Systems for increasing a delay in the gastric emptying time for a patient using a transcutaneous electro-dermal patch

• US 9,956,393 B2
• Filed: 12/06/2016
• Issued: 05/01/2018
• Est. Priority Date: 02/24/2015
• Status: Active Grant

• Current Assignee: Elira, Inc.
• Original Assignee: Elira, Inc.
• Inventors: Perez, Raul E., Hong, Peter I., Diianni, Steven, Malave, Luis Jose, Stengel, Brad
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US15/370,944
• Publication Number:
  US 20170080207A1
• Time in Patent Office: 511 Days
• Field of Search: None
• CPC Class Codes: A61F 5/0003 Apparatus for the treatment of obesity; Anti-eating devices surgical instruments or methods for treatment of obesity, devices specially adapted therefor A61B17/00; hollow or tubular parts of organs A61F2/04
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0502 Skin piercing electrodes
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36085 Eating disorders or obesity

Abstract

The disclosed wearable device modulates a patient'"'"'s gastric emptying time and/or gastric retention time. The wearable device includes a microprocessor, electrical stimulator and at least one electrode configured to deliver electrical stimulation to the epidermis, through a range of 0.1 mm to 10 mm or a range of 0.1 mm to 20 mm of the dermis, of a T2 dermatome to a T12 dermatome or meridian of the patient, a C5 to a T1 dermatome across the hand and/or arm, and/or the upper chest regions. The device is adapted to provide electrical stimulation as per stimulation protocols and to communicate wirelessly with a companion control device configured to monitor and record appetite patterns of the patient. The control device is also configured to monitor, record, and modify stimulation parameters of the stimulation protocols.

Claims

1. An electrical dermal stimulation system configured to cause a delay in emptying of a patient'"'"'s stomach contents, comprising:

a housing having a base surface, wherein said base surface is defined by a total base surface area;

a controller positioned within the housing;

at least one electrode having a base surface and attached to the base surface of said housing, wherein the base surface of the at least one electrode is adapted to be in electrical contact with said patient'"'"'s epidermis and wherein at least one of the base surface of the at least one electrode and the base surface of the housing is adapted to be in physical contact with an epidermis of the patient; and

a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a first plurality of stimulation sessions, wherein each of said first plurality of stimulation sessions comprises a plurality of electrical pulses and wherein each of said plurality of electrical pulses is defined by a first plurality of stimulation parameters, wherein said first plurality of stimulation parameters comprises a pulse width in a range of 10 μ

sec to 10 msec, a pulse amplitude in a range of 100 μ

A to 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz., said pulse width, pulse amplitude, and pulse frequency being defined such that, after applying at least one of said first plurality of stimulation sessions to the epidermis of the patient within 120 minutes of said patient consuming food, a post-prandial time to empty 50% of the patient'"'"'s stomach contents increases by at least 10% relative to a post-prandial time to empty 50% of the patient'"'"'s stomach contents without applying at least one of said plurality of stimulation sessions; and

a plurality of programmatic instructions stored in a non-transient computer readable memory in a device physically separate from said housing wherein, when executed by said device, said programmatic instructions acquire patient status data, said patient status data including data indicative of the patient'"'"'s degree of appetite, determine a second plurality of stimulation parameters for a second plurality of stimulation sessions based on said patient'"'"'s degree of appetite and in response to an onset of an unplanned hunger event, and generate a signal based upon said determination, wherein said signal comprises data indicative of said second plurality of stimulation parameters and wherein, when executed, said plurality of programmatic instructions determine the second plurality of stimulation parameters for the second plurality of stimulation sessions based on a total duration of said first plurality of stimulation sessions and second plurality of stimulations sessions; and

a transceiver positioned within the housing and in data communication with said device and at least one of said controller and pulse generator, wherein the transceiver is configured to receive said signal from the device and wherein the pulse generator is further configured to generate the second plurality of stimulation sessions in response to said signal.

2. The electrical dermal stimulation system of claim 1 wherein said at least one electrode is adapted to be adhered to the epidermis of the patient such that an electrical field, generated by said first plurality of stimulation sessions, directly contacts at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal and lateral dermatomes, does not directly contact the patient'"'"'s gastrointestinal tract, does not directly contact the patient'"'"'s vagus nerve, and penetrates a range of 0.1 mm to 25 mm through the patient'"'"'s epidermis.

