WO2001012105A1 - Anneau de suture a tissu autologue utilise pour l'implantation de valvule cardiaque - Google Patents

Anneau de suture a tissu autologue utilise pour l'implantation de valvule cardiaque Download PDF

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Publication number
WO2001012105A1
WO2001012105A1 PCT/US2000/022728 US0022728W WO0112105A1 WO 2001012105 A1 WO2001012105 A1 WO 2001012105A1 US 0022728 W US0022728 W US 0022728W WO 0112105 A1 WO0112105 A1 WO 0112105A1
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WIPO (PCT)
Prior art keywords
heart valve
tissue
suture ring
valve prosthesis
prosthesis
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Application number
PCT/US2000/022728
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English (en)
Inventor
John P. Dimaccio
Original Assignee
Citron Limited
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Citron Limited filed Critical Citron Limited
Priority to AU67864/00A priority Critical patent/AU6786400A/en
Publication of WO2001012105A1 publication Critical patent/WO2001012105A1/fr

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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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue

Definitions

  • This invention relates to devices and articles of manufacture used affixing implantable mechanical and bioprosthetic devices, such as heart valves, which are used to replace natural portions of the various body organs .
  • the human heart is the primary organ that moves blood through the body. It circulates blood to and from the lungs for oxygenation, and then to all points of the rest of body and back. Blood is moved by the precisely timed contractions of the four chambers of the heart, right atrium, right ventricle, left atrium and left ventricle.
  • the very critical function of regulating the flow of blood through the various chambers of the heart is carried out by the four heart valves, pulmonary, tricuspid, aortic and mitral.
  • heart valves can begin to fail due to damage from disease or infections.
  • Faulty heart valves can also be the result of congenital conditions. Some heart valve conditions can be treated with medication. However, very often the only recourse for the patient is surgical replacement of the faulty valve.
  • a standard implantable mechanical heart valve typically has an annular valve housing or body to provide a passageway for blood. Occluders are mounted m the annular body and open or close the blood flow passageway. There can be one or more occluders. On the outside of the valve body there is usually an external, circumferential surface typically configured as a groove to facilitate attachment of a suture ring to the valve body. The function of the suture ring is to affix the mechanical valve to the heart tissue .
  • a standard bioprosthetic heart valve bears a close resemblance to the human valve it is replacing.
  • the valve leaflets of the bioprosthetic valve are usually fashioned from chemically treated animal tissue, such as the heart valves from a pig heart that have been fixed in glutaraldehyde or similar fixatives.
  • the valve mechanism of the bioprosthetic valve function in an identical fashion as the natural valves. Similar to the mechanical valve, the bioprosthetic valve has around its circular base a suture ring used for affixing the valve to heart tissue .
  • the suture ring is used to sew the heart valve to the patient's heart tissue.
  • the ring generally comprises a knit fabric tube which is rolled into a toroidal form and which is secured about the heart valve m the circumferential groove.
  • Various methods and apparatus have been proposed for securing the suture ring to the heart valve. It is known, for instance, to bind the ring into the groove with a plastic thread. It has also been proposed to form a rotatable suture on the heart valve using heat shrinkable plastic material, as disclosed in U.S. Pat. No. 3,781,969.
  • U.S. Pat. No. 3,491,376 suggest that a suture ring should be formed as a separate sub-assembly which should then be attached to the heart valve.
  • the suture ring is described as including a resilient annular member which is temporarily deformed, so as to snap onto the valve body.
  • U.S. Pat. No. 3,579,642 proposes the use of metal snap rings which must be radially expanded to place the suture ring about the valve body.
  • U.S. Patent No. 4,743,253 proposed a two-part suture ring comprising the knit fabric and an internal crescent -shaped ring which would be deformed inwardly by electromagnetic forming to clamp the heart valve while permitting relative rotation between the suture ring and the heart valve .
  • suture rings are made from synthetic materials that can and often lead to thrombus, pannus and fibrosis in the replacement valve. This condition can hinder the functioning of the replacement valve, and over time may require replacement of the replacement valve.
  • Suture rings are relatively bulky for the space where they are placed. Their bulk reduces the space available for the heart valve assembly, making it difficult if not impossible to orthotopically place the valve in its most ideal location. The additional bulk also increases the time required for the procedure. Additionally , if the patient develops a septic infection, the bacteria associated with such infections often attach to the synthetic material of the suture rings.
  • the infection is extremely difficult to eradicate. Failure to control the infection could ultimately necessitate the surgical replacement of the prosthetic valve.
