US6551341B2
Expired / Lapsed
US
⏱️ 0.0 years remaining
Devices configured from strain hardened Ni Ti tubing
Assignee: Abbott Cardiovascular Systems Inc
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Filing: 2001-06-14
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Granted: 2003-04-22
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Expires: 2021-06-14
Abstract
Abstract Cold worked nickel-titanium alloys that have linear pseudoelastic behavior without a phase transformation or onset of stress-induced martensite as applied to a medical device having a strut formed body deployed from a sheath is disclosed. In one application, an embolic protection device that employs a linear pseudoelastic nitinol self-expanding strut assembly with a small profile delivery system for use with interventional procedures is disclosed. Linear pseudoelastic nitinol is used in the medical device as distinct from non-linear pseudoelastic (i.e., superelastic) nitinol. The expandable strut assembly is made from a small diameter tubing of cold worked nickel-titanium alloys. The self-expanding struts that deploy the filter element is laser cut from a large diameter cold worked nickel-titanium alloy, then joined to the small diameter tubing.
Inventors
- 👤 John F. Boylan
- 👤 William J. Boyle
- 👤 John E. Papp
- 👤 Anuja H. Patel
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 18:16
CPC Classifications
A; A61; A61L; A61L31/00; A61L31/02; A61L31/022; A61F; A61F2/00; A61F2/01; A61F2002/018; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0006; A61F2230/0063; A61F2230/0067
Claims Analysis
Total Claims: 25
Claim 1
Independent Claim
126 words
A medical device for use in a body lumen, comprising: a tubular body formed from small diameter tubing; a plurality of struts formed from a large diameter tubing and disposed on the tubular body such that the struts project radially outward in an unconstrained state; wherein the large diameter tubing includes a cold formed nickel-titanium alloy, and the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy, and wherein the tubular body has been heat treated and a hysteresis curve of the nickel-titanium alloy does not include a stress plateau; and a sheath at least partially enveloping the body and restraining the struts in a compressed state for delivery and retrieval of the device to and from the body lumen.
Claim 2
Dependent Claim
126 words
A medical device for use in a body lumen, comprising: a tubular body formed from small diameter tubing; a plurality of struts formed from a large diameter tubing and disposed on the tubular body such that the struts project radially outward in an unconstrained state; wherein the large diameter tubing includes a cold formed nickel-titanium alloy, and the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy, and wherein the tubular body has been heat treated and a hysteresis curve of the nickel-titanium alloy does not include a stress plateau; and a sheath at least partially enveloping the body and restraining the struts in a compressed state for delivery and retrieval of the device to and from the body lumen.
Claim 3
Dependent Claim
39 words
The medical device of claim 1 , wherein the strut includes a long beam extending from a wide base, and the tubular body includes apertures formed therein, and wherein each aperture receives the wide base of the strut therein.
Claim 4
Dependent Claim
18 words
The medical device of claim 2 , wherein the long beam of the strut includes a sloped profile.
Claim 5
Dependent Claim
24 words
The medical device of claim 2 , wherein the aperture has a beveled interior edge and the wide base has a matching beveled edge.
Claim 6
Dependent Claim
35 words
The medical device of claim 2 , wherein the medical device includes a sleeve that slidably engages the tubular body and covers the wide bases of the struts thereby retaining the struts to the body.
Claim 7
Dependent Claim
17 words
The medical device of claim 1 , wherein the struts assume a shape imparted by cold forming.
Claim 8
Dependent Claim
20 words
The medical device of claim 6 , wherein the cold forming occurs below the recrystallization temperature of the nickel-titanium alloy.
Claim 9
Dependent Claim
22 words
The medical device of claim 1 , wherein the ingot transformation temperature of the nickel-titanium alloy is set above 37 degrees C.
Claim 10
Dependent Claim
16 words
The medical device of claim 1 , wherein the small diameter tubing includes a nickel-titanium alloy.
Claim 11
Dependent Claim
120 words
A medical device for delivery to, deployment within, and removal from a lumen of a mammalian body, comprising: a tubular body derived from small diameter tubing having a plurality of apertures formed therein; a plurality of struts derived from a large diameter tubing; wherein the apertures receive the struts therein and in an unstressed state bend away from the tubular body; wherein the small and large diameter tubing include a cold formed nickel-titanium alloy, and the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy; and a sheath at least partially enveloping the body and restraining the struts in a compressed state for delivery and retrieval of the device to and from the lumen.
