Soft tissue fixation devices

Abstract

Remodeling of body tissue using a bioabsorbable implant that maintains or otherwise mechanically assists a more permanent implant or other treatment take, for example, by the treatment causing fibrosis. For example, the apparatus and methods can be used for hernia, organ prolapse and cosmetic purposes, such as breast and face lifts.

1 . A method of tissue manipulation, comprising:
 (a) inserting in the body an expandable bioabsorbable element in mechanical association with a soft tissue;   (b) treating said soft tissue to cause remodeling thereof, with mechanical assistance of said bioabsorbable element, said remodeling to last after said bioabsorbable element dissipates.   
     
     
         2 . A method according to  claim 1 , wherein said bioabsorbable elements is configured, at least on most of its surface to not cause a fibrosis adhesion to tissue. 
     
     
         3 . A method according to  claim 2 , wherein substantially all of said element is configured to not causes a fibrosis reaction. 
     
     
         4 . A method according to  claim 1 , wherein at least part of said element is configured for causing a tissue adhesion reaction. 
     
     
         5 . A method according to  claim 1 , wherein said mechanical assistance comprises forming a working volume in or near said soft tissue. 
     
     
         6 . A method according to  claim 1 , wherein said mechanical assistance comprises supporting said soft tissue. 
     
     
         7 . A method according to  claim 1 , wherein said treatment comprises treatment using an implant and wherein said mechanical assistance comprises causing an implant to engage said soft tissue. 
     
     
         8 . A method according to  claim 7 , wherein said element is configured to bioabsorb after a time when said implant is expected to adhere to said soft tissue. 
     
     
         9 . A method according to  claim 7 , wherein said implant is permanent. 
     
     
         10 . A method according to  claim 7 , wherein said mechanical assistance comprises urging said implant against said soft tissue. 
     
     
         11 . A method according to  claim 7 , wherein said mechanical assistance comprises positioning said implant relative to said soft tissue. 
     
     
         12 . A method according to  claim 7 , wherein said mechanical assistance comprises pulling said implant against said soft tissue. 
     
     
         13 . A method according to  claim 7 , wherein said mechanical assistance comprises maintaining a shape of said implant by said bioabsorbable element. 
     
     
         14 . A method according to  claim 7 , wherein said mechanical assistance comprises sandwiching said implant between two bioabsorbable elements. 
     
     
         15 . A method according to  claim 7 , wherein said implant includes a plurality of tissue engaging elements. 
     
     
         16 . A method according to  claim 7 , wherein said implant is configured for causing tissue ingrowth. 
     
     
         17 . A method according to  claim 1 , wherein said element is non-planar. 
     
     
         18 . A method according to  claim 1 , wherein said element is inflatable. 
     
     
         19 . A method according to  claim 18 , comprising modifying an inflation of said element after insertion thereof. 
     
     
         20 . A method according to  claim 1 , wherein said element is deformable. 
     
     
         21 . A method according to  claim 20 , wherein said element is pre-filled with a more fluid filling than an outer shell thereof. 
     
     
         22 . A method according to  claim 7 , wherein treating comprises reinforcing a weakness in a tissue wall. 
     
     
         23 . A method according to  claim 22 , wherein said implant is a reinforcing element and wherein said bioabsorbable element is placed on an opposite side of said weakness from said reinforcing element. 
     
     
         24 . A method according to  claim 22 , wherein said implant is a reinforcing element and wherein said bioabsorbable element is placed on a same side of said weakness as said reinforcing element. 
     
     
         25 . A method according to  claim 24 , comprising placing a second bioabsorbable element opposite said weakening, for hernia treatment. 
     
     
         26 . A method according to  claim 22 , wherein said implant is a reinforcing element and wherein said bioabsorbable element comprises two elements, one on either side of said reinforcing element. 
     
     
         27 . A method according to  claim 26 , wherein a first bioabsorbable element is placed inside a peritoneum and a second bioabsorbable element is placed in side an inguinal canal and said reinforcement element covers a hernia neck. 
     
     
         28 . A method according to  claim 22 , wherein said implant comprises two meshes, one positioned on either side of said weakness. 
     
     
         29 . A method according to  claim 22 , wherein said hole is selected from inguinal hernia, linea alba hernia, femoral hernia and ventral hernia. 
     
     
         30 . A method according to  claim 29 , wherein said bioabsorbable element lies in an inguinal canal and causes sealing of a back face of the canal. 
     
