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Publication numberUS3744062 A
Publication typeGrant
Publication dateJul 10, 1973
Filing dateOct 8, 1971
Priority dateOct 8, 1971
Publication numberUS 3744062 A, US 3744062A, US-A-3744062, US3744062 A, US3744062A
InventorsParsonnet V
Original AssigneeParsonnet V
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Heart valve construction having a collagen cover encapsulation thereon
US 3744062 A
Abstract
An autogenous heart valve with three leaflets is formed by a mold having slick back-up segments positioned behind each leaflet while the heart valve is implanted in the human body until a collagen covering has been formed; the heart valve so formed is removed from the host body, the excess collagen and mold are removed and the valve is implanted in the correct valve position in the heart.
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Description  (OCR text may contain errors)

United States Patent 1 [111 3,744,062 Parsonnet July 10, 1973 [54] HEART VALVE CONSTRUCTION HAVING A 3,445,916 5/1969 Schulte 3/1 X COLLAGEN COVER ENCAPSULATION THEREON inventor: Victor Personnel, 113 Sagamore U.S. Cl 3/1, 3/DlG. 3, 425/109 Int. Cl ..A61l' l/22 Field olSea'rch ..3/l DIG. 3

References Cited UNITED STATES PATENTS 6/1970 Sparks 3/1 Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. Frinks Attorney- Popper, Bain, Bobis & Gilfillan [5 7] ABSTRACT An autogenous heart valve with three leaflets is formed by a mold having slick back-up segments positioned behind each leaflet while the heart valve is implanted in the human body until a collagen covering has been formed; the heart valve so formed is removed from the host body, the excess collagen and mold are removed and the valve is implanted in the correct valve position in the heart.

3 Claims, 8 Drawing Figures PA-TENTEDJUI. 10 I975 3.744.062

' FIG. 8

INVENTOR 34 34 VICTOR PARSONNET BMW, wgfiu ATTOR BACKGROUND OF INVENTION 1. Field of the Invention This invention relates generally to a heart valve mold construction, and specifically to a method for making a heart valve construction of autogenous character, and resistant to clotting.

2. Description of the Prior Art When a human heart valve is damaged, and particularly when it ceases to perform efficiently the necessary functions, operations may be performed which repair the defective valve by substituting an artificial valve for the natural valve. There are several heart valves available for this operation. The operations may fail because of several reasons such as disintegration of the substituted valve. The valve is subjected to great stress, in that it must cycle approximately 40 million times a year. This stress can destroy red blood cells (hemolysis) and produce persistant anemia and jaundice. An other cause of failure is the formation of blood clots on various surfaces of the valve and its vicinity. These clots get into the blood stream, and may block the flow of blood. The present invention addresses itself to this last problem.

Various solutions to the problem have been offered.

In some cases, blood clots are sought to be avoided by SUMMARY OF THE INVENTION It has been found that a heart valve construction can be devised which is capable of performing 40 million cycles a year, and which will be compatible with its host. A steel ring with three leaflets forming a valve gate forms an efficient valve structure. This structure when implanted in the body, receives a collagen sheath which closes the interstices of the fabric. The trifoliate structure being formed in its host, is compatible and is not subject to rejection when implanted in the heart tissue. The use of a mold with slick surfaces bearing on the leaflets as the collagen deposits, has been found to prevent clotting, by imparting a smooth ventral surface to the leaflets.

DRAWINGS The foregoing objects and advantages as well as other objects and advantages may be obtained by the device shown by way of illustration of the drawings in which:

FIG. 1 shows a ring of stainless steel with three integral posts with holes,

FIG. 2 shows the ring with a fabric covering and three fabric leaflets attached,

FIG. 3 shows a fabric leaflet dimensioned to fit within the center of the ring, with a top hem containing an attachment thread,

FIG. 4 is a top plan view of the fabric covered ring with the leaflets sewn to the ring and the posts; and the threads attached to the posts;

FIG. 5 is a side elevational view of a trifoliate mold,

FIG. 6 is a top view of the trifoliate mold,

FIG. 7 is an inside elevational view of the tapered portion of one of the segments of the mold, and

FIG. 8 is a bottom view of a mold segment.

