US6090072A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Expandable introducer sheath
Assignee: Boston Scientific Scimed Inc
•
Filing: 1996-03-14
•
Granted: 2000-07-18
•
Expires: 2016-03-14
Abstract
Abstract The present invention comprises a method and device for providing an expandable introducer sheath. The method of employing the inventive device comprises inserting an elongate flexible tubular sheath into a vessel (with a proximal end of the sheath extending proximally outward through the skin), to slidably receive intravascular devices. When a larger size introducer sheath is desired, the sheath is manipulated while still in the vessel to expand its inner diameter to a larger size. In one embodiment, the sheath is made of a shape-memory polymer and is manipulated by inserting a heated mandrel (with an outer diameter larger than the inner diameter of the sheath) within the sheath to cause the sheath to expand to an inner diameter at least approximately equal to an outer diameter of the mandrel. The shape-memory polymer material ensures that the sheath will retain its expanded inner diameter. Alternatively, the sheath is formed from a telescoping multi-tubular arrangement of progressively larger tubes. In any case, insertion of the inventive sheath into the skin requires only a single small puncture which is then only expanded as needed while the sheath remains in place.
Inventors
- 👤 William F. Kratoska
- 👤 Sew-Wah Tay
- 👤 Scott P. Thome
- 👤 Peter T. Keith
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 09:52
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/01; A61M25/06; A61M25/0662; A61B; A61B17/00; A61B17/34; A61B17/3417; A61B17/3421; A61B17/3439; A61B2017/00831; A61B2017/00867; A61M25/0021; A61M25/0023; A61M2025/0024
Claims Analysis
Total Claims: 39
Claim 1
Independent Claim
95 words
A sheath system for introducing intravascular devices percutaneously, the sheath system comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a polymer material and including a wall having a continuous outer surface and a first inner diameter capable of slidably receiving intravascular devices therethrough and capable of being selectively expanded to a second, larger inner diameter while within the vessel and being maintained in the second larger inner diameter in a substantially uniform tubular shape without an additional member extending through the tubular member.
Claim 2
Dependent Claim
95 words
A sheath system for introducing intravascular devices percutaneously, the sheath system comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a polymer material and including a wall having a continuous outer surface and a first inner diameter capable of slidably receiving intravascular devices therethrough and capable of being selectively expanded to a second, larger inner diameter while within the vessel and being maintained in the second larger inner diameter in a substantially uniform tubular shape without an additional member extending through the tubular member.
Claim 3
Dependent Claim
66 words
The sheath system of claim 1 wherein the tubular member further comprises: a longitudinal fold formed in the wall of the tubular member extending along a portion of the length of the member and the fold being laid over onto the outer surface of wall of the tubular member, the fold capable of being unfolded to yield the second larger inner diameter of the tubular member.
Claim 4
Dependent Claim
49 words
The sheath system of claim 2 wherein the means for forcibly expanding further comprises: an elongate mandrel insertable into the tubular member and having an outer diameter greater than the inner diameter of the tubular member when the fold is laid over onto the wall of the tubular member.
Claim 5
Dependent Claim
13 words
The sheath system of claim 3 wherein the mandrel comprises a guide catheter.
Claim 6
Dependent Claim
38 words
The sheath system of claim 1 and further comprising: means for forcibly expanding the tubular member from its first inner diameter to its second larger inner diameter while a portion of the tubular member is in the vessel.
Claim 7
Dependent Claim
92 words
The sheath system of claim 1 wherein the polymer material of the tubular member further comprises: a shape memory polymer material having a glass transition temperature greater than human body temperature wherein the tubular member is capable of being forcibly expanded from the first inner diameter to the second larger inner diameter when the shape memory polymer material is heated above the glass transition temperature and is capable of retaining the second larger inner diameter when the shape memory polymer material is cooled below the glass transition temperature while being forcibly expanded.
Claim 8
Dependent Claim
72 words
The sheath system of claim 6 and further comprising: an elongate mandrel insertable into the tubular member and having an outer diameter greater than the first inner diameter of the tubular member, the mandrel having a heating element disposed on a distal portion of the mandrel and being capable of heating portions of the tubular member adjacent the heating element to exceed the glass transition temperature of the shape memory polymer material.
