US20150134056A1 - Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis - Google Patents
Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis Download PDFInfo
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- US20150134056A1 US20150134056A1 US14/601,451 US201514601451A US2015134056A1 US 20150134056 A1 US20150134056 A1 US 20150134056A1 US 201514601451 A US201514601451 A US 201514601451A US 2015134056 A1 US2015134056 A1 US 2015134056A1
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- Prior art keywords
- heart valve
- valve prosthesis
- heart
- sheath
- prosthesis
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- 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
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61F2/2412—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
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
- A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0017—Angular shapes
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0017—Angular shapes
- A61F2230/0023—Angular shapes triangular
Definitions
- the present disclosure is generally directed to an artificial heart valve and, more particularly, to a catheter deliverable artificial heart valve and delivery system therefor.
- the heart is the organ responsible for keeping blood circulating through the body. This task would not be possible if it was not for the action of valves.
- Heart valves are key components that facilitate blood circulation in a single direction, and that the contraction force exerted by the heart is effectively transformed into blood flow.
- a heart valve Each time the heart contracts or relaxes, two of the four valves close and the other two open. There are two states of the heart: relaxed or contracted. Depending on the state of the heart, a heart valve has two specific functions: either to open smoothly without interfering blood flow or to close sharply to impede the flow in the opposite direction.
- the anatomy of the heart allows it to simultaneously maintain the flow of the two major blood circuits in the body: pulmonary circulation and systemic circulation, which also includes the coronary circulation.
- This simultaneous action of keeping blood flowing through both circuits requires that the heart valves work in pairs, namely, the tricuspid and the pulmonary valve work together to direct the flow toward the lungs, and the mitral and aortic valves direct the flow toward the rest of the body including the heart.
- the systemic circulation is the one that demands most of the energy of the heart because it operates under higher pressures and greater flow resistance. Consequently, the left heart is more susceptible to valve disorders. This condition makes the aortic and mitral valves primary subjects of research.
- the aortic valve representing almost 60% of the valve replacement cases, is located at the beginning of the systemic circulation and right next to the coronary ostia. Once the aortic valve closes the oxygenated blood flows into the heart through the right and left coronary arteries.
- the mitral valve located between the left atrium and the left ventricle offers a different set of conditions. Although the mitral valve is not surrounded by any arterial entrances, it is located in a zone with greater access difficulties, and its anatomical structure contains a set of “leaflet tensors” called chordae tendinae.
- prosthetic heart valves goes back to 1960 when, for the first time, a human aortic valve was replaced. Since then, the use of valvular implants has been enhanced with new materials and new designs.
- the first mechanical valves used a caged-ball mechanism to control blood flow. Pressure gradients across the occluder-ball produced its movement to close or open the flow area. Even though this design performed the function of a valve, there were several problems associated with it: The ball geometry and the closing impact of the ball against the cage ring were both causes of large downstream turbulence and hemolysis. In addition to blood damage, obstruction to myocardial contraction and thrombogenic materials were also problems.
- mechanical heart valve prostheses are made from pyrolytic carbon or other prosthetic materials that require rigorous anticoagulant therapy because the risk of coagulation is higher over the surface of the prosthesis.
- the thrombogenic aspect has drawn the attention of many biomedical institutions towards the creation and study of more biocompatible materials.
- prosthetic heart valve technology includes several designs with disks or leaflets integrated into a rigid stent.
- This rigid stent is generally surrounded by a sewing cuff which allows the surgeon to suture the interface between the cuff and the tissue.
- This procedure is highly invasive and its materials generally have a negative thrombogenic effect.
- Prosthetic heart valves with rigid stents require open heart surgery for implantation. During the implantation procedure the patient is maintained alive by a heart-lung machine while the surgeon sutures the device into the heart. Due to the highly invasive nature of this procedure, not all individuals suffering from heart valve disease are considered proper candidates.
- a heart valve prosthesis includes a collapsible stent and a one-piece multi-leaflet valve.
- the stent includes at least one length of wire having a series of turns forming a spring-like stent.
- the one-piece multi-leaflet valve is attached to the stent and includes a cylinder of polyester material secured thereto at three points.
- the stent is collapsible in a radial direction between an expanded state and a contracted state.
- the contracted state has a radial dimension smaller than a radial dimension of the expanded state.
- the stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart.
- the active state has a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart.
- the one-piece multi-leaflet valve further comprises a cylindrical cuff wrapped around an end of the collapsible stent.
- the cylindrical cuff is for preventing regurgitation during use of the valve.
- the multi-leaflet valve further comprises a polymer coating the polyester material.
- Another embodiment further includes surgical sutures connecting the one-piece multi-leaflet valve to the collapsible stent.
- the collapsible stent includes first and second lengths of wire, each of the first and second lengths of wire occupying a sinusoidal pattern.
- the first and second lengths of sinusoidal wires are disposed adjacent to each other and in opposite phase to provide structural integrity to the collapsible stent.
- the collapsible stent further includes a third length of wire occupying a pattern of alternating bows and attached to the first and second lengths of wires at a location axially offset therefrom.
- the third length of wire serves to bias the collapsible stent into the expanded state.
- the collapsible stent is constructed of a shape memory nickel titanium alloy.
- the collapsible stent occupies a generally tapered cylindrical shape at least when in the expanded state.
- the multi-leaflet valve includes a trileaflet valve.
- the system includes a handle, a flexible elongated sheath, a cavity defined by the sheath, and a tapered tip.
- the flexible elongated sheath extends from the handle.
- the cavity is defined by an end of the elongated sheath that is disposed opposite the handle.
- the cavity is adapted to contain a heart valve prosthesis during intravascular delivery of the heart valve prosthesis.
- the tapered tip is coupled to the end of the elongated sheath adjacent to the cavity.
- the tapered tip is adapted to guide the elongated sheath during intravascular delivery of the heart valve prosthesis.
- the tapered tip and the elongated sheath are separable such that the heart valve prosthesis can be released from the cavity in the elongated sheath upon proper positioning of the heart valve prosthesis.
- the elongated sheath has an inner diameter of less than or equal to 7 mm and an outer diameter of less than or equal to 8 mm.
- One embodiment further includes a string connected to the elongated sheath at a location adjacent the cavity and extending through the sheath to the handle. So configured, a user can pull the string to bend the elongated sheath to facilitate navigation of the elongated sheath during intravascular delivery of the heart valve prosthesis.
- One embodiment further includes a stop plug disposed in the elongated sheath adjacent the cavity.
- the stop plug prevents the heart valve prosthesis from traveling into the elongated sheath beyond the cavity.
- the elongated sheath is movably mounted to the handle such that movement of the sheath toward the handle separates the elongated sheath and the tapered tip.
- the device includes a handle, a pin, and a loop of material.
- the pin is rotatably mounted to the handle.
- the loop of material has a first end fixed to the handle and a second end fixed to the pin.
- the loop of material is adapted to receive a collapsible heart valve prosthesis in an expanded state.
- the pin is rotatable relative to the handle to roll the loop of material onto the pin, thereby applying a radial force to collapse the heart valve prosthesis from the expanded state to a contracted state.
- a radial dimension of the collapsible heart valve prosthesis in the contracted state is less than a radial dimension of the collapsible heart valve prosthesis in the expanded state such that the collapsible heart valve prosthesis in the contracted state can be loaded into the flexible elongated sheath of the intravascular heart valve delivery system.
