EP1335682A2 - Mat riau et structure de manchon hybride - Google Patents

Mat riau et structure de manchon hybride

Info

Publication number
EP1335682A2
EP1335682A2 EP01991597A EP01991597A EP1335682A2 EP 1335682 A2 EP1335682 A2 EP 1335682A2 EP 01991597 A EP01991597 A EP 01991597A EP 01991597 A EP01991597 A EP 01991597A EP 1335682 A2 EP1335682 A2 EP 1335682A2
Authority
EP
European Patent Office
Prior art keywords
stent
catheter
predetermined hardness
inside surface
sleeve
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.)
Withdrawn
Application number
EP01991597A
Other languages
German (de)
English (en)
Inventor
John J. Chen
Daniel J. Horn
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Boston Scientific Ltd Barbados
Original Assignee
Boston Scientific Ltd Barbados
Scimed Life Systems Inc
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US09/716,757 external-priority patent/US6805702B1/en
Application filed by Boston Scientific Ltd Barbados, Scimed Life Systems Inc filed Critical Boston Scientific Ltd Barbados
Publication of EP1335682A2 publication Critical patent/EP1335682A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0019—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in hardness, e.g. Vickers, Shore, Brinell

Definitions

  • This invention relates to medical device delivery catheters in general, and specifically to balloon catheters for use in delivering a medical device such as a stent to a desired body location, such as in a blood vessel. More specifically, this invention relates to socks or sleeves used in retaining the stent in the unexpanded state which have reduced frictional engagement with the ends of a stent and/or balloon cones. In the present invention such reduced frictional interaction is made possible by providing the sleeve or sleeves with an inside surface of which at least a portion is characterized as being harder than the outside surface.
  • Stents and stent delivery assemblies are utilized in a number of medical procedures and situations, and as such their structure and function are well known.
  • a stent is a generally cylindrical prosthesis introduced via a catheter into a lumen of a body vessel in a configuration having a generally reduced diameter and then expanded to the diameter of the vessel. In its expanded configuration, the stent supports and reinforces the vessel walls while maintaining the vessel in an open, unobstructed condition.
  • Both self-expanding and inflation expandable stents are well known and widely available in a variety of designs and configurations. Self-expanding stents must be maintained under positive external pressure in order to maintain their reduced diameter configuration during delivery of the stent to its deployment site.
  • Inflation expandable stents may be crimped to their reduced diameter about the delivery catheter, maneuvered to the deployment site, and expanded to the vessel diameter by fluid inflation of a balloon positioned on the delivery catheter.
  • the present invention is particularly concerned with delivery and deployment of inflation expandable stents, although it is generally applicable to self-expanding stents when used with balloon catheters.
  • the stent Inflation expandable stent delivery and deployment assemblies are known which utilize restraining means that overlie the stent during delivery.
  • the stent is expandable by means of the expandable balloon on the catheter. During expansion of the stent at the deployment site, the stent margins are freed of the protective sleeve(s).
  • U.S. Patent 5,403,341 to Solar relates to a stent delivery and deployment assembly which uses retaining sheaths positioned about opposite ends of the compressed stent. The retaining sheaths of Solar are adapted to tear under pressure as the stent is radially expanded, thus releasing the stent from engagement with the sheaths.
  • U.S. Patent No. 5,108,416 to Ryan et al. describes a stent introducer system which uses one or two flexible end caps and an annular socket surrounding the balloon to position the stent during introduction to the deployment site.
  • friction can occur between the guide catheter and guide wire, between the introducer sheath and the guide catheter, or between the guide catheter and the balloon catheter, for instance, and may increase the difficulty of insertion, cause loss of catheter placement, and result in discomfort to the patient or damage to the vasculature.
  • friction between the balloon and sleeve, and/or the stent and sleeve may also cause retraction of the sleeves to be made more difficult.
  • the relatively soft coating may increase its friction to the sock or sleeve system.
  • Lubricants however may be used in a variety of stent delivery catheters. Many lubricants and lubricious coatings types have been used in conjunction with balloon catheters. Both hydrophilic and hydrophobic coatings and lubricants are well known in the catheter art.
  • copending U.S. Patent Application No. 09/407,836 which was filed on September 28, 1999 and entitled Stent Securement Sleeves and Optional Coatings and Methods of Use, provides for a stent delivery system having sleeves.
  • the sleeves may be made up of a combination of polytetrafluoroethylene (hereinafter PTFE) as well as one or more thermoplastic elastomers.
  • PTFE polytetrafluoroethylene
  • Copending U.S. Patent Application No. 09/427,805 filed October 27, 1999, and entitled End Sleeve Coating for Stent Delivery describes the use of stent retaining sleeves having lubricious coatings applied thereto.
  • Stent delivery systems which may not require the use of lubricants have been proposed, such as copending U.S. Application No. 09/549,286 mentioned above.
  • Another example of a stent delivery system and retaining sleeve which may not require , lubrication is Copending application 09/668,496 filed September 22, 2000 and entitled Striped Sleeve For Stent Delivery describes a two component sleeve having one or more substantially longitudinally oriented stripe of a hard material and a softer material.
  • the striped configuration of materials in the sleeve allows the sleeve to radially expand but with limited or no longitudinal expansion.
  • the unique expansion characteristics provided by the striped configuration helps avoid a need to use a lubricant with the sleeve, though a lubricant may still be utilized therewith if desired.
  • the instant invention is directed to a medical device delivery system comprising a catheter assembly having a medical device receiving region and at least one retaining sleeve for retaining the medical device on the receiving region prior to delivery.
  • An expandable medical device such as a stent, is disposed about the medical device receiving region of the catheter assembly.
  • At least one retaining sleeve is disposed about an end of the expandable medical device and at least a portion of the catheter assembly.
  • the at least one retaining sleeve further comprises an inside surface and an outside surface.
  • the outside surface being comprised of a first material and at least the portion of the inside surface which is constructed to overlay a stent being comprised of a second material.
  • the first and second materials having different harnesses, the second material being harder than the first.
