CA2675209A1 - Rapid-exchange balloon catheter shaft and method - Google Patents

Rapid-exchange balloon catheter shaft and method Download PDF

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Publication number
CA2675209A1
CA2675209A1 CA002675209A CA2675209A CA2675209A1 CA 2675209 A1 CA2675209 A1 CA 2675209A1 CA 002675209 A CA002675209 A CA 002675209A CA 2675209 A CA2675209 A CA 2675209A CA 2675209 A1 CA2675209 A1 CA 2675209A1
Authority
CA
Canada
Prior art keywords
proximal
balloon
shaft
balloon catheter
cut pattern
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
Application number
CA002675209A
Other languages
French (fr)
Other versions
CA2675209C (en
Inventor
Laila Al-Marashi
David Grewe
Stephen Griffin
Elaine Lim
David Majercak
Roger Stevens
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.)
Cardinal Health 529 LLC
Original Assignee
Cordis Corporation
Laila Al-Marashi
David Grewe
Stephen Griffin
Elaine Lim
David Majercak
Roger Stevens
CARDINAL HEALTH SWITZERLAND 515 GmbH
Cardinal Health 529, Llc
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39528388&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2675209(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority claimed from US10/224,168 external-priority patent/US7128718B2/en
Priority claimed from US10/691,823 external-priority patent/US7520863B2/en
Application filed by Cordis Corporation, Laila Al-Marashi, David Grewe, Stephen Griffin, Elaine Lim, David Majercak, Roger Stevens, CARDINAL HEALTH SWITZERLAND 515 GmbH, Cardinal Health 529, Llc filed Critical Cordis Corporation
Publication of CA2675209A1 publication Critical patent/CA2675209A1/en
Application granted granted Critical
Publication of CA2675209C publication Critical patent/CA2675209C/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0054—Catheters; Hollow probes characterised by structural features with regions for increasing flexibility
    • 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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped
    • 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
    • A61F2250/0018—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 elasticity, stiffness or compressibility
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters

Abstract

A balloon catheter or stent delivery system for medical treatment of a pa tient has a proximal hub, a balloon, and an improved shaft design The cathet er shaft has a rapid-exchange configuration, and a tubular outer body that i ncludes a hypotube extending from the catheter proximal end to a position at or near a proximal leg of the balloon An inner tubular body defines a guide wire lumen extending from a distal guidewire port at the catheter distal end to a proximal port located at a position between the balloon and the hub Th e hypotube has an aperture for accepting the inner body proximal end, and a circumferential cut pattern The cut pattern adds flexibility, and may extend from the hypotube distal end to a position proximal of the proximal guidewi re port

Claims (18)

1. A balloon catheter having a proximal end and a distal end, for medically treating a patient, comprising:

a balloon defining an interior;

a hub defining a proximal inflation port;

a flexible shaft having a proximal and distal end; the shaft extending between the balloon and hub; the hub being affixed co the proximal end of the shaft, and the balloon being affixed to the shaft at or near its distal end; the shaft defining an inflation lumen extending from the proximal inflation port to the interior of the balloon, the shaft defining a distal guidewire port at or near the distal end of the catheter and a proximal guidewire port positioned between the hub and balloon, the shaft defining a guidewire lumen extending between the proximal and distal guidewire ports;

at least a portion of the shaft including an inner tubular body and an outer tubular body, each having a proximal and distal end; the outer body surrounding at least a portion of the inner body;

