CA2315718C - Stentless bioprosthetic heart valve with coronary protuberances - Google Patents
Stentless bioprosthetic heart valve with coronary protuberances Download PDFInfo
- Publication number
- CA2315718C CA2315718C CA002315718A CA2315718A CA2315718C CA 2315718 C CA2315718 C CA 2315718C CA 002315718 A CA002315718 A CA 002315718A CA 2315718 A CA2315718 A CA 2315718A CA 2315718 C CA2315718 C CA 2315718C
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- Prior art keywords
- bioprosthesis
- coronary
- aortic
- coronary artery
- segments
- Prior art date
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- Expired - Lifetime
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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
- A61F2/2412—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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0097—Visible markings, e.g. indicia
Abstract
A stentless aortic bioprosthesis having patent, non-ligated coronary artery segments extending therefrom, and methods for surgical replacement of aortic and/or non-aortic (e.g., pulmonary) heart valves with such stentless aortic bioprosthesis. The presence of the patent, non-ligated coronary segments facilitates end to end anastomosis of the patient's native coronary arteries and/or existing coronary artery bypass grafts to the coronary segments of the bioprosthesis even when such native coronary arteries (or coronary grafts) arc too short to reach the wall of the aortic segment of the bioprosthesis. The presence of such patent, non-ligated coronary segments also eliminates the need for removal of a "button" or segment of the native aorta in connection with the native coronary artery segments prior to implantation of the bioprosthesis, and is thus advantageous for patient's whose ascending aorta is diseased or otherwise compromised.
Description
WO 99l334I2 PCTNS98/26344 STENTLESS BIOPROSTHETIC HEART VALVE WITH CORONARY
PROTUBERANCES
S
FIELD OF INVENTION
The present invention pertains generally to medical devices and methods, and more particularly to a bioprosthetic heart valve device and related methods for surgical implantation of such bioprosthetic device.
BACKGROUND OF THE INVEIfTION
Heart valve replacement surgeries have been performed in human beings for many years. Most frequently, these valve replacement procedures are utilized to replace the mitral or aortic valves of patients who suffer from valvular heart disease.
In particular, surgical replacement of the aortic valve has proven to be a successful mode of treatment of patients who are diagnosed with a) obstruction (i.e., stenosis) of the aortic valve or b) leakage (i.e., regurgitation, incompetence or insufficiency) of the aortic valve. In some patients, symptoms of both obstruction and leakage are present, this being known as "mixed disease" or "combined lesions". These types of aortic valvular heart disease may be caused by a number of factors, including congenital deformations, infections, degenerative calcification, and certain rheumatological disorders.
Surgical replacement of the aortic valve is typically performed under general anesthesia, with full cardiopulmonary bypass. An incision is made in the aorta adjacent to the heart, and the leaflets of the endogenous aortic valve . 30 are removed along with any calcified surrounding tissue, thereby creating an annular opening (i.e. the "aortic annulus") at the site previously occupied by the endogenous aortic valve. Thereafter, a prosthetic aortic valve is selected and _. _ _. _.~ _ WO 99!33412 PCT/US98I26344 sutured into the aortic annulus, as a prosthetic replacement for the surgically-removed endogenous valve.
The available types of prosthetic aortic valves have heretofore included mechanical valves as well as valves formed of preserved animal tissue (i.e., "bioprosthetic" valves). Of the bioprosthetic valves, some (known as "stented"
bioprosthetic valves) incorporate a man-made stent or support frame upon which the preserved biological tissue is mounted. Others (known as "stentless"
bioprosthetic valves) do not include any man-made stent or support frame, and are formed entirely of preserved biological tissue.
Tissues for use in bioprosthetic heart valves are typically harvested from the hearts of donor animals and such tissues typically contain large amounts of connective tissue proteins (e.g., collagen and elastin). After the desired tissues have been han~ested from the donor animals, they undergo a chemical "fixing"
process wherein the connective tissue proteins within the tissue are exposed to 1 S one or more chemical cross linking agents capable of forming chemical cross linkages between amino groups present on the connective tissue protein molecules. The types of chemical cross linking agents useable for this purpose include: formaldehyde, glutaraldehyde, dialdehyde starch, hexamcthylene diisocyanate and certain polyepoxy compounds.
Examples of commercially available scented bioprosthetic valves include the Carpentier-Edwards0, PERIMOLTh'TT"' Pericardial Bioprosthesis (Baxter Healthcare Corporation, Edwards CVS Division, Post Office Box 11150, Santa Ana, California 92711-1150) as well as the Carpentier-Edwards~ Porcine Bioprosthesis (Baxter Healthcare Corporation, Edwards CVS Division, Post Office Box 11150, Santa Ana, California 92711-1150).
Examples of commercially available stentless bioprosthetic valves include the Edwards PrimaTM Stentless Bioprosthesis (Baxter Edwards AG, Spierstrasse 5, CH-6848 Horw, Switzerland), the Medtronic FreestyleTM Aortic Root Bioprosthesis (Medtronic, lnc. 7000 Central Avenue NE, Minneapolis, WO 99!33412 PCTNS98/26344 Minnesota 55432-3576) and the St. Jude TorontoTM SPV Stentless Bioprosthesis (St. Jude Medical, Inc. One Lillehei Plaza, St. Paul, Minnesota 55117).
The stentless bioprosthetic valves may offer superior hemodynamic performance when compared to their stented counterparts, due to the absence of flow restrictions which can be created by the presence of a stent and/or sewing ring. Also, the stentless bioprosthetic valves may exhibit better post-implantation durability than the scented bioprosthetic valves, because they provide a more flexible structure which serves to dissipate stress during the cardiac cycle.
At least one of the previously available aortic bioprostheses (i.e., the Medtronic FreestyleTM Aortic Root Bioprosthesis referred to hereabove) has included a segment of the donor animal's ascending aorta, along with ligated remnants of the donor's coronary arteries extending outwardly therefrom.
However, because the coronary artery remnants included in this bioprosthesis have been Iigated prior to fixation, the lumens of these coronary artery segments are substantially collapsed and occluded. As a result, it is typically necessary for the surgeon to trim away a substantial portion of each coronary artery remnant, prior to anastomosis of the patient's endogenous coronary arteries thereto.
It is desirable to devise a new stentless aortic bioprosthesis which includes coronary artery remnants which have been fixed in an unli~ated.
natural configuration, such that the lumens of such coronary artery remnants remain patent, and the patient's endogenous coronary arteries may be anastomosed directly thereto.
SUMMARY OF THE INVENTION
The present invention is a stentless aortic bioprosthesis having patent coronary artery protuberances, and related methods for surgical implantation of such bioprosthesis.
PROTUBERANCES
S
FIELD OF INVENTION
The present invention pertains generally to medical devices and methods, and more particularly to a bioprosthetic heart valve device and related methods for surgical implantation of such bioprosthetic device.
BACKGROUND OF THE INVEIfTION
Heart valve replacement surgeries have been performed in human beings for many years. Most frequently, these valve replacement procedures are utilized to replace the mitral or aortic valves of patients who suffer from valvular heart disease.
