US6056738A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Interstitial fluid monitoring
Assignee: Transmedica International Inc USA
•
Filing: 1997-10-22
•
Granted: 2000-05-02
•
Expires: 2017-10-22
Abstract
Abstract The present invention provides an improved method of measuring analytes in bodily fluids without the use of a sharp. The method having the steps of irradiating the skin of a patient by focused pulses of electromagnetic energy emitted by a laser. By proper selection of wavelength, energy fluence, pulse temporal width and irradiation spot size, the pulses precisely irradiate the skin to a selectable depth, without causing clinically relevant damage to healthy portions of the skin. After irradiation, interstitial fluid is collected into a container or left on the skin. The interstitial fluid is then tested for a desired analyte to approximate the analyte concentration in other bodily fluids. Alternatively, after the forced formation of a microblister, the epidermis covering the microblister is lysed and the interstitial fluid is subsequently collected and tested.
Inventors
- 👤 Kevin S. Marchitto
- 👤 Stephen T. Flock
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-06 13:48
CPC Classifications
A; A61; A61B; A61B18/00; A61B18/18; A61B18/20; A61B18/203; A61B5/00; A61B5/15; A61B5/150007; A61B5/150015; A61B5/150022; A61B5/150053; A61B5/150061; A61B5/150076; A61B5/150099; A61B5/151; A61B5/15134; A61B5/15136; A61B5/15138; A61B5/41; A61B5/411; A61M; A61M37/00; H; H04; H04R; H04R25/00; H04R25/75; A61B17/00; A61B17/34; A61B17/3476; A61B10/00; A61B10/0045; A61B2010/008; A61B2017/00017; A61B2017/00022; A61B2017/00057; A61B2017/00743; A61B2017/00747; A61B2017/00765; A61B2018/00315; A61B2018/00452; A61B90/00; A61B90/39; A61B2090/3937; A61B2090/395; A61B2218/00; A61B2218/001; A61B2218/007; A61B2218/008; A61M2037/0007
Claims Analysis
Total Claims: 45
Claim 1
Independent Claim
86 words
A method of measuring analyte concentrations in bodily fluids, comprising the steps of: a) focusing a laser beam with sufficient energy fluence to alter the skin at least as deep as the stratum corneum, but not as deep as the capillary layer; and b) firing the laser to create a site of alteration, the site having a diameter of between 0.5 microns and 5.0 cm. c) collecting a sample of interstitial fluid released by steps (a) and (b); and d) testing the fluid for analyte concentration.
Claim 2
Independent Claim
86 words
A method of measuring analyte concentrations in bodily fluids, comprising the steps of: a) focusing a laser beam with sufficient energy fluence to alter the skin at least as deep as the stratum corneum, but not as deep as the capillary layer; and b) firing the laser to create a site of alteration, the site having a diameter of between 0.5 microns and 5.0 cm. c) collecting a sample of interstitial fluid released by steps (a) and (b); and d) testing the fluid for analyte concentration.
Claim 3
Dependent Claim
15 words
The method of claim 1, wherein the laser beam has a wavelength of 0.2-10 microns.
Claim 4
Dependent Claim
16 words
The method of claim 1, wherein the laser beam has a wavelength of between 1.5-3.0 microns.
Claim 5
Dependent Claim
16 words
The method of claim 1, wherein the laser beam has a wavelength of about 2.94 microns.
Claim 6
Dependent Claim
51 words
The method of claim 1, wherein a laser selected from the group consisting of Er:YAG, pulsed CO 2 , Ho:YAG, Er:YAP, Er/Cr:YSGG, Ho:YSGG, Er:GGSG, Er:YLF, Tm:YAG, Ho:YAG, Ho/Nd:Yalo 3 , cobalt:MgF 2 , HF chemical, DF chemical, carbon monoxide, deep UV lasers, and frequency tripled Nd:YAG lasers emits the laser beam.
