Patent EP0540858A1 successfully refreshed from Google Patents.
EP0540858A1
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EP
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Inflatable member having elastic expansion with limited range
Assignee: Abbott Cardiovascular Systems Inc
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Filing: 1992-09-11
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Granted: —
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Expires: 2012-09-11
Abstract
Abstract An intravascular catheter (10) such as an angioplasty catheter having a catheter shaft (11) with an expandable tubular element (13) on its distal end which upon inflation to an internal pressure at or above a threshold pressure expands in a manner which is related to the internal pressure. The maximum transverse dimension of the expandable tubular element (13) is generally not greater than the maximum transverse dimension of the catheter shaft (11). Preferably, the expandable tubular element (13) is formed of a heat shrinkable polymeric material such as a polyolefinic ionomer.
Inventors
- 👤 Ketan P. Muni
- 👤 Celso Jacinto Bagaoisan
- 👤 Gerard F. Powers
- 👤 Wilfredj. Samson
- 👤 Kevin D. Taylor
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 13:51
CPC Classifications
A; A61; A61K; A61K51/00; A61K51/12; A61K51/1272; A61L; A61L29/00; A61L29/04; A61L29/041; A61M; A61M25/00; A61M25/10; A61M25/1027; A61M25/1029; A61M25/104; B; B29; B29C; B29C49/00; B29C49/02; B29C49/04; A61M25/0067; A61M25/0074; A61M2025/0079; A61M2025/1043; A61M2025/1059; A61M2025/1079; A61M2025/1084; A61M25/1038; B29C49/42; B29C49/78; B29C49/783; B29C2049/7831; B29C49/786; B29C2049/7864; B29C2049/78645; B29C2949/00; B29C2949/07; B29C2949/079; B29C2949/08; B29K; B29K2105/00; B29K2105/25; B29K2105/253; B29K2105/258; B29L; B29L2022/00; B29L2022/02; B29L2022/022; B29L2031/00; B29L2031/753; B29L2031/7542
Claims Analysis
Total Claims: 30
Claim 1
Independent Claim
37 words
An inflatable member having an expandable wall portion which at internal pressures within a first pressure range exhibits substantial elastic expansion and within a second pressure range, higher than the first pressure range, exhibits relatively little expansion.
Claim 2
Dependent Claim
32 words
The inflatable member of claim 1 wherein the expansion after the first pressure range does not exceed about 25% of the inflatable wall portion at the end of the first pressure range.
Claim 3
Dependent Claim
32 words
The inflatable member of claim 1 wherein the expansion after the first pressure range does not exceed about 10% of the inflatable wall portion at the end of the first pressure range.
Claim 4
Dependent Claim
27 words
The inflatable member of claim 1 wherein the expansion of the expandable wall portion after the first pressure range is essentially linear with respect to the pressure.
Claim 5
Dependent Claim
29 words
The inflatable member of claim 5 wherein the expandable wall portion is thermally treated at a temperature within 50° C of the crystalline melting point of the polymeric material.
Claim 6
Dependent Claim
22 words
The dilatation member of claim 5 is formed of polymer materials which contains up to 30% of polymers other than oleophilic ionomers.
Claim 7
Dependent Claim
45 words
An inflatable member having a wall portion which at internal pressures above a threshold pressure exhibits a limited, controllable expansion directly related to the internal pressure therein which does not exceed about 50% of the expansion of the inflatable wall portion at the threshold pressure.
Claim 8
Dependent Claim
92 words
An elongated intravascular catheter comprising: a) an elongated catheter shaft having proximal and distal extremities and an inner lumen extending therein; b) an inflatable section on the distal extremity of the catheter shaft having an interior in fluid communication with the inner lumen of the catheter shaft and exhibiting upon inflation to an internal pressure within a first pressure range substantial elastic expansion and within a second pressure range, higher than the first pressure range, very little expansion; and c) means to direct inflation fluid to the interior of the inflatable section.
Claim 9
Dependent Claim
32 words
The intravascular catheter of claim 8 wherein the catheter shaft has an inner tubular member with a guidewire receiving inner lumen extending therein which extends through the interior of the inflatable member.
Claim 10
Dependent Claim
46 words
The intravascular catheter of claim 9 wherein the internal tubular member has a portion thereof collapsible at a pressure less than the first pressure range and wherein heating means are provided to increase the temperature of the expandable wall portion to decrease the first pressure range.
Claim 11
Independent Claim
23 words
The device of claims 1 or 8 wherein the inflatable member is formed of radiation cross-linked polymeric material or heat shrinkable polymeric material.
Claim 12
Dependent Claim
26 words
The device of claim 11 wherein the radiation cross-linked polymeric material is a polyolefinic ionomer selected from the group consisting of sodium, zinc and lithium ionomers.
Claim 13
Independent Claim
16 words
The device of claims 1 or 8 wherein the inflatable section exhibits elastic recoil upon deflation.
Claim 14
Dependent Claim
22 words
The dilatation catheter of claim 6 wherein the inflatable member is inflated at the thermal treatment temperature, cooled and then heat shrunk.
Claim 15
Dependent Claim
35 words
The dilatation catheter of any one of the preceding claims wherein the deflated transverse dimensions of the inflatable member are not more than about 10% greater than the transverse dimension of the adjacent catheter shaft.
Claim 16
Dependent Claim
62 words
The elongated dilatation catheter of any one of the preceding claims including means to heat the inflatable member while it is disposed within a patient's body to lower the first pressure range and a guiding element extending out of the distal end of the expandable tubular section with the distal end of the expandable tubular section sealably secured about the guiding element.
