US6527798B2 — Method and apparatus for regional and whole body …

Claim 1

Independent Claim 288 words

A catheter device which is insertable into an anatomical structure of a mammalian patient through which body fluid may flow to a target region of the patient, said catheter device being operative to effect in situ heat exchange with the body fluid to effect temperature alteration of the target region, said catheter device comprising: an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end; at least one fluid lumen in through which said thermal exchange fluid may be circulated; a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter; a body-fluid channeling sleeve formed about a segment of said catheter including the first location at which at least a portion of said heat exchanger is located, said body fluid channeling sleeve defining a body fluid flow space between said body fluid channeling sleeve and said catheter, said body fluid channeling sleeve having a body fluid inlet located proximal to the heat exchanger and a body fluid outlet located distal to at least a portion of said heat exchanger, such that body fluid will enter the flow space through said body fluid inlet, will then flow through said flow space in heat exchange proximity to at least a portion of said heat exchanger, and then out of said body fluid outlet and to a conduit in fluid communication with said target region of the patient's body.

Claim 2

Dependent Claim 288 words

A catheter device which is insertable into an anatomical structure of a mammalian patient through which body fluid may flow to a target region of the patient, said catheter device being operative to effect in situ heat exchange with the body fluid to effect temperature alteration of the target region, said catheter device comprising: an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end; at least one fluid lumen in through which said thermal exchange fluid may be circulated; a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter; a body-fluid channeling sleeve formed about a segment of said catheter including the first location at which at least a portion of said heat exchanger is located, said body fluid channeling sleeve defining a body fluid flow space between said body fluid channeling sleeve and said catheter, said body fluid channeling sleeve having a body fluid inlet located proximal to the heat exchanger and a body fluid outlet located distal to at least a portion of said heat exchanger, such that body fluid will enter the flow space through said body fluid inlet, will then flow through said flow space in heat exchange proximity to at least a portion of said heat exchanger, and then out of said body fluid outlet and to a conduit in fluid communication with said target region of the patient's body.

Claim 3

Dependent Claim 173 words

The catheter device of claim 1 for controlling the temperature of a target region of the patient's body to which a body fluid is flowing through a first anatomical conduit of a first diameter, and wherein said first anatomical conduit is connected to and in fluid communication with a second anatomical conduit of a second diameter larger than said first diameter, wherein said body-fluid channeling sleeve has a distal portion and a proximal portion, said body fluid outlet located on said distal portion and said body fluid inlet located on said proximal portion, said distal. portion is sized to be advanced into said first anatomical conduit while said proximal portion remains positioned within the second anatomical conduit, such that body fluid from said second anatomical conduit will enter the flow space through said body fluid inlet, will then flow through said flow space in heat exchange proximity to said heat exchanger, and then out of said body fluid outlet into said first conduit and thus to said target region of the patient's body.

Claim 4

Dependent Claim 35 words

A catheter device as in claim 2 wherein the cross-sectional diameter of said distal portion of the blood channeling sleeve is smaller than the cross-sectional diameter of said proximal portion of the blood channeling sleeve.

Claim 5

Dependent Claim 54 words

A catheter device as in claim 2 wherein said distal portion has a shoulder formed thereon, said shoulder sized and configured to fit snugly within said anatomical conduit such that substantially all flow of said body fluid from said second anatomical conduit to said first anatomical conduit flows through said body fluid channeling sleeve.

Claim 6

Dependent Claim 33 words

The catheter device of claim 1 wherein the heat exchanger comprises: at least one balloon through which said thermal exchange fluid is circulated, and said heat exchange fins comprise a plurality of lobes.

Claim 7

Dependent Claim 22 words

The catheter device of claim 1 wherein said at least one heat exchange fin comprises at least one outwardly extending longitudinal fin.

Claim 8

Dependent Claim 22 words

The catheter device of claim 1 wherein said at least one heat exchange fin comprises at least one outwardly extending annular fin.

Claim 9

Dependent Claim 22 words

The catheter device of claim 1 wherein said at least one heat exchange fin comprises at least one outwardly extending helical fin.

Claim 10

Dependent Claim 21 words

The catheter device of claim 1 wherein said at least one heat exchange fin comprises a plurality of outwardly extending protuberances.

