CA2199549A1 - Method of catheter balloon manufacture and use - Google Patents
Method of catheter balloon manufacture and useInfo
- Publication number
- CA2199549A1 CA2199549A1 CA002199549A CA2199549A CA2199549A1 CA 2199549 A1 CA2199549 A1 CA 2199549A1 CA 002199549 A CA002199549 A CA 002199549A CA 2199549 A CA2199549 A CA 2199549A CA 2199549 A1 CA2199549 A1 CA 2199549A1
- Authority
- CA
- Canada
- Prior art keywords
- tube portion
- catheter
- plastic
- stent
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
Abstract
A catheter balloon is prepared for inflation, and the balloon is inflated by the following process. At least a portion of an elastic, thermoplastic tube is radially stretched until the radially stretched tube portion exhibits a desired increase in molecular orientation. The stretching conditions, such as selective heating, preferably cause a central section of the stretched tube portion to have less wall thickness than end sections of the tube portion. At least part of the tube portion may be longitudinally stretched relative to the tube, to create a desired biaxial molecular orientation. Thereafter, the tube portion is optionally placed into a stent, the tube portion being part of a catheter. The tube portion is inserted into a patient to position the stent and tube portion at a desired position, such as a location in the coronary artery.
After positioning of the tube portion and stent, the lumen of the tube portion is pressurized to cause radial expansion of the tube portion within the patient, with a central section of the tube portion expanding first.
After positioning of the tube portion and stent, the lumen of the tube portion is pressurized to cause radial expansion of the tube portion within the patient, with a central section of the tube portion expanding first.
Claims (22)
1. The method of preparing a catheter balloon for inflation and for inflating said balloon, which comprises:
(A) radially stretching at least a portion of a plastic tube to undergo work hardening, until said radially stretched tube portion exhibits a desired increase in molecular orientation;
(B) longitudinally stretching at least part of said tube portion to create a desired increased molecular orientation longitudinally relative to said tube; and (C) thereafter inserting said tube portion as part of a catheter into a patient, and pressurizing a lumen of said tube portion to cause radial expansion of said tube portion within said patient.
(A) radially stretching at least a portion of a plastic tube to undergo work hardening, until said radially stretched tube portion exhibits a desired increase in molecular orientation;
(B) longitudinally stretching at least part of said tube portion to create a desired increased molecular orientation longitudinally relative to said tube; and (C) thereafter inserting said tube portion as part of a catheter into a patient, and pressurizing a lumen of said tube portion to cause radial expansion of said tube portion within said patient.
2. The method of Claim 1 in which a central portion of said elastic tube portion is radially expanded in step (C) at least initially to a greater degree than outer portions of said tube portion.
3. The method of Claim 1 in which said tube portion is pressurized in step (C) by an amount sufficient to cause work-hardening of said tube portion to take place.
4. The method of Claim 1 in which, prior to step (A), at least some of said plastic tube portion is longitudinally stretched to create increased longitudinal molecular orientation.
5. The method of Claim 1 in which said plastic tube comprises a formulation selected from the group consisting of nylon and polyethylene.
6. The method of Claim 1 in which said tube portion lumen is pressurized within said patient while being surrounded by an expansible stent for implantation within said patient, whereby said stent is expanded and implanted.
7. The method of Claim 1 in which said tube portion inserted into said patient has a diameter prior to pressurizing said lumen of no more than twice the minimum diameter of adjacent tubing of said catheter, said tube portion having an outer wall that is smooth and free of folds.
8. The method of Claim 1 in which the length of the plastic portion radially stretched in step (A) is less than and included in the length of plastic portion longitudinally stretched in step (B).
9. The method of Claim 8 in which said tube portion lumen is pressurized within said patient while being surrounded by an expansible stent for implantation within said patient, said stent being longitudinally centered on the length of the plastic portion radially stretched in step (A).
10. The method of Claim 9 in which said expansible stent is longer than said plastic portion length radially stretched in step (A).