- the pin includes a slot formed therein that receives the first end of the loop of material.
- FIG. 1 is a cross-sectional representation of a heart
- FIG. 2 is a cross-sectional representation of a heart including a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure
- FIGS. 3A-3C are side, top, and bottom views, respectively, of a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure
- FIG. 4 is a cross-sectional side view of a system for intravascular delivery of a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure
- FIGS. 5 and 6 are detailed views of the system for intravascular delivery of a collapsible heart valve prosthesis of the present disclosure, illustrating its use and taken from circle V, VI of FIG. 4 ;
- FIGS. 7 and 8 are side views of a device for loading the system of FIGS. 4-6 with a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure.
- FIG. 1 is a schematic cross-sectional illustration of the anatomical structure and major blood vessels of a human heart 10 .
- Deoxygenated blood is delivered to the right atrium 12 of the heart 10 by the superior and inferior vena cava 14 , 16 .
- Blood in the right atrium 12 is allowed to pass into the right ventricle 18 through the tricuspid valve 20 .
- the heart 10 delivers this blood through the pulmonary valve to the pulmonary arteries and to the lungs for a gaseous exchange of oxygen.
- the circulatory pressures carry this blood back to the heart via the pulmonary veins 26 and into the left atrium 28 .
- the aorta 36 comprises (i) an ascending aorta 38 , which arises from the left ventricle 32 of the heart 10 , (ii) an aortic arch 10 , which arches from the ascending aorta 38 and (iii) a descending aorta 42 , which descends from the aortic arch 35 towards the abdominal aorta (not shown).
- a disease commonly referred to as heart failure occurs.
- the aortic valve 34 can malfunction for several reasons.
- the aortic valve 34 may be abnormal from birth (e.g., bicuspid, calcification, congenital aortic valve disease), or it could become diseased with age (e.g., acquired aortic valve disease). In such situations, it can be desirable to replace the abnormal or diseased valve 34 .
- FIG. 2 is a schematic illustration of the heart 10 implanted with a heart valve prosthesis 100 , which is constructed in accordance with one embodiment of the present disclosure.
- the heart valve prosthesis 100 replaces the native aortic valve 34 and includes an inlet 100 a and an outlet 100 b .
- the outlet 100 b is naturally located downstream from the inlet 100 a along the flow of blood through the aorta 36 .
- the heart valve prosthesis 100 will be described in detail below. Additionally, a means for and method of delivering the heart valve prosthesis 100 using an intravascular delivery system 300 (shown in FIG. 2 ) is described below.
- a valve such as, for example, the esophagus, stomach, ureter and/or vesice, biliary ducts, the lymphatic system and in the intestines.
- the heart valve prosthesis 100 includes a stent 102 and a multi-leaflet valve 104 .
- the stent 102 is collapsible to facilitate intravascular delivery to the heart 10 , with a catheter for example, as will be described below.
- the multi-leaflet valve 104 includes a one-piece valve component, i.e., it is constructed from a single piece of material, positioned at the inlet 100 a of the prosthesis 100 . More specifically, the multi-leaflet valve 104 includes a single piece of material having a generally cylindrical valve portion 104 a and a generally cylindrical cuff portion 104 b . Because the multi-leaflet valve 104 is constructed from a single piece of material, the cuff portion 104 b rolls outward and back upon or concentric with the valve portion 104 a . As such, the valve portion 104 a is disposed inside of the stent 102 and the cuff portion 104 b is disposed outside of the stent 102 .
- the cuff portion 104 b serves to reduce or prevent regurgitation when the prosthesis is implanted in the heart 10 , as depicted in FIG. 2 .
- the multi-leaflet valve 104 is secured to the stent 102 at a plurality of locations using conventional surgical sutures, but it should be appreciated that other devices for fixing the two components together are intended to be within the scope of the disclosure.
- the valve portion 104 a of the multi-leaflet valve 104 is secured to the stent 102 at three distinct points, each of which are identified with reference numeral 103 . So secured, the valve portion 104 a includes three walls 105 defined as being located between the points 103 . Each of the walls 105 serves as one leaflet of the multi-leaflet valve 104 , thereby defining the multi-leaflet valve 104 as a trileaflet valve. In other embodiments, the multi-leaflet valve 104 can include more or less than three leaflets, as desired.
- the multi-leaflet valve 104 is constructed of a polymer-coated polyester material.
- the polyester material can include DacronTM, which is commercially available from Bard Peripheral Vascular of Tempe, Ariz., USA, and the coating can include QuatromerTM, which is commercially available from Innovia, LLC of Miami, Fla., USA.
- the stent 102 includes at least one length of wire bent and shaped such that the stent 102 has a multitude of turns forming a spring-like member that is resiliently deformable between an expanded state (shown in FIGS. 3A-3C ) and a contracted state (not shown), wherein the stent 102 is collapsed upon itself in the radial direction. That is, in the contracted state, the prosthesis 100 has a radial dimension that is smaller than a radial dimension of the prosthesis 100 in the expanded state.
- the stent 102 is biased toward the expanded state.
- the prosthesis 100 When the prosthesis 100 is positioned in the heart 10 , as depicted in FIG. 2 , it occupies an active state that can be between the contracted state and the expanded state, for example, wherein the prosthesis 100 frictionally and forcefully engages the wall of the heart 10 .
- This design therefore advantageously secures the position of the prosthesis 100 in the heart 10 without requiring any fasteners, mechanical or otherwise.
- the stent 102 of the disclosed embodiment of the prosthesis 100 is formed such that the prosthesis occupies a generally tapered cylindrical shape.
- the stent 102 includes first through third lengths of wire, which are numbered 106 , 108 , and 110 , respectively.
- Other embodiments can have less than or more than three lengths of wire.
- the first and second lengths of wire 106 , 108 of the disclosed embodiment each occupy a wave pattern and are shaped into cylinders.
- the cylinders are generally tapered cylinders and the wave patterns constitute sinusoidal waves.
- the second length of wire 108 is positioned radially inside of the first length of wire 106 and circumferentially offset therefrom.
- the first and second lengths of wire 106 , 108 are secured together at a plurality of locations with conventional surgical sutures, but other devices for securing the two components together are intended to be within the scope of the disclosure. So configured, the sinusoidal patterns of the first and second lengths of wire 106 , 108 can be described as being opposite in phase. That is, each peak 106 a of the first length of wire 106 is aligned with each trough 108 b of the second length of wire 108 , and each peak 108 a of the second length of wire 108 is aligned with each trough 106 b of the first length of wire 106 .
- FIG. 3A only identifies one peak 106 a , 108 a and one trough 106 b , 108 b on each of the first and second lengths of wire 106 , 108 with reference numerals. So configured, the first and second lengths of wire 106 , 108 provide structural rigidity and integrity to the stent 102 and therefore, to the prosthesis 100 .
- the third length of wire 110 of the stent 102 of the prosthesis 100 depicted in FIGS. 3A-3C is also generally shaped as a tapered cylinder at least in the expanded state, and is attached to either or both of the first and second lengths of wire 106 , 108 at a plurality of locations with conventional surgical sutures.
- the third length of wire 110 could be attached to the first and second lengths of wire 106 , 108 with any other foreseeable device.
- the third length of wire 110 includes a wave pattern that also includes alternating bows.
