Annuloplasty system and surgical method

Abstract

An annuloplasty system for repairing incompetent heart valves is provided. This system includes a substantially circular valve reinforcing device adapted to be surgically implanted into around a heart valve annulus; anchoring means for attaching the substantially circular valve reinforcing device to the heart valve, wherein attaching the substantially circular valve reinforcing device to the heart valve annulus reduces the circumference of the heart valve annulus by plicating annular tissue underneath the valve reinforcing device; and constricting means for, if necessary, reducing the circumference of the substantially circular valve reinforcing device, wherein reducing the circumference of the substantially circular valve reinforcing device further reduces the circumference of the heart valve annulus.

1 . An annuloplasty system for repairing incompetent heart valves, comprising:
 (a) a valve reinforcing device adapted to be surgically implanted around a heart valve annulus, wherein the valve reinforcing device further includes:
 (i) a plurality of individual suture support components, wherein the plurality of suture support components further includes:
 a) at least one anchor component covered with a sewing cuff, wherein the at least one anchor component further includes a channel passing lengthwise therethrough; 
 b) at least one terminal component covered with a sewing cuff, wherein the at least one terminal component further includes a channel passing lengthwise therethrough and wherein the terminal component further includes a suture attached to the distal end of the terminal segment; 
 c) a plurality of intermediate components disposed between the at least one anchor component and the at least one terminal component, wherein each intermediate component is covered with a sewing cuff, and wherein each intermediate component further includes a channel passing lengthwise therethrough; and 
 
   (b) anchoring means for attaching the valve reinforcing device to the heart valve annulus, wherein attaching the valve reinforcing device to the heart valve annulus reduces the circumference of the annulus by plicating annular tissue underneath the valve reinforcing device, and wherein the anchoring means further includes:
 (i) a dual-armed suture, wherein at least one end of the suture is attached to a surgical needle, and; 
   (c) constricting means for reducing the circumference of the valve reinforcing device, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the annulus, and wherein the constricting means further includes:
 (i) a supportive drawstring, wherein one end of the drawstring is secured to one end of the anchor component, wherein the supportive drawstring passes through the channel in each intermediate component and the channel in the terminal component. 
   
     
     
         2 . The annuloplasty system of  claim 1 , wherein each individual suture support components has a length of approximately 4.2 millimeters. 
     
     
         3 . The annuloplasty system of  claim 1 , wherein the supportive drawstring further includes suture material, biodegradable suture material, a Teflon strip, a band, a filament, a wire, a strap or combinations thereof. 
     
     
         4 . The annuloplasty system of  claim 1 , wherein the individual suture support segments are rigid or semi-rigid and are cylindrical, tubular, square, round, oval, or combinations thereof. 
     
     
         5 . The annuloplasty system of  claim 1 , wherein the individual suture support segments have rigid or semi-rigid core and resist bucking when the anchoring means are tied and reduce the potential of over-plication of annular tissue underneath the suture support segments when the anchoring means are tied. 
     
     
         6 . The annuloplasty system of  claim 1 , wherein the individual suture support segments further include a textured surface or coating for promoting tissue in-growth and reducing thromboembolism. 
     
