Method of operating a microvalve protection device
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61M-001/34
A61F-002/01
A61B-017/12
A61F-002/24
A61B-017/00
A61B-017/22
A61M-025/00
출원번호
US-0306105
(2011-11-29)
등록번호
US-9539081
(2017-01-10)
발명자
/ 주소
Chomas, James E.
Pinchuk, Leonard
Martin, John
Arepally, Aravind
Naglreiter, Brett E.
Weldon, Norman R.
Pinchuk, Bryan M.
출원인 / 주소
Surefire Medical, Inc.
대리인 / 주소
Gordon & Jacobson, P.C.
인용정보
피인용 횟수 :
0인용 특허 :
122
초록▼
An endovascular valve device for use in a vessel during a therapy procedure includes a catheter having at its distal end a valve. The valve is constructed of a braid of elongate first filaments coupled together at their proximal ends in a manner that the first filaments are movable relative to each
An endovascular valve device for use in a vessel during a therapy procedure includes a catheter having at its distal end a valve. The valve is constructed of a braid of elongate first filaments coupled together at their proximal ends in a manner that the first filaments are movable relative to each other along their lengths. The first filaments have a spring bias that radially expands the valve. A filter is provided to the braid formed by electrostatically depositing or spinning polymeric second filaments onto the braided first filaments. The lumen of the catheter is in communication with the center of the valve. The device is used to provide a therapy in which a therapeutic agent is infused into an organ.
대표청구항▼
1. A method of infusing a therapeutic agent into a fluid-filled vessel during a procedure, comprising: a) providing a device having, i) a catheter including a proximal end, a distal end, and a lumen extending between said proximal and distal ends such that the therapeutic agent can be infused into s
1. A method of infusing a therapeutic agent into a fluid-filled vessel during a procedure, comprising: a) providing a device having, i) a catheter including a proximal end, a distal end, and a lumen extending between said proximal and distal ends such that the therapeutic agent can be infused into said proximal end and out of said distal end of said lumen; andii) a valve coupled to said distal end of said catheter, said valve integrated with a porous filter having pores sized to prevent passage of the therapeutic agent, (A) said valve initially under restraint in a radially collapsed first configuration,(B) upon release of said restraint, said valve biased to expand outwardly within the vessel into a relatively expanded second configuration, wherein in the second configuration said valve permits fluid to flow past said valve in an upstream to downstream direction, and(C) said valve further movable into a third configuration adapted to capture all of the therapeutic agent flowing against said valve in a downstream to upstream direction,said valve automatically dynamically movable between said second and third configurations based on the relative fluid pressures located proximal and distal said valve,wherein when said pressure distal said valve is greater than said pressure proximal said valve, said valve automatically moves from said second configuration to said third configuration, and when said pressure proximal said valve is greater than said pressure distal said valve, said valve moves from said third configuration to said second configuration, andwherein when said valve is in said third configuration, said valve blocks upstream passage of blood past said valve at fluid pressure below a threshold level, permits upstream passage of blood past said valve at fluid pressure exceeding a threshold level, and captures the therapeutic agent at fluid pressures below and above said threshold level;b) inserting the device into the vessel such that said valve dynamically responds to the relative pressures located proximal and distal said valve within the vessel; andc) infusing the therapeutic agent into the vessel through the catheter. 2. A method according to claim 1, wherein: prior to step c) the pressure within said catheter and downstream of said valve is lower than the pressure upstream of said valve resulting in said valve assuming said second configuration. 3. A method according to claim 1, wherein: said infusing the therapeutic agent through the catheter causes said valve to move into said third configuration. 4. A method according to claim 3, wherein: said therapeutic agent is infused by infusing a first amount of the therapeutic agent and then infusing a second larger amount of saline directly behind the therapeutic agent. 5. A method according to claim 1, wherein: said catheter has a distal tip, andsaid proximal end of said valve is in alignment with said distal tip of said catheter. 6. A method according to claim 1, wherein: said filter is provided with a coating that is resistant to adhesion of blood proteins. 7. A method according to claim 1, wherein: in said third configuration said valve expands to a diameter greater than its diameter in its second configuration. 8. A method according to claim 1, wherein: said filter has pores having a size between 10 μm and 500 μm. 9. A method according to claim 1, wherein: said filter has pores having a size between 15 μm and 100 μm. 10. A method according to claim 1, wherein: said filter has pores having a size between 20 μm and 40 μm. 11. A method according to claim 1, wherein: said valve comprises first filaments having a proximal end, a distal end, and a length extending therebetween, said first filaments having a proximal end, a distal end, and a length extending therebetween, said proximal ends secured relative to each other, said first filaments along said lengths distal of said proximal ends not bonded to each other such that said first filaments are movable relative to each other, wherein in said second configuration said first filaments cross one another at an angle of 100° to 150°, andsaid filter defining a pore size not exceeding 500 μm. 12. A method according to claim 11, wherein: said first filaments together form a substantially frustoconical shape when said valve is in said second configuration. 