WO2002087467A2 - Replacement venous valve - Google Patents
Replacement venous valve Download PDFInfo
- Publication number
- WO2002087467A2 WO2002087467A2 PCT/US2002/013640 US0213640W WO02087467A2 WO 2002087467 A2 WO2002087467 A2 WO 2002087467A2 US 0213640 W US0213640 W US 0213640W WO 02087467 A2 WO02087467 A2 WO 02087467A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- valve
- wing
- valve assembly
- support
- flexible sheet
- 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
- A61F2/2412—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
- A61F2/2475—Venous valves
Definitions
- the present invention relates to venous valve replacement and, in particular, to replacement venous valves to lower extremities and a therapeutic method of treating venous circulatory disorders.
- Chronic venous insufficiency (CVT) of the lower extremities is a common condition that is considered a serious public health and socioeconomic problem.
- CVT Chronic venous insufficiency
- Chronic venous insufficiency arises from long duration venous hypertension caused by valvular insufficiency and/or venous obstruction secondary to venous thrombosis.
- Other primary causes of CVT include varicosities of long duration, venous hypoplasia and arteriovenous fistula.
- the signs and symptoms of CVI have been used to classify the degree of severity of the disease, and reporting standards have been published. Studies demonstrate that deterioration of venous hemodynamic status correlates with disease severity.
- Venous reflux measured by ultrasound studies, is the method of choice of initial evaluation of patients with pain and/or swelling in the lower extremities.
- venous stasis ulcers are indicative of incompetent venous valves in all systems, including superficial, common, deep and communicating veins. This global involvement affects at least 30% of all cases.
- Standard principles of treatment are directed at elimination of venous reflux. Based on this observation, therapeutic intervention is best determined by evaluating the extent of valvular incompetence, and the anatomical distribution of reflux.
- Valvular incompetence a major component of venous hypertension, is present in about 60% of patients with a clinical diagnosis of CVI.
- Endovascular valve replacement refers to a new concept and new technology in the treatment of valvular reflux.
- the concept involves percutaneous insertion of the prosthetic device under fluoroscopic guidance.
- the device can be advanced to the desired intravascular location using guide wires and catheters. Deployment at a selected site can be accomplished to correct valvular incompetence.
- Percutaneous placement of a new valve apparatus provides a less invasive solution compared to surgical transposition or open repair of a valve.
- a replacement venous valve comprises a pair of support wings and a pair of valve wings.
- the valve wings are designed to deploy first from a catheter deployment device and provide stability while the support wings then deploy.
- the valve wings support the venous valve material and the support wings maintain patency of the vein above the valve while simultaneously anchoring the location and orientation of the valve.
- Figure 1 is a schematic depiction of the frame of one embodiment of a replacement valve.
- Figure 2 is a generally top perspective view of one embodiment of the replacement valve.
- Figure 3 is a schematic side section view of a replacement valve in a vein.
- Figure 4 is a schematic side view of one embodiment of the angular relationship of a replacement valve structure in a vein.
- Figure 5 is a side section view of a compressed, non-deployed replacement valve in a delivery system component.
- Figure 6 is a schematic side section view of a venous valve being localized prior to release in a vein.
- Figure 7 is a schematic side section view of the valve wing release opening of a venous valve in a vein.
- Figure 8 is a schematic side section view of the stabilizer wing release of a venous valve in a vein.
- Figure 9 is a schematic side section view of a venous valve being localized prior to release in a vein.
- Figure 10 is a schematic side section view of the valve wing release of a venous valve in a vein.
- Figure 11 is a schematic side section view of the valve wing positioning and release of the stabilizer wing in a venous valve in a vein.
- Figure 12 is a schematic side section view of the valve wing positioned and the stabilizer wing being deployed in a venous valve in a vein.
- Figure 13 is a schematic side section view of the valve wing and stabilizer wing fully deployed in a vein.
- Figure 14 is a schematic side section view of the valve functioning in position in a vein.
- Figure 15 is an assembly view of an alternate embodiment replacement valve design.
