EP0778010A2
Expired / Lapsed
EP
⏱️ 0.0 years remaining
Method and apparatus for delivery, deployment and retrieval of stents
Assignee: Medtronic Vascular Inc
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Filing: 1996-12-05
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Granted: —
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Expires: 2016-12-05
Abstract
Abstract The disclosure relates to a delivery, deployment and retrieval device for a stent (28) made from a phase-change material including a balloon catheter (22) modified to allow the stent to be secured on the outside of the balloon (27) without the need for a sheath. A temperature-controlled fluid to effect a phase change to expand the stent is injected through an inflation lumen (25) to maintain the selected temperature and to inflate the balloon. The balloon maintains intimate physical and thermal contact with the stent during deployment. One or more exit apertures (29) are provided for the fluid to escape from the inflation lumen and enhance the phase change by bathing the stent with the fluid.
Inventors
- 👤 Robert Lashinski
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-23 15:18
CPC Classifications
A; A61; A61F; A61F2/00; A61F2/95; A61F2/958; A61F2002/9583; A61F2210/00; A61F2210/0014; A61F2210/0023; A61F2210/0042
Claims Analysis
Total Claims: 31
Claim 1
Independent Claim
115 words
A catheter for use in delivering a stent, the stent having a reduced diameter for intraluminal delivery and an expanded diameter, greater than the reduced diameter, when heated beyond a transition temperature, the catheter comprising: a first tube having a proximal end, a distal end and a wall defining a first lumen; a balloon sealingly connected to the first tube adjacent the distal end, the balloon defining an interior volume and having an exterior surface defining a stent engagement region, the interior volume of the balloon in communication with the first lumen, so that a heated fluid introduced through the proximal end of the first lumen pressurizes the balloon and heats the stent engagement region.
Claim 2
Dependent Claim
29 words
The catheter as defined in claim 1 wherein the exterior surface of the balloon further comprises a portion defining a plurality of perfusion pores in the stent engagement region.
Claim 3
Dependent Claim
40 words
The catheter as defined in claim 2 wherein the first tube further includes a portion defining at least one aperture through the wall, the interior volume of the balloon communicating with the first lumen via the at least one aperture.
Claim 4
Dependent Claim
24 words
The catheter as defined in claim 1 wherein the first tube further comprises a portion defining an exit port located distally of the balloon.
Claim 5
Dependent Claim
40 words
The catheter as defined in claim 4 wherein the first tube further includes a portion defining at least one aperture through the wall, the interior volume of the balloon communicating with the first lumen via the at least one aperture.
Claim 6
Dependent Claim
31 words
The catheter as defined in claim 5 wherein the first lumen is adapted to receive a guidewire, the guidewire extending from the catheter distally of the balloon via the exit port.
Claim 7
Dependent Claim
43 words
The catheter as defined in claim 1 further comprising a second tube defining a second lumen adapted for receiving a guidewire, the first tube further including a portion defining at least one aperture through the wall located proximally of the stent engagement region.
Claim 8
Dependent Claim
32 words
The catheter as defined in claim 7 wherein the second tube is disposed concentrically within the first tube, the first lumen being defined by an annulus between the first and second tubes.
Claim 9
Dependent Claim
38 words
The catheter as defined in claim 1 further comprising a second tube defining a second lumen adapted for receiving a guidewire, the balloon including a portion defining at least one aperture located distally of the stent engagement region.
Claim 10
Dependent Claim
32 words
The catheter as defined in claim 9 wherein the second tube is disposed concentrically within the first tube, the first lumen being defined by an annulus between the first and second tubes.
Claim 11
Dependent Claim
38 words
The catheter as defined in claim 1 further comprising a second tube defining a second lumen adapted for receiving a guidewire, the balloon including a portion defining at least one aperture located distally of the stent engagement region.
Claim 12
Dependent Claim
32 words
The catheter as defined in claim 11 wherein the second tube is disposed concentrically within the first tube, the first lumen being defined by an annulus between the first and second tubes.
Claim 13
Dependent Claim
38 words
The catheter as defined in claim 1 further comprising a second tube defining a second lumen adapted for receiving a guidewire, the balloon including a portion defining a plurality of perfusion pores located in the stent engagement region.
Claim 14
Dependent Claim
32 words
The catheter as defined in claim 13 wherein the second tube is disposed concentrically within the first tube, the first lumen being defined by an annulus between the first and second tubes.
Claim 15
Independent Claim
158 words
A method for manufacturing a stent delivery system including a catheter and a stent formed of a shape-memory material, the method comprising steps of: providing a catheter having proximal and distal ends and an inflation lumen; providing a balloon at the distal end of the catheter so that the interior of the balloon is in fluid communication with the inflation lumen, the balloon having a portion defining a stent engagement region; providing at least one aperture in fluid communication with the inflation lumen to permit temperature-controlled fluid to exit the catheter near the balloon; forming a stent having an expanded diameter from a shape-memory material; heating the stent until the shape-memory material transitions to an austenite phase, cooling the stent until the shape-memory material transitions to a martensite phase; positioning the stent over the stent engagement region of the balloon; and compressing the stent onto the stent engagement region to a reduced diameter less than the expanded diameter.
Claim 16
Dependent Claim
52 words
The method as defined in claim 15 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing one or more perfusion jets located on the catheter proximal to the balloon, the jets being adapted to direct temperature-controlled fluid over the stent.
