CA2494646A1 - Medical device with collapse-resistant liner and method of making same - Google Patents

Medical device with collapse-resistant liner and method of making same Download PDF

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Publication number
CA2494646A1
CA2494646A1 CA002494646A CA2494646A CA2494646A1 CA 2494646 A1 CA2494646 A1 CA 2494646A1 CA 002494646 A CA002494646 A CA 002494646A CA 2494646 A CA2494646 A CA 2494646A CA 2494646 A1 CA2494646 A1 CA 2494646A1
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CA
Canada
Prior art keywords
medical device
slots
tubular member
collapsing structure
liner
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
CA002494646A
Other languages
French (fr)
Other versions
CA2494646C (en
Inventor
Clark C. Davis
Kevin T. Olson
Dewayne C. Fox
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
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Individual
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Filing date
Publication date
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Publication of CA2494646A1 publication Critical patent/CA2494646A1/en
Application granted granted Critical
Publication of CA2494646C publication Critical patent/CA2494646C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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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
    • A61M25/0013—Weakening parts of a catheter tubing, e.g. by making cuts in the tube or reducing thickness of a layer at one point to adjust the flexibility
    • 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
    • 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
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0051—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids made from fenestrated or weakened tubing layer
    • 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
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M25/09016—Guide wires with mandrils
    • A61M25/09025—Guide wires with mandrils with sliding mandrils
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • 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
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • 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
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09066—Basic structures of guide wires having a coil without a core possibly combined with a sheath
    • 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
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • 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
    • A61M2025/09058—Basic structures of guide wires
    • A61M2025/09083—Basic structures of guide wires having a coil around a core
    • A61M2025/09091—Basic structures of guide wires having a coil around a core where a sheath surrounds the coil at the distal part
    • 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
    • A61M2025/09108—Methods for making a guide wire
    • 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
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • 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
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • 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
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A61M25/0053—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
    • 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
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils

Abstract

A medical device for guiding through anatomy, such as a catheter or guidewire, with a tubular body that has been slotted to enhance bending flexibility, and a polymer liner with an anti-collapsing structure, and a method of making a medical device with a kink-resistant corrugated tubular member and an anti-collapsing structure. Anti collapsing structures may be helical or annular, and may be wire, such as ribbon wire, grooves in the liner, corrugations, or a braid. Liners may be bonded to the anti~collapsing structure, or may have two layers, with the anti-collapsing structure between the layers. Corrugations may be formed between sections of the anti-collapsing 'structure with heat, pressure, stretching, compression, a mold, or a combination thereof, and may extend inward or outward. Shape or wall thickness may vary along the length to provide a varying bending stiffness. Slots may be formed in groups of two, three, or more, and adjacent groups may be rotated about the axis forming a helical pattern.

Claims (52)

