WO2001052775A1 - Implant valve for implantation in a blood vessel - Google Patents
Implant valve for implantation in a blood vessel Download PDFInfo
- Publication number
- WO2001052775A1 WO2001052775A1 PCT/NL2001/000027 NL0100027W WO0152775A1 WO 2001052775 A1 WO2001052775 A1 WO 2001052775A1 NL 0100027 W NL0100027 W NL 0100027W WO 0152775 A1 WO0152775 A1 WO 0152775A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- tube
- support
- casing
- blood vessel
- implant
- Prior art date
Links
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
- A61F2/2475—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
- A61F2/02—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
- A61F2/02—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
- 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
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/901—Method of manufacturing prosthetic device
Definitions
- the invention relates to an implant valve for implantation in a blood vessel.
- Such implant valves are known and are applied for regulating the blood circulation through a vascular system, such as the human vascular system.
- the vascular system in particular the venous vascular system in legs and arms, is, at certain locations, provided with bag-shaped valves, also called "cusps".
- the function of the valves is to impede the blood flowing against the direction of the blood circulation through the vascular system. In particular, this function is important in the period of relatively low blood pressure in the vascular system, occurring between systoles of the heart.
- valves in the vessels of the vascular system do not close properly, so that blood can flow through the valves against the blood circulation. This problem especially occurs when the valves are damaged as a result of blood clots (thrombosis). Further, the closing action of the valves or cusps can be lost due to the diameter of veins increasing, for instance when the elasticity of the veins decreases.
- implant valves with artificially formed bag-shaped valves in the veins.
- An implant valve with an expandable support provided with bag-shaped valves and a method for percutaneously fitting such an implant valve in a vein are known from NL 1004827.
- a drawback of the known implant valve is that it, in itself, increases the chance of clotting of blood or thrombosis considerably.
- the known valve body is provided with a relatively rough and irregular surface, which increases the chance of clotting through adhesion.
- the flow resistance in the direction of the blood circulation is not optimally low.
- valve body specific material is a problem.
- the object of the invention is an implant valve which does not have the above-mentioned drawbacks.
- the invention provides an implant valve for implantation in a blood vessel, comprising a flexible tube and a hollow, substantially cylindrical support with a casing which is expandable in diameter from an initial position into an implantation position, the support extending over a part of the length of the tube substantially coaxially along the inner wall of the tube and the casing of the support cooperating with the inner wall of the tube such that, in the implantation position of the support, a first part of the tube can be formed to be a rigid shell which can be clamped substantially coaxially along the inner wall of a blood vessel, while a second, axially contiguous part of the tube can form a flexible, tubular valve body which can extend substantially free in the blood vessel.
- the valve has a simple construction, so that it can be relatively easily manufactured with a small diameter.
- the flexible tube of the valve can relatively easily be designed from body specific material.
- the valve has a relatively low flow resistance, in particular when a substantially cylindrical flexible tube is applied, and when blood flows through it in the direction of the blood circulation from the rigid, tubular part, while circulation in the opposite direction through deformation of the tubular flexible valve body is effectively counteracted. Further, it is achieved that the chance of blood clotting as a result of the valve can be considerably reduced.
- the invention further relates to a method for implanting an implant valve and to a method for manufacturing an implant valve.
- valve an implant valve
- the invention will be further elucidated on the basis of an exemplary embodiment, represented in a drawing. In the drawing:
- Fig. 1 shows a schematic, partly sectional perspective view of a first embodiment of the implant valve
- Fig. 1A shows a schematic perspective view of a support in initial position
- Fig. IB shows a schematic perspective view of a support in implantation position
- Fig. 2A shows a schematic perspective view of the implant valve of Fig. 1 in implanted condition during a systole of the muscle pump;
- Fig. 2B shows the implant valve of Fig. 2A in the diastolic phase between two systoles of the muscle pump
- Fig. 3 shows a schematic cross section of a second embodiment of the implant valve
- Fig. 4 shows a schematic representation of the implantation of the implant valve with the aid of a transport device. It is noted that the Figures are only schematic representations of preferred embodiments of the invention. In the Figures, identical or corresponding parts are designated by the same reference numerals.
