HK1111330B - Button anchor system for moving tissue - Google Patents

Description

Button anchoring system for moving tissue

Technical Field

The present invention relates generally to systems and methods for moving or moving and stretching plastic tissue of a human or animal, applying relatively constant tension over a given distance and being easily adjustable, and more particularly to fasteners (anchors) utilizing such systems.

Background

Generally, surgery and surgery involve one or both of tissue separation and tissue joining. In surgery, medical treatment and medical research, it is desirable to retract tissue, stabilize tissue, and present tissue in many specific orientations so that these areas can be accessed under examination or repair, ideally in a method that produces minimal trauma necessary for the exposure and presentation of the surgical field. Finally, this step should allow for immediate or initial closure of the wound. Unfortunately, in the case of surgery or trauma, the latter option is not always available.

Moving tissue presents a particular challenge because tissue often resists joining or closing, depending on the nature of the tissue structure, the condition of tissue separation, and the general health of the patient. Complications associated with wound closure and healing often result from primary forces, secondary forces, and/or a combined healing response. The primary force is a retractive force generated in addition to tissue viscoelasticity, and may be generated by: (1) increased internal volume, such as obesity, which increases the tension of the cutaneous system; (2) changes in aspect ratio, such as increased abdominal circumference in a prone immobile patient due to muscle atrophy; (3) respiratory muscle activity: (4) muscle reaction; (5) loss of myofascial structure; (6) musculoskeletal deformity; (7) an adjunct to meat quality; (8) a tumor; (9) severe burns.

The secondary force is an internal force generated by the viscoelastic properties of the tissue, which can cause the skin to contract. Plastic tissues, such as skin, are composed primarily of extracellular matrix (ECM) elements and cells that return to a minimally elastic or relaxed state when released from tension. In this relaxed state, tissue tension is minimal and uniform. In this state of minimal elasticity, the skin tissue will remain relaxed, exhibiting behavior similar to a non-elastic substance. In this state, the force required to elongate the cell is typically close to breaking or deflecting (sheet) structural connecting elements, causing local failure or tearing. Soft tissue in this minimally elastic state provides minimal surface coverage and has maximum tensile resistance. It is well known that a flexible constant force below the deflection force limit, combined with appropriate hydration, applied to tissue will over time restore some tissue to near the initial or initial elastic state. In addition, such forces can be applied to stretch tissue beyond the point of equilibrium (normal elastic range) up to the maximum elastic range, resulting in the thinnest structure and coverage of the maximum surface area. If the tension in the tissue does not exceed the equilibrium point (compounded) of the connecting structural elements, the tissue is maintained in a maximally elastic state like healthy tissue, and normal biological processes will restore cell regeneration and associated ECM production to normal skin thickness and tension, which will be described below in terms of biological creep.

Plastic tissues, such as skin and muscle, have certain viscous and elastic rheological properties and are therefore viscoelastic. Certain plastic tissues can increase surface area over time, which is referred to as "creep". "mechanical creep" is the elongation of the skin over time under a certain load, beyond the intrinsic limit, while "biological creep" is the generation of new tissue due to prolonged tensile forces. A steady and sustained force applied to body tissue such as skin or muscle can lead to mechanical and biological creep. Mechanical creep restores the tension that was originally present but was lost on the skin along the incision or wound due to re-stretching of the skin, thereby increasing the coverage of the skin. Biological creep occurs more slowly and involves the generation of new tissue. Tissue augmentation has long been part of the plastic surgery, usually accompanied by implantation of a spherical tissue expander under the skin, and over time expands and enlarges externally, creating a dermal expander (expanded pocket) during breast repair, for example, after complete mastectomy, and stretching healthy tissue prior to plastic surgery for creating a flap after soft tissue closure.

Finally, the combined healing response can complicate wound healing or rehabilitation. Surgical or other incisions become chronic as soon as they lag the normal healing process. Wound management, including treatment and care of large skin defects and severely constricted incisions, is an increasingly important area of health care. The aging population and the growth of diseases associated with obesity and immobility have increased the incidence of chronic wounds and placed an increased burden on health care resources. Factors that contribute to wound healing include the patient's age, weight, nutritional status, dehydration, blood supply to the wound, immune response, sensitivity to occlusive materials, chronic disease, debilitating injury, local or systemic infection, diabetes, and the use of immunosuppressive, corticosteroid or antineoplastic drugs, hormones, or radiation therapy. Chronic wounds include, but are not limited to, surgical wounds, diabetic ulcers, and other chronic ulcers; venous occlusive ulcers; pressure pain or ulcers; burn; late traumatic injury, skin necrosis, crush wounds with ischemic necrosis; wounds with bare exterior tissue or bone; keloid; damage to the skin; insensitive abdominal trauma with perforation; and other acute, subacute, or chronic wounds. Treatment and care of these tissue defects is challenging due to the difficulty in closing open wounds.

