Gel containment structure

• US 5,626,554 A
• Filed: 02/21/1995
• Issued: 05/06/1997
• Est. Priority Date: 02/21/1995
• Status: Expired due to Term

• Current Assignee: Exogen Inc. (Bioventus LLC)
• Original Assignee: Exogen Inc. (Bioventus LLC)
• Inventors: Ryaby, John P., McCabe, Joan M., Talish, Roger J.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/391,109
• Time in Patent Office: 805 Days
• Field of Search: 128/660.01, 128/662.03-662.06, 128/663.01, 601/2-4, 607/51, 607/97, 607/108-111
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61B 8/4227 characterised by straps, belts, cuffs or braces
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

This invention relates to apparatus and methods for providing and using a gel containment structure with an ultrasonic delivery system. The apparatus includes a special bladder, pad or other enclosure means for positioning adjacent the transmitting surface so that the coupling gel is retained adjacent the transmitting surface. The method for delivering ultrasonic energy includes enclosing coupling gel at the transmitting surface, positioning the enclosed coupling gel against the skin or other external location corresponding to the internal injury, and directing ultrasonic waves emitted at the transmitting surface through the enclosed conducting gel to the skin location corresponding to the internal injury.

Claims

1. Ultrasonic delivery system for therapeutic use having a base;

ultrasonic generation means mounted to the base, the ultrasonic generation means including an exposed operative surface positionable adjacent a skin location;

a coupling gel and

enclosure means for sealingly retaining the coupling gel substantially adjacent the operative surface and for isolating the operative surface from a skin location, the enclosure means being attached to the ultrasonic generation means immediately adjacent the outer periphery of the operative surface.

2. Ultrasonic delivery system as in claim 1 wherein the enclosure means is a sheath.

3. Ultrasonic delivery system as in claim 1 wherein the enclosure means is a bladder with an opening for enveloping the operative surface of the ultrasonic generation means.

4. Ultrasonic delivery system as in claim 3 wherein the bladder is formed of a non-porous material.

6. Ultrasonic delivery system as in claim 1 wherein the ultrasonic generation means further includes a telescoping portion having the operative surface;

and

the enclosure means is a cap for covering the operative surface of the telescoping portion of the ultrasonic generation means.

7. Ultrasonic delivery system of claim 1 wherein the enclosure means is a closed bladder with a means for attaching a portion of the exterior surface of the bladder adjacent the operative surface.

8. Ultrasonic delivery system of claim 1 wherein the enclosure means is comprised at least in part of material selected from the group consisting of rubber, polyurethane elastic and supple plastics.

5. Ultrasonic delivery system for therapeutic use having:

a base;

ultrasonic generation means mounted to the base, the ultrasonic generation means including an exposed operative surface positionable adjacent a skin location; and

a bladder for sealingly retaining coupling gel substantially adjacent the operative surface, the bladder having an opening for enveloping the operative surface of the ultrasonic delivery system, wherein the bladder is formed of a material having a plurality of pores which expand in response to a chemical activator to cause the material with the expanded pores to be porous to coupling gel.

9. Ultrasonic delivery system for therapeutic use having

a base defining a forward planar region;

ultrasonic generation means within the base having an exposed operative surface positionable adjacent a skin location, the exposed operative surface housed adjacent and parallel to the forward planar region;

a conductive gel and

a bladder for sealingly retaining the conductive gel substantially adjacent the operative surface and for isolating the operative surface from a skin location, the bladder being attached to the ultrasonic generation means immediately adjacent the outer periphery of the operative surface.

10. Ultrasonic delivery system as in claim 9 wherein the bladder is formed of a non-porous material.

12. Ultrasonic delivery system as in claim 9 wherein the bladder has an opening for receiving the distal end of the base, whereby the bladder envelops the operative surface.

13. Ultrasonic delivery system as in claim 12 wherein the perimeter of the opening of the bladder is expandable for receiving the distal end of the base.

14. Ultrasonic delivery system as in claim 12 wherein the bladder is elastic and has a surface area smaller than the forward planar region, whereby the bladder stretches to receive the distal end of the base and envelop the operative surface.

11. Ultrasonic delivery system for therapeutic use having:

a base defining a forward planar region;

ultrasonic generation means within the base having an exposed operative surface positionable adjacent a skin location, the exposed operative surface housed adjacent and parallel to the forward planar region; and

a bladder for retaining conductive gel substantially adjacent the operative surface wherein the bladder is formed of a material having a plurality of pores which expand in response to a chemical activator to cause the material with the expanded pores to be porous to conductive gel.

15. Ultrasonic delivery system for therapeutic use having

a base with a telescoping portion, one end of the telescoping portion defining a forward planar region;

ultrasonic generation means within the base having an exposed operative surface positionable adjacent a skin location, the exposed operative surface housed adjacent and parallel to the forward planar region of the telescoping portion;

a conductive gel and

a closed bladder containing the conductive gel coupled substantially adjacent the operative surface and for isolating the operative surface from a skin location, the bladder being attached to the ultrasonic generation means immediately adjacent the outer periphery of the operative surface.

16. Ultrasonic delivery system as in claim 15 wherein a portion of the exterior surface of the bladder includes means for removably fastening the bladder to the operative surface.

