CA2433078A1 - Rapid exchange sheath for deployment of medical devices and methods of use - Google Patents

Rapid exchange sheath for deployment of medical devices and methods of use Download PDF

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Publication number
CA2433078A1
CA2433078A1 CA002433078A CA2433078A CA2433078A1 CA 2433078 A1 CA2433078 A1 CA 2433078A1 CA 002433078 A CA002433078 A CA 002433078A CA 2433078 A CA2433078 A CA 2433078A CA 2433078 A1 CA2433078 A1 CA 2433078A1
Authority
CA
Canada
Prior art keywords
distal end
opening
sheath
proximal
tubular member
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
CA002433078A
Other languages
French (fr)
Other versions
CA2433078C (en
Inventor
W. Martin Belef
Ross S. Tsugita
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
Family has litigation
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Application filed by Individual filed Critical Individual
Publication of CA2433078A1 publication Critical patent/CA2433078A1/en
Application granted granted Critical
Publication of CA2433078C publication Critical patent/CA2433078C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2/013—Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
    • 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
    • A61M25/0169—Exchanging a catheter while keeping the guidewire in place
    • 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
    • A61M25/0172—Exchanging a guidewire while keeping the catheter in place
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • 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
    • 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
    • A61F2/01—Filters implantable into blood vessels
    • A61F2002/018—Filters implantable into blood vessels made from tubes or sheets of material, e.g. by etching or laser-cutting
    • 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
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0093—Umbrella-shaped, e.g. mushroom-shaped
    • 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
    • A61M2025/018—Catheters having a lateral opening for guiding elongated means lateral to the catheter
    • 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
    • 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
    • A61M25/104—Balloon catheters used for angioplasty

Abstract

A rapid exchange sheath comprising an elongate tubular member (10), a guidewire (21), and support wire (32). The guidewire passes through a first opening (21) at a distal end of the tubular member and a second opening (16) a short distance proximal from the distal end. The support wire is received in a lumen (11) of the tubular member, or, in certain embodiments, extends proximally through a third opening a short distance proximal from the distal end. The support wire (32) is adapted to receive an endoluminal medical devi ce such as an expandable filter at a distal end. Methods of using the sheaths f or deploying and/or exchanging medical device(s) in a patient's vessel are also disclosed.

Claims (57)

1. A sheath for deployment of a medical device, comprising:
an elongate tubular member having a proximal end, a distal end, and a lumen therebetween, the elongate tubular member having a first opening at the distal end and a second opening proximal to the distal end;
a guidewire that passes through the first opening, through the lumen of the elongate tubular member, and through the second opening; and a support wire having a proximal end and a distal end, the support wire being positioned within the lumen of the elongate tubular member, the support wire adapted to receive an endoluminal medical device.
2. The sheath of claim 1, wherein the sheath is a rapid exchange sheath.
3. The sheath of claim 1, wherein the second opening is a short distance proximal to the distal end.
4. The sheath of claim 1, wherein the support wire further comprises an expandable filter mounted on the distal end.
5. The sheath of claim 4, wherein the support wire and filter are positioned within the lumen of the elongate tubular member.
6. The sheath of claim 1, further comprising an endoluminal medical device.
7. The sheath of claim 1, wherein the proximal end of the elongate tubular member includes a hemostatic valve.
8. The sheath of claim 6, wherein the endoluminal medical device is selected from the group consisting of an angioplasty catheter, a stent-deployment catheter, an atherectomy catheter, an intravascular ultrasound catheter, a filter catheter, a guidewire, and an aspiration catheter.
9. The sheath of claim 1, wherein the second opening is located
10 centimeters proximal from the distal end.