Two common methods of closing wounds and skin defects include grafting and gradual closure of a discrete thickness of skin. Grafting of discrete thickness skin involves removing a partial layer of skin from a donor site (typically the upper leg or thigh) and then leaving a portion of the dermis at the donor site to regenerate and epithelialize. In this manner, the restorative covering of viable skin can be moved or transplanted to cover the injured area. Such grafts are typically fenestrated (mesh), which involves excising the skin at offsets of several longitudinal cross-cuts, to elongate the graft to cover twice or three times the area and provide wound drainage during healing. After the graft is received, the opening is healed by the normal biological function of the skin. Such a perforated-eye graft requires less donor area than a typical non-perforated-eye graft or full-thickness skin graft. However, these methods do not provide optimal masking or performance of the skin surface. Other disadvantages of this approach include pain at the donor site, the creation of additional deformed wounds, and complications associated with incomplete "resorption" of the graft. In addition, skin grafting often requires immobilization of the extremities, which increases the likelihood of contractures. Additional surgery or increased hospital stays are additional economic burdens.

Gradual or progressive closure is the second method of closure. This technique may involve suturing the arterial loops at the wound edges and then pulling them together with more sutures in a manner similar to sewing shoes. In addition, the wound edges may be gradually approximated with sutures or sterile paper tape. The advantages of this gradual or progressive technique are numerous: no donor site need be provided for transplantation, flexibility of the limbs is maintained, better camouflaging effect, longer lasting skin coverage, better protection from the entire skin thickness, and normal skin feel is maintained.

Existing devices for effecting gradual closure have a number of disadvantages. Current methods and devices use mechanical means such as screw-activated devices to pull the wound edges because the small skin movements virtually eliminate a large amount of closure force, thus requiring repeated periodic adjustments. A widely used prior art closure technique involves 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 suture pads, suture bridges, the use of staples as fasteners at the wound edge, and the use of bandages for the purpose of distributing loads along the wound edge. These techniques all rely on stationary tape or suture material, must be re-adjustable repeatedly for functional effectiveness, and have stable re-adjustability, which is difficult if not impossible to achieve over time to maintain near constant tension. The widely used conventional gradual closing method relies on a static force that decreases over a distance and cannot provide a continuous or dynamic tension.

Many existing methods of dehiscence wound reduction apply static or non-elastic devices such as sutures or stiff analogues that reduce the distance between the wound edges and rely on the natural elasticity of the skin to compensate for movement. One disadvantage of these devices is that when they are at the most effective point, when the skin is at the point of maximum stretching, the additional skin tension created with actions such as breathing or walking creates pressure points where the mechanical fasteners contact the wound edges, causing tears and necrosis of the wound edges. This typically requires that the patient remain motionless during treatment. Existing systems for treating animals do not need to be concerned with achieving the external effect to the extent that convalescent patients usually hide the injured area with fur, but external is a strict criterion for a measure of the successful effect of the human treatment system.

One existing method of affecting wound closure uses constant tension, low level force to draw the wound edges together. One device for accomplishing this method includes a pair of slide-loaded hooks that move along a pair of spring-loaded paths. The spring means are located in the plastic housing and have different curvatures. The sharp hooks used in this system have the potential to injure the skin. The constant force used is a non-variable control force. Other closure devices use elastic materials to approximate the wound edges, where elastic materials include rubber bands and other types of compressive and non-compressive materials. One kit requires the skin to be attached with adhesive and requires periodic adjustment to tighten the strap. Other known closure devices use hooks and elastic loops that must be replaced with smaller elastic loops to maintain tension, or a dynamic force source to provide a means of tightening. Finally, another prior device contains two surgical needles, two U-shaped thermoplastic polycarbonate holders with hooks on the bottom surface, a linear tension rod, and a polycarbonate ruler. The needles are passed through the wound edge with each arm positioned over the needle, while the hooks pierce the skin and connect with the needles. The tension rod is then locked and the tension can be adjusted by means of a screw.

Existing methods of gradual wound closure do not provide an effective gradual closure that can restore the original skin tension lost along the wound. For example, one system has a single tension of 460 grams. In many cases, such as aged or damaged skin, this force is too great, resulting in local damage, cracking or necrosis. Many of the prior devices are cumbersome, limit patient movement, must be completely removed for wound dressing and cleaning, and can only be used in limited situations due to size limitations. Many also require surgery that is reset after removal for wound dressing. Finally, many existing devices cannot be easily used for radical closure of wounds due to the limited ability of many existing devices to pull in a single direction along the top cross-beam, thereby limiting their parallel pulling along the same axis.

