CA2396727A1 - Systems and methods for clot dissolution - Google Patents

Systems and methods for clot dissolution Download PDF

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Publication number
CA2396727A1
CA2396727A1 CA002396727A CA2396727A CA2396727A1 CA 2396727 A1 CA2396727 A1 CA 2396727A1 CA 002396727 A CA002396727 A CA 002396727A CA 2396727 A CA2396727 A CA 2396727A CA 2396727 A1 CA2396727 A1 CA 2396727A1
Authority
CA
Canada
Prior art keywords
clot
agent
agitator
over
blood vessel
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
CA002396727A
Other languages
French (fr)
Other versions
CA2396727C (en
Inventor
Michael A. Evans
Denise M. Demarais
Christian S. Eversull
Stephen A. Leeflang
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.)
Covidien LP
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
Priority to CA2755960A priority Critical patent/CA2755960C/en
Publication of CA2396727A1 publication Critical patent/CA2396727A1/en
Application granted granted Critical
Publication of CA2396727C publication Critical patent/CA2396727C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22067—Blocking; Occlusion
    • 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
    • A61B2017/22082—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 after introduction of a substance
    • A61B2017/22084—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 after introduction of a substance stone- or thrombus-dissolving
    • 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
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • 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

Abstract

Clot disruption and dissolution are achieved using a catheter (12) having bo th an agitator (30) and the ability to deliver a thrombolytic agent. The cathet er (12) is introduced to a target region with a blood vessel and the agitator (30) manipulated to engage and disrupt a region of clot therein. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator (30) is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and th e dissolution of the clot is improved.

Claims (45)

1. Apparatus for disrupting clot over a predetermined luminal length of a blood vessel, said apparatus comprising:
a catheter body having a proximal end and a distal end;
means near the distal end of the catheter body for mechanically agitating clot over the predetermined length in the blood vessel; and means near the distal end of the catheter body for distributing an agent over the predetermined length in the blood vessel.
2. Apparatus as in claim 1, wherein the agent is a member selected from the group consisting of a thrombolytic agent, a fibrinolytic agent, a calcium dissolving agent, a gene therapy agent, and a group GP IIb/IIIa Inhibitor.
3. Apparatus as in claim 1, wherein the mechanical agitating means comprises a rotatable and/or axially translatable agitator.
4. Apparatus as in claim 3, wherein the agitator comprises a resilient element which may be radially constrained to have a low profile or may be freed from radial constraint to have an enlarged profile having a non-linear geometry.
5. Apparatus of claim 3, wherein the agitator comprises a resilient element which may be axially shortened to assume an enlarged profile having a non-linear geometry.
6. Apparatus as in claim 4 or 5, wherein the resilient element has a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random.
7. Apparatus as in claim 5, wherein the agent distributing means comprises a porous sheath disposed over the resilient element.
8. Apparatus as in claim 6, wherein the porous sheath is flexible and wherein the resilient element presses the sheath into the clot.
9. Apparatus as in claim 6, wherein the agent distributing means comprises a distribution element in the resilient element, wherein the resilient element includes means for infusing the agent disposed over its length.
10. Apparatus as in claim 9, wherein the infusing means comprises a plurality of spaced-apart ports.
11. Apparatus as in claim 9, wherein the infusing means comprises porous region(s) over the length of the resilient element.
12. Apparatus as in claim 1, wherein the thrombolytic distributing means comprises a porous sheath disposed over the mechanical agitating means.
13. Apparatus as in claim 12, wherein the porous sheath is flexible and wherein the mechanical agitating means presses the sheath into the clot.
14. Apparatus as in claim 1, further comprising means for isolating at least one location on the catheter body to reduce blood flow through a region in a blood vessel being treated.
15. Apparatus as in claim 14, wherein the isolating means isolates both a proximal end and the distal end of the region being treated.
16. Apparatus as in claim 15, wherein the isolating means comprised a pair of axially spaced-apart balloons on the catheter body.
17. Apparatus as in claims 1, 14, 15, or 16, further comprising means for aspirating disrupted clot from a region around the mechanical agitation means.
18. An apparatus for disrupting clot over a target region of a blood vessel, the apparatus comprising:
a catheter body having a proximal end and a distal end;
an agitator disposed near the distal end for mechanically agitating clot over the target region;
a port disposed near the distal end in fluid communication with an agent supply source for introducing an agent along the target region.
19. The apparatus of claim 18, further comprising an aspiration lumen having an aspiration port near the distal end for aspiration of material from the target vessel.
20. The apparatus of claim 19, further comprising at least one member selected from the group consisting of a vacuum source coupled to the aspiration port and a pump disposed within the aspiration lumen.
21. The apparatus of claim 20, further comprising an aspiration catheter defining the aspiration lumen, the aspiration catheter being disposed outside the catheter body.
22. The apparatus of claim 20, wherein the catheter body contains the aspiration lumen.
23. An apparatus for disrupting clot over a region of a blood vessel, an access site being disposed along the vessel, the apparatus comprising:
an introducer sheath for providing access to the access site;
a first elongate body extending through the introducer sheath, the first body having a proximal end and a first distal end with a first agitator;
a second elongate body extending through the introducer sheath, the second body having a second distal end with a second agitator, the access site being disposed between the first and second agitators.
24. An apparatus as claimed in claim 23, wherein a first bloodflow isolator is disposed distally of the first agitator, and wherein a second bloodflow isolator is disposed distally of the second agitator so as to isolate the region of the vessel.
25. A method for disrupting clot over a predetermined luminal length within a blood vessel, said method comprising:
mechanically agitating the clot over the predetermined luminal length; and infusing an agent in a distributed pattern over the predetermined luminal length which is being mechanically agitated.
26. A method as in claim 25, wherein the predetermined luminal length is at least 5 cm.
27. A method as in claim 25, wherein the blood vessel is a vein.
28. A method as in claim 27, wherein the vein is selected from the group consisting of vena cava, iliac vein, femoral vein, popliteal vein, common iliac vein, external iliac vein, brachial vein, and subclavian vein.
29. A method as in claim 25, wherein the blood vessel is an artery.
30. A method as in claim 29, wherein the artery is selected from the group consisting of the internal iliac artery, external iliac artery, popliteal artery, coronary arteries, superficial femoral artery, and the brachial artery.
31. A method as in claim 25, wherein mechanically agitating the clot comprises rotating and/or axially translating a radially expansible agitator within the blood vessel and against the clot.
32. A method as in claim 31, wherein the radially expansible agitator is resilient and radially constrained by the blood vessel so that the agitator presses against the clot as it is rotated and/or axially translated.
33. A method as in claim 31, wherein infusing the agent comprises delivering the agent through a porous sheath disposed over the agitator, wherein the agent is delivered to the clot while it is being mechanically disrupted by the agitator.
34. A method as in claim 31, wherein the agitator comprises a resilient tube which has a non-linear geometry when expanded against the clot, wherein infusing the agent comprises delivering the agent through a lumen of the tube to ports or porous regions distributed over the length of the tube which is in contact with the clot.
35. A method as in claim 25, further comprising isolating at least one end of the predetermined luminal length.
36. A method as in claim 35, further comprising isolating both a proximal end and a distal end of the predetermined luminal length.
37. A method as in claim 35, wherein isolating comprises inflating at least one occlusion balloon.
38. A method as in claim 35, wherein isolating is performed prior to infusing the agent.
39. A method as in claim 38, wherein isolating is maintained until after infusing the agent has stopped.
40. A method as in claim 25, further comprising aspirating disrupted clot material from along the predetermined luminal length.
41. A method as in claim 40, wherein the clot material is agitated by an agitator supported by a catheter body, and wherein the disrupted clot material is aspirated through an aspiration lumen within the catheter body.
42. A method as in claim 41, wherein the disrupted clot material is aspirated using a pump disposed within the aspiration lumen.
43. A method as in claim 40, wherein the clot material is agitated by an agitator supported by a catheter body, and wherein the disrupted clot material is aspirated through an aspiration lumen of an aspiration catheter.
44. A method for disrupting clot over a luminal length within a blood vessel, said method comprising:
isolating the luminal length from blood flow;
infusing an agent along the luminal length; and mechanically agitating the clot along the luminal length.
45. A kit comprising:
a catheter having an agitator and a thrombolytic agent delivery means; and instructions for use according to the method of claim 25.
CA2396727A 2000-01-25 2001-01-24 Systems and methods for clot dissolution Expired - Lifetime CA2396727C (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CA2755960A CA2755960C (en) 2000-01-25 2001-01-24 Systems and methods for clot dissolution