In particular, surgical replacement of the aortic valve has proven to be a successful mode of treatment of patients who are diagnosed with a) obstruction (i.e., stenosis) of the aortic valve or b) leakage (i.e., regurgitation, incompetence or insufficiency) of the aortic valve. In some patients, symptoms of both obstruction and leakage are present, this being known as "mixed disease" or "combined lesions". These types of aortic valvular heart disease may be caused by a number of factors, including congenital deformations, infections, degenerative calcification, and certain rheumatological disorders.
Surgical replacement of the aortic valve is typically performed under general anesthesia, with full cardiopulmonary bypass. An incision is made in the aorta adjacent to the heart, and the leaflets of the endogenous aortic valve . 30 are removed along with any calcified surrounding tissue, thereby creating an annular opening (i.e. the "aortic annulus") at the site previously occupied by the endogenous aortic valve. Thereafter, a prosthetic aortic valve is selected and _. _ _. _.~ _ WO 99!33412 PCT/US98I26344 sutured into the aortic annulus, as a prosthetic replacement for the surgically-removed endogenous valve.
The available types of prosthetic aortic valves have heretofore included mechanical valves as well as valves formed of preserved animal tissue (i.e., "bioprosthetic" valves). Of the bioprosthetic valves, some (known as "stented"
bioprosthetic valves) incorporate a man-made stent or support frame upon which the preserved biological tissue is mounted. Others (known as "stentless"
bioprosthetic valves) do not include any man-made stent or support frame, and are formed entirely of preserved biological tissue.
Tissues for use in bioprosthetic heart valves are typically harvested from the hearts of donor animals and such tissues typically contain large amounts of connective tissue proteins (e.g., collagen and elastin). After the desired tissues have been han~ested from the donor animals, they undergo a chemical "fixing"
process wherein the connective tissue proteins within the tissue are exposed to 1 S one or more chemical cross linking agents capable of forming chemical cross linkages between amino groups present on the connective tissue protein molecules. The types of chemical cross linking agents useable for this purpose include: formaldehyde, glutaraldehyde, dialdehyde starch, hexamcthylene diisocyanate and certain polyepoxy compounds.
Examples of commercially available scented bioprosthetic valves include the Carpentier-Edwards0, PERIMOLTh'TT"' Pericardial Bioprosthesis (Baxter Healthcare Corporation, Edwards CVS Division, Post Office Box 11150, Santa Ana, California 92711-1150) as well as the Carpentier-Edwards~ Porcine Bioprosthesis (Baxter Healthcare Corporation, Edwards CVS Division, Post Office Box 11150, Santa Ana, California 92711-1150).
Examples of commercially available stentless bioprosthetic valves include the Edwards PrimaTM Stentless Bioprosthesis (Baxter Edwards AG, Spierstrasse 5, CH-6848 Horw, Switzerland), the Medtronic FreestyleTM Aortic Root Bioprosthesis (Medtronic, lnc. 7000 Central Avenue NE, Minneapolis, WO 99!33412 PCTNS98/26344 Minnesota 55432-3576) and the St. Jude TorontoTM SPV Stentless Bioprosthesis (St. Jude Medical, Inc. One Lillehei Plaza, St. Paul, Minnesota 55117).
The stentless bioprosthetic valves may offer superior hemodynamic performance when compared to their stented counterparts, due to the absence of flow restrictions which can be created by the presence of a stent and/or sewing ring. Also, the stentless bioprosthetic valves may exhibit better post-implantation durability than the scented bioprosthetic valves, because they provide a more flexible structure which serves to dissipate stress during the cardiac cycle.
At least one of the previously available aortic bioprostheses (i.e., the Medtronic FreestyleTM Aortic Root Bioprosthesis referred to hereabove) has included a segment of the donor animal's ascending aorta, along with ligated remnants of the donor's coronary arteries extending outwardly therefrom.
However, because the coronary artery remnants included in this bioprosthesis have been Iigated prior to fixation, the lumens of these coronary artery segments are substantially collapsed and occluded. As a result, it is typically necessary for the surgeon to trim away a substantial portion of each coronary artery remnant, prior to anastomosis of the patient's endogenous coronary arteries thereto.
It is desirable to devise a new stentless aortic bioprosthesis which includes coronary artery remnants which have been fixed in an unli~ated.
natural configuration, such that the lumens of such coronary artery remnants remain patent, and the patient's endogenous coronary arteries may be anastomosed directly thereto.
SUMMARY OF THE INVENTION
The present invention is a stentless aortic bioprosthesis having patent coronary artery protuberances, and related methods for surgical implantation of such bioprosthesis.
In accordance with the invention, there is provided a stentless heart valve bioprosthesis formed of tanned biological tissue, comprising:
an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough;
an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough;
5 right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens; and, 10 a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment.
15 Further in accordance with the invention, mandrel members such as short segments of plastic tubing may be inserted into the lumens of the coronary artery segments, prior to tanning of the tissue, to maintain the patency of the lumens of the coronary artery segments. Ligatures may be tied about the coronary artery segments to hold the mandrel members in place during the 20 tanning (i.e., chemical fixation) process. The mandrel members and any accompanying ligatures may then be removed after completion of the tanning process.
Still further in accordance with the invention, there is provided a method of surgical implantation of an aortic bioprosthesis of the foregoing character to 25 effect a "total root" aortic valve replacement. Such method generally comprises the steps of:
1. surgically transecting the patient's right and left coronary arteries at locations which are spaced distances away from the wall of the patient's ascending aorta;
2. surgically removing a segment of the patient's ascending aorta, along with at least the leaflets of the endogenous aortic valve;
3. anastomosing the aortic bioprosthesis to the patient's native tissues such that the aortic bioprosthesis replaces the removed segment of the 5 ascending aorta; and, 4. either, a) anastomosing the patient's native coronary arteries (or coronary artery bypass grafts) to the coronary segments of the bioprosthesis, at spaced distances from the wall of the aortic segment of the bioprosthesis or b) ligating or otherwise closing the lumens of the coronary segments and attaching the coronary patient's native coronary arteries (or coronary artery bypass grafts) at other locations as may be desirable in certain patients.
Still further in accordance with the invention, there is provided a method of surgical implantation of an aortic bioprosthesis of the foregoing character to effect replacement of a defective pulmonary valve. Such method generally I S comprises the steps of:
1. surgically removing the patient's pulmonary valve along with an adjacent segment of the pulmonary artery;
2. closing (e.g., ligating, embolizing or placing purse string sutures in) the coronary segments of the bioprosthesis to prevent leakage of blood out of the lumens of such coronary segments; and, 3. anastomosing the aortic bioprosthesis to the patient's native tissues such that the aortic bioprosthesis replaces the removed pulmonary valve and adjacent segment of pulmonary artery.
Still further in accordance with the present invention, there are provided methods of using the aortic bioprosthesis of the foregoing character to effect "mini-root or "sub-coronary" replacement of a malfunctioning aortic valve.
Such mini-root and sub-coronary aortic applications of the bioprosthesis are carried out in accordance with known techniques, by selectively cutting away distal portions) of the bioprosthesis and using the remaining portion of the i bioprosthesis to carry out a mini-root or sub-coronary aortic implantation procedure.
In accordance with an aspect of the invention, a stentless heart valve bioprosthesis comprising:
tissue harvested from a mammalian donor animal, said tissue including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough and right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens; and, a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment.
wherein the bioprosthesis has been subjected to a chemical fixation process comprising placing support members into the coronary lumens during the chemical fixation process.
