JP2005532134A - System and method for moving and stretching a forming tissue - Google Patents

Abstract

Systems and methods for moving and stretching a forming tissue using dynamic forces are provided. A preferred non-reactive force acting component can be adjustably attached to one or more tissue attachment structures for securing the force acting component to the forming tissue, providing a relatively constant tension over a certain distance. Provides an automatic adjustment system that can.

Description

  The present invention relates generally to systems and methods for moving and stretching formed tissue, and in particular for moving and stretching the tissue, which can be easily adjusted by applying a relatively constant tension over a given distance. The present invention relates to a system and method.

  In general, surgical procedures and treatments include one or both of tissue separation and tissue joining. In surgical procedures, surgical treatments, and medical studies, ideally in a way to create a minimal wound other than that required for exposure and visualization of the surgical site, the tissue is contracted, the tissue is stabilized, and the tissue is It is desirable to have access to the site under investigation or recovery in a variety of specific directions. In other words, as in the case of transplantation, it is desirable to apply a force on a tissue structure in relation to some or all of the other tissues that are to become a part. Applying such forces for tissue handling can be accomplished through a very simple and concise array of elements that may or may not include gravity as an important element, or a complex and long array of elements. Also good. Examples of simple rows where gravity is not an important factor include sutures and staples (tissue bonding) and thoracotomy (tissue separation).

  Tissue movement presents a unique challenge because tissue often resists joining or closing depending on the nature of the tissue structure, the environment of tissue separation, and general patient health. The complexity of wound closure and healing is generally the result of a large force, a small force, and / or an impaired healing response. The large force is the contraction force that occurs beyond the viscoelastic nature of the tissue, (1) increased internal capacity, such as in obesity that increases the confinement force in the skin system, and (2) walking prone by muscle atrophy Changes in aspect ratio, such as increased abdominal circumference created in patients who cannot, (3) respiratory muscle activity, (4) muscle reaction, (5) loss of fascial structure, (6) muscular bone deformation, It can be caused by (7) obese appendages, (8) swelling, and (9) severe burns.

  A small force is an internal force created by the viscoelastic nature of the tissue that can contract the skin. Elastic tissue, such as skin, returns to its lowest elastic or relaxed state when released from tension. In this relaxed state, the tissue cells have a spherical shape, the cell walls are thick and strong, and the cell surface tension is minimal and balanced. Cells in this lowest elastic state remain relaxed and behave like inelastic materials. The force required to stretch the cells in this state is often close to the force that breaks or shears the cell-cell bond to cause local breakage or tearing. Soft cells in this lowest elastic state provide minimal surface coverage and have the highest resistance to stretching. A gentle but constant force below the threshold of the shear force applied to the tissue with proper hydration will return the tissue to its original elastic state over time. In addition, this force can be applied to stretch the tissue past the equilibrium point (normal elastic range) to the maximum elastic range, making the thinnest configuration possible and covering the maximum surface area. If the intercellular pressure in the tissue does not exceed the point at which cell-cell connectivity is compromised, the tissue will remain in the most elastic state as a healthy tissue and will be described later as biological creep, but normal biology The process creates additional cells and restores normal skin thickness and tension.

  Forming tissues such as skin and muscle have certain viscous and elasto-rheological properties and are therefore viscoelastic. Certain formation structures can increase surface area over time, which can be referred to as “creep”. “Mechanical creep” refers to the stretching of the skin with a constant load over time, and “biological creep” refers to the generation of new tissue due to chronic stretching forces. A constant and unsagging force applied to body tissue such as skin or muscle results in both mechanical and biological creep. Mechanical creep restores the tension originally present in the skin but lost in the skin over the incision or wound by re-tensioning the cells of the skin or soft tissue, thereby increasing the skin coverage. Biological creep occurs more slowly and necessarily involves the creation of new tissues. Tissue expansion has long been part of the field of plastic surgery, traditionally achieved by a balloon-type tissue dilator that is implanted under the skin and expands and expands over time. Creates an expanded skin pocket for procedures such as breast regeneration after radical mastectomy and stretches healthy tissue prior to plastic surgery to create a skin section for soft tissue closure.

  Finally, impaired healing responses can complicate wound closure or healing. Surgical incisions or other incisions become wounds as soon as they are delayed from the normal healing plan. Wound management, including the treatment and protection of large skin defects and severely contracted incisions, is an area of increasing importance for the health care community. The aging population and the increased illness associated with obesity and inactivity have increased the incidence of chronic wounds and increased the burden on health care resources. Factors that contribute to wound healing include: patient age, weight, nutritional status, dehydration, blood supply to wound location, immune response, allergies to closure materials, chronic illness, debilitating injuries, local Or use of systemic infections, diabetes, and immunosuppressive drugs, corticosteroids or tumor growth inhibitors, hormones, or radiation therapy. Chronic wounds include diabetic and other chronic ulcers, venous hemostatic ulcers, pressure ulcers or decubitus ulcers, burns, after joint dissection, wound cleansing, skin gangrene, colectomy, and ischemic necrosis Post-traumatic injuries such as contusions, collagen diseases including rheumatoid arthritis, vasculitis (damage and ulcers due to arterial failure), amputation, fasciotomy, postoperative dehiscence, sternotomy, necrosis fascia Inflammation, trauma, bone plate or bone exposed wound, wound repair, skin trauma, blunt abdominal trauma with perforation, pancreatitis, neuropathic ulcer, compartment syndrome, and other subacute or chronic There is a serious wound. The difficulty in closing open wounds has prompted and sought treatment and care for these injuries.

  Two common methods of closing wounds and skin injuries are split skin grafting and gradual closure. Split skin grafting requires removing a partial skin layer from the donor site, usually from the upper leg or thigh, and leaving the dermis at the donor site to be covered again with epithelium. Including. In this way, a feasible skin repair fragment can be transferred or transplanted to cover the wound area. Grafts are often reticulated (this involves cutting the skin into a series of cuts that are diagonally engaged with each other in a longitudinal direction) and stretching the graft to cover 2 to 3 times the area As well as draining the wound during healing. The normal biological function of the skin coalesces the pores after the graft is received. This type of reticulated graft requires less area than conventional non-reticulated or full thickness skin grafts. However, these methods do not provide optimal toning or quality of the skin coating. Another disadvantage of this method is the complications associated with pain at the donor site, additional bruising, and incomplete “acquisition” of the graft. In addition, skin grafts often require limb fixation, which increases the likelihood of muscle contracture. Additional treatment and hospital stay extension are additional economic burdens.

  Sequential or gradual closure is the second closure method. This technique involves stitching the transport tube loop to the wound edge and pulling the loop together with large seams in a manner similar to shoelaces. In addition, the wound edges can be joined progressively with sutures or sterile paper tape. The advantages of this sequential or progressive technique are many. This means that the donor site is not needed to remove the graft, the mobility of the limbs is maintained, excellent cosmetic results, more durable skin coverage, better protection from full-thickness skin, and normal All of the maintenance of skin sensation can also be achieved.

  There are many drawbacks to existing devices for performing gradual closure. Current methods and devices use mechanical devices, such as screw-actuated devices, to pull the wound edges together, and such devices are regularly used because relatively small skin movements remove much of the closure force. Adjustments must be repeated. Widely used existing closure techniques involve the use of relatively inelastic materials such as sutures or surgical tape. Excessive tension can cut the skin or cause necrosis due to point loading of the tissue. Current solutions include the use of suture cushions, suture bridges, staples as fasteners at the wound edges, and the use of ligation wires to distribute the load along the wound edges. All of these approaches rely on static ribbons or suture materials, which must be re-adjusted repeatedly to function effectively, and this constant re-adjustment also keeps it approximately constant over time. It is difficult, if not impossible, to achieve the desired tension. Widely used conventional sequential closure methods rely on static forces with fixed distance reduction and do not provide continuous or dynamic tension.