Disclosure of Invention

The present invention provides manipulation and control of tissue position and tension in a living human or animal, utilizing tissue stretch and creep to restore and move tissue. The present invention provides methods and devices for moving or moving and stretching tissue that are simple, easy to use, relatively inexpensive, extremely versatile, self-adjusting, and capable of applying relatively constant forces or tensions at different distances and at different angles of intersection with wounds of simple or complex shapes.

The elements of the present invention exert a dynamic force on the tissue, providing and maintaining a maximum safe counter-traction pressure or force along the wound margin or other area. The system of the present invention produces a controlled constant and sustained tension that can be used to counteract the primary or secondary retractive forces or to obtain maximum mechanical and biological benefits to move and stretch plastic tissue, including closure of large constrictive skin defects.

The terms used herein are defined according to their usual definitions when incorporated, and in some cases by shorthand. For convenience, selected terms are also defined herein. A force applying element ("fac") typically stores energy during application of force and transmission of the force. An elastic force applying element ("efac") combines these two functions in a single elastic element. The tissue manipulation system of the present invention employs a fac that is coupled to a force coupling element ("anchor") that is coupled to the tissue and through which a force is applied. The term "elastomer" refers to a relatively elastic material, such as silicone or latex rubber. The term "non-reactive" is used to describe an immunologically inert or hypoallergenic element.

The fac is simply attached to the tissue by passing the fac or a portion of the fac, such as a suture, through a hole for penetrating the tissue. However, for some reasons, this basic attachment task is poor, mainly involving extremely poor force distribution across the tissue, and does not have any practical means of adjusting the force applied by the suture over a period of time.

The fastener of the present invention includes structure that attaches to the force applying elements allowing for quick and easy attachment and detachment of various fac, including particularly fac made of silicone, which are difficult to attach. The anchors of the present invention provide distribution of the applied force and support the aperture of the adjacent tissue through which the fac passes.

The present invention provides the advantage of a current-based approach for moving or moving and stretching plastic tissue by introducing a gradual but inelastic easily adjustable tension. This can be done quickly when tension adjustment is required, and the force applying element can include an easily readable quantitative visual indicator. The application of dynamic forces to move and stretch tissue may provide the advantage of a reaction force that is not elastic, while allowing for extension and reaction at the wound site, thereby significantly enhancing patient mobility and conforming to respiratory motion.

The present invention can be used to apply dynamic forces that close or remodel tissue to close dermal wounds, incisions or defects associated with various conditions, as well as extensions of healthy skin, flaps, or other remodeling methods in preparation for skin grafting. In one embodiment, the present invention includes a button anchor assembly system for moving or moving and stretching plastic tissue, particularly including the deep fascia and muscle layers of the abdominal or thoracic cavity walls, beyond a distance that allows normal re-approximation during surgery, post-surgery, and post-traumatic regeneration.

Prior patent applications by Canica design incorporated describe in detail the use of elastomers and anchors to move and stretch tissue. While the disclosed structure is highly effective, the present invention extends the principles disclosed in the prior patent application and additionally provides different anchors for re-approximation of severely reduced abdominal wall and chest wounds, where a closure force needs to be applied to the sub-dermal layers. The system of the present invention allows such forces to be applied and externally controlled during treatment.

The system of the present invention comprises a system for moving tissue comprising: (a) at least one non-reactive force-applying element; and (b) at least one anchor secured to the tissue, the anchor including (i) a first slot sized to allow the force applying element to pass freely through the anchor, and (ii) a second slot sized to capture the force applying element without knotting or tearing the force applying element, the structure providing an adjustable attachment of the force applying element; and (c) at least one fastener base connected to the at least one fastener and adapted to distribute forces in the tissue region, the base including a base slot corresponding to the first slot of the fastener.

The system of the present invention also includes a system for moving tissue comprising: (a) at least one non-reactive force-applying element; and (b) at least one fastener secured to the tissue, the fastener including an opening sized to allow a force applying element to pass freely through the fastener, wherein the fastener distributes the force applied to the tissue and supports the perimeter of the percutaneous opening through which the force applying element passes.