In accordance with another aspect of the invention, a tanning kit for manufacturing an implantable stentless heart valve bioprosthesis comprises:
a heart valve harvested from a mammalian donor animal, said heart valve including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough, right and left coronary artery segments extending outwardly from said aortic segment, and a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment;
and support members configured to closely fit within the coronary lumens during tanning so that after tanning said coronary artery segments have open coronary lumens which extend longitudinally therethrough, and blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens.
I
6a Further aspects and elements of the present invention will become apparent to those skilled in the art, upon reading and understanding of the detailed description which follows, and viewing of the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a side perspective view of a stentless aortic bioprosthesis of the present invention having a handle-connection fixture mounted on the outflow end thereof.
Figure 2 is a bottom perspective view of bioprosthesis of Figure 1.
Figure 3a is a plan view of the inflow end bioprosthesis of the present invention.
Figure 3b is a plan view of the outflow end bioprosthesis of the present invention.
Figure 4 is a longitudinal section view of the through line 4-4 of Figure 1.
Figures Sa-Sc are step-wise illustrations of a preferred technique for performing a full-root replacement of a defective aortic valve with a stentless aortic bioprosthesis of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
A. The Preferred Aortic Bioprosthesis having Coronary Protuberances Turning now to Figures 1-4 of the drawings, there is seen a stentless aortic bioprosthesis 10 in accordance with this invention. This aortic bioprosthesis 10 is formed of a preserved segment of mammalian aorta 12 having an inflow rim or inflow end IE. an outflow rim or outflow end OE and the donor animal's aortic valve leaflets ?0 positioned thercwithin. Segments of the donor animal's right and left main coronary a~t~ries I4a, 14b extend from the aortic segment i2, and such coronary artery segments 1.4a, 14b ha~~e open, patent lumens extending therethrough.
The aortic bioprostltesis 10 of th.e present int~cntion is preferably of porcine origin. After the tissue of which the bioprosthesis is .formed has been harvested tiom the donor animal, the coronary artery sec~nents 14a, 14b are trimmed to a desired length, such as 1-6 mm and preferably as lonsz as possible {i.c., up to the first coronary bifurcation present on each main coronary artery of IO tEle donor animal). Thereafter internal or external support tnembvrs are insered or attached to the coronary se~rcnts 14a, 14b to maintain patency of the coronar~r segment lumens 15a, 15b during subsequent tanning. Examples of internal supports v~~hich .r,~ay be used to maintain su.cli pateney of the coronary segment lumens lSa,; 15b are mandrel members 1G wliich are' sized and confi?urcd to be inscrced into the lumens 15 a, 15b of the coronary artery segments 14a, 14b, as shown in figure 1. Such mandrel membexs 1G may comprise solid members of generally cylindi-ieal con~guratiun, or may comprise segments of tubular members as specifically shown in the drawings, such tubular members having bores 17 c.~ctending loneit',~dinally thcrcthrough. The presence of such bores 1 ? in the tubular mandrel members 16 can be used as passageways for pv~s or support members which are used to held or suspend the bioprosihesis 10 during the tanning , process. In irstanecs where internal tnandrel members 16 are used to maintain patency of the coronary lumens 1 Sa, 15b, ligatures 18 may be tied about the coronary ~-tery segments 14a, 14b following insertion of the .mandrel membc,~rs 16 therein, to fractionally retain the mandrel members 1G within the coronary artery segments 14a, 14b. In the preferred cmbodin~cnt shown in the drawings the mandrel members 16 arc formed of silicone tubing, but they may be formed of other materials sucli as AMENDED SHEET
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ss=L --e~ : _ _ _.. r~o ~~ti~n~ v.r:~ : ;v;on vas i polyurethane, polyester, polytetraflouroethylene (PTFE), polyethylene, stainless steel, titanium or a metal alloy.
The bioprosthesis 10 having the mandrel members 16 inserted in its coronary segments 14a, 14b is then exposed to a chemical agent (i.e., a fixative agent or tanning agent) which will form chemical cross linkages between connective tissue protein molecules present in the tissue of the bioprosthesis 10. The chemical tanning agents which are useable for this purpose, formaldehyde, dialdehyde starch, hexamethylene diisocyanate and certain polyepoxy compound(s), as well as combinations of these agents. The presently preferred embodiment, shown in the drawings, is by immersion in a solution of 0.625% HEPES buffered glutaraldehyde at pressures of less than approximately 10 mmHg, as described in detail in United States Patent No. 6,027,530.
After the tanning process is complete, the bioprosthesis 10 is removed from the tanning solution and the internal or external support members (e.g., mandrel members 16) are removed. As specifically shown in Figure 4, in applications wherein internal support members such as the mandrel members 16 have been secured by ligatures 18, such ligatures 18 will typically be removed prior to extraction of the mandrel members 16. Thereafter, if necessary, any distal portions 19 of coronary artery segments 14a, 14b of length LZ located beneath or distal to the ligatures 18 may be cut away and discarded, so as to leave remaining coronary segments 14a, 14b of length L~ and. of substantially normal anatomical configuration attached to the bioprosthesis 10. In this regard, it is desirable that such ligatures 18 be placed as distal as possible, so as to maximize the length L1 of the coronary artery segments 14a, 14b which remain after the distal coronary segments 19 have been cut away and discarded. Preferably, the length Ll of the coronary artery segments remaining after final trimming will be at least 2mm and typicall~~ in the range of. 2-6 mm, white the length L~ of the discarded distal coronary ses,~ncnts 19 is preferably less than 5 mm.
After the infernal or external support members {e.g., mandrels 16) lave been removed and the coronary artery segments 14a~, 14b have undergone final trimming (if necessary), tl~e bioprosthesis .10 is slerilizcd by a suitable technique; such as immersion in a biocompatible stccili~ation solution. The bioprosthesis is tben measured to determine its outside diameter, usually rounded off to the nearest millimeter. For commercial applications, !0 bioprostheses 10 which have outside diameters which would round oftto an odd number of millimeters (e.g., 15, 17. 19, 21, 23, 25 , 27 and 29 mm) may be rcj ccted.
After the bioprosthesis 10 has been sized, it is subjected to a second trimming step in which substantially ah of the myocardial tissue is shaved away, leaving a thin cartilage rim adjacent to the right coronary septal shelf for reinforeernent. The left and right coronary artery segments 14a, 14b arc allowed to remain. All trimming is conducted with the goal of laving an intact aortic wall segment above the protruding coronary segments 14a, 14b, such enact aortic wal l segment being of sufficient width to a) maintain proper alignment of the commissure, b) prevent distortion of thr bioprosthesis 10 during suturing, and/or c) permit replacem.eni of a supracoronary segment of the patient's ascending aorta (e.g., a "total root replacement") if so desired Finally, the inflow end l.F of the bioprosthesis 10 is trimmed on the same plane as the cusps of the valve leaflets 20, usually leaving an intact segrncnt of about 3 to 4 mm in width as measured from the hinge of the leaflet. All. of the fatty tissue in the aorta is trimmed away.
