Interface for use between medical instrumentation and a patient

• US 20050215901A1
• Filed: 01/18/2005
• Published: 09/29/2005
• Est. Priority Date: 01/20/2004
• Status: Abandoned Application

• Current Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Otsuka Medical Devices Co., Ltd. (Otsuka Holdings Company Limited)
• Inventors: Dale, Nathan J., Anderson, Thomas L., Zhang, Jimin, Leonard, Paul C., Perozek, David M., Weng, Lee, Hubler, Robert, Edelman, Peter G., Stiggelbout, John M.
• Application Number:
  US11/038,351
• Publication Number:
  US 20050215901A1
• Time in Patent Office: Days
• US Class Current: 600/445
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue

Abstract

Disclosed herein are methods, devices, compositions, and systems for providing an interface between medical instrumentation and a patient. In various embodiments, the interface provides a sterile barrier, acoustic coupler, and thermal insulator between the patient and a medical instrument. In some embodiments, an acoustic coupler interface is used between an ultrasound instrument and a patient. In some embodiments, the acoustic coupler comprises a thermoplastic elastomer (“TPE”) and in particular oil-enhanced or gelatinous TPEs that can be used in diagnostic and therapeutic (HIFU) ultrasound procedures.

Claims

1. An ultrasound coupling pad, comprising a gelatinous thermoplastic elastomer mass, said mass adapted to permit transmission of ultrasound energy through said mass, said mass comprising a patient surface configured to transmit the acoustic energy to tissues of a patient either directly or through other materials and a transducer surface configured to receive the acoustic energy from one or more ultrasound transducers either directly or through other materials.

2. The ultrasound coupling pad of claim 1, wherein the gelatinous thermoplastic elastomer mass comprises a plurality of thermoplastic elastomers having different compositions.

3. The ultrasound coupling pad of claim 1, further comprising a means for coupling the gelatinous thermoplastic elastomer mass to an ultrasound applicator.

4. The ultrasound coupling pad of claim 1, further comprising a means for coupling the gelatinous thermoplastic elastomer mass to a patient.

5. The ultrasound coupling pad of claim 1, wherein the patient surface of the gelatinous thermoplastic elastomer mass directly contacts a patient.

6. The ultrasound coupling pad of claim 1, wherein an acoustic gel or liquid is disposed between the patient surface of the gelatinous thermoplastic elastomer mass and a patient.

7. The ultrasound coupling pad of claim 1, wherein the transducer surface of the gelatinous thermoplastic elastomer mass directly contacts an ultrasound transducer.

8. The ultrasound coupling pad of claim 1, wherein an acoustic gel or liquid is disposed between the transducer surface of the gelatinous thermoplastic elastomer mass and an ultrasound transducer.

9. The ultrasound coupling pad of claim 1, wherein the gelatinous thermoplastic elastomer mass comprises styrene.

10. The ultrasound coupling pad of claim 1, wherein the gelatinous thermoplastic elastomer mass comprises one or more soft block segments selected from the group consisting of butadiene, isoprene, isoprene-butadiene, ethylene-butylene, ethylene-propylene, ethylene-butylene-ethylene-propylene, and ethylene-ethylene-propylene.

11. The ultrasound coupling pad of claim 1, wherein the gelatinous thermoplastic elastomer mass comprises an oil.

12. The ultrasound coupling pad of claim 1, wherein the patient surface is convex shaped.

13. The ultrasound coupling pad of claim 1, further comprising a reservoir containing an acoustic gel or liquid, wherein said reservoir is adapted to dispense said acoustic gel or liquid onto said patient and/or transducer surfaces.

14. An ultrasound coupling pad, comprising:

a gelatinous thermoplastic elastomer mass, said mass adapted to permit transmission of ultrasound energy through the mass; and

a housing contacting at least some surfaces of the mass for stably holding said mass, said housing adapted to couple to an ultrasound applicator, wherein when said housing is coupled to said ultrasound applicator, at least one surface of the mass is held in close proximity to one or more ultrasound transducers in said ultrasound applicator.

15. The ultrasound coupling pad of claim 14, wherein the housing comprises a tab or tab receptacle for coupling to the ultrasound applicator.

