A first and second tissue parts, the first and second tissue parts comprising a flexible screen for mounting the clips with the peaks oriented outwardly from each of the first and second faces. A medical suture screen system that sutures separation between. A medical suture method of suturing a separation between first and second tissue portions, Providing a plurality of clips each having a peak extending from each clip; Flexibly connecting the clips with the first and second portions to form a screen panel; Orienting the first set of peaks in a first direction corresponding to a relative position of the first tissue portion on the screen panel first portion; Orienting the second set of peaks in a second direction corresponding to a relative position of the second tissue portion on the screen panel second portion; And Engaging the peaks oriented in the first and second directions with the first and second tissue portions, respectively. The method according to claim 32, Providing a body having first and second faces and a perimeter in each of said clips; Punching first and second peaks from the clip body first and second faces, respectively; And Orienting the first and second peaks outwardly from the first and second clip body faces and in a common direction generally toward the clip perimeter. The method according to claim 32, Forming each clip in a loop; Interconnecting loops of each adjacent clip to form extended flexible strands; And And mounting the plurality of strands on the flexible screen to form the screen panel. The method of claim 34, wherein Providing a plurality of strands; Providing a convex face on each strand; Notching the convex surface to form the peaks; And Mounting said strands on a flexible screen to form a screen panel. The method according to claim 32, Positioning the screen panel between opposing first and second edges of the first and second tissue portions, respectively; And Suturing the first and second tissue portion edges. The method according to claim 32, Applying the screen panel across longitudinal tissue separation; Tensioning the first and second tissue portions; Proximity of the tissue portions; And Suturing the tissue separation. The method according to claim 32, And wherein said tissue separation is located in one of the group consisting of tendons, blood vessels, and nerves, said tissue-suture arrangement with flexion. Applying the screen panel across longitudinal tissue separation; Tensioning the first and second tissue portions; Proximity of the tissue portions; And Suturing the tissue separation.

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