Claim 9
Dependent Claim
27 words
The sheath system of claim 6 wherein the shape memory polymer material is a polyurethane material with a tightly controlled glass transition temperature of about 45° C.
Claim 10
Dependent Claim
35 words
The sheath system of claim 6 wherein the tubular member is first formed having an inner diameter larger than the first inner diameter size and then mechanically manipulated to have the first inner diameter size.
Claim 11
Dependent Claim
22 words
The sheath system of claim 1 wherein the tubular member further comprises: a tubular braided material matrix embedded in the polymer material.
Claim 12
Dependent Claim
156 words
A sheath system for introducing intravascular devices percutaneously, the sheath system comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a shape memory polymer and having a first inner diameter capable of being expanded to a second, larger inner diameter and being maintained in the second larger inner diameter in a substantially uniform tubular shape; and a mandrel having an outer diameter approximately equal to the second larger predetermined inner diameter and having a heated distal portion to heat the tubular member above a glass transition temperature of the shape memory polymer material to permit the outer diameter of the mandrel to forcibly expand the sheath to the second larger inner diameter and to cool the sheath below the glass transition temperature of the shape memory polymer with the mandrel within the tubular member so that the tubular member retains the second larger inner diameter.
Claim 13
Dependent Claim
156 words
A sheath system for introducing intravascular devices percutaneously, the sheath system comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a shape memory polymer and having a first inner diameter capable of being expanded to a second, larger inner diameter and being maintained in the second larger inner diameter in a substantially uniform tubular shape; and a mandrel having an outer diameter approximately equal to the second larger predetermined inner diameter and having a heated distal portion to heat the tubular member above a glass transition temperature of the shape memory polymer material to permit the outer diameter of the mandrel to forcibly expand the sheath to the second larger inner diameter and to cool the sheath below the glass transition temperature of the shape memory polymer with the mandrel within the tubular member so that the tubular member retains the second larger inner diameter.
Claim 14
Dependent Claim
64 words
A sheath for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a shape memory polymer material having a glass transition temperature greater than human body temperature, and the tubular member having a first inner diameter capable of being selectively expanded to a second, larger inner diameter.
Claim 15
Dependent Claim
64 words
A sheath for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a shape memory polymer material having a glass transition temperature greater than human body temperature, and the tubular member having a first inner diameter capable of being selectively expanded to a second, larger inner diameter.
Claim 16
Dependent Claim
24 words
The sheath of claim 12 wherein the shape memory polymer material is a polyurethane material having a glass transition temperature of about 45° C.
Claim 17
Independent Claim
113 words
A method of introducing intravascular devices percutaneously comprising: providing an elongate flexible tubular sheath for slidably receiving intravascular catheters, the sheath being formed primarily of a polymer material and including a wall having a continuous outer surface and defining a first inner diameter; inserting a distal end of the sheath into a vascular vessel with a proximal end of the sheath protruding proximally outward from the vessel; and applying a radial force to the wall of the sheath to expand the sheath to have a second inner diameter larger than the first inner diameter of the sheath wherein the second larger inner diameter is maintained without an additional member extending within the sheath.
Claim 18
Independent Claim
113 words
A method of introducing intravascular devices percutaneously comprising: providing an elongate flexible tubular sheath for slidably receiving intravascular catheters, the sheath being formed primarily of a polymer material and including a wall having a continuous outer surface and defining a first inner diameter; inserting a distal end of the sheath into a vascular vessel with a proximal end of the sheath protruding proximally outward from the vessel; and applying a radial force to the wall of the sheath to expand the sheath to have a second inner diameter larger than the first inner diameter of the sheath wherein the second larger inner diameter is maintained without an additional member extending within the sheath.
Claim 19
Dependent Claim
19 words
The method of claim 14 wherein the providing step further comprises: forming the sheath from a shape-memory polymer material.
Claim 20
Dependent Claim
105 words
The method of claim 15 wherein the step of applying force further comprises: providing a mandrel having an outer diameter approximately equal to the second larger predetermined inner diameter and having a heated distal portion; inserting the mandrel within the sheath to heat the sheath above a glass transition temperature of the shape memory polymer material to permit the outer diameter of the mandrel to forcibly expand the sheath to the second larger inner diameter; and cooling the sheath below the glass transition temperature of the shape memory polymer with the mandrel within the sheath so that the sheath retains the second larger inner diameter.