PREFERRED EMBODIMENT Referring now to the drawings in detail. A stainless steel ring 11 is prepared, having a dimension suitable approximately to being attached to the heart structure in place of the natural valve located there. The ring 11 is provided with three arcuate portions to conform with the corresponding section of the aorta to which it will be attached. Three upstanding posts 12 are formed on the ring, generally disposed in parallelism with the central axis of the ring 11. A fabric sheath 13 is applied to completely cover the ring 1 l and the posts 12. The fabric is preferably Dacron, Teflon, Polypropylene or Polyethylene. The fabric can be woven for example from a filament produced by the United States Catheter and Instrument Company, catalog number 6102, denier number 30, 015 mm. thick. Other synthetic inert filaments may be used to form this fabric. These synthetic f laments should be embodied in a fabric which is flexible, has an open mesh, is strong, is noncarcinogenic, and resistant to disintegration when exposed to human tissues. The fabric sheath 13 can be applied by wrapping a fabric around the ring 11 and the posts 12, and sewing it thereon to cover the ring and the posts. The fabric also can be applied by fusing the synthetic fibers together, preferably at their edges where they come together.

Three fabric leaflets 14 are prepared with one arcuate edge 10 and one generally straight edge. The straight edge has a hem 9, and a thread or tie 8 is passed through it. The arcuate edge is attached to the ring 11 and to the posts, and the thread 8 is passed through and tied to an eye or orifice 7 in the posts, thereby holding the leaflets l4 upright in such a manner that their other upper edges may all meet together as shown in FIG. 4 forming a closure for the valve, closing to ventral back pressure, but yielding to dorsal pressure.

Another way of forming the leaflets is to set the leaflets by the application of heat, so as to give the edges of the synthetic fibrous leaflets a normally selfsustaining character. In this manner, the leaflets 14 will yield to fluid pressure in one direction, but fluid pressure if exerted in the opposite direction, will press the hemmed edges 9 together and resist the back pressure. In this manner, a one way valve is devised by reason of the engagement of the leaflets 14 with each other, and forming a resistance to back pressure. The leaflets 14 will resist deflection, and the back pressure will cause them to engage with each other as a closure. In case the leaflets 14 are not shaped, but a thread is used to hold them, the attachment of the thread 8 to the post 12 will also inhibit the leaflets 14 from yielding to reverse pressure. The sheath 13, and the leaflets 14 are formed of a fabric having an open weave so as to be porous or penetrable for the reason hereinafter set forth.

The valve construction is then implanted in the human body, where it will not interfere with normal functions of the tissues or the activity of the host, for example under the skin of the abdomen. A stringy protein is formed by the bodily defense mechanism. This protein is called collagen. On smooth surfaces, it forms with a stringy texture making it strong longitudinally and weak laterally. However, on ,a rough textured surface such as the loosely woven fabrics surface, the collagen invades the interstices of the fabric and forms a strong sheath. It takes on something of the texture of the surface to which it is applied. After five weeks implantation in the host the valve is mature enough to be removed. The collagen deposit entirely incapsulated the valve structure and has filled the leaflets 14. The flanges or hems 9 are split from engagement with each other. The valve is then implanted in place of the defective heart valve, and it is sutured in place. If it is desired, the leaflets may becompressed between mating dies, so as to impart a smooth surfaces to the leaflets to discourage the formation of blood clots on their ventral surfaces. The dorsal surfaces, being constantly swept in the blood stream are not so inclined to the formation of the blood clots.

An alternative procedure to compressing the ventral surfaces is to cover each of them with a die 30 at the time of the implant. The die or segment 30 has a semicylindrical exterior face 31, and a slick inner face 32 which tapers smoothly to an arcuate botom edge 33. The inner face 3Zconforms generally to the normal position of a leaflet 14 when it acts as a closure in the heart valve. The top of the segment 30 has slick interior flat radial faces 34 and a flat top 36, with a threaded hole 35. A disc 37 holds three of the segments 30 with screws 38. The segments 30 are spaced from each other so as to receive the three leaflets 14 mounted on the ring 11 inbetween them, with the slick innerfaces 32, 34 bearing onthe leaflets 14. This imparts agenerally self-sustaining, normally closedcharacter to the collagen coated leaflet 14, while the slick ventral inner faces 32 and the radial faces 34 form corresponding slick surfaces on the leaflets 14 that supply no place for clots to form, that might detach themselves and plug'blood passages. After the collagenages, it forms a psuedo intima which is a substantial replica of the original natural valve construction. it is capable: of long functioning,

4 and its surface is normally repaired by natural processes. As an autogenous body, it is not subject to rejection..

The valve being implanted in the fatty tissue, with the moldas shown in FIG. 5 embracing the ventral faces of the leaflets 14, the collagen soon forms and the valve is removed from the host. Excess collagen coating the valve is trimmed off and the mold is removed. The

valve is then implanted in the correct aortic valve position in the same patient in whom it was previously implanted for the formation of the collagen.