Claim 11

Dependent Claim 54 words

The catheter device of claim 1 , said catheter further comprising an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end; and a working lumen, said working lumen extending through at least part of said insertion portion.

Claim 12

Dependent Claim 24 words

A system comprising the catheter device of claim 10 further in combination with: a guide wire sized to be passable through said working lumnen.

Claim 13

Dependent Claim 24 words

A system comprising the catheter device of claim 10 further in combination with: an apparatus for infusion of a medicament through said working lumen.

Claim 14

Dependent Claim 59 words

The system of claim 12 wherein s aid apparatus for infusion contains a medicament selected from the group of medicaments consisting of: a thrombolytic agent; an anticoagulant; a neuro-protectant; a barbiturate; an anti-seizure agent; an oxygenated perfusate; a vaso-dilator; an agent which prevents vaso-spasm; an agent to prevent platelet activation; and, an agent to deter the adhesion of platelets.

Claim 15

Dependent Claim 23 words

A system comprising the catheter device of claim 10 further in combination with: a diagnostic probe which is passable through said working lumen.

Claim 16

Dependent Claim 34 words

A system as in claim 14 wherein said diagnostic probe is selected from the group consisting of: an angiographic catheter; a temperature sensor; a pressure sensor; a blood gas sensor; and an enzyme sensor.

Claim 17

Dependent Claim 44 words

A system comprising the catheter device of claim 10 further in combination with: an apparatus for infusion of a radiographic contrast agent through said working lumen; and, an imaging apparatus for imaging the radiographic contrast agent which has been infused through said working lumen.

Claim 18

Dependent Claim 23 words

A system comprising the catheter device of claim 10 further in combination with a therapeutic apparatus which is passable through said working lumen.

Claim 19

Dependent Claim 41 words

The system of claim 17 wherein said therapeutic apparatus is selected from the group of therapeutic apparatus consisting of: an angioplasty catheter; an embolectomy catheter; an occlusion member delivering catheter; an embolization member delivering catheter; an electro-cautery device; and, a microcatheter.

Claim 20

Dependent Claim 65 words

A catheter device as in claim 1 wherein said body fluid inlet is provided with valves, said valves operable between an open condition and a closed condition, said open condition permitting flow of body fluid into said blood channeling sleeve through said body fluid inlet, said closed condition preventing the flow of body fluid out of said blood channeling sleeve through said body fluid inlet.

Claim 21

Dependent Claim 73 words

A catheter device as in claim 1 wherein said catheter has a distal shaft portion, said distal shaft portion extending from within said blood channeling sleeve distal of said blood channeling sleeve, said distal shaft portion having a central lumen there through, said central lumen in fluid communication with said flow space at a first location and in fluid communication with said conduit in communication with said target region at a second location.

Claim 22

Dependent Claim 23 words

A catheter device as in claim 20 wherein said blood channeling sleeve is sealed around said distal shaft distal of said first location.

Claim 23

Dependent Claim 180 words

A catheter device for placement in a fluid containing portion of the body of a mammalian patient to effect in situ heat exchange, said catheter device comprising: an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end; said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end; a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter, said heat exchanger being curved and having an outer surface along its outer radius of curvature, and having an inner surface along its inner radius of curvature, said outer surface and said inner surface having substantially different thermal transmissivity.

Claim 24

Dependent Claim 180 words

A catheter device for placement in a fluid containing portion of the body of a mammalian patient to effect in situ heat exchange, said catheter device comprising: an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end; said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end; a heat exchanger located at a first location on the catheter, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter, said heat exchanger being curved and having an outer surface along its outer radius of curvature, and having an inner surface along its inner radius of curvature, said outer surface and said inner surface having substantially different thermal transmissivity.

Claim 25

Dependent Claim 20 words

A catheter device as in claim 22 wherein the upper surface is substantially more thermally transmissive than said lower surface.

Claim 26

Dependent Claim 41 words

A catheter device as in claim 23 sized and configured for placement along the curve of the aortic arch of a human patient such that blood flowing to the head region will pass in heat transfer proximity to the upper surface.

Claim 27

Independent Claim 117 words

A system for controllably affecting the temperature of a patient, said system comprising: a catheter device comprising an elongated flexible catheter having a proximal end, a distal end, and a heat exchanger operative to exchange heat between body fluid flowing in heat exchange proximity to said heat exchanger and heat exchanger fluid circulating through said heat exchanger, a plurality of sensors that sense data from the patient, said data from at least one of said sensors including body temperature, and a controller unit for receiving said signals from said sensor and controlling the operation of said catheter device to achieve and maintain a target body temperature in response to data from at least one of said sensors.

