US20040097878A1 - Distensible dilatation balloon with elastic stress response and manufacture thereof - Google Patents
Distensible dilatation balloon with elastic stress response and manufacture thereof Download PDFInfo
- Publication number
- US20040097878A1 US20040097878A1 US10/637,575 US63757503A US2004097878A1 US 20040097878 A1 US20040097878 A1 US 20040097878A1 US 63757503 A US63757503 A US 63757503A US 2004097878 A1 US2004097878 A1 US 2004097878A1
- Authority
- US
- United States
- Prior art keywords
- balloon
- parison
- balloons
- temperature
- psi
- 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.)
- Abandoned
Links
- 230000003938 response to stress Effects 0.000 title claims abstract description 46
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract description 88
- 230000008569 process Effects 0.000 claims abstract description 69
- 230000001954 sterilising effect Effects 0.000 claims abstract description 38
- 229920001400 block copolymer Polymers 0.000 claims description 28
- 229920002635 polyurethane Polymers 0.000 claims description 26
- 239000004814 polyurethane Substances 0.000 claims description 26
- 229920000642 polymer Polymers 0.000 claims description 21
- IAYPIBMASNFSPL-UHFFFAOYSA-N Ethylene oxide Chemical compound C1CO1 IAYPIBMASNFSPL-UHFFFAOYSA-N 0.000 claims description 15
- -1 polyethylene terephthalate Polymers 0.000 claims description 11
- 230000003993 interaction Effects 0.000 claims description 9
- 239000000203 mixture Substances 0.000 claims description 7
- 229920006147 copolyamide elastomer Polymers 0.000 claims description 6
- 229920000728 polyester Polymers 0.000 claims description 6
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 6
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 6
- 230000007423 decrease Effects 0.000 claims description 5
- 238000002844 melting Methods 0.000 claims description 5
- 230000008018 melting Effects 0.000 claims description 5
- 230000005484 gravity Effects 0.000 claims description 4
- 239000004677 Nylon Substances 0.000 claims description 3
- 230000009477 glass transition Effects 0.000 claims description 3
- 238000010438 heat treatment Methods 0.000 claims description 3
- 229920001778 nylon Polymers 0.000 claims description 3
- 239000000463 material Substances 0.000 abstract description 45
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 37
- 230000002411 adverse Effects 0.000 abstract description 17
- 208000031481 Pathologic Constriction Diseases 0.000 description 21
- 230000036262 stenosis Effects 0.000 description 11
- 208000037804 stenosis Diseases 0.000 description 11
- 210000001367 artery Anatomy 0.000 description 8
- 230000003287 optical effect Effects 0.000 description 6
- 230000000704 physical effect Effects 0.000 description 6
- 239000000126 substance Substances 0.000 description 6
- 239000004698 Polyethylene Substances 0.000 description 5
- 239000012530 fluid Substances 0.000 description 5
- 229920000573 polyethylene Polymers 0.000 description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
- 229910001873 dinitrogen Inorganic materials 0.000 description 4
- 230000001747 exhibiting effect Effects 0.000 description 4
- RYECOJGRJDOGPP-UHFFFAOYSA-N Ethylurea Chemical compound CCNC(N)=O RYECOJGRJDOGPP-UHFFFAOYSA-N 0.000 description 3
- 238000002399 angioplasty Methods 0.000 description 3
- 230000015572 biosynthetic process Effects 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 230000004044 response Effects 0.000 description 3
- 238000004513 sizing Methods 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 2
- 230000010339 dilation Effects 0.000 description 2
- 229920000554 ionomer Polymers 0.000 description 2
- 229920005862 polyol Polymers 0.000 description 2
- 150000003077 polyols Chemical class 0.000 description 2
- KKEYFWRCBNTPAC-UHFFFAOYSA-L terephthalate(2-) Chemical compound [O-]C(=O)C1=CC=C(C([O-])=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-L 0.000 description 2
- 239000004970 Chain extender Substances 0.000 description 1