16. The ultrasound coupling pad of claim 14, wherein the housing comprises threads for coupling to the ultrasound applicator.

17. An ultrasound coupling pad, comprising:

a gelatinous thermoplastic elastomer mass, said mass adapted to permit transmission of ultrasound energy through the mass; and

a housing contacting at least some surfaces of the mass for stably holding the mass, said housing comprising an adhesive coating on a least a portion of the housing'"'"'s outer surface, said adhesive adapted to adhere the housing to a patient, wherein when said housing is adhered to said patient, at least one surface of the mass is held in close proximity to the patient.

18. The ultrasound coupling pad of claim 17, wherein the gelatinous thermoplastic elastomer mass can be removed from the housing while the housing is adhered to the patient.

19. An ultrasound coupling pad, comprising:

a first gelatinous solid mass, said first mass optimized to permit transmission of ultrasound energy having a first frequency through said mass; and

a second gelatinous solid mass, said second mass comprising a different chemical composition than the first mass and optimized to permit transmission of ultrasound energy having a second frequency through said mass, wherein said second frequency is different from said first frequency.

20. The ultrasound coupling pad of claim 19, wherein said first and second gelatinous solid masses comprise hydrogels.

21. The ultrasound coupling pad of claim 19, wherein said first and second gelatinous solid masses comprise thermoplastic elastomers.

22. The ultrasound coupling pad of claim 19, wherein said first gelatinous solid mass comprises a hydrogel and said second gelatinous solid mass comprises a thermoplastic elastomer.

23. The ultrasound coupling pad of claim 19, wherein said first gelatinous solid mass is optimized to permit transmission of ultrasound energy from an imaging ultrasound transducer and said second gelatinous solid mass is optimized to permit transmission of ultrasound energy from a therapeutic ultrasound transducer.

24. A sterile barrier for use between a patient and an instrument, comprising:

a flexible sheath adapted to prevent passage of microbes from one side of the sheath to the other;

said sheath comprising an openable seal, wherein when said seal is closed, said seal prevents passage of microbes from one side of the seal to the other;

said sheath configured to have a predeployed state and a postdeployed state, wherein in said predeployed state, the seal is closed and the flexible sheath with closed seal form a continuous barrier having no opening therein and having no edges, said continuous-barrier having an inside surface and an outside surface, wherein said inside surface is sterilized, and wherein in the postdeployed state, the flexible barrier is inverted such that the sterilized inside surface faces outward and the outside surface faces inward and is placed in contact with a medical instrument, thereby providing a barrier between the medical instrument and the sterilized surface of the sheath.

25. The sterile barrier of claim 24, wherein said flexible sheath comprises polyurethane or polyethylene.

26. The sterile barrier of claim 24, wherein at least a portion of the flexible sheath comprises material that is more rigid than other portions of the flexible sheath.

27. The sterile barrier of claim 24, wherein said seal comprises an adhesive.

28. The sterile barrier of claim 24, wherein said seal comprises Tyvek®

.

29. The sterile barrier of claim 24, wherein said seal comprises a heat induced seal.

30. The sterile barrier of claim 24, further comprising one or more tabs attached to said outside surface.

31. The sterile barrier of claim 30, wherein at least one of said tabs comprises a bar code.

32. The sterile barrier of claim 30, wherein at least one of said tabs comprises an RFID feature.

33. The sterile barrier of claim 30, wherein at least one of said tabs comprises an RFSAW feature.

34. A sterile barrier for use between a patient and an ultrasound applicator, comprising:

a flexible sheath adapted to prevent passage of microbes from one side of the sheath to the other, said sheath adapted to surround an ultrasound applicator; and

a gelatinous solid mass adapted to permit transmission of ultrasound energy through said mass and prevent passage of microbes from one side of the mass to the other, said mass coupled to the flexible sheath such that when the sheath surrounds the ultrasound applicator, the mass may be placed in close proximity to one or more ultrasound transducers in the ultrasound applicator.

35. The sterile barrier of claim 34, wherein said mass is coupled to the sheath by a housing that is coupled to said flexible sheath and contacts at least some surfaces of said gelatinous solid mass and is adapted to couple said gelatinous solid mass to said ultrasound applicator.

