Tissue closing method and apparatus

Abstract

Apparatus for opening or closing a tissue opening in a biological subject, the apparatus including at least two flexible arms coupled to a tissue surface in use, each arm being curved outwardly in a mid-portion to accommodate a tissue opening therebetween and a biasing mechanism that selectively biases opposing ends of each arm to thereby at least one of bias mid-portions of the arms apart to assist in at least partially opening the tissue opening; and bias mid-portions of the arms towards each other to assist in at least partially closing the tissue opening.

What is claimed is: 
     
         1 ) Apparatus for opening or closing a tissue opening in a biological subject, the apparatus including:
 a) at least two flexible arms coupled to a tissue surface in use, each arm being curved outwardly in a mid-portion to accommodate a tissue opening therebetween;   b) a biasing mechanism that selectively biases opposing ends of each arm to thereby at least one of:
 i) bias mid-portions of the arms apart to assist in at least partially opening the tissue opening; and, 
 ii) bias mid-portions of the arms towards each other to assist in at least partially closing the tissue opening. 
   
     
     
         2 ) Apparatus according to  claim 1 , wherein the at least two arms are provided laterally on either side of the tissue opening and wherein the biasing mechanism biases ends of the arms longitudinally relative to the opening. 
     
     
         3 ) Apparatus according to  claim 2 , wherein the biasing mechanism moves ends of the arms:
 a) together so as to increase curvature of the arms to thereby bias mid-portions of the arms apart to assist in at least partially opening the tissue opening; and,   b) apart so as to at least partially straighten the arms to thereby bias mid-portions of the arms towards each other to assist in at least partially closing the tissue opening.   
     
     
         4 ) Apparatus according to any one of the  claims 1  to  3 , wherein the apparatus includes a plurality of laterally spaced first arms on a first side of the tissue opening and a plurality of laterally spaced second arms on a second side of the tissue opening. 
     
     
         5 ) Apparatus according to  claim 4 , wherein at least mid-portions of the first and second arms are curved outwardly in an unbiased state, and wherein the radius of curvature is greater for arms further away from the tissue opening. 
     
     
         6 ) Apparatus according to  claim 4  or  claim 5 , wherein first and second arms further away from the tissue opening have a greater length. 
     
     
         7 ) Apparatus according to any one of the  claims 4  to  6 , wherein mid-portions of the arms are spaced further apart away from the tissue opening. 
     
     
         8 ) Apparatus according to any one of the  claims 4  to  7 , wherein adjusting a separation of the opposing ends of each arm causes a progressively smaller degree of lateral movement of the mid portion a greater distance away from the tissue opening to thereby distribute tension through the tissue surface. 
     
     
         9 ) Apparatus according to any one of the  claims 1  to  8 , wherein the apparatus includes a membrane extending between at least some of the first arms and between at least some of the second arms. 
     
     
         10 ) Apparatus according to  claim 9 , wherein the arms are at least one of:
 a) coupled to the membrane; and,   b) integrally formed with the membrane.   
     
     
         11 ) Apparatus according to  claim 9  or  claim 10 , wherein the membrane provides a contact surface for coupling the apparatus to the subject. 
     
     
         12 ) Apparatus according to any one of the  claims 1  to  11 , wherein the arms are coupled to a frame and wherein the biasing mechanism at least partially deforms the frame to thereby bias opposing ends of each arm. 
     
     
         13 ) Apparatus according to  claim 12 , wherein the biasing mechanism includes a drive ring that engages the frame, and wherein the frame and drive ring are configured to deform the frame upon relative rotation of the frame and drive ring. 
     
     
         14 ) Apparatus according to  claim 13 , wherein the frame is elastically deformable. 
     
     
         15 ) Apparatus according to  claim 13  or  claim 14 , wherein a degree of rotation adjusts an amount of biasing of the arms. 
     
     
         16 ) Apparatus according to any one of the  claims 13  to  15 , wherein the drive ring and frame are complementarily shaped. 
     
     
         17 ) Apparatus according to  claim 16 , wherein the drive ring and frame are elliptical. 
     
