EP0155245A2
Expired / Lapsed
EP
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Cardiac valve prosthesis with valve flaps of biological tissues
Assignee: Sorin Biomedica Cardio SpA
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Filing: 1985-03-13
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Granted: —
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Expires: 2005-03-13
Abstract
Abstract A cardiac valve prosthesis (1) comrises an annular frame (2) through which blood can flow and a valve sleeve (11,12) of biological tissue with a plurality of valve flaps (14) which can be forced apart by the blood passing through the prosthesis (1) in one direction and which prevent the blood flow in the opposite direction, being brought into a mutually mating position under the pressure exerted by the blood itself. τheframe of the prosthesis includes a rigid or semi-rigid stent (2) constituted by a tubular body with a ring of apertures (5) and with first (2a) and second (2b) end edges which, in the implanted position of the prosthesis, are respectively upstream and downstream with respect to the direction of flow of the blood through the prosthesis. The tubular body also has integral axial appendages (4) each of which has respective apertures (6) adjacent its free edge. A covering of biocompatible textile (71, 72, 73) completely covers the rigid stent (2): the covering has associated suture stitches some (92, 93) of which extend through the apertures (5) of the said ring to attach the covering (7) to the stent (2) itself. The valve sleeve includes two sheets of biological tissue (11, 12) sutured (13) together and wound into a tube, the radially outermost one (11) having a shape which substantially reproduced the shape of the stent (2) of the frame and the radially innermost one (12) whereof, carrying the valve flaps (14), has a collar end portion (15) which can be turned outwardly of the frame (2, 7) at the first end edge (2a) of the stent (3) of the frame (2, 7). The valve sleeve is fixed to the frame by further suture stitches, some (10) of which extend through the apertures (16) in the ends of the appendages (4) of the frame stent. Other suture stitches (121) connect the end edge of the collar end portion (15) of the radially inner sheetto the covering of biocompatible textile.
Inventors
- 👤 Pietro Arru
- 👤 Gioachino Bona
- 👤 Maria Curcio
- 👤 Franco Vallana
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 18:30
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2412; A61F2/2409; A61L; A61L27/00; A61L27/28; A61L27/30; A61L27/303; A61F2220/00; A61F2220/0025; A61F2220/0075; A61F2310/00; A61F2310/00389; A61F2310/00574
Claims Analysis
Total Claims: 10
Claim 1
Independent Claim
469 words
Cardiac valve prosthesis comprising an annular frame (2, 7) through which blood can flow in the implant position of the prosthesis, and a valve sleeve of biological tissue (10) with a plurality of valve flaps (14) having free edges projecting inwardly of the frame (2, 7) and intended to be forced apart by the blood flow through the prosthesis (1) in one direction and to prevent the blood flow in the opposite direction, being brought into a mutually mating position by the pressure exerted by the blood itself, characterised in that: a) the frame of the prosthesis has a rigid or semi-rigid stent (2) constituted by a tubular body (3) the wall of which has a ring of apertures (5) and which has first (2a) and second (2b) end edges which, in the implanted position of the prosthesis (1), are respectively upstream and downstream with respect to the direction of free flow of the blood through the prosthesis (1); the tubular body (3) also having integral appendages (4) which project from the second end edge (2b) in an axial direction relative to the tubular body (3) itself and each of which has respective apertures (6) located adjacent its free end, b) a covering of biocompatible textile (7) wrapped completely over the rigid or semi-rigid stent (2); the covering having associated first suture stitches (73a, 91, 92, 93) some (92, 93) of which extend through the apertures (5) in the said ring to attach the covering (7) to the stent (2) itself, c) the valve sleeve (10) includes two sheets of biological tissue (11, 12) sutured together by second suture stitches (13) and wound into a tube, of which the radially outermost one (11) has a shape which substantially reproduces the shape of the said stent and the radially innermost one (12), carrying the said valve flaps (14), has an end collar portion (15) turned outwardly of the frame (2, 7) in correspondence with the first end edge (2a) of the stent (2) of the frame itself; the valve sleeve (10) having associated third suture stitches (101) for fixing it to the frame (2, 7), extending through the end apertures (6) in the appendages of the stent and fourth suture stitches (121) connecting the end edge of the end collar portion (15) to the covering of biocompatible textile (7), and d) the radially outer sheet (11) of the valve sleeve (10) has associated fifth suture stitches (111) connecting the radially outer sheet (11) to the covering (7) of biocompatible textile adjacent the said second end edge (2b) of the stent (2) and is connected to the frame of the prosthesis solely by means of these fifth suture stitches (111) and the third suture stitches (101) extending through the end apertures (6) in the appendages (4) of the stent (2) itself.
