Method of Operating a Microvalve Protection Device

• US 20120116351A1
• Filed: 11/29/2011
• Published: 05/10/2012
• Est. Priority Date: 12/02/2009
• Status: Active Grant

• Current Assignee: Trisalus Life Sciences Incorporated
• Original Assignee: Surefire Medical, Inc.
• Inventors: Chomas, James E., Pinchuk, Leonard, Martin, John, Arepally, Aravind, Weldon, Norman R., Pinchuk, Bryan M., Naglreiter, Brett E.
• Granted Patent: US 9,539,081 B2
• Time in Patent Office: Days
• US Class Current: 604/508
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0075 Valve means

Abstract

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.

Claims

1-33. -33. (canceled)

34. 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 the proximal and distal ends such that the therapeutic agent can be infused into said proximal and out of said distal end of said lumen; and

ii) a valve coupled to said distal end of said catheter, said valve including 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 pressures distal said valve, said valve moves from said third configuration to said second configuration;

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; and

c) infusing the therapeutic agent into the vessel through the catheter.

35. A method according to claim 34, wherein:

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.

36. A method according to claim 34, 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.

37. A method according to claim 34, wherein:

said infusing the therapeutic agent through the catheter causes said valve to move into said third configuration.

38. A method according to claim 37, 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.

39. A method according to claim 34, wherein:

said catheter has a distal tip, and

said proximal end of said valve is in alignment with said distal tip of said catheter.

40. A method according to claim 34, wherein:

said filter is provided with a coating that is resistant to adhesion of blood proteins.

41. A method according to claim 34, wherein:

in said third configuration said valve expands to a diameter greater than its diameter in its second configuration.

42. A method according to claim 34, wherein:

said valve includes a filter with pores having a size between 10 μ

m and 500 μ

m.

43. A method according to claim 42, wherein:

said valve includes a filter with pores having a size between 15 μ

m and 100 μ

m.

44. A method according to claim 43, wherein:

said valve includes a filter with pores having a size between 20 μ

m and 40 μ

m.

45. A method according to claim 34, wherein:

said valve includes a plurality of elongate first filaments each having a diameter of 0.025 mm to 0.127 mm, 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°

, and said first filaments have a Young'"'"'s modulus of elasticity greater than 100 MPa, and

said filter is formed by electrostatically depositing or spinning polymeric second filaments onto the braided first filaments, said filter defining a pore size not exceeding 500 μ

m.

46. A method according to claim 45, wherein:

said first filaments consist essentially of a polymeric material.

47. A method according to claim 45, wherein:

said first filaments are comprised of a material chosen from polyethylene terephthalate (PET), polyethylene-napthalate (PEN), liquid crystal polymer, stainless steel, Nitinol, fluorinated polymers, nylon, polyamide, platinum or platinum-iridium.

48. A method according to claim 45, wherein:

said first filaments together form a substantially frustoconical shape when said valve is in said deployed state.

49. A method according to claim 45, wherein:

said second filaments are electrostatically deposited or spun with a polymer in liquid state, in which a liquid solvent has a concentration of 5%-25% polymer solids.

50. 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, and

ii) 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 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 said first filaments have a Young'"'"'s modulus of elasticity greater than 100 MPa; and

B) a filter provided to said braided first filaments, said filter formed by electrostatically depositing or spinning polymeric second filaments onto the braided first filaments, said filter defining a pore size preventing passage of the therapeutic agent,

wherein said valve has a central opening in fluid communication with said lumen;

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; and

c) infusing the therapeutic agent through said catheter and into the vessel through the catheter at an infusion pressure.

51. A method according to claim 50, 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.

52. A method according to claim 51, wherein:

said infusion pressure is greater than said fluid pressure upstream said valve.

53. A method according to claim 50, wherein:

the vessel is in fluid communication with an organ, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into the distal branches of the organ.

54. A method according to claim 50, 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.

55. A method according to claim 50, wherein:

the vessel is in fluid communication with a kidney, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into the distal branches of the kidney.

56. A method according to claim 50, wherein:

the vessel is in fluid communication with a liver, and said infusing the therapeutic agent causes the therapeutic agent to penetrate into the distal branches of the liver.

57. A method according to claim 50, 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.

58. A method according to claim 50, 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.

59. A method according to claim 50, wherein:

said first filaments consist essentially of a polymeric material.

60. A method according to claim 50, wherein:

said first filaments are comprised of a material chosen from polyethylene terephthalate (PET), polyethylene-napthalate (PEN), liquid crystal polymer, stainless steel, Nitinol, fluorinated polymers, nylon, polyamide, platinum or platinum-iridium.

61. A method according to claim 50, wherein:

said first filaments together form a substantially frustoconical shape when said valve is in said deployed state.

62. A method according to claim 50, wherein:

said second filaments are electrostatically deposited or spun with a polymer in liquid state, in which a liquid solvent has a concentration of 5%-25% polymer solids.

63. 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, and

ii) 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,

wherein said valve has a central opening in fluid communication with said lumen;

b) inserting said device into the vessel; and

c) infusing the therapeutic agent a first infusion pressure through said catheter and into the vessel, wherein said first infusion pressure causing said valve to open across said vessel to prevent reflux of the therapeutic agent in the upstream direction past said 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 valve in the upstream direction past said valve; and

d) 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 valve to permit passage of blood through said pores of said valve in the upstream direction past said valve while preventing reflux of the therapeutic agent in the upstream direction past said valve.

64. A method according to claim 63, 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.

65. A method according to claim 63, wherein:

said filter valve includes,

a valve comprising a plurality of elongate polymeric first filaments each having a diameter of 0.025 mm to 0.127 mm, 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°

, and said first filaments have a Young'"'"'s modulus of elasticity greater than 100 MPa, and

a filter formed by electrostatically depositing or spinning polymeric second filaments onto the braided first filaments, said filter defining a pore size not exceeding 500 μ

m.

66. A method according to claim 65, wherein:

said first filaments together form a substantially frustoconical shape when said valve is in said deployed state.

67. A method according to claim 65, wherein:

said second filaments are electrostatically deposited or spun with a polymer in liquid state, in which a liquid solvent has a concentration of 5%-25% polymer solids.