  • the space taken by the suture ring forces the surgeon to work in less space and sometime resulting m the implantation of a smaller than ideal sized prosthetic valve. Any one or combination of the above-mentioned complications could result m the prosthetic heart valve recipient having to undergo a second procedure to remedy the condition.
  • a second procedure means additional risks for the recipient, and potentially substantial costs to the health care provider or insurer, including replacement of the implanted heart valve. Hence, it is of considerable benefit to the recipient, as well as, the health care provider and insurer, to minimize the need to undergo these second procedures.
  • Fig 1A is a cross-sectional view showing the tissue suture ring m combination with a mechanical heart valve prostheses in accordance with one embodiment of the current invention. The figure depicts how the tissue suture ring is affixed to the mechanical heart valve prosthesis .
  • Fig IB is a cross-sectional view showing the first step of one method for affixing the tissue suture ring to a mechanical heart valve prostheses.
  • Fig 1C is a cross-sectional view showing the second step of the method of Fig IB for affixing the tissue suture ring to a mechanical heart valve prosthesis .
  • Fig ID is a cross-sectional view showing a second method of affixing a tissue suture ring to the suture ring of a mechanical prosthetic heart valve.
  • Fig IE is a cross-sectional view showing a method of affixing a tissue suture ring to the suture ring of a bioprosthetic heart valve.
  • Fig 2 is a top view of the tissue suture ring as affixed to a mechanical heart valve prosthesis.
  • Fig 3 is a top view of the tissue suture ring as affixed to a bioprosthetic heart valve prosthesis.
  • Fig 4 is a cross-sectional perspective view showing the tissue suture ring as affixed to a bioprosthetic heart valve prosthesis .
  • Fig 5 is a cross-sectional perspective view showing the placement of the first and second excisions used obtaining the pericardial sac tissue used for making the tissue suture ring.
  • Fig 6 is a cross-sectional perspective view showing the positioning of the tissue suture ring onto a mechanical heart valve prosthesis.
  • Fig 7 is the top view of a bioprosthetic valve depicting the various parts of the valve.
  • Fig 8 is a cross-sectional perspective view showing the positioning of the tissue suture ring onto a bioprosthetic heart valve prosthesis.
  • Fig 9A is a top view showing the first and second conical cross-sections of a completed tissue suture ring.
  • Fig 9B is a cross-section view of a completed tissue suture ring.
  • Fig 9C is a cross-section perspective view of a complete tissue suture ring.
  • the present invention is directed to a tissue suture ring manufactured from autologous tissue for affixing a heart valve prosthesis to the heart tissue.
  • An embodiment of the present invention is a tissue suture ring which comprises a conical shell shaped band of tissue with a first edge conical cross section which affixes to a heart valve prosthesis, and a second edge conical cross section which affixes to a heart valve annulus .
  • the tissue is pericardial tissue.
  • the heart valve prosthesis is a mechanical heart valve prosthesis, particularly preferred is where the mechanical heart valve is single leaflet disk valve or a bileaflet disk valve.
  • Yet another preferred variation of the present embodiment is where the heart valve prosthesis is a bioprosthetic heart valve.
  • a heart valve prosthesis comprising, a base having an annular outside portion and a passage allowing the flow of blood through the base, a valve means selectively movable relative to said base to open and close the passage to control the flow of blood through the passage, and a tissue suture ring which comprises a conical shell shaped band of tissue with a first edge conical cross section which affixes to a heart valve prosthesis, and a second edge conical cross section which affixes to a heart valve annulus.
  • the tissue is pericardial tissue.
  • the heart valve prosthesis is a mechanical heart valve prosthesis, particularly preferred is where the mechanical heart valve is a single leaflet disk valve or a bileaflet disk valve. Yet another preferred variation of the present embodiment is where the heart valve prosthesis is a bioprosthetic heart valve.
  • Yet another embodiment of the present invention is an improved heart valve prosthesis including, a base having an annular outside portion and a passage allowing the flow of blood through the base, a valve means selectively movable relative to said base to open and close the passage to control the flow of blood through the passage, in combination with a tissue suture ring which comprises, a conical shell shaped band of tissue with a first edge conical cross section which affixes to a heart valve prosthesis, and a second edge conical cross section which affixes to a heart valve annulus.
  • tissue suture ring which comprises, a conical shell shaped band of tissue with a first edge conical cross section which affixes to a heart valve prosthesis, and a second edge conical cross section which affixes to a heart valve annulus.
  • the tissue is pericardial tissue.
