CA1229202A - Stent covering for tissue valves - Google Patents
Stent covering for tissue valvesInfo
- Publication number
- CA1229202A CA1229202A CA000470828A CA470828A CA1229202A CA 1229202 A CA1229202 A CA 1229202A CA 000470828 A CA000470828 A CA 000470828A CA 470828 A CA470828 A CA 470828A CA 1229202 A CA1229202 A CA 1229202A
- Authority
- CA
- Canada
- Prior art keywords
- stent
- layer
- heart valve
- prosthetic heart
- biologically
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/90—Stent for heart valve
Abstract
STENT COVERING FOR TISSUE VALVES
ABSTRACT
A prosthetic heart valve comprising a stent having an annular base and a plurality of legs extending upwardly from said base; a valve element circumscribing said stent and attached thereto, said valve element comprising a number of cooperating valve leaflets equal to the number of said legs; and a layer of biologically-compatible material secured to said stent and positioned between said stent and said leaflets, said layer having a smooth, non-abrasive outer surface and covering all of the surfaces of said stent that, in the absence of said layer, would contact the mobile portions of said leaflets during the normal function of the valve.
ABSTRACT
A prosthetic heart valve comprising a stent having an annular base and a plurality of legs extending upwardly from said base; a valve element circumscribing said stent and attached thereto, said valve element comprising a number of cooperating valve leaflets equal to the number of said legs; and a layer of biologically-compatible material secured to said stent and positioned between said stent and said leaflets, said layer having a smooth, non-abrasive outer surface and covering all of the surfaces of said stent that, in the absence of said layer, would contact the mobile portions of said leaflets during the normal function of the valve.
Description
I
PI (En SHY 6774 STUNT COVERING FOR TISSUE VALVES
_ This invention relates to an improved prosthetic heart valve with a padded stunt. More particularly, the invention is concerned with a prosthetic heart valve comprising a stunt having a smooth, non-abrasive outer layer adapted to avoid abrasion damage during normal function of the valve.
Prosthetic heart valves have been developed since 1960 and since the early development great efforts have lb been expended in the development of tissue heart valve prostheses and in the development of supportive structures, or stunts, for tissue valves.
Some of the earliest heart valve prostheses were flexible two-or three-cusp valves in which the cusps err constructed of various types of fabric. Some of these flexible leaflet valves had good flow characteristics but most failed early. The leaflets tore, separated from thy annuls, or became rigid due to fibrous tissue inqrowth.
From about 1960 into the 1970's, the trend was to mechanical valves. These ranged from the mechanically quite simple Starr-Edwards valve to the relatively sophisticated Bjork-Shirley valve and included a number of disc poppet valves These mechanical valves generally dominated the market and are still very satisfactory for many applications. Tissue valves are still the preferred treatment where anti-coagulation therapy is not tolerated by the patient.
~22gz~
In 1962, implantations were performed with homograft tissue valves some of which were free graft implants and some were mounted on supporting stunts. Fully clothed covered rigid stunts were used in some of these homograft valves.
In lg65 implantations were performed with a specially prepared porcine aortic valve xenograft. These porcine valves were sterilized and treated, e.g. with formaldehyde, and were commonly attacked to a metal stunt. Experience showed that these valves were of short life, largely because formaldehyde was used as the cross lining agent Formaldehyde was found to create reversible cross links in the tissue, thereby allowing early breakdown of the tissue.
In about 1968 there was established the concept of the bioprosthesis by substantially eliminating antigenicity of the tissue, principally by changing the preservative from formaldehyde to glutaraldehyde. Glutaraldehyde has been shown to create cross links of a more permanent nature than those created by formaldehyde.
A number of porcine bioprostheses and specially designed stunts for supporting these prostheses haze been developed in the art. Generally, pig aortic valves are procured under clean conditions placed in a cold, balanced electrolyte solution, excess tissue is trimmed and the xenografts are immersed in 0.2% glutaraldehyde. The leaflets are held in their normal valving potion under pressure during the tanning process and each valve is sutured to a cloth covered stunk by multiple sutures.