- the third length of wire 110 includes a plurality of peaks 110 a and troughs 110 b , but instead of the peaks 110 a and troughs 110 b having smooth sinusoidal transitions, each includes a bow 112 .
- the bows 112 basically constitute small loops of wire extending away from the peaks 110 a and troughs 110 b of the third length of wire 110 .
- This design of the third length of wire 110 advantageously increases the radial stiffness of the stent 102 , which increases the radial load generated by the prosthesis when it occupies the contracted and/or active states.
- the third length of wire 110 is primarily responsible for generating the radial load required for securing the prosthesis in the heart 10
- the first and second lengths of wire 106 , 108 are primarily responsible for maintaining the structural integrity of the overall prosthesis 100 .
- the first, second, and third lengths of wire 106 , 108 , 110 each comprises a continuous piece of a shape memory nickel titanium alloy such as Nitinol.
- the wires 106 , 108 , 110 may be bound at the free ends with a length of stainless steel hypo-tubing and an adhesive, for example.
- the Nitinol wires are heat treated to retain the shapes and patterns illustrated in FIGS. 3A-3C .
- the wires 106 , 108 , 100 can be constructed of generally any other biocompatible material capable of serving the purpose of the stent 102 .
- FIGS. 4-6 depict one embodiment of a system 300 for intravascular delivery of the heart valve prosthesis 100 , which includes, for example, a catheter.
- the system 300 generally comprises a handle 302 , an elongated flexible sheath 304 , and a tip 306 .
- the sheath 304 can be rather long, but for the sake of clarity, FIG. 4 illustrates the sheath 304 only at its end sections adjacent the handle 302 and the tip 306 .
- the sheath 304 is adapted to store a heart valve prosthesis 100 in a cavity 308 formed adjacent to the tip 306 .
- the sheath 304 would preferably have an inner diameter of less than or equal to 7 millimeters and an outer diameter of less than or equal to 8 millimeters to sufficiently accommodate the large payload of the heart valve prosthesis 100 , even when it is in its fully contracted state.
- the tip 306 and sheath 304 can be threaded through a blood vessel from a patient's groin, for example, to the heart 10 to deliver the prosthesis 100 in a manner that will be described below.
- the handle 302 includes a hollow grip 310 , a hollow slide rod 312 , and a hollow spool 314 .
- the grip 310 can be connected to the slide rod 312 at a threaded connection 316 .
- the spool 314 is slidably mounted on the slide rod 312 and fixed to a first end 304 a of the sheath 304 at a threaded connection 316 .
- the spool 314 has a pair of radial flanges 314 a for accommodating a user's grip, as will be described.
- the cavity 308 for receiving the heart valve prosthesis 100 is defined in a second end 304 b of the sheath 304 , which as mentioned is disposed adjacent the tip 306 .
- the tip 306 includes a tapered body portion 306 a and a plug portion 306 b .
- the plug portion 306 b is friction fit within the second end 304 b of the sheath 304 .
- the tip 306 further defines a through bore 318 and a blind bore 320 for receiving wires of the system 300 , as will be described.
- the second end 304 b of the sheath 304 includes a stop plug 322 disposed therein.
- the stop plug 322 includes a generally solid cylindrical disk-shaped member having a plurality of bores therein for receiving various wires of the system, as will be described.
- the stop plug 322 defines the internal boundary of the cavity 308 for receiving the heart valve prosthesis 100 .
- the system 300 includes a plurality of wires extending through the sheath 304 .
- the system 300 includes a guide wire 324 , a first stop wire 326 , a second stop wire 328 , and a maneuvering string 330 .
- the guide wire 324 passes through the through-bore 318 in the tip 306 , through the sheath 304 , through the handle 302 , and out of an opening 332 formed in the grip 310 of the handle 302 .
- the guide wire 324 is a conventional wire that a surgeon may first thread through the blood vessel to the heart 10 of the patient prior to threading the sheath 304 to the heart 10 .
- the guide wire 324 guides the sheath 304 along the proper path to the heart 10 .
- the first stop wire 326 can be fixed to a back wall 302 a of the handle 302 , for example, and extends through the length of the handle 302 and sheath 304 and into the blind bore 320 of the tip 306 . Accordingly, the first stop wire 326 also passes through an opening in the stop plug 322 .
- the first stop wire 326 can be fixed to the stop plug 322 and the tip 306 with an adhesive, for example, to fix the position of the tip 306 and stop plug 322 relative to each other.
- the second stop wire 328 can be fixed to the back wall 302 a of the handle 302 , for example, and extends through the length of the handle 302 and sheath 304 . Unlike the first stop wire 326 , however, the second stop wire 328 stops at the stop plug 322 . In one embodiment, the second stop wire 328 can be fixed into an opening or recess in the stop plug 322 with an adhesive, for example. In another embodiment, the second stop wire 328 may simply terminate immediately adjacent the stop plug 322 . In either case, the second stop wire 328 serves to prevent the stop plug 322 from traveling up into the sheath 304 during operation, as will be described.
- the maneuvering string 330 of the disclosed embodiment includes a first end that is fixed to a ring 333 adjacent the back wall 302 a of the handle 302 , and a second end that is fixed to the second end 304 b of the sheath 304 at a location neat the stop plug 322 , for example.
- the string 330 can include a conventional nylon string, a metallic wire, or generally any other type of material. While threading the sheath 304 into the patient's heart 10 , a surgeon, for example, may pull the ring 333 to bend the second end 304 b of the sheath 304 to help maneuver the sheath 304 through sharp turns. For example, with reference to FIGS. 1 and 2 , this manipulation of the string 330 and sheath 304 may be beneficial to turn the second end 304 b of the sheath 304 to traverse the aortic arch 35 when replacing the aortic valve 34 .
- the cavity 308 in the second end 304 b of the sheath 304 is adapted to accommodate a heart valve prosthesis 100 in a contracted state, as depicted schematically in phantom.
- the tip 306 and sheath 304 can be threaded from the patient's groin, for example, and to the heart 10 such that the tip 306 is positioned just beyond the native aortic valve 34 .
- the surgeon grasps the spool 314 (shown in FIG.
- the heart valve prosthesis 100 With the sheath 304 out of the way, the heart valve prosthesis 100 is free to expand to an active state and engage the walls of the heart 10 , as depicted in FIG. 2 .
- the first stop wire 326 maintains the position of the tip 306 relative to the stop plug 322 and the second stop wire 328 prevents the stop plug 322 from moving in the sheath 304 toward the handle 302 .
- the surgeon can reengage the sheath 304 with the plug portion 306 b of the tip 306 by pushing the spool 314 and sheath 304 away from the grip 310 of the handle 302 . Then, the surgeon can draw the entire system back through the center opening of the prosthesis 100 , out of the heart 10 , and finally out of the patient's groin.
- loading the heart valve prosthesis 100 into the cavity 308 of the sheath 304 can be accomplished by performing the above-described deployment steps in reverse. That is, with the heart valve prosthesis 100 in its expanded state, the tip 306 and second end 304 b of the sheath 304 can be passed through the center thereof and the sheath 304 can be disengaged from the plug portion 306 b of the tip 306 through manipulation of the spool 314 on the handle 302 . With the prosthesis 100 and system 300 arranged as depicted in FIG. 6 , a radial load can be applied to the circumference of the prosthesis 100 .