1. A medical device comprising a tubular body having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end; and a plurality of slots formed into said body, said slots being configured to enhance the bending flexibility of said body; the medical device being characterized by a polymer liner inside at least part of said body, said liner covering at least some of said slots; and at least a portion of said liner comprising an anti-collapsing structure.
2. The medical device of claim 1, said anti-collapsing structure being helical.
3. The medical device of claim 1, said anti-collapsing structure being annular.
4. The medical device of claims 1, 2, or 3, said anti-collapsing structure comprising at least one wire.
5. The medical device of claim 4, said wire being ribbon wire.
6. The medical device of any of the preceding claims, said anti-collapsing structure being bonded to said liner.
7. The medical device of any of the preceding claims, said anti-collapsing structure comprising at least one groove formed in said liner.
8. The medical device of any of the preceding claims, said anti-collapsing structure comprising at least one corrugation formed in said liner.
9. The medical device any of the preceding claims, said anti-collapsing structure comprising a braid.
10. The medical device of any of the preceding claims, said liner being formed from at least two layers.
11. The medical device of claim 10, said anti-collapsing structure being located between said layers.
12. The medical device of any of the preceding claims, said liner comprising at least one corrugation extending outward from said anti-collapsing structure.
13. The medical device of any of the preceding claims, said liner comprising at least one corrugation extending inward from said anti-collapsing structure.
14. The medical device of any of the preceding claims, said slots substantially defining a plurality of segments of said body, said segments forming a substantially helical pattern at least part way along said axis, and said plurality of segments being separated along said substantially helical pattern by said slots.
15. The medical device of claim 14, each said slot having two end points and a midpoint; said segments being substantially between said end points of adjacent said slots; and at least a plurality of said segments being substantially between said midpoints of two axially adjacent said slots.
16. The medical device of claim 14 or 15 wherein alternating said segments along said axis form said substantially helical pattern.
17. The medical device of claims 14 - 16, each said slot being substantially in line with at least one other said slot; and said segments being between adjacent said substantially in-line slots.
18. The medical device of any of the preceding claims, each said slot being substantially parallel to at least two other said slots.
19. The medical device of any of the preceding claims, said slots being arranged in a plurality of groups; each said slot being substantially perpendicular to said axis; and each said slot in a said group being substantially equally spaced around said axis.
20. The medical device of claim 19, each said slot in a said group being located at substantially the same location along said axis.
21. The medical device of claim 19 or 20, at least a plurality of said groups comprising two slots.
22. The medical device of claim 19, 20, or 21, at least a plurality of said groups comprising three slots.
23. The medical device of claim 19 - 22, each longitudinally adjacent said group being rotated around said axis from the previous said group forming said helical pattern along said axis.
24. The medical device of claim 23, said rotated around being by an angle slightly different than 180 degrees divided by the number of said slots in said group, said slightly being more than zero degrees and less than 10 degrees.
25. The medical device of any of the preceding claims, said body being nitinol.
26. The medical device of any of the preceding claims, further comprising a central wire disposed at least partially inside said body.
27. The medical device of claim 26, said central wire being slidable inside said body.
28. The medical device of claim 26, said central wire being a core wire, said core wire being attached to said body.
29. The device of claims 26 - 28, said central wire including at least one bend formed therein.
30. The medical device of any of the preceding claims, the medical device being a catheter.
31. The medical device of any of the preceding claims, further comprising a hollow annular space between said liner and said body.
32. The medical device of any of the preceding claims, said slots having rounded corners.
33. The medical device of any of the preceding claims, said distal end comprising a substantially radiopaque marker.
34. The medical device of any of the preceding claims, the medical device being a guidewire.
35. The medical device of any of the preceding claims further comprising a coil coaxial with said tubular body.
36. The medical device of any of the preceding claims, said slots being arranged with a varying longitudinal spacing, said spacing generally decreasing from said proximal end to said distal end.
37. The medical device of any of the preceding claims, said slots having a varying depth, said depth generally increasing from said proximal end to said distal end.
38. A method of making a medical device with a flexible, kink-resistant tubular member, the method comprising the steps of: providing a tubular member;
providing an anti-collapsing structure concentric with the tubular member, the anti-collapsing structure having a plurality of sections; and deforming the tubular member between the sections into a corrugated shape.
39. The method of claim 38, said deforming comprising applying heat.
40. The method of claims 39 or 39, at least part of the anti-collapsing structure having a helical shape comprising a plurality of loops, the sections being the loops.
41. The method of claims 38, 39, or 40, the anti-collapsing structure comprising at least one wire.
42. The method of claim 41, the wire being ribbon wire.
43. The method of claims 38 - 42, further comprising the step of bonding the anti-collapsing structure to the tubular member.
44. The method of claims 38 - 43, said deforming comprising applying internal pressure to the tubular member.
45. The method of claims 38 - 44, said deforming comprising applying tension to the tubular member in the axial direction.
46. The method of claims 38 - 45, said deforming comprising applying compression to the tubular member in the axial direction.
47. The method of claims 38 - 46, said deforming comprising using a mold.
48. The method of claims 38 - 47, the tubular member comprising two layers, the anti-collapsing structure being located between the two layers.
49. The method of claims 38 - 48, the method further comprising the steps of:
providing a tubular body having a proximal end, a distal end, and a longitudinal axis extending at least from the proximal end to the distal end; forming a plurality of slots into the body; and arranging the body so that the body is concentric with the tubular member.
50. The method of claims 38 - 49, the bending stiffness of the tubular member varying along its length by varying the pitch of the anti-collapsing structure.
51. The method of claims 38 - 50, the bending stiffness of the tubular member varying along its length by varying the wall thickness of the tubular member.
52. The method of claims 38 - 51, the bending stiffness of the tubular member varying along its length by varying the corrugated shape along the tubular member.
CA2494646A 2002-08-05 2003-08-05 Medical device with collapse-resistant liner and method of making same Expired - Fee Related CA2494646C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/213,123 US20030069522A1 (en) 1995-12-07 2002-08-05 Slotted medical device
US10/213,123 2002-08-05
PCT/US2003/024604 WO2004012804A2 (en) 2002-08-05 2003-08-05 Medical device with collapse-resistant liner and method of making same

Publications (2)

Publication Number Publication Date
CA2494646A1 true CA2494646A1 (en) 2004-02-12
CA2494646C CA2494646C (en) 2011-12-20

Family

ID=31494410

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2494646A Expired - Fee Related CA2494646C (en) 2002-08-05 2003-08-05 Medical device with collapse-resistant liner and method of making same

Country Status (7)

Country Link
US (2) US20030069522A1 (en)
EP (2) EP1526887B1 (en)
JP (1) JP4846236B2 (en)
AT (1) ATE525107T1 (en)
AU (1) AU2003261404A1 (en)
CA (1) CA2494646C (en)
WO (1) WO2004012804A2 (en)

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EP1526887A2 (en) 2005-05-04
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JP4846236B2 (en) 2011-12-28
CA2494646C (en) 2011-12-20
US20060189896A1 (en) 2006-08-24
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AU2003261404A8 (en) 2004-02-23
EP2263733A1 (en) 2010-12-22
EP1526887B1 (en) 2011-09-21
AU2003261404A1 (en) 2004-02-23
ATE525107T1 (en) 2011-10-15
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US20030069522A1 (en) 2003-04-10
US7914466B2 (en) 2011-03-29

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