Ultrasound medical diagnostic device having a coupling medium providing self-adherence to a patient

• US 5,394,877 A
• Filed: 03/21/1994
• Issued: 03/07/1995
• Est. Priority Date: 04/01/1993
• Status: Expired due to Fees

• Current Assignee: Axon Medical, Inc.
• Original Assignee: Axon Medical, Inc.
• Inventors: Silva, Fidel H., Orr, Joseph A., Westenskow, Dwayne R.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/216,079
• Time in Patent Office: 351 Days
• Field of Search: 128/662.03, 128/639, 128/640, 128/643, 128/798, 128/802, 128/803, 128/891, 607/149, 607/150
• US Class Current: 600/459
• CPC Class Codes: A61B 2046/205 Adhesive drapes
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 8/02 Measuring pulse or heart rate
• CPC Class Codes: A61B 8/0866 involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
• CPC Class Codes: A61B 8/4236 characterised by adhesive patches
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4455 Features of the external shape of the probe, e.g. ergonomic aspects

Abstract

A contact medium structure attachable to externally-applied medical diagnostic devices for providing self-adherence of the medical device to the skin of a patient thereby eliminating the need for belts or similar means. The contact medium is inherently adhesive, hydrophilic, skin-compatible, ultrasonic-compatible and pressure sensitive to facilitate self-adhesion of the medical device to the patient'"'"'s skin. A particularly suitable contact medium is a mesh-reinforced hydrogel film which adheres to the device and extends beyond the perimeter of the device to provide additional adhesiveness and compliance with the contour of the patient'"'"'s body. A support element associated with and extending beyond the perimeter of the medical device adheres to the contact medium and provides adjustability of the extended hydrogel film relative to the patient'"'"'s skin.

Claims

1. Structure for providing adherence of an externally-applied medical diagnostic device to the skin of a patient comprising:

adhesive coupling medium having a central portion attachable to a diagnostic device configured with an external profile perimeter, said adhesive coupling medium being positionable between said device and the skin of a patient, said adhesive coupling medium being skin-compatible and pressure sensitive and sized with a flap portion which extends laterally a selected distance beyond said external profile perimeter of said diagnostic device; and

flexible support structure attachable to said diagnostic device and substantially laterally coextensive with and attached to said flap portion of said adhesive coupling medium, said flexible support structure being configured to provide variable distance positioning of said flap portion relative to said skin of said patient and to selectively maintain said flap portion in a sustained position away from said skin when said central portion of said adhesive coupling medium is positioned against said skin.

2. The structure of claim 1 wherein said adhesive coupling medium is a film hydrogel having a first adhesive surface attached to said flexible support structure, and a second adhesive side positionable against said skin.

3. The structure of claim 2 wherein said hydrogel further comprises a mesh layer imbedded in said film.

4. The structure of claim 1 wherein said adhesive coupling medium is formed from a material having a density conducive to transmission of sound waves therethrough.

5. A transducer assembly for patient monitoring, comprising:

a housing containing an emitter for producing sound waves transmissible through the body tissues of said patient;

adhesive coupling medium positioned between said housing structure and the skin of said patient, said coupling medium having a density conducive to transmission of said sound waves through said body of said patient and being structured to provide self-adhesion of said assembly to said skin; and

flexible support structure associated with said housing and attachable to said coupling medium to provide selectively sustained variable distance positioning of said coupling medium relative to and away from said skin of said patient.

6. The transducer assembly of claim 5 wherein said coupling medium is a film of solid hydrogel, said hydrogel being hydrophilic, skin-compatible and pressure sensitive.

7. The transducer assembly of claim 6 wherein said film of hydrogel extends beyond the perimeter of said housing a selected distance to provide enhanced adherence of said hydrogel to said skin.

8. The transducer assembly of claim 7 wherein said housing is round, and said selected distance is about twenty-five percent of the radius of said housing.

9. The transducer assembly of claim 7 wherein said flexible support structure extends beyond said perimeter of said housing to facilitate attachment of said extended hydrogel film thereto.

10. The transducer assembly of claim 9 wherein said flexible support structure comprises a skirt of material associated with said housing and shaped to substantially surround said perimeter thereof.

11. The transducer assembly of claim 10 wherein said skirt is notched in an area of said skirt proximate the housing to provide flexibility to said skirt when positioned at said variable distances away from said skin.

12. The transducer assembly of claim 10 wherein said skirt is articulable with respect to said housing.

13. The transducer assembly of claim 10 wherein said skirt comprises a plurality of flexible flaps extending outwardly from said housing, said flaps overlying said hydrogel film.

14. The transducer assembly of claim 10 wherein said support structure further includes a collar surrounding said perimeter of said housing and attached thereto, said skirt being attached to said collar.