As sliown in Figures 3a and fib, the resulting aortic segment contains three valve leaflets 20, each of which is affixed to the aortic segment at a juncture. The inns edges 25 of the valve leaflets 20 meet when the leaflets 20 are in their AMENDED SHEEP
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closed positions, aS ShOwn In the drawings. Also, the leaflets ?0 corm commissures at their junctions witl: the aortic wall, and the leaflets arc joined to the aortic segment 12 along a leaflet junctures 29. The wall of the aortic segment t? adjacent junctures 29 forms thv Sinus of1'alsalva (not shown). The leaflet 20 closest to the right coronary artery sesrment 14a, is positioned somewhat asymmetricallzr with respect to.thc otf~er nwo leaflets 20.
A fabric covcrinst 2S may optioually bc; disposed about the inflow end IB
of th: bioprosthesis 10 andlor upon a portion of one side of the bioprosthcsis which corresponds to the right coronary sepcal shelf, as shown in Figure 1.
This fabric covering 28 enhatTCes the strength of the bioprvthesis 10 which is sutured to the native aortic annulus, and thus serves to deter the sutures from tearinL through the tissue of the bioprosthesis 10. This fabric covering 28 may be formed of a thin, biocetnpatible matcriaf which is strop' enough to hold sutures. For exatnpte, such fabric covering ?8 may be formed of woven polyester having a thickness of O.OJB inch" and~a weight of 72 grams per square meter. 'The Fabric used for the covering 28 is preferably cut on the diagonal to assure a snug fft around curved surfaces. The Cabric i.s than sewn to the bioprosthcsis 10 by hand, using a nonabsorbable, biocompatible thread.
Mid-cusp markings 32; such as stitches formed of thread of a color which contrasts with the body of the hioprostlaesis 10, may be forms on the fabric covering 28 along the inflow ri;n, preferably at the mid-cusp point of each leaflet 20; to aid the surgeon m aligning the bioprosthcsis 10 with the patient's natural aorta. For instance. if the cloth is white, the markings 32 may be 5tliches Of navy blue thread, and the .like. An exemplary light green marking thread is Polyester PTFfi-Coated dread cf 6.0 size, having a denim of 110-134.
Additional cornmissure markings 33 may also -ae fotmcd on the fabric covering andlor inDow enil of the bioprosthcsis 10 at the locations of the valvula-~ commissures to aid the surgeon in ali~'ting the bioprosthcsis with the patient's native anatomical structures. 'these optional commissure markings 33 AMENDED SHEET
C:t I~ : St)i~~66fi~i. 6F3 Eii~+ ~-tUT.i.SS FMS t 1 f) . i.T : ST . fiCi-L -EV
: 3c) ~:~H.~IV3:ItN. Vd3: N4A 'A7?1 may be formed in the same manner as described hereabove with respect to the mid-cusp markings 32, but will preferably of a color which is different from the mid-cusp markings 32 so as to permit the surgeon to easily distinguish between the mid-cusp markings 32 and commissure markings 33.
A valve retainer fixture 34 may be attached to the outflow end OE of the bioprosthesis, as shown, to facilitate the attachment of an elongate handle thereto. Such valve retainer fixture 34 may be of the type described in United States Patent No. 5, 336, 258 (Quintero et al.). Alternatively, in Lieu of the use of such valve retainer fixture 34, the bioprosthesis may be mounted within a cage-like holding apparatus of the type described in copending United States Patent Application Serial No. 08/723,420, entitled Bioprosthetic Heart Valve Implantation Device.
B. Methods of Implanting the Preferred Aortic Bioprost6esis Having Coronary Protuberances:
The currently used methods for surgical implantation of the bioprosthesis 10 of the present invention typically require that the patient be placed under general anesthesia and on cardiopulmonary bypass. An incision is made in the patient's chest wall (e.g., a median stemotomy) and the heart is exposed. The malfunctioning endogenous valve (typically the aortic valve but possibly another cardiac valve such as the pulmonary valve located between the right ventricle and the pulmonary artery) is then removed and the bioprosthesis 10 (or a portion thereof) is sutured into place to act as a prosthetic replacement for the previously-removed endogenous valve.
The bioprosthesis 10 shown in figures 1-4 will typically be implanted at the aortic position to replace the endogenous aortic heart valve. However, in some instances the bioprosthesis 10 may also be utilized to replace another heart valve such as a malfunctioning pulmonary valve located between the right ventricle and pulmonary artery. When used to replace a heart valve other than the aortic valve, the lumens 15a, 15b of the coronary segments 14a, 14b will typically be closed off by suitable closure means such as ligation, embolization, or placement of a purse string suture.
i. Subtotal Aortic Applications of the Bioprosthesis:
5 In the mini-root and sub-coronary techniques previously known in the art, a bioprosthesis 10 of appropriate size is selected and is either a) trimmed along marker thread 30 or at some other location selected by the surgeon to separate the aortic root portion of the bioprosthesis 10 (i.e., the base of the aortic segment 12 having the leaflets 20 disposed therein) from the remainder of its aortic segment 12 and coronary segments 14a, 14b or b) the lumens 15 of the coronary segments 14a, 14b are closed by ligation, placement of a purse string suture thereabout, embolization of other suitable means to prevent blood from subsequently leaking out of the lumens 15 of those coronary segments 14a, 14b.
ThereaRer the bioprosthesis 10 may be implanted at the aortic location to 15 replace the patient's endogenous aortic valve, without attachment of coronary arteries or other vessels or grafts to the coronary segments 14a, 14b.
ii. Total Root Aortic Applications oJthe Bioprosthesis:
In other applications, the entire bioprosthesis 10, including the entire aortic segment 12 and coronary artery segments 14a, 14b may be implanted at 20 the aortic location, in accordance with the procedure shown in Figures Sa-Sc. In this procedure, the patient's right coronary artery RCA and left coronary artery LCA are transected at locations which are spaced distances away from the wall of the patient's ascending aorta AO and a segment of the patient's ascending aorta AO is removed and the native aortic valve leaflets are surgically excised 25 and removed.
A bioprosthesis 10 of correct size is selected, and a handle (not shown) is attached to the handle connection fixture. The handle (not shown) is then used to position the bioprosthesis 10 such that its inflow end IE is in 1j Thereafter, the native right coronary artery RC:A is trimmed to length, if necessary. and a right coronary anastomosis CAR is formed between the transectcd end of the right coronary artery RCA and the distal end of the right coronary segment 14a of the bioprosthcsis 10. 'The native left coronary artery LCA is then trimmed to length, if necessary, and a Icft coronary ana..~tomosis C AL is formed between the transectcd end of the left coronary artery L,C.A
and the distal end of the loft coronary scD~nent 14b of the bioprosthcsis lU. 'The patient's coronary arterial vasculature is thereby connected to the aortic segment 12 of the bioprosthesis l0 such that a portion of the arterial blood v~~laich lU subscquc.-ntly flow is into the aortic segment 12 of the bioprosthesis 10 will tlotv into t :e right and left main coronat~~ arteries RCA, LCA to perfuse the patient's myocardium iv accordance wild normal hemodynarnics.
In paticats where coronary artery bypass graR(sj are present, one of more openings may be made in the aortic segment 12 of the bioprosthesis, and the ends of the bypass ~aft(s) may he sutured~to such openia~gs in accordance with well known Surgical technique.