In another embodiment, the invention provides an anchor assembly for securing to tissue for transmitting forces for moving the tissue, the anchor assembly comprising: (a) at least one anchor secured to the tissue, the anchor including (i) a first slot sized to allow the force applying element to pass freely through the anchor, (ii) a second slot sized to capture the force applying element without knotting or tearing the force applying element, the configuration providing an adjustable attachment of the force applying element, and (b) an anchor tail secured to the anchor, including an adhesive that adheres to a skin surface.

In another embodiment, the invention provides an anchor assembly for securing to tissue for transmitting forces for moving the tissue, the anchor assembly comprising: (a) at least one anchor secured to the tissue, the anchor comprising (i) a first slot sized to allow the force applying element to pass freely through the anchor, (ii) a second slot sized to capture the force applying element without knotting or tearing the force applying element, the structure providing an adjustable attachment of the force applying element, and (iii) a hook connecting the anchor tail to the anchor; and (b) a fastener base adapted to distribute forces in the tissue region, including a base slot corresponding to the fastener first slot; and (c) a fastener tail comprising an adhesive for adhering to the skin surface and engaging the loops of the fastener.

The method of the present invention comprises a method of moving and stretching plastic tissue comprising: passing a force applying element through the skin and muscle or fascia, the force applying element passing out of the skin on the opposite side of the wound or incision, securing a first end of the force applying element to the first anchor, securing a second end of the force applying element to the second anchor, and not tying or tearing the force applying element; the tension is adjusted by removing at least one force applying element and re-securing it with at least one securing member.

Drawings

FIG. 1 is a perspective view of a system for moving tissue according to the present invention.

Fig. 2 is a perspective view of a button anchor and anchor tail of the system of fig. 1.

Fig. 3 is a top view of the button anchor of fig. 2.

Fig. 4 is a front view of the button anchor of fig. 2.

Fig. 5 is a top view of the anchoring portion of the button anchor of fig. 2.

Figure 6 is a top view of the anchor welds of the button anchor of figure 2.

Fig. 7 is a perspective view of a retainer base of the button retainer of fig. 2.

Fig. 8 is a perspective view of a anchor tail of the button anchor of fig. 2.

Fig. 9 is an enlarged detailed perspective view of a portion of the anchor portion of the button anchor of fig. 2 showing the anchor tail locking interface.

Fig. 10 is a perspective view of a mounting portion of the system of fig. 1.

Detailed Description

The fastener of the present invention is used to deliver and distribute forces to tissue to be moved or stretched. The force applying elements according to the present invention may be formed from rods, ropes, straps, rings, sheets, nets, wires, ropes, cables, tubes or other suitable structures. In one embodiment, the fac is an elastic tube that flattens out at the point of maximum load and then becomes load dissipating. In one embodiment, a rod-shaped fac is driven through the tissue using a cannula-shaped device and is secured to each end of the anchor.

The force applying element ("fac") of the present invention may be elastic ("efac") and may be made of any suitable elastomeric material, including but not limited to latex rubber, silicone, natural rubber and materials with similar elasticity, GR-S chloroprene rubber, butyl polythionitrile, vinyl polyurethane, or any other suitable material that exhibits the property of generating a counter force when maintained in an extended state at pressures and distances that are functional in the context of the present invention. efacs may provide a dynamic reaction force equal to or greater than the naturally occurring elastomeric traction of tissue. The efacs of the present invention are typically not closed loop wires but are lengths of single strand wire, sometimes referred to as "singles", which may be solid or hollow. In some cases, multiple wires or closed loops or bands may be used. Importantly, the efacs used in practicing the present invention may be secured to a tissue attachment structure at substantially any point along the efac, providing variable tension over the elastic range of the elastomer used. The use of non-reactive fac is generally desirable. Non-reactive fac include immunologically inert or hypoallergenic elements, such as elastomers formed from hypoallergenic forms of silicone or latex rubber.

Elastomers having different durometers may be used in the force applying element of the present invention. Polyurethane, Thermoplastic (TPE) or rubber elastomers have been found useful in the practice of the present invention in monofilaments having a diameter of 1mm to 8mm, although other elastomeric materials and other sizes of material may be used.

In one embodiment, the efac has a diameter of 0.125 inches and a nominal durometer of 40. Other efacs, such as efacs having smaller diameters, may also be provided and distinguished from one another based on color. Alternative shapes, sizes and strengths may also be suitable in some cases. The extruded silicone efac has a durometer of 40 (which allows for a 5: 1 stretch ratio). The molded silicone efac has a durometer of 5 (which allows for a 12: 1 stretch ratio). In one example, a secure mechanical lock may be achieved by constraining the efac to a constricted aperture having a dimension greater than the strained diameter but less than the relaxed diameter, e.g., the relaxed end of the elastomer acts as a constraint on the aperture.

