CA2426075C - System for implanting a replacement valve - Google Patents

System for implanting a replacement valve Download PDF

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Publication number
CA2426075C
CA2426075C CA 2426075 CA2426075A CA2426075C CA 2426075 C CA2426075 C CA 2426075C CA 2426075 CA2426075 CA 2426075 CA 2426075 A CA2426075 A CA 2426075A CA 2426075 C CA2426075 C CA 2426075C
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CA
Canada
Prior art keywords
balloon
catheter
end portion
heart valve
distal end
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Expired - Fee Related
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CA 2426075
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French (fr)
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CA2426075A1 (en
Inventor
Allen J. Tower
Philipp Bonhoeffer
Michael L. Martin
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Numed Inc
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Numed Inc
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Publication of CA2426075C publication Critical patent/CA2426075C/en
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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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter
    • 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
    • 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
    • A61F2/2475—Venous 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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts

Abstract

A system for percutaneously inserting a prosthesis containing a biological replacement for a defective valve into an implantation site through a body lumen. The system contains a balloon catheter upon which a collapsable stent containing a venous valvular replacement is mounted. A protective shield is slidably mounted upon the catheter that is movable between a closed position over the balloon and an open position wherein the balloon can be inflated to expand the stent. A central lumen runs through the catheter that is formed of stainless steel. The central lumen provides a one to one torque ratio between the proximal end of the catheter and the distal end to enhance the steerability of the catheter. The vein of the replacement is reduced in thickness between 50% and 90% of its original size thereby considerably reducing the size of the replacement package when the stern is collapsed upon the balloon of the catheter.

Description

SYSTEM FOR IMPLANTING A REPLACEMENT VALVE
Field of the Invention This invention relates to a system for the percutaneous implantation of a biological venous valvular replacement for a human valve.

Background of the Invention There exists a need in the medical field for an improved system for carrying out the percutaneous implantation of biological venous valvular replacements for human valves and in particular cardiac valves. Up until recently, many valves such as heart valves had to be replaced surgically. Accordingly, the patients were exposed to all the potential dangers of major surgery.

Recently, procedures have been devised for implanting biological valves harvested from animals percutaneously into humans to replace damaged or malfunctioning valves. Andersen et al. in U.S. Patent No. 5,840,081 describes a system for carrying out such a procedure. In Andersen et al., a biological cardiac valve is mounted upon the expandable stent of a catheter. The assembly is crimped onto the balloon section of the catheter and a protective cap is placed over the package. The catheter is then passed through a body lumen into a predetermined site within the heart. The package is then moved out of the cap and is positioned in the implantation site using well known positioning techniques. The balloon is inflated causing the stent with the replacement valve attached thereto to expand thus implanting the valve within the desire site.

The Andersen et al. type system works well in practice in that it can be carried out in a relatively short period of time when compared to surgical procedures and the risk to the patient is considerably reduced. However, the biological prosthesis that include the venous valvular replacement and the stent tends to be relatively bulky and thick even when tightly compressed against the deflated balloon and thus sometimes difficult to move through the body lumen into the implantation site. Most catheters in present day use can not deliver the necessary torque to guide the prosthesis through the body lumen, particularly where there is a relatively tight bend in the path of travel. In addition, most of the catheters that are equipped with
-2-protective caps do not possess the rigidity needed to hold the prosthesis in the desired location as the balloon is cleared for inflation.

Summary of the Invention It is therefore an object of the present invention to improve percutaneous deliver systems for placing a biological venous valvular replacement for a defective valve within an implantation site.

A further object of the present invention is to improve the steerability of a balloon catheter used to implant a biological valve percutaneously in a patient.
A still further object of the present invention is to more accurately place a biological valve prosthesis with a desired implantation site.