  Many current open wound reduction methods employ static or non-yielding devices such as sutures or rigid accessors that narrow the distance between wound edges and rely on the natural elasticity of the skin to compensate for movement. One problem with these devices is that when they are most effective, when the skin is at its maximum extension point, additional skin tension created by movements such as breathing or walking causes the mechanical fasteners to To create stress that causes tearing at the point where the wound edges meet and causes necrosis of the wound edge. This generally requires the patient not to move during treatment. Existing systems for treating animals generally do not need to think much about cosmetic results because healthy animals typically hide their wounds with fur, but tolerability is applied when applied to humans. It is an important criterion in determining the success of results.

  One existing method for performing wound closure utilizes a low force of constant tension to pull the wound edges together. One apparatus for carrying out this method includes a pair of hooks supported by a pair of sliders that are moved by a pair of springs along a path. This spring device is enclosed in a plastic housing and is available with various curvatures. The sharp hooks used in this system can damage the skin. The constant force used is a determined force that is not variable. Other closure devices use elastomeric materials, including rubber bands and other types of compression and non-compression materials, to bring the wound edges close together. Some kits require adhesion to the skin with an adhesive and also require periodic adjustments to tighten the strap. In other known closure devices, hooks and elastic loops are used, which must be replaced with smaller elastic loops to maintain tension, or use power to provide clamping means. Finally, some other current devices consist of two surgical needles, two U-shaped Lexan polycarbonate arms with hooks on the bottom, a threaded tension bar, and a polycarbonate ruler. The needle is threaded along the wound edge, each arm is positioned over the needle, and the hook pierces the skin and engages the needle. The tension bar can then be secured and the tension can be adjusted using screws.

  Existing methods of sequential wound closure cannot provide an effective sequential closure that restores the original skin tension lost across the wound. For example, one system has a single tension of 460 grams. In many instances with older or damaged skin, this force is too great, resulting in local dysfunction, tearing, and necrosis. Many current devices are cumbersome, limit patient mobility, must be completely removed for wound dressing and cleaning, and can be used in relatively limited situations due to their dimensional limitations It is. Many devices also require a surgeon to reattach after being removed for wound dressing. Finally, many current devices have a limited ability to pull in a single direction along the overhead beam, so they cannot be easily used for radial closure, which allows them to run along the same axis. Limited to parallel pulling.

  The present invention provides manipulation and control of tissue position and tension in living humans and animals that utilizes both tissue stretching and creep to recover and move any formed tissue. The present invention is simple, easy to use, relatively inexpensive, extremely flexible, self-adjustable, and relatively constant at various angles over various distances in wounds having simple or complex dimensions. A method and apparatus for moving and stretching a formed tissue that can provide the same force and tension.

  The components of the present invention provide dynamic force to the tissue to provide and maintain maximum safe antagonistic traction pressure or force across the wound edge or other area. The force stays below the extent of creating local damage at the wound edge. In this way, a constant and constant tension is created that can be applied to counteract large or small contractile forces, or achieve maximum mechanical and biological responses, resulting in large contraction skin damage. Move and stretch the forming tissue. Tissue manipulation according to the present invention utilizes a force acting component (sometimes referred to as “fac”) coupled to a force coupling component (“anchor”), which forces the force imparted by the force acting component to the tissue. Join.

  Force acting components usually perform two functions. That is, (1) energy is accumulated in a manner of applying force, and (2) this force is transmitted. The force acting component can divide these functions into two, such as by (1) storing energy in a coiled telescopic spring, which is stretched to store energy, and (2) the spring It is attached to a relatively inelastic string, cable, wire, rod, filament, or thread located between the anchor and the anchor, and transmits the force applied by the spring to the anchor. In most embodiments of the invention, the energy storage and force transfer functions are combined in a single elastic component such as a rod, filament, tube or sheet of elastomeric material such as silicone. However, in some embodiments, a relatively inelastic material is used to transmit the force provided by an energy storage component such as an elastomeric material or a coiled or other metal or plastic spring.

  An anchor that couples force to tissue includes two components: (1) a tissue coupling component, and (2) a component for coupling to a force acting component. Fac binding can occur by passing through a portion of the fac or fac, such as a suture passing through a hole through tissue. However, such rudimentary bonds are important for several reasons, such as the distribution of very bad forces across the tissue and the lack of practical means to adjust the force exerted by the suture over time. Is bad.

  The anchors of the present invention generally decouple the tissue connective structure from the structure for attachment to the force acting component, thereby optimizing each of the two anchor structures and adapting each anchor structure to a variety of different situations. . The anchor structure according to the invention for coupling to force acting components allows for fast and easy attachment and re-attachment of various facs, especially silicone facs that are extremely difficult to fix. The tissue bonding structures and techniques of the present invention include invasive structures such as keys, staples, and sutures, and tissue penetration by force acting components. Force acting components also include non-invasive structures that utilize adhesives, particularly on plates and fabrics.

  The terminology used herein is generally defined when introduced and is abbreviated in some cases. For convenience, selected terms are also defined herein. A force acting component (“fac”) generally stores energy in a manner that transmits a force applying force. The elastic force acting component (“efac”) combines these two functions into a single elastic component. The term “elastomer” refers to a relatively elastic material such as silicone or latex rubber. The term “non-responsive” is used to describe a component that is either immunologically inert or hypoallergenic. Anchors are commonly used to couple fac to tissue by transmitting force to the tissue to be moved or sutured and providing structures for coupling to fac and structures for coupling to tissue.

  The present invention provides for healthy skin when preparing skin grafts, flaps, or other remodeling procedures, as well as for closing or remodeling tissue to close skin wounds, incisions, or damage associated with various conditions. Can be used to apply dynamic forces when stretching. In the simplest use, such as closing a fasciotomy, the present invention may be used to return the contracted skin to its original position. The present invention can be used to stretch the skin to cover areas where a portion of the original skin is missing, such as can occur in the case of local burns, ulcers, or contractures, or skin grafts, flaps, Or it can be used to stretch the skin prior to other plastic surgery procedures. Depending on age, general health, skin condition, skin hydration, and other factors, most skin can be stretched by about 20%. Under ideal conditions, the skin can stretch as much as 60% over a period of several weeks. Although it is a rare situation, 100% extension is possible. The ability of the system to remodel the skin over time changes the anticipated parameters and limits of the skin's viscoelastic properties (already expressed as Langer lines), creating a new tissue covering option for the surgeon It is also useful in plastic surgery. For example, using the system of the present invention, a 10 cm abdominal injury can be closed with only 12% ambient contribution in an average adult male (36 inches around the waist). The viscoelastic properties of skin are discussed in Wilhelmi et al., “A Review of the Viscoelastic Properties of Skin” (215 Anals of Plastic Science 41) (August 1998), which is incorporated herein by reference. It is.

  The present invention presents several important advantages over existing systems. Human skin changes dramatically in elasticity and thickness with age and health. Unhealthy patients, such as tumor patients, often show thin, fragile ischemic skin in contracted skin from techniques such as mastectomy where the contracted incision is further stimulated by irradiation to significantly weaken the skin. In one embodiment of the present invention, various attachment structures are matched to the tissue adhesive strength for the required movement and stretching forces to minimize necrosis and scars. In addition, various force distribution components can be used in a number of ways to create a wide range of moving and stretching forces to match opposing tensile forces on multiple planes at various locations, and to reduce thickness and cross-section. Alternatively, an almost infinite range of tension can be achieved as required. Unlike some conventional devices, it does not require an overhead beam, so the present invention can provide linear, radial, and circumferential forces that are exerted on multiple points.