10. A method for deploying an endoluminal medical device, comprising the steps of:
providing an elongate tubular member having a proximal end, a distal end, and a lumen therebetween, the elongate tubular member having a first opening at the distal end and a second opening proximal to the distal end;
advancing a guidewire to a region of interest within a patient's vessel;
passing a proximal end of the guidewire through the first opening, through the lumen of the elongate tubular member, and through the second opening;
advancing the elongate tubular member over the guidewire until it is positioned within a region of interest; and advancing an endoluminal medical device through the lumen of the elongate tubular member until it is positioned within the region of interest.
11. The method of claim 10, wherein the second opening is a short distance proximal to the distal end.
12. The method of claim 10, wherein the endoluminal medical device is positioned within the lumen of the elongate tubular member before the step of advancing the elongate tubular member over the guidewire.
13. The method of claim 10, wherein the step of advancing the guidewire to a region of interest is completed before the step of passing a proximal end of the guidewire through the first opening.
14. The method of claim 10, further comprising the step of removing the guidewire.
15. The method of claim 10, further comprising the step of withdrawing the elongate tubular member.
16. The method of claim 10, further comprising the step of deploying the endoluminal medical device.
17. The method of claim 10, wherein the endoluminal medical device is a support wire having a filter mounted on a distal end.
18. The method of claim 17, further comprising the step of advancing a second endoluminal medical device over the support wire.
19. The method of claim 17, further comprising the step of expanding the filter downstream of the region of interest.
20. The method of claim 10, wherein the vessel is an artery.
21. The method of claim 20, wherein the artery is the internal carotid artery.
22. The method of claim 20, wherein the artery is the common carotid artery.
23. The method of claim 20, wherein the artery is the aorta.
24. The method of claim 10, wherein the elongate tubular member is positioned upstream of a lesion.
25. A sheath for deployment of a medical device, comprising an elongate member having a proximal end and a distal end, the elongate member having a first opening at the distal end, a second opening proximal to the distal end, and a third opening proximal to the distal end, the first and second openings adapted to pass a first elongate member, the first and third openings adapted to pass a second elongate member.
26. The sheath of claim 25, wherein the sheath is a rapid exchange sheath.
27. The sheath of claim 25, wherein the second opening is a short distance proximal from the distal end.
28. The sheath of claim 25, wherein the and a third opening is a short distance proximal from the distal end.
29. The sheath of claim 25, wherein the first elongate member is a guidewire.
30. The sheath of claim 25, wherein the second elongate member is a support wire.
31. The sheath of claim 29, wherein the guidewire passes through the first opening and through the second opening.
32. The sheath of claim 30, wherein the support wire has a filter associated with a distal end, the support wire passing through the third opening of the elongate member.
33. The sheath of claim 32, wherein the filter is mounted on the distal end of the support wire.
34. The sheath of claim 32, wherein the filter passes through the first opening of the elongate tubular member.
35. The sheath of claim 25, wherein the elongate member is an elongate tubular member having a lumen between the proximal and distal ends.
36. The sheath of claim 25, wherein the first and third openings are joined by a lumen of a tubular member.
37. A method for deploying an endoluminal medical device, comprising the steps of:
providing a first elongate member having a proximal end and a distal end, the elongate member having a first opening at the distal end, a second opening proximal to the distal end, and a third opening proximal to the distal end;
advancing a guidewire to a region of interest within a patient's vessel;
passing a proximal end of the guidewire through the first opening of the elongate member, and through the second opening; and advancing the elongate member over the guidewire until it is positioned within the region of interest, the elongate member having an endoluminal medical device carried at the distal end of the elongate member.
38. The method of claim 37, wherein the second opening is a short distance proximal to the distal end.
39. The method of claim 37, wherein the third opening is a short distance proximal to the distal end.
40. The method of claim 37, wherein the endoluminal medical device is releasably carried at the distal end of the elongate member.
41. The method of claim 37, wherein the endoluminal device is associated with the distal end of a second elongate member that extends proximal through the third opening, and is operable from a proximal end outside the patient's body.
42. The method of claim 41, wherein the endoluminal device is mounted at the distal end of a second elongate member.
43. The sheath of claim 41, wherein the endoluminal medical device is selected from the group consisting of an angioplasty catheter, a stent-deployment catheter, an atherectomy catheter, an intravascular ultrasound catheter, a filter catheter, a guidewire, and an aspiration catheter.
44. The method of claim 37, wherein the first elongate member is an elongate tubular member having a lumen extending between the proximal and distal ends.
45. The method of claim 44, wherein the endoluminal medical device is positioned within the lumen of the elongate tubular member before the step of advancing the elongate tubular member over the guidewire.
46. The method of claim 37, wherein the step of advancing the guidewire to a region of interest is completed before the step of passing a proximal end of the guidewire through the first opening.
47. The method of claim 37, further comprising the step of removing the guidewire.
48. The method of claim 37, further comprising the step of withdrawing the elongate member.
49. The method of claim 48, further comprising the step of deploying the endoluminal medical device.
50. The method of claim 37, wherein the endoluminal medical device is a support wire having a filter associated with a distal end.
51. The method of claim 37, further comprising the step of advancing a second endoluminal medical device over the second elongate member.
52. The method of claim 50, further comprising the step of expanding the filter downstream of the region of interest.
53. The method of claim 37, wherein the vessel is an artery.
54. The method of claim 53, wherein the artery is selected from the group consisting of an internal carotid artery, a saphenous vein graft, a renal artery, a native coronary artery, a peripheral artery, a femoral artery, and an iliac artery.
55. The method of claim 53, wherein the artery is the common carotid artery.
56. The method of claim 53, wherein the artery is the aorta.
57. The method of claim 37, wherein the elongate tubular member is positioned upstream of a lesion.
CA2433078A 2001-01-16 2002-01-07 Rapid exchange sheath for deployment of medical devices and methods of use Expired - Fee Related CA2433078C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US26213601P 2001-01-16 2001-01-16
US60/262,136 2001-01-16
US10/039,214 US7169165B2 (en) 2001-01-16 2002-01-04 Rapid exchange sheath for deployment of medical devices and methods of use
US10/039,214 2002-01-04
PCT/US2002/000281 WO2002062266A2 (en) 2001-01-16 2002-01-07 Rapid exchange catheter sheath for deployment of medical devices and methods of use

Publications (2)

Publication Number Publication Date
CA2433078A1 true CA2433078A1 (en) 2002-08-15
CA2433078C CA2433078C (en) 2010-05-04

Family

ID=26715921

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2433078A Expired - Fee Related CA2433078C (en) 2001-01-16 2002-01-07 Rapid exchange sheath for deployment of medical devices and methods of use

Country Status (8)

Country Link
US (2) US7169165B2 (en)
EP (4) EP1351737B1 (en)
JP (2) JP4647884B2 (en)
AT (3) ATE300330T1 (en)
AU (1) AU2002251736A1 (en)
CA (1) CA2433078C (en)
DE (2) DE60205212T2 (en)
WO (1) WO2002062266A2 (en)

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WO2002062266A2 (en) 2002-08-15
ATE399036T1 (en) 2008-07-15
US7169165B2 (en) 2007-01-30
ATE300330T1 (en) 2005-08-15
WO2002062266A3 (en) 2002-10-03
EP2308545A1 (en) 2011-04-13
JP2009095682A (en) 2009-05-07
JP2004522525A (en) 2004-07-29
EP1949932B1 (en) 2011-09-07
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EP1351737A2 (en) 2003-10-15
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EP1949932A1 (en) 2008-07-30
US20070083216A1 (en) 2007-04-12
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US20020095141A1 (en) 2002-07-18
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CA2433078C (en) 2010-05-04
EP1598089A1 (en) 2005-11-23
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DE60227295D1 (en) 2008-08-07
US7842065B2 (en) 2010-11-30

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