INFUSION TREATMENT AGENTS, CATHETERS, FILTER DEVICES, AND OCCLUSION DEVICES, AND USE THEREOF
First Claim
1. A system comprising:
- a guide catheter comprising an occlusion device;
a delivery catheter comprising at least one occlusion device having a property to occlude a blood vessel without radially expanding the blood vessel, wherein the delivery catheter is received within the guide catheter; and
a guidewire comprising an occlusion device, wherein the guidewire is received within the guide catheter or the delivery catheter.
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Accused Products
Abstract
Embodiments include an infusion-occlusion system having a delivery catheter, a guide catheter adapted to receive the delivery catheter, and a guidewire with an occlusion device adapted to be received within the guide catheter. The guide catheter of the catheter kit may be provided with an occlusion device at the distal end of the guide catheter. The delivery catheter may have an accessory lumen, coaxial or co-linear lumen, a supporting mandrel, or an occlusion device at its distal end. Moreover, according to some embodiments, occlusion devices may be a single material or a composite balloon having an inner liner and an outer layer of different materials, a high compliance low pressure balloon, or a filter device that restricts particles from passing through but does not restrict fluid, such as blood. An inflation device with a large volume and low volume syringe can be used to inflate the balloon.
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Citations
58 Claims
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1. A system comprising:
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a guide catheter comprising an occlusion device; a delivery catheter comprising at least one occlusion device having a property to occlude a blood vessel without radially expanding the blood vessel, wherein the delivery catheter is received within the guide catheter; and a guidewire comprising an occlusion device, wherein the guidewire is received within the guide catheter or the delivery catheter.
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2. A kit comprising:
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a delivery catheter comprising; a shaft comprising a proximal end and a distal end and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end; a monitoring cannula defining a lumen therethrough, comprising a proximal end and a distal end, a portion of the monitoring cannula disposed within the shaft; a port coupled to the distal end of the monitoring cannula; a balloon inflation cannula defining a lumen therethrough, comprising a proximal end and a distal end, a portion of the balloon inflation cannula within the shaft; a balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, polyetheramides, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block co-polymer, and blends and mixtures thereof; wherein the balloon is adapted to inflate to at least one of a predetermined volume sufficient to occlude a blood vessel without radially expanding the blood vessel and to a pre-determined pressure of about 0.5 to about 5.0 atmospheres. - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. An apparatus comprising:
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a cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal end and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated the balloon will expand in size to an outer diameter sufficient for occlusion of a blood vessel at an inflation pressure less than sufficient to cause an axial force on an inner diameter of the blood vessel and sufficient to cause a radial expansion of the blood vessel. - View Dependent Claims (15, 16, 17)
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18. An apparatus comprising:
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a cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal end and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a polymer moiety represented by the formula; wherein PA represents a polyamide moiety, PEth represents a polyether moiety, and n represents an integer greater than or equal to 1. - View Dependent Claims (19, 20, 21, 23, 24)
comprises a property such that the balloon will inflate to an inflated outer diameter that will occlude a blood vessel and deflate to a post-inflated deflated diameter that will allow the balloon to be withdrawn from the blood vessel; and comprises a property such that the balloon has a pre-inflated volume and a postinflated deflated volume approximately equal to the pre-inflated volume.
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20. The apparatus of claim 18 wherein the balloon comprises a property such that the balloon will have at least 3 wings before being inflated and after being deflated,
wherein each wing has a wing length defined by the length of a line extending within the wing along a medial axis of a cross-section of the wing, wherein a pre-inflated wing length for each wing is approximately equal to a post-inflated deflated wing length of each wing; -
wherein each wing has an outer diameter point defined by a point of the wing radially farthest away from an axis of the cannula, and a wing diameter defined by a length of a straight line extending from the axis of the cannula, radially out to the outer diameter point, wherein a pre-inflated wing diameter for each wing is approximately 30 percent less than a post-inflated deflated wing diameter.
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21. The apparatus of claim 18 wherein the balloon comprises a property such that the balloon can achieve a volumetric expansion of greater than about 40% during inflation and can expanded to an inflated outer diameter between 1.5 mm and 18 mm in diameter, will have a double wall thickness between 0.0003 and 0.0038 inches in thickness and a minimum hoop strength of at least about 23,000 psi strength;
- and will have a durometer hardness of between 50 Shore D and 70 Shore D.
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23. The apparatus of claim 18 wherein the balloon comprises a property such that the balloon will inflate to one of a predetermined volume and a predetermined inflated outer diameter.
