Claims for Patent: 8,123,789

Summary for Patent: 8,123,789

Title:	Central nervous system cooling catheter
Abstract:	The invention provides a method and apparatus for performing selective hypothermia to the brain and spinal cord for injury protection without the need for systemic cooling. A flexible catheter is inserted into the cerebral lateral ventricle or spinal subdural space. The catheter has lumens with a heat transfer element. The lumens of the catheter circulate a coolant and communicate at the distal heat transfer element for transfer of heat from the cerebrospinal fluid. Furthermore a method of maintaining catheter patency and providing blood clot hemolysis and drainage is also provided through the use of ultrasonic and/or laser energy delivered through the catheter.
Inventor(s):	Khanna; Rohit (Daytona Beach, FL)
Assignee:
Application Number:	11/418,849
Patent Claims:	1. A method of cooling the central nervous system wherein a heat exchange catheter is inserted into the central nervous system and a coolant is circulated through the catheter to transfer heat from the surrounding area to the coolant wherein the catheter comprises; i) an elongate flexible catheter with a proximal and distal end, ii) a lumen which is split into two halves by a longitudinal wall which communicates at the distal end, iii) an expandable thermal conductor located at the distal end of the catheter allowing transfer of heat between the said heat exchanger and its surroundings; iv) circulating a coolant with temperature below the body temperature through the lumen, thereby transferring heat from the central nervous system to the coolant. 2. The method of claim 1 wherein, said expandable thermal conductor comprises a balloon. 3. The method of claim 1 wherein, the said central nervous system consists of one or more of the following locations: cerebrospinal fluid, subarachnoid, subdural, epidural, ventricle, cerebral, spinal. 4. The method of claim l wherein, the said catheter is impregnated with antimicrobial and/or anti-clotting agents comprising of one or more of the following: antibiotics, antifungal, iodine, metals, polymeric material, antibodies, anticoagulant, anti-platelet, thrombolytic, chlorhexidine gluconate, anti-inflammatory. 5. The method of claim 1 wherein, the said catheter also delivers ultrasonic and/or laser energy. 6. The method of claim 1, further comprising the act of securing a catheter to the skull with: a T-shaped bolt with a lumen for the catheter and threads at the proximal and distal ends; the distal end of the bolt secures to the skull through a hole drilled into the skull; the proximal end of the bolt secures an outer sleeve; the proximal bolt end also comprising of slits that compress and nanow the lumen and secure the catheter once the outer sleeve is tightened. 7. A method of cooling the central nervous system wherein a heat exchange catheter device is inserted into the central nervous system, a coolant is circulated through the catheter to transfer heat from the surrounding area to the coolant; a portion of the catheter capable of expanding; the catheter also comprising another lumen to drain fluid. 8. The method of claim 7 wherein, the heat exchange catheter device comprises; i) an elongate flexible catheter with a proximal and distal end, ii) two lumens which communicate at the distal catheter end and circulate the coolant, thereby transferring heat from the central nervous system to the coolant, iii) a heat exchanger balloon located at the distal end of the catheter which expands when the coolant is circulated, iv) a third lumen with several holes at the distal end that communicate with the external catheter environment and allow for fluid drainage and pressure monitoring. 9. The method of claim 7 wherein, the heat exchange catheter device comprises; i) an elongate flexible catheter with a proximal and distal end, ii) an inner and an outer lumen, iii) the inner lumen of the catheter communicates with the external catheter environment through several holes at the distal end, iv) the outer lumen is split in the center into two halves by a longitudinal wall which connect at the distal catheter end; v) circulating the coolant through the outer lumen, thereby transferring heat from the central nervous system to the coolant. 10. The method of claim 7 wherein, the heat exchange catheter device comprises; i) an elongate flexible catheter with a proximal and distal end, ii) an inner and an outer lumen, iii) the inner lumen of the catheter communicates with the external catheter environment through several holes at the distal end, iv) the outer lumen is split in the center into two halves by a longitudinal wall which connect at the distal catheter end; v) a thermal conductor located at the distal end of the catheter allowing transfer of heat between the said heat exchange catheter and its surroundings; vi) circulating the coolant through the outer lumen, thereby transferring heat from the central nervous system to the coolant. 11. The method of claim 7 wherein, the said central nervous system consists of one or more of the following locations: cerebrospinal fluid, subarachnoid, subdural, epidural, ventricle, cerebral, spinal. 