     
         18 ) Apparatus according to any one of the  claims 13  to  17 , wherein the drive ring is mounted at least one of:
 a) inwardly of the frame; and, 
 b) outwardly of the frame. 
 
     
     
         19 ) Apparatus according to any one of the  claims 13  to  18 , wherein the frame includes a lip extending circumferentially around at least part of a perimeter of the frame and wherein the drive ring engages the lip. 
     
     
         20 ) Apparatus according to any one of the  claims 13  to  18 , wherein the drive ring is coupled to the frame using a tongue and groove arrangement. 
     
     
         21 ) Apparatus according to any one of the  claims 12  to  20 , wherein the arms are coupled to the frame via a membrane. 
     
     
         22 ) Apparatus according to any one of the  claims 12  to  21 , wherein at least one of the frame and a drive ring at least partially immobilise tissue within a perimeter of the frame. 
     
     
         23 ) Apparatus according to any one of the  claims 13  to  22 , wherein the apparatus includes an actuator including a key coupled to a handle, and wherein in use the key engages the drive ring so that rotation of the handle causes corresponding rotation of the drive ring relative to the frame. 
     
     
         24 ) Apparatus according to any one of the  claims 13  to  23 , wherein, in use, at least one tool can be selectively coupled to the drive ring to thereby support the at least one tool relative to the apparatus. 
     
     
         25 ) Apparatus according to claim  244 , wherein, the tool includes at least one of:
 a) an optical system for viewing the tissue opening;   b) a blade for creating an incision; and,   c) a guide for guiding a surgical instrument.   
     
     
         26 ) Apparatus according to  claim 24  or  claim 25 , wherein, the tool includes:
 a) a tool holder including a tool holder body defining an opening; and, 
 b) a tool body that in use is positioned at least partially within the tool holder body. 
 
     
     
         27 ) Apparatus according to  claim 26 , wherein the tool holder body forms an actuator for rotating the drive ring. 
     
     
         28 ) Apparatus according to  claim 26  or  claim 27 , wherein the tool includes a blade and button movably mounted to the tool body to allow the blade to be deployed upon depression of the button. 
     
     
         29 ) Apparatus according to any one of the  claims 13  to  28 , wherein the arms are coupled to the frame via respective arm end portion, and wherein each arm is connected to the arm end portion via a live hinge. 
     
     
         30 ) Apparatus according to any one of the  claims 1  to  29 , wherein the arms are arranged along either side of the tissue opening so that when biased in a longitudinal direction relative to the tissue opening, the arms apply a lateral closing force to the tissue to thereby close the tissue opening. 
     
     
         31 ) Apparatus according to any one of the  claims 1  to  30 , wherein the arms are resilient and are curved in an unbiased state. 
     
     
         32 ) Apparatus according to  claim 31 , wherein the curve is at least one of:
 a) in a plane;   b) substantially bell shaped; and,   c) a cubic planar curve.   
     
     
         33 ) Apparatus according to any one of the  claims 1  to  32 , wherein arms are at least one of:
 a) resilient; 
 b) incompressible; and, 
 c) unstretchable. 
 
     
     
         34 ) Apparatus according to any one of the  claims 1  to  33 , wherein arms include at least one of:
 a) a biocompatible material; 
 b) a core with a biocompatible coating; 
 c) a polymer; 
 d) high density polyethylene; 
 e) polypropylene; and, 
 f) metal. 
 
     
     
         35 ) Apparatus according to any one of the  claims 1  to  34 , wherein the apparatus is substantially planar and is deformable from a planar shape. 
     
     
         36 ) Apparatus according to any one of the  claims 1  to  35 , wherein the coupling mechanism includes at least one of:
 a) an adhesive surface provided on an underside of the arms; 
 b) an adhesive layer provided on an underside of the arms; 
 c) a number of projections extending from an underside of the arms, the projections penetrating the tissue surface in use; and, 
 d) at least one adhesive patch applied over an upperside of the arms. 
 
