Solid multipurpose ultrasonic biomedical couplant gel in sheet form and method
First Claim
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1. A solid ultrasonic biomedical couplant in sheet form, comprising:
- a hydrogel couplant sheet having a broad upper surface that is exposed to the air during use for receiving ultrasonic waves from a moveable ultrasonic generator such that the exposed upper surface allows direct contact between the generator and the hydrogel sheet, said sheet has a broad lower surface for being placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient,the hydrogel sheet is adapted to extend over an area that includes different positions where readings are taken with the ultrasonic generator such that said ultrasonic generator is moveable to said different positions while in direct contact with said broad upper surface of the hydrogel sheet,said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant,said sheet is an integral self-supporting solid body of material having a defined shape in which the upper surface is a top portion of the solid body, the lower surface forms a bottom portion of the solid body, and an edge defines a periphery of the solid body, and said sheet is flexible and sufficiently pliant to conform to the body contours of the patient,the exposed upper surface of the hydrogel sheet has lubricating properties and the lubricity of the hydrogel sheet facilitates movement of the ultrasonic generator thereacross while the solid body of gel material remains in place on the skin of the patient as the generator is moved thereon, andmeans for holding the sheet against the skin of the patient to facilitate the transfer of ultrasonic waves generated by the ultrasonic generator to and from the body of said patient through different portions of the sheet.
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Abstract
A solid, multipurpose, flexible, ultrasonic biomedical couplant hydrogel in sheet form is applied to the skin of a patient to facilitate the transfer of ultrasound energy between a standard ultrasound instrument and the body. The couplant sheet has broad upper and lower surfaces and a narrow peripheral edge which is usually circular, square or rectangular but can have other shapes such as the shape of the part of the body being monitored. During use, the lower surface of the sheet is applied to the skin of a patient and remain in place throughout use. The ultrasound instrument is then passed back and forth, usually in contact with the exposed upper surface of the hydrogel sheet while ultrasound energy is transmitted through the hydrogel which serves as a transmission path for the sonic energy passing to and from the body of the patient. The hydrogel sheet of the present invention is a flexible, self-supporting solid sheet which holds its form during storage and when placed on the body. The sheet contains water and a humectant such as triethylene glycol or glycerin and a network of long hydrophilic polymer molecules that hold the liquid in place and give solidity to the hydrogel sheet The polymer can comprise polyacrylamide, karaya gum or a modified starch.
232 Citations
23 Claims
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1. A solid ultrasonic biomedical couplant in sheet form, comprising:
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a hydrogel couplant sheet having a broad upper surface that is exposed to the air during use for receiving ultrasonic waves from a moveable ultrasonic generator such that the exposed upper surface allows direct contact between the generator and the hydrogel sheet, said sheet has a broad lower surface for being placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient, the hydrogel sheet is adapted to extend over an area that includes different positions where readings are taken with the ultrasonic generator such that said ultrasonic generator is moveable to said different positions while in direct contact with said broad upper surface of the hydrogel sheet, said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet is an integral self-supporting solid body of material having a defined shape in which the upper surface is a top portion of the solid body, the lower surface forms a bottom portion of the solid body, and an edge defines a periphery of the solid body, and said sheet is flexible and sufficiently pliant to conform to the body contours of the patient, the exposed upper surface of the hydrogel sheet has lubricating properties and the lubricity of the hydrogel sheet facilitates movement of the ultrasonic generator thereacross while the solid body of gel material remains in place on the skin of the patient as the generator is moved thereon, and means for holding the sheet against the skin of the patient to facilitate the transfer of ultrasonic waves generated by the ultrasonic generator to and from the body of said patient through different portions of the sheet. - View Dependent Claims (2, 3)
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4. A solid ultrasonic biomedical couplant in sheet form, comprising:
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a hydrogel couplant sheet having a broad upper surface for receiving ultrasonic waves from an ultrasonic generator and a broad lower surface adapted to be placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient, said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet being flexible, solid and sufficiently pliant to conform to the body contours of the patient, means for holding the sheet against the skin of the patient to facilitate the transfer of said ultrasonic waves generated by said ultrasonic generator to and from the body of said patient through the sheet, a removable liner sheet is secured to at least one of said broad surfaces of said couplant sheet, and a selected portion of said liner sheet secured to said couplant hydrogel sheet is removably connected to the couplant hydrogel sheet and at least a portion of the liner sheet remains bonded to the hydrogel sheet following the removal of said selected portion of the liner sheet. - View Dependent Claims (5, 6)
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7. A solid ultrasonic biomedical couplant in sheet form, comprising:
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a hydrogel couplant sheet having a broad upper surface for receiving ultrasonic waves from an ultrasonic generator and a broad lower surface adapted to be placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient, said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet being flexible, solid and sufficiently pliant to conform to the body contours of the patient, means for holding the sheet against the skin of the patient to facilitate the transfer of said ultrasonic waves generated by said ultrasonic generator to and from the body of said patient through the sheet, said hydrogel includes a gelation inhibitor uniformly distributed therethrough in an amount sufficient to retard gelation of the hydrogel prior to forming the hydrogel into said flexible sheet. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14)
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15. A solid ultrasonic biomedical couplant in sheet form, comprising:
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a hydrogel couplant sheet having an upper surface for receiving ultrasonic waves from a moveable ultrasonic generator and a lower surface for being placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient, the hydrogel sheet is adapted to extend over an area that includes different positions where readings are to be taken so that said ultrasonic generator is moveable to said different positions across the hydrogel sheet by being slid while being pressed toward the sheet, said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet being flexible, solid and sufficiently pliant to conform to the body contours of the patient, the sheet is sized to allow movement of the ultrasonic generator thereacross, means for holding the sheet against the skin of a patient to facilitate the transfer of ultrasonic waves generated by the ultrasonic generator to and from the body of said patient through different portions of the sheet when the generator is moved to said different portions thereon, said hydrogel sheet is surrounded by a flexible border and said flexible border comprises a sheet of plastic or rubber, and said border has upper and lower surfaces and both said upper and lower surfaces have a layer of adhesive thereon.
