CA2535126A1 - Catheter including a unibody distal guidewire port and method of manufacture - Google Patents

Catheter including a unibody distal guidewire port and method of manufacture Download PDF

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Publication number
CA2535126A1
CA2535126A1 CA002535126A CA2535126A CA2535126A1 CA 2535126 A1 CA2535126 A1 CA 2535126A1 CA 002535126 A CA002535126 A CA 002535126A CA 2535126 A CA2535126 A CA 2535126A CA 2535126 A1 CA2535126 A1 CA 2535126A1
Authority
CA
Canada
Prior art keywords
lumen
distal
guidewire
proximal
port joint
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
CA002535126A
Other languages
French (fr)
Other versions
CA2535126C (en
Inventor
Mark S. Holzapfel
Martin J. Plantenberg
Daniel K. Tomaschko
Richard J. Olson
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
Individual
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
Application filed by Individual filed Critical Individual
Publication of CA2535126A1 publication Critical patent/CA2535126A1/en
Application granted granted Critical
Publication of CA2535126C publication Critical patent/CA2535126C/en
Expired - Fee Related 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A61M25/0015—Making lateral openings in a catheter tube, e.g. holes, slits, ports, piercings of guidewire ports; Methods for processing the holes, e.g. smoothing the edges
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • 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
    • 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
    • A61M25/09—Guide wires
    • 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
    • A61M25/1025—Connections between catheter tubes and inflation tubes
    • 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
    • B29C45/00—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor
    • B29C45/14—Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor incorporating preformed parts or layers, e.g. injection moulding around inserts or for coating articles
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0034—Multi-lumen catheters with stationary elements characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
    • 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
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T156/00—Adhesive bonding and miscellaneous chemical manufacture
    • Y10T156/10—Methods of surface bonding and/or assembly therefor
    • Y10T156/1002—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina
    • Y10T156/1005—Methods of surface bonding and/or assembly therefor with permanent bending or reshaping or surface deformation of self sustaining lamina by inward collapsing of portion of hollow body

Abstract

Methods and devices incorporating a guidewire entry port subassembly for use in rapid exchange catheters. The use of a subassembly allows for stronger quality control and simpler fabrication of a rapid exchange device. In several embodiments, methods of making a molded guidewire entry port using a mold, often in conjunction with one or more mandrels, are disclosed. Several device embodiments include a separate molded guidewire port as well as molded guidewire ports which are attached, during a molding step, to segments of a catheter.

Claims (24)

