Claims for Patent: 10,328,177

Summary for Patent: 10,328,177

Title:	Intracorporal ultra high purity calcium sulfate cast mixed with antimicrobials for the treatment of penile implant infections
Abstract:	The present invention includes a method for treating penile implant infections that uses a synthetic high-purity calcium sulfate mixed with antimicrobials, which is capable of providing prolonged exposure of antimicrobials to the infection site and capable of acting as an intracorporal filler preventing fibrosis and loss of phallic length. The technique is especially useful for high-risk patients, and provides another medium for which antimicrobial agents can be delivered to a surgical infection site while at the same time acting as a filler, preventing fibrosis, and loss of the space. The antimicrobial cast lasts 4-6 weeks, making timely re-implantation easier, and preventing intracorporal fibrosis and loss of phallic length.
Inventor(s):	Carrion; Rafael (Lutz, FL), Martinez; Daniel Roberto (Tampa, FL), Akary; Eihab (Tampa, FL), Hakky; Tariq Said (Duluth, GA)
Assignee:	University of South Florida (Tampa, FL)
Application Number:	15/836,992
Patent Claims:	1. A method of treating a penile implant infection in a patient comprising: removing infected components from a penis of the patient through a surgical incision; irrigating intracorporal space of the penis of the patient with antibiotic fluids; preparing a calcium sulfate cast for injection into the intracorporal space of the penis of the patient wherein the calcium sulfate cast is prepared by the process comprising: providing synthetic high purity calcium sulfate; mixing the synthetic high purity calcium sulfate with an antimicrobial agent until a paste forms; inserting the paste into a syringe for administration; injecting the paste into the intracorporal space of the penis of the patient; molding the paste in the intracorporal space to completely fill the intracorporal space with the paste; holding the glans of the patient's penis in a stretched position, from a moment the paste is being injected until the paste solidifies; allowing the paste to solidify to form the calcium sulfate cast in the intracorporal space of the penis; closing the surgical incision in multiple layers to prevent seepage of the paste; and allowing the calcium sulfate cast to remain in the intracorporal space of the penis until the cast is resorbed; wherein the antimicrobial agent is continuously released from the calcium sulfate cast until the calcium sulfate cast is resorbed thus treating the penile implant infection. 2. The method of claim 1, wherein the antimicrobial is an antibiotic or an antifungal agent. 3. The method of claim 1, wherein the antimicrobial is in powder form. 4. The method of claim 3, further comprising adding 6 cc of water to the calcium sulfate/antimicrobial mixture. 5. The method of claim 1, wherein the antimicrobial is in liquid form. 6. The method of claim 1, wherein the calcium sulfate and antimicrobial are mixed for about 60 seconds. 7. The method of claim 1, wherein about 10 cc of the paste are injected into the patient. 8. A method of making a cast for treating a penile implant infection in a patient comprising: providing synthetic high purity calcium sulfate; mixing the synthetic high purity calcium sulfate with an antimicrobial agent until a paste forms; inserting the paste into a syringe for injection into an intracorporal space of a penis of the patient; injecting the paste into the intracorporal space of the penis of the patient; holding glans of the patient's penis in a stretched position, from a moment the paste is being injected until the paste solidifies; and allowing the paste to solidify to form the calcium sulfate cast in the intracorporal space of the penis. 9. The method of claim 8, further comprising molding the paste in the intracorporal space after injection to completely fill the intracorporal space with the paste. 10. The method of claim 8, wherein the antimicrobial is an antibiotic or an antifungal agent. 11. The method of claim 8, wherein the antimicrobial is in powder form. 12. The method of claim 11, further comprising adding 6 cc of water to the calcium sulfate/antimicrobial mixture. 13. The method of claim 8, wherein the antimicrobial is in liquid form. 14. The method of claim 8, wherein the calcium sulfate and antimicrobial are mixed for about 60 seconds. 15. A cast for treating penile implant infections in a patient comprising: synthetic high purity calcium sulfate; and an antimicrobial agent; and about 6 cc of sterile water; wherein the synthetic high purity calcium sulfate, the antimicrobial agent and the water are mixed together to form a paste which is injected into intracorporal space of a penis of the patient while holding glans of a patient's penis in a stretched position from a time the paste is injected until the paste solidifies to treat the penile implant infection. 16. The cast of claim 15, wherein the antimicrobial agent is an antibiotic or an antifungal. 17. The cast of claim 15, wherein the antimicrobial agent is in powder or liquid form. 18. The cast of claim 15, wherein the synthetic high purity calcium sulfate, the antimicrobial agent and the water are mixed together until a water-saturated slurry is formed. 19. The cast of claim 18, wherein the synthetic high purity calcium sulfate, the antimicrobial agent and the water are mixed together for about 60 seconds.

Details for Patent 10,328,177

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2034-01-10