  • the hardness represents the capacity of elongation when the polymer is exposed to an outside acting force, this is especially true for elastomeric materials (e.g. the lower a material's hardness the higher the material's elasticity).
  • the present invention improves sleeve retractability by providing at least the portion of the inside surface of the sleeve which may overlay a stent with a material which has a greater hardness than the majority of the sleeve material.
  • a relatively hard material preferably provides the sleeve with a surface having lower frictional engagement to the stent.
  • first material and second material are co-extruded polymers.
  • second material is a coating on the first material.
  • the inside surface is comprised entirely of the second material.
  • only the portion of the inside surface which is constructed and arranged to overlay a stent is comprised of the harder material.
  • FIG. 1 is a side view of a first embodiment of the invention
  • FIG. 2 is a side view of a second embodiment of the invention
  • FIG. 3 is a side view of a third embodiment of the invention.
  • FIG. 4 is a side view of a forth embodiment of the invention.
  • the present invention may be embodied in a stent delivery catheter, indicated generally at 10.
  • Catheter 10 includes a stent mounting region 12, the stent mounting region 12 may be an inflatable portion of the catheter or may be a separate balloon mounted to the catheter shaft 14.
  • the balloon 12 may have an unexpanded state and an expanded state.
  • a stent 16, disposed about the stent mounting region 12 may be delivered when the balloon 12 is expanded to the expanded state.
  • the stent 16 includes a proximal end 18 and a distal end 20.
  • a stent retaining sleeve 22 overlies at least a portion of each end 18 and 20.
  • the ends of the stent retaining sleeves 22 are configured to retract off of the stent ends 18 and 20.
  • the sleeves 22 have a unique construction which provides the first portion 24 of the sleeve which overlies the stent 16, with a reduced frictional engagement with the stent 16 by providing the inside surface 100 of the first portion 24 with a material 34 which is harder than that of the outer surface 102 of the sleeve 22.
  • the second portion 26 of the sleeve 22 is disposed about and is engaged to a portion of the catheter shaft 14 adjacent to the balloon 12.
  • the present invention ensures that the stent is delivered with improved sleeve retractability.
  • the sleeves 22 are constructed from at least two materials having different hardness characteristics.
  • the first material 30 is formed into a generally tubular body 32 which provides the sleeve with its shape as well as its outer surface 102. At least a portion of the first end 24 of the inside surface 100 is composed of the second material 34. 5
  • the first material 30 may be any elastic material known which has a hardness as measured by a Shore durometer of less than 55D. Preferably the durometer hardness of the first material is between 40A and 100A.
  • the second material 34 may be any material having a durometer hardness greater than about 55D. In at least one embodiment of the invention the first material 30 has a hardness of 35D and the second
  • 10 material 34 has a hardness of 70D.
  • the first material 30 may be selected from one or more of the following substances: soft grade polyester/poly ether elastomers such as ArnitelTM available from DSM Engineering, polyurethane-polyether polymers, such as TecothaneTM 1074A available from Thermedics, Inc.; polyester-polyurethanes, such as PellethaneTM 2102-
  • soft grade polyester/poly ether elastomers such as ArnitelTM available from DSM Engineering, polyurethane-polyether polymers, such as TecothaneTM 1074A available from Thermedics, Inc.
  • polyester-polyurethanes such as PellethaneTM 2102-
  • polyester-polyurethanes such as EstaneTM 5703P sold by BF Goodrich
  • polyether block amides such as PebaxTM 2533 available from Elf Atochem
  • styrene-butadien-styrene triblock copolymers such as KratonTM Dl 101 sold by Shell Chemical company.
  • Other materials which may also be used in the production of the first material 30 include, but are not limited to styrenic block
  • copolymers polyurethanes, silicone rubber, natural rubber, copolyesters, polyamides, EPDM rubber/polyolefin, nitril rubber/PVC, fluoroelastomers, butyl rubber, epichlorohydrin, soft block copolymers, and any combinations thereof.
  • the second material 34 may be selected from one or more of the following substances: polyethyleneterephthalate (PET), polybutylene terephthalate
  • polytrimethylene terephthalate (PTT),NylonTM engineering thermoplastic polyurethanes, fluoropolymers, polyester/polyether elastomers such as ArnitelTM available from DSM Engineering, polyurethane-polyether polymers, such as TecothaneTM 1055D or 1075D both of which are available from Thermedics, Inc.; polyester-polyurethanes, such as EstaneTM 58170 sold by BF Goodrich; polyether block
  • amides such as PebaxTM 7233 or 6333 both of which are available from Elf Atochem.
  • Other materials which may also be used in the production of the second material 34 include, but are not limited to: polyolefins, polystyrene, polyvinyl chloride, acrylonitrile- butadiene-styrene polymers, polyacrylonitrile, polyacrylate, vinyl acetate polymer, cellulose plastics, polyurethanes, polyethylene terephthalate, polyacetal, polyethers, polycarbonates, polyamides, polyphenylene sulfide, polyarylethersulfones, 5 polyaryletherketones, polytetrafluoroethylene, and any combinations thereof.
  • first and second materials 30 and 34 are in no way exhaustive of the potential substances or combinations of substances which may be used.
  • the present invention is directed to a sleeve composed of any materials which have the hardness qualities previously described for the respective materials 30 and 34.
  • the present invention may be embodied in a variety of manners.
  • the catheter 10 is seen with a pair of sleeves 22 each of which have a first portion 24 with an inner surface 100 which is composed of a second material 34, such as is described above.
  • Second material 34 may be a coating of hardened material applied to the inside surface
  • the material 34 may be bonded or welded to the sleeve 22, or first material 30 and second material 34 may have been co-extruded together in the form of sleeve 22 shown.
  • Other methods for joining the materials 30 and 34, such as selective coating by printing, may also be utilized.
  • the entire inside surface 100 of the sleeve(s) 22 0 may be composed of the second material 34.
  • FIGs. 3 and 4 show the sleeve configurations respectfully described in relation to FIGs. 1 and 2 as they may be embodied on a sleeve 22 exclusive of the stent delivery catheter 10.
  • a retractable sheath (not shown) such as are known in the art, may be employed to overlay the stent.
  • a single sleeve or two sleeves such have been shown and described may be employed to retain the self- expanding stent in place.
  • the sheath When the sheath is retracted the stent will expand causing the sleeve(s) to retract.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Abstract