12. The method of claim 7 wherein, the said catheter also delivers ultrasonic and/or laser energy. 13. The method of claim 7 wherein, the said catheter is impregnated with antimicrobial and/or anti-clotting agents comprising of one or more of the following: antibiotics, antifungal, iodine, metals, polymeric material, antibodies, anticoagulant, anti-platelet, thrombolytic, chlorhexidine gluconate, anti-inflammatory. 14. A method of cooling the central nervous system wherein a heat exchange catheter is inserted into the central nervous system; a coolant is circulated through the catheter to transfer heat from the surrounding area to the coolant; the catheter also comprising another lumen to drain fluid and a delivery means to maintain catheter lumen patency. 15. The method of claim 14 wherein, the said delivery means to maintain catheter patency is through ultrasound energy delivered through the catheter to dissolve blood clots. 16. The method of claim of claim 15, wherein said ultrasound energy delivery being through one or more of the following: i) an ultrasound transducer embedded in the catheter wall, ii) an ultrasound transducer in the lumen of the catheter which may be removable, iii) ultrasound energy generated outside the catheter and delivered to the catheter through a conductor, iv) an ultrasound transducer in the catheter with a distal amplifier, v) an ultrasound conductor in the catheter with a distal amplifier. 17. The method of claim 14 wherein, the said delivery means to maintain catheter patency is through a combination of ultrasound and laser energy delivered through the catheter to dissolve blood clots and debris. 18. The method of claim 17, wherein said ultrasound and laser energy being delivered through one or more of the following: i) optical fibers in the catheter wall and ultrasound transducer in the lumen, ii) optical fibers and ultrasound transducer embedded in the catheter wall, iii) ultrasound transducer in the catheter wall and optical fibers in the lumen. 19. The method of claim 14 wherein, the said means to maintain catheter patency is through a combination of ultrasound and laser energy delivered through the catheter to dissolve blood clots and debris and a suction device to facilitate drainage through the said another lumen to drain fluid. 20. The method of claim 14 wherein, the said catheter wall is impregnated with antimicrobial and/or anti-clotting agents comprising of one or more of the following: antibiotics, antifungal, iodine, metals, polymeric material, antibodies, anticoagulant, anti-platelet, thrombolytic, chlorhexidine gluconate, anti-inflammatory. 21. The method of claim 14 wherein, the said means to maintain catheter patency is through ultrasound and/or laser energy delivered through the catheter to dissolve blood clots and debris; blood clot dissolution further facilitated by one or more of the following agents infused through the said lumen to drain fluid: i) thrombolytics like streptokinase, urokinase, prourokinase, ancrod, tissue plasminogen activators (alteplase, anistreplase, tenecteplase, reteplase, duteplase), ii) hemolytic agents, iii) antiplatelet agents like aspirin, ticlopidine, clopidogrel, dipyridamole, iv) anticoagulants like heparin and coumadin. 22. The method of claim 14, further comprising the act of securing a catheter to the skull with: a T-shaped bolt with a lumen for the catheter and threads at the proximal and distal ends; the distal end of the bolt secures to the skull through a hole drilled into the skull; the proximal end of the bolt secures an outer sleeve; the proximal bolt end also comprising of slits that compress and narrow the lumen and secure the catheter once the outer sleeve is tightened. 23. The method of claim 14 wherein, the said means to maintain catheter patency is through photonic or electromagnetic energy delivered through a catheter laser system to dissolve blood clots and debris in the catheter lumen and ports. 24. The method of claim 23, wherein said photonic or electromagnetic energy delivery being through one or more of the following; i) optical fibers in the catheter wall coupled to a laser source at the proximal end, ii) optical fibers in the catheter lumen coupled to a laser source which may be removable. 25. The method of claim 7, further comprising the act of securing a catheter to the skull with: a T-shaped bolt with a lumen for the catheter and threads at the proximal and distal ends; the distal end of the bolt secures to the skull through a hole drilled into the skull; the proximal end of the bolt secures an outer sleeve; the proximal bolt end also comprising of slits that compress and narrow the lumen and secure the catheter once the outer sleeve is tightened.

Details for Patent 8,123,789

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Microbix Biosystems Inc.	KINLYTIC	urokinase	For Injection	021846	01/16/1978		2022-12-20
Genentech, Inc.	ACTIVASE	alteplase	For Injection	103172	11/13/1987		2022-12-20
Genentech, Inc.	CATHFLO ACTIVASE	alteplase	For Injection	103172	09/04/2001		2022-12-20
Chiesi Usa, Inc.	RETAVASE	reteplase	For Injection	103786	10/30/1996		2022-12-20