  • the heart valve prosthesis is a mechanical heart valve prosthesis, particularly preferred is where the mechanical heart valve is a single leaflet disk valve or a bileaflet disk valve. Yet another preferred variation of the present embodiment is where the heart valve prosthesis is a bioprosthetic heart valve.
  • a further embodiment of the present invention is a method of making a tissue suture ring for use in implanting a heart valve prosthesis into a subject comprising, harvesting tissue, preferably pericardial tissue, from said subject, wherein said harvested tissue is a conical shell shaped band of tissue with a first edge conical cross section which affixes to a heart valve prosthesis, and a second edge conical cross section which affixes to a heart valve annulus.
  • tissue is pericardial tissue.
  • the heart valve prosthesis is a mechanical heart valve prosthesis, particularly preferred is where the mechanical heart valve is a single leaflet disk valve or a bileaflet disk valve.
  • the heart valve prosthesis is a bioprosthetic heart valve .
  • the term "affixed” means to physically attach, join or fasten one object to another, such as, affixing a heart valve prosthesis to the tissue suture ring, or affixing a tissue suture ring to heart tissue.
  • affixing include, but are not limited to suturing, gluing (as in the use of surgical or tissue adhesives) , clamping with a metal or polymer wire, or staples.
  • backflow refers to the direction that blood is prevented from flowing by the heart valve prosthesis.
  • immunocompatible donor means a tissue donor whose tissue is sufficiently similar to that of the recipient's, such that tissue from the donor may be implanted to the recipient without tissue rejection.
  • outflow refers to the direction that blood is permitted to flow through the replacement heart valve.
  • the term "rendered immunocompatible” means tissues that have been treated to eliminate the risk of rejection by the recipient's immune system. Treatment can be by chemical means, for example, fixation with glutaraldehyde, or by biochemical means, for example, using suitable agents antagonistic to saturate or otherwise render inert the antigenic sites on the tissue.
  • valve means refers to an assembly in prosthetic heart valves which alternatively occludes and permits the flow of blood through an annulus in one direction only.
  • typical valve means are a ball and cage assembly, a single leaflet disk valve, a bileaflet disk valve or the like.
  • the valve means are typically animal tissue valves, such as, bovine or porcine heart valves, or human tissue donor heart valves, assembly onto a prosthetic base.
  • Heart valves play a critical role in the functioning of the heart.
  • the valves permits blood to flow in one direction, moving from a first chamber to a second chamber, while preventing the blood from backflowing from the second chamber back to the first chamber.
  • the mitral valve permits blood to flow from the left atrium into the left ventricle, while preventing blood from backflowing from the left ventricle back to the left atrium, especially when the left ventricle contracts to pump the blood through the aorta to the rest of the body.
  • a prosthetic heart valve or heart valve prosthesis functions in place of a diseased or defective natural heart valve.
  • a prosthetic heart valve is made up of three primary elements, a valve means, a base with an annulus and a suture ring.
  • the valve means is an assembly which alternatively occludes and permits the flow of blood through an annulus in one direction only.
  • the base corresponds to a toroidal shape.
  • the valve means is attached to the base and blood flows through the center opening of the base, that is, the annulus of the base.
  • the suture ring which is sometimes referred to as the sewing ring, is a toroidal shaped structure, which is affixed to the outer circumference of the toroidal shaped annulus.
  • Suture rings are generally made from a synthetic fiber material, such as, Dacron, Teflon, polyester, and the such.
  • the suture ring is an element of the heart valve prosthesis that is physically affixed, most often sutured to the location m the heart where the defective natural heart valve had been removed.
  • the prosthetic heart valve is affixed over the heart valve opening or heart valve annulus that is exposed by the removal of the defective or diseased natural heart valve.
  • a bioprosthetic replacement heart valve has as a valve means, animal tissue valves, or human tissue valves. Again, regardless of the origin of the tissue valves, a bioprosthetic replacement valve will have a base with an annulus and a suture ring or the like for affixing it to a location.
  • the present invention entails the manufacture of a tissue suture ring from autologous tissue, such as pericardium, muscle fascia, intestinal submucosa, preferably pericardium, most preferably, the pericardial sac, affixing the tissue suture ring to a heart valve prosthesis, and the use of said tissue suture ring as a means of affixing a heart valve prosthesis, preferably a mechanical or bioprosthetic heart valve prosthesis to the operational location of the valve m the subject's heart.
  • autologous tissue such as pericardium, muscle fascia, intestinal submucosa, preferably pericardium, most preferably, the pericardial sac
  • the current invention can be used with any commercially available prosthetic heart valves which employs the use of a suture ring or sewing ring device for affixing the replacement valve to the heart.