15. The transducer assembly of claim 14 wherein said skirt is notched proximate the attachment of said skirt to said collar to provide flexibility to said skirt when positioned at said variable distances away from said skin.

16. The transducer as of claim 14 wherein said skirt is articulable with respect to said collar.

17. A transducer assembly for patient monitoring, comprising:

a housing containing structure to produce and detect sound waves transmissible through the body tissues of a patient, said housing having a perimeter;

adhesive contact medium having a central portion positioned between said housing and said skin of said patient to provide transmission of sound waves therethrough, said adhesive coupling medium being sized to extend laterally beyond said perimeter of said housing a selected distance, said contact medium having a selected density compatible with transmission of said sound waves through said body tissue; and

flexible support structure associated with said housing and sized to extend laterally beyond said perimeter of said housing to support and retain said laterally extending adhesive coupling medium in at least one position away from said skin of said patient when said central portion of said adhesive coupling medium is positioned against said patient'"'"'s skin.

18. The transducer assembly of claim 17 wherein said adhesive contact medium is a mesh-reinforced film of hydrogel, said hydrogel being hydrophilic, skin-compatible and pressure sensitive.

19. The transducer assembly of claim 18 wherein said flexible support structure is adjustable from a first position proximate said skin of said patient to a second position apart from said skin.

20. A method of performing ultrasound diagnoses comprising:

providing an ultrasound device having a housing containing structure for producing and detecting sound waves transmissible through the body tissue of a patient, an adhesive hydrogel film contact medium positioned between said housing and the skin of said patient to transmit sound waves therethrough, said hydrogel film being sized to extend beyond the perimeter of said housing, and flexible support structure associated with said housing to which said hydrogel film is secured, said flexible support structure providing adjustability of said extended hydrogel film relative to said skin;

adjusting said flexible support structure to position and retain said extended hydrogel film away from said skin;

placing said ultrasound device in proximity to said patient'"'"'s skin with said hydrogel film positioned between said housing and said skin;

producing said sound waves from said ultrasound device;

moving said ultrasound device about said patient'"'"'s body until a desired signal is detected by said ultrasound device; and

adjusting said flexible support structure to position said extended hydrogel film against said skin to enhance adherence of said extended hydrogel film to said skin.

21. The method according to claim 20 further including:

repositioning said ultrasound device by adjusting said flexible support structure to position and retain said extended hydrogel film away from said skin;

moving said ultrasound device about said patient'"'"'s skin until a desired new signal is detected; and

adjusting said flexible support structure to position said extended hydrogel film against said skin.

22. The method according to claim 21 further including moistening said hydrogel before positioning said ultrasound device against said patient'"'"'s skin prior to moving said ultrasound device about said patient'"'"'s skin.

23. The method according to claim 22 wherein said hydrogel is moistened with a fluid-like coupling gel to enhance said adhesiveness of said hydrogel.

24. Structure for providing adherence of an externally-applied medical diagnostic device to the skin of a patient comprising:

a flexible support structure having an outer perimeter and an internal perimeter securable to an external profile of a diagnostic device, said outer perimeter of said flexible support structure being variably positionable relative to said internal perimeter, and said flexible support structure being configured to retain said outer perimeter of said flexible support structure in a first position on one side of a lateral plane formed through said internal perimeter and in a second position on an opposite side of said lateral plane formed through said internal perimeter; and

adhesive coupling medium attached to said flexible support structure and being substantially coextensive therewith from said internal perimeter to said external perimeter thereof, said adhesive coupling medium having a central portion located within said internal perimeter of said flexible support structure and attachable to a diagnostic device, and said adhesive coupling medium further being substantially located within said lateral plane of said internal perimeter of said flexible support structure.

25. A self-adherent medical diagnostic device comprising:

support means having a central portion positionable against the skin of a patient, a peripheral outer edge and a laterally extending multipositionable skirt portion extending from proximate said central portion to said peripheral outer edge, said multipositionable skirt portion being rotationally deflectable with respect to the plane of said support means and self-retaining in at least two positions relative to said central portion; and

an adhesive coupling medium attached to said support means for adherence of said support means to the skin of a patient, said adhesive coupling medium being substantially coextensive with said support means and being substantially continuous from any point proximate said peripheral edge and extending across said central portion to an opposite point proximate said peripheral outer edge.

26. The self-adherent medical device of claim 25 wherein said adhesive coupling medium further comprises means for permitting removal of said support means when adhered to a patient'"'"'s skin and readherence of said support means to said skin at least one additional time.

27. The self-adherent medical device of claim 26 wherein said adhesive coupling medium is formed from a material having a density conducive to effective, substantially unimpeded transmission of sound waves therethrough.

28. The self-adherent medical device of claim 27 further including a housing attached to said support means, said housing containing a transducer oriented for generation of said sound waves through said adhesive coupling medium.