Claim 17
Dependent Claim
55 words
The method as defined in claim 15 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing one or more perfusion pores located in the stent engagement region, the perfusion pores being adapted to allow a controlled perfusion of temperature-controlled fluid over the stent.
Claim 18
Dependent Claim
56 words
The method as defined in claim 15 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing one or more apertures located on the catheter distal to the balloon, the apertures being adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 19
Dependent Claim
54 words
The method as defined in claim 17 wherein the step of providing at least one aperture in fluid communication with the inflation lumen further comprises providing at least one aperture located distal to the stent engagement region of the balloon and adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 20
Dependent Claim
69 words
The method as defined in claim 15 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing at least one aperture located between the interior of the balloon and the interior of a central lumen passing through the balloon, the at least one aperture being adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 21
Dependent Claim
71 words
The method as defined in claim 15 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing at least one aperture located between the interior of the balloon and the exterior of the balloon distal of the stent engagement region, the at least one downstream aperture being adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 22
Independent Claim
133 words
A method for manufacturing a stent delivery system including a catheter and a stent formed of a shape-memory material, the method comprising steps of: providing a catheter having proximal and distal ends and an inflation lumen; providing a balloon at the distal end of the catheter so that the interior of the balloon is in fluid communication with the inflation lumen, the balloon having a portion defining a stent engagement region; providing at least one aperture in fluid communication with the inflation lumen to permit temperature-controlled fluid to exit the catheter near the balloon; forming a stent having an expanded diameter from a shape-memory polymer; physically reducing the diameter of the stent; cooling the stent until the polymer enters the glass phase; positioning the stent over the stent engagement region of the balloon.
Claim 23
Dependent Claim
52 words
The method as defined in claim 22 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing one or more perfusion jets located on the catheter proximal to the balloon, the jets being adapted to direct temperature-controlled fluid over the stent.
Claim 24
Dependent Claim
55 words
The method as defined in claim 22 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing one or more perfusion pores located in the stent engagement region, the perfusion pores being adapted to allow a controlled perfusion of temperature-controlled fluid over the stent.
Claim 25
Dependent Claim
56 words
The method as defined in claim 22 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing one or more apertures located on the catheter distal to the balloon, the apertures being adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 26
Dependent Claim
54 words
The method as defined in claim 24 wherein the step of providing at least one aperture in fluid communication with the inflation lumen further comprises providing at least one aperture located distal to the stent engagement region of the balloon and adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 27
Dependent Claim
69 words
The method as defined in claim 22 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing at least one aperture located between the interior of the balloon and the interior of a central lumen passing through the balloon, the at least one aperture being adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 28
Dependent Claim
71 words
The method as defined in claim 22 wherein the step of providing at least one aperture in fluid communication with the inflation lumen comprises a step of providing at least one aperture located between the interior of the balloon and the exterior of the balloon distal of the stent engagement region, the at least one downstream aperture being adapted to allow a controlled flow of temperature-controlled fluid out of the balloon.
Claim 29
Independent Claim
228 words
A method for introducing and deploying a stent comprising a shape-memory material at an affected site within a vessel of a human body, the method comprising steps of: providing a catheter having proximal and distal ends, a balloon located in the region of the distal end, an inflation lumen communicating between the proximal end and the balloon, and at least one aperture in fluid communication with the inflation lumen to permit temperature-controlled fluid to exit the catheter near the balloon; providing a stent that expands to an expanded diameter when heated beyond a transition temperature; positioning the stent over the balloon in a form having a reduced diameter, the reduced diameter being less than the expanded diameter; inserting the catheter transluminally through a body vessel until the stent is located within an area of the vessel to be treated; providing a bio-compatible fluid at a temperature sufficient to heat the stent above the transition temperature; and injecting the biocompatible fluid into the inflation lumen of the catheter at the proximal end of the catheter to cause inflation of the balloon and a controlled flow of the biocompatible fluid through the at least one aperture, the bio-compatible fluid injected at a rate sufficient to maintain the balloon and the stent in intimate physical and thermal contact during transition of the stent from the reduced diameter to the expanded diameter.
Claim 30
Dependent Claim
41 words
The method as defined in claim 29 further comprising steps of: after the step of injecting bio-compatible fluid, dissipating the fluid in the balloon to cause deflation of the balloon; and withdrawing the catheter from the vessel of the human body.
Claim 31
Independent Claim
233 words
A method for retrieving a stent having an expanded diameter comprising a shape-memory material from an affected site within a vessel of a human body, the method comprising steps of: providing a catheter having proximal and distal ends, a balloon located in the region of the distal end, an inflation lumen communicating between the proximal end and the balloon, and at least one aperture in fluid communication with the inflation lumen to permit temperature-controlled fluid to exit the catheter near the balloon; inserting the catheter transluminally through a body vessel until the balloon is located within the stent within the body vessel; providing a bio-compatible fluid at a temperature effective to cause the stent to contract from the expanded diameter to a reduced diameter less than the expanded diameter; injecting the biocompatible fluid into the inflation lumen of the catheter at the proximal end of the catheter to cause inflation of the balloon and a controlled flow of the biocompatible fluid through the at least one aperture, the bio-compatible fluid injected at a rate sufficient to inflate the balloon into intimate physical and thermal contact with the stent while the stent contracts from the expanded diameter to the reduced diameter; dissipating the fluid in the balloon to allow deflation of the balloon as the stent contracts onto the balloon; and withdrawing the catheter and the stent from the vessel of the human body.
References Cited (Backward Citations)
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