Stunts for supporting cusp valves of other tissue members, e.g. fish fate and pericardium, also have been developed by a number of workers.
122g~2 A number of improvements in the basic tissue heart valve have been made. For example, a tissue heart valve has been developed which has a cloth-covered stunt of special construction, in which the outflow annuls diameter of the valve is defined and limited by the positioning of a coaptation stitch on the inside of the supporting legs of the stunt, as has been the practice since the early development of the tissue heart valve. Another improvement in the method for aligning the tissue of the cusps of the tissue heart valve is described in United States Patent No.
4,172,295 which also disclosed the coaptation stitch inside the stunt legs.
A heart valve with a removable cusp protector band is disclosed in United States Patent No. 4,364,126.
A potential problem remains in the heart valves describe Ed in the prior art, namely, that stress is concentrated in the tissue in some areas where sharp bending of the tissue around the stunt occurs. The stress tends to be highest at points of maximum curvature such as around the tips of the stunt legs because of the pinching of the tissue leaflets together inside and above the tip of the stunt leg.
A further problem of prior art prosthetic heart valves is the abrasion caused by the rubbing of a tissue valve leaflet over a fabric covered stunt. This problem is substantially solved by the present invention.
In accordance with the present invention there is pro-voided a prosthetic heart valve comprising: a stunt having an ~29~2 annular base and a plurality of legs extending upwardly from said base; a valve element circumscribing said stunt and attached there to, said valve element comprising a number of cooperating valve leaflets equal to the number of said legs; and, for the purpose ox avoiding abrasion damage caused by the rubbing of said leaflets over said stunt, a layer of biologically-compatible material secured to said stunt and positioned between said stunt and said leaflets said layer having a smooth, non-abrasive outer surface and covering all of the surfaces of said stunt that, in the Abe since of said layer, would contact the mobile portions of said leaflets during the normal function of the valve.
The layer of biologically compatible material is pro-fireball a sheet of a synthetic polymeric material, for example, polyurethane, a silicone elastomers or polytetrafluoroethylene; or a sheet of natural tissue, for example pericardial tissue. The pericardial tissue preferably is cross-linked and the cross-linking may be achieved by fixation or tanning of the tissue, for example, with glutaraldehyde, before or after its attachment to the stunt.
Alternatively the layer may be a coating of the said sync Thetis polymeric material or a coating of organic material, for example collagen or gelatin. Such coating may be applied by dipping the stunt into a solution or other liquid form of the coat-in material.
The invention also provides a stunt for use in a prosthetic heart valve, as described above, which comprises an annular base, a plurality of legs extending upwardly from said ~229~)Z
- pa - 72536-1 base and a layer of biologically-compatible material secured to and covering all the surfaces of the stunt, the said layer having a smooth, non-abrasive outer surface, the said outer surface being that which contacts the mobile portions of the leaflets in the heart valve for which the stunt is adapted to be used.
Jo -~L2Z9~
The material used for the stunt according to the invention may be Any of the known conventional materials, for example, titanium, elfin (an acutely homopolymer), polyacetal, polypropylene or Elgiloy (an alloy of cobalt, chromium and nickel).
It is preferred that the biologically-compatible material used to form the layer covering the surfaces of the stunt has a greater compliance than the material from which the stunt is made.
Compliance, as applied to a prosthetic material may be defined as a mechanical matching characteristic depending upon the elastic response of the material when subjected to pressure and stresses comparable to those experienced by the natural material present at the site of the prosthesis.
The term is described, for example, in US. Patent No.
4,173,689.
In another preferred embodiment of the invention the prosthetic heart valve additionally comprises a layer of fabric covering the entire surface of and attached to the stunt, and positioned between the stunt and the layer of biologically-compatible material.
As in the previously described embodiments the biologically-compatible material is preferably a synthetic polymeric material, for example, polyurethane, a silicone elastomers or polytetrafluoroethylene; or a natural tissue material, for example pericardial tissue, which may be cross-linked. The biologically-compatible material may be attached to the fabric by means of a biologically-compatible glue or by meats of sutures. When sutures are used they are located so that no abrasion results.