The force applying element may comprise indicia indicative of tension or elongation. The indicia may be formed from a colorant including any method that provides a visual contrast, such as ink, dye, paint, or the like. The force applying elements may also be arranged arbitrarily.

As noted above, it is generally desirable to use a non-reactive resilient force applying element, such as silicone, which is difficult to secure. The viscoplasticity of low durometer materials such as silicone is below the threshold where the material is knotted. Sufficient constricting force may not be applied to the material by the material itself, thereby retaining it below the load, as the application of the load reduces the diameter of the material beyond the minimum compressed diameter of the constricting ring. This precludes the use of conventional surgical knotting techniques because the knot cannot be retained. An additional complication is that when alternative capture methods are used, the material has a tendency to creep or slip. Thus, it is difficult to secure a silicone efac when a force is applied to the efac without cutting the efac away, or otherwise causing failure due to the securing structure.

A successful structure for securing silicone elastomer (or other low durometer material) must grip the silicone elastomer structure with sufficient force to secure it (prevent creep), but with sufficient force dispersed so that the elastomer is not severed. The present invention provides structures that achieve sufficient contact between the efac (including silicone efac) and the anchor structure so that the two do not slide relative to each other and avoid cutting or tearing the efac. Such a structure may be provided to squeeze or push the efac between planar or larger radius arcuate surfaces while avoiding contact of the efac with corners (intersections of the planar surfaces) that may cut through the elastomer.

A configuration may be obtained in which the V-shape is formed with opposed planar or arcuate surfaces and positioned so that tension in the efac inserted into the gap in the surfaces causes any reduction in the outer diameter of the efac, for example, with increased load, resulting in the efac fastening a lifting device (jack) in the V-shape at the lower portion. In this manner, contact of the efac of the fastener structure is maintained, thereby enhancing the lock between the elastomer and the fastener structure. Similarly, to provide the maximum available tension and overall safe release, parallel surfaces may be designed to provide clamping force and specified release tension for the efac.

Different configurations may provide opposing surfaces, such as arcuate surfaces provided by suitably rigid circular wires or rods or by circular opposing edges of a sheet of metal, plastic or other suitable material. This structure may also be provided in other forms. For example, by having opposed flanges that are generally placed on a straight bar or cylinder and shaped, the opposed surfaces between which the efac is controlled may also be provided so that the opposed flange surfaces come closer together at a point near the cylinder. In such a configuration, if the other flange or other efac contact structure provides a surface that moves in the direction of the force applied as the force tends to move the efac, the surface becomes closer to the first surface, then the first of the opposing surfaces may be planar or may be, for example, a planar base. For example, the other flange may be a truncated conical surface.

As shown in fig. 1-3, button anchor 8 of the present invention includes an anchor portion 10 located on anchor pad 12 and optionally engaged with load distribution anchor tail 14. The button anchor 8 is located outside the human or animal tissue and includes the specific features of a fac that anchors to extend over or through the tissue, and by its presence and ability to apply a reduced force, provides the particular advantage of moving or moving and stretching the tissue, allowing a full thickness wound to be reduced or closed, wherein the wound edges do not require undue force beyond their initial closing distance. In one example, the fac is passed through the skin, engages or encircles the subcutaneous structure to be closed, and returns to the skin on the other side of the wound or incision. The button anchor 8 is applied to the end of the fac to tension and anchor the fac, thereby applying a subcutaneous reducing force, as shown in fig. 1. In an alternative embodiment, button anchors 8 on opposite sides of the wound ensure that the fac passes through the wound and does not penetrate the tissue.

As shown in fig. 2-5, anchor portion 10 has a large slot 16 and a small slot 18 for engaging an efac, such as an elastomer. The groove 18 includes walls 36 and is a measured tension and elastomer locking groove shaped, long and sized to capture and anchor the elastomer in the groove 18 but allow the elastomer to migrate if the tension exceeds a predetermined level, thereby creating a limit to the total force applied by the system. This limit is determined by controlling the relationship between the size of the slot 18 and the diameter or cross-sectional area of the elastomer when making the anchor portion 10. As the elastomer elongates under increased tension, the cross-sectional area of the untensioned portion of the elastomer decreases. If the force applied to the elastomer exceeds the therapeutic force range, the elongation and resulting decrease in diameter causes the elastomer to relax in the groove, returning the amount of tension to a value within the therapeutic range of the elastomer.

The raised upstanding region 38 (visible in fig. 1 and 4) of the anchor portion 10 prevents other objects from contacting the edge of the button anchor 8.