     
         31 . A method according to  claim 1 , wherein treating comprises tightening tissue. 
     
     
         32 . A method according to  claim 31 , wherein said tissue comprises subcutaneous tissue. 
     
     
         33 . A method according to  claim 31 , wherein said tissue tightening comprises lifting sagging tissue. 
     
     
         34 . A method according to  claim 33 , wherein said lifted tissue comprises a breast. 
     
     
         35 . A method according to  claim 34 , wherein lifting comprises:
 (a) inserting a device including said biodegradable element between skin and a breast fascia;   (b) engaging said breast fascia with a plurality of tissue engaging elements of said device;   (c) lifting the breast; and   (d) engaging a chest tissue with a second plurality of tissue engaging elements of said device.   
     
     
         36 . A method according to  claim 35 , comprising supporting said breast from a bottom thereof, using a biodegradable element. 
     
     
         37 . A method according to  claim 31 , said element urges a plurality of facing tissue engaging elements against tissue. 
     
     
         38 . A method according to  claim 37 , wherein urging comprises first urging a first set of said tissue engaging elements, then shortening the tissue then urging a second set of said tissue engaging elements. 
     
     
         39 . A method according to  claim 38 , wherein said tissue engaging elements are mounted on a plurality of supports and comprising separately moving each of said supports to achieve different foldings of tissue at different locations associated with different supports. 
     
     
         40 . A method according to  claim 31 , comprising inserting a second biodegradable element to support said tissue. 
     
     
         41 . A method according to  claim 1 , wherein treating comprises supporting an organ. 
     
     
         42 . A method according to  claim 41 , wherein said organ comprises a pelvic organ, selected from bladder, uterus, rectum and vagina. 
     
     
         43 . A method according to  claim 42 , used for vaginal prolapse, comprising:
 (a) separating vaginal tissue from another tissue using said bioabsorbable element;   (b) positioning a reinforcing element between the vaginal tissue and other tissue; and   (c) maintaining said reinforcing element in place using a bioabsorbable expandable element.   
     
     
         44 . A method according to  claim 41 , wherein said organ comprises a urethra. 
     
     
         45 . A method according to  claim 41 , wherein supporting comprises supporting a support implant on either side of where said support implant supports said organ. 
     
     
         46 . A method according to  claim 41 , wherein supporting comprises peripheral support of a support implant. 
     
     
         47 . A method according to  claim 41 , wherein supporting comprises expanding a peripherally placed bioabsorbable element that is peripheral to a reinforcement element. 
     
     
         48 . A method according to  claim 1 , wherein treating comprises narrowing a passageway by causing fibrosis adjacent a wall of the passageway, such that said wall extends into the passageway. 
     
     
         49 . A method according to  claim 48 , wherein said passageway is selected from a group consisting of a gastro-esophageal junction, a ureteral orifice, a urethra, a bladder neck and an anus. 
     
     
         50 . A method of tissue remodeling, comprising:
 (a) inserting a device with a plurality of facing tissue engagement elements mounted thereon, between two tissue layers;   (b) causing a first set of said tissue engagement elements to engage a tissue layer;   (c) moving said device while folding said tissue layer; and   (d) causing a second set of said tissue engagement elements to engage said tissue layer in a folded form.   
     
     
         51 . A method according to  claim 50 , comprising leaving said device in said location, to bioabsorb. 
     
     
         52 . A method according to  claim 50 , comprising urging said barbs against said later using an expandable element. 
     
     
         53 . A method of tissue remodeling, comprising:
 (a) inserting an expandable device against a passageway of a body duct, such that said device causes at least a portion of a layer of said duct to extend into said passageway; and   (b) allowing said device to form fibrosis.   
     
     
         54 . A method according to  claim 53 , wherein said device is bioabsorbable. 
     
     
         55 . A prosthesis, comprising:
 (a) a permanent implant adapted to cause a soft tissue reaction of adhesion; and   (b) an expandable bioabsorbable implant mechanically coupled to said permanent implant.   
     
     
         56 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant has a consistency similar to that of soft tissue. 
     
     
         57 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant is configured to dissipate after said implant is adhered to soft tissue by said reaction. 
     
     
         58 . A prosthesis according to  claim 55 , wherein said permanent implant is resilient. 
     
     
         59 . A prosthesis according to  claim 55 , wherein said permanent implant is pliable. 
     
     
         60 . A prosthesis according to  claim 55 , wherein said permanent implant is planar. 
     