36. An ultrasound coupling pad kit, comprising:

a sterilized gelatinous thermoplastic elastomer mass, said mass adapted to permit transmission of ultrasound energy through said mass; and

a protective barrier surrounding at least a portion of the mass, said barrier adapted to prevent passage of microbes from one side of the barrier to the other, thereby maintaining sterility of the mass, at least a portion of the barrier adapted to be removed from surrounding the mass prior to use of the mass for transmission of ultrasound energy.

37. The ultrasound coupling pad kit of claim 36, wherein said protective barrier comprises a polymer sheet.

38. The ultrasound coupling pad kit of claim 36, wherein the polymer sheet is constructed of material selected from the group consisting of polyurethane, Teflon, mylar, and polyethylene.

39. A kit for a sterile barrier for use between a patient and an ultrasound applicator, comprising:

a flexible sheath adapted to prevent passage of microbes from one side of the sheath to the other, said sheath adapted to surround an ultrasound applicator, at least one surface of the flexible sheath sterilized; and

a gelatinous solid mass adapted to permit transmission of ultrasound energy through said mass, said mass comprising a sterilized patient surface configured to transmit the acoustic energy to tissues of a patient either directly or through other materials and a transducer surface configured to receive the acoustic energy from one or more ultrasound transducers in said ultrasound applicator either directly or through other materials.

40. The kit of claim 39, wherein said gelatinous solid mass is coupled to the flexible sheath.

41. An ultrasound coupling pad, comprising:

a gelatinous thermoplastic elastomer mass, said mass adapted to permit transmission of ultrasound energy through said mass; and

a means for coupling said mass to an ultrasound applicator.

42. An ultrasound coupling pad, comprising:

a gelatinous thermoplastic elastomer mass, said mass adapted to permit transmission of ultrasound energy through said mass; and

a means for coupling said mass to a patient.

43. A sterile barrier for use between a patient and an ultrasound applicator, comprising:

a gelatinous solid mass, said mass adapted to permit transmission of ultrasound energy through said mass and prevent passage of microbes from one side of the mass to the other;

a means for preventing passage of microbes from at a least a portion of an ultrasound applicator'"'"'s surface to a patient;

a means for coupling said gelatinous solid mass to said means for preventing passage of microbes.

44. A method of transmitting ultrasound energy from an ultrasound transducer to tissue of a patient, comprising:

positioning one surface of a gelatinous thermoplastic elastomer mass in close proximity to an ultrasound transducer, said mass adapted to permit transmission of ultrasound energy through said mass;

positioning another surface of the gelatinous thermoplastic elastomer mass in close proximity to tissue of a patient; and

energizing the ultrasound transducer such that ultrasound energy passes from the ultrasound transducer, through the mass, and into the tissue of the patient.

45. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to an ultrasound transducer comprises directly contacting the ultrasound transducer with the mass.

46. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to tissue of a patient comprises directly contacting the tissue with the mass.

47. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to an ultrasound transducer comprises applying an acoustic gel or liquid between the mass and the ultrasound transducer.

48. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to tissue of a patient comprises applying an acoustic gel or liquid between the mass and the patient.

49. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to an ultrasound transducer comprises coupling the mass to the ultrasound transducer.

50. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to tissue of a patient comprises coupling the mass to the patient.

51. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to an ultrasound transducer is performed prior to said step of positioning a surface of the mass in close proximity to tissue of a patient.

52. The method of claim 44, wherein said step of positioning a surface of the mass in close proximity to tissue of a patient is performed prior to said step of positioning a surface of the mass in close proximity to an ultrasound transducer.

53. A method of acoustic hemostasis, comprising:

positioning one surface of a gelatinous solid mass in close proximity to a wound on a patient, said mass adapted to permit transmission of ultrasound energy through said mass;

applying sufficient pressure to the gelatinous solid mass so as to temporarily stop or slow bleeding from said wound; and

transmitting ultrasound energy through said mass into said wound, thereby stopping bleeding from said wound.

54. The method of claim 53, wherein said step of applying pressure to the mass comprises contacting the mass with an ultrasound applicator and applying force to the ultrasound applicator.

