Multi-valve catheter for improved reliability
First Claim
1. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
- a cannula having an outer-wall made of a biocompatible material, the cannula having a distal end and a proximal end and at least one internal lumen for transmitting liquids, the at least one internal lumen providing for two-way fluid flow between the proximal end and the distal end of the cannula such that the fluid flow is initiated by the application of a pressure differential to the fluid;
means for selectively communicating between the at least one lumen of the cannula and the exterior of the cannula, said means for selectively communicating comprising a plurality of valves, the plurality of valves being comprised of a primary valve and a secondary valve, the primary valve being constructed to operate at a lower threshold pressure differential than the secondary valve so as to be preferably operable relative to the secondary valve during aspiration or infusion, the secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate.
1 Assignment
0 Petitions
Accused Products
Abstract
A novel apparatus for a catheter for use in aspirating and/or infusing fluids into a patient. The catheter, having a proximal end and a distal end, comprises a plurality of valves in the walls of the catheter comprised of relatively soft material while maintaining a predetermined degree of structural integrity at the catheter tip. The plurality of valves are radially distributed in offset relation around the distal end of the catheter such that no two valves lie in any one radial plane. Similarly, the plurality of valves are longitudinally separated or offset in their placement at relatively short, but differentiated, distances from the distal end of the catheter such that no two valves lie in any one axial plane. The radial and longitudinal separation of the valves helps avoid structrual weakness in the catheter, particularly at the distal end of the catheter. The catheter may be a single-lumen catheter, or a multi-lumen catheter.
The plurality of valves are comprised of a primary valve constructed to be preferably operable during infusion and/or aspiration, and at least one secondary valve which operates as a surrogate should the primary valve become partially or totally occluded. The catheter enables repeated infusion and/or aspiration over a period of time.
The present invention also includes methods for using and manufacturing the catheter by following certain steps.
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Citations
95 Claims
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1. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
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a cannula having an outer-wall made of a biocompatible material, the cannula having a distal end and a proximal end and at least one internal lumen for transmitting liquids, the at least one internal lumen providing for two-way fluid flow between the proximal end and the distal end of the cannula such that the fluid flow is initiated by the application of a pressure differential to the fluid; means for selectively communicating between the at least one lumen of the cannula and the exterior of the cannula, said means for selectively communicating comprising a plurality of valves, the plurality of valves being comprised of a primary valve and a secondary valve, the primary valve being constructed to operate at a lower threshold pressure differential than the secondary valve so as to be preferably operable relative to the secondary valve during aspiration or infusion, the secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35)
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12. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
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a single-lumen cannula having an outer-wall made of a biocompatible material, the cannula having a distal end and a proximal end and an internal lumen for transmitting liquids, the internal lumen providing for two-way fluid flow between the proximal end and the distal end of the cannula such that the fluid flow is initiated by the application of a pressure differential to the fluid; a plurality of multi-position valves communicating between the lumen of the cannula and the exterior of the cannula having edges which abut each other to prevent fluid flow therethrough, the edges moving outwardly from one another upon the application of a positive pressure differential to the lumen to infuse fluids from the lumen, the edges moving inwardly upon the application of a negative pressure differential to the lumen to withdraw fluid from the lumen, and wherein the material from which the cannula adjacent each valve is chemically softened with silicone oil in order to provide for the two-way operation; and the plurality of valves comprised of a primary valve constructed to be preferably operable during aspiration or infusion, and at least one secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate.
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25. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
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a single-lumen cannula having an outer-wall made of a biocompatible material, the cannula having a distal end and a proximal end and an internal lumen for transmitting liquids, the internal lumen providing for two-way fluid flow between the proximal end and the distal end of the cannula such that the fluid flow is initiated by the application of a pressure differential to the fluid; a plurality of multi-position valves communicating between the lumen of the cannula and the exterior of the cannula having edges which abut each other to prevent fluid flow therethrough, the edges moving outwardly from one another upon the application of a positive pressure differential to the lumen to infuse fluids from the lumen, the edges moving inwardly upon the application of a negative pressure differential to the lumen to withdraw fluid from the lumen; and the plurality of valves comprised of a primary valve constructed to be preferably operable during aspiration or infusion, and at least one secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate, wherein the primary valve is preferably operable to any secondary valves because the primary valve is chemically softened to a greater degree than any secondary valves.
