PUSH-IN RETAINER SYSTEM FOR USE IN THE DIRECT PLICATION ANNULOPLASTY TREATMENT OF MITRAL VALVE REGURGITATION
A system for using a barbed tubular retainer in the treatment of mitral valve regurgitation by reshaping the mitral valve annulus using one or more plications of annular tissue each fixed by a retaining clip is described. The system includes four devices to achieve such percutaneous direct plication annuloplasty. The first is a crossing catheter. Second, a deflecting guide catheter is used to provide a means for guiding the plication device into proper position at the subvalvular region of the mitral valve annulus. Third, the plication device is then used to make placations in the subvalvular region of the mitral valve annulus. Fourth, a barbed tubular retainer deployed by the plication device in order to retain the plicated tissue in the plicated form. Alternatively, the fourth device is a retainer delivery catheter that enables delivery of a barbed tubular retainer that is attached to its distal end over the outside of the plication device.
1 . A system for the treatment of mitral valve regurgitation through direct plication annuloplasty of a patient comprising:
a deflecting guide catheter having an elongate body with lumen therethrough ending in a distal opening for insertion through the aortic valve into the left ventricle of the patient;
a plication device having a set of opposing jaws operable to plicate tissue in the mitral valve of the patient;
wherein the plication device comprises at least one barbed tubular retainer for retaining plications in tissue created by the opposing jaws.
2 . The system of claim 1 further comprising a crossing catheter for insertion through the aortic valve into the left ventricle of the patient;
3 . The system of claim 2 further comprising a guidewire for use in guiding the crossing catheter and the deflecting guide catheter through the vasculature of the patient and into the left ventricle.
4 . The system of claim 1 wherein a proximal section of the elongate tubular body of the plication device is comprised of nitinol and a distal section of the elongate tubular body is comprised of stainless steel.
5 . The system of claim 1 wherein the plication device further includes a pusher adapted to engage the proximal end of the barbed tubular retainer.
6 . The system of claim 7 wherein the plication device further includes a firing knob connected to a firing control wire adapted to rotate upon rotation of the firing knob in a first direction causing the pusher to move longitudinally and push the barbed tubular retainer into the plicated tissue.
7 . The system of claim 1 wherein the barbed tubular retainer comprises a tubular base member having at least one barbed prong disposed on said tubular base member for engaging with the plicated tissue.
8 . The system of claim 7 wherein the barbed tubular comprises four barbed prongs disposed on said tubular base member.
9 . The system of claim 1 wherein the barbed tubular retainer has at least one radiopaque marker disposed thereon.
10 . The system of claim 9 wherein the radiopaque marker disposed on the barbed tubular retainer is a tantalum microcoil.
11 . The system of claim 1 wherein the barbed tubular retainer is comprised of stainless steel, MP35N, platinum, nitinol, cobalt chromium or alloys thereof.
12 . The system of claim 1 wherein the barbed tubular retainer is comprised of a polymeric material.
13 . The system of claim 12 wherein the polymeric material is poly lactic acid (PLA) and/or poly glycolic acid (PGA).
14 . A system for the treatment of mitral valve regurgitation through direct plication annuloplasty of a patient comprising:
a deflecting guide catheter having an elongate body with lumen therethrough ending in a distal opening for insertion through the aortic valve into the left ventricle of the patient;
a plication device having a set of opposing jaws operable to plicate tissue in the mitral valve of the patient; and,
a retainer delivery catheter having a proximal end and a distal end and having a barbed tubular retainer disposed on the distal end for retaining plications in tissue created by the set of opposing jaws of the plication device.
15 . The system of claim 14 further comprising a crossing catheter having a distal end for insertion through the aortic valve into the left ventricle of the patient;
16 . The system of claim 14 wherein the retainer delivery catheter has an elongate tubular body comprised of a composite of a polymeric material and a braided wire mesh.
17 . The system of claim 15 wherein the retainer delivery catheter has an elongate tubular body comprised of metal with a pattern cut through the metal along at least a portion of the elongate tubular body.
18 . The system of claim 17 wherein the pattern is a trapezoidal pattern.
19 . The system of claim 17 wherein the elongate tubular body of the retainer delivery catheter is comprised of nitinol or stainless steel.
20 . The system of claim 14 wherein the retainer delivery catheter further includes an adaptor adapted to releasably engage a mated adapter at the proximal end of the helical retainer.
21 . The system of claim 20 wherein the adaptor on the retainer delivery catheter disengages the adapter on the barbed tubular retainer when the retainer delivery catheter is rotated in a first direction.
22 . The system of claim 14 wherein the barbed tubular retainer comprises a tubular base member having at least one barbed prong disposed on said tubular base member for engaging with the plicated tissue.
23 . The system of claim 22 wherein the barbed tubular comprises four barbed prongs disposed on said tubular base member.
24 . The system of claim 14 wherein the barbed tubular retainer has at least one radiopaque marker disposed thereon.
25 . The system of claim 24 wherein the radiopaque marker disposed on the barbed tubular retainer is a tantalum microcoil.
25 . The system of claim 14 wherein the barbed tubular retainer is comprised of stainless steel, MP35N, platinum, nitinol, cobalt chromium or alloys thereof.
27 . The system of claim 14 wherein the barbed tubular retainer is comprised of a polymeric material.
28 . The system of claim 27 wherein the polymeric material is poly lactic acid (PLA) and/or poly glycolic acid (PGA).
29 . The system of claim 23 wherein the base member of the barbed tubular retainer comprises a plurality of holes adapted to receive a suture.
30 . The system of claim 29 wherein the barbed tubular retainer is releasably attached to the distal end of the retainer delivery catheter with a suture that runs from the proximal end of the retainer delivery catheter to the distal end of the retainer delivery catheter through the plurality of holes in the base member of the barbed tubular retainer.
31 . The system of claim 30 wherein the barbed tubular retainer is released from the distal end of the retainer delivery catheter by removal of the suture from the patient.
32 . The system of claim 22 wherein the base member and the barbed prongs are fabricated from one piece of material.
33 . The system of claim 22 wherein the base member and the barbed prongs are fabricated separately and joined together after the distal end of the base member is sharpened.