Physiologic mitral valve bioprosthesis

• US 5,824,067 A
• Filed: 07/07/1997
• Issued: 10/20/1998
• Est. Priority Date: 12/01/1995
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gross, Jeffrey M.
• Primary Examiner(s): Willse, David H.
• Application Number:
  US08/888,563
• Time in Patent Office: 470 Days
• Field of Search: 623/2
• US Class Current: 128/898
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia

Abstract

A mitral valve is removed from a pig heart with the annulus, leaflets, cordae tendineae and papillary heads intact. The porcine mitral valve is fixed. A covering material is attached to the papillary heads around the cordae tendineae. A sewing tube of a flexible material is attached to each of the papillary heads by sutures that extend through the covering material. The sewing tube extends away from the porcine mitral valve'"'"'s papillary head remnants. A covering material is attached to the annulus. A human heart with a diseased or damaged human mitral valve is imaged in vivo to size the length between the mitral valve annulus and the papillary heads. The porcine mitral valve annulus to sewing tube length is adjusted to match the like dimension in the human heart by trimming the sewing tube. The human heart is opened and the mitral valve excised. The human heart'"'"'s cordae tendineae are removed leaving the papillary heads intact. The porcine mitral valve is placed in the left ventricle and the sewing tubes are sutured to a respective papillary head. The mitral valve is sutured in place in the annulus and the human heart is closed.

Claims

1. A method for replacing a damaged or diseased mitral valve in a human comprising the steps of:

(a) collecting a whole animal heart having endocardium, a mitral valve having an annulus, chordae tendineae, papillary heads, left ventricle and left atrium shortly after the death of the animal;

(b) exposing the mitral valve, chordae tendineae and papillary heads of the animal heart;

(c) fixing the mitral valve;

(d) excising the mitral valve from the result of step c to include a portion of the endocardium containing the papillary heads so that for each set of chordae tendineae and papillary head, the entire chordae tendineae and substantially the entire corresponding papillary head are removed;

(e) attaching an annular cover to the annulus of the mitral valve;

(f) covering the remnants of the papillary heads with a section of flexible material;

(g) fashioning a sewing tube of a flexible material;

(h) attaching the sewing tube directly to the remnant of the papillary head so that the sewing tube extends away from the mitral valve;

(i) locating trigones and short axis of the human mitral valve for geometric reference;

(j) removing the human mitral valve from the human heart;

(k) cutting the chordae tendineae in the human heart near the papillary heads;

(l) placing pledgeted sutures through native papillary heads;

(m) trimming the sewing tube in length to correspond to the length of the human papillary head to annulus dimension;

(n) sliding the sewing tube down the pledgeted sutures into contact with the native papillary head;

(o) securing the sewing tube to the native papillary head;

(p) placing the replacement mitral valve in the human heart annulus aligned with stay sutures; and

(q) sewing the replacement mitral valve into position in the human heart annulus using the stay sutures.