3. The electrical dermal stimulation system of claim 1 wherein the base surface of the housing is not configured to be adhered to the patient'"'"'s epidermis and is positioned less than 4 mm above the patient'"'"'s epidermis and wherein the base surface of the at least one electrode is configured to be adhered to the patient'"'"'s epidermis and has a maximum surface area of 10 in².

4. The electrical dermal stimulation system of claim 1 further comprising a second electrode and wherein the at least one electrode and second electrode are separated by a distance of less than 20 mm and wherein the housing, the at least one electrode, and the second electrode, in combination, have a height not exceeding 1 inch.

5. The electrical dermal stimulation system of claim 1 wherein said plurality of stimulation parameters are further defined such that each of said plurality of electrical pulses has a pulse width of less than 1 ms and wherein the at least one electrode is a foam electrode or a hydrocolloid electrode.

6. The electrical dermal stimulation system of claim 1 wherein the patient status data comprises data indicative of a degree of well-being experienced by the patient and wherein, when executed by said device, said programmatic instructions determine whether the patient should receive the second plurality of stimulation sessions in addition to the first plurality of stimulations sessions based on whether the patient'"'"'s degree of well-being is above or below a predefined level.

7. The electrical dermal stimulation system of claim 1 wherein said pulse width, pulse amplitude, and pulse frequency are further defined such that, after applying at least one of said first plurality of stimulation sessions to the epidermis of the patient, the patient'"'"'s appetite or hunger decreases relative to the patient'"'"'s appetite or hunger before applying said at least one of said first plurality of stimulation sessions.

8. An electrical dermal stimulation system configured to cause a delay in gastric emptying of a patient having a body mass index of at least 25 comprising:

a housing having a base surface, wherein said base surface is defined by a total base surface area;

a controller positioned within the housing;

at least one electrode having a base surface and attached to the base surface of said housing, wherein the base surface of the at least one electrode is adapted to be in electrical contact with said patient'"'"'s epidermis and wherein at least one of the base surface of the at least one electrode and the base surface of the housing is adapted to be in physical contact with an epidermis of the patient; and

a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate a first plurality of stimulation sessions, wherein each of said first plurality of stimulation sessions comprises a plurality of electrical pulses and wherein each of said plurality of electrical pulses is defined by a scheduled time and a first plurality of stimulation parameters, wherein said first plurality of stimulation parameters comprises a pulse width in a range of 10 μ

sec to 10 msec, a pulse amplitude in a range of 100 μ

A to 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz., said pulse width, pulse amplitude, and pulse frequency being defined such that, after applying at least one of said first plurality of stimulation sessions for at least 5 minutes to the epidermis of the patient within 120 minutes of said patient consuming food, a post-prandial time to empty 50% of the patient'"'"'s stomach contents increases by at least 10% relative to a post-prandial time to empty 50% of the patient'"'"'s stomach contents without applying at least one of said first plurality of stimulation sessions;

a plurality of programmatic instructions stored in a non-transient computer readable memory in a device physically separate from said housing wherein, when executed by said device, said programmatic instructions acquire patient status data, said patient status data including data indicative of the patient'"'"'s degree of appetite or hunger, determine a second plurality of stimulation parameters for a second plurality of stimulation sessions based on said patient'"'"'s degree of appetite or hunger and in response to an onset of an unplanned hunger event, and generate a signal based upon said determination, wherein said signal comprises data indicative of said second plurality of stimulation parameters and wherein, when executed, said plurality of programmatic instructions determine the second plurality of stimulation parameters for the second plurality of stimulation sessions based on a total duration of said first plurality of stimulation sessions and second plurality of stimulations sessions; and

a transceiver positioned within the housing and in data communication with said device and at least one of said controller and pulse generator, wherein the transceiver is configured to receive said signal from the device and wherein the pulse generator is further configured to generate the second plurality of stimulation sessions in response to said signal.

9. The electrical dermal stimulation system of claim 8 wherein said at least one electrode is adapted to be adhered to the epidermis of the patient such that an electrical field, generated by said first plurality of stimulation sessions, directly contacts at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal and lateral dermatomes, does not directly contact the patient'"'"'s gastrointestinal tract, does not directly contact the patient'"'"'s vagus nerve, and penetrates no more than 25 mm through the patient'"'"'s epidermis.

