Absolutions Med, Inc. (Mountain View, CA)

A bioabsorbable and magnetic device to heal ventral hernias and/or distribute tension for healing. It does not leave a permanent mark of foreign material or preclude substances that go beyond the abdominal closure’s internal layer.

There are 4 million open abdominal surgical procedures in the US (emedicine.medscape.com/article/1961789-technique). A commonly documented postoperative complication is incisional hernia resulting from the inability of the structural tissue healing,which occurs in approximately 9-20% of patients after the closure of their abdominals. Ventral hernias not related to surgery can also occur, but they are extremely rare. Umbilical hernias are a common defect within the ventral wall.

Two problems are common among abdominal surgeons when it comes to closing the abdominal wall.

The ABRA.RTM is an apparatus that can be utilized to retrace the abdominal wall’s edges. Abdominal Closure System (Southmedic Inc. Ontario, Canada). Through gradual dynamic tension, the edges ofan abdominal wall defect get distracted back to their normal anatomy. The ABRA.RTM. device is situated inside the abdomen and thus presents the possibility of an intra-abdominal visceral trauma. Its position across the wound opening inhibitsintra-abdominal wound management. It is also recommended for patients who undergo open abdominal wound management, which are a small percent of ventral deformities compared to those with closed skin but an underlying fascial problem. The Trans Abdominal Strap, TAS Medical Inc. San Carlos, Calif. USA, uses a zip tie-type ratcheting mechanism to attach a strap to the abdominal wall edges. (FIG. 1). It has a segment running across the closure site over and deep into the abdominal wall, wherein the segment deep into the abdominal wall is danger to the viscera beneath. The Trans Abdominal Strap doesn’t provide an option for dynamic closure.

There are only limited options for safe and effective strengthening of the abdominal wall that is closing as the wound heals, and builds the strength of tensile. There are four types of techniques that generally fall into: (1) closure of the wound with suture; (2) closure with mesh reinforcement (3) Bridging of the defect with mesh and (4) part separation of abdominal wall layers using mesh reinforcement. Different forms of suture exist which add an extra layer of surface to the interface to provide additional anchoring strength such as suture that is made up of filamentous mesh, and various barbed sutures.

To avoid dehiscence, surgeons could also use large retention stitches to hold the abdominal wall in place throughout the initial phases of post-operative care. These sutures can cut through tissue under high tension. Additionally the retention sutures, due to their nature, usually have a segment running across the closure site above and deep to the abdominal wall. Any segment that extends past the abdominal wall can cause a danger to the viscera that is beneath it.

Mesh, the common denominator for many surgical techniques to abdominal wall closure, is a double-edged weapon. Surgeons utilize mesh in a variety of areas of the abdominal wall to strengthen closure and attempt to prevent the development of primary or recurrent hernias. Mesh is an essential component of current procedures, but it can also cause problems in the short and long term that could lead to severe consequences.

Anchoring techniques for mesh deployment create additional risks. Broadly applied mattress sutures can injure large areas of tissue, as well as crucial structures that are located in the region, such as motornerves or abdominal musculature. This can lead to paralysis of a portion of the abdominal wall as well as pain.

New methods and technologies are needed to normalize retracted abdominal wall hernia edges, and also to aid in tight abdominal closures associated either with hernia reconstruction or higher risk primary closures, without compromising mesh and other long term or permanent implantable components.

The most effective method of restoring the ventral abdominal hernia back to its normal anatomical state without the need for separation of components, high tension closure, or mesh reinforcement is the following: a. gradual, dynamic disengagement of tissues from their normal, normal state without any compromise in function, b. the removal of straps, loops, or other device components with large intraperitoneal segments that could pose the risk of causing damage to the viscera, c. limited effect on the patient’s activity while distracted using wearable components, in addition. the ability to disengage easily in the event of complications arise, and. under ideal conditions avoidance of transcutaneous components.

These devices fulfill the above criteria and allow for devices that restore normal anatomy by using magnetic distraction that is linked to bioabsorbable tissues anchors. After achieving tissue edge apposition, the magneticcomponent may be removed, while the bioabsorbable component remains to anchor the tissue and enhance healing.

A component may be utilized to repair the anatomical location of the abdominal walls hernia edges after primary closures or reconstruction of the hernia. It can do this by: a. avoiding spanningmaterials deeper than the abdominal wall (in contrast to retention sutures) as well as. avoiding any mesh that is permanent or materials that are prone to causing problems for years following surgery; third. Avoiding resorbable and other scaffolding materials that could lead to a mechanically mismatched scar by: a. avoiding resorbable or other scaffolding material that could cause.

One form of the embodiment that is used following tissue edge apposition includes bioabsorbable elements that help maintain the closure of tissues and speed up healing. Mechanisms are employed to connect the bioabsorbable components to the anterior (exterior) and posterior (interior) abdominal wall structures. These mechanisms may include various ways of fastening, e.g., threaded features, ratchet features, threaded features as well as other features. used in conjunction with securementmechanisms, e.g., ratchets. Furthermore, various methods are discussed for the connection of the components to one to each other over the wound. The mechanisms include ratcheting straps, ball chains, perforated strips etc.

A variation of a tissue anchoring system could comprise a first component that has one or more first piercing elements that extend from the first surface for contact with the first tissue region. A second member that has one or more second piercing element extending from the second layer for contact with the second tissue region is also feasible. The second component can create two or more openings that correspond to the location of one, several or all initial elements of piercing and the first and second members are constructed to be secured

In one method of approximating tissue, the method could generally involve attaching a primary tissue anchoring system to a primary region of tissue, wherein the initial tissue anchoring system comprises a platform or base having one or more first piercing elements that extend from a first surface. The method can also comprise the attachment of a second tissue anchoring assembly to a second area of tissue that is adjacent to the first area of tissue, wherein the second tissue anchoring assembly comprises a second platform or base that has one or more piercing elements extending from a second surface, and approximating the first tissue region towards the second region of tissue by adjusting the connecting element that is attached to the firsttissue anchoring assembly and the second assembly for tissue anchoring.

A second variation of the tissue anchor device may comprise a first piece which defines one or more anchoring parts. Each piece of anchoring have a length which extends out from the surface of the initial piece. The first member may include one or two openings through which the anchoring parts are received. A thirdmember may be included within the apparatus. The thirdmember is intended to hold the anchoring member in a particular position in relation to it and also to hold the location of the second member relative to the first member.

A different variant of a tissue anchoring system may generally comprise a first member having one or more first piercing components extending from a first surface configured to be in contact with a primary tissue region and a second member that is configured for contact with a second tissue region, wherein the second member defines one or more openings which correspond to the position of the first or other piercing elements, and wherein the first and second member are configured to besecured against one another by the one or more first piercing elements. Attachment magnetable elements can be connected to either the first or second members.

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