The anchoring portion 10 may be molded from a carbon rich plastic or any other suitably stiff and strong polymeric material suitable for use in the surgical applications of the present invention. Alternatively, the anchor portion 10 may be molded, machined, or formed or constructed of any other suitably strong and surgically acceptable material, such as stainless steel.

The size of the button holder 8 of the present invention may vary depending on the use, and the diameter of the anchoring portion 10 is about 32 mm. The anchoring portion 10, having a resilient 3mm diameter and 40 durometer (durometer) silicon wire (cord), has a slot 18 with a width of 1mm (i.e. the distance between the walls 36), a height of 7.3mm and a length of 11 mm. Many other dimensions are also useful if the desired connection to the elastomer is obtained (as described above).

Various arcuate or curved surface shapes for fastener efac attachment structures are described above. It will be appreciated that functionally equivalent shapes may also be used, for example a rod having a polygonal cross-section rather than an arcuate cross-section.

As shown in fig. 6 and 7, anchor pad 12 includes a slot 15 corresponding to slot 16 of anchor portion 10. Anchor pad 12 distributes the compressive load applied by one or more facs connected to anchor portion 10 on the surface of the patient's skin and prevents maceration or undue restriction of the intrinsic blood circulation. The anchor pad 12 is generally the same size and shape as the anchor portion 10, but may be smaller or larger in alternative embodiments. For example, larger bases may be used for patients with exposed skin tissue, including elderly or people with disease, such as diabetes.

The anchor pad 12 may be made of a compressible material, such as silicon or any other suitable material. To accommodate the dispersed body fluid, the skin contacting surface (i.e., the underside) of the anchor pad 12 is smooth or textured. The skin contacting surface may be flat, convex, concave, or a multi-planar structure to accommodate anatomical contours. The skin-contacting surface of the base 12 may also be covered or treated to provide antimicrobial properties. In one embodiment, the skin-contacting surface of the anchor pad comprises an adhesive.

As shown in fig. 5, the anchor portion 10 is penetrated by the hole 20, securing the anchor portion 10 to the anchor pad 12. The projection 13 (shown in fig. 7) extends from the anchor pad 12 and is received in the hole 20 of the anchor portion 10. The enlarged diameter end 17 of the projection 13 retains the anchor portion 10 on the seat 12. In an alternative embodiment, anchor pad 12 is bonded, adhesively attached, or molded to anchor portion 10. In one example, anchor pad 12 and anchor portion 10 are one integral unit.

As shown in fig. 2 and 5, fingers 22 facilitate gripping and manipulation of button anchor 8 by opposing fingers. In the embodiment shown in the drawings, the fingers 22 are concave, but the gripping portions may also be convex, multi-planar or textured.

As shown in fig. 2, 3, and 8, the optional anchor tail 14 may be applied to further distribute and distribute the shear load on the skin by performing wound closure over the largest possible surface area. In one embodiment, the anchor tail 14 is made of polyurethane foam with an adhesive for adhering to the skin and includes wires that eliminate the loop 28 and tip 26. In alternative embodiments, the anchor tail 14 may be made of any suitable fabric, foam or film. Such materials may be elastic or inelastic. The material of the anchor tail 14 preferably conforms to the skin surface and mimics the elasticity of the skin surface. Further, the ring 28 may be formed or molded as a single or integrated element.

The anchoring portion 10 of button anchor 8 includes structure that engages anchor tail 14. Such structures may include holes, protrusions, cleats, or other suitable structures. In one embodiment, as shown, and particularly in FIG. 9, anchor portion 10 includes a hook 30 having a ramp 32, ramp 32 for guiding wire loop 28 of tail 14 up or into a recessed portion 34 of anchor portion 10. In use, the anchor tail 14 is secured to the anchoring portion 10 and adhered to the skin by the engagement hook 30. In this way, the anchor tail 14 supports the button anchor 8 and distributes the load of the forward force (force vector moving towards the wound edge and parallel to the skin surface) over a larger area of healthy skin located behind the button anchor 8. While the hooks 30 and loops 28 provide one example of a structure for attaching the fastener tails to the fasteners, any suitable structure may be used.

The system of the present invention can be used to provide deep fascia repair and deep fascia dynamic wound reduction. In one embodiment, as shown in FIG. 10, prior to installation of the system, the silicone elastomer 13 is attached to the cannula-like device 42 at optional anchor placement indicia 50 located on the skin and passes through the dermis 44, fat layer 46 and fascia 48. After passing through the area of the wound 7, the elastomer 13 passes through the slot 16 of the anchor portion 10 and the slot 15 of the fastener base 12 of the button fastener 8, capturing and securing in the smaller slot 18 of the anchor portion 10. In this way, a closing force is applied to the wound or incision 7. Multiple sets of fasteners and elastomers may be used as shown in fig. 1.