  • Prosthetic heart valves vary in the design of the valve means, that is, the means which restricts the flow of blood to one direction. Indeed, it is generally the valve means that differs from model to model and manufacturer to manufacturer. All prosthetic valves, whether mechanical or bioprosthetic, have the common feature of a base with an annulus through which the blood flows, that is required to be affixed to heart tissue at a specific location. It is to this aspect of a prosthetic heart valve that the current invention is directed.
  • the current invention can be used to equal advantage with prosthetic mechanical heart valves having such valve means as, ball and cage, single leaflet disk and bileaflet disk, m particular, the St. Jude Valve Bileaflet valve, manufactured by St. Jude Medical, Inc., One Lillehei Plaza, St. Paul, MN 55117; the On-X Valve, manufactured by Medical Carbon Research Institute, LLC . 8200 Cameron Rd, St A-196, Austin, TX 78754; the Carbomedics Valve, manufactured by Sulzer Carbomedics, Inc. 1300 East Anderson Lane, Austin, TX 78752; and the Edwards Duromedics Valve, manufactured by Baxter-Edwards,
  • the current invention can be used to equal advantage with bioprosthetic valves, m particular, the Carpentier- Edwards Porcine Valve, manufactured by Baxter Healthcare Corporation, Edwards CVS Division, 17221 Red Hill Ave . , Irvine, CA 92614; the Carpentier-Edwards Pericardial Valve, manufactured by Baxter Healthcare Corporation, Edwards CVS Division, 17221 Red Hill Ave., Irvine, CA 92614; and the St. Jude Toronto Stentless Porcine Valve (SPV) , manufactured by St. Jude Medical, Minneapolis, MN.
  • the suture ring assembly which is usually part of the overall mechanical heart valve assembly is removed, and a tissue suture ring of the present invention is affixed in place of the suture ring.
  • the combined assembly is then affixed in a standard manner known to those of ordinary skill in the art to the recipient's cardiac valve annulus, thereby replacing a defective or otherwise malfunctioning heart valve.
  • the existing suture ring is not removed, instead the tissue suture ring is attached directly to the existing suture ring such that the tissue suture ring completely covers the exposed synthetic material of the pre-existing suture ring. This is particularly advantageous for the instances where the pre-existing suture ring on the replacement heart valve either cannot be removed, or cannot be removed without undue effort.
  • the pre-attached suture ring is trimmed down in size leaving just enough material for affixing the tissue suture ring.
  • the tissue suture ring is then affixed to the outer circumference of the bioprosthetic heart valve prosthesis.
  • the combined assembly is then affixed by a standard manner known to those of ordinary skill in the art to the location in the heart where the defective or otherwise malfunctioning heart valve had been removed.
  • the existing suture ring is not removed, instead the tissue suture ring is attached directly to the existing suture ring such that the tissue suture ring completely covers the exposed synthetic material of the pre-existing suture ring. This is particularly advantageous for the instances where the pre-existing suture ring on the replacement heart valve either cannot be removed, or cannot be removed without undue effort.
  • a tissue suture ring can be made from pericardium, muscle fascia, intestinal submucosa, preferably pericardium, most preferably, the pericardial sac of the patient's heart.
  • any of the aforementioned tissues obtained from an immunocompatible donor can also be used.
  • the tissue suture ring can be made from any of the aforementioned tissues or the like that are suitable obtained from another human or animal, for example, bovine or porcine, that has been rendered immunologically inert by chemical, biochemical or immunological techniques and methods known to those of ordinary skill m the art.
  • the pericardial sac is a serous membrane lining covering the outer surface of the heart .
  • the pericardial sac is not attached to the heart, rather it is a loose fitting sac around the heart. A small amount of fluid is secreted from the sac, which lubricates heart and sac contact, and prevents the sac from adhering to the heart surface .
  • the pericardial tissue is harvested as follows, referring to Fig 5, a first 360° excision 10 is made approximately from 5mm to 1.5 cm from the apical tip of the heart 11. This first excision will define the edge of the tissue suture ring 9 that will be affixed to the heart distal from the heart valve prosthesis 16, as shown m Figure 6. This first excision corresponds to the second edge conical cross section 1, as depicted in Figures 9A, 9B and 9C. The placement of the first excision relative to the apical tip is based on the desired length of the tissue suture ring desired 12, as depicted in Figure 6. The first excision is made leaving the underlining heart muscle tissue intact.