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24. The apparatus of claim 18 wherein the balloon comprises a property such that the balloon will inflate to an inflated outer diameter in a range of between 1.25 mm and 18 mm in diameter, and:
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at an inflation pressure of 1 atmosphere the balloon will inflate to an inflated outer diameter of approximately 10% of a pre-inflated outer diameter; at an inflation pressure of 2 atmospheres the balloon will inflate to an inflated outer diameter of at least 20% of the pre-inflated outer diameter; at an inflation pressure of 3 atmospheres the balloon will inflate to an inflated outer diameter of at least 30% of the pre-inflated outer diameter; at an inflation pressure of 4 atmospheres the balloon will inflate to an inflated outer diameter of at least 40% of the pre-inflated outer diameter; at an inflation pressure of 5 atmospheres the balloon will inflate to an inflated outer diameter of at least 50% of the pre-inflated outer; and at an inflation pressure of 6 atmospheres the balloon will inflate to an inflated outer diameter of least 60% of the pre-inflated outer diameter.
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22. An apparatus comprising:
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a cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal end and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that the balloon will inflate to an inflated outer diameter that will occlude a blood vessel and at a predetermined pressure of between 0.5 atmospheres and 5.0 atmospheres of pressure.
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25. An apparatus comprising:
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a cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal end and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated to a plurality of selected increasing inflation volumes the balloon forms a plurality of predictably increasing radial outer diameters and has an inflation pressure that increases by less than five percent in pressure. - View Dependent Claims (26, 27)
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28. An apparatus comprising:
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a cannula having a dimension suitable for percutaneous advancement through a blood vessel, the cannula comprising a proximal end and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprises a property such that when inflated to a first inflation volume, the balloon has a first inflated axial length and an outer diameter of the balloon exerts a first inflation pressure on an inner diameter of a blood vessel sufficient to occlude the blood vessel at a treatment region, and when inflated to a second greater inflation volume, the balloon has a second inflated axial length that is sufficiently greater than the first inflated axial length to allow the outer diameter of the balloon to exert a second inflation pressure that is less than five percent greater than the first inflated pressure on the inner diameter. - View Dependent Claims (29, 30, 31, 33, 34, 35, 36, 37, 38, 39)
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32. An apparatus comprising:
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a cannula having an outer diameter less than 0.090 inches, a proximal end, and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated to a selected inflation volume the balloon will expand in size to an outer diameter sufficient to occlude the blood vessel; and an infusion lumen having an inner diameter greater than 0.010 inches extending from the proximal end to the distal end of the cannula and exiting an infusion opening distal to the balloon; an accessory lumen extending from the proximal end to the distal end of the cannula and exiting an accessory opening distal to the balloon; wherein at least one of the infusion lumen and the accessory lumen is adapted to have a guide wire disposed therethrough to guide the cannula through the blood vessel to a treatment region.
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40. An apparatus comprising:
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a cannula having a proximal end, and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated the balloon will expand in size to an outer diameter sufficient to occlude the blood vessel at a treatment region; a guidewire tube extending from the proximal end to the distal end of the cannula and exiting a guidewire opening in the distal end of the cannula; an infusion tube around the guidewire tube extending from the proximal end to the distal end of the cannula and exiting an infusion opening in the distal end of the cannula; an inflation lumen defined between the infusion tube and the cannula; wherein the guidewire tube, infusion tube, and inflation lumen are co-axially aligned with an axis of the cannula. - View Dependent Claims (41, 42, 45)
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43. An apparatus comprising:
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a cannula having a proximal end, and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated the balloon will expand in size to an outer diameter sufficient to occlude the blood vessel at a treatment region; a guidewire tube extending from the proximal end to the distal end of the cannula and exiting a guidewire opening in the distal end of the cannula, the guidewire tube co-linearly or co-axially aligned with an axis of the cannula; an infusion lumen defined between the guidewire tube and the cannula; an inflation tube extending from the proximal end of the cannula to the balloon, the inflation tube co-linearly aligned with an axis of the cannula.
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44. The apparatus of claim 44 wherein the infusion lumen is co-linearly or co-axially aligned with the cannula;
- and wherein the inflation tube extends from the proximal end of the cannula to the balloon and has a dimension suitable to inflate the balloon, the infusion lumen has a dimension sufficient to infuse a treatment agent to the treatment region distal to the balloon, and the guidewire tube has a sufficient outer diameter and is adapted to have a guide wire disposed therethrough to guide the cannula through the blood vessel to a treatment region.
