Methods and devices for repairing damaged or diseased tissue using a scanning beam assembly

• US 8,160,678 B2
• Filed: 06/18/2007
• Issued: 04/17/2012
• Est. Priority Date: 06/18/2007
• Status: Active Grant

• Current Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Cropper, Michael S., Huitema, Thomas W., Weir, Michael P., Dunki-Jacobs, Robert J., Brophy, Jere J., Trusty, Robert M., Byrum, Randal T., Youmans, David C., Conlon, Sean P., Long, Gary L., Ritchie, Paul G., Sheetz, Jane A.
• Primary Examiner(s): Chen, Tse
• Assistant Examiner(s): Brutus, Joel F
• Application Number:
  US11/764,261
• Publication Number:
  US 20080312490A1
• Time in Patent Office: 1,765 Days
• Field of Search: 600/427, 623/17, 623/11, 623/902, 623/16, 606/214
• US Class Current: 600/427
• CPC Class Codes: A61B 1/00082 Balloons
• CPC Class Codes: A61B 1/00096 Optical elements
• CPC Class Codes: A61B 1/00101 the distal tip features being detachable
• CPC Class Codes: A61B 1/00172 with means for scanning
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/0623 for off-axis illumination
• CPC Class Codes: A61B 1/07 using light-conductive means, e.g. optical fibres
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 18/24 with a catheter A61B18/26, A61B18/28 take precedence
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61B 2017/22085 light-absorbing A61B2017/22087 takes precedence
• CPC Class Codes: A61B 2017/22087 photodynamic
• CPC Class Codes: A61B 2018/2025 with a pilot laser
• CPC Class Codes: A61B 2018/20351 Scanning mechanisms
• CPC Class Codes: A61B 2018/20361 with redirecting based on sensed condition, e.g. tissue analysis or tissue movement
• CPC Class Codes: A61B 2018/208 with multiple treatment beams not sharing a common path, e.g. non-axial or parallel
• CPC Class Codes: A61B 5/0062 Arrangements for scanning
• CPC Class Codes: A61B 5/0084 for introduction into the body, e.g. by catheters A61B5/1459 takes precedence
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61M 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 5/0601 : Apparatus for use inside the body
• CPC Class Codes: A61N 5/062 : Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: Y10S 623/902 : Method of implanting

Abstract

A method for repairing or modifying an area of a patient'"'"'s anatomy that comprises directing at least a portion of a scanning beam assembly to an area of a patient'"'"'s anatomy, applying a radiation-responsive agent to portion of the anatomy, and exposing the radiation-responsive agent to radiation directed onto the agent by the reflector to cause the agent to therapeutically interact with the site. The scanning beam assembly including a radiation source capable of emitting radiation, a reflector that receives the radiation from the radiation source to direct the radiation onto the anatomy, wherein the reflector oscillates in at least two directions to create a scan of the anatomy, a detector to detect radiation returned from the anatomy, and a controller to convert the detected radiation into a displayable anatomy image.

Claims

1. A method for repairing or modifying an area of a patient'"'"'s anatomy comprising the steps of:

(a) directing at least a portion of a scanning beam assembly to an area of a patient'"'"'s anatomy, the scanning beam assembly comprising;

a radiation source capable of emitting radiation;

an optical fiber for directing the radiation from the radiation source toward a distal end of the scanning beam assembly in the form of a beam;

a reflector that receives the beam of radiation from the optical fiber to direct the radiation onto the anatomy, wherein the reflector oscillates in at least two directions to create a scan of the anatomy with the radiation, the scan including sinusoidal angular deflections of the reflector yielding a bi-resonant or bi-sinusoidal scan path;

a detector to detect radiation returned from the anatomy; and

a controller to convert the detected radiation into a displayable image of the anatomy that was scanned by the radiation directed thereto by the reflector;

wherein the controller comprises an interface management component that is electrically coupled to a user interface, the reflector, and the radiation source, wherein the interface management component upon receipt of specified treatment parameters transmits signals to a source control to drive the radiation source to provide a requisite emitting radiation output during the bi-resonant or bi-sinusoidal scan path;

(b) applying a radiation-responsive agent to a portion of the anatomy;

(c) exposing the radiation-responsive agent to radiation directed onto the agent by the reflector to cause the agent to therapeutically interact with the site;

(d) imaging the anatomy using the scanning beam assembly;

(e) displaying an image of the anatomy including the agent;

(f) using the displayed image of the anatomy to plan the placement of the radiation-responsive agent; and

(g) selecting a treatment path where the reflector will direct therapeutic radiation for exposing the radiation-responsive agent.

