Subcutaneous implant useful in effecting hyperthermic treatment
First Claim
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1. A totally subcutaneous implant for use with an apparatus providing an extracorporeal blood flow path extending from a blood withdrawing percutaneous cannula cooperable with said implant to a blood returning percutaneous cannula cooperable with said implant, which blood flow path has a capacity of maintaining a minimum flow rate of approximately 1 liter per minute, said implant comprising:
- a body of elastomeric material adapted to be implanted totally subcutaneously in a femoral extremity,means in said body defining an arterial passage, a spaced venous passage, and a bypass conduit extending from one end of said arterial passage to one end of said venous passage,an arterial tube of vascular prosthesis material having one end connected in communicating relation with the other end of said arterial passage and an opposite end adapted to be connected with a main femoral artery side wall in communicating relation with the interior of the femoral artery,a venous tube of vascular prosthesis material having one end connected in communicating relation with the other end of said venous passage and an opposite end adapted to be connected with a main femoral vein side wall in communicating relation with the interior of the femoral vein,blood withdrawing percutaneous cannula receiving means in said elastomeric body extending from a position exterior of said elastomeric body inwardly thereof to a position in communicating relation with said arterial passage movable between (1) a closed condition excluding fluid containing space within said body between said two positions so that blood flowing from said arterial tube through said arterial passage will pass therefrom through said bypass conduit into said venous passage and out of said venous tube and (2) an open condition excluding fluid receiving space within said body from the exterior periphery of the portion of a blood withdrawing cannula extending between said two positions which also extends percutaneously and in communicating relation with said arterial passage so that blood flowing from said arterial tube through said arterial passage will flow through said blood withdrawing cannula at a minimum rate of approximately 1 liter per minute and said bypass conduit, andblood returning percutaneous cannula receiving means in said elastomeric body extending from a position exterior of said body inwardly thereof to a position in communicating relation with said venous passage movable between (1) a closed condition excluding fluid containing space within said body between the associated two positions of extent thereof so that blood flowing from said bypass conduit will pass therefrom into said venous passage and out of said venous tube, and (2) an open condition excluding fluid receiving space within said body from the exterior periphery of the portion of a blood returning cannula extending between the associated two positions of extent thereof which blood returning cannula also extends percutaneously and in communicating relation with the venous passage so that said venous passage will receive blood flowing both from said blood returning cannula at a minimum rate of approximately 1 liter per minute and said bypass conduit.
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Abstract
A process of hyperthermic treatment of a patient which comprises the steps of establishing a sterile extracorporeal flow path for blood having an inlet, an outlet and a temperature control zone therebetween, establishing communication of the flow path inlet with the patient'"'"'s bloodstream so that blood can be supplied to the extracorporeal flow path without adversely affecting the blood circulation in the area from which the blood is withdrawn, establishing communication of the flow path outlet with the patient'"'"'s bloodstream so that blood is returned to the bloodstream in such a way as to be distributed systemically, pumping blood withdrawn from the patient'"'"'s bloodstream through the temperature control zone at a controlled rate of at least approximately 1 liter per minute and returning the same to the patient'"'"'s bloodstream to be distributed systemically, controlling the temperature of the blood flowing through the temperature control zone for an initial period during which the temperature level of the blood within the zone is raised without subjecting the same to localized temperatures in excess of approximately 45° C. so that the systemic distribution of the returned blood gradually increases the core temperature of the patient'"'"'s body to a generally stable temperature condition at a level of approximately 41.5° C. but not higher than approximately 42.5° C., and maintaining control of the temperature of the blood flowing through the temperature control zone at the generally stable temperature for a second time period sufficient to effect the desired treatment and apparatus for carrying out the method.
104 Citations
16 Claims
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1. A totally subcutaneous implant for use with an apparatus providing an extracorporeal blood flow path extending from a blood withdrawing percutaneous cannula cooperable with said implant to a blood returning percutaneous cannula cooperable with said implant, which blood flow path has a capacity of maintaining a minimum flow rate of approximately 1 liter per minute, said implant comprising:
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a body of elastomeric material adapted to be implanted totally subcutaneously in a femoral extremity, means in said body defining an arterial passage, a spaced venous passage, and a bypass conduit extending from one end of said arterial passage to one end of said venous passage, an arterial tube of vascular prosthesis material having one end connected in communicating relation with the other end of said arterial passage and an opposite end adapted to be connected with a main femoral artery side wall in communicating relation with the interior of the femoral artery, a venous tube of vascular prosthesis material having one end connected in communicating relation with the other end of said venous passage and an opposite end adapted to be connected with a main femoral vein side wall in communicating relation with the interior of the femoral vein, blood withdrawing percutaneous cannula receiving means in said elastomeric body extending from a position exterior of said elastomeric body inwardly thereof to a position in communicating relation with said arterial passage movable between (1) a closed condition excluding fluid containing space within said body between said two positions so that blood flowing from said arterial tube through said arterial passage will pass therefrom through said bypass conduit into said venous passage and out of said venous tube and (2) an open condition excluding fluid receiving space within said body from the exterior periphery of the portion of a blood withdrawing cannula extending between said two positions which also extends percutaneously and in communicating relation with said arterial passage so that blood flowing from said arterial tube through said arterial passage will flow through said blood withdrawing cannula at a minimum rate of approximately 1 liter per minute and said bypass conduit, and blood returning percutaneous cannula receiving means in said elastomeric body extending from a position exterior of said body inwardly thereof to a position in communicating relation with said venous passage movable between (1) a closed condition excluding fluid containing space within said body between the associated two positions of extent thereof so that blood flowing from said bypass conduit will pass therefrom into said venous passage and out of said venous tube, and (2) an open condition excluding fluid receiving space within said body from the exterior periphery of the portion of a blood returning cannula extending between the associated two positions of extent thereof which blood returning cannula also extends percutaneously and in communicating relation with the venous passage so that said venous passage will receive blood flowing both from said blood returning cannula at a minimum rate of approximately 1 liter per minute and said bypass conduit. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12)