Another object of the present invention is to provide a more compact system for percutaneously inserting a biological replacement valve into an implantation site.
These and other objects of the present invention are attained by a system for percutaneously inserting a biological venous valvular replacement for a defective valve within a patient through a body lumen. The system includes a balloon catheter upon which a collapsable stent containing a venous valvular replacement is mounted in a collapsed condition upon the deflated balloon. A protective shield is placed over the balloon and the replacement valve unit. The shield is movable from a closed position over the balloon to a fully opened position without having to axially displace the balloon so that the balloon can be inflated to expand the stent and accurately implant the replacement valve. A central lumen formed of a stainless steel tube passes through the catheter to provide a one to one torque ratio between the proximal end of the catheter and its distal end. The wall thickness of the venous valvular replacement is reduced from its original size by between 50% and 90%
to provide for a more compact replacement package when the package is collapsed upon the uninflated balloon.
-3 Brief Description of the Drawing For a better understanding of these and other objects of the invention, reference will be made to the following detailed description of the invention which is to be read in association with the accompanying drawing, wherein:
FIG. 1 is a perspective view illustrating a delivery system embodying the teachings of the present invention for the percutaneous insertion and implantation of a biological replacement valve within a patient;

FIG 2. is a partial perspective view illustrating the distal end of the system shown in Fig. 1 with its protective shield moved back away from the balloon section of the system;

FIG. 3 is an enlarged side elevation of an expanded stent used in the practice of the present invention;

FIG. 4 is a perspective view of the stent with a biological replacement valve unit mounted inside the stent;

FIG. 5 is an enlarged section taken along lines 4-4 in Fig. 2; and FIG. 6 is a side elevation illustrating a biological replacement valve suitable for use in the present invention as the wall thickness of the vein which supports the valve is being reduced.

Detailed Description of the Invention Fig. 1 and 2 illustrate a system, generally referenced 10, for percutaneous insertion and implantation of a biological venous valvular replacement for a defective or malfunctioning valve. The system includes an elongated balloon catheter 12 having an inflatable balloon 13 joined to the distal end of the catheter.

The balloon is connected in fluid flow communication with a lumen 15 through which the balloon is inflated or deflated in a manner well known in the art.
Preferably the balloon is inflated using a radio-opaque fluid. Although a single balloon is shown in the present embodiment of the invention, it should be obvious to one skilled in the art that a plurality of balloons in various configurations may be employed in the practice of the present invention.
-4-The catheter further includes a centrally located lumen 17 that passes through the entire length of the catheter from its proximal end to its distal end. The central lumen, unlike other catheter lumens employed in the prior art, is formed from a length of stainless steel tubing. A pointed nose cone 20 is affixed to the distal end of the tubing and the rear section 21 of the nose cone is secured to the front part of the balloon. The distal end of the central lumen 17 opens to the surrounding ambient at one end through the front of the nose cone and at the other end through the rear section of the catheter as illustrated in Fig. 1.

A thin guide wire 24 passes through the central lumen which is used in a conventional manner to guide the catheter into the implantation site.

It has been found that when a stent containing a biological valve is mounted upon the balloon of a catheter, the package tends to become overly large and clumsy to maneuver. Accordingly, maneuvering of the catheter through a vein or artery to the implantation site becomes difficult, particularly where the catheter has to be conducted through a number of bends along the intended path of travel.
Conventional catheters and the lumens running there-through are fabricated from plastic materials that tend to twist when a torque is applied to the proximal or steering end of the device. This twisting adversely effects the steering control at the distal end of the catheter making it difficult to direct the catheter around any bends in the intended path of travel and accurately place the replacement package in the implantation region. The stainless steel tube running down the center of the present catheter is designed to provide the catheter with a 1 to 1 torque ratio between the proximal end of the catheter and its distal end. This in turn, enhances the steerability of the catheter as well as providing the user with the ability to more easily push the catheter along the desired path of travel. It has been found that a stainless steel tube having an inside diameter of about 0.039" will provide the above noted desired properties while at the same time providing the catheter with sufficient flexibility to pass readily through bent regions along the path of travel. This, along with the contoured nose cone, enables the user to rapidly guide the catheter into a desired
-5-implantation site and thus considerably shorten the implantation procedure when compared to similar systems used in the art.
An elongated sheath 30 is placed over the catheter. A close running fit is provided between the sheath and the catheter so that the sheath can slide easily over the body of the catheter. A protective shield 31 is attached to the distal end of the sheath so that the shield can be repositioned by simply moving the sheath over the catheter. In assembly, the shield is movable between a fully closed position as illustrated in Fig. 1 wherein the balloon and the replacement package are protectively enclosed and a fully opened position as illustrated in Fig. 2 wherein the balloon is cleared for inflation. An annular stop 33 is mounted on the catheter adjacent to the back edge of the balloon section. The stop is arranged to arrest the forward motion of the sheath once the shield reaches a fully closed position insuring that the shield will not ride over the nose cone.