  Finally, the present invention provides an advance over current methods for moving and stretching the formed tissue through the introduction of adjustable sequential but constant tension. The system according to the present invention is practically infinitely variable in stretch or closure force and is used in limited areas such as the lower chest and neck-shoulder joints that do not fit in other skin closure systems. For example, a small attachment structure may be used for ulcer closure and a large attachment structure for abdominal closure, which may be enlarged and reduced as needed. The system of the present invention allows for rapid removal to replace the dressing during routine cleaning procedures and to view the wound base without obstruction. When tension adjustment is required, this can be accomplished rapidly and the force acting component can include an easily readable indicator. Thus, the nurse can easily replace the wound dressing and reapply the force instructed by the surgeon.

  Utilizing dynamic forces to move and stretch the tissue provides the advantage of persistent antagonistic traction, allowing the wound site to stretch and contract, which greatly increases patient mobility and facilitates respiratory movements. To adapt. Furthermore, the traction range increases beyond the elasticity of the skin itself. For example, a closure rate in the range of 1.25 to 1.75 cm per day is an average value during the course of treatment, which is significantly higher than that achieved using prior art static antagonistic traction methods. Fast (about twice as fast).

  As a result, the present invention is a system of non-reactive components for moving and stretching the formed tissue that provides a relatively constant dynamic force over various distances and dimensions, which is easily adjustable Yes, it is also adjustable automatically.

  One feature of the invention includes at least one non-reactive force acting component and at least one anchor for attachment to tissue, the anchor having at least one curved surface for contacting the force acting component. And a system for moving tissue that provides an adjustable attachment to the force acting component.

  Another feature of the present invention is an anchor that transmits forces to attach to and move tissue, and the anchor is opposed non-parallel to engage the non-reactive elastomer without cutting or knotting the elastomer. Includes structure.

  Yet another feature of the present invention is to attach at least one anchor for attachment to tissue, including an opposing non-parallel structure adapted to secure the force acting component and the aperture, and to attach to the anchor without knotting. A force acting component is a system for moving tissue that passes through the tissue and an opening in the anchor.

  Yet another feature of the present invention includes at least one non-reactive force acting component and an elastic fabric, wherein the fabric is attached to the tissue to distribute the force applied to the tissue, and the force A system for moving tissue, including a structure for securing at least one non-reactive force acting component without knotting or cutting the working component, the system providing an adjustable tension.

  Yet another feature of the present invention is that it assesses the direction of tissue movement and extension, determines the number of anchors to be used, attaches at least one anchor, and has at least one non-existent two ends. Tension is adjusted by securing reactive force application components to at least one anchor without knotting non-reactive force application components, removing at least one force application component and re-fixing to at least one anchor A method for moving and stretching a forming tissue.

  Another feature of the present invention includes at least two force acting components, at least two anchors each including an opposing non-parallel structure for securing a non-reactive force acting component, and packaging surrounding the anchors. A kit comprising components for moving and stretching a forming tissue.

I. Force acting component The force acting component of the present invention can integrate energy accumulation and force transmission, such as in an elastomer rod, or separate energy accumulation and transmission, as in a spring connected to a cable. can do.

A. Integrated Force Acting Component The integrated force acting component according to the present invention may be formed as a rod, cord, band, loop, sheet, net, wire, strand, cable, tube, or other suitable structure. In one embodiment, fac is an elastic tube that will distribute the load leveling off at the highest load point. The tubular force acting component can also be slid over the end of the trocar to drive the force acting component through the tissue. For example, the force acting component can be driven through the wound edge using a trocar to prevent valgus. In an alternative embodiment, the rod-shaped force acting component is driven through the tissue using a needle swaged onto the rod-shaped fac. In yet another alternative embodiment, the force acting component is a belt having an opening adapted to capture the structure of the tissue attachment structure.

  The force acting component ("fac") of the present invention can also have elastic properties ("efac"), without limitation, latex rubber, silicone, natural rubber and similar elastic materials, GR-S, neoprene, Made from nitrile butyl polysulfide, ethylene polyurethane, polyurethane, or other suitable materials that exhibit the property of providing a return force when held in the stretched state at the pressure and distance useful in connection with the present invention Can do. The efac may provide a dynamic counteracting force equal to or greater than the tissue's naturally occurring elastomeric traction force. The efac of the present invention is generally not an endless loop, but is a single strand length, also referred to as a “monostrand”, and can be either solid or hollow. In some examples, multiple strands, endless loops or bands may be used. It is important that the efac used to carry out the present invention can be secured to a tissue attachment structure at virtually any point along the efac to provide variable tension within the elastic limits of the elastomer used. It is. The use of unreactive fac is generally desirable. Non-reactive fac includes components that are either immunologically inert or hypoallergenic, and such elastomers are formed from silicone or a hypoallergenic form of latex rubber. The efac 40 is shown in FIG. 1 and is shown attached to the anchor in some of the other figures.

  Elastomers having various durometers may be used for the force acting component of the present invention. In one embodiment, efac has a diameter of 0.125 inches (3.175 mm) and a nominal durometer of 40. Another efac, such as an efac with a smaller diameter, may be prepared and distinguished from each other based on color. In some situations, other shapes, dimensions, and strengths may be appropriate. Extruded silicone efac may have a durometer of 40 (this allows a 5: 1 stretch ratio). The molded silicone efac may have a durometer of 5 (this allows for a 12: 1 stretch ratio). In one embodiment, the tubing efac has an inner diameter of 0.625 inches (15.9 mm) and an outer diameter of 0.125 inches (3.175 mm), and the Poisson's ratio (longitudinal strain) of the tubing efac. The ratio of lateral strain to durometer and durometer confirms mechanical lock when sleeved on a structure having an outer diameter smaller than the inner diameter of efac when efac is compressed longitudinally, This outer diameter is larger than the inner diameter of efac under longitudinal tension, and efac is placed on the structure at a distance of twice or more than the outer diameter of the structure. These inherent qualities make it easy to slide the end of the efac over the trocar and still lock in place under tension. Conversely, a secure mechanical lock can also be achieved by constraining the efac into a contraction opening that is larger than the tensioned diameter but smaller than the untensioned diameter, resulting in: The end portion not subjected to the tension of the elastomer acts as a restraining means for the opening.

  The force acting component may include a mark indicating tension or extension, such as a mark 42 printed as a dotted line on the efac 40 shown in the figure. These indicia can also be formed by colorants including any means for providing visual contrast such as inks, dyes, paints and the like. The force acting component can also be disposable. The force acting component can also be a conventional spring made of other materials such as metal or plastic.

  In an alternative embodiment of the present invention, the force acting component may be coupled to a relatively inelastic force transmission component, such as a relatively inelastic cord, thread, or other suitable structure. Such relatively inelastic force transmission components may be used with both efac and other facs such as conventional coiled plastic or metal springs, as described below.

B. Two Element Force Acting Components In one alternative embodiment shown in FIGS. 2 and 3, the force acting device 44 is attached to an adhesive base 46. Alternatively, the base 46 may be secured to the tissue using a mechanical connector such as a staple or suture. The device 44 includes an internal deflection mechanism, such as a spring 48, that can provide a dynamic force between the body 50 of the device and the slider 53, the slider 53 having a mounting structure 52, which can be a wound or It includes a non-elastic band 47 used to bridge, surround or engage the wound edge, a slot 54 for catching cables, cords, monofilaments, tubes, chains or other materials. The anchor 44 may also include a force indicator 49 that represents the amount of force applied with reference to the position of the slider 53. The anchor 44 can also capture an inelastic force acting component 47 that still provides dynamic force to the tissue. In one embodiment, the body 50 and slider 53 are formed from injection molded plastic. As shown in FIG. 3, multiple pairs of anchors 44 may be opposed to each other across the wound, and a dynamic closure force may be created by shortening the attachment cord 47 and pulling the device 44 together. Compressing the internal spring 48, the device 44 applies a constant force to the tissue ahead of the wound edge 51 and is attached to this tissue.