  • a second 360° excision 13 is made near the apical tip of the detached pericardial sac, such that the perimeter length of the second 360° excision approximates the perimeter length about the base of the mechanical or bioprosthetic heart valve prosthesis that is to be implanted.
  • the second 360° excision defines the edge of the tissue suture ring 14 that will be affixed to the heart valve prosthesis 16, as shown in Figure 6.
  • This second excision corresponds to said first edge conical cross section 2, as depicted m Figure 9A, 9B and 9C.
  • the completed tissue suture is a roughly conical shell shaped band of tissue.
  • references to geometric shapes such as, conical cross sections, ellipsoid, circular, trapezoidal, rectangular and the like, are only meant as approximations of the shape and appearance of the tissue suture ring.
  • tissue suture ring does not independently maintain the shape terms used to describe them because of the pliable nature of the tissue.
  • the tissue suture ring can be oriented to roughly approximate said descriptions.
  • the tissue suture ring When viewed from a top view, as depicted in Fig 9A, the tissue suture ring has two conical cross sections, a first edge conical cross section 2, that is generally circular, however, can be ellipsoid which affixes to a heart valve prosthesis with a perimeter that approximates that of the prospective heart valve prosthesis to which it will be affixed, and a second edge conical cross section 1 that is generally circular, however, can be ellipsoid, which affixes to a heart valve annulus with a parameter that is marginally larger than the heart valve annulus so that said second edge conical cross section can be affixed around the outside perimeter of a heart valve annulus.
  • the tissue suture ring when view from the cross section shows a roughly trapezoidal shape, where 1 and 2 correspond to the two sides parallel sides of a trapezoid.
  • the cross section can vary from a trapezoidal shape to a rectangular shape, for example, where the perimeter lengths of 1 and 2 are nearly equal. rectangle like shape to a trapezoidal like shape.
  • Figure 6 shows the orientation of the tissue suture ring to the mechanical valve and the direction of the flow of blood.
  • the top of the Figure 6 is the backflow side of the valve, and the bottom of the
  • Figure 6 is the outflow side of the valve, that is when implanted, the blood flows from the direction at the top of the Figure to the bottom of the Figure.
  • a mechanical heart valve prosthesis 16 is prepared for implantation by removing the suture ring, if there is one present.
  • the exposed base of the prosthesis has a surface that is typically an outwardly open annular groove 17.
  • the tissue suture ring is positioned relative to the mechanical heart valve 16.
  • the lowermost edge of the tissue suture ring 14 is positioned proximate to the backflow side of the mechanical heart valve 22, such that when the mechanical heart valve prosthesis is implanted into the heart, the bloodflow will travel from the uppermost edge of the tissue suture ring 9 towards the lowermost edge of the tissue suture ring 14.
  • the tissue suture ring is positioned adjacent to the outwardly open annular groove of the mechanical valve 17 by folding the lowermost edge of the tissue suture ring 14 inward and toward the backflow direction, such that a crease is formed 18 positioned at the outward flow side 19 of the open annular groove 17.
  • a first wire 20 is wrapped around the tissue suture ring and the annular groove proximate to the outflow side of the valve 19 affixing the tissue suture ring to the annular groove.
  • the tissue suture ring is folded back over the first wire at the crease 18, and a second wire 21 is wrapped around the outside surface of the tissue suture ring and positioned proximate to the backflow side of the annular groove 22.
  • FIG. 1A There is shown in Figure 1A the tissue suture ring affixed by the first 20 and second wires 21, whereby the tissue suture ring is affixed to the mechanical replacement heart valve.
  • the tissue suture ring may be affixed to a prosthetic heart valve where the groove 17 of the prosthetic valve is "flocked” with Dacron, or the like.
  • “Flocking” is a process where small particles of a material, in this example Dacron, are attached to the inner surface of the groove. The presence of the Dacron or a similar material in the groove 17 facilitates healing of the tissue suture ring to the replacement heart valve.
  • the original suture ring 11 is left on the heart valve prosthesis 16.
  • the outflow edge of the tissue suture ring 14 is affixed directly to the outflow side of the suture ring 17 so that the tissue suture ring covers the suture ring.
  • the tissue suture ring provides a means of permanently connecting the mechanical heart valve to an operative position m a heart m need of a replacement valve.
  • the combination of the mechanical replacement heart valve and tissue suture ring is implanted into the heart by suture, glue, staple or the like, where the combination is affixed to the backflow edge of the tissue suture ring 9 to the desired location in the recipient ' s heart.
  • a bioprosthetic heart valve prosthesis 30 is prepared by carefully trimming away portions of the suture ring 31 leaving enough of the suture ring to adequately affix the tissue suture ring to it.