     
     
         37 ) Apparatus according to any one of the  claims 1  to  36 , wherein the biasing mechanism is adjustable to allow closing forces on the tissue opening to be controlled. 
     
     
         38 ) Apparatus according to any one of the  claims 1  to  37 , wherein a first end of each arm is coupled to a first arm end portion and a second end of each arm is coupled of to a second arm end portion and wherein a relative separation of the first and second arm end portions provides the biasing mechanism. 
     
     
         39 ) Apparatus according to  claim 38 , wherein the first and second arm end portions are coupled to the tissue surface in use. 
     
     
         40 ) Apparatus according to  claim 39 , wherein the first and second arm end portions are coupled to the tissue surface by at least one of:
 a) an adhesive surface provided on an underside of the arm end portions;   b) an adhesive layer provided on an underside of the arm end portions;   c) a number of projections extending from an underside of the arm end portions, the projections penetrating the tissue surface in use; and,   d) at least one adhesive patch applied over an upperside of the arm end portions.   
     
     
         41 ) Apparatus according to any one of the  claims 1  to  40 , wherein the apparatus is adhesive and the apparatus includes one or more releasable layers. 
     
     
         42 ) Apparatus according to  claim 41 , wherein the apparatus includes separate releasable layers on the arms and on arm end portions. 
     
     
         43 ) Apparatus according to any one of the  claims 1  to  42 , wherein the apparatus includes a plurality of laterally spaced first arms on a first side of the tissue opening and a plurality of laterally spaced second arms on a second side of the tissue opening. 
     
     
         44 ) Apparatus according to  claim 43 , wherein at least mid-portions of the first and second arms are curved outwardly in an unbiased state, and wherein the radius of curvature is greater for arms further away from the tissue opening. 
     
     
         45 ) Apparatus according to  claim 43  or  claim 44 , wherein first and second arms further away from the tissue opening have a greater length. 
     
     
         46 ) Apparatus according to any one of the  claims 43  to  45 , wherein mid-portions of the arms are spaced further apart away from the tissue opening. 
     
     
         47 ) Apparatus according to any one of the  claims 43  to  46 , wherein biasing of the first and second arms causes a progressively smaller degree of lateral movement further away from the tissue opening. 
     
     
         48 ) Apparatus according to  claim 47 , wherein the degree of movement distributes tension through the tissue surface. 
     
     
         49 ) Apparatus according to any one of the  claims 40  to  48 , wherein the apparatus includes at least one biasing member extending between the arm end portions to bias the arm end portions. 
     
     
         50 ) Apparatus according to  claim 49 , wherein the at least one biasing member is telescopic. 
     
     
         51 ) Apparatus according to  claim 49  or  claim 50 , wherein the at least one biasing member is adjustably coupled to at least one of the arm end portions after the arm end portions are biased apart. 
     
     
         52 ) Apparatus according to any one of the  claims 38  to  51 , wherein at least one of first and second arm end portions are coupled to a frame. 
     
     
         53 ) Apparatus according to  claim 52 , wherein the frame at least one of:
 a) extends around at least part of a perimeter of the apparatus; and,   b) surrounds at least part of the arms and arm end portions.   
     
     
         54 ) Apparatus according to  claim 52  or  claim 54 , wherein the frame is coupled to the tissue surface. 
     
     
         55 ) Apparatus according to  claim 54 , wherein the frame is coupled to the tissue surface by at least one of:
 a) an adhesive surface provided on an underside of the arm end portions; and,   b) an adhesive layer provided on an underside of the arm end portions.   
     
     
         56 ) Apparatus according to any one of the  claims 52  to  55 , wherein a first arm end portion is coupled to the frame and a second arm end portion is movable relative to the frame so that movement of the second arm end portion provides the biasing mechanism. 
     
     
         57 ) Apparatus according to any one of the  claims 52  to  56 , wherein the second arm end portion is selectively secured to the frame using a releasable fastener. 
     