- This radial load contracts the prosthesis 100 into a small cylinder that is able to fit into the cavity 308 of the sheath 304 .
- the second end of the sheath 304 can then be slide over the prosthesis 100 either by manually grasping the second end 304 b of the sheath 304 or through manipulation of the spool 314 .
- the second end 304 b of the sheath 304 can be friction fit onto the plug portion 306 b of the tip 306 . This completes the loading process.
- the loading process can include the use of a device 400 for loading the heart valve prosthesis 100 , such as that depicted in FIGS. 7 and 8 .
- the device 400 includes a handle 402 , a pin 404 , and a loop of material 406 .
- the handle 402 is a generally U-shaped member defining a pair of legs 408 having through-bores 410 .
- a plurality of threaded fasteners 428 are positioned in a corresponding plurality of threaded bores 430 formed in the handle 402 .
- the pin 404 is rotatably disposed in the through-bores 410 of the handle 402 and includes a knurled knob 412 on one end and a button 414 on the other end.
- the knurled knob 412 includes a pair of pins 416 adapted to be received in a pair of corresponding bores 418 formed in the handle 402 for locking rotation of the pin 404 .
- the end of the pin 404 adjacent the button 414 accommodates a spring 420 between the button 414 and the adjacent leg 408 of the handle 402 .
- the pin 404 includes an elongated slot 422 formed in a central portion thereof and a pair of threaded fasteners 424 positioned in threaded bores 426 of the pin 404 that traverse radially to the elongated slot 422 .
- the loop of material 406 can include generally any type of material such as nylon, for example, and includes a first end 406 a and a second end 406 b .
- the first end 406 a is fixed to the handle 402 .
- the first end 406 a of the loop of material 406 includes a plurality of holes (not shown) that receive the plurality of fasteners 428 such that the fasteners 428 can be tightened against the handle 402 to fix the position of the first end 406 a of the loop of material 406 .
- the second end 406 b of the loop of material 406 is fixed to the pin 404 . More specifically, the second end 406 b of the loop of material 406 is received in the slot 422 formed in the pin 404 and the fasteners 424 are tightened to clamp the second end 406 b of the loop of material 406 in place.
- the loop of material 406 when the loop of material 406 is fixed to the device 400 , it is adapted to receive the heart valve prosthesis 100 (shown schematically in phantom) in its expanded state.
- a user pulls knurled knob 412 of the pin 404 to the left relative to the orientation of FIG. 7 .
- Rotation of the pin 404 rolls the loop of material 406 onto the pin 404 which thereby apples a radial force to collapse the heart valve prosthesis 100 from the expanded state to the contracted state, which is depicted schematically in phantom in FIG.
- a radial dimension of the heart valve prosthesis 100 in the contracted state is less than a radial dimension of the heart valve prosthesis 100 in the expanded state such that the prosthesis 100 can be loaded into the cavity 308 of the sheath 304 .
- the surgeon or other user can manipulate the second end 304 b of the sheath 304 into the loop of material 406 and around the prosthesis 100 , and finally in engagement with the plug portion 306 b of the tip 306 .
- the prosthesis 100 With the prosthesis 100 thus loaded, it can be implanted according to the process described above.
- the present disclosure provides a heart valve prosthesis 100 adapted for intravascular delivery and which is constructed completely of synthetic materials that are more resistant to degradation and rejection than animal based materials. Moreover, the prosthesis 100 advantageously retains its position in the heart 10 with friction and self-loading and does not require the use of any sutures, hooks, or other type of invasive mechanical fasteners.
- the present disclosure advantageously provides a unique system for implanting a heart valve prosthesis.
- the system 300 disclosed with reference to FIGS. 4-6 advantageously enables the surgeon to remotely deflect the tip 406 of the system 300 in vivo through the use of the maneuvering string 300 , thereby facilitating the traversal of difficult passageways such as the aortic arch.
- the system 300 is advantageously designed to accommodate the large pay load of a heart valve prosthesis, which may have a diameter of approximately 25 millimeters in the fully expanded state and approximately 7 millimeters when occupying the contracted state within the sheath 304 .
- the manual manipulation of the spool 314 relative to the grip 312 of the handle 310 provides for precise retraction of the sheath 304 and calculated deployment of the prosthesis 100 .
Abstract
Description
- The priority benefit of U.S. Provisional Patent Application No. 61/032,636, filed Feb. 29, 2008 is hereby claimed and the entire contents thereof are incorporated herein by reference.
- The present disclosure is generally directed to an artificial heart valve and, more particularly, to a catheter deliverable artificial heart valve and delivery system therefor.
- The heart is the organ responsible for keeping blood circulating through the body. This task would not be possible if it was not for the action of valves. Four heart valves are key components that facilitate blood circulation in a single direction, and that the contraction force exerted by the heart is effectively transformed into blood flow.
- Each time the heart contracts or relaxes, two of the four valves close and the other two open. There are two states of the heart: relaxed or contracted. Depending on the state of the heart, a heart valve has two specific functions: either to open smoothly without interfering blood flow or to close sharply to impede the flow in the opposite direction.
- The anatomy of the heart allows it to simultaneously maintain the flow of the two major blood circuits in the body: pulmonary circulation and systemic circulation, which also includes the coronary circulation. This simultaneous action of keeping blood flowing through both circuits requires that the heart valves work in pairs, namely, the tricuspid and the pulmonary valve work together to direct the flow toward the lungs, and the mitral and aortic valves direct the flow toward the rest of the body including the heart.
- From the two circulations, the systemic circulation is the one that demands most of the energy of the heart because it operates under higher pressures and greater flow resistance. Consequently, the left heart is more susceptible to valve disorders. This condition makes the aortic and mitral valves primary subjects of research.
- According to the American Heart Association it is estimated that around 19,700 people in the United States die every year from heart valve disease, and another 42,000 die from different causes aggravated by valvular problems. During 1996, 79,000 heart valve replacements were carried out in the United States, a quantity that was reported to increase by 5,000 more replacements by 1997. Although improvement has been evident in this area of medical treatments, still a mortality rate between 30% and 55% exists in patients with valvular prostheses during the first 10 years after surgery.
- The aortic valve, representing almost 60% of the valve replacement cases, is located at the beginning of the systemic circulation and right next to the coronary ostia. Once the aortic valve closes the oxygenated blood flows into the heart through the right and left coronary arteries.
- The mitral valve, located between the left atrium and the left ventricle offers a different set of conditions. Although the mitral valve is not surrounded by any arterial entrances, it is located in a zone with greater access difficulties, and its anatomical structure contains a set of “leaflet tensors” called chordae tendinae.
- The human application of prosthetic heart valves goes back to 1960 when, for the first time, a human aortic valve was replaced. Since then, the use of valvular implants has been enhanced with new materials and new designs.
- The first mechanical valves used a caged-ball mechanism to control blood flow. Pressure gradients across the occluder-ball produced its movement to close or open the flow area. Even though this design performed the function of a valve, there were several problems associated with it: The ball geometry and the closing impact of the ball against the cage ring were both causes of large downstream turbulence and hemolysis. In addition to blood damage, obstruction to myocardial contraction and thrombogenic materials were also problems.
- Several designs having new materials including disks or leaflets instead of balls, improved the hemodynamic performance and durability of the implants, but two critical aspects remain pending for better solutions: 1) the highly invasive surgery required to implant the prosthesis, and 2) the thrombogenic effect of the implant's materials.
