CA2601134A1 - Implantable devices with reduced needle puncture site leakage - Google Patents
Implantable devices with reduced needle puncture site leakage Download PDFInfo
- Publication number
- CA2601134A1 CA2601134A1 CA002601134A CA2601134A CA2601134A1 CA 2601134 A1 CA2601134 A1 CA 2601134A1 CA 002601134 A CA002601134 A CA 002601134A CA 2601134 A CA2601134 A CA 2601134A CA 2601134 A1 CA2601134 A1 CA 2601134A1
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- CA
- Canada
- Prior art keywords
- implantable device
- tubular
- elastomeric material
- vascular graft
- tube
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
- F16L—PIPES; JOINTS OR FITTINGS FOR PIPES; SUPPORTS FOR PIPES, CABLES OR PROTECTIVE TUBING; MEANS FOR THERMAL INSULATION IN GENERAL
- F16L11/00—Hoses, i.e. flexible pipes
- F16L11/04—Hoses, i.e. flexible pipes made of rubber or flexible plastics
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/28—Materials for coating prostheses
- A61L27/34—Macromolecular materials
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
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- 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
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/56—Porous materials, e.g. foams or sponges
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- B29D—PRODUCING PARTICULAR ARTICLES FROM PLASTICS OR FROM SUBSTANCES IN A PLASTIC STATE
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- B29D23/001—Pipes; Pipe joints
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
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- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
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- B32B3/26—Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar form; Layered products having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
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- B32B5/00—Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
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- B32B5/142—Variation across the area of the layer
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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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C35/00—Heating, cooling or curing, e.g. crosslinking or vulcanising; Apparatus therefor
- B29C35/02—Heating or curing, e.g. crosslinking or vulcanizing during moulding, e.g. in a mould
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C41/08—Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder
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- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C63/00—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor
- B29C63/18—Lining or sheathing, i.e. applying preformed layers or sheathings of plastics; Apparatus therefor using tubular layers or sheathings
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/01—General aspects dealing with the joint area or with the area to be joined
- B29C66/344—Stretching or tensioning the joint area during joining
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2021/00—Use of unspecified rubbers as moulding material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
- B29K2027/12—Use of polyvinylhalogenides or derivatives thereof as moulding material containing fluorine
- B29K2027/18—PTFE, i.e. polytetrafluorethene, e.g. ePTFE, i.e. expanded polytetrafluorethene
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- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/24—Condition, form or state of moulded material or of the material to be shaped crosslinked or vulcanised
- B29K2105/246—Uncured, e.g. green
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- B29L2023/007—Medical tubes other than catheters
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Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- General Engineering & Computer Science (AREA)
- Vascular Medicine (AREA)
- Dispersion Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
Abstract
A prosthetic implantable device that offers a reduction in fluid loss when the device is punctured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device may be made to be thin and flexible, and with longitudinal stretch, in order that it also offers good handling and kink resistance to a surgeon. While the device is preferably of tubular form, flat sheets or other forms may also be made. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces of the adjacent surfaces of the inner and outer layers, that is, the inner surface of the outer layer and the outer surface of the inner layer.
Claims (52)
1. An implantable device comprising:
a.) an inner layer of porous material having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration;
b.) a middle layer of an elastomeric material; and c.) an outer layer of porous material having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration.
a.) an inner layer of porous material having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration;
b.) a middle layer of an elastomeric material; and c.) an outer layer of porous material having a microstructure of nodes and fibrils wherein a substantial portion of said fibrils are in a bent configuration.
2. An implantable device according to claim 1 wherein said device is tubular.
3. An implantable device according to claim 1 wherein at least one of said inner and outer layers comprise expanded polytetrafluoroethylene.
4. An implantable device according to claim 3 wherein said device is tubular.
5. An implantable device according to claim 4 wherein at least one of said inner and outer layers is provided with a helical wrap of expanded polytetrafluoroethylene film about at least a portion of an outer surface of said layer.
6. An implantable device according to claim 4 wherein said elastomeric material comprises silicone.
7. An implantable device according to claim 4 wherein said elastomeric material comprises polyurethane.
8. An implantable device according to claim 4 wherein said elastomeric material comprises a fluoroelastomer.
9. An implantable device according to claim 4 wherein said device further comprises nitinol.
10. An implantable device according to claim 4 wherein said inner and outer layers of porous material each have a thickness and said elastomer extends into void spaces of the porous material for a portion of said thickness.