The layer of biologically-active material may be a coating of polymeric material, preferably a silicone elastomers or polyurethane, applied to the layer of fabric.
~2:~9;~2 In a further embodiment of the invention the layer of biologically-compatible material is a coating of an organic material, for example collagen or gelatin, which may be cross-linked or uncross linked The invention will now be more particularly described with reference to the accompanying drawings, in which:-Figure 1 is a side elevation of a prosthetic heart valve having a pericardial padding on a covered stunt;
Figure 2 is a top plan view of the valve of Figure 1 î
Figure 3 is a sectional view taken along section line 3-3 in Figure 2;
Figure 4 is a perspective view of a padded covered stunt with a cloth sewing ring;
Figure 5 is a plan view of the stent-sewing ring assembly of Figure 4;
Figure 6 is a sectional view taken along section line 6-6 in Figure 5;
Figure 7 is a perspective view of a padded, covered stunt without sewing ring; and Figure 8 is a plan view of the stunt of Figure 7.
Referring to the embodiments of the invention illustrated in the drawings, Figure 1 illustrates a prosthetic heart valve comprising a valving element having three tissue leaflets 11, a stunt assembly 12 and a suture or sewing ring assembly 13. The coaptation stitches 14 across the top of the stunt legs cause coaptation or joining of the edges of the tissue leaflets around the stunt legs. Stitches 24 join the edges of the tissue leaflet forming lines or seams on the outside of the valve. Stitches 25 (Figure 4) hold down the padding to the cloth covering of the stunt.
z As shown in Figure 2 the stunt assembly has three substantially identical legs 15,16,17. The configure-lion of the legs is shown in more detail in Figures 4 and 7. The legs extend upwardly toward the outflow end of the valve from the lower-most portion of the stunt base lo and each of the legs is separated from its neighboring legs by a scallop 18 as best shown in Figure 7. The bottom or inflow edge of the stunt, indicated by arrow 20 in Figure 7, is also scalloped to conform generally to the arc of the scallops between the legs. these bottom scallops generally follow the configuration of the scallops 18 of the outflow edge so as to generally form parallel edges defining the annular ring or base 19, which defines the flow orifice of the valve.
The scallops of the lower or inflow edge of the base and the scallops of the outflow edge between the legs vertically define three generally elliptically shaped one-third portions of the base between the centerlines of the respective upright legs which together circumferential form a right cylinder of constant diameter with the legs extending parallel to the axis of the cylinder.
Referring again to Figures l, 2 and 3, a sewing or suture ring 13 extends outwardly circumferential forming an annuls vertically following the scalloped curvature of the base 19 (Figure 7) of the stunt. The sewing ring provides a place wherein the surgeon may anchor his sutures when sewing the valve into its position in the heart. This ring may be in any of the forms disclosed in the prior art.
~Z29~:~Z
In one embodiment of the invention a layer of material 21 (Figure 3) covers the stunt and is joined along the lower edge of the stunt, to which the sewing ring is attached.
In this embodiment of the invention the layer 21 may be a layer of biologically-compatible material having a smooth non-abrasive outer surface as described above.
Alternatively, as illustrated in Figure 6, the layer of material 21' covering the surface of the stunt is a layer of fabric, as described above, and this in turn is covered with a layer 22 of biologically-compatible material having a smooth non-abrasive outer surface.
In a further embodiment the layer of biologically-compatible material may be a moating of a smooth non-abrasive surface material applied to the layer of fabric 21'.
Heart valves provided with a layer of biologically-compatible material having a smooth, non-abrasive outer surface secured to and covering all the surfaces of the stunt 'hat are in contact with the leaflets, in accord dance with the invention, were subjected to in vitro life cycle testing.
The tests were conducted in a Roan Ash heart valve fatigue tester using a solution containing 0.2 glutaraldehyde in normal saline solution.
In a typical in vitro experiment, valves that were padded in accordance with the invention lasted an average of 220 x 10~ cycles before failure, whereas unpadded counterparts, made according to standard prior art procedure, failed after an average of 74 x 106 cycles.
these results show a three fold increase in durability of the valves according to the invention as compared to prior art counterparts.