10. The electrical dermal stimulation system of claim 8 wherein the base surface of the housing is not configured to be adhered to the patient'"'"'s epidermis and is positioned less than 4 mm above the patient'"'"'s epidermis and wherein the base surface of the at least one electrode is configured to be adhered to the patient'"'"'s epidermis and has a maximum surface area of 10 in².

11. The electrical dermal stimulation system of claim 8 further comprising a second electrode and wherein the at least one electrode and second electrode are separated by a distance of less than 10 mm and wherein the housing, the at least one electrode, and the second electrode, in combination, have a height not exceeding 1 inch.

12. The electrical dermal stimulation system of claim 8 wherein the housing has a volume in a range from 0.10 in³ to 0.5 in³, a weight in a range from 10 grams to 80 grams, and a ratio of a surface area of the base surface of the at least one electrode to said weight in a range of 0.1 to 0.8 in² per gram weight of the housing.

13. The electrical dermal stimulation system of claim 8 wherein the patient status data comprises data indicative of a degree of well-being experienced by the patient.

14. The electrical dermal stimulation system of claim 13 wherein, when executed by said device, said programmatic instructions determine the second plurality of stimulation parameters for the second plurality of stimulation sessions based on said patient'"'"'s degree of well-being, and generate said signal based upon said determination.

15. The electrical dermal stimulation system of claim 8 wherein said pulse width, pulse amplitude, and pulse frequency are further defined such that, after applying at least one of said first plurality of stimulation sessions to the epidermis of the patient, the patient'"'"'s appetite or hunger decreases relative to the patient'"'"'s appetite or hunger before applying said at least one of said first plurality of stimulation sessions and a nausea level of the patient does not increase relative to the patient'"'"'s nausea level before applying said at least one of said first plurality of stimulation sessions.

16. The electrical dermal stimulation system of claim 8 further comprising an adhesive layer positioned a base surface of the at least one electrode and wherein, when the adhesive layer of the at least one electrode is configured to be adhered to the patient'"'"'s epidermis, the at least one electrode has a peel strength in a range of 1.0 to 2.1 newtons.

17. The electrical dermal stimulation system of claim 8 wherein said pulse width, pulse amplitude, and pulse frequency are further defined such that, after applying at least one of said first plurality of stimulation sessions to the epidermis of the patient, a body weight of the patient reduces by at least 3% relative to a body weight of the patient before applying said at least one of said first plurality of stimulation sessions.

18. An electrical dermal system configured to cause a delay in gastric emptying of a patient comprising:

a housing;

a controller positioned within the housing;

at least one electrode attached to said housing and adapted to be in electrical contact with said patient'"'"'s epidermis such that an electrical field, generated by a first plurality of stimulation sessions, directly contacts at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal and lateral dermatomes; and

a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate said first plurality of stimulation sessions, wherein each of said first plurality of stimulation sessions comprises a plurality of electrical pulses and wherein each of said plurality of electrical pulses is defined by pre-programmed time and a plurality of stimulation parameters, wherein said plurality of stimulation parameters comprises a pulse width in a range of 10 μ

sec to 10 msec, a pulse amplitude in a range of 100 μ

A to 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz., said pulse width, pulse amplitude, and pulse frequency being defined such that, after applying at least one of said plurality of stimulation sessions for at least 5 minutes to the epidermis of the patient within 120 minutes of said patient consuming a meal, a post-prandial time to empty 50% of the patient'"'"'s stomach contents increases by at least 10% relative to a post-prandial time to empty 50% of the patient'"'"'s stomach contents without applying at least one of said plurality of stimulation sessions;

a plurality of programmatic instructions stored in a non-transient computer readable memory in a device physically separate from said housing wherein, when executed by said device, said programmatic instructions acquire patient status data, said patient status data including data indicative of the patient'"'"'s degree of appetite or hunger and data indicative of the patient'"'"'s degree of well-being, determine a second plurality of stimulation parameters for a second plurality of stimulation sessions based on said patient'"'"'s degree of appetite or hunger, degree of well-being, and in response to an onset of an unplanned hunger event, and generate a signal based upon said determination, wherein said signal comprises data indicative of said second plurality of stimulation parameters and wherein, when executed, said plurality of programmatic instructions determine the second plurality of stimulation parameters for the second plurality of stimulation sessions based on at least one of a total energy of said first plurality of stimulation sessions and second plurality of stimulations sessions and a total duration of said first plurality of stimulation sessions and second plurality of stimulations sessions; and

a transceiver positioned within the housing and in data communication with said device and at least one of said controller and pulse generator, wherein the transceiver is configured to receive said signal from the device and wherein the pulse generator is further configured to generate the second plurality of stimulation sessions in response to said signal.