- a stent is assembled having excellent length and stability characteristics, as well as an improved profile for ease of placement and automatic deployment at a deployment site.
- the assembly does not rely only on placement at a previous valvular site but may also be utilized either proximal or distal to the incompetent valve site due to the self-expanding and self-orienting features and improved anti-migration characteristics of the assembly.
- the material chosen for endovascular valve leaflet portions of the replacement valve of this assembly may be selected from a variety of biocompatible substances. Whether the material is formed of elastomer, sclera, small intestine sub-mucosa (SIS), other mammalian tissue, or other suitable material, the venous stent device of this invention may serve as a substitute for deteriorated venous valves which have been altered by thrombosis or congenital hypoplasia.
- the valve prosthesis which self-expands similar to a stent will be percutaneously introduced with a small sized catheter delivery system, but demonstrates improved self-righting and orienting within the vein.
- Figure 1 is a schematic depiction of one embodiment of venous valve assembly 20 with a frame having a first support wing 21, an opposite second support wing 24, a first valve wing 22 with its opposite second valve wing 23.
- the first interlink 25 joins the support wings 21, 24 with the valve wings 22, 23 at a first junction.
- a second interlink 26 joins the support wings 21, 24 with the valve wings 22, 23 at a second junction.
- Valve 20 is preferably of unitary, single wire construction, but alternate configurations having a plurality of wires are possible.
- Figure 2 shows a venous valve assembly 20 with a first valve leaflet or flexible sheet 30 and a second valve leaflet or flexible sheet 34 with aperture 32 between the flexible sheets. It is recognized that, in operation, aperture 32 includes trailing edge portions 35 which open and closes as valve leaflets respond to the pressure and pumping action of the blood through the valve.
- first support wing 21 and second support wing 24 provide lateral stability by exertion of outward radial force in the form of a support ring exerting outward pressure against the inner lumenal wall 44 at a venous location for the valve.
- the valve wings 22, 23 exert similar force in the form of a valve ring force exerted outwardly against the lumenal wall 44, and provide similar stabilizing and self-righting advantage to the valve as will be further discussed.
- Figure 4 illustrates the approximate included angle desired between each support wing 21 and each valve wing 23 as generally about 60° +/- about no more than 10° and preferably only about +/- a maximum of about 5°, and between first valve wing 23 and second valve wing 22 as their ends push into vein wall 44.
- Figure 5 illustrates the folding of the venous valve stent 20 to a closed position within a deployment system device 50. It is shown how the respective valve and support wings fold compactly together in an overlapping, butterfly-like relationship.
- Figure 6 illustrates the folded venous valve stent 20 inside a delivery system device 50, such as a catheter.
- Figures 7 and 8 further illustrate the deployment sequence of the replacement valve stent 20 in relation to a vein wall 44.
- the venous valve 20 is pushed toward the delivering end of the delivery system 50 until the first valve wing 23 and the second valve wing 22 spring open and engage the vein lumenal wall 44.
- the delivery system 50 is withdrawn after the venous valve wings are in the desired position. With the delivery system 50 separated from the venous valve stent 20, the first support wing 21 and the second support wing 24 then engage the vein wall 44.
- Figures 9 - 14 are simpler schematic depictions of the steps of delivering the venous valve stent 20 into a vein.
- the final step illustrates the position of the venous valve stent in relation to blood flow arrows and depicts the functionality of the valve leaflets.
- Figure 15 is an assembly sequence view of another embodiment of a venous valve assembly 200 in which the first support wing 140 is conjoined with the first valve wing 150 to form half of venous valve assembly 200.
- the second support wingl ⁇ O is conjoined with second valve wing 170 to form the other half of venous valve assembly 200.
- the two halves are attached by connectors 180 at opposite locations on the frame.