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/491,401 US6663613B1 (en) 2000-01-25 2000-01-25 System and methods for clot dissolution
US09/491,401 2000-01-25
PCT/US2001/002406 WO2001054754A1 (en) 2000-01-25 2001-01-24 Systems and methods for clot dissolution

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CA2755960A Division CA2755960C (en) 2000-01-25 2001-01-24 Systems and methods for clot dissolution

Publications (2)

Publication Number Publication Date
CA2396727A1 true CA2396727A1 (en) 2001-08-02
CA2396727C CA2396727C (en) 2011-12-13

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CA2396727A Expired - Lifetime CA2396727C (en) 2000-01-25 2001-01-24 Systems and methods for clot dissolution

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US (5) US6663613B1 (en)
EP (1) EP1251892B1 (en)
JP (1) JP4792554B2 (en)
AT (1) ATE556735T1 (en)
AU (1) AU778546B2 (en)
CA (2) CA2755960C (en)
ES (1) ES2387762T3 (en)
WO (1) WO2001054754A1 (en)

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ATE556735T1 (en) 2012-05-15
CA2755960A1 (en) 2001-08-02
WO2001054754A1 (en) 2001-08-02
US7763010B2 (en) 2010-07-27
US8241241B2 (en) 2012-08-14
US20140171911A1 (en) 2014-06-19
EP1251892A4 (en) 2008-01-09
US8986241B2 (en) 2015-03-24
EP1251892B1 (en) 2012-05-09
US20020188276A1 (en) 2002-12-12
CA2396727C (en) 2011-12-13
AU778546B2 (en) 2004-12-09
JP2003523803A (en) 2003-08-12
JP4792554B2 (en) 2011-10-12
US8535290B2 (en) 2013-09-17
US6663613B1 (en) 2003-12-16
US20110046542A1 (en) 2011-02-24
CA2755960C (en) 2014-11-25
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ES2387762T3 (en) 2012-10-01
EP1251892A1 (en) 2002-10-30

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