11. The method for preparing a catheter balloon for inflation and inflating said balloon, which comprises:
(A) radially stretching at least a portion of an elastic thermoplastic tube while causing a central section of said tube portion to stretch to a lesser wall thickness than outer sections of said tube portion;
(B) longitudinally stretching at least part of said tube portion; and (C) thereafter inserting said tube portion as part of a catheter into a patient, and pressurizing the lumen of said tube by an amount sufficient to cause radial expansion of said tube portion to take place within said patient while surrounded by an expansible stent for implantation, whereby at least initially more radial expansion of said central section than said end sections of said tube portion takes place, to expand said stent within said patient; and thereafter (D) depressurizing the lumen of said tube portion to reduce the radial expansion thereof, and withdrawing said tube portion from the patient while leaving the expanded stent in the patient.
(A) radially stretching at least a portion of an elastic thermoplastic tube while causing a central section of said tube portion to stretch to a lesser wall thickness than outer sections of said tube portion;
(B) longitudinally stretching at least part of said tube portion; and (C) thereafter inserting said tube portion as part of a catheter into a patient, and pressurizing the lumen of said tube by an amount sufficient to cause radial expansion of said tube portion to take place within said patient while surrounded by an expansible stent for implantation, whereby at least initially more radial expansion of said central section than said end sections of said tube portion takes place, to expand said stent within said patient; and thereafter (D) depressurizing the lumen of said tube portion to reduce the radial expansion thereof, and withdrawing said tube portion from the patient while leaving the expanded stent in the patient.
12. The method of Claim 11 in which, prior to step A, at least some of said plastic tube portion is longitudinally stretched to create an increased longitudinal molecular orientation.
13. The method of Claim 12 in which said plastic tube portion becomes biaxially oriented in step A.
14. The method of Claim 11 in which said tube portion inserted in said patient has a diameter prior to pressurizing said lumen of no more than twice the minimum diameter of the adjacent tubing of said catheter, said tube portion having an outer wall that is smooth and free of folds.
15. The method of Claim 11 in which the length of the plastic portion radially stretched in step (A) is less than the length of plastic portion longitudinally stretched in step (B).
16. The method of Claim 11 in which said stent is longitudinally centered on the length of the stretched plastic portion.
17. A catheter which comprises a tubular catheter body, an inflation lumen, and a tubular plastic distal portion having a bore communicating with said catheter inflation lumen, said tubular plastic distal portion being made of a plastic material capable of radial and longitudinal stretching to undergo molecular orientation on stretching; said plastic tube portion being surrounded by a radially expansible tubular stent.
18. The catheter of Claim 17 in which said plastic tube portion comprises a formulation selected from the group consisting of nylon and polyethylene.
19. The catheter of Claim 17 in which said tube portion has a maximum diameter prior to said pressurizing of no more than twice the minimum diameter of an adjacent tubing of said catheter, said tube portion having an outer wall that is smooth and free of folds.
20. A catheter which comprises a tubular catheter body, an inflation lumen, and a tubular plastic distal portion having a bore communicating with said catheter inflation lumen, said tubular plastic distal portion comprising an elongated, inflatable, stretchable catheter balloon having a central portion and end portions, said central portion having a lesser wall thickness than said end portions to cause the central portion of said balloon to inflate more rapidly than said end portions.
21. The catheter of Claim 20 in which said balloon is surrounded by a tubular, expansible stent, said stent being centered on said balloon whereby, upon balloon inflation, a central portion of said stent inflates prior to end portions of said stent, driven by the inflation of said balloon.