- the last sequence view in this figure shows the connected halves with first valve leaflet or flexible sheet 300 and second valve leaflet or flexible sheet 340 attached to the valve wings thereby forming aperture 320 with trailing edges 350 in operation.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/476,363 US20040193253A1 (en) | 2001-04-30 | 2002-04-30 | Replacement venous valve |
AU2002254758A AU2002254758A1 (en) | 2001-04-30 | 2002-04-30 | Replacement venous valve |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US28751901P | 2001-04-30 | 2001-04-30 | |
US60/287,519 | 2001-04-30 | ||
US31281401P | 2001-08-16 | 2001-08-16 | |
US60/312,814 | 2001-08-16 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002087467A2 true WO2002087467A2 (en) | 2002-11-07 |
WO2002087467A3 WO2002087467A3 (en) | 2003-01-03 |
Family
ID=26964501
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/013640 WO2002087467A2 (en) | 2001-04-30 | 2002-04-30 | Replacement venous valve |
Country Status (3)
Country | Link |
---|---|
US (1) | US20040193253A1 (en) |
AU (1) | AU2002254758A1 (en) |
WO (1) | WO2002087467A2 (en) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1476095A2 (en) * | 2002-02-20 | 2004-11-17 | Francisco J. Osse | Venous bi-valve |
FR2874812A1 (en) * | 2004-09-07 | 2006-03-10 | Perouse Soc Par Actions Simpli | INTERCHANGEABLE PROTHETIC VALVE |
WO2019045766A1 (en) * | 2017-08-17 | 2019-03-07 | Incubar Llc | Prosthetic vascular valve and methods associated therewith |
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US7452371B2 (en) * | 1999-06-02 | 2008-11-18 | Cook Incorporated | Implantable vascular device |
DE60128069D1 (en) * | 2000-01-31 | 2007-06-06 | Cook Biotech Inc | STENT VALVE FLAP |
US6602286B1 (en) | 2000-10-26 | 2003-08-05 | Ernst Peter Strecker | Implantable valve system |
US6752828B2 (en) | 2002-04-03 | 2004-06-22 | Scimed Life Systems, Inc. | Artificial valve |
US6945957B2 (en) | 2002-12-30 | 2005-09-20 | Scimed Life Systems, Inc. | Valve treatment catheter and methods |
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US20050075729A1 (en) * | 2003-10-06 | 2005-04-07 | Nguyen Tuoc Tan | Minimally invasive valve replacement system |
US20070151570A1 (en) * | 2003-11-26 | 2007-07-05 | Farmache Alejandro H | Repairing procedure for the treatment of superficial and/or perforant venous insufficiency of the lower limbs by means of the application of clips, stoppers and/or artificial valves |
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US7854761B2 (en) | 2003-12-19 | 2010-12-21 | Boston Scientific Scimed, Inc. | Methods for venous valve replacement with a catheter |
US8128681B2 (en) | 2003-12-19 | 2012-03-06 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
US8430925B2 (en) * | 2004-02-27 | 2013-04-30 | Cardiacmd, Inc. | Prosthetic heart valves, scaffolding structures, and systems and methods for implantation of same |
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US7458987B2 (en) * | 2004-10-29 | 2008-12-02 | Cook Incorporated | Vascular valves having implanted and target configurations and methods of preparing the same |
US7905826B2 (en) * | 2004-11-03 | 2011-03-15 | Cook Incorporated | Methods for modifying vascular vessel walls |
US7387604B2 (en) | 2004-11-03 | 2008-06-17 | Cook Incorporated | Methods for treating valve-associated regions of vascular vessels |
WO2006062976A2 (en) | 2004-12-07 | 2006-06-15 | Cook Incorporated | Methods for modifying vascular vessel walls |
US20060173490A1 (en) | 2005-02-01 | 2006-08-03 | Boston Scientific Scimed, Inc. | Filter system and method |
US7854755B2 (en) | 2005-02-01 | 2010-12-21 | Boston Scientific Scimed, Inc. | Vascular catheter, system, and method |
US7878966B2 (en) | 2005-02-04 | 2011-02-01 | Boston Scientific Scimed, Inc. | Ventricular assist and support device |