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13. A totally subcutaneous implant for use with an apparatus providing an extracorporeal blood flow path extending from a blood withdrawing percutaneous cannula cooperable with said implant to a blood returning percutaneous cannula cooperable with said implant, said implant comprising:
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a body of elastomeric material adapted to be implanted totally subcutaneously in an extremity, means in said body defining an arterial passage, a spaced venous passage, and a bypass conduit extending from one end of said arterial passage to one end of said venous passage, an arterial tube of vascular prosthesis material having one end connected in communicating relation with the other end of said arterial passage and an opposite end adapted to be connected in communicating relation with the interior of an extremity artery, a venous tube of vascular prosthesis material having one end connected in communicating relation with the other end of said venous passage and an opposite end adapted to be connected in communicating relation with the interior of a vein, means in said elastomeric body extending from a position exterior of said body inwardly thereof to a position in communicating relation with said arterial passage movable between (1) a closed condition excluding fluid containing space within said body between said two positions so that blood flowing from said arterial tube through said arterial passage will pass therefrom through said bypass conduit into said venous passage and out of said venous tube and (2) an open condition excluding fluid receiving space within said body from the exterior periphery of the portion of a blood withdrawing cannula extending between said two positions which also extends percutaneously and in communicating relation with said arterial passage so that blood flowing from said arterial tube through said arterial passage will flow through said blood withdrawing cannula and said bypass conduit, and means in said elastomeric body extending from a position exterior of said body inwardly thereof to a position in communicating relation with said venous passage movable between (1) a closed condition excluding fluid containing space within said body between the associated two positions of extent thereof so that blood flowing from said bypass conduit will pass therefrom into said venous passage and out of said venous tube, and (2) an open condition excluding fluid receiving space within said body from the exterior periphery of the portion of a blood returning cannula extending between the associated two positions of extent thereof which blood returning cannula also extends percutaneously and in communicating relation with the venous passage so that said venous passage will receive blood flowing both from said blood returning cannula and said bypass conduit.
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14. In apparatus providing an extracorporeal blood flow path, the improvement which comprises a totally subcutaneous implant for connection with an artery and a vein of a patient and outlet and inlet assemblies cooperable with said implant for establishing communication with said implant so as to direct blood from the implant to the extracorporeal flow path and blood from the extracorporeal flow path to the implant respectively, each of said outlet and inlet assemblies comprising
an elongated percutaneous cannula having a subcutaneous end portion and an extracorporeal end portion, said subcutaneous end portion providing an exterior periphery having a cross-sectional configuration elongated in one direction with sharp points defining opposite ends thereof in the direction of elongation, said cannula having an interior passage extending from the extracorporeal end portion thereof to the extremity of said subcutaneous end portion and an elongated trocar including a pointed end, said trocar having an exterior periphery extending from said pointed end of a shape to enable said trocar (1) to be inserted pointed end first through said interior passage of said cannula in a direction and to an extent sufficient to position the pointed end thereof outwardly of the extremity of said subcutaneous end portion thereof and (2) to be withdrawn from said interior passage in the opposite direction, said implant comprising a body of elastomeric material adapted to be implanted totally subcutaneously in an extremity, means in said body defining an arterial passage, a spaced venous passage, and a bypass conduit extending from one end of said arterial passage to one end of said venous passage, an arterial tube of vascular prosthesis material having one end connected in communicating relation with the other end of said arterial passage and an opposite end adapted to be connected in communicating relation with the interior of an extremity artery, a venous tube of vascular prosthesis material having one end connected in communicating relation with the other end of said venous paassage and an opposite end adapted to be connected in communicating relation with the interior of a vein, outlet valving slit means in said elastomeric body extending from a position exterior of said body inwardly thereof to a position in communicating relation with said arterial passage movable between (1) a closed condition in self-sealing relation so that blood flowing from said arterial tube through said arterial passage passes therefrom through said bypass conduit into said venous passage and out of said venous tube and (2) an open condition in sealingly engaged relation with the exterior periphery of the portion of the cannula of said outlet assembly extending between said two positions which also extends percutaneously and in communicating relation with said arterial passage so that blood flowing from said arterial tube through said arterial passage will flow through said outlet assembly cannula and said bypass conduit, and inlet valving slit means in said elastomeric body extending from a position exterior of said body inwardly thereof to a position in communicating relation with said venous passage movable between (1) a closed condition in self-sealing relation so that blood flowing from said bypass conduit will pass therefrom into said venous passage and out of said venous tube, and (2) an open condition in sealingly engaged relation with the portion of the cannula of said inlet assembly extending between the associated two positions of extent thereof which inlet assembly cannula also extends percutaneously and in communicating relation with the venous passage so that said venous passage will receive blood flowing both from said inlet assembly cannula and said bypass conduit.
Specification
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Current AssigneeResearch Against Cancer Incorporated
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Original AssigneeResearch Against Cancer Incorporated
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InventorsParks, Leon C.
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Primary Examiner(s)Thaler, Michael H.
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Application NumberUS06/212,750Time in Patent Office1,426 DaysField of Search128/214 R, 128/214.4, 128/214 B, 128/347, 128/348, 128/DIG. 26, 128/399, 604/4, 604/175US Class Current604/175CPC Class CodesA61M 1/3655 Arterio-venous shunts or fi...A61M 1/369 Temperature treatmentA61M 2205/3606 cooledA61M 2205/366 by liquid heat exchangers