13. A method of infusing a therapeutic agent into a fluid-filled vessel during a procedure, comprising: a) providing a device having, i) a catheter having a proximal end, a distal end, and a lumen, andii) a valve coupled to said distal end of said catheter, said valve comprising, A) a plurality of elongate first filaments each having a diameter of 0.025 mm to 0.127 mm, said first filaments extending in a braided formation and having a proximal end, a distal end, and a length extending therebetween,said proximal ends secured relative to each other, said first filaments along said lengths distal of said proximal ends not bonded to each other such that said first filaments are movable relative to each other,said valve fully collapsible into an undeployed state, and expandable from said undeployed state into a radially-expanded deployed state by a spring bias of said first filaments,wherein in said deployed state said first filaments cross one another at an angle of 100° to 150°; and B) a filter integrated with said first filaments, said filter formed by electrostatically depositing or spinning polymeric second filaments onto said first filaments, said filter defining a pore size preventing passage of the therapeutic agent;b) inserting the device into the vessel such that said valve dynamically responds to the relative fluid pressures located both (i) downstream said valve and (ii) upstream said valve, all while said valve is located within said vessel; andc) infusing the therapeutic agent through said catheter and into the vessel through the catheter at an infusion pressure. 14. A method according to claim 13, wherein: said infusion pressure causes said valve to open into a configuration in which said valve extends completely across said vessel and blocks movement of the therapeutic agent in an upstream direction past said valve. 15. A method according to claim 14, wherein: said infusion pressure is greater than said fluid pressure upstream said valve. 16. A method according to claim 13, wherein: the vessel is in fluid communication with an organ, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into distal branches of the organ. 17. A method according to claim 13, wherein: the vessel is in fluid communication with a tumor, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into the tumor. 18. A method according to claim 13, wherein: the vessel is in fluid communication with a kidney, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into distal branches of the kidney. 19. A method according to claim 13, wherein: the vessel is in fluid communication with a liver, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into distal branches of the liver. 20. A method according to claim 13, wherein: when said infusion pressure reaches a threshold level, blood within said vessel is permitted to flow upstream past said valve while said valve continues to capture the therapeutic agent. 21. A method according to claim 13, further comprising: said infusing the therapeutic agent includes infusing a first amount of the therapeutic agent and infusing a second larger amount of saline directly behind the therapeutic agent. 22. A method according to claim 13, wherein: said first filaments together form a substantially frustoconical shape when said valve is in said deployed state. 23. A method of infusing a therapeutic agent into a blood-filled vessel during a procedure, the vessel having a blood flow with upstream and downstream directions, the blood having proteins, said method comprising: a) providing a device having, i) a catheter having a proximal end, a distal end, and a lumen, andii) a filter valve coupled to said distal end of said catheter, said filter valve defining pores with a pore size preventing passage of the therapeutic agent;b) inserting said device into the vessel; andc) infusing the therapeutic agent at a first infusion pressure through said catheter and into the vessel, wherein said first infusion pressure causing said filter valve to open across said vessel to prevent reflux of the therapeutic agent in the upstream direction past said filter valve, wherein at the first infusion pressure the proteins in the blood adhere to the filter valve and create a barrier to passage of blood through said pores of said filter valve in the upstream direction past said filter valve; andd) infusing the therapeutic agent a second infusion pressure through said catheter and into the vessel, wherein said second infusion pressure is greater than said first infusion pressure, and at said second infusion pressure the proteins in the blood are at least partially removed from said pores of said filter valve to permit passage of blood through said pores of said filter valve in the upstream direction past said filter valve while preventing reflux of the therapeutic agent in the upstream direction past said filter valve. 24. A method according to claim 23, wherein: said valve automatically dynamically responds to the relative fluid pressures located (i) within said catheter, (ii) downstream said valve, and (iii) upstream said valve, all while said valve is located within said vessel. 25. A method according to claim 23, wherein: said filter valve includes, a valve comprising a plurality of elongate polymeric first filaments braided together, said first filaments having a proximal end, a distal end, and a length extending therebetween, said proximal ends secured relative to each other, said first filaments along said lengths distal of said proximal ends not bonded to each other such that said first filaments are movable relative to each other, wherein in said second configuration said first filaments cross one another at an angle of 100° to 150°, anda filter formed by polymeric second filaments on the first filaments. 26. A method according to claim 25, wherein: said first filaments together form a substantially frustoconical shape when said valve is in said deployed state. 27. A method according to claim 1, wherein: the vessel is in a vascular bed of a target organ. 28. A method according to claim 27, wherein: the target organ is one of a liver, a kidney, and a pancreas. 29. A method according to claim 27, wherein: the therapeutic agent is adapted to treat cancer of the target organ. 30. A method according to claim 14, wherein: said valve has a central opening in fluid communication with said lumen. 31. A method according to claim 14, wherein: the vessel is in a vascular bed of a target organ. 32. A method according to claim 31, wherein: the target organ is one of a liver, a kidney, and a pancreas. 33. A method according to claim 31, wherein: the therapeutic agent is adapted to treat cancer of the target organ. 34. A method according to claim 23, wherein: said valve has a central opening in fluid communication with said lumen. 35. A method according to claim 23, wherein: the vessel is in a vascular bed of a target organ. 36. A method according to claim 35, wherein: the target organ is one of a liver, a kidney, and a pancreas. 37. A method according to claim 36, wherein: the therapeutic agent is adapted to treat cancer of the target organ.
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