II. Anchors Anchors are used to transmit force to tissue to be moved or stretched and generally comprise (a) a structure for binding to fac and (b) a structure for binding to tissue, Connect force acting components to the tissue.

A. efac mounting structure As pointed out above, it is generally desirable to use a non-reactive elastomeric force acting component such as silicone which is difficult to fix. The viscoelastic properties of low durometer materials such as silicone do not reach the threshold at which the material holds the knot. Appropriate tightening force cannot be applied to the material by the material itself and held under load. This is because when the load is applied, the diameter of the material decreases below the minimum compression diameter of the tight loop. This eliminates traditional surgical nodule ligation techniques. This is because such a nodule does not last. Yet another complication is that the material tends to creep or slip when another capture method is used. Therefore, it is difficult to fix the silicone efac when force is applied to the efac without cutting the efac or otherwise causing failure by the fixing structure.

  The structure that successfully secures the silicone elastomer (or other low durometer material) is sufficiently dispersed to keep the silicone elastomer in place (to avoid creep), but not to allow the elastomer to cut Must be tightened with force. The present invention provides a structure that provides sufficient contact between efac (including silicone efac) and other structures, where both the efac and anchor structure do not slide against each other, avoiding efac tearing and tearing To do. Such a structure squeezes efac between a flat or relatively large radius arcuate surface while avoiding contact between efac and ridges that may cut the elastomer (intersection of planar surfaces) Or obtained by pressing against these surfaces.

  Such a structure can be achieved by opposing planar or arcuate surfaces that form a V-shape, which has a tension efac generated by e.g. an additional load against efac pressed against the gap between the surfaces. Is oriented to reduce the outer diameter of the sphere, so that efac fixes the insulator action in a V-like manner. In this way, contact between the efac and the anchor structure is maintained, thereby improving the lock between the elastomer and the anchor structure. Similarly, parallel surfaces can be strengthened to provide a capture force for efac and a defined release tension in order to obtain maximum applicable tension and total safety release.

  The opposing surface is provided by a variety of structures, such as an arcuate surface obtained by a suitably strong round wire or rod, or by a rounded opposing edge of a plate of metal, plastic, or other suitable material. Can do. Such a structure may be provided in other forms. For example, opposing surfaces on which efac is captured may be provided by opposing flanges, typically positioned on a post or column, that are opposed flange surfaces. Are shaped so as to gradually approach each other closer to the column. In such a structure, the first surface of the opposing surface may be flat, for example a flat base, but as efac moves in the direction that the force applied to efac moves it during use. , Provided that other flanges or other efac contact structures provide a surface that progressively approaches the first surface. For example, other flanges can provide a frustoconical surface.

  4-7, the tissue anchor 58 with the key shown in detail in FIGS. 4 and 5 has a generally flat body 60 placed on the skin or other tissue; It has a hook 62 around which a force acting component is placed and a lock wire 64 to which the efac can engage. An eye 66 is opened in the hook 62 of the anchor 58, through which efac can optionally pass. The lock wire 64 extends from the fender 68 and includes a keyhole shaped opening 70. The lock wire 64 can rotate as indicated by the arrow 77 shown in FIG. A protrusion 71 extends inwardly from each fender 68 to limit the rotation of the lock wire 64. Fender 68 protects the surrounding tissue from lock wire arm 72 and tab 74. Each tab 74 includes an opening adapted to receive the arm 72 of the lock wire 64. Opposing edges of fender 68 contact arm 72 and approach together between indentations 73 and 75 so that lock wire 64 is in one of two positions, as shown in FIG. Or select the top as shown by arrow 77. In one embodiment, the lock wire 64 is pulled steel so that the arm 72 is held in the tab 74 by spring tension. In another embodiment, the lock wire is formed as a staple. A hip 78 and wing 80 extend outwardly from the main body 60 and the central opening 82. A recess 84 hides the tabs that result from making the anchor from a metal plate.

  The efac 40 may be held by a lock wire 64 as shown in FIGS. The large opening 86 of the keyhole opening 70 receives the efac 40 and the efac 40 is compressed and locked into the small elastomeric wedge segment 88 of the opening 70 as shown in FIG. The wire 64 presents a round and arcuate surface 90. The efac 40 may be held from a subcutaneous orientation by a lock wire 64 or through the first through eye 66 of the hook 62 or through the central opening 82 of the anchor 58. Alternatively, the lock wire 64 may be formed in any shape that provides a parallel or near surface that captures the efac.

  In one alternative embodiment, the locking rivet efac securing structure illustrated as anchor 92 in FIGS. 9-11 includes a rivet 94 extending from body 96, which includes post 98 and cap 100. Cap 100 includes a rim 102 and a conical section 104 (visible with rivet 156 in FIG. 12). A slot 106 that extends partially through the cap 100 and into the post 98 to divide the post 98 by the slot 106 is adapted to receive the efac 40, and the efac 40 also includes at least the post 98 as shown in FIG. It is wound on a part. The efac 40 thus contacts a substantial portion of the anchor surface by passing through the first through slot 106 of the post 98 and wrapping around a significant portion around the post 98. By wrapping efac 40 around a corner of a virtually 90 ° when efac 40 exits slot 106, efac 40 is flattened at the corner and establishes substantial surface contact between efac 40 and anchor 92. This resists slipping between both. The efac 40 may also wrap around the second corner and pass through the slot 106 of the post 98 a second time to secure the efac 40 in place. The anchor 92 also includes a hook 110 that can position the efac around the hook 110. An eye 112 is opened on the hook 110, and the efac 40 can pass through the eye 112 at will.

  Various arcuate or curved surface shapes for the anchor efac mounting structure have been described above. It should be understood that functionally equivalent shapes can also be used, such as, for example, a rod that is not curved but has a polygonal cross section.

B. Tissue Attachment Structure The anchor of the present invention is attached to tissue non-invasively using adhesives, or invasively using hooks, staples, sutures, and optionally adhesives. Depending on the nature and location of the wound, the engagement between the attachment structure and the tissue occurs in different ways. In particular, it may be necessary (or desirable) to attach only to exposed skin surfaces. In other cases, the structure that penetrates the skin surface at least partially engages the skin, or forces are applied not only to the surface tissue (skin) but also to a portion of the underlying tissue (fascia) It is necessary to engage with relatively deep tissue.

i. Invasive Tissue Attachment Structure In one “invasive” embodiment of the invention, the tissue attachment structure is an anchor that includes a key for engaging the tissue and can also be secured to the tissue using sutures or staples. is there. In another invasive embodiment, the anchor has no key and may be attached using staples, sutures, any suitable adhesive, or any combination thereof.

  The tissue anchor 58 having the key shown in FIGS. 4-7 provides a relatively large contact area with tissue such as the skin 114, thereby providing the highest level of antagonistic traction while simultaneously reducing localized tissue damage. Minimize. The wing 80 enhances the stability of the anchor body 60. A tissue anchor 58 having a key is secured by at least one staple 116 or by a suture 118 that can also pass at least partially through one or both sides of the slot 120 and around one or both hips 78 or surgically. It may be attached to skin 114 by skin glue or by other adhesives. Staples may be attached to travel way 122 across central section 124 or across one or both hips 78. One staple may be attached across travel way 122 and a second staple across central compartment 124. Alternatively, one staple may be mounted across each travel way 122, two additional staples, one on each hip 78. A staple can also be attached using a surgical stapler, while the slot 120, hip opening 126, and central opening 82 provide access to the staples to facilitate removal.