  • the valve leaflets 32 and base 33 portions of the bioprosthetic heart valve prosthesis are not modified.
  • the outflow edge of the tissue suture ring 14 is positioned adjacent to the base of the bioprosthetic heart valve prosthesis 33, such that when the bioprosthetic heart valve prosthesis is implanted into its operative position, the bloodflow will travel from the backflow edge of the tissue suture ring 9 towards the outflow edge of the tissue suture ring 14.
  • the outflow edge of the tissue suture ring 14 is placed over the trimmed suture ring 31 and affixed around the circumference of the base 33. Under certain circumstances, such as, where there is adequate space, or an inability to remove the suture ring the suture ring is not trimmed and the tissue suture ring 14 is attached directly over the existing suture ring 31.
  • the outflow edge of tissue suture ring 14 is positioned so that it covers the covers the existing sewing ring to the leaflet base 33.
  • the tissue suture ring is affixed to the junction of the bioprosthetic valve at the leaflet base and base of the heart valve 33 by a continuous 360° suture 34, preferably 6-0 suture or the like, around the circumference of the base, whereby the tissue suture ring is affixed to the bioprosthetic heart valve.
  • the tissue suture ring can also be affixed to a bioprosthetic heart valve base by gluing, stapling or other like means.
  • the tissue suture ring provides a means of permanently connecting the bioprosthetic replacement heart valve m operative position m a heart m need of a replacement valve.
  • the combination of the bioprosthetic replacement heart valve and tissue suture ring is implanted into the heart by suturing, gluing, stapling or otherwise permanently affixing the backflow edge of the tissue suture ring 19 to the recipient heart .
  • Suture rings are generally made from a synthetic polymer material, such as, Teflon, Dacron, polyester, polypropylene, etc. Suture rings are usually an assembly where the solid base is covered with a flexible knit polymer cloth material. This presents a coarse surface which predisposes it to thrombus early in the post operative period. Later as the healing progresses it becomes susceptible to severe pannus and fibrosis .
  • suture rings Another difficulty with the current design of suture rings is their size. Space that otherwise would be available for the heart valve is taken by the suture ring. In the case of a smaller person, the space loss to the suture ring can result m the implantation of a replacement heart valve that is smaller than optimal or preferred for the patient.
  • tissue suture ring is made from pericardium.
  • Pericardium is much more pliable and manipulative allowing for placement of a larger valve with a smaller tissue suture ring.
  • Pericardium is not as strong as the materials used to make synthetic suture rings, however, pericardium is sufficiently strong, durable and resilient to withstand any physiological stresses it will encounter m a clinical setting.
  • the current invention provides several important advantages over the existing suture rings used for both mechanical and bioprosthetic heart valve prosthesis .
  • a tissue suture ring has the advantage of being manufactured from tissue, which is more pliable than synthetic materials. It is therefore easier to affixed the combination of the tissue suture ring and prosthetic heart valve to any of the valve locations m the heart, for example, aortic, pulmonic, mitral, and tricuspid.
  • the ease m handling due to the pliability makes the replacement heart valve procedure easier and faster to accomplish.
  • the heart valve replacement procedure is, by definition, an open heart procedure.
  • the reduction m the length of time for the procedure has the beneficial impact of reducing morbidity and mortality of the patients undergoing the procedure.
  • tissue suture ring Another advantage of the pliability of the tissue suture ring is its ability to "float" during the cardiac cycle and not be nearly as stiff and fixed as the current conventional synthetic polymer constructed suture ring designs. From a hemodynamic perspective, the floating prosthesis permits a more physiologic blood flow, and would act as a shock absorber during valve closure. The shock absorber role is instrumental m limiting damage to blood elements during left ventricular ejection, as occurs with current mitral mechanical prostheses with standard synthetic polymer constructed suture rings. In addition the "shock absorber" feature would possibly limit the stress, trauma and long-term deleterious observed in tissue valves currently available .
  • tissue suture ring's flexibility and conformity has additional advantages. These characteristics makes the tissue suture readily applicable to newer implantation techniques at orthotopic valve positions utilizing alternative to suturing, such as, tissue adhesives or staples. This is turn, makes heart valve transplantation more amenable to these new technique. Implementation of these new techniques to heart valve transplantation has the immediate virtue of shortening surgical time, a benefit to patient and health care provider alike, and also, makes the heart valve transplantation procedure avenues for newer minimally invasive and "post" type surgical techniques as they developed.