11. An implantable device according to claim 4 wherein said inner and outer layers each has a length and at least one of said inner and outer layers has regions of higher density alternating with regions of lower density alternating along said length.
12. An implantable device according to claim 4 wherein at least one of said inner and outer layers comprises expanded polytetrafluoroethylene film.
13. An implantable device according to claim 1 wherein said elastomeric material comprises silicone.
14. An implantable device according to claim 1 wherein said elastomeric material comprises polyurethane.
15. An implantable device according to claim 1 wherein said elastomeric material comprises a fluoroelastomer.
16. An implantable device according to claim 1 wherein said device further comprises nitinol.
17. An implantable device according to claim 1 wherein said inner and outer layers of porous material each has a thickness and said elastomer extends into void spaces of the porous material for a portion of said thickness.
18. An implantable device according to claim 1 wherein said inner and outer layers each has a length and at least one of said inner and outer layers has regions of higher density alternating with regions of lower density along said length.
19. A tubular implantable device comprising first and second tubes having inner and outer surfaces and a microstructure including fibrils between the inner and outer surfaces, wherein said second tube is arranged concentrically around said first tube, wherein the outer surface of said first tube and the inner surface of said second tube are adhered with an elastomeric material, and wherein at least a substantial portion of the fibrils of the first and second tubes are in a bent configuration.
20. A tubular implantable device according to claim 19 wherein at least one of said first and second tubes comprises expanded polytetrafluoroethylene.
21 21. A tubular implantable device according to claim 20 wherein at least one of said first and second tubes is provided with a helical wrap of expanded polytetrafluoroethylene film about at least a portion of the outer surface of said tube.
22. A tubular implantable device according to claim 20 wherein said elastomeric material comprises silicone.
23. A tubular implantable device according to claim 20 wherein said elastomeric material comprises polyurethane.
24. A tubular implantable device according to claim 20 wherein said elastomeric material comprises a fluoroelastomer.
25. A tubular implantable device according to claim 20 wherein said first and second tubes each has a thickness and said elastomer extends into void spaces of the microstructure for a portion of said thickness.
26. A tubular implantable device according to claim 20 wherein said first and second tubes each has a length and at least one of said first and second tubes has regions of higher density alternating with regions of lower density along said length.
27. A tubular implantable device according to claim 20 wherein at least one of said inner and outer layers comprises expanded polytetrafluoroethylene film.
28. A tubular implantable device according to claim 19 wherein said elastomeric material comprises silicone.
29. A tubular implantable device according to claim 19 wherein said elastomeric material comprises polyurethane.
30. A tubular implantable device according to claim 19 wherein said elastomeric material comprises a fluoroelastomer.
31. A tubular implantable device according to claim 19 wherein said first and second tubes each has a thickness and said elastomer extends into void spaces of the microstructure for a portion of said thickness.
32. The tubular implantable device of claim 19 wherein a tubular layer of elastomeric material is located between the outer surface of the first tube and the inner surface of the second tube.
33. A tubular implantable device according to claim 32 wherein at least one of said first and second tubes comprises expanded polytetrafluoroethylene.
34. A tubular implantable device according to claim 33 wherein at least one of said first and second tubes is provided with a helical wrap of expanded polytetrafluoroethylene film about at least a portion of the outer surface of said tube.
35. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises silicone.
36. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises polyurethane.
37. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises a fluoroelastomer.
38. A tubular implantable device according to claim 33 wherein said tubular layer of elastomeric material comprises nitinol.
39. A vascular graft for dialysis comprising at least two layers of expanded polytetrafluoroethylene with an elastomeric material between the two layers of expanded polytetrafluoroethylene, the vascular graft having a bend radius of 30mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.
40. A vascular graft according to claim 39 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.
41. A vascular graft according to claim 39 having a bend radius of 25mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.
42. A vascular graft according to claim 41 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.
43. A vascular graft according to claim 39 having a bend radius of 20mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.
44. A vascular graft according to claim 43 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.
45. A vascular graft according to claim 39 having a bend radius of 17mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.