- 206010048631 Coronary artery dissection Diseases 0.000 description 1
- 238000005273 aeration Methods 0.000 description 1
- 229920005601 base polymer Polymers 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 230000009172 bursting Effects 0.000 description 1
- 238000007887 coronary angioplasty Methods 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 125000005442 diisocyanate group Chemical group 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000012948 isocyanate Substances 0.000 description 1
- 150000002513 isocyanates Chemical class 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000006069 physical mixture Substances 0.000 description 1
- 229920000098 polyolefin Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000012414 sterilization procedure Methods 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 238000003856 thermoforming Methods 0.000 description 1
Images
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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
- A61L2/20—Gaseous substances, e.g. vapours
- A61L2/206—Ethylene oxide
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/04—Macromolecular materials
- A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
-
- 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
- A61M2025/0019—Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/46—Component parts, details or accessories; Auxiliary operations characterised by using particular environment or blow fluids other than air
- B29C2049/4602—Blowing fluids
- B29C2049/4605—Blowing fluids containing an inert gas, e.g. helium
- B29C2049/4608—Nitrogen
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
- B29C49/42—Component parts, details or accessories; Auxiliary operations
- B29C49/78—Measuring, controlling or regulating
- B29C49/783—Measuring, controlling or regulating blowing pressure
- B29C2049/7831—Measuring, controlling or regulating blowing pressure characterised by pressure values or ranges
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2022/00—Hollow articles
- B29L2022/02—Inflatable articles
- B29L2022/022—Balloons
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7542—Catheters
Definitions
- Distensibility Another important characteristic of balloons in general, and more specifically dilatation balloons, is the distensibility of the finished balloon product.
- the balloons and balloon catheters are then subjected to an aeration step in which the ethylene oxide is allowed to dissipate.
- the novel sterilization process does not adversely affect the improved overall combination of properties exhibited by the balloons of this invention.
- These polymers can be considered to be comprised of polymer chains with individual regions of crystalline and amorphous material and can be referred to as “hard” and “soft” segments respectively.
- the individual polymer chains are able, to a substantial extent, to coil upon themselves and/or around each other in such a way that soft segments are associated with soft segments and hard segments with hard segments, thereby forming separate “domains” approximating soft and hard bodies of polymer, each exhibiting its own physical properties in varying degrees.
- the hard segments are comprised of regions which have significant inter-molecular chain interaction. This provides regions with increased strength and increased elastic stress response. In addition to providing strength, the hard segments are sufficiently rigid to permit the soft segments to stretch and uncoil which provides distensibility.
- the sterilization process cannot, however, be conducted above the heat set temperature since this would relieve the orientation of the polymer chains which was “locked” into place during heat set process.