55. A method of providing a sterile barrier between a patient and a medical instrument, comprising:

opening a seal in a flexible sheath, said sheath adapted to prevent passage of microbes from one side of the sheath to the other, the seal disposed on said sheath, wherein when said seal is closed, said seal prevents passage of microbes from one side of the seal to the other, wherein prior to opening the seal, the flexible sheath with closed seal forms a continuous barrier having no opening therein and having no edges, said continuous barrier having an inside surface and an outside surface, wherein said inside surface is sterilized;

contacting a medical instrument with said outside surface of the flexible sheath; and

inverting the flexible sheath so that the sterilized inside surface faces outward and the outside surface faces inward in contact with the medical instrument, thereby providing a barrier between the medical instrument and the sterilized surface of the sheath.

56. The method of claim 55, wherein said opening of the seal and inverting of the flexible sheath is accomplished by pulling on tabs fixed on said outside surface.

57. The method of claim 55, wherein said step of opening of the seal is performed prior to said step of contacting a medical instrument with said outside surface.

58. The method of claim 55, wherein said step of contacting a medical instrument with said outside surface is performed prior to said step of opening of the seal.

59. The method of claim 55, wherein said opening, contacting, and inverting steps are performed by non-sterile personnel.

60. The method of claim 55, wherein said contacting step is performed by partially inverting said flexible sheath prior to said opening step.

61. A method of providing a sterile barrier for use between a patient and an ultrasound applicator, comprising:

inserting an ultrasound applicator within a flexible sheath adapted to prevent passage of microbes from one side of the sheath to the other; and

coupling a gelatinous solid mass to the ultrasound applicator in close proximity to one or more ultrasound transducers, the gelatinous solid mass adapted to permit transmission of ultrasound energy through said mass and prevent passage of microbes from one side of the mass to the other.

62. The method of claim 61, wherein said gelatinous solid mass is coupled to said flexible sheath such that the coupling step is performed after the ultrasound applicator is at least partially inserted within the flexible sheath.

63. The method of claim 61, wherein the coupling step comprises sandwiching the flexible sheath between the ultrasound applicator and the gelatinous solid mass.

64. A method of providing a sterile barrier for use between a patient and an ultrasound applicator, comprising:

coupling a gelatinous solid mass to an ultrasound applicator in close proximity to one or more ultrasound transducers, the gelatinous solid mass adapted to permit transmission of ultrasound energy through said mass and prevent passage of microbes from one side of the mass to the other, said mass comprising a sterilized patient surface and a protective barrier applied to the surface, whereby sterility of the surface is maintained; and

removing the protective barrier from the patient surface.

65. The method of claim 64, wherein said removing step is performed after said coupling step.

66. The method of claim 64, wherein said protective barrier comprises a film and said removing step comprises peeling off the film from the patient surface.

67. A method of providing a sterile barrier for use between a patient and an ultrasound applicator, comprising:

removing a protective barrier from a patient surface of gelatinous solid mass, the mass adapted to permit transmission of ultrasound energy therethrough and prevent passage of microbes from one side of the mass to the other, the protective barrier applied to the patient surface of the mass to maintain sterility of the surface prior to use; and

coupling the gelatinous solid mass to a patient so that the patient surface is in close proximity to the patient.

68. A method of optimizing a thermoplastic elastomer for use as an acoustic coupler, the thermoplastic elastomer comprising a soft block segment, a hard block segment, and one or more modifier, the modifier selected from the group consisting of a hard block compatible modifier and a soft block compatible modifier, the method comprising varying at least one of the soft block segment, the hard block segment, and the modifier until an elastomer having one or more desired properties is obtained.

69. The method of claim 68, wherein said varying comprises varying the relative amounts of the soft block segment, hard block segment, and the modifier.

70. The method of claim 68, wherein said varying comprises varying the composition of at least one of the soft block segment, the hard block segment, and the modifier.

71. The method of claim 68, wherein at least one desired property is an acoustic property.

72. The method of claim 71, wherein the acoustic property comprises acoustic impedance.

73. The method of claim 71, wherein the acoustic property comprises acoustic attenuation.

74. The method of claim 68, wherein at least one desired property is a mechanical property.

75. The method of claim 74, wherein the mechanical property comprises compression force transmission.

76. The method of claim 74, wherein the mechanical property comprises elasticity.

77. The method of claim 68, wherein at least one desired property is a thermal insulative property.