Finally, the outflow end of the handle knot shown) and valve retainer fixture 34 arc disconnected and removed, artd to erd approximation with the outflow end of the bioprosthesis lU. A distal anastomosis DA is then formed ?0 therehetweerl, as shown in fgurc Sc.
Thereai~cr, the patient may be removed from cardiopulmonary bypass and the chest incision may be closed.
The invention has been described hercabove with reference to certain presently preferred embodiments only, and no- attempt has been mane to ZS exhaustively describe ill possible embodiments of the invenfiion. For cxarnplc, with respect to the method for implantation of the bioprosthcsis lU, i.t may be possible to accomplish implmta;ion oC the bioprosthesis by a minimal access (e.g. "keyhole"j technique without the need for forming Iarge incisions in the patient's chest wall, but rather by forming a plurality of small minimal access AMENDED SHED
-bT # : ~~3~vRf;FT, c8 Bi~+ ~I4~<.9S Eia I I ti . ~. I : g I . fiG-L -f:e. :
:30 N~HJN:if7W'.. Vd~ : NU:1 ' ~~J:1 (e.g. "keyhole") technique without the need for forming large incisions in the patient's chest wall, but rather by forming a plurality of small minimal access incisions-- and using a thoracoscopic technique to perform the implantation surgery. Accordingly, it is intended that the above-described preferred 5 embodiments as well as all possible other embodiments of the invention be included within the scope of the following claims.
15 Further in accordance with the invention, mandrel members such as short segments of plastic tubing may be inserted into the lumens of the coronary artery segments, prior to tanning of the tissue, to maintain the patency of the lumens of the coronary artery segments. Ligatures may be tied about the coronary artery segments to hold the mandrel members in place during the 20 tanning (i.e., chemical fixation) process. The mandrel members and any accompanying ligatures may then be removed after completion of the tanning process.
Still further in accordance with the invention, there is provided a method of surgical implantation of an aortic bioprosthesis of the foregoing character to 25 effect a "total root" aortic valve replacement. Such method generally comprises the steps of:
1. surgically transecting the patient's right and left coronary arteries at locations which are spaced distances away from the wall of the patient's ascending aorta;
2. surgically removing a segment of the patient's ascending aorta, along with at least the leaflets of the endogenous aortic valve;
3. anastomosing the aortic bioprosthesis to the patient's native tissues such that the aortic bioprosthesis replaces the removed segment of the 5 ascending aorta; and, 4. either, a) anastomosing the patient's native coronary arteries (or coronary artery bypass grafts) to the coronary segments of the bioprosthesis, at spaced distances from the wall of the aortic segment of the bioprosthesis or b) ligating or otherwise closing the lumens of the coronary segments and attaching the coronary patient's native coronary arteries (or coronary artery bypass grafts) at other locations as may be desirable in certain patients.
Still further in accordance with the invention, there is provided a method of surgical implantation of an aortic bioprosthesis of the foregoing character to effect replacement of a defective pulmonary valve. Such method generally I S comprises the steps of:
1. surgically removing the patient's pulmonary valve along with an adjacent segment of the pulmonary artery;
2. closing (e.g., ligating, embolizing or placing purse string sutures in) the coronary segments of the bioprosthesis to prevent leakage of blood out of the lumens of such coronary segments; and, 3. anastomosing the aortic bioprosthesis to the patient's native tissues such that the aortic bioprosthesis replaces the removed pulmonary valve and adjacent segment of pulmonary artery.
Still further in accordance with the present invention, there are provided methods of using the aortic bioprosthesis of the foregoing character to effect "mini-root or "sub-coronary" replacement of a malfunctioning aortic valve.
Such mini-root and sub-coronary aortic applications of the bioprosthesis are carried out in accordance with known techniques, by selectively cutting away distal portions) of the bioprosthesis and using the remaining portion of the i bioprosthesis to carry out a mini-root or sub-coronary aortic implantation procedure.
In accordance with an aspect of the invention, a stentless heart valve bioprosthesis comprising:
tissue harvested from a mammalian donor animal, said tissue including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough and right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens; and, a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment.
wherein the bioprosthesis has been subjected to a chemical fixation process comprising placing support members into the coronary lumens during the chemical fixation process.
In accordance with another aspect of the invention, a tanning kit for manufacturing an implantable stentless heart valve bioprosthesis comprises:
a heart valve harvested from a mammalian donor animal, said heart valve including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough, right and left coronary artery segments extending outwardly from said aortic segment, and a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment;
and support members configured to closely fit within the coronary lumens during tanning so that after tanning said coronary artery segments have open coronary lumens which extend longitudinally therethrough, and blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens.
I
6a Further aspects and elements of the present invention will become apparent to those skilled in the art, upon reading and understanding of the detailed description which follows, and viewing of the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1 is a side perspective view of a stentless aortic bioprosthesis of the present invention having a handle-connection fixture mounted on the outflow end thereof.
Figure 2 is a bottom perspective view of bioprosthesis of Figure 1.
Figure 3a is a plan view of the inflow end bioprosthesis of the present invention.
Figure 3b is a plan view of the outflow end bioprosthesis of the present invention.
Figure 4 is a longitudinal section view of the through line 4-4 of Figure 1.
Figures Sa-Sc are step-wise illustrations of a preferred technique for performing a full-root replacement of a defective aortic valve with a stentless aortic bioprosthesis of the present invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
A. The Preferred Aortic Bioprosthesis having Coronary Protuberances Turning now to Figures 1-4 of the drawings, there is seen a stentless aortic bioprosthesis 10 in accordance with this invention. This aortic bioprosthesis 10 is formed of a preserved segment of mammalian aorta 12 having an inflow rim or inflow end IE. an outflow rim or outflow end OE and the donor animal's aortic valve leaflets ?0 positioned thercwithin. Segments of the donor animal's right and left main coronary a~t~ries I4a, 14b extend from the aortic segment i2, and such coronary artery segments 1.4a, 14b ha~~e open, patent lumens extending therethrough.
The aortic bioprostltesis 10 of th.e present int~cntion is preferably of porcine origin. After the tissue of which the bioprosthesis is .formed has been harvested tiom the donor animal, the coronary artery sec~nents 14a, 14b are trimmed to a desired length, such as 1-6 mm and preferably as lonsz as possible {i.c., up to the first coronary bifurcation present on each main coronary artery of IO tEle donor animal). Thereafter internal or external support tnembvrs are insered or attached to the coronary se~rcnts 14a, 14b to maintain patency of the coronar~r segment lumens 15a, 15b during subsequent tanning. Examples of internal supports v~~hich .r,~ay be used to maintain su.cli pateney of the coronary segment lumens lSa,; 15b are mandrel members 1G wliich are' sized and confi?urcd to be inscrced into the lumens 15 a, 15b of the coronary artery segments 14a, 14b, as shown in figure 1. Such mandrel membexs 1G may comprise solid members of generally cylindi-ieal con~guratiun, or may comprise segments of tubular members as specifically shown in the drawings, such tubular members having bores 17 c.~ctending loneit',~dinally thcrcthrough. The presence of such bores 1 ? in the tubular mandrel members 16 can be used as passageways for pv~s or support members which are used to held or suspend the bioprosihesis 10 during the tanning , process. In irstanecs where internal tnandrel members 16 are used to maintain patency of the coronary lumens 1 Sa, 15b, ligatures 18 may be tied about the coronary ~-tery segments 14a, 14b following insertion of the .mandrel membc,~rs 16 therein, to fractionally retain the mandrel members 1G within the coronary artery segments 14a, 14b. In the preferred cmbodin~cnt shown in the drawings the mandrel members 16 arc formed of silicone tubing, but they may be formed of other materials sucli as AMENDED SHEET
i~ c n : so-~~~;sFr. cf3 Ft~+ ~ c ~m.~=~s sb i i o . _ _ _ _ . . . y-y: s I .
ss=L --e~ : _ _ _.. r~o ~~ti~n~ v.r:~ : ;v;on vas i polyurethane, polyester, polytetraflouroethylene (PTFE), polyethylene, stainless steel, titanium or a metal alloy.