The proximal end of the sheath contains a cylindrical flange 34 by which aids the operator to manually slide the sheath over the catheter body to open or close the protective shield. The distal end 35 of the catheter passes out of the sheath through the flange and extend back a distance that is greater than the axial length of the shield. Indicator marks 36 and 37 are placed on the extended length of the catheter for informing the operator when the shield is located in either the open or the closed position.

A cylindrical fluid barrier 40 is slidably mounted upon the proximal end of the sheath. The barrier includes a tubular body section 41 and a radially extended end flange 42. The outside diameter of the body section is about equal to that of the protective shield. In practice, once the balloon shield has passed into the body lumen through the physician's incision, the body of the fluid barrier is passed into the body lumen through the incision and the flange is placed in contact against the incision opening. Once inserted, the barrier restricts the flow of body fluid through the incision opening while, at the same time, allowing the sheath and the catheter to be advanced and maneuvered within the body lumen into the implantation site.
-6-As will be further explained below, the prosthetic device made up of an expandable stent and a biological venous valvular replacement is mounted in a collapsed state upon the balloon section of the catheter. The replacement is preferably has been harvested from the jugular vein of an animal, such as a cow, and is secured to the inside of the stem. Initially, the sheath is pulled back along the catheter to expose the collapsed balloon and the prosthetic device is passed over the balloon and crimped tightly onto the balloon to establish a compact low profile package. The sheath is then moved forward along the catheter to place the shield over the package to protect it during insertion. Once the package is positioned within the insertion site the shield again is moved back over the stationary body of the catheter as explained above and the balloon is inflated to implant the biological replacement within the site.
Turning more specifically to Figs. 2-5, there is illustrated a stent 50 that is particularly well suited for use in the present system. A biological venous valvular replacement 51 for a defective valve is carried inside of the stent. Although the present valve replacement is ideally suited for percutaneous implantation of a pulmonary valve, it should clear that the present system can be used in a number of similar applications without departing from the teachings of the invention: As illustrated in Fig. 3, the biological replacement unit 51 includes a section of vein 55 that contain a valve 56. As will be explained below in further detail the venous valvular replacement is attached to the stent by means of sutures 58.
The present expandable stent includes a series of fine wire ribbon sections, each designated 60 that are joined together to create a tubular or cylindrical member.
The wire stand 59 of each section is fabricated of a soft, highly malleable metal alloy that has been fully annealed to remove as much of its spring memory as possible.
Preferably the wire material is fabricated of an alloy consisting of about 90%
platinum and 10% iridium that has a tensile strength of between 150,000 psi and 175,000 psi. Although a platinum iridium wire is preferred for use in the present stent, other alloys having similar properties such as a gold nickle alloy may also be employed. Prior to winding the wire ribbon sections into a cylindrical shape, each
-7-section is formed so that it contains a series of alternating sinusoidal bends 61. The sections are formed by winding the strand of wire between rows of vertical pins projecting from the surface of a flat substrate. The strand is then wound about the pins in alternate rows to create a sinusoidal shaped ribbon section having a desired number of bends and a free length of wire is located at each end of the ribbon section.

Each ribbon section is next wound into a cylinder and the cylinders are then placed in axial alignment so that the apex of each bend section is located in close proximity with the apex of a bend section on an adjacent ribbon section.
The adjacent bends are then welded together to cojoin the ribbon section in assembly.

Although not shown, the free ends of the adjacent cylindrical ribbon sections, in turn, are bent into parallel overlapping alignment and are cojoined using similar welds.
Referring to Fig. 5, there is illustrated a typical weld joint 64 used in the practice of the present invention. Each weld is formed so that it lies inside the boundaries of the cylindrical stent as described by the inside diameter and outside diameter of the stent. Accordingly, the welds do not protrude beyond the boundaries of the wire cylinder into regions where rough edges of the welds might come in contact with the tissue of the biological valve replacement thereby preventing the tissue from becoming damaged during insertion and implantation.

A stent of the construction and configuration as herein describe has extremely good flexibility, dimensional stability, very smooth surfaces, a low profile when collapsed and an immunity to fatigue and corrosion. As should be evident the length of the stent can be varied by varying the number of ribbon sections that are utilized.
By the same token, the working range of the stent between its fully collapsed condition and it fully expanded condition can also be varied by varying the number of bends in each of the ribbon sections. As can be seen each stent can be tailored for insertion into a particular body site to provide for the most effective implantation of the biological valve which is attached to the stent.