22. The catheter of Claim 21 in which said balloon comprises a material having sufficient crystallinity to undergo molecular orientation on stretching.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US08/614,399 US5643279A (en) | 1996-03-12 | 1996-03-12 | Method of catheter balloon manufacture and use |
| US08/614,399 | 1996-03-12 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2199549A1 true CA2199549A1 (en) | 1997-09-12 |
| CA2199549C CA2199549C (en) | 2010-08-31 |
Family
ID=24461088
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA2199549A Expired - Lifetime CA2199549C (en) | 1996-03-12 | 1997-03-17 | Method of catheter balloon manufacture and use |
Country Status (5)
| Country | Link |
|---|---|
| US (3) | US5643279A (en) |
| EP (1) | EP0795340B1 (en) |
| JP (2) | JP4509230B2 (en) |
| CA (1) | CA2199549C (en) |
| DE (1) | DE69726481T2 (en) |
Families Citing this family (47)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8280682B2 (en) * | 2000-12-15 | 2012-10-02 | Tvipr, Llc | Device for monitoring movement of shipped goods |
| US6602281B1 (en) * | 1995-06-05 | 2003-08-05 | Avantec Vascular Corporation | Radially expansible vessel scaffold having beams and expansion joints |
| US5868705A (en) * | 1996-05-20 | 1999-02-09 | Percusurge Inc | Pre-stretched catheter balloon |
| US6554795B2 (en) | 1997-03-06 | 2003-04-29 | Medtronic Ave, Inc. | Balloon catheter and method of manufacture |
| US5868783A (en) * | 1997-04-16 | 1999-02-09 | Numed, Inc. | Intravascular stent with limited axial shrinkage |
| US5954737A (en) * | 1997-12-19 | 1999-09-21 | Neurovasx, Inc. | Thrombus macerator catheter |
| US9586023B2 (en) | 1998-02-06 | 2017-03-07 | Boston Scientific Limited | Direct stream hydrodynamic catheter system |
| US6319229B1 (en) | 1998-02-19 | 2001-11-20 | Medtronic Percusurge, Inc. | Balloon catheter and method of manufacture |
| DE19839646A1 (en) * | 1998-08-31 | 2000-03-09 | Jomed Implantate Gmbh | Stent |
| US6645174B1 (en) * | 1998-09-30 | 2003-11-11 | Jay S. Yadav | Stent delivery system |
| JP2000217924A (en) * | 1999-02-01 | 2000-08-08 | Kanegafuchi Chem Ind Co Ltd | Extended body for extended catheter and its manufacture |
| JP2001269410A (en) * | 2000-03-24 | 2001-10-02 | Aisin Seiki Co Ltd | Balloon catheter |
| SE524080C2 (en) * | 2000-05-19 | 2004-06-22 | Premetec Ab | Device with hose |
| US7037318B2 (en) * | 2000-12-18 | 2006-05-02 | Boston Scientific Scimed, Inc. | Catheter for controlled stent delivery |
| US20040082859A1 (en) | 2002-07-01 | 2004-04-29 | Alan Schaer | Method and apparatus employing ultrasound energy to treat body sphincters |
| US6808524B2 (en) * | 2002-09-16 | 2004-10-26 | Prorhythm, Inc. | Balloon alignment and collapsing system |
| US7189229B2 (en) * | 2002-09-16 | 2007-03-13 | Prorhythm, Inc. | Balloon alignment and collapsing system |
| US7128868B2 (en) * | 2003-01-10 | 2006-10-31 | Boston Scientific Scimed, Inc. | Balloon wing forming apparatus and method |
| EP1596746B1 (en) * | 2003-02-20 | 2016-10-19 | ReCor Medical, Inc. | Ultrasonic ablation devices |
| DE10331169A1 (en) * | 2003-07-09 | 2005-02-10 | Basf Ag | Housing shell for an electronic device |
| US7727442B2 (en) * | 2003-07-10 | 2010-06-01 | Boston Scientific Scimed, Inc. | Medical device tubing with discrete orientation regions |
| JP4611301B2 (en) * | 2003-07-31 | 2011-01-12 | ウィルソン−クック・メディカル・インコーポレーテッド | System and method for introducing multiple medical devices |
