US20020099431A1
Expired / Lapsed
US
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Deployment system for intraluminal devices
Assignee: W.L. Gore and Associates Inc
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Filing: 2002-01-22
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Granted: —
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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. A endoprosthesis assembly incorporating a constraining sheath according to one embodiment of the invention is also provided with an additional packaging sheath.
Inventors
- 👤 Joseph Armstrong
- 👤 Edward Cully
- 👤 Mark Ulm
- 👤 Michael Vonesh
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 04:08
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: 51
Claim 1
Independent Claim
77 words
1 . 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.
Claim 2
Dependent Claim
77 words
1 . 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.
Claim 3
Dependent Claim
61 words
2 . 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 21 hours.
Claim 4
Dependent Claim
61 words
3 . 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 5
Dependent Claim
62 words
4 . 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 6
Dependent Claim
61 words
5 . 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 7
Dependent Claim
61 words
6 . 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 8
Dependent Claim
61 words
7 . 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 9
Dependent Claim
61 words
8 . 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 10
Dependent Claim
61 words
9 . 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 11
Dependent Claim
61 words
10 . 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 12
Dependent Claim
16 words
11 . An endoprosthesis assembly according to claim 1 wherein the endoprosthesis is a self-expanding endoprosthesis.
Claim 13
Dependent Claim
61 words
12 . An endoprosthesis assembly according to claim 11 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.
Claim 14
Dependent Claim
61 words
13 . An endoprosthesis assembly according to claim 11 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 15
Dependent Claim
61 words
14 . An endoprosthesis assembly according to claim 11 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 16
Dependent Claim
61 words
15 . An endoprosthesis assembly according to claim 11 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 17
Dependent Claim
61 words
16 . An endoprosthesis assembly according to claim 11 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 18
Dependent Claim
61 words
17 . An endoprosthesis assembly according to claim 11 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 19
Dependent Claim
61 words
18 . An endoprosthesis assembly according to claim 11 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 20
Dependent Claim
61 words
19 . An endoprosthesis assembly according to claim 11 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 21
Dependent Claim
61 words
20 . An endoprosthesis assembly according to claim 11 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 22
Dependent Claim
18 words
21 . An endoprosthesis assembly according to claim 1 wherein the delicate constraining sheath comprises porous expanded polytetrafluoroethylene.
Claim 23
Dependent Claim
61 words
22 . An endoprosthesis assembly according to claim 21 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.
Claim 24
Dependent Claim
61 words
23 . An endoprosthesis assembly according to claim 21 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 25
Dependent Claim
61 words
24 . An endoprosthesis assembly according to claim 21 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 26
Dependent Claim
61 words
25 . An endoprosthesis assembly according to claim 21 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 27
Dependent Claim
61 words
26 . An endoprosthesis assembly according to claim 21 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 28
Dependent Claim
61 words
27 . An endoprosthesis assembly according to claim 21 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 29
Dependent Claim
61 words
28 . An endoprosthesis assembly according to claim 21 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 30
Dependent Claim
61 words
29 . An endoprosthesis assembly according to claim 21 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 31
Dependent Claim
61 words
30 . An endoprosthesis assembly according to claim 21 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 32
Dependent Claim
16 words
31 . An endoprosthesis assembly according to claim 21 wherein the endoprosthesis is a self-expanding endoprosthesis.
Claim 33
Dependent Claim
54 words
32 . An endoprosthesis assembly according to claim 31 wherein the delicate constraining 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.
Claim 34
Dependent Claim
61 words
33 . An endoprosthesis assembly according to claim 31 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 35
Dependent Claim
61 words
34 . An endoprosthesis assembly according to claim 31 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 36
Dependent Claim
61 words
35 . An endoprosthesis assembly according to claim 31 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 37
Dependent Claim
61 words
36 . An endoprosthesis assembly according to claim 31 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 38
Dependent Claim
61 words
37 . An endoprosthesis assembly according to claim 31 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 39
Dependent Claim
61 words
38 . An endoprosthesis assembly according to claim 31 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 40
Dependent Claim
61 words
39 . An endoprosthesis assembly according to claim 31 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 41
Dependent Claim
61 words
40 . An endoprosthesis assembly according to claim 31 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 42
Dependent Claim
80 words
41 . 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 stored at a temperature of less than about 5° C. for at least 30 days.
Claim 43
Dependent Claim
80 words
41 . 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 stored at a temperature of less than about 5° C. for at least 30 days.
Claim 44
Dependent Claim
28 words
42 . An endoprosthesis assembly according to claim 41 wherein the assembly is stored at a temperature of less than about 5° C. for at least 60 days.
Claim 45
Dependent Claim
93 words
43 . An endoprosthesis assembly comprising a catheter balloon having a working length, an implantable endoprosthesis having a length and capable of being diametrically expanded from a smaller diameter to a larger diameter; said endoprosthesis being fitted coaxially over the catheter balloon with the length of the endoprosthesis approximately centered axially over the working length of the catheter balloon, and a generally tubular constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, wherein the working length of the catheter balloon is less than the length of the endoprosthesis.
Claim 46
Dependent Claim
93 words
43 . An endoprosthesis assembly comprising a catheter balloon having a working length, an implantable endoprosthesis having a length and capable of being diametrically expanded from a smaller diameter to a larger diameter; said endoprosthesis being fitted coaxially over the catheter balloon with the length of the endoprosthesis approximately centered axially over the working length of the catheter balloon, and a generally tubular constraining sheath provided coaxially around the endoprosthesis at the smaller diameter of the endoprosthesis, wherein the working length of the catheter balloon is less than the length of the endoprosthesis.
Claim 47
Dependent Claim
28 words
44 . An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 90 percent of the length of the endoprosthesis or less.
Claim 48
Dependent Claim
28 words
45 . An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 80 percent of the length of the endoprosthesis or less.
Claim 49
Dependent Claim
28 words
46 . An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 70 percent of the length of the endoprosthesis or less.
Claim 50
Dependent Claim
28 words
47 . An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 60 percent of the length of the endoprosthesis or less.
Claim 51
Dependent Claim
28 words
48 . An endoprosthesis assembly according to claim 43 wherein the working length of the balloon is about 50 percent of the length of the endoprosthesis or less.
References Cited (Backward Citations)
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