- Typically, mechanical heart valve prostheses are made from pyrolytic carbon or other prosthetic materials that require rigorous anticoagulant therapy because the risk of coagulation is higher over the surface of the prosthesis. The thrombogenic aspect has drawn the attention of many biomedical institutions towards the creation and study of more biocompatible materials.
- Currently, prosthetic heart valve technology includes several designs with disks or leaflets integrated into a rigid stent. This rigid stent is generally surrounded by a sewing cuff which allows the surgeon to suture the interface between the cuff and the tissue. This procedure, however, is highly invasive and its materials generally have a negative thrombogenic effect.
- Prosthetic heart valves with rigid stents require open heart surgery for implantation. During the implantation procedure the patient is maintained alive by a heart-lung machine while the surgeon sutures the device into the heart. Due to the highly invasive nature of this procedure, not all individuals suffering from heart valve disease are considered proper candidates.
- In those cases where a heart valve replacement has been performed, the risk of coagulation of blood becomes higher over the surface of the prosthesis. Mechanical heart valve prostheses made from pyrolytic carbon or other prosthetic metals require rigorous anticoagulant therapy. Other prosthetic valves use animal tissues, with which the thrombogenic effect is not as severe as for other materials, but durability is noticeably lower. Specifically, prosthetic valves constructed using animal tissue are prone to hardening as a result of being rejected by the body. Such hardening and rejection can ultimately lead to less than optimal performance.
- A heart valve prosthesis includes a collapsible stent and a one-piece multi-leaflet valve. The stent includes at least one length of wire having a series of turns forming a spring-like stent. The one-piece multi-leaflet valve is attached to the stent and includes a cylinder of polyester material secured thereto at three points. The stent is collapsible in a radial direction between an expanded state and a contracted state. The contracted state has a radial dimension smaller than a radial dimension of the expanded state. The stent is spring biased toward the expanded state such that it occupies an active state when implanted into a heart. The active state has a radial dimension that is between the radial dimension of the contracted state and the radial dimension of the expanded state such that a radial load generated by the bias of the collapsible stent is sufficient to retain the heart valve prosthesis in the heart.
- In one embodiment, the one-piece multi-leaflet valve further comprises a cylindrical cuff wrapped around an end of the collapsible stent. The cylindrical cuff is for preventing regurgitation during use of the valve.
- In one embodiment, the multi-leaflet valve further comprises a polymer coating the polyester material.
- Another embodiment further includes surgical sutures connecting the one-piece multi-leaflet valve to the collapsible stent.
- In one embodiment, the collapsible stent includes first and second lengths of wire, each of the first and second lengths of wire occupying a sinusoidal pattern.
- In one embodiment, the first and second lengths of sinusoidal wires are disposed adjacent to each other and in opposite phase to provide structural integrity to the collapsible stent.
- In one embodiment, the collapsible stent further includes a third length of wire occupying a pattern of alternating bows and attached to the first and second lengths of wires at a location axially offset therefrom. The third length of wire serves to bias the collapsible stent into the expanded state.
- In one embodiment, the collapsible stent is constructed of a shape memory nickel titanium alloy.
- In one embodiment, the collapsible stent occupies a generally tapered cylindrical shape at least when in the expanded state.
- In one embodiment, the multi-leaflet valve includes a trileaflet valve.
- Another aspect of the present disclosure includes a system for intravascular delivery of a heart valve prosthesis. The system includes a handle, a flexible elongated sheath, a cavity defined by the sheath, and a tapered tip. The flexible elongated sheath extends from the handle. The cavity is defined by an end of the elongated sheath that is disposed opposite the handle. The cavity is adapted to contain a heart valve prosthesis during intravascular delivery of the heart valve prosthesis. The tapered tip is coupled to the end of the elongated sheath adjacent to the cavity. The tapered tip is adapted to guide the elongated sheath during intravascular delivery of the heart valve prosthesis. The tapered tip and the elongated sheath are separable such that the heart valve prosthesis can be released from the cavity in the elongated sheath upon proper positioning of the heart valve prosthesis.
- In one embodiment, the elongated sheath has an inner diameter of less than or equal to 7 mm and an outer diameter of less than or equal to 8 mm.
- One embodiment further includes a string connected to the elongated sheath at a location adjacent the cavity and extending through the sheath to the handle. So configured, a user can pull the string to bend the elongated sheath to facilitate navigation of the elongated sheath during intravascular delivery of the heart valve prosthesis.
- One embodiment further includes a stop plug disposed in the elongated sheath adjacent the cavity. The stop plug prevents the heart valve prosthesis from traveling into the elongated sheath beyond the cavity.
- In one embodiment, the elongated sheath is movably mounted to the handle such that movement of the sheath toward the handle separates the elongated sheath and the tapered tip.
- Another aspect of the present disclosure includes a device for loading a collapsible heart valve prosthesis into a flexible elongated sheath of an intravascular heart valve delivery system. The device includes a handle, a pin, and a loop of material. The pin is rotatably mounted to the handle. The loop of material has a first end fixed to the handle and a second end fixed to the pin. The loop of material is adapted to receive a collapsible heart valve prosthesis in an expanded state. The pin is rotatable relative to the handle to roll the loop of material onto the pin, thereby applying a radial force to collapse the heart valve prosthesis from the expanded state to a contracted state. A radial dimension of the collapsible heart valve prosthesis in the contracted state is less than a radial dimension of the collapsible heart valve prosthesis in the expanded state such that the collapsible heart valve prosthesis in the contracted state can be loaded into the flexible elongated sheath of the intravascular heart valve delivery system.
- In one embodiment, the pin includes a slot formed therein that receives the first end of the loop of material.
