WO2005048884A1 - Temporary absorbable venous occlusive device and superficial vein treatment method - Google Patents
Temporary absorbable venous occlusive device and superficial vein treatment method Download PDFInfo
- Publication number
- WO2005048884A1 WO2005048884A1 PCT/US2004/038274 US2004038274W WO2005048884A1 WO 2005048884 A1 WO2005048884 A1 WO 2005048884A1 US 2004038274 W US2004038274 W US 2004038274W WO 2005048884 A1 WO2005048884 A1 WO 2005048884A1
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- WIPO (PCT)
- Prior art keywords
- stent
- accordance
- vein
- absorbable
- bio
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/1204—Type of occlusion temporary occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0467—Instruments for cutting sutures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
- A61B2090/3954—Markers, e.g. radio-opaque or breast lesions markers magnetic, e.g. NMR or MRI
Definitions
- This invention relates to vascular disease and the treatment thereof. More particularly, the invention pertains to an apparatus and method for treating varicose veins.
- the radio frequency ablation technique represents an improvement over surgical ligation and stripping because it can be performed percutaneously as an ambulatory procedure.
- the high radio frequency energy could damage tissue that surrounds the treated area if the procedure is not performed properly.
- the electronic equipment and procedural instrumentation required for the radio frequency technique are relatively costly.
- the foregoing problems are solved and an advance in the art is obtained by a novel temporary absorbable venous occlusive stent and a related varicose vein treatment method.
- the stent includes a stent body, a bio-absorbable material associated with the body, and a closure for blocking blood flow past the stent when implanted in a vein.
- the stent promotes localized blood clotting, fibrosis and vein collapse as the stent is absorbed. A permanent blockage is thereby produced that prevents the undesirable back flow of blood from above the stent implantation site, thereby reducing distension of the varicose vein below the implantation site.
- a temporary absorbable venous occlusive stent is introduced via a deep venous system or superficial venous system approach to an implantation site proximate to or above a varicose vein to be treated. There, the stent is deployed against the walls of the vein. Closure of the stent is performed as necessary to block blood flow past the stent. As indicated above, the stent is gradually absorbed while producing a permanent blockage resulting from localized blood clotting, fibrosis and vein collapse.
- Fig. 1 is a diagrammatic view showing the outline of a human upper thigh and groin area and a portion of the venous circulatory system therein;
- Fig. 2 is a perspective view showing a temporary absorbable venous occlusive stent in accordance with a first exemplary embodiment of the invention in various stages of closure;
- Fig. 3 A is a longitudinal cross-sectional view of a varicose vein and a perspective view showing the stent of Fig. 2 being inserted therein;
- Fig. 1 is a diagrammatic view showing the outline of a human upper thigh and groin area and a portion of the venous circulatory system therein;
- Fig. 2 is a perspective view showing a temporary absorbable venous occlusive stent in accordance with a first exemplary embodiment of the invention in various stages of closure;
- Fig. 3 A is a longitudinal cross-sectional view of a varicose vein and a perspective view showing the s
- FIG. 3B is a view according to Fig. 3A showing the stent in an initial deployed condition in the varicose vein
- Fig. 3C is a view according to Fig. 3 A showing the stent in a final deployed condition in the varicose vein
- Fig. 3D is a view according to Fig. 3 A showing the stent in a partially absorbed condition and the varicose vein in a state of partial collapse
- FIG. 3E is a view according to Fig. 3 A after the stent has been completely absorbed and the varicose vein is fully collapsed and permanently blocked
- Fig. 3A is a view according to Fig. 3A showing the stent in an initial deployed condition in the varicose vein
- Fig. 3C is a view according to Fig. 3 A showing the stent in a final deployed condition in the varicose vein
- Fig. 3D is a view according to Fig. 3 A showing the stent in a partially absorbed condition
- FIG. 4A is a perspective view of a temporary absorbable venous occlusive stent in accordance with a second exemplary embodiment of the invention in which the stent is formed as a generally tubular member having a closed end;
- Fig. 4B is a perspective view according to Fig. 4A in which the stent is cross- sectionally divided to illustrate its hollow interior;
- Fig. 5 A is a perspective view of a temporary absorbable venous occlusive stent in accordance with a third exemplary embodiment of the invention in which the stent is formed as a solid member;
- Fig. 5B is a perspective view according to Fig. 5A in which the stent is cross- sectionally divided to illustrate its solid interior;
- FIG. 6 A is a longitudinal cross-sectional view showing a portion of a venous circulatory system in a human upper thigh and groin area and a perspective view of a stent delivery system including a guide wire that has been advanced from a percutaneous point of entry (not shown) to the site of a varicose vein to be implanted, and a sheath introducer passing over the guide wire and approaching the sapheno-femoral junction;
- Fig. 6B is a view according to Fig. 6A showing the sheath introducer after it has been advanced through the long saphenous vein (and any intervening superficial branch veins) to the site of the varicose vein to be implanted;
- Fig. 6C is a view according to Fig.