- the sterilization process appears to be an important factor in determining the final physical characteristics of the balloons and balloon catheters of this invention. Therefore, the novel sterilization process is necessary to ensure a clinically useful and safe finished balloon and balloon catheter with an overall advantageous combination of physical properties (i.e., distensibility, elastic stress response and wall tensile strength) superior to those exhibited by the “compliant” balloons of the prior art.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/637,575 US20040097878A1 (en) | 1992-09-30 | 2003-08-11 | Distensible dilatation balloon with elastic stress response and manufacture thereof |
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/954,750 US5500180A (en) | 1992-09-30 | 1992-09-30 | Method of making a distensible dilatation balloon using a block copolymer |
US44070095A | 1995-05-15 | 1995-05-15 | |
US08/883,261 US6210364B1 (en) | 1992-09-30 | 1997-06-26 | Distensible dilatation balloon with elastic stress response |
US09/192,893 US6283939B1 (en) | 1992-09-30 | 1998-11-16 | Distensible dilatation balloon with elastic stress |
US09/942,920 US6620381B2 (en) | 1992-09-30 | 2001-08-31 | Sterilization process for a distensible dilatation balloon with elastic stress response |
US10/637,575 US20040097878A1 (en) | 1992-09-30 | 2003-08-11 | Distensible dilatation balloon with elastic stress response and manufacture thereof |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/942,920 Continuation US6620381B2 (en) | 1992-09-30 | 2001-08-31 | Sterilization process for a distensible dilatation balloon with elastic stress response |
Publications (1)
Publication Number | Publication Date |
---|---|
US20040097878A1 true US20040097878A1 (en) | 2004-05-20 |
Family
ID=25495874
Family Applications (5)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/954,750 Expired - Lifetime US5500180A (en) | 1992-09-30 | 1992-09-30 | Method of making a distensible dilatation balloon using a block copolymer |
US08/883,261 Expired - Fee Related US6210364B1 (en) | 1992-09-30 | 1997-06-26 | Distensible dilatation balloon with elastic stress response |
US09/192,893 Expired - Lifetime US6283939B1 (en) | 1992-09-30 | 1998-11-16 | Distensible dilatation balloon with elastic stress |
US09/942,920 Expired - Fee Related US6620381B2 (en) | 1992-09-30 | 2001-08-31 | Sterilization process for a distensible dilatation balloon with elastic stress response |
US10/637,575 Abandoned US20040097878A1 (en) | 1992-09-30 | 2003-08-11 | Distensible dilatation balloon with elastic stress response and manufacture thereof |
Family Applications Before (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US07/954,750 Expired - Lifetime US5500180A (en) | 1992-09-30 | 1992-09-30 | Method of making a distensible dilatation balloon using a block copolymer |
US08/883,261 Expired - Fee Related US6210364B1 (en) | 1992-09-30 | 1997-06-26 | Distensible dilatation balloon with elastic stress response |
US09/192,893 Expired - Lifetime US6283939B1 (en) | 1992-09-30 | 1998-11-16 | Distensible dilatation balloon with elastic stress |
US09/942,920 Expired - Fee Related US6620381B2 (en) | 1992-09-30 | 2001-08-31 | Sterilization process for a distensible dilatation balloon with elastic stress response |
Country Status (5)
Cited By (31)
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US20080051819A1 (en) * | 2006-08-25 | 2008-02-28 | Nishith Chasmawala | Apparatus and methods for use of expandable members in surgical applications |
US7736388B2 (en) | 1999-04-09 | 2010-06-15 | Evalve, Inc. | Fixation devices, systems and methods for engaging tissue |
US7753923B2 (en) | 1999-04-09 | 2010-07-13 | Evalve, Inc. | Leaflet suturing |
US7811296B2 (en) | 1999-04-09 | 2010-10-12 | Evalve, Inc. | Fixation devices for variation in engagement of tissue |
US7981123B2 (en) | 1997-09-12 | 2011-07-19 | Evalve, Inc. | Surgical device for connecting soft tissue |
US7981139B2 (en) | 2002-03-01 | 2011-07-19 | Evalve, Inc | Suture anchors and methods of use |
US8029518B2 (en) | 1999-04-09 | 2011-10-04 | Evalve, Inc. | Methods and devices for capturing and fixing leaflets in valve repair |
US8052592B2 (en) | 2005-09-27 | 2011-11-08 | Evalve, Inc. | Methods and devices for tissue grasping and assessment |