17. Ultrasonic delivery system as in claim 15 wherein a portion of the exterior surface of the bladder includes adherent for adhering the bladder to the operative surface.

18. Ultrasonic delivery system for therapeutic use having

an ultrasonic treatment module with a telescoping portion, the distal end of the telescoping portion defining a forward planar region;

ultrasonic generation means housed within the ultrasonic treatment module and including an exposed operative surface approximately co-planar with the forward planar region of the telescoping portion;

a positionable fixture for retaining and aligning the ultrasonic treatment module with the operative surface adjacent a skin location;

a coupling gel,

a bladder with an expandable opening for receiving the distal end of the telescoping portion and sealingly retaining the coupling gel substantially between the operative surface and the skin location and for isolating the operative surface from a skin location, the bladder being attached to the ultrasonic generation means immediately adjacent the outer periphery of the operative surface.

19. Ultrasonic delivery system as in claim 18 wherein said bladder is formed of a non-porous material.

20. Ultrasonic delivery system for therapeutic use having:

an ultrasonic treatment module with a telescoping portion, the distal end of the telescoping portion defining a forward planar region;

ultrasonic generation means housed within the ultrasonic treatment module and including an exposed operative surface approximately co-planar with the forward planar region of the telescoping portion;

a positionable fixture for retaining and aligning the ultrasonic treatment module with the operative surface adjacent a skin location;

a bladder with an expandable opening for receiving the distal end of the telescoping portion and sealingly retaining coupling gel substantially between the operative surface and the skin location, wherein said bladder is formed of a material having a plurality of pores which expand in response to a chemical activator to cause the material with the expanded pores to be porous to coupling gel.

21. Ultrasonic delivery system for therapeutic use comprising

an ultrasonic treatment module with a telescoping portion, the distal end of the telescoping portion defining a forward planar region;

ultrasonic generation means housed within the ultrasonic treatment module and including an exposed operative surface approximately co-planar with the forward planar region of the telescoping portion;

a positionable fixture for retaining and aligning the ultrasonic treatment module with the operative surface adjacent a skin location;

a non-porous closed bladder containing coupling gel with an ultrasonically conductive adherent on a portion of its external surface that adheres to the operative surface for retaining coupling gel substantially between the operative surface and the skin location.

22. Method for delivering ultrasonic therapy to an internal injury from an ultrasonic delivery system having a base housing an ultrasonic generation means and an exposed operative surface, comprising the steps of:

a) sealingly enclosing coupling gel substantially adjacent the operative surface to isolate the operative surface from a skin location by attaching an enclosure member to the ultrasonic generation means immediately adjacent the outer periphery of the operative surface;

b) positioning the enclosed coupling gel adjacent an external location corresponding to the internal injury; and

c) directing ultrasonic waves emitted at the operative surface through the enclosed coupling gel to the external location corresponding to the internal injury.

23. Method as in claim 22, wherein the step of sealingly enclosing coupling gel substantially adjacent the operative surface includes the step of disposing coupling gel on the operative surface.

24. Method as in claim 22, wherein the step of sealingly enclosing coupling gel substantially adjacent the operative surface includes disposing a bladder over the operative surface.

25. Method as in claim 22, wherein the step of sealingly enclosing coupling gel substantially adjacent the operative surface includes disposing coupling gel on the operative surface and stretching an opening of a bladder and receiving the operative surface within the bladder.

26. Method as in claim 25, wherein the step of positioning the enclosed coupling gel adjacent an external location corresponding to the internal injury includes the step of positioning at least part of the external surface of the bladder opposite the operative surface adjacent a skin location corresponding to an internal injury.

27. Method as in claim 22, wherein the step of sealingly enclosing coupling gel substantially adjacent the operative surface includes the step of adhering a portion of the surface area of a closed bladder containing coupling gel to at least part of the operative surface.

28. Method as in claim 27, wherein the step of positioning the enclosed coupling gel adjacent an external location corresponding to the internal injury includes the step of positioning at least part of the external surface of the bladder opposite the operative surface adjacent a skin location corresponding to an internal injury.

29. Method as in claim 22 wherein said external location corresponding to the internal injury comprises a human clavicle region.

30. Method as in claim 22, wherein the step of sealingly enclosing coupling gel substantially adjacent the operative surface includes disposing a non-porous bladder over the operative surface.

31. Method as in claim 22, wherein the step of sealingly enclosing coupling gel substantially adjacent the operative surface includes disposing a bladder formed of a material having a plurality of pores which expand in response to a chemical activator to cause the material with the expanded pores to be porous to the coupling gel over the operative surface.

32. Ultrasonic delivery system for therapeutic use having:

a base mountable adjacent a skin location;

ultrasonic generation means mounted to the base, the ultrasonic generation means including an exposed operative surface positionable adjacent a skin location;

a coupling gel and

enclosure means for sealingly retaining the coupling gel substantially adjacent the operative surface and for isolating the operative surface from a skin location, the enclosure means being attached to the ultrasonic generation means immediately adjacent the outer periphery of the operative surface.

33. Ultrasonic delivery system of claim 32 further comprising:

means for removably mounting the base adjacent the skin location for allowing the ultrasonic delivery system to be portable.