- Objects, features, and advantages of the present invention will become apparent upon reading the following description in conjunction with the drawing figures, in which:
-
FIG. 1 is a cross-sectional representation of a heart; -
FIG. 2 is a cross-sectional representation of a heart including a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure; -
FIGS. 3A-3C are side, top, and bottom views, respectively, of a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure; -
FIG. 4 is a cross-sectional side view of a system for intravascular delivery of a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure; -
FIGS. 5 and 6 are detailed views of the system for intravascular delivery of a collapsible heart valve prosthesis of the present disclosure, illustrating its use and taken from circle V, VI ofFIG. 4 ; and -
FIGS. 7 and 8 are side views of a device for loading the system ofFIGS. 4-6 with a collapsible heart valve prosthesis constructed in accordance with the teachings of the present disclosure. -
FIG. 1 is a schematic cross-sectional illustration of the anatomical structure and major blood vessels of ahuman heart 10. Deoxygenated blood is delivered to theright atrium 12 of theheart 10 by the superior andinferior vena cava right atrium 12 is allowed to pass into theright ventricle 18 through thetricuspid valve 20. Once in theright ventricle 18, theheart 10 delivers this blood through the pulmonary valve to the pulmonary arteries and to the lungs for a gaseous exchange of oxygen. The circulatory pressures carry this blood back to the heart via thepulmonary veins 26 and into theleft atrium 28. Filling of theleft atrium 28 occurs as themitral valve 30 opens to allow blood to be drawn into theleft ventricle 32 for expulsion through theaortic valve 34 and on to the body extremities through theaorta 36. Theaorta 36 comprises (i) an ascendingaorta 38, which arises from theleft ventricle 32 of theheart 10, (ii) anaortic arch 10, which arches from the ascendingaorta 38 and (iii) a descendingaorta 42, which descends from theaortic arch 35 towards the abdominal aorta (not shown). When theheart 10 fails to continuously produce normal flow and pressures, a disease commonly referred to as heart failure occurs. - One cause of heart failure is failure or malfunction of one or more of the valves of the
heart 10. For example, theaortic valve 34 can malfunction for several reasons. Theaortic valve 34 may be abnormal from birth (e.g., bicuspid, calcification, congenital aortic valve disease), or it could become diseased with age (e.g., acquired aortic valve disease). In such situations, it can be desirable to replace the abnormal ordiseased valve 34. -
FIG. 2 is a schematic illustration of theheart 10 implanted with aheart valve prosthesis 100, which is constructed in accordance with one embodiment of the present disclosure. InFIG. 2 , theheart valve prosthesis 100 replaces the nativeaortic valve 34 and includes aninlet 100 a and anoutlet 100 b. Theoutlet 100 b is naturally located downstream from theinlet 100 a along the flow of blood through theaorta 36. Theheart valve prosthesis 100 will be described in detail below. Additionally, a means for and method of delivering theheart valve prosthesis 100 using an intravascular delivery system 300 (shown inFIG. 2 ) is described below. - While the following disclosure primarily focuses on replacing or repairing an abnormal or diseased
aortic valve 34, the various features, aspects, structures, and methods disclosed herein are applicable to replacing or repairing the mitral 30, pulmonary 22, and/or tricuspid 20 valves of theheart 10 as those of ordinary skill in the art will appreciate. In addition, those of ordinary skill in the art will also recognize that the various features and aspects of the methods and structures disclosed herein can be used in other parts of the body that include valves or can benefit from the addition of a valve, such as, for example, the esophagus, stomach, ureter and/or vesice, biliary ducts, the lymphatic system and in the intestines. - Referring now to
FIGS. 3A-3C , one embodiment of theheart valve prosthesis 100 of the present disclosure will be described. In general, theheart valve prosthesis 100 includes astent 102 and amulti-leaflet valve 104. Thestent 102 is collapsible to facilitate intravascular delivery to theheart 10, with a catheter for example, as will be described below. - The
multi-leaflet valve 104 includes a one-piece valve component, i.e., it is constructed from a single piece of material, positioned at theinlet 100 a of theprosthesis 100. More specifically, themulti-leaflet valve 104 includes a single piece of material having a generallycylindrical valve portion 104 a and a generallycylindrical cuff portion 104 b. Because themulti-leaflet valve 104 is constructed from a single piece of material, thecuff portion 104 b rolls outward and back upon or concentric with thevalve portion 104 a. As such, thevalve portion 104 a is disposed inside of thestent 102 and thecuff portion 104 b is disposed outside of thestent 102. So configured, thecuff portion 104 b serves to reduce or prevent regurgitation when the prosthesis is implanted in theheart 10, as depicted inFIG. 2 . In the disclosed embodiment, themulti-leaflet valve 104 is secured to thestent 102 at a plurality of locations using conventional surgical sutures, but it should be appreciated that other devices for fixing the two components together are intended to be within the scope of the disclosure. - As shown in
FIG. 3B , thevalve portion 104 a of themulti-leaflet valve 104 is secured to thestent 102 at three distinct points, each of which are identified with reference numeral 103. So secured, thevalve portion 104 a includes threewalls 105 defined as being located between the points 103. Each of thewalls 105 serves as one leaflet of themulti-leaflet valve 104, thereby defining themulti-leaflet valve 104 as a trileaflet valve. In other embodiments, themulti-leaflet valve 104 can include more or less than three leaflets, as desired. - In one embodiment, the
multi-leaflet valve 104 is constructed of a polymer-coated polyester material. The polyester material can include Dacron™, which is commercially available from Bard Peripheral Vascular of Tempe, Ariz., USA, and the coating can include Quatromer™, which is commercially available from Innovia, LLC of Miami, Fla., USA. - In the disclosed form of the prosthesis, the
stent 102 includes at least one length of wire bent and shaped such that thestent 102 has a multitude of turns forming a spring-like member that is resiliently deformable between an expanded state (shown inFIGS. 3A-3C ) and a contracted state (not shown), wherein thestent 102 is collapsed upon itself in the radial direction. That is, in the contracted state, theprosthesis 100 has a radial dimension that is smaller than a radial dimension of theprosthesis 100 in the expanded state. - So configured, the
stent 102 is biased toward the expanded state. When theprosthesis 100 is positioned in theheart 10, as depicted inFIG. 2 , it occupies an active state that can be between the contracted state and the expanded state, for example, wherein theprosthesis 100 frictionally and forcefully engages the wall of theheart 10. This design therefore advantageously secures the position of theprosthesis 100 in theheart 10 without requiring any fasteners, mechanical or otherwise. - With continued reference to
FIGS. 3A-3C , thestent 102 of the disclosed embodiment of theprosthesis 100 is formed such that the prosthesis occupies a generally tapered cylindrical shape. Thestent 102 includes first through third lengths of wire, which are numbered 106, 108, and 110, respectively. Other embodiments can have less than or more than three lengths of wire. The first and second lengths of wire 106, 108 of the disclosed embodiment each occupy a wave pattern and are shaped into cylinders. In the present embodiment, the cylinders are generally tapered cylinders and the wave patterns constitute sinusoidal waves. - The second length of wire 108 is positioned radially inside of the first length of wire 106 and circumferentially offset therefrom. The first and second lengths of wire 106, 108 are secured together at a plurality of locations with conventional surgical sutures, but other devices for securing the two components together are intended to be within the scope of the disclosure. So configured, the sinusoidal patterns of the first and second lengths of wire 106, 108 can be described as being opposite in phase. That is, each peak 106 a of the first length of wire 106 is aligned with each trough 108 b of the second length of wire 108, and each peak 108 a of the second length of wire 108 is aligned with each trough 106 b of the first length of wire 106. For the sake of clarity,