| US7635510B2 (en) * | 2004-07-07 | 2009-12-22 | Boston Scientific Scimed, Inc. | High performance balloon catheter/component |
| US20080275393A1 (en) * | 2004-08-24 | 2008-11-06 | Bonnette Michael J | Isolation thrombectomy catheter system |
| US20060182907A1 (en) * | 2005-02-11 | 2006-08-17 | Boston Scientific Scimed, Inc. | Novel microfibrillar reinforced polymer-polymer composites for use in medical devices |
| US8162878B2 (en) * | 2005-12-05 | 2012-04-24 | Medrad, Inc. | Exhaust-pressure-operated balloon catheter system |
| WO2007136566A2 (en) | 2006-05-19 | 2007-11-29 | Prorhythm, Inc. | Ablation device with optimized input power profile and method of using the same |
| US7654264B2 (en) | 2006-07-18 | 2010-02-02 | Nellcor Puritan Bennett Llc | Medical tube including an inflatable cuff having a notched collar |
| US8926620B2 (en) | 2006-08-25 | 2015-01-06 | Kyphon Sarl | Apparatus and methods for use of expandable members in surgical applications |
| US8043296B2 (en) * | 2006-08-25 | 2011-10-25 | Kyphon Sarl | Apparatus and methods for use of expandable members in surgical applications |
| ITMI20062333A1 (en) * | 2006-12-05 | 2008-06-06 | Mario Salerno | DEVICE TO ASSIST THE SCLORESANT TREATMENT OF VARICOSE VEINS |
| WO2009079539A1 (en) * | 2007-12-17 | 2009-06-25 | Medrad, Inc. | Rheolytic thrombectomy catheter with self-inflation distal balloon |
| WO2009082669A1 (en) | 2007-12-26 | 2009-07-02 | Medrad, Inc. | Rheolytic thrombectomy catheter with self-inflating proximal balloon with drug infusion capabilities |
| DE112009000700T5 (en) | 2008-03-20 | 2011-02-10 | Medrad, Inc. | Hydrodynamic direct current catheter system |
| CA2727000C (en) | 2008-06-04 | 2014-01-07 | Gore Enterprise Holdings, Inc. | Controlled deployable medical device and method of making the same |
| CA2725736C (en) | 2008-06-04 | 2013-09-17 | Gore Enterprise Holdings, Inc. | Controlled deployable medical device and method of making the same |
| US9265918B2 (en) | 2008-09-03 | 2016-02-23 | Boston Scientific Scimed, Inc. | Multilayer medical balloon |
| US8974445B2 (en) | 2009-01-09 | 2015-03-10 | Recor Medical, Inc. | Methods and apparatus for treatment of cardiac valve insufficiency |
| JP5566171B2 (en) * | 2009-08-25 | 2014-08-06 | 雅之 山田 | Cuffed tube |
| JP2011101701A (en) * | 2009-11-10 | 2011-05-26 | Fujifilm Corp | Optical probe, drive control method therefor, and endoscope apparatus |
| JP6035033B2 (en) * | 2012-03-13 | 2016-11-30 | テルモ株式会社 | Stent expansion balloon, balloon catheter and stent delivery system |
| JP2016533218A (en) | 2013-10-15 | 2016-10-27 | ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． | High pressure tear resistant balloon |
| US10207449B2 (en) | 2014-06-24 | 2019-02-19 | Cook Medical Technologies Llc | Sequential biaxial strain of semi-crystalline tubes |
| WO2017180639A1 (en) | 2016-04-12 | 2017-10-19 | Boston Scientific Scimed, Inc. | Medical balloon |
| CN106178231A (en) * | 2016-08-03 | 2016-12-07 | 武汉福脉医疗科技有限公司 | Medical double-deck high pressure resistant sacculus and preparation method thereof |
| US10849629B2 (en) | 2016-12-13 | 2020-12-01 | Boston Scientific Scimed, Inc. | Medical balloon |
| EP3615099B1 (en) | 2017-04-25 | 2023-03-01 | Boston Scientific Scimed, Inc. | Medical balloon |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4490421A (en) * | 1983-07-05 | 1984-12-25 | E. I. Du Pont De Nemours And Company | Balloon and manufacture thereof |