2. The method of claim 1 wherein the area of the anatomy is selected from the group consisting of the stomach, colon, large or small intestine, ureter, urethra, biliary duct, artery, vein, abdominal cavity, esophagus, trachea, bronchial tubes, external tissue, internal tissue, and lumen.

3. The method of claim 1 wherein the portion of the anatomy is a tissue separation.

4. The method of claim 3 wherein the tissue separation is a surgical incision.

5. The method of claim 3 wherein the agent therapeutically interacts with the site to bond the tissue on each side of the incision together.

6. The method of claim 3 wherein the agent includes at least one of albumin, collagen, gelatin, curing aides, medicines, and healing aides to crosslink the tissue at the tissue separation.

7. The method of claim 1 wherein the agent is at least one of a paste, a gelatin, a liquid, a solid, a ribbon, a mesh, a film, a graft, a stent and a powder.

8. The method of claim 1 wherein the agent is a layer on a film, tape mesh, graft, or annular sleeve.

9. The method of claim 1 wherein the agent is cured by the radiation.

10. The method of claim 1 wherein the agent is bioabsorbable.

11. The method of claim 1 wherein the agent is a medical adhesive.

12. The method of claim 11 wherein the medical adhesive includes at least one of albumin, collagen, gelatin, curing aides, medicines, and healing aides.

13. The method of claim 1 wherein the agent is a medical drug.

14. The method of claim 1 wherein applying the radiation-responsive agent comprises directing an applicator through a channel of a medical instrument to the selected area of the anatomy.

15. The method of claim 14 wherein exposing the radiation-responsive agent to radiation forms a stent from the applied radiation-responsive agent.

16. The method of claim 15 wherein the stent includes slots made by selectively curing the radiation-responsive agent.

17. The method of claim 1 wherein exposing the agent with radiation is done to selectively cure a portion of the applied agent.

18. The method of claim 1 wherein the portion of the scanning beam assembly being directed to the anatomy includes a medical guidewire.

19. The method of claim 1 wherein the scanning beam assembly further comprises a collector that intercepts the radiation returned from the anatomy and passes the radiation to the detector.

20. The method of claim 19 wherein the collector includes a plurality of multimode collecting fibers.

21. The method of claim 19 wherein the scanning beam assembly further comprises a housing enclosing the collector and the reflector, wherein the housing is insertable within an area of the anatomy.

22. The method of claim 20 wherein the scanning beam assembly further comprises a housing enclosing the collector and the reflector, wherein the housing is insertable within an area of the anatomy.

23. The method of claim 1 wherein the radiation returned from the anatomy is radiation reflected from the scanned portion of the anatomy.

24. An intraluminal vascular graft made according to the method of claim 23.

25. The method of claim 23 wherein the portion of the scanning beam assembly is directed to the area of the body as part of a balloon catheter, wherein a quantity of the radiation-responsive agent is applied onto the balloon, and the balloon is expanded to apply the agent to the site.

26. The method of claim 25 wherein the radiation-responsive agent is dispensed onto the balloon from an infusion port within the balloon catheter.

27. The method of claim 25 wherein the radiation-responsive agent is applied to the balloon before the catheter is directed to the portion of the anatomy.

28. The method of claim 27 wherein the radiation-responsive agent is applied to the balloon as at least one of a coating, a film, and an annular sleeve.

29. The method of claim 28 wherein the annular sleeve is a mesh with a coating of a medical adhesive.

30. The method of claim 28 wherein the balloon has a cover to protect the radiation-responsive agent while the catheter is directed toward the portion of the anatomy.