Claim 28

Independent Claim 117 words

A system for controllably affecting the temperature of a patient, said system comprising: a catheter device comprising an elongated flexible catheter having a proximal end, a distal end, and a heat exchanger operative to exchange heat between body fluid flowing in heat exchange proximity to said heat exchanger and heat exchanger fluid circulating through said heat exchanger, a plurality of sensors that sense data from the patient, said data from at least one of said sensors including body temperature, and a controller unit for receiving said signals from said sensor and controlling the operation of said catheter device to achieve and maintain a target body temperature in response to data from at least one of said sensors.

Claim 29

Dependent Claim 27 words

A system as in claim 25 , further comprising a heat exchange unit, said heat exchange unit being operative to exchange heat with sad heat exchange fluid.

Claim 30

Dependent Claim 16 words

A system as in claim 26 wherein said heat exchange unit comprises a solid-state thermoelectric cooler.

Claim 31

Dependent Claim 29 words

A system as in claim 26 wherein said target parameter is a temperature, the sensor is a temperature sensor and said controller is operable to activate said heating unit.

Claim 32

Dependent Claim 24 words

A system as in claim 25 , further comprising a plurality of catheter devices, said controller operable to control each of said catheter devices.

Claim 33

Dependent Claim 38 words

A system as in claim 29 wherein at least one catheter device imparts heat to said body fluid at a first location, and at least one catheter device removes heat from said body fluid at a second location.

Claim 34

Independent Claim 227 words

A system for controllably affecting the temperature of a patient, said system comprising: a plurality of catheter devices each comprising an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end, said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end, a heat exchanger located at a first location on the catheter, said heat exchanger having heat exchange fins extending from the surface of said heat exchanger, said heat exchange fins comprising increased surface area for enhanced heat exchange, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter; a plurality of sensors each of which senses data from the patient and generates a signal in response thereto; a manual input whereby an operator may specify a target parameter; a controller unit for receiving the signals from the sensors and said target parameter, and controlling the operation of each of said catheter devices in response to said signals and in relation to said target parameter.

Claim 35

Independent Claim 227 words

A system for controllably affecting the temperature of a patient, said system comprising: a plurality of catheter devices each comprising an elongate flexible catheter having a proximal end and a distal end, the entire length of said flexible catheter being defined as the distance from its proximal end to its distal end, said flexible catheter having an insertion portion, said insertion portion for insertion into the patient, said insertion portion extending from the distal end to a point short of the proximal end, a heat exchanger located at a first location on the catheter, said heat exchanger having heat exchange fins extending from the surface of said heat exchanger, said heat exchange fins comprising increased surface area for enhanced heat exchange, said heat exchanger being operative to exchange heat between body fluid in heat exchange proximity to said heat exchanger and heat exchange fluid circulating through said heat exchanger, said first location extending less than the entire length of the catheter; a plurality of sensors each of which senses data from the patient and generates a signal in response thereto; a manual input whereby an operator may specify a target parameter; a controller unit for receiving the signals from the sensors and said target parameter, and controlling the operation of each of said catheter devices in response to said signals and in relation to said target parameter.

Claim 36

Dependent Claim 27 words

A system as in claim 31 , further comprising a heat exchange unit, said heat exchange unit being operative to exchange heat with the heat exchange fluid.

Claim 37

Dependent Claim 16 words

A system as in claim 32 wherein said heat exchange unit comprises a solid-state thermoelectric cooler.

Claim 38

Dependent Claim 29 words

A system as in claim 32 wherein said target parameter is a temperature, the sensors comprise temperature sensors and the controller is operable to activate the heat exchange unit.

Claim 39

Dependent Claim 42 words

A system as in claim 31 wherein at least one of the catheter devices imparts heat to said body fluid at a first location and at least one of the catheter devices removes heat from said body fluid at a second location.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2006-03-03	2006-09-02	2007-03-04	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2010-03-03	2010-09-02	2011-03-04	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2014-03-03	2014-09-02	2015-03-04	$7700.00	Window Closed / Lapsed

Method and apparatus for regional and whole body temperature modification

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