CA2532449A1 - Devices and methods for percutaneously treating aortic valve stenosis - Google Patents

Devices and methods for percutaneously treating aortic valve stenosis Download PDF

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Publication number
CA2532449A1
CA2532449A1 CA002532449A CA2532449A CA2532449A1 CA 2532449 A1 CA2532449 A1 CA 2532449A1 CA 002532449 A CA002532449 A CA 002532449A CA 2532449 A CA2532449 A CA 2532449A CA 2532449 A1 CA2532449 A1 CA 2532449A1
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CA
Canada
Prior art keywords
aortic valve
fluid
valve
dissolution fluid
stenotic
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
CA002532449A
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French (fr)
Other versions
CA2532449C (en
Inventor
Rob Laird
Rick Helkowski
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Cardinal Health 529 LLC
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Individual
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Filing date
Publication date
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Publication of CA2532449A1 publication Critical patent/CA2532449A1/en
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Publication of CA2532449C publication Critical patent/CA2532449C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/12127—Double occlusion, e.g. for creating blood-free anastomosis site
    • 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
    • A61B2017/22054—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 with two balloons
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/109—Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1095—Balloon catheters with special features or adapted for special applications with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
    • 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

Abstract

Devices and methods for their use in percutaneously increasing the aortic valve flow of a stenotic aortic valve are provided. The subject devices include an aortic valve isolation element (10), a shunt element (16) and an aortic valve flushing element (not shown). Also provided are systems and kits that include the subject devices and can be employed in practicing the subject methods. The subject devices, methods, systems and kits find use in treating conditions associated with the presence of stenotic aortic valves.

Claims (31)

1. A device comprising:
(a) a valve isolation element that includes:
(i) a ventricular side aortic valve occlusion element; and (ii) an ascending aorta occlusion element; and (b) an aortic valve flushing element.
2. The device according to Claim 1, wherein said flushing element includes:
(a) a fluid introducing element; and (b) a fluid aspiration element.
3. The device according to Claim 2, wherein said fluid introducing element is in fluid communication with a source of stenotic dissolution fluid.
4. The device according to Claim 4, wherein said stenotic dissolution fluid is an acidic dissolution fluid.
5. The device according to Claim 1, wherein said ventricular side aortic valve occlusion element is a balloon.
6. The device according to Claim 1, wherein said ventricular side aortic valve occlusion element is a funnel.
7. The device according to Claim 1, wherein said device further includes shunt element that provides for blood flow through an aortic valve isolated with said valve isolation element.
8. The device according to Claim 7, wherein said shunt element further includes a valve element.
9. The device according to Claim 8, wherein said valve is positioned distal from said isolation element.
10. The device according to Claim 8, wherein said valve is positioned proximal to said isolation element.
11. The device according to Claim 1, wherein said device further includes a fluid flow diverter element.
12. The device according to Claim 1, wherein said device is configured for percutaneous delivery to a target site.
13. The device according to Claim 13, wherein said device further comprises an integrated introducer.
14. The device according to Claim 1, wherein said an ascending aorta occlusion element has an isolation bell configuration.
15. A method of increasing the aortic valve area of a stenotic aortic valve, said method comprising:
(a) isolating said stenotic aortic valve with a valve isolation element that includes:
(i) a ventricular side aortic valve occlusion element; and (ii) an ascending aorta occlusion element; and (b) flushing said isolated stenotic aortic valve with a stenosis dissolution fluid for a period of time sufficient to increase said stenotic aortic valve's aortic valve area.
16. The method according to Claim 15, wherein said flushing comprises contacting said isolated stenotic aortic valve with said stenosis dissolution fluid and removing fluid from said isolated stenotic aortic valve.
17. The method according to Claim 16, wherein said dissolution fluid is an acidic dissolution fluid.
18. The method according to Claim 15, wherein said method further comprises contacting said isolated stenotic aortic valve with a dissolution fluid attenuating fluid.
19. The method according to Claim 18, wherein said dissolution fluid is an acidic dissolution fluid and said dissolution fluid attenuating fluid is a pH
elevating fluid.
20. The method according to Claim 19, wherein said pH elevating fluid is a buffer.
21. The method according to Claim 18, wherein said isolated stenotic aortic valve is contacted with said dissolution fluid attenuating fluid after said valve has been contacted with said dissolution fluid.
22. The method according to Claim 15, wherein said stenotic aortic valve is present in a heart of a mammalian host.
23. The method according to Claim 22, wherein said mammalian host is a human.
24. The method according to Claim 22, wherein said heart is beating.
25. A method comprising:
(a) isolating an aortic valve with a valve isolation element that includes:
(i) a ventricular side aortic valve occlusion element; and (ii) an ascending aorta occlusion element; and (b) flushing said isolated aortic valve with an acidic dissolution fluid for a period of time sufficient to reduce the amount of calcium mineral present on said aortic valve.
26. A system comprising:
(i) a device according to Claim 1; and (ii) a dissolution fluid.
27. The system according to Claim 26, wherein said system further comprises a negative pressure element.
28. The system according to Claim 26, wherein said system further comprises a dissolution fluid attenuating fluid.
29. A kit for comprising:
a device according to Claim 1.
30. The kit according to Claim 29, wherein said kit further includes a dissolution fluid.
31. The kit according to Claim 29, wherein said kit further includes a dissolution fluid attenuating fluid.
CA2532449A 2003-07-17 2004-07-16 Devices and methods for percutaneously treating aortic valve stenosis Expired - Fee Related CA2532449C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US48850703P 2003-07-17 2003-07-17
US60/488,507 2003-07-17
US53147303P 2003-12-19 2003-12-19
US60/531,473 2003-12-19
PCT/US2004/022800 WO2005009505A2 (en) 2003-07-17 2004-07-16 Devices and methods for percutaneously treating aortic valve stenosis

Publications (2)

Publication Number Publication Date
CA2532449A1 true CA2532449A1 (en) 2005-02-03
CA2532449C CA2532449C (en) 2013-04-16

Family

ID=34107771

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2532449A Expired - Fee Related CA2532449C (en) 2003-07-17 2004-07-16 Devices and methods for percutaneously treating aortic valve stenosis

Country Status (8)

Country Link
US (2) US20050054977A1 (en)
EP (1) EP1673131B1 (en)
JP (1) JP4599353B2 (en)
AT (1) ATE460201T1 (en)
AU (1) AU2004259205C1 (en)
CA (1) CA2532449C (en)
DE (1) DE602004025954D1 (en)
WO (1) WO2005009505A2 (en)

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Also Published As

Publication number Publication date
AU2004259205C1 (en) 2009-09-03
JP2007531548A (en) 2007-11-08
US20050054977A1 (en) 2005-03-10
JP4599353B2 (en) 2010-12-15
US7803131B2 (en) 2010-09-28
EP1673131A2 (en) 2006-06-28
DE602004025954D1 (en) 2010-04-22
ATE460201T1 (en) 2010-03-15
EP1673131B1 (en) 2010-03-10
EP1673131A4 (en) 2007-09-12
US20060161133A1 (en) 2006-07-20
CA2532449C (en) 2013-04-16
WO2005009505A2 (en) 2005-02-03
AU2004259205B2 (en) 2009-04-23
WO2005009505A3 (en) 2005-09-22
AU2004259205A1 (en) 2005-02-03

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