- the implant valve 1 for implantation in a blood vessel 2.
- the implant valve 1 comprises a flexible tube 3 and a hollow, substantially cylindrical support 4.
- the tube 3 is manufactured from biocompatible material, preferably body specific material.
- the support 4 has a casing 5, expandable in diameter from an initial position I to an implantation position II.
- Fig. 1A shows the support 4 in the initial position I
- Fig. IB shows the support 4 in the implantation position II. From the initial position I, the support 4 expands over its entire length 1 in radial direction in relation to its longitudinal axis A, such that the diameter of the casing 5 of the support 4 increases from a first value Dl to a greater value D2.
- the casing 5 of support 4 is preferably built up from an interlacement of two cylindrically interwoven, zigzagging, biocompatible metal wires 6.
- the interlacement can be designed to be pushed, with the aid of a balloon catheter, from the initial position I into the implantation position II (Balloon extendable type), but can also be designed from memory metal which, upon expansion, unfolds itself from the initial condition into the implantation condition II (Self expandable type).
- Such supports are usually referred to as "stents", and, since they are generally known, will not be further elucidated here.
- the support 4 extends over a part 1 of the length L of the tube 3.
- the casing 5 of the support 4 is connected to the inner wall 3A of the tube 3, for instance in that the wires 6 of the casing 5 of the support 4 are sewn to the tube 3, such that the inner wall 3A, in the implantation position I, loosely envelops the outer casing surface 5A of the support 4.
- the outer surface 5A of the casing 5 cooperates with the inner wall 3A of the tube 3 such that, in the implantation position, the inner wall 3A is pulled taut by the outer surface 5A of the support to form a rigid shell 9.
- the rigid shell 9 extends over a first part
- a second part of the tube 3 contiguous thereto in axial direction A is not supported by the support 4 and forms a flexible, tubular valve body 10.
- the rigid shell 9 In implanted condition in a blood vessel 2, the rigid shell 9 extends substantially coaxially along the inner wall 2A of the blood vessel, and the outer wall 3B of the tube 3 is clamped by the support 4 in implantation position II, in a tubular shape, against the inner wall 2A of the blood vessel 2.
- the second part of the tube 3 contiguous thereto in axial direction forms a flexible, tubular valve body 10 extending over a part k of the length L of the tube, extending substantially clear in the blood vessel 2.
- the outer wall 3B of the tube 3 is then substantially clear of the inner wall 2A of the blood vessel 2.
- blood can pass in the direction of the arrow
- the flexible tube 3 is preferably substantially cylindrical, or diverging so that an orifice can be achieved whose opening increases or is as constant as possible.
- the outflow opening 14 can be slightly smaller than the inflow opening 12.
- the flexible, tubular valve body 10 will collapse and cover the flow orifice of the rigid shell 9 as a valve and thus impede the flow through the valve body 1.
- the flexible, tubular valve body 10 will be stretched again as a result of a flow in the direction of the blood circulation. Since the flexible tubular valve body 10 in each case virtually abuts the inner wall of the blood vessel 2 to subsequently collapse, it is avoided that blood can reside between the tubular valve body 10 and the inner wall 2A of the blood vessel 2 for a long time.
- the ratio of the length of the part 1 to the part k is in the interval of 1:2 tot 2:1.
- the length of the part 1 is less than or equal to the length of the part k.
- the support 4 can be provided with support means extending in the direction of the longitudinal axis A.
- the support means support the inner wall 3A along a part P of the circumference over at least a part of the length F of the second part k of the tube 3, corresponding to the flexible, tubular valve body 10.
- the support means are designed as a finger-shaped extension 17 of the casing 5 of the support 4.
- FIG. 3 there is shown a second embodiment of the implant valve 1.
- the tube 3 is folded double so that the inner wall 3A of the tube 3, from the outer surface 5A of the casing 5, while forming the flexible tubular valve body 10, extends along the inner surface 5B of the casing of the support 4.
- the support 4, along its inner casing 5B can be smoothly covered, which facilitates the circulation through the valve and decreases the chance of blood clotting.
