US6827731B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Deployment system for intraluminal devices
Assignee: W.L. Gore and Associates Inc
•
Filing: 2002-01-22
•
Granted: 2004-12-07
•
Expires: 2022-01-22
Abstract
Abstract A constraining sheath for use around an endoprosthesis (e.g., a stent device, with or without a graft covering), which may be a balloon expandable endoprosthesis but more preferably is a self-expanding prosthesis. The endoprosthesis is coaxially enclosed within the constraining sheath, which is an outer, disruptable, preferably implantable tubular sheath, preferably made of ePTFE. The constraining sheath and endoprosthesis are preferably mounted together as an assembly on an angioplasty balloon for delivery. Deployment of the endoprosthesis entails inflating the angioplasty balloon to a pressure sufficient to disrupt or break the constraining sheath in a prescribed fashion, thereby allowing a self-expanding endoprosthesis to spontaneously deploy. The constraining sheath of ePTFE may be attached to the endoprosthesis and implanted along with the device, or alternatively attached to the balloon catheter shaft and removed with the balloon catheter. The angioplasty balloon's working length is preferably shorter than the length of the endoprosthesis. An endoprosthesis assembly incorporating a constraining sheath according to one embodiment of the invention is also provided with an additional packaging sheath.
Inventors
- 👤 Joseph R. Armstrong
- 👤 Edward H. Cully
- 👤 Mark J. Ulm
- 👤 Michael J. Vonesh
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 21:12
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/95; A61F2/962; A61F2/97; A61F2/9522; A61F2/958; A61F2/82; A61F2/86; A61F2002/9505; A61F2002/9511; A61F2002/9583; A61F2250/00; A61F2250/0058; A61F2250/0071
Claims Analysis
Total Claims: 37
Claim 1
Independent Claim
136 words
An endoprosthesis assembly comprising an implantable endoprosthesis capable of being diametrically expanded from a smaller diameter to a larger diameter; and a generally tubular, delicate constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, said constraining sheath being provided with means for disruption initiated by application of a distending force to the constraining sheath, wherein said assembly is contained within a packaging sheath which is not required to be implantable, and wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 21 hours and less than or equal to 60 days.
Claim 2
Dependent Claim
136 words
An endoprosthesis assembly comprising an implantable endoprosthesis capable of being diametrically expanded from a smaller diameter to a larger diameter; and a generally tubular, delicate constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, said constraining sheath being provided with means for disruption initiated by application of a distending force to the constraining sheath, wherein said assembly is contained within a packaging sheath which is not required to be implantable, and wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 21 hours and less than or equal to 60 days.
Claim 3
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 24 hours.
Claim 4
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 48 hours.
Claim 5
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 5 days.
Claim 6
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 10 days.
Claim 7
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 20 days.
Claim 8
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 30 days.
Claim 9
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 45 days.
Claim 10
Dependent Claim
59 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 60 days.
Claim 11
Dependent Claim
14 words
An endoprosthesis assembly according to claim 1 wherein the endoprosthesis is a self-expanding endoprosthesis.
Claim 12
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 24 hours.
Claim 13
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 48 hours.
Claim 14
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 5 days.
Claim 15
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 10 days.
Claim 16
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 20 days.
Claim 17
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 30 days.
Claim 18
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 45 days.
Claim 19
Dependent Claim
59 words
An endoprosthesis assembly according to claim 10 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 60 days.
Claim 20
Dependent Claim
16 words
An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath comprises porous expanded polytetrafluoroethylene.
Claim 21
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 24 hours.
Claim 22
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 48 hours.
Claim 23
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 5 days.
Claim 24
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 10 days.
Claim 25
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 20 days.
Claim 26
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 30 days.
Claim 27
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 45 days.
Claim 28
Dependent Claim
59 words
An endoprosthesis assembly according to claim 19 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 60 days.
Claim 29
Dependent Claim
14 words
An endoprosthesis assembly according to claim 19 wherein the endoprosthesis is a self-expanding endoprothesis.
Claim 30
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 24 hours.
Claim 31
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 48 hours.
Claim 32
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 5 days.
Claim 33
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 10 days.
Claim 34
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 20 days.
Claim 35
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 30 days.
Claim 36
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 45 days.
Claim 37
Dependent Claim
59 words
An endoprosthesis assembly according to claim 28 wherein the delicate constraining sheath, in the absence of the packaging sheath, either at least partially disrupts or allows an increase in a maximum diameter of the endoprosthesis assembly of at least 0.15 mm, when exposed to a temperature of at least 60° C. for a time of at least 60 days.
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