Claim 12
Dependent Claim
120 words
A medical device for delivery to, deployment within, and removal from a lumen of a mammalian body, comprising: a tubular body derived from small diameter tubing having a plurality of apertures formed therein; a plurality of struts derived from a large diameter tubing; wherein the apertures receive the struts therein and in an unstressed state bend away from the tubular body; wherein the small and large diameter tubing include a cold formed nickel-titanium alloy, and the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy; and a sheath at least partially enveloping the body and restraining the struts in a compressed state for delivery and retrieval of the device to and from the lumen.
Claim 13
Dependent Claim
21 words
The medical device of claim 10 , wherein the strut is cold formed to provide a curvature in a profile thereof.
Claim 14
Dependent Claim
37 words
The medical device of claim 10 , wherein the strut includes a long beam extending from a wide base, and the wide base includes a radius of curvature matching a radius of curvature of the tubular body.
Claim 15
Dependent Claim
50 words
The medical device of claim 12 , wherein some of the apertures have a first shape and the wide bases of the struts have a second shape complementary to the first shape so that at least a portion of the struts is recessed into the tubular body when attached thereto.
Claim 16
Dependent Claim
36 words
The medical device of claim 10 , wherein the strut includes a long beam extending from a wide base, and the wide base includes a beveled periphery that wedges against a beveled periphery of the aperture.
Claim 17
Dependent Claim
28 words
The medical device of claim 10 , wherein the strut has been heat treated and a hysteresis curve of the nickel-titanium alloy does not include a stress plateau.
Claim 18
Dependent Claim
26 words
The medical device of claim 10 , wherein the nickel-titanium alloy has received low temperature heat treating and does not undergo a phase transformation when stressed.
Claim 19
Dependent Claim
16 words
The medical device of claim 10 , wherein the struts are bonded to the tubular body.
Claim 20
Independent Claim
130 words
A method for providing a medical device for use in a body lumen, comprising: providing a small diameter tubing; forming the small diameter tubing into a tubular body; providing a large diameter tubing wherein the large diameter tubing includes a cold formed nickel-titanium alloy wherein the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy; heat treating the nickel-titanium alloy at a low temperature; fashioning a plurality of struts from the large diameter tubing; disposing the struts on the tubular body such that the struts project radially outward in an unconstrained state; and providing a sheath that at least partially envelopes the body and restrains the struts in a compressed state for delivery and retrieval of the device to and from the body lumen.
Claim 21
Independent Claim
130 words
A method for providing a medical device for use in a body lumen, comprising: providing a small diameter tubing; forming the small diameter tubing into a tubular body; providing a large diameter tubing wherein the large diameter tubing includes a cold formed nickel-titanium alloy wherein the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy; heat treating the nickel-titanium alloy at a low temperature; fashioning a plurality of struts from the large diameter tubing; disposing the struts on the tubular body such that the struts project radially outward in an unconstrained state; and providing a sheath that at least partially envelopes the body and restrains the struts in a compressed state for delivery and retrieval of the device to and from the body lumen.
Claim 22
Dependent Claim
43 words
The method for providing a medical device of claim 18 , wherein the method further comprises providing a small tubing including a cold formed nickel-titanium alloy wherein the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy.
Claim 23
Dependent Claim
22 words
The method for providing a medical device of claim 18 , wherein the strut is cold formed to achieve a curved profile.
Claim 24
Dependent Claim
122 words
A medical device for use in a body lumen, comprising: a tubular body formed from small diameter tubing; a plurality of struts formed from a large diameter tubing and disposed on the tubular body such that the struts project radially outward in an unconstrained state; wherein the large diameter tubing includes a cold formed nickel-titanium alloy that includes heat treating and wherein a hysteresis curve of the nickel-titanium alloy does not include a stress plateau, and the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy; and a sheath at least partially enveloping the body and restraining the struts in a compressed state for delivery and retrieval of the device to and from the body lumen.
Claim 25
Dependent Claim
122 words
A medical device for use in a body lumen, comprising: a tubular body formed from small diameter tubing; a plurality of struts formed from a large diameter tubing and disposed on the tubular body such that the struts project radially outward in an unconstrained state; wherein the large diameter tubing includes a cold formed nickel-titanium alloy that includes heat treating and wherein a hysteresis curve of the nickel-titanium alloy does not include a stress plateau, and the nickel-titanium alloy is in a martensitic phase only regardless of stress applied to the alloy; and a sheath at least partially enveloping the body and restraining the struts in a compressed state for delivery and retrieval of the device to and from the body lumen.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2006-04-21 | 2006-10-21 | 2007-04-22 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2010-04-21 | 2010-10-21 | 2011-04-22 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2014-04-21 | 2014-10-21 | 2015-04-22 | $7700.00 | Window Closed / Lapsed |