Claim 2
Dependent Claim
469 words
Cardiac valve prosthesis comprising an annular frame (2, 7) through which blood can flow in the implant position of the prosthesis, and a valve sleeve of biological tissue (10) with a plurality of valve flaps (14) having free edges projecting inwardly of the frame (2, 7) and intended to be forced apart by the blood flow through the prosthesis (1) in one direction and to prevent the blood flow in the opposite direction, being brought into a mutually mating position by the pressure exerted by the blood itself, characterised in that: a) the frame of the prosthesis has a rigid or semi-rigid stent (2) constituted by a tubular body (3) the wall of which has a ring of apertures (5) and which has first (2a) and second (2b) end edges which, in the implanted position of the prosthesis (1), are respectively upstream and downstream with respect to the direction of free flow of the blood through the prosthesis (1); the tubular body (3) also having integral appendages (4) which project from the second end edge (2b) in an axial direction relative to the tubular body (3) itself and each of which has respective apertures (6) located adjacent its free end, b) a covering of biocompatible textile (7) wrapped completely over the rigid or semi-rigid stent (2); the covering having associated first suture stitches (73a, 91, 92, 93) some (92, 93) of which extend through the apertures (5) in the said ring to attach the covering (7) to the stent (2) itself, c) the valve sleeve (10) includes two sheets of biological tissue (11, 12) sutured together by second suture stitches (13) and wound into a tube, of which the radially outermost one (11) has a shape which substantially reproduces the shape of the said stent and the radially innermost one (12), carrying the said valve flaps (14), has an end collar portion (15) turned outwardly of the frame (2, 7) in correspondence with the first end edge (2a) of the stent (2) of the frame itself; the valve sleeve (10) having associated third suture stitches (101) for fixing it to the frame (2, 7), extending through the end apertures (6) in the appendages of the stent and fourth suture stitches (121) connecting the end edge of the end collar portion (15) to the covering of biocompatible textile (7), and d) the radially outer sheet (11) of the valve sleeve (10) has associated fifth suture stitches (111) connecting the radially outer sheet (11) to the covering (7) of biocompatible textile adjacent the said second end edge (2b) of the stent (2) and is connected to the frame of the prosthesis solely by means of these fifth suture stitches (111) and the third suture stitches (101) extending through the end apertures (6) in the appendages (4) of the stent (2) itself.
Claim 3
Dependent Claim
60 words
Prosthesis according to Claim 1, characterised in that the rigid or semi-rigid stent (2) has integral appendages (4) distributed substantially uniformly around the periphery of the tubular body (3) of the stent (2) itself and in that the body (3) has an axial extent which varies angularly with minimum values in correspondence with the regions between two adjacent appendages (4).
Claim 4
Dependent Claim
244 words
Prosthesis according to Claim 1 or Claim 2, having an outer annulus (8, 73) for suturing to the cardiac wall, characterised in that: - the covering of biocompatible textile (7) includes a first sheet (71) applied to the outer surface of the stent (2) in the region between the ring of apertures (5) and the second end edge (2b), and a second sheet (72) applied to the inner surface of the stent (2) and having an end portion (72b) which extends outwardly of the stent (2) and forms a loop (73) defining the suture ring in correspondence with the ring of apertures (5) of the stent (2); the first suture stitches including a first group of stitches (91) connecting the first (71) and the second (72) sheets of biocompatible textile together at their mutually facing edges along the said second end edge (2b) of the stent (2) and a second (92) and a third (93) group of stitches extending through the apertures (5) in the said ring and connecting the region of the second sheet (72) of the covering facing the ring of apertures (5), respectively, to the region of the first sheet (71) of biocompatible textile facing the ring of apertures (5) and to the end edge of the end portion (72b) of the second sheet (72) of biocompatible textile forming the said loop (73) through the said region of the first sheet (71) of biocompatible textile facing the ring of apertures (5).
Claim 5
Dependent Claim
47 words
Prosthesis according to Claim 3, characterised in that the end edge of the end collar portion (15) of the radially innermost sheet of biological tissue (12) extends into at least marginal contact with the upper face of the loop (73) defining the suture ring of the prosthesis.
Claim 6
Dependent Claim
65 words
Prosthesis according to any one of Claims 1 to 4, characterised in that the radially outermost sheet (11) of the valve sleeve (10) has a margin (llc) partially turned over the covering of biocompatible textile in correspondence with the second end edge (2b) of the stent of the frame and in that the fifth suture stitches (111) are formed along the partially turned margin (llc).
Claim 7
Dependent Claim
46 words
Prosthesis according to any one of the preceding claims, characterised in that, in the region of application of each of the third suture stitches (101) the radially innermost sheet (12) of the valve sleeve (10) rests on the radially outermost sheet (11) of the sleeve (10).
Claim 8
Dependent Claim
23 words
Prosthesis according to Claim 1, characterised in that the covering of biocompatible textile (7) is at least partially coated with biocompatible carbonaceous material.
Claim 9
Dependent Claim
38 words
Prosthesis according to Claim 1 or Claim 7, characterised in that the first (91, 92, 93) second (13), third (101), fourth and fifth (121) suture stitches are at least partly constituted by thread coated with biocompatible carbonaceous material.
Claim 10
Dependent Claim
30 words
Prosthesis according to Claim 7 or Claim 8, characterised in that the biocompatible carbonaceous material is applied by cathode sputtering with the use of a target constituted essentially of carbon.
References Cited (Backward Citations)
No citation records indexed.
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