PI (En SHY 6774 STUNT COVERING FOR TISSUE VALVES
_ This invention relates to an improved prosthetic heart valve with a padded stunt. More particularly, the invention is concerned with a prosthetic heart valve comprising a stunt having a smooth, non-abrasive outer layer adapted to avoid abrasion damage during normal function of the valve.
Prosthetic heart valves have been developed since 1960 and since the early development great efforts have lb been expended in the development of tissue heart valve prostheses and in the development of supportive structures, or stunts, for tissue valves.
Some of the earliest heart valve prostheses were flexible two-or three-cusp valves in which the cusps err constructed of various types of fabric. Some of these flexible leaflet valves had good flow characteristics but most failed early. The leaflets tore, separated from thy annuls, or became rigid due to fibrous tissue inqrowth.
From about 1960 into the 1970's, the trend was to mechanical valves. These ranged from the mechanically quite simple Starr-Edwards valve to the relatively sophisticated Bjork-Shirley valve and included a number of disc poppet valves These mechanical valves generally dominated the market and are still very satisfactory for many applications. Tissue valves are still the preferred treatment where anti-coagulation therapy is not tolerated by the patient.
~22gz~
In 1962, implantations were performed with homograft tissue valves some of which were free graft implants and some were mounted on supporting stunts. Fully clothed covered rigid stunts were used in some of these homograft valves.
In lg65 implantations were performed with a specially prepared porcine aortic valve xenograft. These porcine valves were sterilized and treated, e.g. with formaldehyde, and were commonly attacked to a metal stunt. Experience showed that these valves were of short life, largely because formaldehyde was used as the cross lining agent Formaldehyde was found to create reversible cross links in the tissue, thereby allowing early breakdown of the tissue.
In about 1968 there was established the concept of the bioprosthesis by substantially eliminating antigenicity of the tissue, principally by changing the preservative from formaldehyde to glutaraldehyde. Glutaraldehyde has been shown to create cross links of a more permanent nature than those created by formaldehyde.
A number of porcine bioprostheses and specially designed stunts for supporting these prostheses haze been developed in the art. Generally, pig aortic valves are procured under clean conditions placed in a cold, balanced electrolyte solution, excess tissue is trimmed and the xenografts are immersed in 0.2% glutaraldehyde. The leaflets are held in their normal valving potion under pressure during the tanning process and each valve is sutured to a cloth covered stunk by multiple sutures.
Stunts for supporting cusp valves of other tissue members, e.g. fish fate and pericardium, also have been developed by a number of workers.
122g~2 A number of improvements in the basic tissue heart valve have been made. For example, a tissue heart valve has been developed which has a cloth-covered stunt of special construction, in which the outflow annuls diameter of the valve is defined and limited by the positioning of a coaptation stitch on the inside of the supporting legs of the stunt, as has been the practice since the early development of the tissue heart valve. Another improvement in the method for aligning the tissue of the cusps of the tissue heart valve is described in United States Patent No.
4,172,295 which also disclosed the coaptation stitch inside the stunt legs.
A heart valve with a removable cusp protector band is disclosed in United States Patent No. 4,364,126.
A potential problem remains in the heart valves describe Ed in the prior art, namely, that stress is concentrated in the tissue in some areas where sharp bending of the tissue around the stunt occurs. The stress tends to be highest at points of maximum curvature such as around the tips of the stunt legs because of the pinching of the tissue leaflets together inside and above the tip of the stunt leg.
A further problem of prior art prosthetic heart valves is the abrasion caused by the rubbing of a tissue valve leaflet over a fabric covered stunt. This problem is substantially solved by the present invention.
In accordance with the present invention there is pro-voided a prosthetic heart valve comprising: a stunt having an ~29~2 annular base and a plurality of legs extending upwardly from said base; a valve element circumscribing said stunt and attached there to, said valve element comprising a number of cooperating valve leaflets equal to the number of said legs; and, for the purpose ox avoiding abrasion damage caused by the rubbing of said leaflets over said stunt, a layer of biologically-compatible material secured to said stunt and positioned between said stunt and said leaflets said layer having a smooth, non-abrasive outer surface and covering all of the surfaces of said stunt that, in the Abe since of said layer, would contact the mobile portions of said leaflets during the normal function of the valve.
