Devices for covering ultrasound probes of ultrasound machines

• US 20080139944A1
• Filed: 12/08/2006
• Published: 06/12/2008
• Est. Priority Date: 12/08/2006
• Status: Abandoned Application

• Current Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Original Assignee: Siemens Medical Solutions USA Incorporated (Siemens AG)
• Inventors: Randall, Kevin S., Klessel, Jodi Schwartz, Urbano, Joseph A., Lannutti, Anthony P., Cannon, Michael G., Engle, Lawrence A., Weymer, Raymond F.
• Application Number:
  US11/635,961
• Publication Number:
  US 20080139944A1
• Time in Patent Office: Days
• US Class Current: 600/459
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4422 related to hygiene or sterilisation
• CPC Class Codes: A61B 8/4472 Wireless probes

Abstract

Preferred embodiments of devices for covering an ultrasound probe can include a membrane, such as a sheath, having one or more ultrasonic couplers attached thereto for transferring ultrasonic energy between the ultrasound probe and a body surface of a patient.

Claims

1. A device for covering an ultrasound probe that generates and receives acoustical energy, the device comprising:

a sheath that receives the ultrasound probe and is capable of forming a barrier between the ultrasound probe and a body surface toward which the acoustical energy is directed; and

an ultrasonic coupler attached to the sheath and capable of transferring the acoustical energy between the ultrasound probe and the body surface.

2. The device of claim 1, further comprising a second ultrasonic coupler, wherein the ultrasonic couplers are attached to opposite sides of the sheath and are aligned with each other whereby the acoustical energy can be transferred between the ultrasound probe and the body surface by way of the ultrasonic couplers and the sheath.

3. The device of claim 1, wherein the sheath has an opening formed therein, and the ultrasonic coupler spans the opening whereby a first side of the ultrasonic coupler can be placed against the body surface while the ultrasound probe is placed against a second side of the ultrasonic coupler.

4. The device of claim 3, wherein an outer peripheral edge of the ultrasonic coupler is attached to an edge of the sheath proximate the opening.

5. The device of claim 1, wherein the ultrasonic coupler comprises a pad formed from cellulose, and at least a portion of the pad is impregnated with a mixture of glycerin and water.

6. The device of claim 5, wherein an outer peripheral edge of the pad is substantially free of the mixture of glycerin and water, and the outer peripheral edge of the pad is attached to the sheath.

7. The device of claim 1, wherein the ultrasonic coupler comprises a water-containing polymeric gel.

8. The device of claim 1, wherein the ultrasonic coupler comprises a hydrophilic block co-polymer and an approximately 20 percent to approximately 95 percent by weight biocompatible liquid.

9. The device of claim 8, wherein the ultrasonic coupler comprises a hydrophilic block co-polymer and an approximately 70 percent higher by weight biocompatible liquid.

10. The device of claim 1, wherein the ultrasonic coupler comprises a frame formed from a rigid or semi-rigid material.

11. The device of claim 10, wherein the ultrasonic coupler further comprises a gelled material, wherein at least a portion of the gelled material is hardened.

12. The device of claim 11, wherein the frame is integrally formed with the hardened portion of the gelled material.

13. The device of claim 11, wherein the frame is molded into the hardened portion of the gelled material.

14. The device of claim 11, wherein the gelled material is a water-containing polymeric compound.

15. The device of claim 10, wherein the frame is attached to the sheath by a heat seal or an adhesive.

16. The device of claim 1, further comprising a removable cover positioned over the ultrasonic coupler.

17. The device of claim 1, wherein the ultrasonic coupler is attached to a first end of the sheath, and the device further comprises a closure that closes a second end of the sheath.

18. The device of claim 17, wherein the closure is a drawstring, an adhesive strip, or an elastic band.

19. The device of claim 1, further comprising a strap attached to the sheath for securing the device to a hand of a user.

20. The device of claim 1, wherein the sheath is formed from a fluid-impermeable material.

21. The device of claim 20, wherein the fluid-impermeable material is flexible and sterilizable.

22. A system, comprising the device of claim 1, and a sterile barrier, wherein the device is sealed within the sterile barrier.

23. The system of claim 22, wherein the sterile barrier is a package.

24. The system of claim 22, further comprising the ultrasound probe, wherein the ultrasound probe is disposed within the sheath.

25. The system of claim 24, wherein the ultrasound probe is wireless.

26. A device for transferring acoustical energy, comprising:

a membrane;

a first ultrasonic coupler in contact with a first side of the membrane; and

a second ultrasonic coupler in contact with a second side of the membrane and aligned with the first ultrasonic coupler whereby the acoustical energy can be transferred between the first and second ultrasonic couplers by way of the membrane.

27. The device of claim 26, wherein the membrane is a sheath that receives an ultrasound probe that generates the acoustical energy.

28. The device of claim 27, wherein the sheath is formed from a fluid-impermeable material.

29. The device of claim 28, wherein the fluid-impermeable material is flexible and sterilizable.

30. The device of claim 26, wherein the first ultrasonic coupler is attached to the first side of the membrane by adhesive applied to an outer peripheral edge of the first ultrasonic coupler, and the second ultrasonic coupler is attached to the second side of the membrane by adhesive applied to an outer peripheral edge of the second ultrasonic coupler.