Claim 21
Dependent Claim
27 words
The method of claim 14 wherein the providing step further comprises: forming the sheath from an alloy of an ester-based polyurethane material and an ester-based polyurethane material.
Claim 22
Dependent Claim
61 words
The method of claim 14 wherein the providing step further comprises: extruding the sheath to have the second larger inner diameter; shrinking the sheath to assume the first inner diameter; placing a tubular sleeve over the shrunken sheath to maintain the first inner diameter size; and removing the sleeve from the sheath prior to insertion of the sheath within the vessel.
Claim 23
Dependent Claim
105 words
The method of claim 18 wherein the step of applying radial force further comprises: providing a mandrel having an outer diameter approximately equal to the second larger inner diameter and having a heated distal portion; inserting the mandrel within the sheath to heat the sheath above a glass transition temperature of the shape memory polymer material to permit the outer diameter of the mandrel to forcibly expand the sheath to the second larger inner diameter; and cooling the sheath below the glass transition temperature of the shape memory polymer with the mandrel within the sheath so that the sheath retains the second larger inner diameter.
Claim 24
Dependent Claim
74 words
The method of claim 14 wherein the sheath as initially provided has a longitudinal fold in a wall of the sheath extending along a portion of the length of the sheath, and wherein the step of applying radial force further comprises; unfolding the fold in the sheath to expand the sheath so that the sheath has the second larger inner diameter that is greater than the first inner diameter of the sheath when folded.
Claim 25
Dependent Claim
34 words
The method of claim 20 wherein the unfolding step further comprises: inserting a mandrel into the sheath to expand the sheath from the folded first inner diameter to the second larger unfolded inner diameter.
Claim 26
Dependent Claim
111 words
A sheath for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member having a first inner diameter and comprising a shape memory polymer material having a glass transition temperature greater than human body temperature wherein the tubular member is capable of being forcibly expanded from the first inner diameter to a second larger inner diameter when the shape memory polymer material is heated above the glass transition temperature and is capable of retaining the second larger inner diameter when the shape memory polymer material is cooled below the glass transition temperature while being forcibly expanded.
Claim 27
Dependent Claim
111 words
A sheath for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member having a first inner diameter and comprising a shape memory polymer material having a glass transition temperature greater than human body temperature wherein the tubular member is capable of being forcibly expanded from the first inner diameter to a second larger inner diameter when the shape memory polymer material is heated above the glass transition temperature and is capable of retaining the second larger inner diameter when the shape memory polymer material is cooled below the glass transition temperature while being forcibly expanded.
Claim 28
Dependent Claim
26 words
The sheath of claim 22 wherein the shape memory polymer material is a polyurethane material with a tightly controlled glass transition temperature of about 45° C.
Claim 29
Dependent Claim
34 words
The sheath of claim 22 wherein the tubular member is first formed having an inner diameter larger than the first inner diameter size and then mechanically manipulated to have the first inner diameter size.
Claim 30
Dependent Claim
23 words
The sheath of claim 22 wherein the tubular member further comprises: a tubular braided material matrix embedded in the shape memory polymer material.
Claim 31
Independent Claim
163 words
A method of introducing intravascular devices percutaneously comprising: providing an elongate flexible tubular sheath for slidably receiving intravascular catheters, the sheath being formed primarily ot a shape-memory polymer material and including a wall having a continuous outer surface and defining a first inner diameter; inserting a distal end of the sheath into a vascular vessel with a proximal end of the sheath protruding proximally outward from the vessel; providing a mandrel having an outer diameter approximately equal to a second larger predetermined inner diameter of the sheath and having a heated distal portion; inserting the mandrel within the sheath to heat the sheath above a glass transition temperature of the shape memory polymer material to permit the outer diameter of the mandrel to forcibly expand the sheath to the second larger inner diameter; and cooling the sheath below the glass transition temperature of the shape memory polymer with the mandrel within the sheath so that the sheath retains the second larger inner diameter.
