Source: http://www.google.co.uk/patents/US20120303076
Timestamp: 2017-11-25 02:10:14
Document Index: 225695605

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61']

Patent US20120303076 - Systems and Methods of Powered Muscle Stimulation Using an Energy Guidance Field - Google Patents
NMES systems and methods for stimulating muscle tissue, and in some embodiments deep muscle tissue. The impedance near the surface of the skin is controllably increased to increase the percentage of energy delivered to a subject that stimulates muscle tissue....http://www.google.co.uk/patents/US20120303076?utm_source=gb-gplus-sharePatent US20120303076 - Systems and Methods of Powered Muscle Stimulation Using an Energy Guidance Field
Publication number US20120303076 A1
Application number US 13/568,859
Also published as CA2751527A1, EP2398552A2, EP2398552A4, US8433403, US8676332, US20100217349, WO2010096776A2, WO2010096776A3
Publication number 13568859, 568859, US 2012/0303076 A1, US 2012/303076 A1, US 20120303076 A1, US 20120303076A1, US 2012303076 A1, US 2012303076A1, US-A1-20120303076, US-A1-2012303076, US2012/0303076A1, US2012/303076A1, US20120303076 A1, US20120303076A1, US2012303076 A1, US2012303076A1
Original Assignee Fahey Brian J
US 20120303076 A1
1. A muscle stimulation system, comprising:
2. The system of claim 1 wherein the cooling element is configured to substantially avoid cooling of superficial tissue where the electrodes are positioned.
3. The system of claim 1 wherein the cooling element is adapted to substantially eliminate superficial current paths.
4. The system of claim 1 wherein the stimulation pad comprises the cooling element.
5. The system of claim 1 wherein the cooling element has a width and the plurality of electrodes span a width, and the width of the cooling element is greater than the width of the plurality of electrodes.
6. The system of claim 5 wherein the width of the cooling element is configured to substantially prevent superficial arcing around the cooling element.
7. The system of claim 1 further comprising a cooling element control unit which is adapted to control the operation of the cooling element.
8. The system of claim 7 wherein the cooling element control unit in is fluid communication with the cooling element and is configured to control the flow of a fluid through the cooling element.
9. The system of claim 8 wherein the cooling element control unit comprises a pump configured to pump the fluid through the cooling element.
10. The system of claim 7 wherein the cooling element comprises an internal lumen in fluid communication with the cooling element control unit.
11. The system of claim 7 wherein the cooling element control unit is configured to control a thermoelectric element.
12. A muscle stimulation system, comprising:
13. The system of claim 12 wherein the cooling element control unit is configured to control the temperature of the cooling element.
14. The system of claim 13 wherein the cooling element control unit is configured to maintain the cooling element at a substantially constant temperature.
15. The system of claim 13 wherein the cooling element control unit is configured to decrease the temperature of the cooling element after it has been activated.
16. The system of claim 12 wherein the cooling element control unit is configured to activate the cooling element.
17. The system of claim 16 wherein the cooling element control unit is configured to deactivate the cooling element while the stimulation control unit is delivering electrical stimulation to the plurality of electrodes.
18. The system of claim 16 wherein the cooling element control unit is configured to intermittently activate the cooling element.
19. The system of claim 12 wherein the cooling element is sized and shaped to be disposed between the plurality of stimulation electrodes.
20. The system of claim 19 wherein the cooling element is sized and shaped to be disposed at least partially surrounding the plurality of electrodes.
21. The system of claim 12 wherein the plurality of electrodes are integrated into a simulation pad.
22. The system of claim 12 wherein the cooling element is integrated into the stimulation pad.
23. The system of claim 12 wherein the cooling element has an internal lumen therein in fluid communication with the cooling element control unit, and wherein the cooling element control unit comprises a pump to pump fluid through the cooling element.
24. The system of claim 12 wherein the control element is a thermoelectric device, and wherein the cooling element control unit is adapted to control the thermoelectric device.
This application is a divisional application of pending U.S. application Ser. No. 12/710,243, filed Feb. 22, 2010, which application claims the benefit of the following U.S. Provisional Applications: Application No. 61/208,119, filed Feb. 20,2009; and Application No. 61/230,587, filed Jul. 31, 2009, which are incorporated by reference herein.
This application is related to the following patent applications: Application No. 61/260,324, filed Nov. 11, 2009; application Ser. No. 12/497,230, filed Jul. 2, 2009; Application No. 61/189,558, filed Aug. 19, 2008; application Ser. No. 12/548,155, filed Aug. 26, 2009, Application No. 61/190,602, filed Aug. 29, 2008; and Application No. 61/201,877, filed Dec. 15, 2008, all of which are incorporated herein by reference.