  Wing 80 stops movement of staple 116 at the end of travel way 122 extending between wing 80 and indicia 128. Indicia 128 may be a half-thick etch mark that is used both for part identification and as a visual target by the surgeon to locate the location of the back staple. The indicia 128 can be chemically processed on the body 60 or applied in another suitable manner. The travel way 122 provides free movement for the staple 116 and allows differential stretching between the skin contribution (tension in the tissue that occurs between the key and the posterior anchor) and the key 130 and the anchor body 60. . The differential stretching can occur in the skin located directly below the anchor body 60. Anchoring with staples in this manner counteracts the lifting force under high loads at high stress pull points. The travel way 122 allows the body 60 of the anchor 58 to slide in a direction generally perpendicular to the wound, but holds the anchor 58 firmly against the skin 114. The movement of the anchor 58 in this manner prevents the key 130 from plunging into the subcutaneous layer of the skin, resulting in a high antagonistic traction load that exhibits off-axis thrust above the torque balance force provided by the tissue. be able to.

  Prior to attaching the anchor 58, the marking device may be used to mark the tissue. When a fork or key 130 having legs 132 and feet 134 is inserted into and penetrates the subcutaneous layer of skin 114, the tissue anchor 58 with the key is held firmly in place. Thus, the key 130 acts as a trap, engages the skin 114 by its shape and angle, and keeps it engaged under tension. The foot 134 assists in the capture function, prevents the tissue anchor 58 with the key from bouncing off the skin, acts as a safety feature, and the key 130 is driven further into the tissue when direct pressure is applied to the anchor 58 To prevent that. The key 130 can also be removed from the skin 114 by releasing the tension provided by the efac 40 and pulling the key 130 at an angle opposite to the engagement angle.

  The key 130 shown in the drawing is merely illustrative, and the key may have a different cross-section and longitudinal shape, and may be bent during the attachment process. As an example, one variation of the key 130 may have wider and longer legs and feet. The cross section of the key 130 may be circular instead of square or rectangular. In another embodiment, the anchor incorporates a staple function so that the anchor includes a fork that bends and captures the skin as well as a fork on the staple. In this manner, the anchor will function as both an anchor and a staple.

ii. Non-invasive Tissue Attachment Structure As an alternative to more invasive structures and techniques, the tissue attachment structure of the present invention can be attached to tissue using a suitable adhesive. In one such embodiment, the tissue attachment structure is a generally flat portion lined with an anchor adhesive having a structure for securing a force acting component. This flat portion may be a thin stainless steel “coin” with a suitable adhesive, which provides a peel-off skin adhesive anchor to secure the anchor to the tissue. Adhesive anchors of various shapes and sizes can be provided.

  The adhesive may be a hydrocolloid adhesive film that grips the skin or other tissue without damaging it. For example, an invasive high-tack adhesive can be combined with a hydrocolloid gel to create a skin seal that can remain on the skin or other tissues for extended periods without complications or damage to tissue health. Good. Furthermore, the viscous nature of the gel minimizes the shear load on the adhesive. In this manner, the hydrocolloid synchronizes with skin stretch, thereby minimizing the shear load on the adhesive.

  The anchor 92 shown in detail in FIGS. 9 and 10 has a generally flat body 96 that is laminated to a hydrocolloid adhesive base 136 so that the base 136 is over the skin or other tissue. Placed against. Base 136 includes an adhesive 137 attached to base sheet 139, which may be a nonwoven fabric, a plastic film, a metal plate, or some other suitable material. The body 96 of the anchor 92 has a notch 138 that allows maximum surface area for lamination to the adhesive base 136 and provides adequate stability to anchor under load within the intended operating load limit. Alleviate the tendency to lean forward. The anchor 92 also includes a hook 110 and a rivet 94, where the efac can be positioned around the hook 110, and the efac can be secured to the rivet 94 as described above. Anchor 92 may also include an opening 144 that extends through post 98, cap 100, and base 136 and is adapted to receive efac.

  The adhesive anchor 92 shown in FIGS. 9-11 has a teardrop shaped adhesive base that allows multiple anchors to be positioned along the wound edge and applied over as large an area of healthy skin as possible. The distributed load can be distributed. The teardrop shape also allows the anchor to be placed close together inside the curve. In alternative embodiments, such as anchor 146 in FIG. 8, adhesive base 147 is circular. Any other suitable shape may be used.

  As also illustrated in FIG. 8, an anchor having a lock wire and hook can also be attached to the adhesive base so that the lock wire secures the force acting component as described above. As shown in FIG. 8, anchor 146 includes hook 148 and locking wire 150 as described above.

  In another embodiment, a keyed anchor includes a lock rivet and a hook to secure the efac as described above. For example, as shown in FIG. 12, the hooked anchor 152 includes a hook 154 and a lock rivet 156 as described above. An ear 158 extends from hip 160 into opening 162 and forward of rivet 156 and slot 164. The ear 158 forms a staple landing to further stabilize the front portion of the anchor, if necessary.

  In another embodiment shown in FIG. 13, a woven or non-woven tape 166 with invasive skin adhesive is folded to capture the wire bars that pass through the holes 170 in the tape and secure the efac as described above. A lock wire 172 is formed. Tape 166 may be applied to the tissue and left as it is for several weeks. In the configuration of the components of this system shown in FIG. 13, at least two such devices may be taped to opposite sides of the wound to engage the tensioned efac.

  In yet another embodiment of the present invention, the force acting component may be attached directly to the bond using an adhesive. For example, a silicone elastomer structure with an adhesive end portion for adhering to the skin or other tissue may be designed so that each adhesive end portion is a tissue attachment structure.

  Any of the other anchors described and illustrated herein can be made from metal, plastic, or other suitable material. For example, the anchor can be made from a metal plate or coiled metal and formed by punching, pressing, precision stamping, rolling, or chemical milling. The anchor can also be chemically milled using a tabless free etching method and the logo and identification mark can be half etched in a single step. The photoresist mask is chemically stripped and the anchor is turned in the abrasive for deburring and then passivated, cleaned and processed. The anchors of the present invention may be manufactured by rotating on a threading machine or by metal injection molding. The tissue attachment structures and anchor designs described herein may all be made in various sizes.

  In one embodiment of the present invention, each pair of tissue attachment structures transmits a controlled dynamic stretching or closing force of about 0 to about 1000 grams as measured in a static state. In one alternative embodiment, the components of the present invention are scaled down to provide a smaller force, while another embodiment includes a larger scale component and thus provides a greater force. The anchors of the present invention generally have a body length of about 5 mm to about 60 mm and a body width of about 2 mm to about 50 mm. The smallest anchor generally has a body width of about 2 mm to about 10 mm and a body length of about 5 mm to about 15 mm. Anchors for normal surgical use typically have a body width of about 10 mm to about 25 mm and a body length of about 20 mm to about 30 mm. In a large example for treating abdominal injury, the anchor generally has a body width of about 20 mm to about 50 mm and a body length of about 25 mm to about 60 mm.

III. Force Distribution Structure Some embodiments of the present invention include a force distribution structure. The use of a force distribution structure distributes the closure force evenly, eliminates high stress points, minimizes discomfort, and minimizes severe local skin defects, especially when skin health is compromised This is advantageous because it is limited to the limit.