The bioprosthesis 10 having the mandrel members 16 inserted in its coronary segments 14a, 14b is then exposed to a chemical agent (i.e., a fixative agent or tanning agent) which will form chemical cross linkages between connective tissue protein molecules present in the tissue of the bioprosthesis 10. The chemical tanning agents which are useable for this purpose, formaldehyde, dialdehyde starch, hexamethylene diisocyanate and certain polyepoxy compound(s), as well as combinations of these agents. The presently preferred embodiment, shown in the drawings, is by immersion in a solution of 0.625% HEPES buffered glutaraldehyde at pressures of less than approximately 10 mmHg, as described in detail in United States Patent No. 6,027,530.
After the tanning process is complete, the bioprosthesis 10 is removed from the tanning solution and the internal or external support members (e.g., mandrel members 16) are removed. As specifically shown in Figure 4, in applications wherein internal support members such as the mandrel members 16 have been secured by ligatures 18, such ligatures 18 will typically be removed prior to extraction of the mandrel members 16. Thereafter, if necessary, any distal portions 19 of coronary artery segments 14a, 14b of length LZ located beneath or distal to the ligatures 18 may be cut away and discarded, so as to leave remaining coronary segments 14a, 14b of length L~ and. of substantially normal anatomical configuration attached to the bioprosthesis 10. In this regard, it is desirable that such ligatures 18 be placed as distal as possible, so as to maximize the length L1 of the coronary artery segments 14a, 14b which remain after the distal coronary segments 19 have been cut away and discarded. Preferably, the length Ll of the coronary artery segments remaining after final trimming will be at least 2mm and typicall~~ in the range of. 2-6 mm, white the length L~ of the discarded distal coronary ses,~ncnts 19 is preferably less than 5 mm.
After the infernal or external support members {e.g., mandrels 16) lave been removed and the coronary artery segments 14a~, 14b have undergone final trimming (if necessary), tl~e bioprosthesis .10 is slerilizcd by a suitable technique; such as immersion in a biocompatible stccili~ation solution. The bioprosthesis is tben measured to determine its outside diameter, usually rounded off to the nearest millimeter. For commercial applications, !0 bioprostheses 10 which have outside diameters which would round oftto an odd number of millimeters (e.g., 15, 17. 19, 21, 23, 25 , 27 and 29 mm) may be rcj ccted.
After the bioprosthesis 10 has been sized, it is subjected to a second trimming step in which substantially ah of the myocardial tissue is shaved away, leaving a thin cartilage rim adjacent to the right coronary septal shelf for reinforeernent. The left and right coronary artery segments 14a, 14b arc allowed to remain. All trimming is conducted with the goal of laving an intact aortic wall segment above the protruding coronary segments 14a, 14b, such enact aortic wal l segment being of sufficient width to a) maintain proper alignment of the commissure, b) prevent distortion of thr bioprosthesis 10 during suturing, and/or c) permit replacem.eni of a supracoronary segment of the patient's ascending aorta (e.g., a "total root replacement") if so desired Finally, the inflow end l.F of the bioprosthesis 10 is trimmed on the same plane as the cusps of the valve leaflets 20, usually leaving an intact segrncnt of about 3 to 4 mm in width as measured from the hinge of the leaflet. All. of the fatty tissue in the aorta is trimmed away.
As sliown in Figures 3a and fib, the resulting aortic segment contains three valve leaflets 20, each of which is affixed to the aortic segment at a juncture. The inns edges 25 of the valve leaflets 20 meet when the leaflets 20 are in their AMENDED SHEEP
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closed positions, aS ShOwn In the drawings. Also, the leaflets ?0 corm commissures at their junctions witl: the aortic wall, and the leaflets arc joined to the aortic segment 12 along a leaflet junctures 29. The wall of the aortic segment t? adjacent junctures 29 forms thv Sinus of1'alsalva (not shown). The leaflet 20 closest to the right coronary artery sesrment 14a, is positioned somewhat asymmetricallzr with respect to.thc otf~er nwo leaflets 20.
A fabric covcrinst 2S may optioually bc; disposed about the inflow end IB
of th: bioprosthesis 10 andlor upon a portion of one side of the bioprosthcsis which corresponds to the right coronary sepcal shelf, as shown in Figure 1.
This fabric covering 28 enhatTCes the strength of the bioprvthesis 10 which is sutured to the native aortic annulus, and thus serves to deter the sutures from tearinL through the tissue of the bioprosthesis 10. This fabric covering 28 may be formed of a thin, biocetnpatible matcriaf which is strop' enough to hold sutures. For exatnpte, such fabric covering ?8 may be formed of woven polyester having a thickness of O.OJB inch" and~a weight of 72 grams per square meter. 'The Fabric used for the covering 28 is preferably cut on the diagonal to assure a snug fft around curved surfaces. The Cabric i.s than sewn to the bioprosthcsis 10 by hand, using a nonabsorbable, biocompatible thread.
Mid-cusp markings 32; such as stitches formed of thread of a color which contrasts with the body of the hioprostlaesis 10, may be forms on the fabric covering 28 along the inflow ri;n, preferably at the mid-cusp point of each leaflet 20; to aid the surgeon m aligning the bioprosthcsis 10 with the patient's natural aorta. For instance. if the cloth is white, the markings 32 may be 5tliches Of navy blue thread, and the .like. An exemplary light green marking thread is Polyester PTFfi-Coated dread cf 6.0 size, having a denim of 110-134.
Additional cornmissure markings 33 may also -ae fotmcd on the fabric covering andlor inDow enil of the bioprosthcsis 10 at the locations of the valvula-~ commissures to aid the surgeon in ali~'ting the bioprosthcsis with the patient's native anatomical structures. 'these optional commissure markings 33 AMENDED SHEET
C:t I~ : St)i~~66fi~i. 6F3 Eii~+ ~-tUT.i.SS FMS t 1 f) . i.T : ST . fiCi-L -EV
: 3c) ~:~H.~IV3:ItN. Vd3: N4A 'A7?1 may be formed in the same manner as described hereabove with respect to the mid-cusp markings 32, but will preferably of a color which is different from the mid-cusp markings 32 so as to permit the surgeon to easily distinguish between the mid-cusp markings 32 and commissure markings 33.