- FIG. 6A showing a balloon catheter carrying a temporary absorbable venous occlusive stent within the sheath introducer, with the stent approaching the sapheno-femoral junction
- Fig. 6D is a view according to Fig. 6 A showing the stent at the distal end of the sheath introducer
- Fig. 6E is a view according to Fig. 6A showing the stent following deployment in the varicose vein to be implanted and expansion by the balloon catheter, and further showing withdrawal of the balloon catheter back into the sheath introducer
- Fig. 6F is a view according to Fig. 6A following removal of the balloon catheter from the sheath introducer
- Fig. 6G is a view according to Fig.
- FIG. 6A showing the closure of the stent using drawstring members extending from the stent to the percutaneous entry point
- Fig. 6H is a view according to Fig. 6 A following securement of the stent drawstring members and cutting thereof proximate to the stent
- Fig. 61 is a view according to Fig. 6 A following removal of the sheath introducer
- Fig. 6J is a view according to Fig. 6A showing the stent in a partially absorbed condition and the varicose vein in a state of partial collapse
- Fig. 6K. is a view according to Fig. 6A after the stent has been fully absorbed and the implanted section of varicose vein is fully collapsed and permanently blocked
- Fig. 6H is a view according to Fig. 6 A following securement of the stent drawstring members and cutting thereof proximate to the stent
- Fig. 61 is a view according to Fig. 6 A following removal of the shea
- FIG. 7 is a longitudinal cross-sectional view showing a portion of a venous circulatory system in a human upper thigh and groin area and a perspective view of a stent delivery system including a guide wire having a ferromagnetic tip that has been advanced at least partially under the guidance of a magnet from a percutaneous point of entry (not shown) to the site of a varicose vein to be implanted, and a sheath introducer passing over the guide wire and approaching the sapheno-femoral junction; and Fig.
- FIG. 8 is a longitudinal cross-sectional view showing a portion of a venous circulatory system in a human upper thigh and groin area and a perspective view of a stent delivery system including an sheath introducer having a ferromagnetic tip that has., been guided at least partially by way of a magnet to the sapheno-femoral junction.
- a stent delivery system including an sheath introducer having a ferromagnetic tip that has., been guided at least partially by way of a magnet to the sapheno-femoral junction.
- Fig. 1 the thigh-groin region (TG) of a human leg is shown to illustrate a portion of the venous circulatory system and an exemplary area of the human body in which the present invention may be implemented.
- Fig. 1 the thigh-groin region (TG) of a human leg is shown to illustrate a portion of the venous circulatory system and an exemplary area of the human body in which the present invention
- sapheno-femoral junction SFJ
- CBV common femoral vein
- varicose veins such as the varicose vein (W) shown in the inset in Fig. 1.