L'invention porte sur un système d'apport d'endoprothèse comprenant un cathéter muni d'une zone de pose d'endoprothèse. Une endoprothèse est disposée autour de la zone de montage d'endoprothèse du cathéter, l'endoprothèse possédant une extrémité distale et une extrémité proximale et présente un étata déployé ou non-déployé. Au moins un manchon de retenue d'endoprothèse comporte une première extrémité recouvrant une extrémité de l'endoprothèse lorsque cette dernière se trouve à l'état déployé ; une deuxième extrémité vient en prise avec au moins une partie du cathéter près de la zone de montage d'endoprothèse. La surface extérieure du manchon de retenue d'endoprothèse est constitué d'un premier matériau, au moins une partie de la première extrémité de la surface intérieure composée d'un deuxième matériau. Le premier matériau présente une première dureté prédéterminée et le deuxième matériau présente une deuxième dureté prédéterminée, la deuxième dureté prédéterminée possédant une valeur au duromètre plus élevée que la première dureté prédéterminée.
EP01991597A 2000-11-20 2001-10-24 Mat riau et structure de manchon hybride Withdrawn EP1335682A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US716757 2000-11-20
US09/716,757 US6805702B1 (en) 2000-09-22 2000-11-20 Hybrid sleeve material and structure
PCT/US2001/050707 WO2002039929A2 (fr) 2000-11-20 2001-10-24 Matériau et structure de manchon hybride

Publications (1)

Publication Number Publication Date
EP1335682A2 true EP1335682A2 (fr) 2003-08-20

Family

ID=24879309

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01991597A Withdrawn EP1335682A2 (fr) 2000-11-20 2001-10-24 Mat riau et structure de manchon hybride

Country Status (5)

Country Link
EP (1) EP1335682A2 (fr)
JP (1) JP2004513703A (fr)
AU (1) AU2002231320A1 (fr)
CA (1) CA2424061A1 (fr)
WO (1) WO2002039929A2 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1814623A4 (fr) * 2004-11-18 2008-10-01 Cordis Corp Ballon complexe a usage medical

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5980530A (en) * 1996-08-23 1999-11-09 Scimed Life Systems Inc Stent delivery system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0239929A3 *

Also Published As

Publication number Publication date
WO2002039929A2 (fr) 2002-05-23
CA2424061A1 (fr) 2002-05-23
JP2004513703A (ja) 2004-05-13
WO2002039929A3 (fr) 2002-11-28
AU2002231320A1 (en) 2002-05-27

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Legal Events

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PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

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Effective date: 20030611

AK Designated contracting states

Designated state(s): AT BE CH CY DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE TR

AX Request for extension of the european patent

Extension state: AL LT LV MK RO SI

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: BOSTON SCIENTIFIC LIMITED

17Q First examination report despatched

Effective date: 20041021

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18D Application deemed to be withdrawn

Effective date: 20050503