  The force distribution structure can be either a woven or non-woven reinforced fabric, a monomer or polymer film, an extruded or formed viscoelastic material, or a vulcanized or solidified material having specific stretch properties. Force distribution structures can also include providing wound edge stability and viscoelastic properties ranging from inelastic to elastic modulus equal to that found in healthy skin. In one embodiment, the force distribution material is bonded to a hydrocolloid adhesive or other suitable adhesive and then attached to the tissue. Other mounting structures can also be used.

  The pockets or tunnels can be woven or formed in a repeating pattern into a force distribution material. The tunnel may be of a fixed length, such as about 3/4 inch (1.9 cm), and may be located at the edge of the force distribution material. The tunnel allows engagement of the lock wire and provides a way to couple the force distribution structure to the force acting component as described above. The fabric may be designed to support sutures or staples if additional support is required for a particular wound part, and the wound edge can be lifted off the wound edge by simple knot stitching. May be used to prevent warping.

  The fabric distributes the load throughout the fabric and transmits the load to the tissue over a very large area. In this example, the fabric is designed to stretch with the same measure as the speed required to return the heavily contracted skin to an elastic state.

  In one alternative embodiment, the force distribution structure is a loop top fabric. The fabric includes a loop top that allows hook-type fasteners to engage at any point. The fabric may also include a method for bonding the fabric to a force acting component, such as a lock wire having a hooked base for engaging a plastic rivet or fabric loop.

IV. System A. Surgical System When applying the surgical system of the present invention to a patient, the surgeon determines which direction the tissue needs to be moved. The wound length is measured to estimate the number of anchors required. The proper spacing of the anchors will depend on the location, nature and other factors of the wound. For example, a long wound in a human forearm would use an anchor placed about every 3 centimeters. Using a skin marker, a line is drawn from about 0.5 to about 1 centimeter from the wound border or edge. The anchors are then typically attached as opposed pairs, typically starting from the center of the wound. Either a marking instrument or an anchor key to provide the surgeon with a guide mark for inserting the key 130 of the anchor 58 into the skin 114 and to pierce and penetrate with a suitable blade such as a # 11 blade Is used. The anchored anchor 58 is then stapled and sutured or glued to secure it in place on the skin. When secured using at least one staple, staple 116 is mounted across travel way 122. If stability of the front portion of anchor 58 is required, second and possibly third staples can also be attached. The use of two staples provides maximum closure force and is often used in the treatment of severely contracted wounds. In order to obtain a maximum load distribution in thin or damaged skin, it is desirable to attach three staples.

  The wound bed is treated with either wet, dry, or other suitable dressing so that the fac does not directly contact the open wound area. One such suitable bandage is Duderm® commercially available from Smith & Nephew or Tegaderm® commercially available from 3M. The anchor is then coupled to a force acting structure, which is a silicone elastomer 40 in the embodiment shown in FIGS. efac applies a relatively constant force over a relatively large distance. The efac 40 may be threaded through the penetrating eye 66 of the hook 62 of the anchor 58, or may be passed around the hook 62 of the anchor 58, or may be grasped by a lock wire. Pass efac through the eye and wire and pull efac to the desired tension, then hold down the wire clip and pull efac upward to lock efac in place.

  As shown in FIGS. 6 and 11, efac 40 may be “laced” through a series of anchor hooks by passing around the hooks of each anchor unit on the wound boundary or edge. The efac 40 may engage the lock wire (or lock rivet) to terminate the end of the string. The lacing attachment method provides equal tension along the wound, facilitating rapid bandage replacement. This laced version is used when uniform tension is desired along the shear plane, as desired by a long straight incision.

  As shown in FIGS. 7 and 14, efac can also be used as multiple pairs of anchors. Opposite ends of the efac 40 are passed through the eye 66 of the hook 62 of the anchor 58 and then again grasped by the lock wire 64. This method allows the tension of the unbalanced wound to be controlled and is desirable when different closing force or alternating tension solutions are required. The efac length between two opposing anchors is set individually or in multiple units when irregularly shaped damage requires different forces along two or more thrust surfaces. This is typical in Z-shaped plastic surgery, L-flap incisions, or incisions that are not percutaneous. Further, the efac may be wrapped around the body portion. A single efac can also be used to surround an object or wound and create radial tension. In all attachment methods, the efac string is unwound or repeatedly unscrewed to allow easy bandage change, repositioning, and re-tensioning.

  An example of wound closure using the point unit attachment method as described above is shown in FIG. External forces such as respiratory or ambulatory activity apply various stress points on the wound. For example, by adjusting the elastomer tension in bandage changes, the physician can guide the healing pattern.

  FIGS. 15-18 illustrate the use of the system according to the present invention to perform a composite, non-linear incision closure, showing the difficulty of closing as a contracted abdominal incision, for example in obese patients. FIG. 15 illustrates the process of mapping the original incision 178 and comparing this contracted wound area 180. By referring to landmarks such as the navel 182 and by comparing the wound area 180 to the original incision 178, the force acting on the wound can be ascertained and the anti-contraction strategy can be formulated. FIG. 16 shows the first reduction stage applied across the wound. In some cases, a second row of anchors 184 may be used as shown in FIG. The second reduction stage shown in FIG. 17 involves the application of a subset of anchors 186. FIG. 18 illustrates the third reduction stage. In each figure, the reduction of the wound is shown by comparison with the wound 180.

  FIG. 19 illustrates the use of a system according to the present invention to close a wound in an extremity such as arm 187.

B. Clinical System Non-traumatic embodiments, such as those using a hydrocolloid adhesive or an anchor without a suture or staple, may be applied in a clinical environment by a nurse instead of a physician. For example, as shown in FIG. 9, an atraumatic system utilizing a teardrop-shaped hydrocolloid anchor 92 can be applied to wound length in a manner similar to that described for surgical or traumatic embodiments. It can also be applied by attaching anchors along. The force acting component can also be applied by lacing as described above, or connected by two opposing anchors.

C. Force distribution structural system Some systems utilize a reinforced fabric with a tunnel that is adapted to hold a formed wire anchor, which couples a force acting component such as a silicone elastomer to a mounting structure such as a fabric However, the attachment structure can also be attached to tissue using either adhesives, sutures, or staples, so that this embodiment can be invasive or non-invasive. Another embodiment incorporating a force distribution structure such as a reinforced fabric includes a strip-shaped fabric. The strip fabric can also be attached to the tissue using adhesives, sutures, or staples. Coupled to a force acting structure such as a silicone elastomer by a forming wire anchor, the forming wire anchor being secured to the fabric by either sewing, weaving, or direct mechanical means such as staples or rivets, or Attached using adhesive. Yet another example of a system that uses a force distribution structure includes a reinforced fabric having a loop top that can be attached to tissue using adhesives, sutures, or staples. This loop top fabric is attached to a force acting structure. The force acting structure may be a silicone elastomer having hook ends that engage the loop top of the reinforced fabric. Alternatively, the silicone elastomer can be attached to an anchor having a hooked base attached to a loop top fabric.

D. Deep Fascial Repair System The system of the present invention can also be used to perform deep fascial repair and deep fascia dynamic wound reduction. In one embodiment shown in FIG. 20, a cylindrical silicone elastomer 188 is coupled to the trocar, passes through the skin 190, loops through the fascia 192, and at the wound edge at the central opening 194 of the anchor 196. And then secured here to the lock rivet 198. Alternatively, the efac may be secured using an anchor having a lock wire or other suitable structure. Although efac can be used to apply tension to the inferior skin structure (deep fascia), the efac tension can also be adjusted from above the skin by increasing or decreasing the tension on the lock rivet.