19. The electrical dermal stimulation system of claim 18 wherein said pulse width, pulse amplitude, and pulse frequency are further defined such that, after applying at least one of said plurality of stimulation sessions to the epidermis of the patient, the patient'"'"'s gastric retention increases by 50% relative to the patient'"'"'s gastric retention before applying said at least one of said plurality of stimulation sessions.

20. An electrical dermal system configured to cause a delay in gastric emptying of a patient comprising:

a housing;

a controller positioned within the housing;

at least one electrode attached to said housing and adapted to be in electrical contact with said patient'"'"'s epidermis such that an electrical field, generated by a first plurality of stimulation sessions, directly contacts at least one of the patient'"'"'s C5, C6, C7, C8, T1, T2, T3, T4, T5, T6, T7, T8, T9, T10, T11, and T12 frontal and lateral dermatomes; and

a pulse generator positioned within the housing and in electrical communication with the controller and said at least one electrode, wherein the pulse generator is configured to generate said first plurality of stimulation sessions, wherein each of said first plurality of stimulation sessions comprises a plurality of electrical pulses and wherein each of said plurality of electrical pulses is defined by pre-programmed time and a plurality of stimulation parameters, wherein said plurality of stimulation parameters comprises a pulse width in a range of 10 μ

sec to 10 msec, a pulse amplitude in a range of 100 μ

A to 100 mA, and a pulse frequency in a range of 1 Hz and 100 Hz;

a plurality of programmatic instructions stored in a non-transient computer readable memory in a device physically separate from said housing wherein, when executed by said device, said programmatic instructions acquire data indicative of the patient'"'"'s degree of appetite, determine a second plurality of stimulation sessions based on said patient'"'"'s degree of appetite and in response to an onset of an unplanned hunger event, and generate a signal based upon said determination, wherein, when executed, said plurality of programmatic instructions determine the second plurality of stimulation sessions based on a total duration of said first plurality of stimulation sessions and second plurality of stimulations sessions; and

a transceiver positioned within the housing and in data communication with said device and at least one of said controller and pulse generator, wherein the transceiver is configured to receive said signal from the device and wherein the pulse generator is further configured to generate the second plurality of stimulation sessions in response to said signal.

21. The electrical dermal stimulation system of claim 20 wherein said at least one electrode is adapted to be adhered to the epidermis of the patient such that an electrical field, generated by said first plurality of stimulation sessions, does not directly contact the patient'"'"'s gastrointestinal tract, does not directly contact the patient'"'"'s vagus nerve, and penetrates a range of 0.1 mm to 25 mm through the patient'"'"'s epidermis.

22. The electrical dermal stimulation system of claim 20 further comprising a second electrode and wherein the at least one electrode and the second electrode are separated by a distance of less than 20 mm and wherein the housing, the at least one electrode, and the second electrode, in combination, have a height not exceeding 1 inch.

23. The electrical dermal stimulation system of claim 20 wherein said plurality of stimulation parameters are further defined such that each of said plurality of electrical pulses has a pulse width of less than 1 ms and wherein the at least one electrode is a foam electrode or a hydrocolloid electrode.

24. The electrical dermal stimulation system of claim 20 wherein said programmatic instructions acquire data indicative of a degree of well-being experienced by the patient and wherein, when executed by said device, said programmatic instructions determine whether the patient should receive the second plurality of stimulation sessions in addition to the first plurality of stimulations sessions based on whether the patient'"'"'s degree of well-being is above or below a predefined level.

25. The electrical dermal stimulation system of claim 20 wherein said pulse width, pulse amplitude, and pulse frequency are further defined such that, after applying at least one of said first plurality of stimulation sessions to the epidermis of the patient, the patient'"'"'s appetite decreases relative to the patient'"'"'s appetite before applying said at least one of said first plurality of stimulation sessions.