Claim 7
Dependent Claim
13 words
The method of claim 1, wherein an Er:YAG laser emits the laser beam.
Claim 8
Dependent Claim
28 words
The method of claim 1, wherein a modulated laser selected from the group consisting of continuous-wave CO 2 , Nd:YAG, Thallium:YAG and diode lasers emits the laser beam.
Claim 9
Dependent Claim
24 words
The method of claim 1, wherein the laser beam is focused to a diameter of 0.1 mm-5.0 mm at a site on the skin.
Claim 10
Dependent Claim
21 words
The method of claim 1, wherein the energy fluence of the laser beam at the skin is 0.03-100,000 J/cm 2 .
Claim 11
Dependent Claim
21 words
The method of claim 1, wherein the energy fluence of the laser beam at the skin is 0.03-9.6 J/cm 2 .
Claim 12
Dependent Claim
12 words
The method of claim 1, wherein multiple sites of alteration are created.
Claim 13
Dependent Claim
21 words
The method of claim 1, further comprising a beam splitter positioned to create, simultaneously from the laser, multiple sites of alteration.
Claim 14
Dependent Claim
29 words
The method of claim 12, wherein the beam splitter is selected from a series of partially silvered mirrors, a series of dichroic mirrors, and a series of beam-splitting prisms.
Claim 15
Dependent Claim
33 words
The method of claim 1, further comprising an acousto-optic modulator outside the laser cavity wherein the modulator consecutively deflects the beam at different angles to create different sites of alteration on the skin.
Claim 16
Dependent Claim
61 words
The method of claim 1, wherein the analyte to be measured is selected from the group consisting of Na + , K + , Ca ++ , Mg ++ , Cl - , HCO 3 - , HHCO 3 , phosphates, S 4 -- , glucose, amino acid, cholesterol, phospholipids, neutral fat, PO 2 -- , pH, organic acids or proteins.
Claim 17
Dependent Claim
29 words
The method of claim 1, further comprising a container positioned proximal to the site of alteration and through which the laser beam passes for collection of the interstitial fluid.
Claim 18
Dependent Claim
21 words
The method of claim 1, wherein the analyte concentration is tested while the container unit is attached to the laser device.
Claim 19
Dependent Claim
24 words
The method of claim 1, further comprising the step of applying a therapeutically effective amount of a pharmaceutical composition at the site of alteration.
Claim 20
Dependent Claim
19 words
The method of claim 18, wherein the anaylyte concentration is used to determine the amount of pharmaceutical substance administered.
Claim 21
Dependent Claim
32 words
The method of claim 1, further comprising the step of applying a pressure gradient to the skin after formation of the site of alteration to increase the diffusion rate of interstitial fluid.
Claim 22
Dependent Claim
25 words
The method of claim 1, further comprising the step of mechanically increasing the diffusion rate of interstitial fluid after formation of a site of alteration.
Claim 23
Dependent Claim
18 words
The method of claim 21, wherein sub-atmospheric pressure is applied at the site of alteration to increase diffusion.
Claim 24
Dependent Claim
13 words
The method of claim 22, wherein the container unit is under sub-atmospheric pressure.
Claim 25
Dependent Claim
23 words
The method of claim 1, wherein the removal of bodily fluids is increased by applying a pressure gradient at the site of alteration.
Claim 26
Independent Claim
73 words
A method of measuring analyte concentration in bodily fluids, comprising the steps of: a) applying sub-atmospheric pressure at the surface of the skin to induce the formation of a microblister; b) focusing a laser beam with sufficient energy fluence to lyse a microblister; c) firing the laser to lyse the blister; d) collecting a sample of interstitial fluid released by steps (a), (b) and (c); and e) testing the fluid for analyte concentration.