     
         61 . A prosthesis according to  claim 55 , wherein said permanent implant comprises a reinforcement element. 
     
     
         62 . A prosthesis according to  claim 55 , wherein said permanent implant comprises a mesh. 
     
     
         63 . A prosthesis according to  claim 55 , wherein said permanent implant comprises a plurality of elongate elements, each having at one facing tissue engaging elements at either end thereof. 
     
     
         64 . A prosthesis according to  claim 55 , wherein said permanent implant encourages tissue ingrowth thereto. 
     
     
         65 . A prosthesis according to  claim 55 , wherein said permanent implant comprises a plurality of tissue engaging barbs. 
     
     
         66 . A prosthesis according to  claim 55 , comprising a pharmaceutical eluting portion. 
     
     
         67 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant is configured to avoid tissue adhesion. 
     
     
         68 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant is inflatable. 
     
     
         69 . A prosthesis according to  claim 68 , wherein said bioabsorbable implant is packaged with an inflation element. 
     
     
         70 . A prosthesis according to  claim 68 , comprising a delivery tube with an inflation lumen. 
     
     
         71 . A prosthesis according to  claim 68 , comprising a delivery tube with two inflation lumens. 
     
     
         72 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant is deformable. 
     
     
         73 . A prosthesis according to  claim 72 , wherein said bioabsorbable implant comprises a shell and a more fluid interior and is pre-sealed. 
     
     
         74 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant is packaged with at least one delivery tube having a diameter smaller than a smallest dimension of said bioabsorbable implant. 
     
     
         75 . A prosthesis according to  claim 55 , wherein said mechanical coupling comprises a flexible cord. 
     
     
         76 . A prosthesis according to  claim 55 , wherein said mechanical coupling comprises an inflation lumen for said bioabsorbable implant. 
     
     
         77 . A prosthesis according to  claim 55 , wherein said mechanical coupling comprises a mounting of said bioabsorbable implant on said permanent implant. 
     
     
         78 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant is peripherally located with respect to said implant. 
     
     
         79 . A prosthesis according to  claim 78 , comprising a second bioabsorbable implant. 
     
     
         80 . A prosthesis according to  claim 55 , wherein said bioabsorbable implant comprises two bioabsorbable implants, one on either side of said permanent implant. 
     
     
         81 . A prosthesis according to  claim 80 , wherein said permanent implant is sandwiched between said two bioabsorbable implants. 
     
     
         82 . A prosthesis according to  claim 80 , wherein said bioabsorbable implant comprises two bioabsorbable implants, one on either end of said permanent implant. 
     
     
         83 . A prosthesis according to  claim 82 , comprising at least one pull wire adapted to tighten said permanent implant. 
     
     
         84 . A prosthesis according to  claim 55 , wherein said biodegradable implant is an annular balloon and wherein said permanent element is a flat element surrounded by said annular balloon. 
     
     
         85 . A prosthesis according to  claim 84 , comprising a second annular biodegradable implant surrounding said annular balloon. 
     
     
         86 . A prosthesis according to  claim 55 , wherein said biodegradable implant is configured to shield a side of said implant from tissue. 
     
     
         87 . A prosthesis according to  claim 55 , wherein said biodegradable implant is a balloon surrounded by said permanent implant on at least one side thereof. 
     
     
         88 . A prosthesis according to  claim 87 , wherein said biodegradable implant is a balloon surrounded by said permanent implant on at least two sides thereof. 
     
     
         89 . A prosthesis according to  claim 87 , wherein said prosthesis is flat. 
     
     
         90 . A prosthesis according to  claim 87 , wherein said prosthesis is sized for an inguinal canal. 
     
     
         91 . A prosthesis according to  claim 55 , comprising a delivery tube within which said prosthesis is enclosed. 
     
     
         92 . A prosthesis, comprising:
 (a) a bioabsorbable backing expandable expanding element;   (b) a bioabsorbable front, comprising a plurality of facing tissue engaging elements; and   (c) a detachable delivery element.   
     
     
         93 . A prosthesis according to  claim 92 , comprising a mesh mounted on said front. 
     
     
         94 . A prosthesis, comprising:
 (a) a bioabsorbable mesh in a generally tubular or sealed tubular form, having a distal end and a proximal end; and   (b) a puller attached to said distal end,   wherein said mesh is configured to radially expand when said puller is retracted relative to said proximal end.