Claims for Patent: 5,120,316

Summary for Patent: 5,120,316

Title:	Urethral catheter and catheterization process
Abstract:	A device for delivering medication into a human body, comprising a catheter having proximate and distal ends, and first and second lumina extending substantially the entire length of the catheter. A first opening in the catheter near its distal end drains fluid from a body when the catheter is inserted therein. There is a second opening in the catheter between the first opening and the distal end of the catheter. The second opening is fluidly connected with the second lumen. A diaphragm is located adjacent to the second opening for blocking off the second opening from the second lumen, and the diaphragm is burstable by a predetermined pressure for unblocking the second opening for fluidly connecting it with the second lumen. Thus, medications can be safely administered without the possibility of premature contact of the medication with the body. The catheter is particularly well suited to the administration of toxic substances such as BCG vaccine into the bladder of bladder cancer patients.
Inventor(s):	Morales; Alvaro (Kingston, CA), Hanna, Jr.; Michael G. (Frederick, MD)
Assignee:	Akzo N.V. (Arnhem, NL)
Application Number:	07/589,721
Patent Claims:	1. A device for delivering medication into a human body, comprising: a catheter having proximate and distal ends; a lumen extending substantially the entire length of said catheter; means defining an opening in said catheter near said distal end, said opening being fluidly connected to said lumen for administering fluid to a body when said catheter is inserted therein; and a diaphragm disposed in said opening for blocking off said opening from said lumen, and said diaphragm being burstable by a predetermined pressure for unblocking said lumen for fluidly connecting said opening with said lumen. 2. A device as defined in claim 1, wherein said diaphragm includes means for causing said diaphragm to distend before bursting by the predetermined pressure. 3. A device as defined in claim 1, wherein said diaphragm is disposed in said lumen and spaced from said opening. 4. A device as defined in claim 1, wherein groove means is disposed on said diaphragm for causing said diaphragm to burst in a controlled manner by the predetermined pressure. 5. A device as defined in claim 1, wherein said diaphragm is burstable by a pressure less than the pressure required for causing said diaphragm to distend within a human urethra. 6. A device as defined in claim 1, further comprising a balloon disposed at said distal end, and means for inflating said balloon for anchoring said catheter in a human bladder. 7. A device for delivering medication into a human body, comprising: a catheter having proximate and distal ends; first and second lumina extending substantially the entire length of said catheter; means defining a first opening in said catheter near said distal end, said first opening being fluidly connected to said first lumen for draining fluid from a body when said catheter is inserted therein; means defining a second opening in said catheter between said first opening and said distal end of said catheter, and said second opening being fluidly connected with said second lumen; and a diaphragm disposed in said second opening for blocking off said second opening from said second lumen, and said diaphragm being burstable by a predetermined pressure for unblocking said second lumen for fluidly connecting said second opening with said second lumen. 8. A device as defined in claim 7, wherein said diaphragm includes means for causing said diaphragm to distend before bursting by the predetermined pressure. 9. A device as defined in claim 7, wherein said diaphragm is disposed in said second lumen and spaced from said second opening. 10. A device as defined in claim 7, wherein groove means is disposed on said diaphragm for causing said diaphragm to burst in a controlled manner by the predetermined pressure. 11. A device as defined in claim 7, wherein said diaphragm is burstable by a pressure less than the pressure required for causing said diaphragm to distend within a human urethra. 12. A device as defined in claim 7, further comprising a balloon disposed at said distal end, and means for inflating said balloon for anchoring said catheter in a human bladder. 13. A method of delivering concentrated bacillus Calmette-Guerin (BCG) vaccine into the bladder of bladder cancer patients for treating bladder cancer, said method comprising: inserting a urethral catheter having a lumen extending substantially the entire length thereof through the urethra into the bladder; and applying a pressure for bursting a diaphragm disposed in and blocking the lumen for causing BCG to be administered into the bladder only after the diaphragm has been ruptured. 14. A method as defined in claim 13, wherein said pressure applying step comprises applying the pressure at a level that prevents distension and rupturing of the diaphragm when the diaphragm is in the urethra. 15. A method of delivering concentrated bacillus Calmette-Guerin (BCG) vaccine into the bladder of bladder cancer patients for treating bladder cancer, said method comprising: inserting a urethral catheter having proximate and distal ends, said urethral catheter including: first and second lumina extending substantially the entire length of said catheter; means defining a first opening in said catheter near said distal end, said first opening being fluidly connected to said first lumen for draining fluid from a body when said catheter is inserted therein; means defining a second opening in said catheter between said first opening and said distal end of said catheter, and said second opening being fluidly connected with said second lumen; and a diaphragm disposed adjacent to said second opening for blocking off said second opening from said second lumen, and said diaphragm being burstable by a predetermined pressure for unblocking said second lumen for fluidly connecting said second opening with said second lumen through the urethra into the bladder; applying a pressure sufficient to distend and burst the diaphragm; closing the first lumen; and introducing BCG vaccine through the second lumen, wherein the first lumen is closed before introducing BCG vaccine in order to prevent premature leakage of BCG vaccine. 16. A method as defined in claim 15, wherein said pressure applying step comprises applying the pressure at a level that prevents distension and rupturing of the diaphragm when the diaphragm is in the urethra.

Details for Patent 5,120,316

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Teknika Llc	TICE BCG	bcg live	For Injection	102821	06/21/1989		2040-01-28
Merck Teknika Llc	N/A	bcg vaccine	For Injection	103050	06/21/1989		2040-01-28