  By using a hollow or tubular efac 188 to pass tissue, the tube can be flattened as it enters and exits the tissue, so that the load is better distributed. In addition, the anchor acts as a rope, removing point loads from the exit hole, reducing local damage, and also allowing for adjustment of tension across the wound. Reduction of local damage also reduces scarring.

  The combination of efac and anchor creates a straight pulling surface, so that the skin is moved and stretched, the wound is reduced over as short a distance as possible, and it is not necessary to follow the contours of the body cavity. This is important in situations such as severely debilitated patients with contracted abdominal wounds and large cavities present after tumor removal. In such situations, lock rivets and hydrocolloid adhesive anchors can be used to terminate and tension efac at the point where it passes through the skin.

E. Fasciotomy system Using embodiments of the present invention, severe contractions occur after a fasciotomy that stabilizes the wound and releases pressure between compartments, but performs such release in an irreversible procedure. To prevent. In current fasciotomy, complications occur due to lack of tension on the skin at the wound site. Embodiments of the present invention applied prior to surgery relaxes the skin tension by adjusting it to a level that restores vascular function without releasing the skin tissue to the point where severe contraction occurs. As the section pressure decreases, the system of the present invention provides tension to reconstruct the original form of the skin.

  In one example used to close a fasciotomy, a gradual wound closure method allows the system to be in close proximity to the wound edge and heal the wound as if suturing is appropriate Therefore, no subsequent stitching is required. Because it eliminates delayed closure, a single surgical treatment is provided. Regulated radial pressure promotes migration of edema fluid across the cell wall and allows faster absorption by the lymphatic system. Thus, when applied to a fasciotomy, the device according to the present invention accelerates the reduction of expansion. Skin contraction is controlled, thereby reducing the amount of re-proximity required to close the wound after swelling has been reduced and compartment pressure has normalized.

F. Other Systems and Applications The system according to the present invention can also provide stabilization of the abdominal procedure. For example, it can be used to restore radial abdominal integrity during prolonged surgery of complications such as those requiring management of abdominal infection or access to a wide abdomen. The system increases patient comfort and mobility by providing abdominal containment and support, and maintains normal skin tension during surgery to minimize contraction.

  Another system provides stability to the lack of fusion of the sternum. In addition, the system of the present invention can be used in conjunction with normal initial wound closure to distribute skin system tension to healthy skin ahead of the wound, thereby minimizing stress at the wound site and tearing. Reduce opening. The system of the present invention is used prior to surgery to tension the skin, create excess tissue, and allow the covering and closing of the cuts in the usual manner. Embodiments according to the present invention can also be used as a dressing retention system by providing an efac that covers and secures the wound dressing in place and laces across the wound site.

  In another embodiment, an elastic tension bandage is adhered to the hydrocolloid membrane to stretch the bandage placed over the open portion of the wound and perform dynamic wound closure.

  In yet another embodiment, a tensioned silicone membrane containing either a hook and loop interface or a post and hole interface to the wound edge tape is stretched across the wound and joined to the tape. And perform dynamic wound closure. This example can also be used for the treatment and suppression of hypertrophy and keloid scars. In this example, the membrane is a silicone gel membrane.

  The system and method for moving and stretching a formed tissue according to the present invention is not limited to the embodiments described herein, but includes variations and modifications within the scope and intent of the foregoing description and accompanying drawings. . For example, the scale of the components of the present invention can vary substantially depending on the nature and location of the tissue in which the present invention is used. The configuration of the tissue mounting structure can also vary for the same reason and aesthetic reasons. Although many of the elements of the exemplary embodiment of the anchor of the present invention shown in the drawings are functional, the shape and appearance aspects of the exemplary embodiment are decorative rather than functional It is.

  The materials used to make the components used in practicing the present invention can be the materials described above, and have appropriate properties such as strength and elasticity that will be apparent to those skilled in the art in light of the above. Also included are materials that have not yet been developed. For example, useful materials must generally be sterilizable or sterilizable and unresponsive. Although the illustrated components are generally intended to be reusable, the present invention can be applied to the surface of the anchor to protect the adhesive until it is supplied in sterile packaging and used. It can also be carried out using disposable components, such as metal or plastic anchors, optionally with a pressure sensitive adhesive covered by a take-off film.

It is a perspective view of efac by one example of the present invention. 1 is a perspective view of a fac and anchor system according to one embodiment of the present invention. FIG. FIG. 3 is a schematic top view of the fac and anchor group shown in FIG. 2 positioned to close a wound. FIG. 6 is a perspective view of an anchor according to another embodiment of the present invention. FIG. 5 is a top view of the anchor of FIG. 4. FIG. 5 is a top view of a group of anchors as shown in FIG. 4 in which an efac as shown in FIG. 1 is tightened with a string across the wound. FIG. 7 is a top view of the system of FIG. 6 according to an alternative mounting method. FIG. 6 is a top view of an anchor according to an alternative embodiment of the present invention. FIG. 2 is a perspective view of another alternative anchor according to the present invention with the efac of FIG. FIG. 10 is a top view of the anchor of FIG. 9. FIG. 6 is a top view of a system according to another embodiment of the present invention. FIG. 6 is a perspective view of an anchor according to an alternative embodiment of the present invention. FIG. 6 is a perspective view of a system according to another embodiment of the present invention. FIG. 8 is a top view of the same system as shown in FIG. 7, similar to FIG. 7, schematically showing tissue healing patterns. FIG. 6 illustrates the use of the present invention in a combined and non-linear incision. FIG. 6 illustrates the use of the present invention in a combined and non-linear incision. FIG. 6 illustrates the use of the present invention in a combined and non-linear incision. FIG. 6 illustrates the use of the present invention in a combined and non-linear incision. FIG. 2 shows the use of the system according to the invention for closing a wound in the arm. FIG. 6 is a schematic perspective view of a system according to another embodiment of the present invention showing the use of the present invention to move fascia.

Claims (93)