The layer of biologically compatible material is pro-fireball a sheet of a synthetic polymeric material, for example, polyurethane, a silicone elastomers or polytetrafluoroethylene; or a sheet of natural tissue, for example pericardial tissue. The pericardial tissue preferably is cross-linked and the cross-linking may be achieved by fixation or tanning of the tissue, for example, with glutaraldehyde, before or after its attachment to the stunt.
Alternatively the layer may be a coating of the said sync Thetis polymeric material or a coating of organic material, for example collagen or gelatin. Such coating may be applied by dipping the stunt into a solution or other liquid form of the coat-in material.
The invention also provides a stunt for use in a prosthetic heart valve, as described above, which comprises an annular base, a plurality of legs extending upwardly from said ~229~)Z
- pa - 72536-1 base and a layer of biologically-compatible material secured to and covering all the surfaces of the stunt, the said layer having a smooth, non-abrasive outer surface, the said outer surface being that which contacts the mobile portions of the leaflets in the heart valve for which the stunt is adapted to be used.
Jo -~L2Z9~
The material used for the stunt according to the invention may be Any of the known conventional materials, for example, titanium, elfin (an acutely homopolymer), polyacetal, polypropylene or Elgiloy (an alloy of cobalt, chromium and nickel).
It is preferred that the biologically-compatible material used to form the layer covering the surfaces of the stunt has a greater compliance than the material from which the stunt is made.
Compliance, as applied to a prosthetic material may be defined as a mechanical matching characteristic depending upon the elastic response of the material when subjected to pressure and stresses comparable to those experienced by the natural material present at the site of the prosthesis.
The term is described, for example, in US. Patent No.
4,173,689.
In another preferred embodiment of the invention the prosthetic heart valve additionally comprises a layer of fabric covering the entire surface of and attached to the stunt, and positioned between the stunt and the layer of biologically-compatible material.
As in the previously described embodiments the biologically-compatible material is preferably a synthetic polymeric material, for example, polyurethane, a silicone elastomers or polytetrafluoroethylene; or a natural tissue material, for example pericardial tissue, which may be cross-linked. The biologically-compatible material may be attached to the fabric by means of a biologically-compatible glue or by meats of sutures. When sutures are used they are located so that no abrasion results.
The layer of biologically-active material may be a coating of polymeric material, preferably a silicone elastomers or polyurethane, applied to the layer of fabric.
~2:~9;~2 In a further embodiment of the invention the layer of biologically-compatible material is a coating of an organic material, for example collagen or gelatin, which may be cross-linked or uncross linked The invention will now be more particularly described with reference to the accompanying drawings, in which:-Figure 1 is a side elevation of a prosthetic heart valve having a pericardial padding on a covered stunt;
Figure 2 is a top plan view of the valve of Figure 1 î
Figure 3 is a sectional view taken along section line 3-3 in Figure 2;
Figure 4 is a perspective view of a padded covered stunt with a cloth sewing ring;
Figure 5 is a plan view of the stent-sewing ring assembly of Figure 4;
Figure 6 is a sectional view taken along section line 6-6 in Figure 5;
Figure 7 is a perspective view of a padded, covered stunt without sewing ring; and Figure 8 is a plan view of the stunt of Figure 7.