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46. An apparatus comprising:
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a cannula having a proximal end, and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated to a selected inflation volume the balloon will expand in size to an outer diameter sufficient to occlude the blood vessel at a treatment region; a lumen extending from the proximal end to the distal end of the cannula and exiting an opening in the cannula distal to the balloon; at least one hole through the exterior surface of the cannula and to the lumen at a location proximal to the balloon to allow perfusion of a blood or a treatment agent between a location in the blood vessel proximal to the balloon and the treatment region.
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47. The apparatus of claim 47 further including a guidewire disposed through lumen and slidably adjustable such that a distal end of the guidewire can be extended past the at least one hole;
- wherein guidewire lumen has an inner diameter and the guidewire has an outer diameter sufficient in diameter to occlude the guidewire lumen; and
wherein the at least one hole includes between four and eight holes and the guidewire has a dimension to be slidably adjustable to extend or retract a distal end of the guidewire to a location past none or any of the holes. - View Dependent Claims (48)
- wherein guidewire lumen has an inner diameter and the guidewire has an outer diameter sufficient in diameter to occlude the guidewire lumen; and
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49. An apparatus comprising:
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a cannula having a proximal end, and a distal end; a balloon axially coupled to an exterior surface of the cannula at or adjacent the distal end of the cannula, the balloon comprising a property such that when inflated to a selected inflation volume the balloon will expand in size to an outer diameter sufficient to occlude the blood vessel at a treatment region; the cannula having a lumen having a proximal end at a location proximal to the balloon and extending to a distal end at a location distal to the balloon, a proximal hole through the exterior surface of the cannula and to the lumen at a location proximal to the balloon, and a distal hole through the exterior surface of the cannula and to the lumen at a location distal to the balloon. - View Dependent Claims (50, 51, 52, 53)
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54. A catheter comprising:
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a shaft comprising a proximal end and a distal end, and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end; a delivery port coupled to the distal end of the delivery lumen; a pressure monitoring lumen, a portion of the pressure monitoring lumen disposed within the shaft, comprising a proximal end and a distal end; a pressure port coupled to the distal end of the pressure monitoring lumen; a balloon inflation lumen, a portion of the balloon inflation lumen disposed within the shaft, comprising a proximal end and a distal end; a balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block copolymer, and blends and mixtures thereof; wherein the balloon is adapted to inflate to at least an elasticity of about 40% at a pre-determined gauge pressure of about 0.5 to about 6.0 atmospheres; a balloon inflation port within the balloon and coupled to the distal end of the balloon inflation lumen; wherein at least one of the delivery lumen and pressure monitoring lumen are adapted to receive a guidewire. - View Dependent Claims (55)
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56. A catheter comprising:
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a shaft comprising a proximal end and a distal end and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end; a delivery port coupled to the distal end of the delivery lumen; a pressure monitoring lumen comprising a proximal end and a distal end, a portion of the pressure monitoring lumen disposed within the flexible shaft; a pressure port coupled to the distal end of the pressure monitoring lumen; a balloon inflation lumen comprising a proximal end and a distal end, a portion of the balloon inflation lumen within the flexible shaft; a balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block copolymer, and blends and mixtures thereof; a balloon inflation port coupled to the distal end of the balloon inflation lumen and the balloon inflation port within the balloon; wherein a first wall thickness of the balloon adjacent a proximal end of the balloon is smaller than a second wall thickness of the balloon adjacent a distal end of the balloon; and wherein upon inflation, a first diameter of the balloon adjacent to a proximal end of the balloon is larger than a second diameter adjacent a distal end of the balloon. - View Dependent Claims (57)
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58. A catheter comprising:
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a shaft comprising a proximal end and a distal end, and defining a delivery lumen through a portion thereof, the delivery lumen comprising a proximal end and a distal end; a delivery port coupled to the distal end of the delivery lumen; a pressure monitoring lumen, a portion of the pressure monitoring lumen disposed within the shaft, comprising a proximal end and a distal end; a pressure port coupled to the distal end of the pressure monitoring lumen; a balloon inflation lumen, a portion of the balloon inflation lumen disposed within the shaft, comprising a proximal end and a distal end; a balloon adjacent to the distal end of the flexible shaft, the balloon comprising at least one material selected from the group consisting of polyether block amide resins, blends of polyether block amide resins, a composite including an elastomeric material and EPTFE, a styrene-isoprene-styrene tri-Block copolymer, and blends and mixtures thereof; a balloon inflation port within the balloon and coupled to the distal end of the balloon inflation lumen; wherein the delivery lumen is distal to the pressure monitoring lumen defining at least one of a tapered and a staggered tip, and the delivery lumen is adapted to receive the guidewire.
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Specification