US8123703B2 (en) | 1999-04-09 | 2012-02-28 | Evalve, Inc. | Steerable access sheath and methods of use |
US8216256B2 (en) | 1999-04-09 | 2012-07-10 | Evalve, Inc. | Detachment mechanism for implantable fixation devices |
US8343174B2 (en) | 1999-04-09 | 2013-01-01 | Evalve, Inc. | Locking mechanisms for fixation devices and methods of engaging tissue |
US8926620B2 (en) | 2006-08-25 | 2015-01-06 | Kyphon Sarl | Apparatus and methods for use of expandable members in surgical applications |
US10188392B2 (en) | 2014-12-19 | 2019-01-29 | Abbott Cardiovascular Systems, Inc. | Grasping for tissue repair |
US10238495B2 (en) | 2015-10-09 | 2019-03-26 | Evalve, Inc. | Delivery catheter handle and methods of use |
US10238494B2 (en) | 2015-06-29 | 2019-03-26 | Evalve, Inc. | Self-aligning radiopaque ring |
US10314586B2 (en) | 2016-12-13 | 2019-06-11 | Evalve, Inc. | Rotatable device and method for fixing tricuspid valve tissue |
US10363138B2 (en) | 2016-11-09 | 2019-07-30 | Evalve, Inc. | Devices for adjusting the curvature of cardiac valve structures |
US10376673B2 (en) | 2015-06-19 | 2019-08-13 | Evalve, Inc. | Catheter guiding system and methods |
US10390943B2 (en) | 2014-03-17 | 2019-08-27 | Evalve, Inc. | Double orifice device for transcatheter mitral valve replacement |
US10398553B2 (en) | 2016-11-11 | 2019-09-03 | Evalve, Inc. | Opposing disk device for grasping cardiac valve tissue |
US10413408B2 (en) | 2015-08-06 | 2019-09-17 | Evalve, Inc. | Delivery catheter systems, methods, and devices |
US10426616B2 (en) | 2016-11-17 | 2019-10-01 | Evalve, Inc. | Cardiac implant delivery system |
US10524912B2 (en) | 2015-04-02 | 2020-01-07 | Abbott Cardiovascular Systems, Inc. | Tissue fixation devices and methods |
US10631871B2 (en) | 2003-05-19 | 2020-04-28 | Evalve, Inc. | Fixation devices, systems and methods for engaging tissue |
US10667815B2 (en) | 2015-07-21 | 2020-06-02 | Evalve, Inc. | Tissue grasping devices and related methods |
US10736632B2 (en) | 2016-07-06 | 2020-08-11 | Evalve, Inc. | Methods and devices for valve clip excision |
US10743876B2 (en) | 2011-09-13 | 2020-08-18 | Abbott Cardiovascular Systems Inc. | System for fixation of leaflets of a heart valve |
US10779837B2 (en) | 2016-12-08 | 2020-09-22 | Evalve, Inc. | Adjustable arm device for grasping tissues |
US11065119B2 (en) | 2017-05-12 | 2021-07-20 | Evalve, Inc. | Long arm valve repair clip |
US11304715B2 (en) | 2004-09-27 | 2022-04-19 | Evalve, Inc. | Methods and devices for tissue grasping and assessment |
US11653947B2 (en) | 2016-10-05 | 2023-05-23 | Evalve, Inc. | Cardiac valve cutting device |
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US5500180A (en) * | 1992-09-30 | 1996-03-19 | C. R. Bard, Inc. | Method of making a distensible dilatation balloon using a block copolymer |
US6025044A (en) | 1993-08-18 | 2000-02-15 | W. L. Gore & Associates, Inc. | Thin-wall polytetrafluoroethylene tube |
US20030032963A1 (en) | 2001-10-24 | 2003-02-13 | Kyphon Inc. | Devices and methods using an expandable body with internal restraint for compressing cancellous bone |
US6120523A (en) | 1994-02-24 | 2000-09-19 | Radiance Medical Systems, Inc. | Focalized intraluminal balloons |
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US6406457B1 (en) * | 1994-03-02 | 2002-06-18 | Scimed Life Systems, Inc. | Block copolymer elastomer catheter balloons |
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Also Published As
Publication number | Publication date |
---|---|
US6620381B2 (en) | 2003-09-16 |
US20020053349A1 (en) | 2002-05-09 |
US6283939B1 (en) | 2001-09-04 |
JPH06304920A (ja) | 1994-11-01 |
EP1683539A2 (en) | 2006-07-26 |
EP1683539A3 (en) | 2008-11-05 |
EP1683539B1 (en) | 2010-01-27 |
DE69334318D1 (de) | 2010-03-18 |
EP0592885A2 (en) | 1994-04-20 |
EP0592885B1 (en) | 2009-07-01 |
US6210364B1 (en) | 2001-04-03 |
EP0592885A3 (en) | 1995-09-06 |
DE69334289D1 (de) | 2009-08-13 |
US5500180A (en) | 1996-03-19 |
CA2107378A1 (en) | 1994-03-31 |
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