Claim 32
Independent Claim
163 words
A method of introducing intravascular devices percutaneously comprising: providing an elongate flexible tubular sheath for slidably receiving intravascular catheters, the sheath being formed primarily ot a shape-memory polymer material and including a wall having a continuous outer surface and defining a first inner diameter; inserting a distal end of the sheath into a vascular vessel with a proximal end of the sheath protruding proximally outward from the vessel; providing a mandrel having an outer diameter approximately equal to a second larger predetermined inner diameter of the sheath and having a heated distal portion; inserting the mandrel within the sheath to heat the sheath above a glass transition temperature of the shape memory polymer material to permit the outer diameter of the mandrel to forcibly expand the sheath to the second larger inner diameter; and cooling the sheath below the glass transition temperature of the shape memory polymer with the mandrel within the sheath so that the sheath retains the second larger inner diameter.
Claim 33
Dependent Claim
113 words
A sheath system for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising an elastomeric material with a substantially uniform wall thickness, having a wall with a continuous outer surface, and having a first inner diameter with a substantially uniform tubular shape capable of being selectively expanded to a second, larger inner diameter while within the vessel and having at least one rib extending longitudinally along an inner surface of the wall of the tubular member when the tubular member has the first inner diameter and when the tubular member has the second larger inner diameter.
Claim 34
Dependent Claim
113 words
A sheath system for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising an elastomeric material with a substantially uniform wall thickness, having a wall with a continuous outer surface, and having a first inner diameter with a substantially uniform tubular shape capable of being selectively expanded to a second, larger inner diameter while within the vessel and having at least one rib extending longitudinally along an inner surface of the wall of the tubular member when the tubular member has the first inner diameter and when the tubular member has the second larger inner diameter.
Claim 35
Dependent Claim
90 words
The sheath system of claim 27 and further comprising: an elongate flexible intravascular device adapted for insertion within the tubular member and having an outer diameter equal to the second larger inner diameter of the tubular member so that insertion of the intravascular device within the tubular member causes radial expansion of the tubular member to its second larger inner diameter and the rib on the inner surface of the wall maintaining spacing between the outer diameter of the intravascular device and the second inner diameter of the tubular member.
Claim 36
Dependent Claim
130 words
A sheath system for introducing intravascular devices percutaneously, the sheath system comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a tubular hub and a tubular shaft extending from the hub, the shaft member comprising a polymeric material and including a wall having a continuous outer surface and having a first inner diameter capable of slidably receiving intravascular devices therethrough and capable of being selectively expanded to a second, larger inner diameter while within the vessel and being maintained in the second larger inner diameter in a substantially uniform tubular shape without an additional member extending through the tubular member, wherein the hub has an inner diameter at least as large as the second inner diameter of the shaft.
Claim 37
Dependent Claim
130 words
A sheath system for introducing intravascular devices percutaneously, the sheath system comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member comprising a tubular hub and a tubular shaft extending from the hub, the shaft member comprising a polymeric material and including a wall having a continuous outer surface and having a first inner diameter capable of slidably receiving intravascular devices therethrough and capable of being selectively expanded to a second, larger inner diameter while within the vessel and being maintained in the second larger inner diameter in a substantially uniform tubular shape without an additional member extending through the tubular member, wherein the hub has an inner diameter at least as large as the second inner diameter of the shaft.
Claim 38
Dependent Claim
106 words
A sheath for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member including a proximal hub portion and a distal shaft portion extending from the hub portion, the distal shaft portion comprising a shape memory polymer material having a glass transition temperature greater than human body temperature, and the tubular member having a first inner diameter capable of being selectively expanded to a second, larger inner diameter, wherein the proximal hub portion has an inner diameter at least as large as the second inner diameter of the distal shaft portion.
Claim 39
Dependent Claim
106 words
A sheath for introducing intravascular devices percutaneously, the sheath comprising: an elongate flexible tubular member for placement within a vessel to slidably receive intravascular devices, the tubular member including a proximal hub portion and a distal shaft portion extending from the hub portion, the distal shaft portion comprising a shape memory polymer material having a glass transition temperature greater than human body temperature, and the tubular member having a first inner diameter capable of being selectively expanded to a second, larger inner diameter, wherein the proximal hub portion has an inner diameter at least as large as the second inner diameter of the distal shaft portion.
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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) | 2003-07-18 | 2004-01-17 | 2004-07-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-07-18 | 2008-01-17 | 2008-07-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-07-18 | 2012-01-17 | 2012-07-18 | $7700.00 | Window Closed / Lapsed |