FIG. 3A only identifies onepeak stent 102 and therefore, to theprosthesis 100. - The third length of
wire 110 of thestent 102 of theprosthesis 100 depicted inFIGS. 3A-3C is also generally shaped as a tapered cylinder at least in the expanded state, and is attached to either or both of the first and second lengths of wire 106, 108 at a plurality of locations with conventional surgical sutures. In other embodiments, the third length ofwire 110 could be attached to the first and second lengths of wire 106, 108 with any other foreseeable device. In contrast to the sinusoidal patterns of the first and second lengths of wire 106, 108, however, the third length ofwire 110 includes a wave pattern that also includes alternating bows. That is, the third length ofwire 110 includes a plurality ofpeaks 110 a andtroughs 110 b, but instead of thepeaks 110 a andtroughs 110 b having smooth sinusoidal transitions, each includes abow 112. Thebows 112 basically constitute small loops of wire extending away from thepeaks 110 a andtroughs 110 b of the third length ofwire 110. This design of the third length ofwire 110 advantageously increases the radial stiffness of thestent 102, which increases the radial load generated by the prosthesis when it occupies the contracted and/or active states. Thus, it may be said that the third length ofwire 110 is primarily responsible for generating the radial load required for securing the prosthesis in theheart 10, while the first and second lengths of wire 106, 108 are primarily responsible for maintaining the structural integrity of theoverall prosthesis 100. - In one embodiment, the first, second, and third lengths of
wire 106, 108, 110 each comprises a continuous piece of a shape memory nickel titanium alloy such as Nitinol. Thewires 106, 108, 110 may be bound at the free ends with a length of stainless steel hypo-tubing and an adhesive, for example. In one form, the Nitinol wires are heat treated to retain the shapes and patterns illustrated inFIGS. 3A-3C . In other embodiments of theprosthesis 100, thewires 106, 108, 100 can be constructed of generally any other biocompatible material capable of serving the purpose of thestent 102. - As mentioned above, the
heart valve prosthesis 100 of the present disclose is designed to be implanted via intravascular delivery. One device for accomplishing such a delivery is depicted inFIGS. 4-6 . Specifically,FIGS. 4-6 depict one embodiment of asystem 300 for intravascular delivery of theheart valve prosthesis 100, which includes, for example, a catheter. Thesystem 300 generally comprises a handle 302, an elongatedflexible sheath 304, and atip 306. In practice, thesheath 304 can be rather long, but for the sake of clarity,FIG. 4 illustrates thesheath 304 only at its end sections adjacent the handle 302 and thetip 306. - During use, the
sheath 304 is adapted to store aheart valve prosthesis 100 in acavity 308 formed adjacent to thetip 306. As such, thesheath 304 would preferably have an inner diameter of less than or equal to 7 millimeters and an outer diameter of less than or equal to 8 millimeters to sufficiently accommodate the large payload of theheart valve prosthesis 100, even when it is in its fully contracted state. So configured, thetip 306 andsheath 304 can be threaded through a blood vessel from a patient's groin, for example, to theheart 10 to deliver theprosthesis 100 in a manner that will be described below. - Referring to the bottom portion of
FIG. 4 , the handle 302 includes ahollow grip 310, ahollow slide rod 312, and ahollow spool 314. Thegrip 310 can be connected to theslide rod 312 at a threadedconnection 316. Thespool 314 is slidably mounted on theslide rod 312 and fixed to afirst end 304 a of thesheath 304 at a threadedconnection 316. Thespool 314 has a pair ofradial flanges 314 a for accommodating a user's grip, as will be described. - Referring now to the top portion of
FIG. 4 , thecavity 308 for receiving theheart valve prosthesis 100 is defined in asecond end 304 b of thesheath 304, which as mentioned is disposed adjacent thetip 306. Thetip 306 includes a taperedbody portion 306 a and aplug portion 306 b. Theplug portion 306 b is friction fit within thesecond end 304 b of thesheath 304. Thetip 306 further defines a throughbore 318 and ablind bore 320 for receiving wires of thesystem 300, as will be described. Also, as depicted inFIG. 4 , thesecond end 304 b of thesheath 304 includes astop plug 322 disposed therein. Thestop plug 322 includes a generally solid cylindrical disk-shaped member having a plurality of bores therein for receiving various wires of the system, as will be described. Thestop plug 322 defines the internal boundary of thecavity 308 for receiving theheart valve prosthesis 100. - As mentioned and illustrated in
FIG. 4 , thesystem 300 includes a plurality of wires extending through thesheath 304. Specifically, thesystem 300 includes aguide wire 324, afirst stop wire 326, asecond stop wire 328, and amaneuvering string 330. - The
guide wire 324 passes through the through-bore 318 in thetip 306, through thesheath 304, through the handle 302, and out of anopening 332 formed in thegrip 310 of the handle 302. Theguide wire 324 is a conventional wire that a surgeon may first thread through the blood vessel to theheart 10 of the patient prior to threading thesheath 304 to theheart 10. When positioned in the blood vessel, theguide wire 324 guides thesheath 304 along the proper path to theheart 10. - The
first stop wire 326 can be fixed to aback wall 302 a of the handle 302, for example, and extends through the length of the handle 302 andsheath 304 and into theblind bore 320 of thetip 306. Accordingly, thefirst stop wire 326 also passes through an opening in thestop plug 322. Thefirst stop wire 326 can be fixed to thestop plug 322 and thetip 306 with an adhesive, for example, to fix the position of thetip 306 and stopplug 322 relative to each other. - Similar to the
first stop wire 326, thesecond stop wire 328 can be fixed to theback wall 302 a of the handle 302, for example, and extends through the length of the handle 302 andsheath 304. Unlike thefirst stop wire 326, however, thesecond stop wire 328 stops at thestop plug 322. In one embodiment, thesecond stop wire 328 can be fixed into an opening or recess in the stop plug 322 with an adhesive, for example. In another embodiment, thesecond stop wire 328 may simply terminate immediately adjacent thestop plug 322. In either case, thesecond stop wire 328 serves to prevent the stop plug 322 from traveling up into thesheath 304 during operation, as will be described. - Finally, the
maneuvering string 330 of the disclosed embodiment includes a first end that is fixed to aring 333 adjacent theback wall 302 a of the handle 302, and a second end that is fixed to thesecond end 304 b of thesheath 304 at a location neat thestop plug 322, for example. Thestring 330 can include a conventional nylon string, a metallic wire, or generally any other type of material. While threading thesheath 304 into the patient'sheart 10, a surgeon, for example, may pull thering 333 to bend thesecond end 304 b of thesheath 304 to help maneuver thesheath 304 through sharp turns. For example, with reference toFIGS. 1 and 2 , this manipulation of thestring 330 andsheath 304 may be beneficial to turn thesecond end 304 b of thesheath 304 to traverse theaortic arch 35 when replacing theaortic valve 34. - Referring now to
FIG. 5 , as mentioned, thecavity 308 in thesecond end 304 b of thesheath 304 is adapted to accommodate aheart valve prosthesis 100 in a contracted state, as depicted schematically in phantom. With theprosthesis 100 so loaded into thecavity 308, thetip 306 andsheath 304 can be threaded from the patient's groin, for example, and to theheart 10 such that thetip 306 is positioned just beyond the nativeaortic valve 34. Once thetip 306 is properly positioned, the surgeon, for example, grasps the spool 314 (shown inFIG. 4 ) of the handle 302 of thesystem 300 and pulls thespool 314 backwards along theslide rod 312 toward thegrip 310. This movement of thespool 314 pulls thesheath 304 backwards such that thesecond end 304 b of thesheath 304 disengages theplug portion 306 b of thetip 306. The surgeon pulls thespool 314 until thesecond end 304 b of thesheath 304 reaches the position depicted inFIG. 6 . - With the