The elastomer 13 may be passed through the skin or through the slot 16 of a previously placed anchor, and the elastomer 13 may also be passed out of the skin, while the slot 16 and base slot 15 of the anchor 8 are moved around the elastomer 13. The efac can be used to apply tension to the subcutaneous structures (deep fascia), but the efac tension can be adjusted from above the skin by increasing or decreasing the tension of the small groove 18. The fixture 8 acts as a gasket (grommet) to remove point loads from the exit orifice to reduce the incidence of localized failure and to allow adjustment of the tension on the wound. In this way, the fixation member supports the perimeter of the percutaneous opening through which the elastomer passes, reducing localized failure and reducing scarring.

The system according to the invention provides wound stability for abdominal treatment. For example, the system may be used to restore radial abdominal integrity in the case of prolonged intervention for complications such as abdominal infection management or the need for a large abdominal opening. The system increases patient comfort and mobility by providing abdominal sealing and support, and maintains normal skin tension in an interference treatment that minimizes contraction.

Another system of the invention provides stability to sternal or thoracic unions that may occur after open heart surgery. In addition, the system of the present invention can be used in traditional primary wound closure methods to distribute skin system tension to healthy skin outside the wound, thereby minimizing pressure at the wound and reducing dehiscence. The system of the present invention may be applied to pre-tension the skin to create additional tissue so that the excision heals and closes in a conventional manner. Embodiments of the present invention may also be used as a dressing maintenance system by providing efac lacing (lacing) along the wound, which passes over the wound dressing to secure it. Adhesives may be used for the skin contacting surface of the anchor pad, but such adhesives are generally not required, thereby further facilitating periodic inspection and cleaning of the tissue beneath the anchor pad.

All of the tissue attachment structures and anchor designs described herein are produced in a variety of sizes.

The system and method for moving and moving or stretching plastic tissue according to the present invention is not limited to the embodiments described herein, but includes variations and modifications within the scope and spirit of the foregoing description and accompanying drawings. For example, the proportions of the elements of the present invention can vary substantially depending on the nature and location of the tissue with which the present invention is used. The structure of the tissue attachment may also vary for the same reasons and for aesthetic reasons. While most of the elements of the exemplary embodiment of the anchor of the present invention depicted in the drawings are functional, the shape and appearance aspects of the exemplary embodiment are non-functional and decorative.

The materials used for the elements in the practice of the present invention may be prepared as described above, or may be otherwise prepared, including those not disclosed, but having suitable strength, elasticity and other properties as will be apparent to those skilled in the art in light of the foregoing disclosure. For example, useful materials must generally be sterile or sterilizable, as well as non-reactive. The illustrated elements are typically intended to be disposable, but the invention may also be used with reusable elements.

Claims (44)

1. A system for moving tissue, comprising:

(a) at least one non-reactive force-applying element; and

(b) at least one fastener for securing to the tissue, the fastener comprising

(i) A first slot sized to allow the force applying element to pass freely through the fixture, an

(ii) A second slot sized to capture the force applying element without knotting or tearing the force applying element, the structure providing an adjustable attachment of the force applying element; and

(c) at least one fastener base connected to the at least one fastener and adapted to distribute forces in the tissue region, the base including a base channel corresponding to the first channel of the fastener.

2. The system of claim 1, further comprising a fastener tail.

3. The system of claim 2, wherein the anchor tail further comprises an adhesive and an engagement ring.

4. The system of claim 2, wherein the anchor tail further comprises polyurethane foam.

5. The system of claim 2, wherein the anchor tail further comprises a fabric.

6. The system of claim 5, wherein the fabric is elastic and conforms to a skin surface.

7. The system of claim 3, wherein the ring is comprised of a metal wire.

8. The system of claim 3, wherein the anchor further comprises a hook having a ramp for guiding a loop of the anchor tail up or into the anchor recess.

9. The system of claim 1, wherein the second groove of the anchor is a locking groove having a measured tension, the shape, length and size of which are such that the groove captures the force applying element but moves the element if the tension exceeds a predetermined level.

10. The system of claim 1, wherein the force applying element comprises an elastomer.

11. The system of claim 10, wherein the elastomer comprises silicone.

12. The system of claim 1, wherein the tension is adjustable within the elastic range of the force applying element.

13. The system of claim 1, wherein the force applying member is adapted to deform so as to release from the anchor after application of the predetermined force.