31. The method of claim 23 wherein exposing the radiation-responsive agent lo radiation forms a stent from the applied radiation-responsive agent.

32. The method of claim 31 wherein the radial ion-responsive agent is bioabsorbable.

33. The method of claim 31 wherein the stent has tubular walls of uniform thickness.

34. The method of claim 31 wherein the stent includes slots made by selectively curing the radiation-responsive agent.

35. The method of claim 31 wherein the stent is made to a custom length by repealing the method as the catheter is moved along the area of the body.

36. The method of claim 23 wherein the radiation-responsive agent is a shape memory alloy.

37. The method of claim 36 wherein the shape memory alloy is a stent assembly.

38. The method of claim 37 wherein the stent is applied by a catheter.

39. The method of claim 36 wherein the shape memory alloy is at least one of a nickel based alloy, a nickel titanium alloy, and a copper based alloy.

40. A balloon catheter comprising:

(a) an expandable balloon;

(b) a catheter body having a plurality of lumens, wherein at least one lumen opens into the interior of the expandable balloon; and

(c) at least a portion of a scanning beam assembly, the scanning beam assembly comprising;

a radiation source capable of emitting radiation;

a reflector that receives the radiation from the radiation source to direct the radiation onto a patient'"'"'s anatomy, wherein the reflector oscillates in at least two directions to create a scan of the anatomy;

a detector to detect radiation returned from the anatomy; and

a controller to convert the detected radiation into a displayable image of the anatomy;

wherein the controller comprises an interface management component that is electrically coupled to a user interface, the reflector, and the radiation source, wherein the interface management component upon receipt of specified treatment parameters transmits signals to a source control to drive the radiation source to provide a requisite emitting radiation output for said treatment parameters.

41. The balloon catheter of claim 40 wherein the portion of the scanning beam assembly is fed through the lumen that opens into the interior of the expandable balloon.

42. The balloon catheter of claim 40 further comprising:

(d) an infusion port for dispensing a radiation-responsive agent, the infusion port connected to at least one lumen within the catheter body.

43. The balloon catheter of claim 40 wherein the expandable balloon is made of a material that can transmit the radiation from the reflector through the balloon.

44. The balloon catheter of claim 40 wherein at least one lumen exits the catheter body near the proximal end of the expandable balloon.

45. The balloon catheter of claim 44 wherein the scanning beam portion of the scanning beam assembly is fed through the lumen that exits the catheter body near the proximal end of the expandable balloon.

46. A method for repairing or modifying an area of a patient'"'"'s anatomy comprising the steps of:

(a) directing at least a portion of a scanning beam assembly to an area of a patient'"'"'s anatomy, the scanning beam assembly comprising;

a radiation source capable of emitting radiation;

an optical fiber for directing the radiation from the radiation source toward a distal end of the scanning beam assembly in the form of a beam;

a reflector that receives the beam of radiation from the optical fiber to direct the radiation onto the anatomy, wherein the reflector oscillates in at least two directions to create a scan of the anatomy with the radiation, the scan including sinusoidal angular deflections of the reflector yielding a bi-resonant or bi-sinusoidal scan path;

a detector to detect radiation returned from the anatomy; and

a controller lo convert the detected radiation into a displayable image of the anatomy that was scanned by the radiation directed thereto by the reflector;

wherein the controller comprises an interface management component that is electrically coupled to a user interface, the reflector, and the radiation source, wherein the interface management component upon receipt of specified treatment parameters from a user transmits signals a source control to drive the radiation source to provide the requisite emitting radiation output for said treatment parameters;

wherein the radiation is itself capable of making a channel into an organ or is itself capable of removing or making a channel opening through an occlusion within a lumen or organ;

(b) displaying an image of the anatomy that includes the lumen or organ;

(c) identifying where the radiation is to open a channel within a portion of the lumen or organ; and

(d) emitting the radiation to make the channel.

47. The method of claim 46 wherein the organ is the heart.

48. The method of claim 47 wherein the channel is made in the wall of the heart.