Transurethral volume reduction of the prostate (TUVOR)

• US 6,491,672 B2
• Filed: 02/07/2001
• Issued: 12/10/2002
• Est. Priority Date: 02/10/2000
• Status: Expired due to Fees

• Current Assignee: Harmonia Medical Technologies Incorporated, LuK Automobiltechnik GmbH & Co. KG.
• Original Assignee: Harmonia Medical Technologies Incorporated
• Inventors: Sohn, Zeev, Hossainy, Syed, Levy, Baruch, Yachia, Daniel, Slepian, Marvin J.
• Primary Examiner(s): Derakshani, Philippe
• Application Number:
  US09/778,651
• Publication Number:
  US 20010047147A1
• Time in Patent Office: 671 Days
• Field of Search: 604/266, 604/267, 606/170, 606/171, 606/180
• US Class Current: 604/267
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00274 Prostate operation, e.g. prostatectomy, turp, bhp treatment
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/22072 with an instrument channel, e.g. for replacing one instrument by the other in cannulas A61B17/3417
• CPC Class Codes: A61B 2017/3445 used as instrument channel for multiple instruments catheters A61B2017/22072
• CPC Class Codes: A61B 2018/00547 Prostate
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras

Abstract

A process has been developed to reduce or relieve prostatic obstruction. The steps involved in the TUVOR Process include: 1. Transurethral Incision; 2. De-bulking and Intra-Prostatic Volume Reduction; 3. Intra-prostatic void exclusion and space filling with adhesive and/or therapeutic polymeric materials, alone or in combination with bioactive agents and/or mechanical means for closure; 4. Endourethral compression and prostatic mass remolding; 5. Endourethral Polymer Liner Layer. This liner formed from structurally supportive, yet eventually biodegradable, polymers further bolsters and supports the urethra and peri-urethral tissue during healing, eliminating the need for post-procedure catheter drainage. This step may be optional in specific clinical circumstances. The process is designed to allow outpatient treatment under local anesthesia for BPH.

Claims

1. A method for treating prostate disease comprising:

making an incision into the prostate,

reducing the volume of the prostate by removing endomural tissue to form at least one void in the prostate, and

closing the voids in the prostate,

wherein an adhesive material is applied within the void prior to closure or a supportive material is applied to the urethra lining to provide structural support.

2. The method of claim 1 comprising applying an adhesive biodegradable material within the voids prior to closure.

3. The method of claim 2 wherein the adhesive biodegradable material is sufficient to effect closure of the voids until healing occurs.

4. The method of claim 1 wherein the voids are closed by mechanical means.

5. The method of claim 4 wherein the voids are closed using a balloon catheter within the urethra.

6. The method of claim 1 wherein the incision is a transurethral incision.

7. The method of claim 1 wherein multiple voids are created in the prostate.

8. The method of claim 1 wherein the incision and tissue removal is effected using a cutter device positioned within a catheter that can be passed into the urethra to the prostate.

9. The method of claim 1 further comprising administering bioactive agents to the urethra or voids within the prostate.

10. The method of claim 9 wherein the bioactive agents are selected from the group consisting of drugs, genes, cells, and molecules altering cellular adhesion.

11. The method of claim 10 wherein the drugs are selected from the group consisting of antibiotics, antivirals, antiinflammatories, hormones, antineoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, enzymes, enzyme inhibitors, anticoagulants, growth factors, DNA, RNA and protein synthesis inhibitors, anti-cell migratory agents, and vasodilating agents.

12. The method of claim 11 wherein the drugs are selected from the group consisting of hormones and chemotherapeutic agents.

13. The method of claim 1 wherein the material applied to the urethra lining provides structural support sufficient to allow flow of urine through the urethra.

14. The method of claim 1 wherein material applied to the voids or urethra lining is a polymer.

15. The method of claim 14 wherein the polymer is a biodegradable polymer.

16. The method of claim 15 wherein the polymer is conformable by a change in temperature or mechanical forces in situ.

17. The method of claim 15 wherein the polymer is applied in a fluent state and converted in situ to a non-fluent state.

18. The method of claim 17 wherein the polymer is polymerized in situ by application of a stimulus.

19. The method of claim 18 wherein the stimulus is light, temperature change, exposure to ions, addition of a catalyst or initiator, or radiation.

20. The method of claim 1 further comprising mechanically compressing the voids.

21. The method of claim 20 wherein the voids are compressed by expansion of a balloon catheter in the urethra.

22. The method of claim 21 further comprising mechanically closing the voids.

23. A kit for treating prostate disease comprising making an incision into the prostate, reducing the volume of the prostate by removing endomural tissue to form at least one void in the prostate, and closing the voids in the prostate, wherein an adhesive material is applied within the void prior to closure or a supportive material is applied to the urethra lining to provide structural support, comprising

a catheter suitable for insertion into the urethra comprising means for making a transurethral incision, means for cutting and morselating tissue, one or more lumens for administration of an adhesive material or a supportive material to the urethra, means for removal of morselated tissue, and

a biocompatible, biodegradable material suitable for administration within the prostate to adhere tissue or within the urethral to provide structural support.

24. The kit of claim 23 wherein the biocompatible, biodegradable material is a solution forming an adhesive polymer in situ following application.

25. The kit of claim 23 wherein the biocompatible, biodegradable material is a solution forming a structurally supportive lining in the urethra following application.

26. The kit of claim 23 wherein the biocompatible, biodegradable material is a conformable solid that can be inserted into the urethra and conformed to the surface to form a barrier or support structure.

27. The kit of claim 23 further comprising bioactive agents for administration to the urethra or voids within the prostate.

28. The kit of claim 27 wherein the bioactive agents are selected from the group consisting of drugs, genes, cells, and molecules altering cellular adhesion.

29. The kit of claim 28 wherein the drugs are selected from the group consisting of antibiotics, antivirals, antiinflammatories, hormones, antineoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, enzymes, enzyme inhibitors, anticoagulants, growth factors, DNA, RNA and protein synthesis inhibitors, anti-cell migratory agents, and vasodilating agents.

30. The kit of claim 29 wherein the drugs are selected from the group consisting of hormones and chemotherapeutic agents.

31. The kit of claim 23 wherein material applied to the voids or urethra lining is a polymer.

32. The kit of claim 31 wherein the polymer is a biodegradable polymer.

33. The kit of claim 32 wherein the polymer is conformable by a change in temperature or mechanical forces in situ.

34. The kit of claim 32 wherein the polymer is in a fluent state which is convertable in situ to a non-fluent state.

35. The kit of claim 34 wherein the polymer is polymerized in situ by application of a stimulus.

36. The kit of claim 35 wherein the stimulus is light, temperature change, exposure to ions, addition of a catalyst or initiator, or radiation.

37. The kit of claim 23 wherein the catheter further comprises expansion means.

38. The kit of claim 37 wherein the catheter further comprises means for suturing or stapling.

39. The kit of claim 23 wherein the catheter further comprises means for generating light, radiation or a temperature change in the voids or urethra.

40. The kit of claim 23 wherein the catheter further comprises means for conforming a lining within the urethra.

41. The kit of claim 23 wherein the catheter further comprises suction or vacuum means.