Because of the stent construction there is very little or no axial deformation of the stent as it is radially expanded or collapsed. Another feature of the present
-8-stent is its ability to be reconfigured even after implantation without adversely effecting the stents performance. This feature is important in cases where a valve has been implanted in a growing child. Rather than replacing a valve periodically during the growth period, the supporting stent can be simply reconfigured to accommodate for growth using a percutaneously introduced balloon catheter for re-engaging the stent to reconfigure the stent so that it will conform to the changes in the implantation site produced by growth.

As illustrated in Fig. 4, the stent is initially expanded to a desired diameter which generally conforms to the body vessel configuration at the implantation site.
Next, as illustrated in Fig. 6, the vein section of the valve is trimmed to a desired length conforming to the length of the stent with the valve 56 being located in about the mid-region of the stent. In addition, the wall of the vein 56 is reduced in thickness to between 50% to 90% of its original thickness to considerably reduce the size of the valve package when the stent is collapsed over the balloon prior to insertion. It has been found that the jugular vein of a bovine animal is formed by layers of tissue that can be readily peeled back using a sharp instrument 75.
The layers can be removed without destroying the integrity of the vein structure or its ability to function in a replacement prosthesis. The wall of the vein is trimmed so that its outside diameter about matches the inside diameter of the expanded stent.

The vein is then passed into the expanded stent and the vein sutured to the stent as illustrated in Fig. 3. The sutures are arranged to support the vein in a fully opened circular configuration within the expanded stent.

Once the prosthesis has been sutured in place, it is passed over the balloon section of the catheter and the stent is collapsed tightly against the balloon to provide a more compact than normal package that can more easily be delivered through a body lumen into an implantation site when compared to similar devices employing bovine or eqvine biological valves replacements.

While the present invention has been particularly shown and described with reference to the preferred mode as illustrated in the drawing, it will be understood by
-9-one skilled in the art that various changes in detail may be effected therein without departing from the spirit and scope of the invention as defined by the claims.

Claims (43)

Claims:
1. A system for percutaneously inserting a biological valve prosthesis in an implantation site within a heart of a patient, said system comprising:

an elongated catheter having a proximal end and a distal end;

an elongated inflatable balloon mounted at the distal end of said catheter, said balloon being connected to a lumen to permit inflating and deflating of said balloon;

a biological valvular heart valve prosthesis mounted upon the catheter balloon, said valvular heart valve prosthesis including an expandable stent and a biological heart valve comprising at least one valve leaflet mounted inside said stent, and wherein said biological valvular heart valve prosthesis is crimped against the balloon with said stent and biological heart valve in a collapsed state to restrict movement of the biological valvular heart valve prosthesis relative to the balloon, the biological heart valve positioned between the stent and the balloon with the valve leaflet collapsed;

a protective shield slidably mounted upon said catheter for movement between a first closed position wherein said biological valvular prosthesis is located under the shield and wherein said shield for substantially protecting the biological valve prosthesis during implantation and a second open position wherein said shield is moved back clear of said biological valvular prosthesis and said balloon to free said balloon for inflation;

a flexible metal component located at least along a distal end portion of the catheter wherein the proximal portion of said elongated catheter includes a portion that is operatively associated with said flexible metal component to assist in manoeuvring the system through bends along an intended path of travel through a blood vessel to the implantation site; and wherein, at least the stent, the valve leaflet, the balloon and the shield contribute to a diameter of the system in the first closed position.
2. The system of claim 1 wherein said stent contains a plurality of ribbon sections each of which is fabricated from a strand of fine wire with the sections being interconnected to form a tubular member, each wire ribbon section contains a periodic series of substantially sinusoidal shaped bends along the length of said ribbon section wherein each bend contains an apex that is welded to an apex on an adjacent ribbon section, said welds being weaker than the tensile strength of the fine wire strands.
3. The system of claim 2 wherein the wire is fabricated of an alloy containing 90% platinum and 10% iridium.
4. The system of claim 3 wherein said wire has a tensile strength of between 150,000 and 175,000 psi.
5. The system of claim 4 wherein said stent is cylindrical in form when expanded and said welds are contained within a region bounded by the inside diameter and the outside diameter of the expanded stent.
6. The system of claim 1 wherein the flexible metal component is tubular and has an inside diameter.
7. The system of any one of claims 1 to 6 wherein the flexible metal component, extends at least partially through the elongated inflatable balloon.
8. The system of any one of claims 1 to 7 wherein the flexible metal component is stainless steel tubing, wherein said stainless steel tubing has an inside diameter of about 0.039".
9. The system of claim 1 that further includes a contoured nose cone mounted at the distal end of the catheter in front of the balloon.
10. The system of claim 1 that further includes an elongated sheath slidably mounted upon the catheter, said sheath having a proximal end and a distal end wherein said distal end of said sheath is connected to said shield.
11. The system of claim 10 wherein the axial length of catheter is greater than the axial length of said sheath such that an extended length of catheter having an axial length that is equal to or slightly greater than that of the shield protrudes rearwardly from the proximal end of the sheath when said shield is in the first closed position.
12. The system of claim 11, that further includes index markings on the extended length of said catheter indicating the axial position of the sheath where the shield is in either the open position or the closed position.
13. The system of claim 1, that further includes a guide wire that is slidably contained within the center lumen of said catheter.
14. A system for percutaneously implanting a heart valve prosthesis in an implantation site within a heart of a patient, said system comprising:

a heart valve assembly comprising an expandable metal stent and a valve mounted inside the stent, the valve including a biological component, the biological component being sutured to the metal stent, the heart valve assembly comprising a substantially tubular heart valve assembly with a plurality of internal valve leaflets;

an elongated catheter having a proximal end portion and a distal end portion;
a guide wire that is slidably received within said catheter;

an elongated inflatable balloon mounted at the distal end portion of said catheter, said balloon being connectable to a device for inflating and deflating said balloon, the heart valve assembly being crimped onto the balloon so to permit expansion of the heart valve assembly by expansion of the balloon, the heart valve assembly positioned between the stent and the balloon with the valve leaflets collapsed;

the catheter including a blunt nose tip located distal to the balloon;

a protective shield slidably mounted upon said catheter for movement between a first closed position wherein said biological valvular prosthesis is located under the shield and said shield covers a proximal portion of said blunt nose tip for transitioning said nose tip with said inflatable balloon and said heart valve assembly as covered by said shield and a second open position wherein said shield is moved back clear of said biological valvular prosthesis and said balloon to free said balloon for inflation;

a flexible metal component located at least along a distal end portion of the catheter wherein the proximal portion of said elongated catheter includes a portion that is operatively associated with said flexible metal component to assist in manoeuvring the system through bends along an intended path of travel through a blood vessel to the implantation site; and the heart valve assembly being movable by the system from i) a collapsed configuration in which the heart valve assembly is received on the elongate inflatable balloon in a shape capable of being transported by the catheter to an implantation site, to ii) an expanded configuration suitable for implantation at the implantation site, and wherein, at least the stent, the valve leaflet, the balloon and the shield contribute to a stiffness of a distal end portion of the system in the first closed position.
15. A system according to claim 14 wherein the flexible, metal component is tubular and has an inside diameter.
16. The system according to claim 14 or 15 wherein the flexible metal component extends at least partially through the elongated inflatable balloon.
17. The system of any one of claims 14 to 16 wherein the tubular metal component is stainless steel.
18. A system according to any one of claims 14 to 17 wherein the flexible metal component is a continuous tube.
19. A system according to any one of claims 14 to 18 wherein the flexible metal component extends from a proximal portion of the catheter to a distal portion of the catheter.
20. A system according to any one of claims 14 to 19 wherein the flexible metal component has an internal lumen.
21. A system according to any one of claims 14 to 20 wherein the torque ratio between the distal end portion and the proximal end portion of the catheter is about one to one.
22. A system according to claim 14 wherein the biological component comprises a bovine jugular vein.
23. A system according to claim 14 wherein the shield is positionable in an intermediate position between the first and second positions for operatively disconnecting the nose tip and heart valve assembly as provided on the balloon.
24. A delivery system for percutaneously implanting a heart valve assembly in an implantation site within a heart of a patient, the heart valve assembly comprising an expandable metal stent and a valve mounted inside the stent, the valve including a biological component, the biological component being sutured to the metal stent, the heart valve assembly comprising a substantially tubular heart valve assembly with a plurality of internal valve leaflets; the delivery system comprising:

an elongated catheter having a proximal end portion and a distal end portion;

a passageway that is sized and shaped to slidably receive a guide wire within at least a portion of the delivery system;