- the ends 20, 21 of the tube 3 are connected to form a ring around the support. Hence, the tube 3 is connected around the support 4.
- the ends 20, 21 of the tube 3 are pushed against the inner wall 2A of the blood vessel 2 and no blood flows around them.
- the entire surface of the implant valve 1, around which, in implanted condition, blood flows, can be smooth, so that the flow resistance of the implant valve 1 is further reduced and the chance of blood clotting is further reduced.
- the implant valve is manufactured from a substantially cylindrical part of a vein.
- the outer surface 3B of the tube 3 is formed by endothelial cells.
- an implant valve 1 is obtained with a very low flow resistance in the direction of the blood stream and a very small chance of it causing blood clotting.
- the implant valve 1 is manufactured from a part of a body specific vein.
- a substantially cylindrical part of a vein situated near the surface of the body can be removed to be subsequently applied as a flexible tube 3 for an implant valve 1 which is implanted in a deeper vein.
- a part of a vein situated near the surface of the lower leg can be removed to be subsequently applied as a flexible tube in an implant valve which is implanted in a deeper vein in the lower leg of that patient.
- the implant valve 1 can be manufactured by positioning the support 4 with its inner casing 5B around the outer wall 3B of the tube-shaped part 3, and turning the tube-shaped part 3 inside out by folding the ends 20, 21 of the tube part along the outer casing 5A of the support 4, and connecting the ends to each other, thus forming a flexible, tubular valve body 10 axially contiguous to the support 4.
- the ends 20, 21 of the tube can be connected to each other in a surgical manner known per se, for instance by stitches 18. In such a manner, the inner surface 3A of the tube 3, i.e.
- the original outer surface of the vein can be connected to the outer and inner surface 5N 5B of the casing 5, respectively, such that the tube 3, in implantation position II of the support 4, is positioned tightly along the outer surface 5A of the casing 5.
- the tube 3 in implantation position II of the support 4 is positioned tightly along the outer surface 5A of the casing 5.
- the implant valve 1 can be implanted by positioning the implant valve 1 with the support 4 in initial position I in a blood vessel and transporting it, with the aid of a transport device, through the vein to an implantation site (Fig. 4).
- An example of this is the percutaneous or minimally invasive insertion of the implant valve in a vein at the location of the groin 26 of a person and, after possible removal of badly functioning valves present in the vein 26, transporting the implant valve 1 through the vein 26 to a part of that vein which forms the location of implantation 28, situated just below or over the knee 27.
- the implant valve 1 can then be fixed by bringing support 4 into the implantation position II, so that a first part of the tube is clamped as a rigid shell 9 substantially coaxially along the inner wall 27A of the vein 27, while a second part of the tube 3, contiguous in the direction of the axis A, forms a flexible, tubular valve body, extending substantially clear in the vein.
- the flexible, tubular valve body 10 is then, for instance, viewed from the groin 26, situated before the rigid shell-shaped part 9, so that a downward flow through the valve body 10 against the blood circulation, resulting from gravity, is avoided, while an upward flow as a result of the systole of the heart in the direction of the blood circulation is obstructed as little as possible.
- a balloon catheter 30 can be used as a transport device.
- the implant valve with the support 4 in initial position I, is then fitted coaxially around the balloon 31 of the balloon catheter 30.
- the implant valve can be fixed at the implantation location 28 by expanding the balloon 3, thus bringing the support 4 into the implantation position II. After shrinkage of the balloon 3, the balloon catheter 30 can subsequently, while leaving the implant valve 1 behind, be recovered. Balloon catheters and the manner of operation thereof are known to the skilled person and will not be further elucidated here.
- an implant valve can be equipped with a support of the "Self- expandable" type, in which the support is kept in the initial position by fitting the implant valve into a sleeve.
- the transport device can then be formed by a sleeve which, with the aid of a coaxial cable, can be inserted and where, by displacing the cables relative to each other, the implant valve can be pushed from the container, after which it expands itself.
- the flexible tube and/or the support can be manufactured from biocompatible plastic material.