31. The device of claim 30, wherein:

the first ultrasonic coupler comprises a pad formed from cellulose, and a portion of the pad inward of the outer peripheral edge of the first ultrasonic coupler is impregnated with a mixture of glycerin and water; and

the second ultrasonic coupler comprises a pad formed from cellulose, and a portion of the pad of the second ultrasonic coupler inward of the outer peripheral edge of the second ultrasonic coupler is impregnated with the mixture of glycerin and water.

32. The device of claim 26, wherein:

the first ultrasonic coupler comprises a frame formed from a rigid or semi-rigid material, and the frame is attached to the first side of the membrane; and

the second ultrasonic coupler comprises a frame formed from the rigid or semi-rigid material, and the frame of the second ultrasonic coupler is attached to the second side of the membrane.

33. The device of claim 27, wherein the first and second ultrasonic couplers are attached to a first end of the sheath, and the device further comprises means for closing a second end of the sheath.

34. The device of claim 27, further comprising a strap attached to the sheath for securing the device to a hand of a user.

35. The device of claim 26, wherein the first and second ultrasonic couplers comprise a water-containing polymeric compound.

36. The device of claim 26, wherein the first and second ultrasonic couplers comprise a hydrophilic block co-polymer and an approximately 20 percent to approximately 95 percent by weight biocompatible liquid.

37. The device of claim 36, wherein the first and second ultrasonic coupler comprises a hydrophilic block co-polymer and an approximately 70 percent higher by weight biocompatible liquid.

38. A system, comprising the device of claim 27, and a sterile barrier, wherein the device is sealed within the sterile barrier.

39. The system of claim 38, wherein the sterile barrier is a package.

40. The system of claim 38, further comprising the ultrasound probe, wherein the ultrasound probe is disposed within the sheath.

41. The system of claim 40, wherein the ultrasound probe is wireless.

42. A method for acoustically coupling an ultrasound probe and a body surface, the method comprising:

inserting the ultrasound probe into a sheath;

urging a sensing face of the ultrasound probe against an ultrasonic coupler attached to a sheath; and

directing the ultrasonic energy though the ultrasonic coupler.

43. The method of claim 42, further comprising urging another ultrasonic coupler attached to the sheath against the body surface and directing the ultrasonic energy though the ultrasonic couplers and the sheath.

44. The method of claim 43, wherein urging a sensing face of the ultrasound probe against an ultrasonic coupler attached to a sheath comprises urging the ultrasound probe against a first side of the ultrasonic coupler and urging a second side of the ultrasonic coupler against the body surface.

45. The method of claim 42, further comprising closing an end of the sheath through which the ultrasound probe is inserted, and securing the end in a closed position.

46. The method of claim 42, further comprising supporting the ultrasound probe by way of a strap attached to the sheath.

47. The method of claim 42, further comprising removing a cover disposed over the ultrasonic coupler before urging the sensing face of the ultrasound probe against the ultrasonic coupler.

48. The method of claim 42, wherein the ultrasound probe is wireless.

49. A method for preparing an ultrasound probe for use, comprising:

covering a portion of the ultrasound probe with a sheath while the ultrasound probe is positioned on a device that holds the ultrasound probe;

grasping the portion of the ultrasound probe covered by the sheath;

lifting the probe from the device that holds the ultrasound probe;

covering a remainder of the ultrasound probe with the sheath; and

closing an open end of the sheath.

50. The method of claim 49, wherein the device that holds the ultrasound probe is a stand.

51. The method of claim 49, wherein the device that holds the ultrasound probe is located outside of a sterile field.

52. The method of claim 51, further comprising moving the ultrasound probe into the sterile field after closing the open end of the sheath.

53. The method of claim 49, wherein lifting the ultrasound probe from the stand comprises lifting the ultrasound probe from the stand using one hand of the user;

and covering a remainder of the ultrasound probe with the sheath comprises covering a remainder of the ultrasound probe with the sheath using another hand of the user.

54. A device for covering an ultrasound probe, the device comprising:

a sheath that receives the ultrasound probe;

a layer of ultrasonic gel disposed on an interior surface of the sheath; and

a cover positioned over the ultrasonic gel and sealed to the interior surface of the sheath.

55. The device of claim 54, wherein the cover is removably attached to the interior surface of the sheath.

56. The device of claim 54, wherein the cover has a weakened area formed therein that can rupture when the ultrasound probe is pressed against the cover.

57. A process for supplying ultrasound probes for use in ultrasound procedures, comprising:

providing the ultrasound probes to a user, with each of the ultrasound probes being packaged in (i) a sheath that can form a sterile, fluid-impermeable barrier between the ultrasound probe and a body surface of a patient, and (ii) a sealed package that covers the sheath and the ultrasound probe and forms a barrier around the sheath and the ultrasound probe;

receiving the ultrasound probes from the user after the ultrasound probes have been used in the ultrasound procedures;

repackaging the ultrasound probes in new ones of the sheaths and the packages; and

supplying the repackaged ultrasound probes to the user.