Referring to the embodiments of the invention illustrated in the drawings, Figure 1 illustrates a prosthetic heart valve comprising a valving element having three tissue leaflets 11, a stunt assembly 12 and a suture or sewing ring assembly 13. The coaptation stitches 14 across the top of the stunt legs cause coaptation or joining of the edges of the tissue leaflets around the stunt legs. Stitches 24 join the edges of the tissue leaflet forming lines or seams on the outside of the valve. Stitches 25 (Figure 4) hold down the padding to the cloth covering of the stunt.
z As shown in Figure 2 the stunt assembly has three substantially identical legs 15,16,17. The configure-lion of the legs is shown in more detail in Figures 4 and 7. The legs extend upwardly toward the outflow end of the valve from the lower-most portion of the stunt base lo and each of the legs is separated from its neighboring legs by a scallop 18 as best shown in Figure 7. The bottom or inflow edge of the stunt, indicated by arrow 20 in Figure 7, is also scalloped to conform generally to the arc of the scallops between the legs. these bottom scallops generally follow the configuration of the scallops 18 of the outflow edge so as to generally form parallel edges defining the annular ring or base 19, which defines the flow orifice of the valve.
The scallops of the lower or inflow edge of the base and the scallops of the outflow edge between the legs vertically define three generally elliptically shaped one-third portions of the base between the centerlines of the respective upright legs which together circumferential form a right cylinder of constant diameter with the legs extending parallel to the axis of the cylinder.
Referring again to Figures l, 2 and 3, a sewing or suture ring 13 extends outwardly circumferential forming an annuls vertically following the scalloped curvature of the base 19 (Figure 7) of the stunt. The sewing ring provides a place wherein the surgeon may anchor his sutures when sewing the valve into its position in the heart. This ring may be in any of the forms disclosed in the prior art.
~Z29~:~Z
In one embodiment of the invention a layer of material 21 (Figure 3) covers the stunt and is joined along the lower edge of the stunt, to which the sewing ring is attached.
In this embodiment of the invention the layer 21 may be a layer of biologically-compatible material having a smooth non-abrasive outer surface as described above.
Alternatively, as illustrated in Figure 6, the layer of material 21' covering the surface of the stunt is a layer of fabric, as described above, and this in turn is covered with a layer 22 of biologically-compatible material having a smooth non-abrasive outer surface.
In a further embodiment the layer of biologically-compatible material may be a moating of a smooth non-abrasive surface material applied to the layer of fabric 21'.
Heart valves provided with a layer of biologically-compatible material having a smooth, non-abrasive outer surface secured to and covering all the surfaces of the stunt 'hat are in contact with the leaflets, in accord dance with the invention, were subjected to in vitro life cycle testing.
The tests were conducted in a Roan Ash heart valve fatigue tester using a solution containing 0.2 glutaraldehyde in normal saline solution.
In a typical in vitro experiment, valves that were padded in accordance with the invention lasted an average of 220 x 10~ cycles before failure, whereas unpadded counterparts, made according to standard prior art procedure, failed after an average of 74 x 106 cycles.
these results show a three fold increase in durability of the valves according to the invention as compared to prior art counterparts.
Claims (10)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A prosthetic heart valve comprising: a stent having an annular base and a plurality of legs extending upwardly from said base;
a valve element circumscribing said stent and attached thereto, said valve element comprising a number of cooperating valve leaflets equal to the number of said legs, and, for the pur-pose of avoiding abrasion damage caused by the rubbing of said leaflets over said stent, a layer of biologically-compatible material secured to said stent and positioned between said stent and said leaflets, said layer having a smooth, non-abrasive outer surface and cover-ing all of the surfaces of said stent that, in the absence of said layer, would contact the mobile portions of said leaflets during the normal function of the valve.
a valve element circumscribing said stent and attached thereto, said valve element comprising a number of cooperating valve leaflets equal to the number of said legs, and, for the pur-pose of avoiding abrasion damage caused by the rubbing of said leaflets over said stent, a layer of biologically-compatible material secured to said stent and positioned between said stent and said leaflets, said layer having a smooth, non-abrasive outer surface and cover-ing all of the surfaces of said stent that, in the absence of said layer, would contact the mobile portions of said leaflets during the normal function of the valve.
2. A prosthetic heart valve according to claim 1, character-ized in that said layer is a sheet of a synthetic polymeric material, a coating of synthetic polymeric material or a sheet of natural tissue.
3. A prosthetic heart valve according to claim 2, character-ized in that said synthetic polymeric material is polyurethane, a silicone elastomer or polytetrafluoroethylene.