     
         58 ) Apparatus according to any one of the  claims 52  to  57 , wherein the apparatus includes a threaded member coupled to the second arm end portion and the frame so that rotation of the threaded member adjusts a separation of the second arm end portion and the frame. 
     
     
         59 ) Apparatus according to  claim 58 , wherein the threaded member includes at least one of a universal joint and flexible torque transmission system. 
     
     
         60 ) Apparatus according to any one of the  claims 1  to  59 , wherein the arms have at least one of:
 a) a substantially rectangular cross section; and, 
 b) a flattened underside. 
 
     
     
         61 ) Apparatus according to any one of the  claims 1  to  60 , wherein biasing of the arms generates a torsional force in the mid-portions of the arms, and wherein the torsional force results in a downward force on the tissue surface. 
     
     
         62 ) Apparatus according to any one of the  claims 1  to  61 , wherein arms include projections that extend from an underside of the arms and penetrate the tissue surface in use and wherein at least one of:
 a) the projections are adapted to the deliver a bioactive material into the tissue around the tissue opening; and, 
 b) the projections generate a closing force in the dermal layers below the tissue surface thereby closing the tissue opening below the tissue surface. 
 
     
     
         63 ) A method of closing a tissue opening in a biological subject, the method including:
 a) coupling at least two flexible arms to a tissue surface on either side of the tissue opening with each arm being curved outwardly in a mid-portion to thereby accommodate the tissue opening therebetween; and,   b) biasing opposing ends of each arm apart to thereby at least partially straighten the arms, which in turn biases the mid-portions towards each other to at least partially close the tissue opening.   
     
     
         64 ) A method according to  claim 63 , wherein the method includes:
 a) removing a releasable layer from at least the arms;   b) adhering the arms to the tissue on either side of the tissue opening;   c) removing a releasable layer from arm end portions at either end of the arms;   d) pulling the arm end portions apart; and,   e) adhering the arm end portions to the tissue.   
     
     
         65 ) A method according to  claim 63  or  claim 64 , wherein the method includes:
 a) applying a frame and arms to tissue surrounding a tissue opening; 
 b) adjusting a position of an arm end portion relative to the frame to thereby bias opposing ends of each arm apart. 
 
     
     
         66 ) A method according to any one of the  claim 63  to  65 , wherein the method includes:
 a) coupling arms to a tissue surface; 
 b) at least partially biasing the arms; 
 c) creating an incision between the arms; and, 
 d) at least partially unbiasing the arms so that the mid-portions move apart to thereby open the incision and create a tissue opening. 
 
     
     
         67 ) Apparatus for opening and closing a tissue opening in a biological subject, the apparatus including:
 a) at least two flexible arms;   b) a coupling mechanism that couples the arms to a tissue surface, wherein each arm is curved outwardly in a mid-portion to thereby provide an opening therebetween;   c) a biasing mechanism for selectively biasing opposing ends of each arm apart to thereby at least one of:
 i) increase curvature of the arms to thereby bias mid-portions of the arms apart to assist in at least partially opening the tissue opening; and, 
 ii) at least partially straighten the arms to thereby bias mid-portions of the arms towards each other to assist in at least partially closing the tissue opening. 
   
     
     
         68 ) A method of creating a tissue opening in a biological subject, the method including:
 a) coupling at least two flexible arms to a tissue surface, wherein in an unbiased state the arms are resilient and curved in at least a mid-portion;   b) at least partially biasing opposing ends of each arm apart so that the arms are at least partially straightened;   c) creating an incision between the arms; and,   d) at least partially biasing the opposing ends of the arms so that the mid-portions move apart to thereby open the incision and create a tissue opening.   
     
     
         69 ) Apparatus for closing a tissue opening in a biological subject, the apparatus including:
 a) at least two flexible arms;   b) a coupling mechanism that couples the arms to a tissue surface on either side of the tissue opening with each arm being curved outwardly in a mid-portion to thereby accommodate the tissue opening therebetween;   c) a biasing mechanism for biasing opposing ends of each arm apart to thereby at least partially straighten the arms, which in turn biases the mid-portions towards each other to at least partially close the tissue opening.