FIG. 1B illustrates limb 102 from FIG. 1A but includes a surface cooling element 105 placed in contact with the surface of the skin, and is disposed on the skin at a location between stimulation electrodes 101. Cooling element 105 generally creates an energy guidance ield to drive energy deeper towards muscle tissue. In this embodiment, cooling element 105 creates a temperature gradient from the surface of the skin to a location below the surface of the skin. The surface of the skin can be considered the low temperature end of the temperature gradient. The frequencies of electrical energy utilized by muscle stimulators are generally lower (generally lower than about 10 kHz) than those used in ablative or cosmetic applications (generally greater than about 300 kHz for RF and greater than about 3 GHz for microwave), and thus typically do not generate significant tissue heating, especially in deep tissue regions. Additionally, the use of muscle stimulators typically does not produce tissue temperatures greater than about 40° C. (consistent with many regulatory and governing body guidelines—see Prausnitz 2006 above). For tissue temperatures below 40° C., the effect of temperature on tissue impedance is generally opposite that found at the higher temperatures used during ablative and cosmetic procedures, with tissue impedance increasing by about 2%/° C. (see Miklavcic et al, Electrical Properties of Tissues, Wiley Encyclopedia of Biomedical Engineering, 2006, which is incorporated herein by reference). When the tissue nearest the surface of the skin is cooled due to the application of cooling element 105, a three-dimensional temperature gradient will be created in the tissue, which will essentially create a 3-dimensional impedance gradient where the impedance of a tissue will increase in proportion to the degree to which it is cooled. The amount of tissue impedance increase from body temperature impedance level is therefore at least partially dependent on the distance between cooling element 105 and the tissue. Tissues nearest the surface where cooling element 105 is disposed are cooled the most and will experience the largest impedance increases relative to body temperature impedance levels. The impedance at depths near muscle tissue 103 will increase less (if at all) than the impedance of the tissue directly under cooling element 105. NMES coupled with surface cooling therefore has the opposite effect that superficial cooling has when used with higher temperature applications such as ablation or cosmetic procedures described above.
In some embodiments the stimulation pad is comprised of a thin and flexible housing with an adhesive hydrogel backing to facilitate maintenance of skin contact. The hydrogel backing will also enhance the coupling of electrical energy and signals between stimulation electrodes and the person's body.
FIGS. 10A-10C illustrate exemplary embodiments of activation mechanisms for a chemical cooling pack to be incorporated with NMES therapy. In FIG. 10A(1), chemical cooling pack 900 is squeezed, thereby breaking an inner lumen to mix chemicals and provide a cold source. In FIG. 10A(2), cold source 901 is placed in the region of muscle stimulation in a location between stimulation electrodes 902. In FIG. 10B, stimulation pad 906 includes stimulation electrodes 902, chemical cooling pack 904, and strap and hook mechanism 905. After positioning the cooling pack in the desired location on the skin, the strap is pulled tight around pivot point 907. Pulling the strap exerts force on the chemical pack 904, breaking an inner lumen and mixing chemicals to create a cold source. The strap is then secured to itself using, for example, a Velcro strap, snap, or other securing mechanism. The cold source is thereafter held in place. In FIG. 10C, the stimulation pad is in electrical communication with control unit 908. A cross-sectional view of the chemical cooling pack is shown. Wires 909 from control unit 908 extend through outer compartment 910 of the cooling pack and connect to resistive heating components 912 secured to inner lumen 911 of the cooling pack. At a desired time, control unit 908 sends electrical signals to resisting heating components 912 via wires 909, which melts portions of the inner lumen, causing the chemicals to mix and thereby create a cold source which can then be applied to the skin.
A research study has investigated the NMES therapy with skin cooling disclosed herein. Twenty healthy volunteers were recruited. The first group (Group 1) of ten volunteers included all-comers (median age 44 years, range 22-70 years, median BMI 25.0, range 22.0-38.3). The second group (Group 2) of volunteers consisted entirely of clinically obese (BMI>30.0) individuals (median age 53 years, range 25-75 years, median BMI 32.4, range 30.1-39.6). An additional research study that recruits critically ill patients is underway, and preliminary results are available.
US5097828 * 25 Sep 1990 24 Mar 1992 Richard Deutsch Thermoelectric therapy device
US5336255 * 11 Jan 1993 9 Aug 1994 Kanare Donald M Electrical stimulation heat/cool pack
US20060142816 * 29 Dec 2004 29 Jun 2006 Fruitman Clinton O Transcutaneous electrical nerve stimulator with hot or cold thermal application
US8433403 22 Feb 2010 30 Apr 2013 Niveus Medical, Inc. Systems and methods of powered muscle stimulation using an energy guidance field
US8892210 8 Oct 2012 18 Nov 2014 Niveus Medical, Inc. Devices, systems, and methods for automated optimization of energy delivery
US9126039 1 Nov 2013 8 Sep 2015 Niveus Medical, Inc. Synergistic muscle activation device
US9149386 25 Jun 2013 6 Oct 2015 Niveus Medical, Inc. Devices and systems for stimulation of tissues
International Classification A61F7/10, A61N1/36
Cooperative Classification A61F7/10, A61F7/03, A61F2007/0276, A61F2007/0056, A61F2007/0075, A61N1/0452, A61N1/0492, A61N1/36003
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:FAHEY, BRIAN J.;REEL/FRAME:029413/0583