14. The system of claim 1, wherein the at least two anchors are adapted to be secured to tissue on opposite sides of the wound or incision.

15. The system of claim 14, wherein at least two anchors secure at least one force applying element, wherein the force applying element passes through tissue and fascia.

16. The system of claim 1, wherein the fixture base further comprises a compressible material.

17. The system of claim 1, wherein the anchor base further comprises silicone.

18. The system of claim 1, the anchor pad further comprising a skin-contacting surface having antimicrobial properties.

19. The system of claim 1, wherein the fixture further comprises an aperture, the fixture base further comprising a protrusion extending through the aperture and connecting the fixture base to the fixture.

20. The system of claim 1, wherein the fixture and the fixture base are adhesively attached.

21. The system of claim 1, wherein the fixture and the fixture base are integral.

22. The system of claim 1, wherein the fixture further comprises a finger.

23. The system of claim 1, wherein the tissue to be moved is healthy tissue.

24. A system for moving tissue, comprising:

(a) at least one non-reactive force-applying element; and

(b) at least one fastener secured to the tissue, the fastener including an opening sized to allow a force applying element to freely pass through the fastener, wherein the fastener distributes force applied to the tissue and supports a perimeter of a percutaneous opening through which the force applying element passes, the fastener further comprising:

(i) a first slot sized to allow the force applying element to pass freely through the fixture, an

(ii) A second slot sized to capture the force applying element without knotting or tearing the force applying element, the structure providing an adjustable attachment of the force applying element.

25. The system of claim 24, further comprising at least one fastener base.

26. The system of claim 25, wherein at least one fastener base is coupled to at least one fastener and includes a base slot corresponding to the first slot of the fastener.

27. The system of claim 24, further comprising at least one anchor tail.

28. The system of claim 27, wherein at least one anchor tail comprises an adhesive that adheres to the tissue, wherein the anchor tail is coupled to the anchor.

29. An anchor assembly for securing to tissue for transmitting forces for moving the tissue, the anchor assembly comprising:

(a) at least one fastener for securing to the tissue, the fastener comprising

(i) A first slot sized to allow the force applying element to pass freely through the fixture,

(ii) a second slot sized to capture the force applying element without knotting or tearing the force applying element, the structure providing an adjustable attachment of the force applying element, an

(b) The tail of the fixing member fixed to the fixing member includes an adhesive for adhering to the skin surface.

30. The anchor assembly of claim 29 wherein the anchor tail further comprises a loop.

31. The anchor assembly of claim 29 further comprising a fastener base.

32. The anchor assembly of claim 31 further comprising a slot sized to allow the force applying member to pass freely through the fastener.

33. An anchor assembly for securing to tissue for transmitting forces for moving the tissue, the anchor assembly comprising:

(a) at least one fastener for securing to the tissue, the fastener comprising

(i) A first slot sized to allow the force applying element to pass freely through the fixture,

(ii) a second slot sized to capture the force applying element without knotting or tearing the force applying element, the structure providing an adjustable attachment of the force applying element, an

(iii) A hook connecting the tail of the fixed member with the fixed member; and

(b) a fastener base adapted to distribute forces in the tissue region, including a base slot corresponding to the fastener first slot; and

(c) a fastener tail comprising an adhesive for adhering to a skin surface and a loop for engaging the fastener.

34. The anchor assembly of claim 33 wherein the anchor tail further comprises polyurethane foam.

35. The anchor assembly of claim 33 wherein the anchor tail further comprises an elastic fabric.

36. The anchor assembly of claim 33 wherein the loop of the anchor tail is comprised of a wire.

37. The anchor assembly of claim 33, the anchor further comprising a recess, the anchor hook further comprising a ramp for guiding the loop of the anchor tail up or into the anchor recess.

38. The anchor assembly of claim 33 wherein the second groove of the anchor is a locking groove having a measured tension and is shaped, long and dimensioned such that the groove captures the force applying member but moves the force applying member if the tension exceeds a predetermined level.

39. The anchor assembly of claim 33 wherein the anchor base further comprises silicone.

40. The anchor assembly of claim 33 wherein the anchor pad further comprises a skin-contacting surface having antimicrobial properties.

41. The anchor assembly of claim 33 wherein the anchor further comprises an aperture, and the anchor base further comprises a protrusion extending through the aperture and connecting the anchor base to the anchor.

42. The anchor assembly of claim 33 wherein the anchor and anchor base are adhesively attached.

43. The anchor assembly of claim 33 wherein the anchor and anchor base are integral.

44. The anchor assembly of claim 33 wherein the securing member further comprises a finger.