I claim:

l. A heart valve construction comprising:

a. a ring,

b. three posts on the ring generally parallel to the axis of the ring,

c. an orifice in the top of each post,

d. an open mesh fabric cover on the ring and posts,

c. three arcuate edged fabric leaflets attached to the ring and the posts,

f. a top hem on the leaflets,

g. atie passed through the hem, b

h.. opposite ends of the ties attached to the orifices, i. a collagen cover on the ring, posts, cover and leaflets, I a

j. a slick collagen ventral face on each leaflet. 2. A heart valve construction according to claim 1, and the arcuate edges of the leaflets positioned on two posts and the intervening portion of the ring.

3. Aheart valve construction according to claim 1, and the ties of sufficient length to hold the leaflets upright and to permit their upper edges and hems to meet together to form a closure responsive to ventral back pressu re,.but yieldable to dorsal pressure.

a :n =0: a:

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3445916 *Apr 19, 1967May 27, 1969Schulte Rudolf RMethod for making an anatomical check valve
US3514791 *Jul 25, 1967Jun 2, 1970Charles H SparksTissue grafts
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US4218782 *May 19, 1978Aug 26, 1980Biocoating AnpartsselskabHeart valve prosthesis and method for the production thereof
US4222126 *Dec 14, 1978Sep 16, 1980The United States Of America As Represented By The Secretary Of The Department Of Health, Education & WelfareUnitized three leaflet heart valve
US4259753 *May 29, 1979Apr 7, 1981Liotta Domingo SFrame support for cardiac tissue valves
US4265694 *Jan 22, 1980May 5, 1981The United States Of America As Represented By The Department Of Health, Education And WelfarePolyurethanes
US4291420 *Jun 13, 1980Sep 29, 1981Medac Gesellschaft Fur Klinische Spezialpraparate MbhArtificial heart valve
US4364127 *Oct 2, 1981Dec 21, 1982Research CorporationTrileaflet type prosthetic heart valve
US4473423 *Sep 16, 1983Sep 25, 1984University Of UtahUsing thermoplastic elastomer material
US4510628 *May 3, 1982Apr 16, 1985University Of UtahArtificial heart valve made by vacuum forming technique
US4645068 *Jun 13, 1985Feb 24, 1987Klockner-Humboldt-Deutz AktiengesellschaftBonding of highly wear-resistant plates, particularly ceramic plates, to a carrier to be protected against wear
US4680031 *Oct 24, 1984Jul 14, 1987Tascon Medical Technology CorporationHeart valve prosthesis
US4851000 *Jul 31, 1987Jul 25, 1989Pacific Biomedical Holdings, Ltd.Bioprosthetic valve stent
US5358518 *Jan 25, 1993Oct 25, 1994Sante CamilliArtificial venous valve
US6334873Sep 28, 1998Jan 1, 2002AutogenicsHeart valve having tissue retention with anchors and an outer sheath
US6494909 *Dec 1, 2000Dec 17, 2002Prodesco, Inc.Endovascular valve
US7244244 *Oct 9, 2002Jul 17, 2007Tyco Healthcare Group LpTrocar seal system
US7896846Nov 20, 2003Mar 1, 2011Tyco Healthcare Group LpTrocar seal system
US8002934Aug 25, 2009Aug 23, 2011Tyco Healthcare Group LpTrocar seal system
US8096966 *Jun 21, 2010Jan 17, 2012Gi Dynamics, Inc.Eversion resistant sleeves
US8192405Aug 25, 2009Jun 5, 2012Tyco Healthcare Group LpTrocar seal system
US8267898Oct 5, 2010Sep 18, 2012Tyco Healthcare Group LpTrocar seal system
US8702657Feb 23, 2012Apr 22, 2014Covidien LpTrocar seal system
DE2807467A1 *Feb 22, 1978Aug 24, 1978Robert Bernard DavisHerzklappenprothese
DE2858676C2 *Feb 22, 1978Apr 6, 1989Robert Bernard Framingham Mass. Us DavisTitle not available
EP0000949A1 *Aug 25, 1978Mar 7, 1979Philip Nicholas SawyerCardiac and vascular prostheses and methods of making the same
WO1983000617A1 *Jul 29, 1982Mar 3, 1983American Hospital Supply CorpLeaflet attachment and method of attachment for prosthetic heart valves
WO2002024241A2 *Sep 20, 2001Mar 28, 2002Regeneration Tech IncCombination biological-non-biological material prosthetic implant and method
WO2002043620A1 *Dec 3, 2001Jun 6, 2002Greenhalgh E SkottEndovascular valve
WO2003007795A2 *Jul 16, 2002Jan 30, 2003Edwards Lifesciences CorpTissue engineered heart valve
Classifications
U.S. Classification623/2.19
International ClassificationA61F2/24
Cooperative ClassificationA61F2/2412
European ClassificationA61F2/24D