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36. A multi-lumen catheter for use in aspirating or infusing fluids to a patient, the multi-lumen catheter comprising:
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a cannula having an outer-wall made of a biocompatible material, the cannula having a distal end and a proximal end and a plurality of internal lumens for transmitting liquids, the internal lumens providing for two-way fluid flow between the proximal end and the distal end of the cannula such that the fluid flow is initiated by the application of a pressure differential to the fluid; a plurality of three-position valves communicating between each of the lumens of the cannula and the exterior of the cannula having edges which abut each other to prevent fluid flow therethrough, the edges moving outwardly from one another upon the application of a positive pressure differential to the lumens to infuse fluids from the lumens, the edges moving inwardly upon the application of a negative pressure differential to the lumen to withdraw fluid from the lumens; and the plurality of valves comprised of a primary valve and a secondary valve, the primary valve constructed to operate at a lower threshold pressure differential than the secondary valve so as to be preferably operable relative to the secondary valve during aspiration or infusion, and the secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate. - View Dependent Claims (37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 70)
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48. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
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a cannula having a distal end and a proximal end and defining a tubular wall providing for fluid flow from the proximal end to the distal end, fluid being initiated by applying a pressure differential at the proximal end of the cannula; and a plurality of multi-positioned valves placed in the wall layers of the cannula near the distal end, each of the plurality of valves enabling fluid flow through the cannula through the valve subject to the differential applied to the proximal end, each of the plurality of valves being configured to reseal such that fluid is prevented from passing through the valve when the pressure differential is terminated, the plurality of valves comprised of a primary valve and a secondary valve, the primary valve constructed to operate at a lower threshold pressure differential than the secondary valve so as to be preferably operable relative to the secondary valve during aspiration or infusion, and the secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate. - View Dependent Claims (49, 50, 51, 52, 53, 54, 55, 56, 58, 59, 60, 61, 62, 63, 65, 66, 67, 68, 69, 71, 72, 73, 74)
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57. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
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a single-lumen cannula having a distal end and a proximal end and defining a tubular wall providing for fluid flow from the proximal end to the distal end, fluid being initiated by applying a pressure differential at the proximal end of the cannula; and a plurality of multi-positioned valves placed in the wall layers of the cannula near the distal end, each of the plurality of valves enabling fluid flow through the cannula through the valve subject to the differential applied to the proximal end, each of the plurality of valves being configured to reseal such that fluid is prevented from passing through the valve when the pressure differential is terminated, the plurality of valves comprised of a primary valve constructed to be preferably operable during aspiration or infusion, and at least one secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate, and wherein the cannula adjacent each valve is chemically softened with silicone in order to provide for the two-way, three-position operation.
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64. A catheter for use in aspirating or infusing fluids to a patient, the catheter comprising:
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a cannula having a distal end and a proximal end and defining a tubular wall providing for fluid flow from the proximal end to the distal end, fluid being initiated by applying a pressure differential at the proximal end of the cannula; and a plurality of multi-positioned valves placed in the wall layers of the cannula near the distal end, each of the plurality of valves enabling fluid flow through the cannula through the valve subject to the differential applied to the proximal end, each of the plurality of valves being configured to reseal such that fluid is prevented from passing through the valve when the pressure differential is terminated, the plurality of valves comprised of a primary valve constructed to be preferably operable during aspiration or infusion, and at least one secondary valve acting as a surrogate to the primary valve should the primary valve fail to operate, and wherein the primary valve is preferably operable to any secondary valves because the primary valve is chemically softened to a greater degree than any secondary valve.
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75. An intravascular catheter for infusing and aspirating fluids in the area surrounding the catheter, the catheter comprising:
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a close-ended single lumen catheter having a distal end and a proximal end and defining a tubular wall which allows an even flow through the lumen of the catheter, the even flow being initiated when a pressure differential is applied to said catheter; and two valves in the walls of the catheter comprised of a material for resealing when the pressure differential is withdrawn, the catheter maintaining a predetermined degree of catheter-tip rigidity to maintain structural integrity while the valves consistently and reproducibly open and close to enable infusion and aspiration, the valves comprised of a single, normally closed, linearly extending slit extending through the catheter wall, one of the two slits being radially and longitudinally displaced from the other slit while still providing structural integrity at the distal end of the catheter, the first of the two valves being a primary valve constructed to be preferably operable during aspiration or infusion, the second of the two valves acting as a surrogate to the primary valve should the primary valve fail to operate, the primary valve being treated to operate at a lower threshold pressure differential relative to the secondary valve so as to be preferably operable to the secondary valve. - View Dependent Claims (76, 77, 78, 79, 80, 81, 82, 83, 85, 86, 87, 88, 89, 91, 92, 93, 94, 95)
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84. An intravascular catheter for infusing and aspirating fluids in the area surrounding the catheter, the catheter comprising:
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a close-ended single lumen catheter having a distal end and a proximal end and defining a tubular wall which allows an even flow through the lumen of the catheter, the even flow being initiated when a pressure differential is applied to said catheter; and two valves in the walls of the catheter comprised of a material for resealing when the pressure differential is withdrawn, the catheter maintaining a predetermined degree of catheter-tip rigidity to maintain structural integrity while the valves consistently and reproducibly open and close to enable infusion and aspiration, the valves comprised of a single, normally closed, linearly extending slit extending through the catheter wall, one of the two slits being radially and longitudinally displaced from the other slit while still providing structural integrity at the distal end of the catheter, the first of the two valves being a primary valve constructed to be preferably operable during aspiration or infusion, the second of the two valves acting as a surrogate to the primary valve should the primary valve fail to operate, the primary valve being treated to be preferably operable to the secondary valve, and wherein the valves are chemically softened with silicone oil.
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90. An intravascular catheter for infusing and aspirating fluids in the area surrounding the catheter, the catheter comprising:
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a close-ended single lumen catheter having a distal end and a proximal end and defining a tubular wall which allows an even flow through the lumen of the catheter, the even flow being initiated when a pressure differential is applied to said catheter; and two valves in the walls of the catheter comprised of a material for resealing when the pressure differential is withdrawn, the catheter maintaining a predetermined degree of catheter-tip rigidity to maintain structural integrity while the valves consistently and reproducibly open and close to enable infusion and aspiration, the valves comprised of a single, normally closed, linearly extending slit extending through the catheter wall, one of the two slits being radially and longitudinally displaced from the other slit while still providing structural integrity at the distal end of the catheter, the first of the two valves being a primary valve constructed to be preferably operable during aspiration or infusion, the second of the two valves acting as a surrogate to the primary valve should the primary valve fail to operate, the primary valve being treated to be preferably operable to the secondary valve, and wherein the primary valve is preferable operable to any secondary valve because the primary valve is chemically softened to a greater degree than any secondary valve.
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Specification