an elongated inflatable balloon associated with a distal end portion of the delivery system, said balloon being connectable to a device for inflating and deflating said balloon;

an elongate, substantially frusto-conically shaped nose cone located distal to the balloon, the nose cone having a proximal end portion and a distal end portion and at least a portion of the passageway for slidably receiving the guide wire;

the balloon being sized and shaped to afford crimping of the heart valve assembly onto the balloon so that the heart valve may be expanded by the balloon;

a flexible metal component located at least along a distal end portion of the catheter wherein the proximal portion of said elongated catheter includes a portion that is operatively associated with said flexible metal component to assist in manoeuvring the system through bends along an intended path of travel through a blood vessel to the implantation site;
and the delivery assembly capable of moving the heart valve assembly from i) a collapsed configuration in which the heart valve assembly is received on the elongate inflatable balloon in a shape capable of being transported to an implantation site with the shield covering the heart valve assembly; to ii) an expanded configuration suitable for implantation at the implantation site.
25. A system according to claim 24 wherein at least a portion of the delivery system comprises a metal tube.
26. A system according to claim 25 wherein the metal is stainless steel.
27. A system according to claim 24 further comprising a sheath having a passageway adapted to slidably receive therein, at least a portion of the catheter.
28. A system according to claim 27 further comprising a protective shield mounted upon a distal end of the sheath, the protective shield having a proximal end mounted to the sheath and a distal end portion, the distal end portion of the shield being sized and shaped to afford engagement with a proximal end portion of the nose cone.
29. A system according to claim 28 wherein the sheath and protective shield are moveable between a first closed position with the distal end portion of the shield engaged with the proximal end portion of the nose cone, and the heart valve assembly positioned between the shield and the balloon; and a second open position with the shield sufficiently distanced from the heart valve assembly to permit expansion of the heart valve assembly by expansion of the balloon;
30. A system according to claim 29 wherein a distal end portion of the catheter has indicator marks for informing the operator when the shield is located in either the first closed position or the second open position.
31. A system according to claim 24 wherein flexible metal component is tubular and has an inside diameter.
32. The system according to any one of claims 24 to 31 wherein the flexible metal component extends at least partially through the elongated inflatable balloon.
33. A system according to claim 31 wherein the tubular metal component is a continuous tube.
34. A system according to claim 31 wherein the tubular metal component extends from a proximal portion of the catheter to a distal portion of the catheter.
35. A system according to claim 31 wherein the torque ratio between the distal end portion and the proximal end portion of the catheter is about one to one.
36. A delivery system for percutaneously implanting a heart valve assembly in an implantation site within a heart of a patient, the heart valve assembly comprising an expandable metal stent and a valve mounted inside the stent, the valve including a biological component, the biological component being sutured to the metal stent, the heart valve assembly comprising a plurality of internal valve leaflets; the delivery system comprising:

an elongated catheter having a proximal end portion and a distal end portion;

a passageway within the catheter that is sized and shaped to slidably receive a guide wire within at least a portion of the delivery system;

an elongated inflatable balloon associated with a distal end portion of the delivery system, said balloon being connectable to a device for inflating and deflating said balloon;

an elongate, substantially frusto-conically shaped nose cone located distal to the balloon, the nose cone having a proximal end portion and a distal end portion and at least a portion of the passageway for slidably receiving the guide wire;

the balloon affords crimping of the heart valve assembly onto the balloon so that the heart valve may be expanded by the balloon;

the balloon being expendable to move the heart valve assembly from i) a collapsed configuration in which the heart valve assembly is received on the elongate inflatable balloon in a shape capable of being transported by the catheter to an implantation site;
to ii) an expanded configuration suitable for implantation at the implantation site; and wherein the delivery system includes a flexible, tubular metal component having an inside diameter, located at least along a distal end portion of the delivery system, wherein a proximal end portion of said delivery system includes a portion that is operatively associated with said flexible, tubular metal component so that rotation of a proximal end portion of the delivery system steers the system through bends along an intended path of travel through a blood vessel to an implantation site.
37. A delivery system according to claim 36 further including a protective shield mounted upon a distal end of a sheath, the protective shield having a proximal end mounted to the sheath and a distal end portion, the distal end portion of the shield being sized and shaped to afford engagement with a proximal end portion of the nose cone.
38. A system for percutaneously implanting a heart valve assembly in an implantation site within a heart of a patient, the system comprising:

a heart valve assembly comprising an expandable metal stent and a valve mounted inside the stent, the valve including a biological component, the biological component being sutured to the metal stent, the heart valve assembly comprising a substantially tubular heart valve assembly with a plurality of internal valve leaflets; the stent substantially surrounding substantially all of the valve assembly; and a delivery system comprising:

an elongated catheter having a proximal end portion and a distal end portion;

a passageway within the catheter that is sized and shaped to slidably receive a guide wire within at least a portion of said catheter;

an elongated inflatable balloon associated with the distal end portion of said catheter, said balloon being connectable to a device for inflating and deflating said balloon;

the catheter including an elongate, substantially frusto-conically shaped nose cone located distal to the balloon, the nose cone having a proximal end portion and a distal end portion and a passageway for affording passage of the guide wire;

a sheath having a passageway adapted to slidably receive at least a portion of the catheter therein;

a protective shield mounted upon a distal end of the sheath, the protective shield having a proximal end mounted to the sheath and a distal end portion, the distal end portion of the shield being sized and shaped to afford engagement with a proximal end portion of the nose cone;

the balloon and protective shield being sized and shaped to afford crimping of the heart valve assembly onto the balloon so that the heart valve may be placed between the balloon and the shield;

the sheath and protective shield being slidably associated with the balloon to be moveable between a first closed position with the distal end portion of the shield engaged with the proximal end portion of the nose cone, and the heart valve assembly positioned between shield and the balloon; and a second open position with the shield sufficiently spaced from the heart valve assembly to permit expansion of the heart valve assembly by expansion of the balloon;

the delivery assembly capable of moving the heart valve assembly from i) a collapsed configuration in which the heart valve assembly is received on the elongate inflatable balloon in a shape capable of being transported by the catheter to an implantation site, and with the shield covering the heart valve assembly; to ii) an expanded configuration suitable for implantation at the implantation site;

wherein, at least the stent, the valve leaflet, the balloon and the shield contribute to a diameter of the system in the first closed position; and wherein the catheter includes a flexible, tubular metal component having an inside diameter, the tubular metal component being located at least along a distal end portion of the catheter and extending at least partially through the elongated inflatable balloon, wherein a proximal end portion of said delivery system includes a portion that is operatively associated with said flexible, tubular metal component so that rotation of the proximal end portion of the delivery system steers the system through bends along an intended path of travel through a blood vessel to an implantation site.
39. A system according to claim 38 wherein the tubular metal component is a continuous tube.
40. A system according to claim 38 wherein the tubular metal component extends from a proximal portion of the catheter to a distal portion of the catheter.
41. A system according to claim 38 wherein the torque ratio between the distal end portion and the proximal end portion of the catheter is about one to one.
42. A delivery system for deploying a prosthetic valve within a human heart comprising:
a tubular sleeve;

a selectively steerable section positioned distal to the sleeve, the steerable section having a lumen with an inner diameter;

A metal steerable element fixed to a distal end portion of the steerable section for selectively controlling a curvature of the steerable section, the steerable section capable of achieving sufficient curvature to navigate around bends in the heart vasculature to access a cardiac heart valve;

an elongate balloon catheter extending through the sleeve and being longitudinally moveable relative to the sleeve;

a prosthetic valve disposed over an expandable balloon along a distal portion of the elongate balloon catheter, the prosthetic valve having an outer diameter larger than the inner diameter of the steerable section such that the prosthetic valve is prevented from moving proximally through the steerable section when the balloon is deflated and the prosthetic valve is in a radially compressed state on the deflated balloon, the prosthetic valve comprising an expandable stent portion and a valve structure;

wherein the sleeve, steerable section, balloon catheter and prosthetic valve are configured for advancement as a single unit through a patients vasculature while the prosthetic valve is positioned distal to the steerable section and wherein the balloon catheter and prosthetic valve are movable relative to the sleeve and steerable section for implanting the prosthetic valve within a native aortic valve.
43. Use of a system according to any one of claims 1 to 42 for the implantation of a heart valve prosthesis.
CA 2426075 2002-04-23 2003-04-22 System for implanting a replacement valve Expired - Fee Related CA2426075C (en)

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US8858619B2 (en) 2014-10-14
CA2426075A1 (en) 2003-10-23
EP1356793A2 (en) 2003-10-29
US20060206192A1 (en) 2006-09-14
US20030199963A1 (en) 2003-10-23
US8721713B2 (en) 2014-05-13

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