A system for moving the organization,
(A) at least one non-reactive force acting component;
(B) a system comprising at least one curved surface for contacting a force acting component and at least one anchor for attachment to tissue, wherein the force acting component is adjustably attached.   The system of claim 1, further comprising an opposing non-parallel structure for the anchor to engage the force acting component.   The system of claim 1, wherein the anchor further comprises a side-by-side cylindrical rod.   The system of claim 1, wherein the force acting component comprises an elastomer.   The system of claim 1, wherein the force acting component comprises silicone.   The system of claim 1, wherein the force acting component further comprises a tension indicating function.   The system of claim 6, wherein the tension indicating function is at least two indicia comprising a colorant on the force acting component.   The system of claim 6, wherein the tension indicating function is at least two indicia including a structure on the force acting component.   The system of claim 1, wherein tension is adjustable within elastic limits of the force acting component.   The system of claim 1, wherein the anchor further comprises a lock wire for securing the force acting component.   The system of claim 10, further comprising at least one curved surface interface between the lock wire and the force acting component.   The system of claim 1, further comprising at least one key adapted to penetrate the tissue.   The system of claim 12, wherein the key includes a foot.   The system of claim 1, further comprising a fork bent to penetrate the tissue to secure the anchor to the tissue.   The system of claim 1, further comprising at least one hook adapted to engage the anchor with the force acting component.   The system of claim 15, further comprising an eye inside the hook.   The system of claim 1, wherein the anchor is adapted to deform to release the force acting component by applying a predetermined force.   The system of claim 1, wherein the anchor further comprises a body including a central opening.   The system of claim 1, wherein the anchor is adapted to be attached to the tissue by at least one staple.   The system of claim 1, wherein the anchor includes a travel way adapted to receive staples to allow lateral movement relative to the tissue.   The system of claim 1, wherein the anchor comprises a hip.   The system of claim 1, wherein the anchor is adapted to be attached to the tissue by at least one suture.   The system of claim 1, wherein the anchor is adapted to be attached to the tissue using an adhesive.   24. The system of claim 23, wherein the adhesive is a hydrocolloid adhesive.   The system of claim 1, wherein the anchor is adapted to be attached to the tissue near a wound or incision edge.   The system of claim 1, wherein at least two anchors are adapted to be attached to the tissue on opposite sides of a wound or incision.   The system of claim 1, wherein the at least two anchors secure at least one force acting component.   The system of claim 1, wherein the force acting component is laced between at least three anchors.   The force acting component has two ends, the at least one anchor includes at least three anchors, and one end of the force acting component is secured to one of the at least three anchors; The system of claim 1, wherein a loop formed between the ends engages a second anchor and the other end of the force acting component is secured to a third anchor.   The system of claim 1, wherein the force acting component has two ends, one of which is secured to a first anchor and the other is secured to a second anchor.   32. The system of claim 30, wherein the two anchors are attached to the tissue on opposite sides of a wound.   An anchor for transmitting force to attach and move the tissue, wherein the anchor includes opposing non-parallel structures for engaging the non-reactive elastomer without cutting or knotting the elastomer.   The anchor of claim 32, wherein the non-parallel structure comprises two plates.   34. The anchor of claim 33, wherein one of the two plates is flat and the other plate comprises at least a portion of a frustoconical surface.   The anchor of claim 32, wherein the non-parallel structure comprises a wire.   35. The anchor of claim 32, wherein the non-parallel structure includes a split post that supports a piece of frustoconical portion.   33. An anchor according to claim 32, adapted to fixably adjust the elastomer.   33. An anchor according to claim 32, adapted to secure an elastomer comprising silicone.   The anchor of claim 32, wherein the opposing non-parallel structures comprise two parallel cylindrical rods.   35. The anchor of claim 32, further comprising at least one key adapted to penetrate the tissue.   The anchor of claim 32, wherein the key includes a foot.   35. The anchor of claim 32, further comprising a fork bent through the tissue to secure the anchor to the tissue.   35. The anchor of claim 32, further comprising at least one hook adapted to engage the force acting component.   44. The anchor of claim 43, further comprising an eye inside the hook.   33. An anchor according to claim 32, adapted to be attached to the tissue by at least one staple.   33. An anchor according to claim 32, adapted to be attached to the tissue by at least one suture.   33. An anchor according to claim 32, adapted to be attached to the tissue using an adhesive.   46. An anchor according to claim 45, wherein the adhesive is a hydrocolloid adhesive.   33. An anchor according to claim 32, adapted to be attached to the tissue near the edge of a wound or incision. A system for moving the organization,
(A) at least one anchor for attachment to the tissue comprising opposing non-parallel structures and openings adapted to secure the force acting component;
(B) a system comprising at least one non-reactive force acting component that passes through the tissue, passes through the opening of the anchor, and attaches to the anchor without knotting.   51. The system of claim 50, wherein the force acting component comprises an elastomer.   51. The system of claim 50, wherein the force acting component comprises silicone.   51. The system of claim 50, further comprising at least one arcuate interface between the opposing non-parallel structure and the force acting component.   51. An anchor according to claim 50, wherein the non-parallel structure comprises two plates.   55. The anchor of claim 54, wherein one of the two plates is flat and the other plate includes at least a portion of a frustoconical surface.   51. An anchor according to claim 50, wherein the non-parallel structure comprises a wire.   51. The anchor of claim 50, wherein the non-parallel structure includes a split post that supports a piece of frustoconical portion.   51. The anchor of claim 50, wherein the elastomer is adjustably secured to the anchor.   51. An anchor according to claim 50, wherein the opposing non-parallel structures comprise two parallel cylindrical rods.   51. The system of claim 50, further comprising at least one key adapted to penetrate the tissue.   51. The system of claim 50, wherein the anchor is adapted to be attached to the tissue by at least one staple.   51. The system of claim 50, wherein the anchor is adapted to be attached to the tissue by an adhesive.   64. The system of claim 62, wherein the adhesive comprises a hydrocolloid adhesive.   51. The system of claim 50, wherein the anchor is adapted to be attached to the tissue near a wound or incision edge. A system for moving the organization,
(A) at least one non-reactive force acting component;
(B) an adhesive for attachment to the tissue and a structure for securing the at least one non-reactive force acting component without cutting or knotting the force acting component, adjustable by the system A system that provides tension.   66. The system of claim 65, wherein the force acting component comprises an elastomer.   66. The system of claim 65, wherein the force acting component comprises silicone.   66. The system of claim 65, wherein the fabric further comprises opposing non-parallel structures adapted to secure the force acting component.   69. The system of claim 68, further comprising at least one arcuate interface between the opposing non-parallel structure and the force acting component.   66. The system of claim 65, adapted to be attached to the tissue near the edge of a wound or incision.   66. The system of claim 65, wherein the adhesive is a hydrocolloid adhesive. A method for moving and stretching a forming tissue, comprising:
(A) evaluating the required direction of movement or stretching of the tissue;
(B) determining the number of anchors to use;
(C) attaching at least one anchor;
(D) securing at least one non-reactive force acting component having two ends to the at least one anchor without knotting the force acting component;
(E) adjusting the tension by removing the at least one force acting component and re-fixing to the at least one anchor.   73. The method of claim 72, wherein attaching the at least one anchor further comprises creating a guide mark using a marking instrument.   73. The method of claim 72, wherein attaching the at least one anchor further comprises attaching the at least one anchor to the tissue with the at least one staple.   73. The method of claim 72, wherein attaching the at least one anchor further comprises attaching the at least one anchor to the tissue by at least one suture.   73. The method of claim 72, wherein attaching the at least one anchor further comprises attaching the at least one anchor to the tissue with an adhesive.   73. The method of claim 72, further comprising covering the attachment area with a bandage prior to securing the force acting component.   Securing the force acting component secures one end of the force acting component to the opposing non-parallel structure of the first anchor, and laces the force acting component around the hook of the second anchor; 73. The method of claim 72, further comprising securing the other end of the force acting component to an opposing non-parallel structure of a third anchor.   73. The method of claim 72, wherein the tension adjustment further comprises referencing a tension indicating function of the force acting component.   Securing the force acting component further includes securing a first end of the force acting component to a first anchor and securing a second end of the force acting component to a second anchor. 73. The method of claim 72.   73. The method of claim 72, wherein attaching the at least one anchor further comprises inserting a fork into the tissue that bends and engages the tissue to attach the anchor to the tissue.   66. The method of claim 65, further comprising inserting the force acting component through the tissue. A kit of components for moving and stretching the forming tissue,
(A) at least one non-reactive force acting component;
(B) at least two anchors, each including opposing non-parallel structures for securing a non-reactive force acting component;
(C) A kit including a package surrounding the anchor.   84. The kit of claim 83, wherein the force acting component comprises an elastomer.   84. The kit of claim 83, wherein the force acting component comprises silicone.   84. The kit of claim 83, further comprising hooks, wherein the at least two anchors are each adapted to engage a force acting component.   84. The kit of claim 83, wherein the at least two anchors each further comprise at least one key for engaging the tissue.   84. The kit of claim 83, wherein the at least two anchors each further comprise an adhesive.   90. The kit of claim 88, wherein the adhesive comprises a hydrocolloid adhesive.   The kit of claim 83, further comprising an elastic fabric.   The kit of claim 83, further comprising a marking device.   The kit of claim 83, further comprising a trocar.   The kit of claim 83, further comprising a stapler.

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