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16. A solid ultrasonic biomedical couplant in sheet form, comprising:
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a hydrogel couplant sheet having a broad upper surface for receiving ultrasonic waves from an ultrasonic generator and a broad lower surface adapted to be placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient, said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet being flexible, solid and sufficiently pliant to conform to the body contours of the patient, means for holding the sheet against the skin of the patient to facilitate the transfer of said ultrasonic waves generated by said ultrasonic generator to and from the body of said patient through the sheet, said hydrogel sheet is surrounded by a flexible border and said flexible border comprises a sheet of foamed plastic or a foamed rubber, said border has upper and lower surfaces and at least said lower surface has a layer of adhesive thereon, and the upper and lower surface of the hydrogel sheet and the upper and lower surfaces of the surrounding border each have a liner sheet bonded thereto to thereby enclose the hydrogel sheet on all sides and at least the liner sheet that is bonded to the lower surface of the hydrogel sheet is removably bonded to the hydrogel sheet.
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17. A method of performing ultrasonic diagnostics on the body of a patient by means of an ultrasonic transducer, comprising:
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providing a hydrogel sheet having a broad upper surface for receiving ultrasonic waves from the ultrasonic transducer and a broad lower surface adapted to placed against the skin of the patient and for transmitting the sonic waves through the skin interface to the body of the patient, said hydrogel sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet is sufficiently pliant to conform to the body contours of the patient, the hydrogel sheet is adapted to extend over an area where readings are to be taken at different locations on the patient so that said ultrasonic transducer is moveable on said broad upper surface of the hydrogel sheet to multiple positions where said readings are to be taken, applying said hydrogel sheet to the skin of a patient, moving the transducer to different positions on the hydrogel sheet, transmitting ultrasonic wave energy from said instrument through different portions of the hydrogel sheet into the body of the patient, and receiving reflected ultrasonic energy from the body of the patient through the hydrogel sheet. - View Dependent Claims (18, 19, 20, 21)
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22. A solid ultrasonic biomedical couplant in sheet form, comprising:
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a hydrogel couplant sheet having a broad upper surface for receiving ultrasonic waves from an ultrasonic generator and a broad lower surface adapted to be placed against the skin of a patient and for transmitting the ultrasonic waves through the skin interface to and from the body of the patient, said sheet comprising a dispersion of a natural or synthetic hydrophilic polymer, water and a humectant, said sheet being flexible, solid and sufficiently pliant to conform to the body contours of the patient, means for holding the sheet against the skin of the patient to facilitate the transfer of said ultrasonic waves generated by said ultrasonic generator to and from the body of said patient through the sheet, a piece of cloth embedded within said hydrogel sheet for strengthening said sheet. - View Dependent Claims (23)
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Specification
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Current AssigneeCovidien AG (Medtronic Plc)
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Original AssigneeLecTec Corporation
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InventorsRolf, David, Montecalvo, David A.
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Primary Examiner(s)Zele, Krista M.
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Assistant Examiner(s)Casler, Brian L.
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Application NumberUS08/054,745Time in Patent Office1,135 DaysField of Search128/24 AA, 128/639-641, 128/662.03, 128/663.01, 607/152, 607/97, 604/20, 73/644, 252/500, 601/2US Class Current600/459CPC Class CodesA61B 8/4281 characterised by sound-tran...A61N 1/04 Electrodes electrosurgical ...
