Apparatus for manufacture of valve flaps for cardiac valve prostheses

• US 4,758,151 A
• Filed: 06/06/1986
• Issued: 07/19/1988
• Est. Priority Date: 07/25/1983
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica SpA (Snia SpA)
• Inventors: Bona, Gioacchino, Vallana, Franco, Curcio, Maria, Arru, Pietro
• Primary Examiner(s): Hoag, Willard E.
• Application Number:
  US06/871,861
• Time in Patent Office: 774 Days
• Field of Search: 425/85, 425/387.1, 425/388, 425/392, 425/446, 623/2
• US Class Current: 425/388
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2310/00161 Carbon; Graphite
• CPC Class Codes: A61K 35/30 Nerves; Brain; Eyes; Corneal cells; Cerebrospinal fluid; Neuronal stem cells; Neuronal precursor cells; Glial cells; Oligodendrocytes; Schwann cells; Astroglia; Astrocytes; Choroid plexus; Spinal cord tissue
• CPC Class Codes: A61K 35/34 Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes vascular smooth muscle A61K35/44
• CPC Class Codes: A61L 27/08 Carbon ; Graphite
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3683 subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A vacuum forming apparatus for fixing and shaping animal tissue into the shape of a cardiac valve prosthesis, including a tapered form, with elongated through apertures, suspended in a reservoir of fixative and vacuum means for producing a reduced pressure within the tapered form.

Claims

1. Apparatus for the manufacture of valve flaps for a cardiac prosthesis of the kind comprising a frame which can be traversed by blood flow and a sleeve of biological tissue with a plurality of valve flaps anchored to the frame along respective crescent shaped edges and provided with free edges projecting into the frame and which can be separated by blood flowing through the prosthesis in one direction and which can prevent the flow of blood in the opposite direction by moving to closely matching positions under the pressure exerted by the blood itself, wherein the apparatus comprises:

a reservoir which can be filled with a fluid for the fixation of biological tissue;

at least one forming element projecting into said reservoir in a position for immersion in said fixation fluid, said forming element being substantially tubular and having a peripheral wall defining plural elongated through apertures, edges of said wall defining said apertures being sloped from the outside toward the inside of said element and free from sharp edges, and means for forming a reduced pressure within said at least one forming element as compared with pressure outside of said element, surfaces defining said apertures being of a configuration suitable for forming said crescent shaped edges of a heart valve.

2. Apparatus as defined in claim 1, wherein the shaped wall elements are of generally flattened form, oriented in a radial direction with respect to the forming element and are delimited, on the radially outer side, by a substantially discontinuity-free surface.

3. Apparatus as defined in claim 1, wherein the said forming element has, at least in the region in which the said apertures are provided, a frustoconical shape.

4. Apparatus as defined in claim 1, wherein the reservoir has associated therewith a source of gas under pressure selectively adjustable to introduce gas under controlled pressure into the reservoir above the free surface of the fixation liquid in the said reservoir in use of the apparatus.

5. Apparatus as defined in claim 1, including a vacuum generator and means connecting the vacuum generator to the interior cavity of each said forming element.

6. Apparatus as defined in claim 1, wherein the said reservoir includes a cover having holes each of which forms a mounting seat for an associated forming element each of the said holes being associated with a transparent fluid-tight closure member which allows observation of the interior cavity of the associated forming element.

7. Apparatus as defined in claim 6, including a vacuum generator and wherein the said cover is provided with ducts communicating with said holes for putting said vacuum generator into communication with the interior cavity of each said forming element.

8. Apparatus as defined in claim 1, wherein said apertures are so spaced peripherally about said forming element that a sheath of biological tissue covering the apertures and deformed to protrude inward through the apertures by a reduction of pressure within said forming element brings the deformed portions of the sheath of biological tissue into a configuration of mutual matched shaping substantially similar to flaps of a heart valve.