     
         7 . A method for surgically implanting the annuloplasty system of  claim 1 , comprising:
 (a) utilizing the anchoring means for securing the valve reinforcing device to the heart valve annulus, wherein securing the valve reinforcing device to the heart valve annulus reduces the circumference of the heart valve annulus by plicating annular tissue underneath the valve reinforcing device, and wherein utilizing the anchoring means further includes:
 (i) affixing the suture to the heart valve annulus as a horizontal mattress stitch by passing one of the surgical needles attached to the sutures through the heart valve annulus; 
 (ii) threading the surgical needles attached to the suture through the sewing cuff of the anchor component; 
 (iii) pushing the anchor component down over the strands of the suture until the anchor component is aligned with the heart valve annulus; 
 (iv) securing the anchor component to the heart valve annulus by tying the ends of the sutures together; 
 (v) affixing another suture to a incompetent heart valve annulus as a horizontal mattress stitch by passing one of the surgical needles attached to the sutures through the heart valve annulus; 
 (vi) threading the surgical needles attached to the suture through the sewing cuff on the intermediate component; 
 (vii) using the supportive drawstring and the strands of the suture to guide the intermediate component to a position above the heart valve annulus; 
 (viii) pushing the intermediate component down the suture strands until the intermediate component is aligned with the heart valve annulus; 
 (ix) securing the intermediate component to the heart valve annulus by tying the ends of the sutures together; 
 (x) repeating steps (v)-(ix) until the desired circumference around the heart valve annulus is covered by a plurality of intermediate suture support components; 
 (xi) threading the supportive drawstring through the channel which passes through the length of the terminal component; 
 (xii) affixing the suture to a heart valve annulus by passing one of the surgical needles attached to the sutures through the heart valve annulus; 
 (xiii) threading the surgical needles attached to the suture through the sewing cuff on the terminal component; 
 (xiv) using the supportive drawstring and the strands of the suture to guide the terminal component to the position above the heart valve annulus; 
 (xv) pushing the terminal component down over the strands of the sutures until the terminal component is aligned with the heart valve annulus; 
 (xvi) securing the terminal component to the heart valve annulus by tying the ends of the sutures together; and 
 (xvii) testing the repaired heart valve to verify that appropriate constriction has been achieved; and 
   (b) utilizing the constricting means to reduce the circumference of the valve reinforcing device, wherein reducing the circumference of the valve reinforcing device further reduces the circumference of the heart valve annulus by plicating the annular tissue between adjacent components of the valve reinforcing device, and wherein utilizing the constricting means further includes:
 (i) pulling the supportive drawstring to the desired tension to decrease the circumference of the heart valve annulus; and 
 (ii) tying the supportive drawstring that runs through the terminal component to the suture attached to the distal end of the terminal component. 
   
     
     
         8 . An annuloplasty system for repairing incompetent heart valves without traditional knotting, comprising:
 (a) a flexible valve reinforcing device adapted to be surgically implanted into a heart valve annulus, wherein the valve reinforcing device further includes a core formed of a plurality of thin fibers which are held together by a tubular polyester velour cloth; and   (b) anchoring means for attaching the flexible valve reinforcing device to the heart valve annulus and for pleating the annulus to reduce its circumference to substantially that of the flexible valve reinforcing device, wherein the anchoring means further includes:
 (i) a plurality of suture apparatuses containing a surgical suture and at least one surgical needle at each proximal end of the surgical suture; and 
 (ii) a plurality of barbed structures formed at a medial point on each of the plurality of suture apparatuses with a first barb structure being placed a distance away from a second barb structure to create a bridge area, wherein the first barbed structure is oriented to permit passage of the suture through the heart valve annulus in a forward direction and prevent movement in a reverse direction, and wherein the second barbed structure is oriented to prevent passage of the suture through the heart valve annulus in a forward direction. 
   
     
     
         9 . A method for surgically implanting the annuloplasty system of  claim 8 , comprising:
 (a) utilizing the anchoring means to secure the valve reinforcing device to the heart valve annulus, wherein utilizing the anchoring means further includes:
 (i) providing the plurality of suture apparatuses; 
 (ii) inserting one of the surgical needles of the suture apparatus into the heart valve annulus and pulling the surgical needle which draws a first portion of the suture apparatus through the heart valve annulus until the second barbed structure engages the surface of the annulus at the insertion point preventing further advancement of the suture apparatus into the heart valve annulus; 
 (iii) inserting another suture apparatus into the heart valve annulus approximately 2 millimeters apart from the previous suture apparatus and pulling the surgical needle which draws the first portion of the suture apparatus through the heart valve annulus until the second barbed structure engages the surface of the heart valve annulus at the insertion point preventing further advancement of the suture apparatus into the heart valve annulus; 
 (iv) repeating step (ii) until the entire circumference of the posterior annulus of the heart valve is sutured; 
 (v) using both surgical needles of each of the plurality of suture apparatuses to pierce the annuloplasty ring 
 (vi) sliding the annuloplasty ring over the surgical sutures of each of the plurality of suture apparatuses into position above the heart valve annulus; 
 (vii) pushing the annuloplasty ring onto the first and second barbed structures, wherein the first and second barbed structures catch the thin fibers in the annuloplasty ring; 
 (viii) using the first and second barbed structures of each of the plurality of suture apparatuses to hold the annuloplasty ring into place; and 
 (ix) cutting off any excess portion of the surgical sutures of the plurality of the suture apparatuses at a point beyond the annuloplasty ring. 
   