A valve retainer fixture 34 may be attached to the outflow end OE of the bioprosthesis, as shown, to facilitate the attachment of an elongate handle thereto. Such valve retainer fixture 34 may be of the type described in United States Patent No. 5, 336, 258 (Quintero et al.). Alternatively, in Lieu of the use of such valve retainer fixture 34, the bioprosthesis may be mounted within a cage-like holding apparatus of the type described in copending United States Patent Application Serial No. 08/723,420, entitled Bioprosthetic Heart Valve Implantation Device.
B. Methods of Implanting the Preferred Aortic Bioprost6esis Having Coronary Protuberances:
The currently used methods for surgical implantation of the bioprosthesis 10 of the present invention typically require that the patient be placed under general anesthesia and on cardiopulmonary bypass. An incision is made in the patient's chest wall (e.g., a median stemotomy) and the heart is exposed. The malfunctioning endogenous valve (typically the aortic valve but possibly another cardiac valve such as the pulmonary valve located between the right ventricle and the pulmonary artery) is then removed and the bioprosthesis 10 (or a portion thereof) is sutured into place to act as a prosthetic replacement for the previously-removed endogenous valve.
The bioprosthesis 10 shown in figures 1-4 will typically be implanted at the aortic position to replace the endogenous aortic heart valve. However, in some instances the bioprosthesis 10 may also be utilized to replace another heart valve such as a malfunctioning pulmonary valve located between the right ventricle and pulmonary artery. When used to replace a heart valve other than the aortic valve, the lumens 15a, 15b of the coronary segments 14a, 14b will typically be closed off by suitable closure means such as ligation, embolization, or placement of a purse string suture.
i. Subtotal Aortic Applications of the Bioprosthesis:
5 In the mini-root and sub-coronary techniques previously known in the art, a bioprosthesis 10 of appropriate size is selected and is either a) trimmed along marker thread 30 or at some other location selected by the surgeon to separate the aortic root portion of the bioprosthesis 10 (i.e., the base of the aortic segment 12 having the leaflets 20 disposed therein) from the remainder of its aortic segment 12 and coronary segments 14a, 14b or b) the lumens 15 of the coronary segments 14a, 14b are closed by ligation, placement of a purse string suture thereabout, embolization of other suitable means to prevent blood from subsequently leaking out of the lumens 15 of those coronary segments 14a, 14b.
ThereaRer the bioprosthesis 10 may be implanted at the aortic location to 15 replace the patient's endogenous aortic valve, without attachment of coronary arteries or other vessels or grafts to the coronary segments 14a, 14b.
ii. Total Root Aortic Applications oJthe Bioprosthesis:
In other applications, the entire bioprosthesis 10, including the entire aortic segment 12 and coronary artery segments 14a, 14b may be implanted at 20 the aortic location, in accordance with the procedure shown in Figures Sa-Sc. In this procedure, the patient's right coronary artery RCA and left coronary artery LCA are transected at locations which are spaced distances away from the wall of the patient's ascending aorta AO and a segment of the patient's ascending aorta AO is removed and the native aortic valve leaflets are surgically excised 25 and removed.
A bioprosthesis 10 of correct size is selected, and a handle (not shown) is attached to the handle connection fixture. The handle (not shown) is then used to position the bioprosthesis 10 such that its inflow end IE is in 1j Thereafter, the native right coronary artery RC:A is trimmed to length, if necessary. and a right coronary anastomosis CAR is formed between the transectcd end of the right coronary artery RCA and the distal end of the right coronary segment 14a of the bioprosthcsis 10. 'The native left coronary artery LCA is then trimmed to length, if necessary, and a Icft coronary ana..~tomosis C AL is formed between the transectcd end of the left coronary artery L,C.A
and the distal end of the loft coronary scD~nent 14b of the bioprosthcsis lU. 'The patient's coronary arterial vasculature is thereby connected to the aortic segment 12 of the bioprosthesis l0 such that a portion of the arterial blood v~~laich lU subscquc.-ntly flow is into the aortic segment 12 of the bioprosthesis 10 will tlotv into t :e right and left main coronat~~ arteries RCA, LCA to perfuse the patient's myocardium iv accordance wild normal hemodynarnics.
In paticats where coronary artery bypass graR(sj are present, one of more openings may be made in the aortic segment 12 of the bioprosthesis, and the ends of the bypass ~aft(s) may he sutured~to such openia~gs in accordance with well known Surgical technique.
Finally, the outflow end of the handle knot shown) and valve retainer fixture 34 arc disconnected and removed, artd to erd approximation with the outflow end of the bioprosthesis lU. A distal anastomosis DA is then formed ?0 therehetweerl, as shown in fgurc Sc.
Thereai~cr, the patient may be removed from cardiopulmonary bypass and the chest incision may be closed.
The invention has been described hercabove with reference to certain presently preferred embodiments only, and no- attempt has been mane to ZS exhaustively describe ill possible embodiments of the invenfiion. For cxarnplc, with respect to the method for implantation of the bioprosthcsis lU, i.t may be possible to accomplish implmta;ion oC the bioprosthesis by a minimal access (e.g. "keyhole"j technique without the need for forming Iarge incisions in the patient's chest wall, but rather by forming a plurality of small minimal access AMENDED SHED
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:30 N~HJN:if7W'.. Vd~ : NU:1 ' ~~J:1 (e.g. "keyhole") technique without the need for forming large incisions in the patient's chest wall, but rather by forming a plurality of small minimal access incisions-- and using a thoracoscopic technique to perform the implantation surgery. Accordingly, it is intended that the above-described preferred 5 embodiments as well as all possible other embodiments of the invention be included within the scope of the following claims.
Claims (21)
1. A stentless heart valve bioprosthesis comprising:
tissue harvested from a mammalian donor animal, said tissue including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough and right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens;
and, a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment.
wherein the bioprosthesis has been subjected to a chemical fixation process comprising placing support members into the coronary lumens during the chemical fixation process.
tissue harvested from a mammalian donor animal, said tissue including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough and right and left coronary artery segments extending outwardly from said aortic segment, said coronary artery segments having open coronary lumens which extend longitudinally therethrough, such that some of the blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens;
and, a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment.
wherein the bioprosthesis has been subjected to a chemical fixation process comprising placing support members into the coronary lumens during the chemical fixation process.
2. The bioprosthesis of Claim 1 wherein said support members comprise mandrel members which are inserted into the coronary lumens to maintain patency of said coronary lumens during said tanning process.
3. The bioprosthesis of Claim 2 wherein the mandrel members are formed of material selected from the group of materials consisting of:
silicone:
polyurethane;
polyester;
polytetrafluoroethylene;
polyethylene;
stainless steel; titanium; and, a metal alloy.
silicone:
polyurethane;
polyester;
polytetrafluoroethylene;
polyethylene;
stainless steel; titanium; and, a metal alloy.
4. The bioprosthesis of Claim 2 wherein said mandrel members have bores extending longitudinally therethrough.
5. The bioprosthesis of Claim 2 further comprising;
removable mandrel retaining apparatus for placing upon said coronary artery segments to hold said mandrel members within said coronary lumens.
removable mandrel retaining apparatus for placing upon said coronary artery segments to hold said mandrel members within said coronary lumens.