Claim 27
Independent Claim
73 words
A method of measuring analyte concentration in bodily fluids, comprising the steps of: a) applying sub-atmospheric pressure at the surface of the skin to induce the formation of a microblister; b) focusing a laser beam with sufficient energy fluence to lyse a microblister; c) firing the laser to lyse the blister; d) collecting a sample of interstitial fluid released by steps (a), (b) and (c); and e) testing the fluid for analyte concentration.
Claim 28
Dependent Claim
15 words
The method of claim 25, wherein the laser beam has a wavelength of 0.2-10 microns.
Claim 29
Dependent Claim
16 words
The method of claim 25, wherein the laser beam has a wavelength of between 1.5-3.0 microns.
Claim 30
Dependent Claim
16 words
The method of claim 25, wherein the laser beam has a wavelength of about 2.94 microns.
Claim 31
Dependent Claim
50 words
The method of claim 25, wherein a laser selected from the group consisting of Er:YAG, pulsed CO 2 Ho:YAG, Er:YAP, Er/Cr:YSGG, Ho:YSGG, Er:GGSG, Er:YLF, Tm:YAG, Ho:YAG, Ho/Nd:Yalo 3 , cobalt:MgF 2 , HF chemical, DF chemical, carbon monoxide, deep UV lasers, and frequency tripled Nd:YAG lasers emits the laser beam.
Claim 32
Dependent Claim
13 words
The method of claim 25, wherein an Er:YAG laser emits the laser beam.
Claim 33
Dependent Claim
28 words
The method of claim 25, wherein a modulated laser selected from the group consisting of continuous-wave CO 2 , Nd:YAG, Thallium:YAG and diode lasers emits the laser beam.
Claim 34
Dependent Claim
23 words
The method of claim 25, wherein the laser beam is focused to a diameter 0.1 mm-5.0 mm at a site on the skin.
Claim 35
Dependent Claim
21 words
The method of claim 25, wherein the energy fluence of the laser beam at the skin is 0.03-100,000 J/cm 2 .
Claim 36
Dependent Claim
21 words
The method of claim 25, wherein the energy fluence of the laser beam at the skin is 0.03-9.6 J/cm 2 .
Claim 37
Dependent Claim
10 words
The method of claim 25, wherein multiple microblisters are created.
Claim 38
Dependent Claim
19 words
The method of claim 25, further comprising a beam splitter positioned to lyse, simultaneously from the laser, multiple microblisters.
Claim 39
Dependent Claim
29 words
The method of claim 36, wherein the beam splitter is selected from a series of partially silvered mirrors, a series of dichroic mirrors, and a series of beam-splitting prisms.
Claim 40
Dependent Claim
28 words
The method of claim 25, further comprising an acousto-optic modulator outside the laser cavity wherein the modulator consecutively deflects the beam at different angles to lyse different microblisters.
Claim 41
Dependent Claim
61 words
The method of claim 25, wherein the analyte to be measured is selected from the group consisting of Na + , K + , Ca ++ , Mg ++ , Cl - , HCO 3 - , HHCO 3 , phosphates, S 4 -- , glucose, amino acid, cholesterol, phospholipids, neutral fat, PO 2 -- , pH, organic acids or proteins.
Claim 42
Dependent Claim
27 words
The method of claim 25, further comprising a container positioned proximal to the microblister and through which the laser beam passes for collection of the interstitial fluid.
Claim 43
Dependent Claim
21 words
The method of claim 25, wherein the analyte concentration is tested while the container unit is attached to the laser device.
Claim 44
Dependent Claim
23 words
The method of claim 25, further comprising the step of applying a therapeutically effective amount of a pharmaceutical composition at the microblister site.
Claim 45
Dependent Claim
19 words
The method of claim 42, wherein the analyte concentration is used to determine the amount of pharmaceutical substance administered.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2003-05-02 | 2003-11-01 | 2004-05-02 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2007-05-02 | 2007-11-01 | 2008-05-02 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2011-05-02 | 2011-11-01 | 2012-05-02 | $7700.00 | Window Closed / Lapsed |