  • thrombosis is defined as an aggregate of coagulated blood containing platelets, fibrin, and entrapped cellular elements.
  • a thrombus is, by definition, adherent to the vascular endothelium or endomyocardium, which is distinguished from a simple blood clot, which reflects only the activation of the coagulation cascade and can form in vi tro or in si tu in the post mortem state.
  • Fibrosis is the formation of fibrous tissue as a reparative or reactive process, as opposed to formation of fibrous tissue as a normal constituent of an organ or tissue.
  • Pannus is the formation of a membrane of granulation tissue covering a normal surface. All three conditions are brought about by the presence of materials that are recognized by the body as not being part of the body. In extreme instances of these complications, additional surgery may be required to correct or negate the condition. Since the pericardial tissue suture ring is comprised of natural tissue, the incidence of the aforementioned complications are greatly reduced.
  • a final advantage of the pericardial valve suture ring as compared to current suture ring technology is that it will be living tissue. As such it will be much less likely to become infected. If it should become infected - treatment is much more likely to be successful when compared to a fibrotic, synthetic suture ring infection.
  • tissue suture rings constructed from tissue from the pericardial sac of the recipient
  • the techniques set forth herein shall not be limited to just this tissue.
  • Other tissues that may be used to provide the same advantages as tissue from pericardial sac, include muscle fascia and intestinal submucosa.
  • tissues that have been rendered immunologically inert or tissue from immunocompatible donors can also be used advantageously to construct tissue suture rings.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un anneau de suture tissulaire fabriqué à partir de tissu autologue, destiné à la fixation d'une prothèse de valvule cardiaque de remplacement à l'endroit où se situe la valvule du patient, la combinaison de l'anneau de suture tissulaire et de la prothèse de valvule cardiaque, des procédés de fabrication de cet anneau de suture, ainsi que des procédés d'utilisation de cet anneau de suture tissulaire.
PCT/US2000/022728 1999-08-16 2000-08-16 Anneau de suture a tissu autologue utilise pour l'implantation de valvule cardiaque WO2001012105A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU67864/00A AU6786400A (en) 1999-08-16 2000-08-16 Autologous tissue suture ring used in heart valve implantation

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US14910499P 1999-08-16 1999-08-16
US60/149,104 1999-08-16
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WO2003034950A1 (fr) * 2001-09-26 2003-05-01 Edwards Lifesciences Corporation Anneau de suture extra-plat de valvule cardiaque
WO2004105651A1 (fr) * 2003-05-28 2004-12-09 Cook Incorporated Valve prothetique a element de contact avec les vaisseaux
WO2005087140A1 (fr) * 2004-03-11 2005-09-22 Percutaneous Cardiovascular Solutions Pty Limited Prothèse de valvule cardiaque percutanée
US8366769B2 (en) 2000-06-01 2013-02-05 Edwards Lifesciences Corporation Low-profile, pivotable heart valve sewing ring
US10166014B2 (en) 2008-11-21 2019-01-01 Percutaneous Cardiovascular Solutions Pty Ltd Heart valve prosthesis and method
WO2020115188A1 (fr) 2018-12-05 2020-06-11 Xeltis Ag Anneau de suture électrofilé
US10940167B2 (en) 2012-02-10 2021-03-09 Cvdevices, Llc Methods and uses of biological tissues for various stent and other medical applications
US11406495B2 (en) 2013-02-11 2022-08-09 Cook Medical Technologies Llc Expandable support frame and medical device

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US3579642A (en) 1968-04-15 1971-05-25 Bart T Heffernan Heart valve assembly and method of implanting in the body
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WO1989000841A1 (fr) * 1987-07-27 1989-02-09 St. Jude Medical, Inc. Piece de protection pour valvules cardiaques prothetiques
EP0581233A1 (fr) * 1992-07-28 1994-02-02 Biocor Industria E Pesquisa Ltda. Bioprothèse hétéroloque de valve cardiaque mitrale ou tricuspide