wherein the outer body has a hypotube with a proximal and distal end, extending from the proximal end of the shaft to a point at or near the balloon proximal leg; a portion of the hypotube having a cut pattern providing a flexibility transition from a proximal portion to a distal portion of the outer body; the proximal guidewire port being positioned in the cut pattern portion of the hypotube, between a proximal and distal end of the cut pattern portion; and a fluid-tight outer layer surrounding at least the cut pattern portion of the hypocube, except for an aperture for the proximal guidewire port.
2. The balloon catheter of claim 1, wherein the cut pattern has a helical spiral shape.
3. The balloon catheter of claim 2, wherein a pitch angle of the cut pattern is constant throughout the cut pattern region.
4. The balloon catheter of claim 2, wherein a pitch angle of the cut changes in a linear manner.
5. The balloon catheter of claim 2, wherein a pitch angle of the cut changes in a manner along a curve having more than one slope.
6. The balloon catheter of claim 2, wherein a pitch angle of the cut changes exponentially.
7. The balloon catheter of claim 2, wherein a pitch angle of the cut changes in a manner along a curve having more than one slope.
8. The balloon catheter of claim 1, further comprising a stent crimped around the balloon in a deflated state.
9. The balloon catheter of claim 1, wherein the fluid-tight outer layer is heat-shrink polymer material.
10. The balloon catheter of claim 1, wherein the proximal guidewire port is positioned between adjacent cut portions of the cut pattern.
11. The balloon catheter of claim 1, wherein the proximal guidewire port intersects the cut pattern.
12. The balloon catheter of claim 1, wherein the cut pattern follows an undulating serpentine path.
13. The balloon catheter of claim 12, wherein the cut pattern follows an overlapping undulating serpentine path having inflection points.
14. The balloon catheter of claim 1, further comprising a soft tip component, affixed to the inner body and the balloon distal leg.
15. The balloon catheter of claim 1, wherein the hypotube is made of stainless steel.
16. The balloon catheter of claim 1, wherein the hypotube is made of nitinol.
17. The balloon catheter of claim 1, further comprising a hydrophilic coating.
18. A balloon catheter having a proximal end and a distal end, for medically treating a patient, comprising:

a balloon defining an interior;

a hub defining a proximal inflation port;

a flexible shaft having a proximal and distal end; the shaft extending between the balloon and hub; the hub being affixed to the proximal end of the shaft, and the balloon being affixed to the shaft at or near its distal end; the shaft defining an inflation lumen extending from the proximal inflation port to the interior of the balloon, the shaft defining a distal guidewire port at or near the distal end of the catheter and a proximal guidewire port positioned between the hub and balloon, the shaft defining a guidewire lumen extending between the proximal and distal guidewire ports;

at least a portion of the shaft including an inner tubular body and an outer tubular body, each having a proximal and distal end; the outer body surrounding at least a portion of the inner body;

wherein the outer body has a hypotube with a proximal and distal end, extending from the proximal end of the shaft to a point at or near the balloon proximal leg; a portion of the hypotube having a cut pattern providing a flexibility transition from a proximal portion to a distal portion of the outer body; wherein the cut pattern follows an overlapping undulating serpentine path having inflection points;

the proximal guidewire port being positioned in the cut pattern portion of the hypotube, between a proximal and distal end of the cut pattern portion; and a fluid-tight outer layer surrounding at least the cut pattern portion of the hypotube, except for an aperture for the proximal guidewire port.
CA2675209A 2002-03-22 2008-01-11 Rapid-exchange balloon catheter shaft and method Active CA2675209C (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US36673902P 2002-03-22 2002-03-22
US10/224,168 US7128718B2 (en) 2002-03-22 2002-08-20 Guidewire with deflectable tip
US10/691,823 US7520863B2 (en) 2002-03-22 2003-10-23 Guidewire with deflectable tip having improved torque characteristics
US88000007P 2007-01-11 2007-01-11
US60/880,000 2007-01-11
US93047107P 2007-05-16 2007-05-16
US60/930,471 2007-05-16
PCT/US2008/000438 WO2008088766A1 (en) 2002-03-22 2008-01-11 Rapid-exchange balloon catheter shaft and method

Publications (2)

Publication Number Publication Date
CA2675209A1 true CA2675209A1 (en) 2008-07-24
CA2675209C CA2675209C (en) 2013-01-08

Family

ID=39528388

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2675209A Active CA2675209C (en) 2002-03-22 2008-01-11 Rapid-exchange balloon catheter shaft and method

Country Status (5)

Country Link
US (2) US7815600B2 (en)
EP (3) EP3505143B1 (en)
AU (1) AU2008205550B2 (en)
CA (1) CA2675209C (en)
WO (1) WO2008088766A1 (en)

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EP2099516B2 (en) 2019-07-31
CA2675209C (en) 2013-01-08
AU2008205550B2 (en) 2012-11-01
US8454673B2 (en) 2013-06-04
WO2008088766A1 (en) 2008-07-24
AU2008205550A1 (en) 2008-07-24
EP3505143A1 (en) 2019-07-03
US20110034989A1 (en) 2011-02-10
EP2099516A4 (en) 2011-03-30
EP3505143B1 (en) 2022-12-14
EP2099516A1 (en) 2009-09-16
US7815600B2 (en) 2010-10-19
EP2099516B1 (en) 2016-04-06
US20080147001A1 (en) 2008-06-19
EP3042688A1 (en) 2016-07-13

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