Claims for Patent: 8,323,270

Summary for Patent: 8,323,270

Title:	Enhanced method for delivering bevacizumab (avastin) into a brain tumor using an implanted magnetic breather pump
Abstract:	A magnetically controlled pump is implanted into the brain of a patient and delivers a plurality of medicating agents mixed with Avastin at a controlled rate corresponding to the specific needs of the patient. The current invention comprises a flexible double walled pouch that is formed from two layers of polymer. The pouch is alternately expanded and contracting by magnetic solenoid. When contracted, the medicating agent Avastin is pushed out of the pouch through a plurality of needles. When the pouch is expanded, surrounding cerebral fluid is drawn into the space between the double walls of the pouch from which it is drawn through a catheter to an analyzer. In cases where a tumor resection is not performed, an intratumoral catheter will be implanted. Cerebral fluid drawn from the patient is analyzed. The operation of the apparatus and hence the treatment is remotely controlled based on these measurements and displayed through an external controller.
Inventor(s):	Shachar; Yehoshua (Santa Monica, CA), Chen; Thomas C. (La Canada, CA), Farkas; Leslie (Ojai, CA), Marx; Bruce (Ojai, CA), Johnson; David (West Hollywood, CA), Farkas; Laszlo (Ojai, CA)
Assignee:	Pharmaco-Kinesis Corporation (Inglewood, CA)
Application Number:	12/581,770
Patent Claims:	1. A method for delivering Avastin into a brain tumor in a patient comprising: surgically implanting a cranium pump beneath the skull and dura of the patient's brain into a treatment site; coupling the cranium pump to an analyzer unit via a fluid exchange catheter; operating the cranium pump within the brain of the patient in order to infuse Avastin to the treatment site under control of the analyzer unit; suctioning in a sample of cerebral fluid from the treatment site and transferring it to the analyzer unit; tracking and monitoring the progress of the patient's treatment via the analyzer unit; altering and changing the patient's treatment proactively by controlling the analyzer unit via an external controller communicated to the analyzer unit by an RF link, the external controller allowing proactive alteration of a delivery schedule of Avastin to the brain of the patient by the cranium delivery pump based on measurements of a plurality of tumor parameters obtained from the cranium delivery pump and quantified by the analyzer unit; displaying the tumor parameter measurements on a display coupled to the external controller; and refilling and replacing a reservoir of Avastin located in the analyzer unit, wherein suctioning the sample of the patient's cerebral fluid further comprises suctioning the sample cerebral fluid at a variable rate into an intra-membrane reservoir defined between an outer and inner membrane in the cranium pump by the oscillation of a magnetic solenoid and a plurality of pores defined within the surface of the outer membrane and around each distal tip of a plurality of hollow needles coupled to the inner membrane. 2. The method of claim 1 where operating the cranium pump comprises: contracting and expanding a plurality of hollow needles fluidly coupled to an inner membrane reservoir in the cranium pump by oscillation of a magnetic solenoid; extending the plurality of hollow needles through an outer membrane and an intra-membrane reservoir defined between the outer membrane and inner membrane reservoir when the inner membrane reservoir is being expanded; retracting the plurality of hollow needles through the outer membrane and the intra-membrane reservoir defined between the outer membrane and the inner membrane reservoir when the inner-membrane reservoir is being contracted such that the distal ends of the plurality of hollow needles do not retract past the outer membrane; and preventing any fluid communication between the inner membrane reservoir and the intra-membrane reservoir. 3. The method of claim 1 where tracking and monitoring the progress of the patient's treatment further comprises passing the sample of cerebral fluid through a lab-on-a-chip in the analyzer unit. 4. The method of claim 3 where passing the sample of cerebral fluid through a lab-on-a-chip further comprises measuring the effectiveness of intratumoral Avastin administration with the lab-on-a-chip. 5. The method of claim 4 where measuring the effectiveness of intratumoral Avastin administration further comprises displaying the results obtained from the lab-on-a-chip on a display. 6. The method of claim 1 further comprising providing a preoperative simulation of the infusion of Avastin and other intratumoral infusates to maximize efficiency and minimize toxicity by means of a diffusion model. 7. The method of claim 1 where altering and changing the patient's treatment by controlling the analyzer unit further comprises entering command functions and data into the analyzer unit from a remote keypad and displaying the commands on a display. 8. The method of claim 7 where altering and changing the patient's treatment by controlling the analyzer unit further comprises sending command functions and data to the analyzer unit by means of a wireless transceiver and antenna. 9. The method of claim 1 where refilling and replacing the reservoir of Avastin located in the analyzer unit further comprises refilling and replacing at least four drug ampoules coupled to the analyzer unit, wherein at least one of the four drug ampoules is for Avastin only. 10. A method for delivering Avastin into a brain tumor in a patient comprising: surgically implanting a multidelivery catheter beneath the skull and dura of the patient's brain into a treatment site; coupling the multidelivery catheter to an analyzer unit; operating the multidelivery catheter within the brain of the patient in order to infuse Avastin to the treatment site under control of the analyzer unit; suctioning in a sample of cerebral fluid from the treatment site and transferring it to the analyzer unit; tracking and monitoring the progress of the patient's treatment via the analyzer unit; altering and changing the patient's treatment by controlling the analyzer unit via an external controller communicated to the analyzer unit by an RF link, the external controller allowing proactive alteration of a delivery schedule of medicating agents to the brain of the patient by the cranium delivery pump based on measurements of a plurality of tumor parameters obtained from the cranium delivery pump and quantified by the analyzer unit; displaying the tumor parameter measurements on a display coupled to the external controller; and refilling and replacing a reservoir of Avastin located in the analyzer unit, wherein suctioning the sample of the patient's cerebral fluid further comprises suctioning the sample cerebral fluid at a variable rate into an intra-membrane reservoir defined between an outer and inner membrane of an inflatable balloon by the inflation and contraction of the inflatable balloon and a plurality of pores defined within the surface of the outer membrane and around each distal tip of a plurality of hollow needles coupled to the inner membrane. 11. The method of claim 10 where tracking and monitoring the progress of the patient's treatment via the analyzer unit further comprises displaying the amount of Avastin dispensed over time by the multidelivery catheter within the treatment site. 12. The method of claim 10 where tracking and monitoring the progress of the patient's treatment further comprises passing the sample of cerebral fluid through a lab-on-a-chip in the analyzer unit. 13. The method of claim 12 where passing the sample of cerebral fluid through a lab-on-a-chip further comprises measuring the effectiveness of intratumoral Avastin administration with the lab-on-a-chip. 14. The method of claim 13 where measuring the effectiveness of intratumoral Avastin administration further comprises displaying the results obtained from the lab-on-a-chip on a display. 15. The method of claim 10 further comprising providing a preoperative simulation of the infusion of Avastin and other intratumoral infusates to maximize efficiency and minimize toxicity by means of a diffusion model. 16. The method of claim 10 where altering and changing the patient's treatment by controlling the analyzer unit further comprises entering command functions and data into the analyzer unit from a remote keypad and displaying the commands on a display. 17. The method of claim 16 where altering and changing the patient's treatment by controlling the analyzer unit further comprises sending command functions and data to the analyzer unit by means of a wireless transceiver and antenna. 18. The method of claim 10 where refilling and replacing the reservoir of Avastin located in the analyzer unit further comprises refilling and replacing at least four drug ampoules coupled to the analyzer unit, wherein at least one of the four drug ampoules is for Avastin only.

Details for Patent 8,323,270

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2039-02-26