WO1995016412A1 (fr) * 1993-12-17 1995-06-22 Autogenics Supports pour une valvule cardiaque en tissu autologue
WO1996040007A1 (fr) * 1992-07-28 1996-12-19 Peredo Mario O V Bioprothese mitrale complete heterologue pour remplacement valvulaire mitral ou tricuspide
WO1998029146A1 (fr) * 1996-12-31 1998-07-09 St. Jude Medical, Inc. Marquage pour dispositif prothetique

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US3491376A (en) 1965-10-06 1970-01-27 Donald P Shiley Heart valve with separate suturing ring sub-assembly
US3579642A (en) 1968-04-15 1971-05-25 Bart T Heffernan Heart valve assembly and method of implanting in the body
US3781969A (en) 1972-08-11 1974-01-01 Medical Inc Method of forming rotatable suturing member on a device
US4612011A (en) * 1983-07-22 1986-09-16 Hans Kautzky Central occluder semi-biological heart valve
US4743253A (en) 1986-03-04 1988-05-10 Magladry Ross E Suture rings for heart valves and method of securing same to heart valves
WO1989000841A1 (fr) * 1987-07-27 1989-02-09 St. Jude Medical, Inc. Piece de protection pour valvules cardiaques prothetiques
EP0581233A1 (fr) * 1992-07-28 1994-02-02 Biocor Industria E Pesquisa Ltda. Bioprothèse hétéroloque de valve cardiaque mitrale ou tricuspide
WO1996040007A1 (fr) * 1992-07-28 1996-12-19 Peredo Mario O V Bioprothese mitrale complete heterologue pour remplacement valvulaire mitral ou tricuspide
WO1995016412A1 (fr) * 1993-12-17 1995-06-22 Autogenics Supports pour une valvule cardiaque en tissu autologue
WO1998029146A1 (fr) * 1996-12-31 1998-07-09 St. Jude Medical, Inc. Marquage pour dispositif prothetique

Cited By (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9439762B2 (en) 2000-06-01 2016-09-13 Edwards Lifesciences Corporation Methods of implant of a heart valve with a convertible sewing ring
US10238486B2 (en) 2000-06-01 2019-03-26 Edwards Lifesciences Corporation Heart valve with integrated stent and sewing ring
US8366769B2 (en) 2000-06-01 2013-02-05 Edwards Lifesciences Corporation Low-profile, pivotable heart valve sewing ring
WO2003034950A1 (fr) * 2001-09-26 2003-05-01 Edwards Lifesciences Corporation Anneau de suture extra-plat de valvule cardiaque
WO2004105651A1 (fr) * 2003-05-28 2004-12-09 Cook Incorporated Valve prothetique a element de contact avec les vaisseaux
US7628804B2 (en) 2003-05-28 2009-12-08 Cook Incorporated Prosthetic valve with vessel engaging member
US8979922B2 (en) 2004-03-11 2015-03-17 Percutaneous Cardiovascular Solutions Pty Limited Percutaneous heart valve prosthesis
US11213390B2 (en) 2004-03-11 2022-01-04 Percutaneous Cardiovascular Solutions Pty Ltd Method of implanting a heart valve prosthesis
US11974918B2 (en) 2004-03-11 2024-05-07 Percutaneous Cardiovascular Solutions Pty Ltd Percutaneous heart valve prosthesis
US10213298B2 (en) 2004-03-11 2019-02-26 Percutaneous Cardiovascular Solutions Pty Ltd Percutaneous heart valve prosthesis
WO2005087140A1 (fr) * 2004-03-11 2005-09-22 Percutaneous Cardiovascular Solutions Pty Limited Prothèse de valvule cardiaque percutanée
US11744705B2 (en) 2004-03-11 2023-09-05 Percutaneous Cardiovascular Solutions Pty Ltd Method of implanting a heart valve prosthesis
US11622856B2 (en) 2004-03-11 2023-04-11 Percutaneous Cardiovascular Solutions Pty Ltd Percutaneous heart valve prosthesis
US10085835B2 (en) 2004-03-11 2018-10-02 Percutaneous Cardiovascular Solutions Pty Ltd Percutaneous heart valve prosthesis
US10993806B2 (en) 2004-03-11 2021-05-04 Percutaneous Cardiovascular Solutions Pty Ltd Percutaneous heart valve prosthesis
US10856858B2 (en) 2008-11-21 2020-12-08 Percutaneous Cardiovascular Solutions Pty Ltd Heart valve prosthesis and method
US10842476B2 (en) 2008-11-21 2020-11-24 Percutaneous Cardiovascular Solutions Pty Ltd Heart valve prosthesis and method
US10166014B2 (en) 2008-11-21 2019-01-01 Percutaneous Cardiovascular Solutions Pty Ltd Heart valve prosthesis and method
US10940167B2 (en) 2012-02-10 2021-03-09 Cvdevices, Llc Methods and uses of biological tissues for various stent and other medical applications
US11406495B2 (en) 2013-02-11 2022-08-09 Cook Medical Technologies Llc Expandable support frame and medical device
WO2020115188A1 (fr) 2018-12-05 2020-06-11 Xeltis Ag Anneau de suture électrofilé

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