- W varicose vein
- Similar problems can occur due to valve leakage at the sapheno-popliteal junction of the short saphenous vein and the popliteal vein behind the knee. Leakage of any of the valves in the perforator veins connecting the superficial leg veins to the deep veins of the leg can likewise lead to varicose veins.
- the present invention contemplates a varicose vein treatment apparatus and method wherein a distended varicose vein, such as the vein W of Fig.
- a temporary absorbable venous occlusive stent is implanted with a temporary absorbable venous occlusive stent.
- the stent is placed either within the distended area or into an adjacent (or non-adjacent) venous section that is delivering unwanted downward blood flow to the distended area.
- the stent stops the flow of blood past the implantation site and promotes localized blood clotting, fibrosis and vein collapse as the stent is absorbed.
- Fig. 2 illustrates an exemplary embodiment 2 of a temporary absorbable venous occlusive stent that may be used in accordance with the invention.
- the stent 2 is configured as a generally tubular body 4 having a proximal end 6 and a distal end 8.
- the body 4 is made from a bio-absorbable material having the capability to absorb within a time frame that is long enough to allow the aforementioned permanent blockage to form in a vein to be implanted.
- a fabric woven from threads of dissolvable (e.g., polylactic acid) suture material could be used to form the body 4.
- Such material has an absorption schedule of about 28 days, which should be more than adequate for purposes of the present invention.
- Both ends of the stent 2 are initially open, but the proximal end 6 is provided with a suitable closure system that allows it to be closed following deployment, Fig.
- FIG. 2 shows one exemplary closure system in the form of a drawstring arrangement.
- a drawstring 10 made from a dissolvable suture or other bio- absorbable material is secured around the circumferential periphery of the proximal end 6 of the body 4 in a manner that allows the proximal end to be closed by pulling on the drawstring's end portions 12 and 14.
- the drawstring 10 could likewise be placed at the distal end 8 of the stent 2. It could also be arranged on the stent 2 so that only a single drawstring end portion is required for stent closure.
- Figs. 3A-3E illustrate a series of the sequential steps by which the stent 2 can be used to treat a varicose vein. In Fig.
- the stent 2 is in the process of being deployed to the varicose vein (VV) to be treated, with the stent's proximal end being oriented toward its point of entry into the patient (not shown).
- VV varicose vein
- Fig. 3B the stent 2 is shown at an implantation site within the vein.
- Fig. 3C the drawstring 10 has been manipulated to close the stent's proximal end 6. At this point, blood flow is prevented from passing through the stent 2, such that distention of the vein should be alleviated. Closure of the stent 2 also causes blood in the vicinity of the stent to pool and begin clotting. This produces fibrotic tissue and vein collapse as the stent is absorbed.
- FIG. 3D shows the stent 2 in a partially absorbed condition and the vein in a state of partial collapse.
- Fig. 3E the stent 2 is completely absorbed and the vein is fully collapsed and permanently blocked at 20.
- the blockage 20 prevents the back flow of blood from leaky vein valves situated above the implantation site.
- many alternative constructions may be used to provide a temporary absorbable venous occlusive stent in accordance with the invention.
- such stents may be produced in variety of diameters and lengths for implantation at different locations of the body. It may also be desirable to utilize several stents at a single implantation site in lieu of a single longer stent.
- the several stents could be provided with suitable connectors for establishing serial interconnections between adjacent stents.
- Stents in accordance with the invention can also be treated with a suitable drug, such as rapamycin (a cell cycle inhibitor). Such drug-alluded stents may be more efficient promoters of vein collapse than untreated stents.
- Another alternative would be to treat a stent with a suitable radioactive substance that produces localized cell death and an increased rate of vein collapse.
- Stents in accordance with the invention could be treated with drugs or radioactive substances by via impregnation into the bio-absorbable material that forms the stents.
- the stents could be formed with a double lumen or the like to provide an enclosed pocket for containing a drug or radioactive substance.