Claim 17
Independent Claim
336 words
A method of performing a balloon dilatation procedure within a patient's vascular system comprising: a) providing a balloon dilatation catheter having, i) an elongated catheter shaft which has proximal and distal extremities and an inner lumen extending therein, ii) an inflatable member on the distal extremity of the catheter shaft which has an interior in fluid communication with the inner lumen of the catheter shaft and which exhibits upon inflation to an internal pressure within a first pressure range substantial elastic expansion and within a second pressure range, higher than the first pressure range, very little expansion, and iii) means to direct inflation fluid to the interior of the tubular section having the inflatable balloon through the inner lumen extending through the catheter shaft, and iv) an inner tubular member which is disposed within the catheter shaft, which extends at least in part within the interior of the inflatable member and which is adapted to collapse at a pressure below the pressure range in which substantial elastic expansion of the inflatable member occurs; b) advancing the intravascular catheter into and through a patient's vasculature over a guidewire disposed within the inner tubular member; c) inflating the inflatable member to a pressure which is at a sufficient level to collapse the inner tubular member about a guidewire disposed within the inner lumen and to releasably secure the guidewire therein but which is insufficient to cause substantial expansion of the inflatable balloon; d) advancing the intravascular catheter with the guidewire secured within the inner lumen thereof to provide increased pushability through the patient's vasculature to a desired location therein; e) further increasing the pressure of the inflation fluid within the inflatable balloon to a pressure within the first pressure range to perform an dilatation procedure within the patient's vasculature at the desired location; f) deflating the inflatable balloon to an internal pressure below the first pressure range which allows the release of the guidewire within the inner lumen; and g) withdrawing the catheter from the patient's vascular system.
Claim 18
Independent Claim
181 words
A method of performing an angioplasty procedure within a patient's arterial system comprising: a) providing a dilatation catheter having, i) an elongated catheter shaft which has proximal and distal extremities and an inner lumen extending therein, ii) an inflatable member on the distal extremity of the catheter shaft which has an interior in fluid communication with the inner lumen of the catheter shaft and which exhibits upon inflation within a first pressure range substantial elastic expansion and within a second pressure range, higher than the first pressure range at least in part, very little expansion, and iii) means at the proximal extremity of the catheter shaft to direct inflation fluid to the interior of the inflatable member; b) advancing the dilatation catheter into and through a patient's arterial system until the inflatable member is disposed within a stenosis to be dilated; c) inflating the inflatable member to a pressure within the first pressure range to substantially expand the inflatable member and thereby dilate the stenosis; d) deflating the inflated tubular section; and e) withdrawing the catheter from the patient's arterial system.
Claim 19
Dependent Claim
51 words
The method of claim 18 further comprising a porous outer tubular member which is disposed about the inflatable member and which is adapted to absorb a drug-ladened or therapeutic fluid, wherein during said inflating step, the therapeutic fluid absorbed therein is driven out to deliver the fluid to the desired location.
Claim 20
Dependent Claim
38 words
The method of claim 18 further comprising the step of heating the inflatable balloon to reduce the first pressure range in which substantial elastic expansion of the inflatable member occurs, said step being taken after the advancing step.
Claim 21
Dependent Claim
69 words
An inflatable dilatation member which upon inflation has a relatively high rate of expansion to a first diameter within an first pressure range and a relatively low rate of expansion to a second diameter larger than the first diameter within a second pressure range higher than the first pressure range and which upon deflation exhibits elastic recoil to a third diameter smaller than the first and the second diameters.
Claim 22
Dependent Claim
27 words
The dilatation member of claim 18 wherein said member is formed of one or more oleophilic polymers selected from the group consisting of zinc and sodium ionomers.
Claim 23
Independent Claim
87 words
A method of making an inflatable dilatation member comprising: a) extruding a tubular product formed of an olefinic ionomer at an elevated temperature; b) cool the extruded tubular product after its extrusion to obtain a relatively amorphous structure therein; c) irradiate at least a portion of the amorphous tubular product which will form the inflatable member; and d) heat treating the portion of the tubular product which will form the inflatable member at a temperature between about 50°C above and about 50°C below the crystalline melting temperature.
Claim 24
Dependent Claim
76 words
The method of claim 23 including the steps of expanding the irradiated portion of the tubular product to a first outer diameter by injecting inflation fluid into the interior of the irradiated portion at an elevated temperature to cause the expansion of the irradiated portion, cooling the expanded portion of the tubular product and then heat shrinking the expanded portion of the tubular product to a second outer diameter much smaller than the first outer diameter.
Claim 25
Dependent Claim
32 words
The method of claim 23 wherein the extruded tubular product is stabilized at a temperature between about 40°C to about 80°C for about 2 to about 6 hours before the irradiation thereof.
Claim 26
Dependent Claim
30 words
The method of claim 23 wherein the extruded tubular product is quenched upon exiting from the extruding operation in a bath at a temperature of about 40°F to about 60°F.
Claim 27
Dependent Claim
22 words
The method of claim 23 wherein the extruded tubular product is irradiated with about 50 to about 70 Mrads of gamma radiation.
Claim 28
Dependent Claim
41 words
The method of claim 27 wherein the irradiated portion of the extruded tubular product is subjected to a temperature of about 230°C to about 250°C.and an inflation pressure of about 50 to about 85 psi to form into an inflated balloon.
Claim 29
Dependent Claim
45 words
The method of claim 28 wherein the inflated balloon is cooled and then subjected to a temperature of about 50°C to about 75°C for about 5 to about 60 minutes to heat shrink the expanded balloon from a first diameter to a smaller second diameter.
Claim 30
Dependent Claim
22 words
The method of claim 23 wherein the olefinic ionomer is selected from the group consisting of sodium, zinc and lithium olefinic ionomers.
References Cited (Backward Citations)
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