Microvalve Protection Device and Method of Use for Protection Against Embolization Agent Reflux
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Accused Products
Abstract
An apparatus is provided that is useful in an embolization procedure and enables substantially unrestricted forward flow of blood in a vessel and reduces or stops reflux (regurgitation or backward flow) of embolization agents which are introduced into the blood. A method of using the apparatus is also provided.
174 Citations
147 Claims
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1-76. -76. (canceled)
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77. An endovascular valve device for reducing reflux of an infusate having an embolic agent in a vessel during a therapy procedure, comprising:
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i) 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; andii) 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 not exceeding 500 μ
m,wherein said valve expands from said undeployed state to said deployed state in less than one second in an at-rest fluid having a viscosity of 3.2 cP, said once said valve is in said deployed state, said valve dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on the local biological fluid flow conditions about said valve, and when said valve is in said valve-open configuration said pore size of said filter renders said filter impermeable to the embolic agent of the infusate. - View Dependent Claims (78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88, 89, 90, 91, 92, 93, 94, 95, 96, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112)
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113. An endovascular valve device for reducing reflux of an infusate in a vessel during a procedure, the device comprising:
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a) an elongated delivery catheter having a proximal end and a distal end, a lumen defining an inner diameter, and an outer diameter, wherein the infusate can be delivered through said lumen; b) a valve coupled at said distal end of said delivery catheter, said valve having a housed state with a first smaller diameter and a radially-expanded deployed state with a second larger diameter, said second larger diameter being substantially larger than said outer diameter and capable of extending across a vessel through which said device is used, said valve comprising, i) 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, 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; andii) 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 not exceeding 500 μ
m,wherein said valve expands from said undeployed state to said deployed state in less than one second in an at-rest fluid having a viscosity of 3.2 cP, said once said valve is in said deployed state, said valve dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on the local biological fluid flow conditions about said valve, and when said valve is in said valve-open configuration said pore size of said filter renders said filter impermeable to the embolic agent of the infusate; and c) a control element moving said valve from said housed state to said deployed state, and, said valve in said deployed state having an opening through which infusate can be delivered along a pathway extending through said delivery catheter and into the vessel, said valve in said deployed state automatically allowing biological fluid in the vessel to flow in a proximal to distal direction relative to the valve and preventing reflux of the infusate in the distal to proximal direction. - View Dependent Claims (114)
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115. An endovascular device for reducing reflux of an infusate in a vessel during a procedure, the device comprising:
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a) an elongated delivery catheter having a proximal end and a distal end, a lumen defining an inner diameter, and an outer diameter, wherein the infusate can be delivered through said lumen to the vessel; b) a valve seat provided at said distal end of said delivery catheter; c) a valve distally displaceable through said delivery catheter to said valve seat, said valve having i) 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, 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; andii) 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 not exceeding 500 μ
m, andiii) mating structure that is engaged with said valve seat when said valve is advanced to said valve seat to thereby lock said valve relative to said valve seat, wherein said valve in said undeployed state has a diameter smaller than or approximately equal to an inner diameter of said catheter, and in said deployed state has a diameter substantially larger than an outer diameter of said catheter, and said valve in said deployed state having an opening in fluid communication with said lumen for delivery of the infusate from said delivery catheter to the vessel, wherein said valve expands from said undeployed state to said deployed state in less than one second in an at-rest fluid having a viscosity of 3.2 cP, and wherein once said valve is in said deployed state, said valve dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on the local biological fluid flow conditions about said valve, and when said valve is in said valve-open configuration said pore size of said filter renders said filter impermeable to the embolic agent of the infusate. - View Dependent Claims (116, 117, 118, 119, 120, 121, 122, 123, 124, 125)
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126. An endovascular valve system for reducing reflux of an infusate in a vessel during a therapy procedure, comprising:
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a) a first tubular member having a proximal end, a distal end, a lumen having a first inner diameter, and a first outer diameter sized to be inserted into the vessel; b) a second tubular member having a proximal end with a proximal face, a distal end, a lumen having a second inner diameter smaller than said first inner diameter, and a second outer diameter sized to be inserted into the vessel; c) a valve longitudinally displaced between said first and second tubular members, said valve comprising a braid of first filaments each having a proximal end and a distal end, said proximal ends of said first filaments coupled to said distal end of said first member, and said distal end of said first filaments coupled to said proximal end of said second member, said braid of first filaments biased to radially expand outward at an expansion location to a diameter larger than the first and second outer diameters, said valve defining a proximal portion and a distal portion; d) a filter formed across the valve proximal of said expansion location, said filter defines a pore size not exceeding 500 μ