- the support means, in particular the finger-shaped extensions can be provided with a protective layer or can be made of a somewhat flexible design to reduce the chance of damage to the flexible tube during use and to increase durability of the implant valve.
Abstract
Description
Claims
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE60143251T DE60143251D1 (en) | 2000-01-17 | 2001-01-16 | VALVE IMPLANT TO IMPLANT INTO A BLOOD VESSEL |
EP01906396A EP1248579B1 (en) | 2000-01-17 | 2001-01-16 | Implant valve for implantation in a blood vessel |
AT01906396T ATE484261T1 (en) | 2000-01-17 | 2001-01-16 | VALVE IMPLANT FOR IMPLANTATION INTO A BLOOD VESSEL |
US10/181,703 US7811315B2 (en) | 2000-01-17 | 2001-01-16 | Implant valve for implantation in a blood vessel |
AU2001234225A AU2001234225A1 (en) | 2000-01-17 | 2001-01-16 | Implant valve for implantation in a blood vessel |
US12/807,405 US20110004295A1 (en) | 2000-01-17 | 2010-09-03 | Implant valve for implantation in a blood vessel |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
NL1014095 | 2000-01-17 | ||
NL1014095A NL1014095C2 (en) | 2000-01-17 | 2000-01-17 | Implant valve for implantation into a blood vessel. |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/807,405 Continuation US20110004295A1 (en) | 2000-01-17 | 2010-09-03 | Implant valve for implantation in a blood vessel |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2001052775A1 true WO2001052775A1 (en) | 2001-07-26 |
Family
ID=19770610
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/NL2001/000027 WO2001052775A1 (en) | 2000-01-17 | 2001-01-16 | Implant valve for implantation in a blood vessel |
Country Status (8)
Country | Link |
---|---|
US (2) | US7811315B2 (en) |
EP (1) | EP1248579B1 (en) |
AT (1) | ATE484261T1 (en) |
AU (1) | AU2001234225A1 (en) |
DE (1) | DE60143251D1 (en) |
ES (1) | ES2356198T3 (en) |
NL (1) | NL1014095C2 (en) |
WO (1) | WO2001052775A1 (en) |
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US6454799B1 (en) | 2000-04-06 | 2002-09-24 | Edwards Lifesciences Corporation | Minimally-invasive heart valves and methods of use |
US6733525B2 (en) | 2001-03-23 | 2004-05-11 | Edwards Lifesciences Corporation | Rolled minimally-invasive heart valves and methods of use |
US7896887B2 (en) | 2001-10-25 | 2011-03-01 | Spiration, Inc. | Apparatus and method for deployment of a bronchial obstruction device |
US8926647B2 (en) | 2002-03-20 | 2015-01-06 | Spiration, Inc. | Removable anchored lung volume reduction devices and methods |
US8956319B2 (en) | 2002-05-17 | 2015-02-17 | Spiration, Inc. | One-way valve devices for anchored implantation in a lung |
US8974484B2 (en) | 2001-09-11 | 2015-03-10 | Spiration, Inc. | Removable lung reduction devices, systems, and methods |
US8974527B2 (en) | 2003-08-08 | 2015-03-10 | Spiration, Inc. | Bronchoscopic repair of air leaks in a lung |
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US9198669B2 (en) | 2006-03-31 | 2015-12-01 | Spiration, Inc. | Articulable anchor |
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US7766973B2 (en) * | 2005-01-19 | 2010-08-03 | Gi Dynamics, Inc. | Eversion resistant sleeves |
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Also Published As
Publication number | Publication date |
---|---|
EP1248579A1 (en) | 2002-10-16 |
US20030060875A1 (en) | 2003-03-27 |
US20110004295A1 (en) | 2011-01-06 |
DE60143251D1 (en) | 2010-11-25 |
US7811315B2 (en) | 2010-10-12 |
EP1248579B1 (en) | 2010-10-13 |
ATE484261T1 (en) | 2010-10-15 |
ES2356198T3 (en) | 2011-04-05 |
NL1014095C2 (en) | 2001-07-18 |
AU2001234225A1 (en) | 2001-07-31 |
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