Vascular wound closing apparatus and method

Abstract

Wound closure apparatus is provided including a body having an elongated, lowermost force-transmitting surface operable to be placed in a proximal, external, wound-closing position on a patient, together with a force-exerting assembly coupled with the body and operable to exert a downwardly directed force serving to generate wound-closing pressure against the patient's tissue. The force-transmitting surface is preferably three-dimensionally asymmetric so that forces of different magnitude are exerted at different locations along the length of the surface. The apparatus is especially designed for the closure of wounds attendant to endovascular interventions, e.g., a femoral artery puncture wound incident to percutaneous cardiac intervention (PCI), and is capable of quickly effecting wound closure with a time-to-ambulation (TTA) of approximately 60 minutes, and with a very low complication rate.

1 . Apparatus operable to close a wound in a patient's tissue, said wound presenting an insertion site and an elongated, obliquely oriented tract extending into the patient's tissue and in communication with said insertion site, said apparatus comprising:
 a body having an elongated force-transmitting surface having a length greater than the width thereof, said body operable to be placed in an external wound-closing position with said force-transmitting surface proximal to the patient's skin, adjacent said wound and in general axial alignment with said tract; and   a force-exerting assembly coupled with said body and operable to exert forces of different magnitudes at different locations along the length of said force-transmitting surface in order to close the wound,   said forces being greatest adjacent one end of said force-transmitting surface, and decreasing along the length of the force-transmitting surface.   
     
     
         2 . The apparatus of  claim 1 , said force-transmitting surface being solid and three-dimensionally asymmetric. 
     
     
         3 . The apparatus of  claim 2 , said force-transmitting surface comprising first and second surface sections having different force-transmitting areas, respectively, said first and second surface sections being substantially coplanar, there being a third, generally T-shaped surface section bridging said first and second surface sections and presenting an elongated segment and a segment transverse to the elongated segment. 
     
     
         4 . The apparatus of  claim 3 , said elongated segment being obliquely oriented relative to said first and second sections. 
     
     
         5 . The apparatus of  claim 1 , said force-exerting assembly including structure for securing said body to the patient's tissue, and a mechanism including a shiftable component for generating a mechanically-derived force through said force-transmitting surface, said securing structure comprising a suture passing through the patient's tissue and tied to said body to hold the body in said wound-closing position. 
     
     
         6 . The apparatus of  claim 5 , said mechanism comprising biasing structure including at least one spring. 
     
     
         7 . The apparatus of  claim 6 , said biasing structure comprising:
 a plurality of spaced apart springs carried by said body and operable to alternately assume a cocked position and a force-exerting position;   an operator operably engaging said springs, said operator selectively shiftable between   a first orientation maintaining said springs in said cocked position, and a second   orientation allowing said springs to exert said force.   
     
     
         8 . The apparatus of  claim 7 , said operator comprising an elongated, axially rotatable paddle, said paddle having structure for maintaining said springs in said cocked position at a first orientation thereof, and for allowing the springs to exert said force upon rotation of the paddle to a second orientation. 
     
     
         9 . The apparatus of  claim 7 , said body having a plurality of generally spaced apart tubular spring retainers with a spring within each retainer, said spring retainers each having recesses for receiving said operator and allowing selective axial rotation thereof, said operator having respective sections passing through said retainers and engaging the spring therein, said operator shiftable between a lower spring-cocking position wherein said springs are held in said cocked positions thereof, and an upper spring-releasing position wherein said springs are released from said cocked positions thereof. 
     
     
         10 . The apparatus of  claim 9 , said operator sections being generally oval in cross-section and presenting major and minor axes, said spring retainer recesses configured to retain said operator sections in said lower positions thereof when the operator is oriented so that said major axes extend in one direction, and to release said springs when said operator is oriented with said major axes in a second, different direction. 
     
     
         11 . The apparatus of  claim 1 , said wound tract communicating with an opening formed in a vascular vessel within the patient's tissue, said body and force-exerting assembly cooperatively configured to reduce the blood flow within said vascular vessel. 
     
     
         12 . The apparatus of  claim 1 , said wound being attendant to a vascular procedure. 
     
     
         13 . The apparatus of  claim 1 , said different magnitude mechanically-derived forces being substantially invariantly exerted over a period of time to close said wound. 
     
     
         14 . A method of closing a wound in a patient's tissue, said wound presenting an insertion site and an elongated, obliquely oriented tract extending into said patient's tissue and in communication with said opening, said method comprising the steps of:
 positioning a body in a wound-closing position proximal to the patient's skin and adjacent said wound, said body having an elongated force-transmitting surface having a length greater than the width thereof and positioned in general axial alignment with said tract; and   exerting a force through said force-transmitting surface in order to close the wound, said force having different magnitudes of pressure at different locations along the length of said force-transmitting surface,   said force being greatest adjacent one end of said force-transmitting surface, and decreasing along the length of the force-transmitting surface.   
     
     
         15 . The method of  claim 14 , including the step of exerting said force substantially invariantly over a period of time to close said wound. 
     
     
         16 . The method of  claim 14 , said force-exerting step comprising the steps of passing a suture through the patient's tissue at a point adjacent to said insertion site, tying said body with the ends of said suture, and generating a mechanically-derived force in order to exert said force through said force-transmitting surface against the patient's tissue. 
     
     
         17 . The method of  claim 16 , said body supporting a plurality of spaced apart springs and an operator engaging said springs, said operator shiftable between a first orientation maintaining said springs in a cocked position, and a second orientation allowing said springs to generate said mechanically-derived force, said force-exerting step comprising the step of shifting said operator to said second orientation, said operator comprising an elongated, axially rotatable paddle, said paddle having structure for maintaining said springs in said cocked position at a first orientation thereof, and for allowing the springs to exert said force upon rotation of the paddle to a second orientation. 
     
     
         18 . The method of  claim 17 , said body having a pair of generally spaced apart tubular spring retainers with a spring within each retain, said spring retainers each having recesses for receiving said operator and allowing selective axial rotation thereof, said operator having respective sections passing through said retainers and engaging the spring therein, said operator shiftable between a first spring-cocking position wherein said springs are held in said cocked positions thereof, and a second spring-releasing position wherein said springs are released from said cocked positions thereof. 
     
     
         19 . The method of  claim 18 , said operator sections being generally oval in cross-section and presenting major and minor axes, said spring retainer recesses configured to retain said operator sections in said first positions thereof when the operator is oriented so that said major axes extend in one direction, and to release said springs when said operator is oriented with said major axes in a second, different direction. 
     
     
         20 . The method of  claim 14 , said wound tract communicating with an opening formed in a vascular vessel within the patient's tissue, said body and force-exerting assembly cooperatively configured to reduce the blood pressure within and downstream of said vascular vessel.