46. A vascular graft according to claim 45 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.
47. A vascular graft according to claim 39 having a bend radius of 15mm without kinking, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.
48. A vascular graft according to claim 47 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.
49. A vascular graft for dialysis comprising at least two layers of expanded polytetrafluoroethylene with an elastomeric material between the two layers of expanded polytetrafluoroethylene, the expanded polytetrafluoroethylene having a microstructure of substantially bent fibrils, wherein the vascular graft is adapted for cannulation with a dialysis needle within 48 hours after implantation.
50. A vascular graft according to claim 49 wherein the vascular graft is adapted for cannulation with a dialysis needle within 24 hours after implantation.
51. A method of making a tubular implantable device comprising:
a) providing first and second expanded polytetrafluoroethylene tubes, said tubes having outer surfaces;
b) fitting said first expanded polytetrafluoroethylene tube over a mandrel with a slight interference fit;
c) coating at least a portion of the outer surface of said first tube with an elastomeric material;
d) fitting said second expanded polytetrafluoroethylene tube over the coated surface of said first tube;
e) longitudinally compressing said first and second expanded polytetrafluoroethylene tubes;
f) curing said elastomeric material; and g) removing said first and second tubes from said mandrel.
a) providing first and second expanded polytetrafluoroethylene tubes, said tubes having outer surfaces;
b) fitting said first expanded polytetrafluoroethylene tube over a mandrel with a slight interference fit;
c) coating at least a portion of the outer surface of said first tube with an elastomeric material;
d) fitting said second expanded polytetrafluoroethylene tube over the coated surface of said first tube;
e) longitudinally compressing said first and second expanded polytetrafluoroethylene tubes;
f) curing said elastomeric material; and g) removing said first and second tubes from said mandrel.
52. A method of making a tubular implantable device comprising:
a) providing first and second tubes of expanded polytetrafluoroethylene, said tubes having outer surfaces;
b) providing an elastomeric tube having an outer surface;
c) fitting said first tube of expanded polytetrafluoroethylene over a mandrel with a slight interference fit;
d) coating at least a portion of the outer surface of said first tube with an elastomeric material;
e) fitting said elastomeric tube over the first expanded polytetrafluoroethylene tube;
f) applying tension longitudinally to said elastomeric tube and restraining both ends of said elastomeric tube to maintain said elastomeric tube in a state of tension;
g) coating at least a portion of the outer surface of said elastomeric tube with an elastomeric material;
h) fitting said second expanded polytetrafluoroethylene tube over the coated surface of said elastomeric tube;
i) curing said elastomeric material; and j) removing all three tubes from said mandrel and trimming both ends.of the resulting tubular implantable device.
a) providing first and second tubes of expanded polytetrafluoroethylene, said tubes having outer surfaces;
b) providing an elastomeric tube having an outer surface;
c) fitting said first tube of expanded polytetrafluoroethylene over a mandrel with a slight interference fit;
d) coating at least a portion of the outer surface of said first tube with an elastomeric material;
e) fitting said elastomeric tube over the first expanded polytetrafluoroethylene tube;
f) applying tension longitudinally to said elastomeric tube and restraining both ends of said elastomeric tube to maintain said elastomeric tube in a state of tension;
g) coating at least a portion of the outer surface of said elastomeric tube with an elastomeric material;
h) fitting said second expanded polytetrafluoroethylene tube over the coated surface of said elastomeric tube;
i) curing said elastomeric material; and j) removing all three tubes from said mandrel and trimming both ends.of the resulting tubular implantable device.
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PCT/US2005/043058 WO2006058322A2 (en) | 2004-11-29 | 2005-11-28 | Implantable devices with reduced needle puncture site leakage |
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CA2601134C CA2601134C (en) | 2010-08-10 |
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CA2601134A Active CA2601134C (en) | 2004-11-29 | 2005-11-28 | Implantable devices with reduced needle puncture site leakage |
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EP (1) | EP1890640B1 (en) |
CA (1) | CA2601134C (en) |
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EP1890640A4 (en) | 2011-08-24 |
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WO2006058322A3 (en) | 2006-12-21 |
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EP1890640B1 (en) | 2017-08-30 |
US8029563B2 (en) | 2011-10-04 |
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CA2601134C (en) | 2010-08-10 |
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