m, and said valve distal said expansion location being at least partially free of said filter; ande) an elongate member insertable into said first tubular member and removable therefrom during the therapy procedure, said elongate member having a distal surface with a diameter smaller than said first inner diameter and larger than said second inner diameter, wherein said elongate member is insertable into said first tubular member through said valve such that said distal surface is brought into contact with said proximal face of said second tubular member to apply a tensile force to said braid to reduce a diameter of said braid to place said valve in an undeployed state for delivery within the vessel, and wherein said elongate member is thereafter removable from said contact and said valve to provide said valve in a deployed state in which said valve is dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on the local biological fluid flow conditions about said valve, and when said valve is in said valve-open configuration said pore size of said filter renders said filter impermeable to the embolic agent of the infusate. - View Dependent Claims (127, 128, 129, 130, 131, 132)
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133. A method of treating a blood vessel or other duct of a human or animal, comprising:
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a) delivering an elongate delivery catheter to the blood vessel or other duct, said delivery catheter having a proximal end and a distal end, a valve seat at said distal end, a lumen defining an inner diameter, and an outer diameter; b) then advancing a valve from said proximal end to said distal end of said delivery catheter, said valve having mating structure which contacts said valve seat when said valve is advanced to said distal end, said valve having i) 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, 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 within said delivery catheter, and expandable from said undeployed state into a radially-expanded deployed state outside said delivery catheter 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, andii) 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 not exceeding 500 μ
m,wherein said valve expands from said undeployed state to said deployed state in less than one second in an at-rest fluid having a viscosity of 3.2 cP, and wherein said valve in said undeployed state has a diameter smaller than or approximately equal to said inner diameter of said lumen, and in said deployed state has a diameter substantially larger than said outer diameter of said delivery catheter, and wherein when said valve is at said proximal end of said delivery catheter, said valve is in said undeployed state, and when said mating structure of said valve is engaged in said valve seat, a portion of said valve extends from said distal end of said delivery catheter and moves to said deployed state, said valve is in said deployed state dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on the local biological fluid flow conditions about said valve; and c) then infusing an agent through said delivery catheter and out of said opening of said valve and into the blood vessel or other duct, the agent having a characteristic size larger than said characteristic diameter of said plurality of pores such that reflux of the agent in the blood vessel or other duct in a proximal direction through said pores is inhibited. - View Dependent Claims (134, 135, 136, 137, 138, 139, 140)
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141. A method of treating a blood vessel or other duct of a human or animal, comprising:
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a) providing a device comprising a proximal first catheter, a distal second catheter, and a valve longitudinally displaced between the first and second catheters, with the proximal end of the valve coupled to the distal end of the first catheter and the distal end of the valve coupled to the proximal end of the second catheter, wherein the first catheter has a larger inner diameter than the second catheter, and wherein the valve comprises a braid structure and has a proximal portion that is coated with a material having a plurality of pores of a characteristic size, the valve biased to a deployed state with a enlarged first diameter; b) inserting a removable elongate member through the device and against the proximal end of the second catheter to apply a tensile force on the valve and thereby elongate the valve and reduce the valve in diameter to a smaller second diameter; c) then advancing the device to a target site in a patient with the valve configured in the smaller second diameter; d) then removing the elongate member from contact with the proximal end of the second catheter to allow the valve to assume the deployed state; e) then infusing an agent through the first catheter and out of said second portion of said valve and into the blood vessel or other duct, the agent having a characteristic size larger than the characteristic size of said plurality of pores such that reflux of the agent in the blood vessel or other duct in a proximal direction through said pores is inhibited; and f) then withdrawing the device from the patient. - View Dependent Claims (142, 143, 144, 145)
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146. A method of treating a blood vessel of a human or animal with an infusate, comprising:
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a) delivering a system into the blood vessel, the system comprising, i) an inner catheter having a proximal end and a distal end, an outer diameter, and a lumen defining an inner diameter, a valve located at said distal end of said inner catheter, said valve having, 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, 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 within said delivery catheter, and expandable from said undeployed state into a radially-expanded deployed state outside said delivery catheter 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, andB) 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 not exceeding 500 μ
m,wherein said valve expands from said undeployed state to said deployed state in less than one second in an at-rest fluid having a viscosity of 3.2 cP, and said valve in said deployed state dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on the local biological fluid flow conditions about said valve, and said valve having an opening, and ii) an outer catheter having a proximal end, a distal end, a lumen defining an inner diameter, and an outer diameter, said inner catheter extending through said catheter, with said valve being located within said lumen of said outer catheter in the undeployed state; b) then moving said inner and outer catheters relative to each other to move said valve out of said distal end of said outer catheter so that said valve expands into the said deployed state, wherein said opening of said valve is in fluid communication with said lumen of said inner catheter at least when the valve is in said deployed state, said valve having a diameter sized to extend across the vessel when in the deployed state and open; c) infusing an embolic agent through said inner catheter and out of said opening in said valve and into the blood vessel; and d) allowing said valve to dynamically open and close in accord with blood flow conditions, wherein said valve is impermeable to the infusate so as to prevent passage of the infusate past said valve in a distal to proximal direction when the valve is open. - View Dependent Claims (147)
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Specification