| JPH0771579B2 (en) * | 1986-08-05 | 1995-08-02 | 住友ベークライト株式会社 | Medical balloon catheter |
| EP0274411A3 (en) * | 1987-01-09 | 1988-11-30 | C.R. Bard, Inc. | Thin wall high strength balloon and method of manufacture |
| US4943278A (en) * | 1988-02-29 | 1990-07-24 | Scimed Life Systems, Inc. | Dilatation balloon catheter |
| US5156612A (en) * | 1988-10-04 | 1992-10-20 | Cordis Corporation | Balloons for medical devices and fabrication thereof |
| US5304197A (en) * | 1988-10-04 | 1994-04-19 | Cordis Corporation | Balloons for medical devices and fabrication thereof |
| US5290306A (en) * | 1989-11-29 | 1994-03-01 | Cordis Corporation | Puncture resistant balloon catheter |
| US5674192A (en) * | 1990-12-28 | 1997-10-07 | Boston Scientific Corporation | Drug delivery |
| JP2555298B2 (en) * | 1990-11-10 | 1996-11-20 | テルモ株式会社 | CATHETER BALLOON, CATHETER BALLOON MANUFACTURING METHOD, AND BALLOON CATHETER |
| US5479945A (en) * | 1990-12-31 | 1996-01-02 | Uromed Corporation | Method and a removable device which can be used for the self-administered treatment of urinary tract infections or other disorders |
| JPH05192408A (en) * | 1991-09-06 | 1993-08-03 | C R Bard Inc | Production of expansion balloon |
| JPH0691006A (en) * | 1992-09-16 | 1994-04-05 | Olympus Optical Co Ltd | Balloon catheter for expansion |
| CA2107271A1 (en) * | 1992-09-30 | 1994-03-31 | Eugene Tedeschi | Process for preparing functionally coated expanded products from expandable tubing |
| US5490838A (en) * | 1993-06-16 | 1996-02-13 | Cordis Corporation | Method of inserting a balloon catheter |
| US5645560A (en) * | 1995-12-15 | 1997-07-08 | Cardiovascular Dynamics, Inc. | Fixed focal balloon for interactive angioplasty and stent implantation |
| US5456694A (en) * | 1994-05-13 | 1995-10-10 | Stentco, Inc. | Device for delivering and deploying intraluminal devices |
| JPH07303701A (en) * | 1994-05-13 | 1995-11-21 | Takashi Nishimura | Balloon catheter for recovering contrast medium |
| US5609605A (en) * | 1994-08-25 | 1997-03-11 | Ethicon, Inc. | Combination arterial stent |
| US5766201A (en) * | 1995-06-07 | 1998-06-16 | Boston Scientific Corporation | Expandable catheter |
-
1996
- 1996-03-12 US US08/614,399 patent/US5643279A/en not_active Expired - Lifetime
-
1997
- 1997-02-10 US US08/795,248 patent/US5728104A/en not_active Expired - Lifetime
- 1997-03-11 EP EP97301599A patent/EP0795340B1/en not_active Expired - Lifetime
- 1997-03-11 DE DE69726481T patent/DE69726481T2/en not_active Expired - Lifetime
- 1997-03-12 JP JP07463197A patent/JP4509230B2/en not_active Expired - Lifetime
- 1997-03-17 CA CA2199549A patent/CA2199549C/en not_active Expired - Lifetime
-
1998
- 1998-01-27 US US09/014,225 patent/US5913861A/en not_active Expired - Lifetime
-
2010
- 2010-03-15 JP JP2010057090A patent/JP5005784B2/en not_active Expired - Lifetime
Also Published As
| Publication number | Publication date |
|---|---|
| EP0795340A3 (en) | 1998-03-11 |
| JP2010131438A (en) | 2010-06-17 |
| US5913861A (en) | 1999-06-22 |
| US5643279A (en) | 1997-07-01 |
| DE69726481D1 (en) | 2004-01-15 |
| US5728104A (en) | 1998-03-17 |
| EP0795340A2 (en) | 1997-09-17 |
| JP5005784B2 (en) | 2012-08-22 |
| JP4509230B2 (en) | 2010-07-21 |
| DE69726481T2 (en) | 2004-09-16 |
| EP0795340B1 (en) | 2003-12-03 |
| CA2199549C (en) | 2010-08-31 |
| JPH10238A (en) | 1998-01-06 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKEX | Expiry |
Effective date: 20170317 |