sheath 304 out of the way, theheart valve prosthesis 100 is free to expand to an active state and engage the walls of theheart 10, as depicted inFIG. 2 . During this process of setting theheart valve prosthesis 100, thefirst stop wire 326 maintains the position of thetip 306 relative to thestop plug 322 and thesecond stop wire 328 prevents the stop plug 322 from moving in thesheath 304 toward the handle 302. With theheart valve prosthesis 100 expanded and set in theheart 10, the surgeon can reengage thesheath 304 with theplug portion 306 b of thetip 306 by pushing thespool 314 andsheath 304 away from thegrip 310 of the handle 302. Then, the surgeon can draw the entire system back through the center opening of theprosthesis 100, out of theheart 10, and finally out of the patient's groin. - In view of the foregoing description, it should be understood that loading the
heart valve prosthesis 100 into thecavity 308 of thesheath 304 can be accomplished by performing the above-described deployment steps in reverse. That is, with theheart valve prosthesis 100 in its expanded state, thetip 306 andsecond end 304 b of thesheath 304 can be passed through the center thereof and thesheath 304 can be disengaged from theplug portion 306 b of thetip 306 through manipulation of thespool 314 on the handle 302. With theprosthesis 100 andsystem 300 arranged as depicted inFIG. 6 , a radial load can be applied to the circumference of theprosthesis 100. This radial load contracts theprosthesis 100 into a small cylinder that is able to fit into thecavity 308 of thesheath 304. The second end of thesheath 304 can then be slide over theprosthesis 100 either by manually grasping thesecond end 304 b of thesheath 304 or through manipulation of thespool 314. Finally, thesecond end 304 b of thesheath 304 can be friction fit onto theplug portion 306 b of thetip 306. This completes the loading process. - In one embodiment, the loading process can include the use of a
device 400 for loading theheart valve prosthesis 100, such as that depicted inFIGS. 7 and 8 . In the depicted embodiment, thedevice 400 includes ahandle 402, apin 404, and a loop ofmaterial 406. Thehandle 402 is a generally U-shaped member defining a pair of legs 408 having through-bores 410. Moreover, a plurality of threaded fasteners 428 are positioned in a corresponding plurality of threaded bores 430 formed in thehandle 402. - The
pin 404 is rotatably disposed in the through-bores 410 of thehandle 402 and includes aknurled knob 412 on one end and abutton 414 on the other end. Theknurled knob 412 includes a pair ofpins 416 adapted to be received in a pair ofcorresponding bores 418 formed in thehandle 402 for locking rotation of thepin 404. The end of thepin 404 adjacent thebutton 414 accommodates aspring 420 between thebutton 414 and the adjacent leg 408 of thehandle 402. Additionally, thepin 404 includes anelongated slot 422 formed in a central portion thereof and a pair of threaded fasteners 424 positioned in threaded bores 426 of thepin 404 that traverse radially to theelongated slot 422. - The loop of
material 406 can include generally any type of material such as nylon, for example, and includes a first end 406 a and a second end 406 b. The first end 406 a is fixed to thehandle 402. More specifically, the first end 406 a of the loop ofmaterial 406 includes a plurality of holes (not shown) that receive the plurality of fasteners 428 such that the fasteners 428 can be tightened against thehandle 402 to fix the position of the first end 406 a of the loop ofmaterial 406. - The second end 406 b of the loop of
material 406 is fixed to thepin 404. More specifically, the second end 406 b of the loop ofmaterial 406 is received in theslot 422 formed in thepin 404 and the fasteners 424 are tightened to clamp the second end 406 b of the loop ofmaterial 406 in place. - As depicted in
FIG. 7 , when the loop ofmaterial 406 is fixed to thedevice 400, it is adapted to receive the heart valve prosthesis 100 (shown schematically in phantom) in its expanded state. To contract theprosthesis 100, a user pullsknurled knob 412 of thepin 404 to the left relative to the orientation ofFIG. 7 . This pulls thepins 416 on theknurled knob 412 out of the correspondingbores 418 such that the user can rotate thepin 404. Rotation of thepin 404 rolls the loop ofmaterial 406 onto thepin 404 which thereby apples a radial force to collapse theheart valve prosthesis 100 from the expanded state to the contracted state, which is depicted schematically in phantom inFIG. 8 . A radial dimension of theheart valve prosthesis 100 in the contracted state is less than a radial dimension of theheart valve prosthesis 100 in the expanded state such that theprosthesis 100 can be loaded into thecavity 308 of thesheath 304. Thus, with theprosthesis 100 sufficiently contracted, as depicted inFIG. 8 , the surgeon or other user can manipulate thesecond end 304 b of thesheath 304 into the loop ofmaterial 406 and around theprosthesis 100, and finally in engagement with theplug portion 306 b of thetip 306. With theprosthesis 100 thus loaded, it can be implanted according to the process described above. - In light of the foregoing, it should be appreciated that the present disclosure provides a
heart valve prosthesis 100 adapted for intravascular delivery and which is constructed completely of synthetic materials that are more resistant to degradation and rejection than animal based materials. Moreover, theprosthesis 100 advantageously retains its position in theheart 10 with friction and self-loading and does not require the use of any sutures, hooks, or other type of invasive mechanical fasteners. - Furthermore, the present disclosure advantageously provides a unique system for implanting a heart valve prosthesis. The
system 300 disclosed with reference toFIGS. 4-6 advantageously enables the surgeon to remotely deflect thetip 406 of thesystem 300 in vivo through the use of themaneuvering string 300, thereby facilitating the traversal of difficult passageways such as the aortic arch. Additionally, thesystem 300 is advantageously designed to accommodate the large pay load of a heart valve prosthesis, which may have a diameter of approximately 25 millimeters in the fully expanded state and approximately 7 millimeters when occupying the contracted state within thesheath 304. Furthermore, the manual manipulation of thespool 314 relative to thegrip 312 of thehandle 310 provides for precise retraction of thesheath 304 and calculated deployment of theprosthesis 100. - The scope of the invention is not limited to the specific embodiments described hereinabove, but rather, is intended to be defined by the spirit and scope of the claims and all equivalents thereof.
Claims (8)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US14/601,451 US20150134056A1 (en) | 2008-02-29 | 2015-01-21 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
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US3263608P | 2008-02-29 | 2008-02-29 | |
PCT/US2009/035121 WO2009111241A2 (en) | 2008-02-29 | 2009-02-25 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
US86416610A | 2010-10-28 | 2010-10-28 | |
US14/601,451 US20150134056A1 (en) | 2008-02-29 | 2015-01-21 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
Related Parent Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2009/035121 Division WO2009111241A2 (en) | 2008-02-29 | 2009-02-25 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
US12/864,166 Division US9011525B2 (en) | 2008-02-29 | 2009-02-25 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
Publications (1)
Publication Number | Publication Date |
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US20150134056A1 true US20150134056A1 (en) | 2015-05-14 |
Family
ID=41056549
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
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US12/864,166 Expired - Fee Related US9011525B2 (en) | 2008-02-29 | 2009-02-25 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
US14/601,451 Abandoned US20150134056A1 (en) | 2008-02-29 | 2015-01-21 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
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US12/864,166 Expired - Fee Related US9011525B2 (en) | 2008-02-29 | 2009-02-25 | Catheter deliverable artificial multi-leaflet heart valve prosthesis and intravascular delivery system for a catheter deliverable heart valve prosthesis |
Country Status (3)
Country | Link |
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US (2) | US9011525B2 (en) |
EP (1) | EP2247264A4 (en) |
WO (1) | WO2009111241A2 (en) |
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US11903827B1 (en) | 2022-09-30 | 2024-02-20 | Anteris Technologies Corporation | Prosthetic heart valves |
Also Published As
Publication number | Publication date |
---|---|
WO2009111241A3 (en) | 2010-02-18 |
WO2009111241A2 (en) | 2009-09-11 |
US9011525B2 (en) | 2015-04-21 |
EP2247264A2 (en) | 2010-11-10 |
EP2247264A4 (en) | 2011-08-31 |
US20110295361A1 (en) | 2011-12-01 |
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