4. A prosthetic heart valve according to claim 2, character-ized in that said natural tissue is pericardial tissue which is cross-linked by fixation of the tissue before or after its attach-ment to the stent.
5. A prosthetic heart valve according to claim 1, character-ized in that it comprises additionally a layer of fabric covering the entire surface of and attached to said stent, and positioned between said stent and said layer of biologically-compatible material.
6. A prosthetic heart valve according to claim 5, character-ized in that the biologically-compatible material is attached to the fabric by means of a biologically-compatible glue or by means or sutures.
7. A prosthetic heart valve according to claim 5, character-ized in that said layer of biologically-compatible material is a coating of organic material applied to the fabric.
8. A prosthetic heart valve according to claim 7, character-ized in that the organic material is collagen or gelatin which may be uncross-linked or cross-linked.
9. A prosthetic heart valve according to cliam 1, 2 or 5, characterized in that the biologically-compatible material has a greater compliance than the material from which the stent is made.
10. A stent for use in a prosthetic heart valve comprising an annular base and a plurality of legs extending upwardly from said base, characterized in that a layer of biological-compatible material is secured to and covers all the surfaces thereof, the said layer having a smooth, non-abrasive outer surface, the said outer surface being that which contacts the mobile portions of the leaflets in the heart valve for which the stunt is adapted to be used.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/566,133 US4629459A (en) | 1983-12-28 | 1983-12-28 | Alternate stent covering for tissue valves |
US566,133 | 1983-12-28 |
Publications (1)
Publication Number | Publication Date |
---|---|
CA1229202A true CA1229202A (en) | 1987-11-17 |
Family
ID=24261636
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA000470828A Expired CA1229202A (en) | 1983-12-28 | 1984-12-21 | Stent covering for tissue valves |
Country Status (9)
Country | Link |
---|---|
US (1) | US4629459A (en) |
EP (1) | EP0150608B1 (en) |
JP (1) | JPS60158858A (en) |
AU (1) | AU566778B2 (en) |
CA (1) | CA1229202A (en) |
DE (1) | DE3471879D1 (en) |
ES (1) | ES8608850A1 (en) |
MX (1) | MX157676A (en) |
ZA (1) | ZA8410032B (en) |
Families Citing this family (137)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4759758A (en) * | 1984-12-07 | 1988-07-26 | Shlomo Gabbay | Prosthetic heart valve |
US4725274A (en) * | 1986-10-24 | 1988-02-16 | Baxter Travenol Laboratories, Inc. | Prosthetic heart valve |
US4790844A (en) * | 1987-01-30 | 1988-12-13 | Yoel Ovil | Replacement of cardiac valves in heart surgery |
GB2206395A (en) * | 1987-05-14 | 1989-01-05 | Dr Dhani Ram Baruah | Bioprosthetic heart valve |
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-
1983
- 1983-12-28 US US06/566,133 patent/US4629459A/en not_active Expired - Fee Related
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1984
- 1984-12-19 DE DE8484308927T patent/DE3471879D1/en not_active Expired
- 1984-12-19 EP EP84308927A patent/EP0150608B1/en not_active Expired
- 1984-12-21 ZA ZA8410032A patent/ZA8410032B/en unknown
- 1984-12-21 CA CA000470828A patent/CA1229202A/en not_active Expired
- 1984-12-24 AU AU37178/84A patent/AU566778B2/en not_active Ceased
- 1984-12-27 JP JP59281881A patent/JPS60158858A/en active Granted
- 1984-12-27 ES ES539100A patent/ES8608850A1/en not_active Expired
- 1984-12-28 MX MX203926A patent/MX157676A/en unknown
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EP0150608A1 (en) | 1985-08-07 |
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US4629459A (en) | 1986-12-16 |
JPS6352899B2 (en) | 1988-10-20 |
ES539100A0 (en) | 1986-07-16 |
JPS60158858A (en) | 1985-08-20 |
ZA8410032B (en) | 1986-08-27 |
EP0150608B1 (en) | 1988-06-08 |
DE3471879D1 (en) | 1988-07-14 |
AU566778B2 (en) | 1987-10-29 |
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