Flow directional infusion device
DC
First Claim
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1. A flow directional infusion device for reducing reflux of an agent in an infusate in a vessel during a therapy procedure, comprises:
- a) a catheter having a proximal portion and a distal portion with a distal end; and
b) a composite filter valve located at said distal portion of said catheter, said filter valve having a proximal end fixed to said catheter, and a distal end, said filter valve comprising,i) a plurality of elongate polymeric first filaments provided in a braid and together defining a valve, each of said first filaments 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 between the proximal and distal ends of the said first filaments, said proximal ends of said first filaments secured 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, said first filaments extending relative to each other in said braid in a non-bonded state such that they are movable relative to each other as said valve moves from said undeployed state to said deployed state,wherein in said deployed state said first filaments cross one another within said braid 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 formed by polymeric second filaments that are integrated with said valve by electrostatically depositing or spinning said second filaments onto the first filaments, said filter defining a pore size not exceeding 500 μ
m,wherein said filter 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,wherein once said filter valve is in said deployed state in the vessel, said filter valve is dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on local biological fluid flow conditions about said filter valve, and when said filter valve is in said valve-open configuration, said pore size of said filter renders said filter impermeable to the agent of the infusate, andsaid filter valve having a circumferential wall defining an opening located proximal of said distal end of said filter valve for transfer of the infusate from a location within said catheter, through said opening in said circumferential wall of said filter so as to exit the filter valve in a radially non-uniform manner, and to deliver the infusate from said filter valve into the vessel at a location proximal said distal end of said filter valve.
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Abstract
A flow directional infusion device includes a filter valve located at the distal end of a catheter. The filter valve constrains delivery of an embolic agent through the catheter to the locus of the aneurysm. In order to provide such delivery, the valve includes a longitudinal opening, radial opening or is otherwise partially permeable in a direction of the aneurysm so that the embolic agent or a delivery element for such agent is limited toward the aneurysm. In addition, the filter valve permits and directs blood flow within the blood vessel about the aneurysm during the treatment without obstructing the vessel and without allowing retrograde flow of the embolic agent in the vessel upstream of the aneurysm.
132 Citations
17 Claims
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1. A flow directional infusion device for reducing reflux of an agent in an infusate in a vessel during a therapy procedure, comprises:
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a) a catheter having a proximal portion and a distal portion with a distal end; and b) a composite filter valve located at said distal portion of said catheter, said filter valve having a proximal end fixed to said catheter, and a distal end, said filter valve comprising, i) a plurality of elongate polymeric first filaments provided in a braid and together defining a valve, each of said first filaments 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 between the proximal and distal ends of the said first filaments, said proximal ends of said first filaments secured 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, said first filaments extending relative to each other in said braid in a non-bonded state such that they are movable relative to each other as said valve moves from said undeployed state to said deployed state, wherein in said deployed state said first filaments cross one another within said braid 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 formed by polymeric second filaments that are integrated with said valve by electrostatically depositing or spinning said second filaments onto the first filaments, said filter defining a pore size not exceeding 500 μ
m,wherein said filter 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, wherein once said filter valve is in said deployed state in the vessel, said filter valve is dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on local biological fluid flow conditions about said filter valve, and when said filter valve is in said valve-open configuration, said pore size of said filter renders said filter impermeable to the agent of the infusate, and said filter valve having a circumferential wall defining an opening located proximal of said distal end of said filter valve for transfer of the infusate from a location within said catheter, through said opening in said circumferential wall of said filter so as to exit the filter valve in a radially non-uniform manner, and to deliver the infusate from said filter valve into the vessel at a location proximal said distal end of said filter valve. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A flow directional infusion device for reducing reflux of an embolic agent in an infusate in a vessel during a therapy procedure, comprises:
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a) a catheter having a proximal portion and a distal portion with a distal end; and b) a composite filter valve located at said distal portion of said catheter, said filter valve having a proximal end fixed to said catheter, and a distal end, said filter valve comprising, i) a plurality of elongate polymeric first filaments provided in a tubular form braid, each of said first filaments 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 between the proximal and distal ends of the said first filaments, said proximal ends of said first filaments secured relative to each other and defining a valve, 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, said first filaments extending relative to each other in said braid in a non-bonded state such that they are movable relative to each other as said valve moves from said undeployed state to said deployed state, wherein in said deployed state said first filaments cross one another within said braid 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 formed by polymeric second filaments that are integrated with said valve by electrostatically depositing or spinning said second filaments onto said first filaments, said filter defining a pore size not exceeding 500 μ
m such that said filter is impermeable to the embolic agent, and said filter applied to said braid of first filaments about an axis of rotation that is less than 360°
around said tubular form braid to thereby define a non-filtering portion of said filter valve that is permeable to the embolic agent, said non-filtering portion for transfer of the embolic agent from a location within said catheter, through said non-filtering portion, and to outside said filter valve,wherein once said filter valve is in said deployed state in the vessel, said filter valve is dynamically movable within the vessel between an expanded valve-open configuration and a collapsed valve-closed configuration depending on local biological fluid flow conditions about said filter valve. - View Dependent Claims (16, 17)
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Specification
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Litigation Data
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Current AssigneeTrisalus Life Sciences Incorporated
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Original AssigneeSurefire Medical, Inc.
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InventorsChomas, James E., Weldon, Norman R., Pinchuk, Leonard
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Primary Examiner(s)Mehta, Bhisma
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Assistant Examiner(s)SHAH, NILAY J
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Application NumberUS13/611,080Publication NumberTime in Patent Office1,049 DaysField of Search604/264, 604/266, 604/268, 604/96.01, 604/99.02, 604/104, 606/200US Class Current1/1CPC Class CodesA61B 17/12113 within an aneurysmA61B 17/12186 liquid materials adapted to...A61B 2017/1205 Introduction devicesA61F 2/01 Filters implantable into bl...A61M 2039/2406 designed to quickly shut up...A61M 2039/2433 Valve comprising a resilien...A61M 2205/75 with filtersA61M 2205/7545 for solid matter, e.g. micr...A61M 2205/7554 with means for unclogging o...A61M 25/0043 characterised by structural...A61M 25/0097 characterised by the hub co...