6. The bioprosthesis of Claim 5 wherein said mandrel retaining apparatus are selected from the group of mandrel retaining apparatus consisting of:
ligatures for placing about said coronary artery segments; and, clamps for placing upon said coronary artery segments.
ligatures for placing about said coronary artery segments; and, clamps for placing upon said coronary artery segments.
7. The bioprosthesis of Claim 1 wherein the coronary artery segments are of substantially normal configuration.
8. The bioprosthesis of Claim 1 wherein said coronary artery segments are at least 2 mm in length at the time of surgical implantation of the bioprosthesis.
9. The bioprosthesis of Claim 1 wherein said tissue is of porcine origin.
10. The bioprosthesis of Claim 1 wherein said tissue comprises connective tissue proteins having chemical crosslinkages.
11. The bioprosthesis of Claim 7 wherein the coronary artery segments are 2-6 mm in length.
12. The bioprosthesis of Claim 1 further comprising:
a fabric reinforcement formed on at least a portion of the bioprosthesis to enhance its strength.
a fabric reinforcement formed on at least a portion of the bioprosthesis to enhance its strength.
13. The bioprosthesis of Claim 12 wherein the reinforcement fabric is formed about the inflow end of the bioprosthesis.
14. The bioprosthesis of Claim 1 further comprising:
a valve retainer fixture attached to said bioprosthesis, said valve retainer fixture being configured to facilitate the attachment of an elongate handle thereto to facilitate holding of the bioprosthesis during surgical implantation.
a valve retainer fixture attached to said bioprosthesis, said valve retainer fixture being configured to facilitate the attachment of an elongate handle thereto to facilitate holding of the bioprosthesis during surgical implantation.
15. The bioprosthesis of Claim 1 wherein the valve leaflets disposed within the aortic segment lumen are attached at points to the interior of the aortic segment wall generally at the inflow end, the bioprosthesis further including a marker thread provided on the interior of the aortic segment wall between the points of attachment of the valve leaflets and coronary segments to facilitate trimming of said biprosthesis to separate the aortic segment with the valve leaflets from the aortic segment with the coronary segments.
16. A tanning kit for manufacturing an implantable stentless heart valve bioprosthesis comprising:
a heart valve harvested from a mammalian donor animal, said heart valve including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough, right and left coronary artery segments extending outwardly from said aortic segment, and a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment; and support members configured to closely fit within the coronary lumens during tanning so that after tanning said coronary artery segments have open coronary lumens which extend longitudinally therethrough, and blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens.
a heart valve harvested from a mammalian donor animal, said heart valve including an aortic segment having a wall, an inflow end, an outflow end, and a lumen extending therethrough, right and left coronary artery segments extending outwardly from said aortic segment, and a plurality of valve leaflets disposed within said aortic segment, said valve leaflets being alternately moveable between i) open positions whereby blood is permitted to flow in a first direction through the lumen of said aortic segment; and ii) closed positions whereby blood is prevented from backflowing in a second direction through the lumen of said aortic segment; and support members configured to closely fit within the coronary lumens during tanning so that after tanning said coronary artery segments have open coronary lumens which extend longitudinally therethrough, and blood which enters the lumen of the aortic segment may flow outwardly through said coronary lumens.
17. The kit of Claim 16 wherein said coronary artery segments are at least 2 mm in length.
18. The kit of Claim 16 wherein said support members comprise mandrel members formed of material selected from the group of materials consisting of silicone:
polyurethane; polyester; polytetrafluoroethylene; polyethylene; stainless steel;
titanium; and, a metal alloy.
polyurethane; polyester; polytetrafluoroethylene; polyethylene; stainless steel;
titanium; and, a metal alloy.
19. The kit of Claim 18 wherein said mandrel members have bores extending longitudinally therethrough.
20. The kit of Claim 18 further comprising;
mandrel retaining apparatus placed upon said coronary artery segments to hold said mandrel members within said coronary lumens, each of said mandrel retaining apparatus being removable following tanning.
mandrel retaining apparatus placed upon said coronary artery segments to hold said mandrel members within said coronary lumens, each of said mandrel retaining apparatus being removable following tanning.
21. The kit of Claim 20 wherein said mandrel retaining apparatus are selected from the group of mandrel retaining apparatus consisting of:
ligatures placed about said coronary artery segments; and, clamps placed upon said coronary artery segments.
ligatures placed about said coronary artery segments; and, clamps placed upon said coronary artery segments.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/998,318 | 1997-12-24 | ||
| US08/998,318 US6001126A (en) | 1997-12-24 | 1997-12-24 | Stentless bioprosthetic heart valve with coronary protuberances and related methods for surgical repair of defective heart valves |
| PCT/US1998/026344 WO1999033412A1 (en) | 1997-12-24 | 1998-12-11 | Stentless bioprosthetic heart valve with coronary protuberances |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2315718A1 CA2315718A1 (en) | 1999-07-08 |
| CA2315718C true CA2315718C (en) | 2004-09-14 |
Family
ID=25545049
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002315718A Expired - Lifetime CA2315718C (en) | 1997-12-24 | 1998-12-11 | Stentless bioprosthetic heart valve with coronary protuberances |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US6001126A (en) |
| EP (1) | EP1041942B1 (en) |
| JP (2) | JP3775991B2 (en) |
| AU (1) | AU728106B2 (en) |
| BR (1) | BR9814491A (en) |
| CA (1) | CA2315718C (en) |
| DE (1) | DE69834945T2 (en) |
| WO (1) | WO1999033412A1 (en) |
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-
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- 1998-12-11 CA CA002315718A patent/CA2315718C/en not_active Expired - Lifetime
- 1998-12-11 BR BR9814491-0A patent/BR9814491A/en not_active IP Right Cessation
- 1998-12-11 JP JP2000526173A patent/JP3775991B2/en not_active Expired - Lifetime
- 1998-12-11 WO PCT/US1998/026344 patent/WO1999033412A1/en active IP Right Grant
- 1998-12-11 DE DE69834945T patent/DE69834945T2/en not_active Expired - Lifetime
- 1998-12-11 EP EP98960843A patent/EP1041942B1/en not_active Expired - Lifetime
- 1998-12-11 AU AU16345/99A patent/AU728106B2/en not_active Ceased
-
1999
- 1999-12-14 US US09/461,304 patent/US6342070B1/en not_active Expired - Lifetime
-
2005
- 2005-05-20 JP JP2005147913A patent/JP2005230580A/en not_active Withdrawn
Also Published As
| Publication number | Publication date |
|---|---|
| EP1041942B1 (en) | 2006-06-14 |
| JP2005230580A (en) | 2005-09-02 |
| DE69834945T2 (en) | 2006-10-19 |
| CA2315718A1 (en) | 1999-07-08 |
| JP2001526932A (en) | 2001-12-25 |
| DE69834945D1 (en) | 2006-07-27 |
| EP1041942A1 (en) | 2000-10-11 |
| US6001126A (en) | 1999-12-14 |
| AU728106B2 (en) | 2001-01-04 |
| AU1634599A (en) | 1999-07-19 |
| WO1999033412A1 (en) | 1999-07-08 |
| US6342070B1 (en) | 2002-01-29 |
| JP3775991B2 (en) | 2006-05-17 |
| BR9814491A (en) | 2000-10-10 |
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