US7670368B2 (en) | 2005-02-07 | 2010-03-02 | Boston Scientific Scimed, Inc. | Venous valve apparatus, system, and method |
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US7867274B2 (en) | 2005-02-23 | 2011-01-11 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US8303647B2 (en) * | 2005-03-03 | 2012-11-06 | Cook Medical Technologies Llc | Medical valve leaflet structures with peripheral region receptive to tissue ingrowth |
US8454678B2 (en) | 2005-03-19 | 2013-06-04 | Cook Biotech Incorporated | Prosthetic implants including ECM composite material |
US7722666B2 (en) | 2005-04-15 | 2010-05-25 | Boston Scientific Scimed, Inc. | Valve apparatus, system and method |
US8012198B2 (en) | 2005-06-10 | 2011-09-06 | Boston Scientific Scimed, Inc. | Venous valve, system, and method |
US8771340B2 (en) | 2005-08-25 | 2014-07-08 | Cook Medical Technologies Llc | Methods and devices for the endoluminal deployment and securement of prostheses |
US8470022B2 (en) | 2005-08-31 | 2013-06-25 | Cook Biotech Incorporated | Implantable valve |
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US20070112423A1 (en) * | 2005-11-16 | 2007-05-17 | Chu Jack F | Devices and methods for treatment of venous valve insufficiency |
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US20090248142A1 (en) | 2008-03-25 | 2009-10-01 | Medtronic Vascular, Inc. | Methods, Devices and Systems for Treating Venous Insufficiency |
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US20100131049A1 (en) * | 2008-11-24 | 2010-05-27 | Medtronic Vascular, Inc. | One-Way valve Prosthesis for Percutaneous Placement Within the Venous System |
US8348997B2 (en) * | 2009-02-24 | 2013-01-08 | Medtronic Vascular, Inc. | One-way replacement valve |
US8292948B2 (en) * | 2010-02-17 | 2012-10-23 | Medtronic Vascular, Inc. | Apparatus and methods for creating a venous valve from autologous tissue |
US9504572B2 (en) * | 2010-02-17 | 2016-11-29 | Medtronic Vascular, Inc. | Apparatus and methods for creating a venous valve from autologous tissue |
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US10173027B2 (en) | 2015-10-07 | 2019-01-08 | Cook Medical Technologies Llc | Methods, medical devices and kits for modifying the luminal profile of a body vessel |
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2002
- 2002-04-30 US US10/476,363 patent/US20040193253A1/en not_active Abandoned
- 2002-04-30 AU AU2002254758A patent/AU2002254758A1/en not_active Abandoned
- 2002-04-30 WO PCT/US2002/013640 patent/WO2002087467A2/en not_active Application Discontinuation
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Cited By (9)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1476095A2 (en) * | 2002-02-20 | 2004-11-17 | Francisco J. Osse | Venous bi-valve |
EP1476095A4 (en) * | 2002-02-20 | 2007-04-25 | Francisco J Osse | Venous bi-valve |
FR2874812A1 (en) * | 2004-09-07 | 2006-03-10 | Perouse Soc Par Actions Simpli | INTERCHANGEABLE PROTHETIC VALVE |
WO2006027500A2 (en) * | 2004-09-07 | 2006-03-16 | Laboratoires Perouse | Interchangeable prosthetic valve |
WO2006027500A3 (en) * | 2004-09-07 | 2006-06-01 | Perouse Lab | Interchangeable prosthetic valve |
US7806927B2 (en) | 2004-09-07 | 2010-10-05 | Laboratoires Perouse | Interchangeable prosthetic valve |
WO2019045766A1 (en) * | 2017-08-17 | 2019-03-07 | Incubar Llc | Prosthetic vascular valve and methods associated therewith |
US10350095B2 (en) | 2017-08-17 | 2019-07-16 | Incubar, LLC | Prosthetic vascular valve and methods associated therewith |
US11013625B2 (en) | 2017-08-17 | 2021-05-25 | Incubar Llc | Prosthetic vascular valve and methods associated therewith |
Also Published As
Publication number | Publication date |
---|---|
AU2002254758A1 (en) | 2002-11-11 |
WO2002087467A3 (en) | 2003-01-03 |
US20040193253A1 (en) | 2004-09-30 |
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