- a pocket could also be used to carry a cryomaterial that further promotes cell death and vein collapse.
- Another use for a pocket formed on the stent would be to carry a dye material to guide stent placement at an implantation site. Implantation could also be aided by providing the stent with a radioopaque marker.
- Figs. 4A-4B and 5A-5B illustrate additional stent configuration alternatives.
- a second exemplary embodiment 102 of a temporary absorbable venous occlusive stent is shown.
- the stent 102 is configured as a generally tubular body 104 having a proximal end 106 and a distal end 108.
- the body 104 is similar to the body 4 of Fig. 2 except that the proximal end 106 of the body 104 has a closed end wall 110.
- the end wall 110 provides a closure system for the stent 102 that represents an alternative to the drawstring closure system used in the stent 2 of Fig. 2.
- end wall 110 can either be permanently formed as part of the body 104, or alternatively could be separately attached thereto, either prior to, during or after deployment of the stent 102 (e.g., as an insertable plug). Although the end wall 110 is located at the proximal end 106 of the stent 102, it could also be located at the distal end 108. A wall could also be located at any point between the ends 106 and 108 of the stent 102, such as at the stent's longitudinal midpoint. In Fig. 5 A, a third exemplary embodiment 202 of a temporary absorbable venous occlusive stent is shown.
- the stent 202 is configured as a generally solid cylindrical body 204 having a proximal end 206 and a distal end 208.
- the use of a solid body 204 provides a closure system for the stent 202 that represents an alternative to the drawstring closure system used in the stent 2 of Fig. 2.
- the body 204 can be made from any suitable bio-absorbable material, such as packed or bundled bio-absorbable filaments, folded bio-absorbable fabric, or a bio- absorbable foam.
- this vein can be reached via a common femoral vein (FV), a sapheno- femoral junction (SFJ), a long saphenous vein (LSV), and a possible intervening section (IS) that may contain one or more side branches of the type shown by reference numeral (SB).
- FV common femoral vein
- SFJ sapheno- femoral junction
- LSV long saphenous vein
- IS possible intervening section
- SB possible intervening section
- a percutaneous opening (not shown) is formed in the patient's cephalic vein located in the upper arm (or any other suitable location that allows access to the patient's deep venous system).
- an optional guide wire is introduced and passed upwardly (e.g., using conventional optical guidance means as necessary) through the subclavian vein, then downwardly through the superior vena cava and the inferior vena cava to a desired one of the femoral veins. Advancement of the guide wire then continues along the selected femoral vein to the sapheno-femoral junction, at which point the long saphenous vein is entered. The guide wire is then further advanced along appropriate tributaries of the long saphenous vein until the implantation site in the varicose vein (W) is reached. As shown in Figs.
- W varicose vein
- a sheath introducer is introduced over the guide wire and advanced along the venous pathways in which the guide wire is situated until the distal end of the introducer is adjacent to the implantation site.
- the sheath introducer can be inserted without the use of a guide wire, or a guide wire could be inserted after the sheath introducer (in order to guide a balloon catheter as described below).
- the guide wire is designated by reference numeral 300 and the sheath introducer is designated by reference numeral 302.
- the stent's drawstring ends 12 and 14 will extend back to the percutaneous entry site (not shown) as the stent 2 is advanced into the patient.
- Fig. 6C and 6D the stent's drawstring ends 12 and 14 will extend back to the percutaneous entry site (not shown) as the stent 2 is advanced into the patient.
- a stent might also be constructed with resilient properties so as to be outwardly expandable (e.g., using bio-absorbable foam). In that case, the stent would be compressed while in the catheter but would expand to engage the vein walls when deployed.
- Figs. 7 and 8 show a further aspect of the invention in which a magnet 400 is used to direct either the guide wire 300 or the sheath introducer 302 (without a guide wire) to the implantation site in the varicose vein (W).