1. ~A method of making a catheter, the method comprising:
providing a port joint for coupling a proximal member to one or more distal members, the port joint adapted to couple a lumen in the proximal member to a lumen defined by the distal member(s), the port joint including:
a guidewire port for receiving a guidewire; and a guidewire lumen for coupling the guidewire into a lumen defined by said distal member(s).
2. ~The method of claim 1 further comprising attaching the port joint to the proximal member.
3. ~The method of claim 1 further comprising attaching the port joint to a distal member.
4. ~The method of claim 1 wherein the port joint comprises material that does not come from either the proximal member or the distal members.
5. ~A method of making a catheter, the catheter including a proximal member defining a first lumen and a distal member defining a second lumen and a guidewire lumen, the method comprising:
molding a port joint for joining the proximal member to the distal member, the port joint adapted to couple the first lumen to the second lumen and including a guidewire port for directing a guidewire from outside the catheter into the guidewire lumen.
6. ~The method of claim 5, wherein:
the distal member includes a first tubular member and a second tubular member;
the step of molding the port joint includes using a mold; and the method further comprises the step of coupling the first tubular member to the mold such that, when the port joint is molded, the first tubular member becomes attached to the port joint.
7. ~The method of claim 6, wherein the step of coupling the first tubular member to the mold includes passing a portion of the first tubular member over a mandrel.
8. ~The method of claim 7, wherein the mandrel extends from the mold prior to passing the first tubular member thereover.
9. ~The method of claim 7, wherein the method includes coupling the mandrel to the mold after passing a portion of the first tubular member over a portion of the mandrel.
10. ~The method of claim 7, further comprising the step of coupling the proximal member to the mold such that, when the port joint is molded, the proximal member becomes attached to the port joint.
11. ~The method of claim 10, wherein the step of coupling the proximal member to the mold includes the step of passing a portion of the proximal member over a portion of the mandrel.
12. ~The method of claim 5, wherein:~
the distal member includes a first tubular member and a second tubular member;
the step of molding the port joint includes using a mold; and the method further comprises the step of coupling the second tubular member to the mold such that, when the port joint is molded, the second tubular member becomes attached to the port joint.
13. ~The method of claim 12, wherein the step of coupling the second tubular member to the mold includes the step of passing a portion of the second tubular member over a mandrel.
14. ~The method of claim 13, wherein the mold includes the mandrel extending therefrom.
15. ~The method of claim 13, wherein the step of coupling the second tubular member to the mold includes the step of coupling the mandrel to the mold after passing the second tubular member over a portion thereof.
16. ~A method of making a rapid exchange type catheter, the catheter including a proximal member defining a first inflation lumen, a distal outer member defining a second inflation lumen, and a distal inner member defining a guidewire lumen, the method comprising:
molding a port joint for joining the proximal member to the distal outer member and the distal inner member, the port joint adapted to fluidly couple the first inflation lumen to the second inflation lumen and including a guidewire port for directing a guidewire into the guidewire lumen, the port joint having a proximal portion for attachment to the proximal member and a distal portion for attachment to the distal outer member and the distal inner member.
17. ~The method of claim 16, wherein the step of molding the port joint includes providing a structure adapted for attachment to the distal inner member.
18. ~The method of claim 16, wherein the step of molding the port joint includes providing a portion of the distal inner member within a mold and molding the port joint such that the distal inner member becomes attached to the port joint during the molding step.
19. ~The method of claim 16, further comprising:
providing a mandrel within a mold in which the port joint is molded prior to the step of molding; and removing the mandrel after the step of molding;
wherein the mandrel is placed within the mold to create an inflation passageway for connecting the first inflation lumen to the second inflation lumen once the proximal member and the distal outer members are attached to the port joint.
20. ~The method of claim 16, further comprising the steps of:
providing a core wire passing through a mold into which the port joint is molded prior to the step of molding; and leaving at least a portion of the core wire in place after the step of molding to provide strain relief across a joint from the proximal member to the distal inner member and distal outer member.
21. ~The method of claim 16, further comprising:
providing a void in the port joint for allowing a core wire to pass therethrough;
providing a core wire through the void to provide strain relief to the port joint.
22. ~A sub-assembly for use as part of a rapid exchange catheter having a proximal end and a distal end, the sub-assembly comprising:~
a proximal end having a first opening;
a distal end having a second opening and a third opening;
a first lumen extending from the first opening to the second opening;
a guidewire entry port shaped and sized to receive a guidewire; and a second lumen extending from the guidewire entry port to the third opening.
23. ~A component for use as part of a rapid exchange catheter having a proximal end and a distal end, the component comprising:
a member having a proximal end and a distal end, the proximal end having a first opening, the distal end having a second opening and a third opening, the member including a guidewire entry port, the member further defining a first lumen between the first opening and the second opening and a second lumen between the guidewire entry port and the third opening; and a tubular member having a proximal end and a distal end, with the proximal end attached to the distal end of the member, the tubular member defining a third lumen;
wherein the tubular member is attached to the section such that the second lumen is in fluid communication with the third lumen.
24. ~A component for use as part of a rapid exchange catheter having a proximal end and a distal end, the component comprising:
a member having a proximal end and a distal end, the proximal end having a first opening, the distal end having a second opening and a third opening, the member including a guidewire entry port, the member defining a first lumen between the first opening and the second opening and a second lumen between the guidewire entry port and the third opening; and a tubular member having a proximal end and a distal end, with the distal end attached to the proximal end of the member, the tubular member defining a third lumen;
wherein the tubular member is attached to the member such that the third lumen is in fluid communication with the first lumen.
CA2535126A 2003-09-02 2004-08-11 Catheter including a unibody distal guidewire port and method of manufacture Expired - Fee Related CA2535126C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/653,375 US7662328B2 (en) 2003-09-02 2003-09-02 Proximal guidewire port
US10/653,375 2003-09-02
PCT/US2004/025955 WO2005021080A1 (en) 2003-09-02 2004-08-11 Catheter including a unibody distal guidewire port and method of manufacture

Publications (2)

Publication Number Publication Date
CA2535126A1 true CA2535126A1 (en) 2005-03-10
CA2535126C CA2535126C (en) 2012-05-29

Family

ID=34217878

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2535126A Expired - Fee Related CA2535126C (en) 2003-09-02 2004-08-11 Catheter including a unibody distal guidewire port and method of manufacture

Country Status (5)

Country Link
US (4) US7662328B2 (en)
EP (1) EP1660166B1 (en)
JP (1) JP4808620B2 (en)
CA (1) CA2535126C (en)
WO (1) WO2005021080A1 (en)

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Also Published As

Publication number Publication date
WO2005021080A1 (en) 2005-03-10
JP4808620B2 (en) 2011-11-02
US8834509B2 (en) 2014-09-16
EP1660166A1 (en) 2006-05-31
US7662328B2 (en) 2010-02-16
CA2535126C (en) 2012-05-29
US20150005705A1 (en) 2015-01-01
US20120143169A1 (en) 2012-06-07
JP2007503869A (en) 2007-03-01
US9878135B2 (en) 2018-01-30
US20100096077A1 (en) 2010-04-22
EP1660166B1 (en) 2013-04-17
US20050049552A1 (en) 2005-03-03
US8123994B2 (en) 2012-02-28

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Effective date: 20180813