     
     
         10 . A flexible annuloplasty system adapted to be surgically implanted around a heart valve annulus without traditional knotting, wherein the flexible annuloplasty system further includes:
 (a) a plurality of substantially identical suture support components, wherein each suture support component has a proximal end and a distal end, and wherein the plurality of suture support components further includes:
 (i) at least one anchor component, wherein the at least one anchor component further includes an opening at its distal end having a one-way suture retaining device for engaging a suture threaded therethrough; 
 (ii) a plurality of intermediate components, wherein each intermediate component further includes at least two channels passing lengthwise therethrough, and wherein each intermediate component further includes an opening at its distal end having a one-way suture retaining device for engaging a suture threaded therethrough; and 
   (b) a surgical suture pre-attached at the proximal end of each suture support component, and;   (c) at least two supportive drawstrings, wherein one end of each drawstring is attached to one end of the at least one anchor component, wherein the drawstrings pass through the two channels in each intermediate component, and wherein the ends of the drawstrings are tied together over a final individual suture support component after the heart valve repair is completed.   
     
     
         11 . The annuloplasty system of  claim 10 , wherein each of the individual suture support components has a length of approximately 4.3 millimeters. 
     
     
         12 . The annuloplasty system of  claim 10 , wherein the center of the opening of each individual suture support component is approximately 4 millimeters in distance from the suture attached to the proximal end of each of the individual suture support components. 
     
     
         13 . The annuloplasty system of  claim 10 , wherein the surgical suture has a core formed of a plurality of fibers which are held together by tubular braided cover and wherein the fibers are thermally bonded together to form a plurality of rigid bridges at selected short intervals along the longitudinal axis of the suture. 
     
     
         14 . The annuloplasty system of  claim 10 , wherein the one-way suture retaining device comprises a plurality of flexible fingers, barbs, or series of sheets configured to engage the suture threaded therethrough. 
     
     
         15 . The annuloplasty system of  claim 10 , wherein the plurality of flexible fingers, barbs or series of sheets of the one-way suture retaining device include a plurality of sharp points in a common axial direction adapted to prevent the suture from sliding in a direction opposite to a direction of an inclination of the plurality of flexible fingers, barbs or series of sheets. 
     
     
         16 . The annuloplasty system according to  claim 10 , wherein the one-way suture retaining device includes a passage having a sufficient diameter to allow the suture to pass through the opening, wherein the passage allows the plurality of sharp points on the plurality of flexible barbs or fingers to engage the suture when the suture is moved in the direction opposite to the direction of inclination of the plurality of barbs, and wherein the sharp points of the flexible fingers, barbs or series of sheets penetrate the core of the suture between the rigid bridges. 
     
     
         17 . The annuloplasty system of  claim 10 , wherein the opening in each of the individual suture support components contains a meltable polymeric material, wherein the suture is threaded through the opening, and wherein the polymeric material and suture are melted together to form a seal for the purpose of tying. 
     
     
         18 . The annuloplasty system of  claim 10 , wherein the suture includes a needle attached thereto. 
     
     
         19 . The annuloplasty system of  claim 10 , wherein the suture is stored within each of the individual suture support components. 
     
     
         20 . A method for surgically implanting the flexible annuloplasty system of  claim 10 , comprising:
 (a) utilizing the anchoring means for securing the annuloplasty system to the heart valve annulus, wherein securing the annuloplasty system to the heart valve annulus reduces the circumference of the heart valve annulus by plicating annular tissue underneath the suture support components, and wherein utilizing the anchoring means further includes:
 (i) affixing the suture of the anchor component to the heart valve annulus by passing a needle attached to the suture through the heart valve annulus; 
 (ii) passing the needle attached to the suture through the opening and pulling the needle and the suture through the opening; 
 (iii) pushing the anchor component down over the suture until the anchor component is aligned with the heart valve annulus; 
 (iv) cutting off the excess portion of the suture of the anchor component; 
 (v) passing a needle attached to the suture on the intermediate suture support component through the heart valve annulus at approximately 2 millimeters apart from the anchor component; 
 (vi) threading the needle through the opening on the intermediate suture support component; 
 (vii) pulling the suture through the opening on the intermediate suture component and pushing the intermediate suture support component down over the suture and the supportive drawstring until the intermediate component is aligned with the heart valve annulus; 
 (viii) cutting off the excess portion of the of the suture of the intermediate suture component; 
 (ix) repeating steps (v)-(viii) until the desired circumference around the heart valve annulus is covered by the plurality of intermediate suture support components; and 
 (x) tying the ends of the supportive drawstrings around the final suture support component.