- the tip portion 402 of the guide wire 300 is made from ferromagnetic material.
- the tip of the sheath introducer 302 is provided with a ferromagnetic guide element 404.
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Abstract
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Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP04819147A EP1696834A1 (en) | 2003-11-17 | 2004-11-16 | Temporary absorbable venous occlusive device and superficial vein treatment method |
CA002546167A CA2546167A1 (en) | 2003-11-17 | 2004-11-16 | Temporary absorbable venous occlusive device and superficial vein treatment method |
JP2006539989A JP2007511294A (en) | 2003-11-17 | 2004-11-16 | Temporary absorbable vein occlusion device and superficial vein treatment method |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US52053003P | 2003-11-17 | 2003-11-17 | |
US60/520,530 | 2003-11-17 | ||
US10/754,919 US20050107867A1 (en) | 2003-11-17 | 2004-01-10 | Temporary absorbable venous occlusive stent and superficial vein treatment method |
US10/754,919 | 2004-01-10 |
Publications (1)
Publication Number | Publication Date |
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WO2005048884A1 true WO2005048884A1 (en) | 2005-06-02 |
Family
ID=34576962
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2004/038274 WO2005048884A1 (en) | 2003-11-17 | 2004-11-16 | Temporary absorbable venous occlusive device and superficial vein treatment method |
Country Status (5)
Country | Link |
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US (4) | US20050107867A1 (en) |
EP (1) | EP1696834A1 (en) |
JP (1) | JP2007511294A (en) |
CA (1) | CA2546167A1 (en) |
WO (1) | WO2005048884A1 (en) |
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US11109867B2 (en) | 2018-03-16 | 2021-09-07 | Boston Scientific Scimed, Inc. | Devices and methods for vein closure |
EP3906962A1 (en) * | 2020-05-07 | 2021-11-10 | Gefässpraxis Dr. Erpen AG | Device for closing the opening of a vein in the treatment of varicosis |
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US20050107867A1 (en) * | 2003-11-17 | 2005-05-19 | Taheri Syde A. | Temporary absorbable venous occlusive stent and superficial vein treatment method |
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- 2004-01-10 US US10/754,919 patent/US20050107867A1/en not_active Abandoned
- 2004-11-16 CA CA002546167A patent/CA2546167A1/en not_active Abandoned
- 2004-11-16 EP EP04819147A patent/EP1696834A1/en not_active Withdrawn
- 2004-11-16 WO PCT/US2004/038274 patent/WO2005048884A1/en active Application Filing
- 2004-11-16 JP JP2006539989A patent/JP2007511294A/en not_active Withdrawn
-
2006
- 2006-04-20 US US11/407,847 patent/US20060282159A1/en not_active Abandoned
- 2006-04-20 US US11/407,482 patent/US20060190076A1/en not_active Abandoned
- 2006-04-20 US US11/407,689 patent/US20060282158A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20020188348A1 (en) * | 1999-10-21 | 2002-12-12 | Scimed Life Systems, Inc. | Implantable prosthetic valve |
WO2001056500A2 (en) * | 2000-02-03 | 2001-08-09 | Cook Incorporated | Implantable vascular device |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11109867B2 (en) | 2018-03-16 | 2021-09-07 | Boston Scientific Scimed, Inc. | Devices and methods for vein closure |
EP3906962A1 (en) * | 2020-05-07 | 2021-11-10 | Gefässpraxis Dr. Erpen AG | Device for closing the opening of a vein in the treatment of varicosis |
Also Published As
Publication number | Publication date |
---|---|
US20050107867A1 (en) | 2005-05-19 |
JP2007511294A (en) | 2007-05-10 |
US20060282158A1 (en) | 2006-12-14 |
US20060282159A1 (en) | 2006-12-14 |
EP1696834A1 (en) | 2006-09-06 |
CA2546167A1 (en) | 2005-06-02 |
US20060190076A1 (en) | 2006-08-24 |
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