Systems, Methods, and Devices for Reducing the Pain of Glucose Monitoring and Diabetes Treatment

• US 20150157250A1
• Filed: 02/16/2015
• Published: 06/11/2015
• Est. Priority Date: 09/07/2010
• Status: Active Grant

• Current Assignee: Innova Medical Design, Llc.
• Original Assignee: Innova Medical Design, Llc.
• Inventors: O'Malley, Timothy, Vallero, Rommel P.
• Granted Patent: US 10,149,641 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150053 for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
• CPC Class Codes: A61B 5/150083 by vibration, e.g. ultrasound
• CPC Class Codes: A61B 5/150091 by electricity
• CPC Class Codes: A61B 5/150137 by vibration enhancing collection by vibration A61B5/150175
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150778 having complementary physical shapes for indexing or registration purposes
• CPC Class Codes: A61B 5/150793 Electrical or magnetic identification means
• CPC Class Codes: A61B 5/150954 Means for the detection of operative contact with patient, e.g. by temperature sensitive sensor
• CPC Class Codes: A61B 5/150961 Means for the detection of the presence or absence of a module, a component or an abnormal condition; detection of leaks
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15109 Fully automatically triggered, i.e. the triggering does not require a deliberate action by the user, e.g. by contact with the patient's skin
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 5/422 Desensitising skin

Abstract

The various embodiments disclosed herein are devices that deliver electrical stimulation and/or vibration stimulation to the surface of skin in proximity to insulin injections and/or glucose testing in order to decrease or eliminate the pain of these procedures.

Claims

1. A combination blood testing and pain reduction device, the device comprising:

(a) a body;

(b) a concave-shaped distal end of the body, the distal end defining a testing site adjacent to the distal end;

(c) a bottom portion of the body comprising a concave shape;

(d) a stimulation component disposed along the bottom portion of the body, the stimulation component comprising an electrode configured to be capable of delivering at least one of electrical stimulation and vibration stimulation; and

(e) a stimulation generating unit disposed within the body, the stimulation generating unit configured to transmit at least one of electrical energy and vibration energy to the stimulation component.

2. The device of claim 1, further comprising a testing strip opening defined in the distal end of the body, the testing strip opening configured to receive a testing strip.

3. The device of claim 2, further comprising a testing component operably coupled to the testing strip opening and a display operably coupled to the testing component.

4. The device of claim 1, wherein the body comprises a rounded top portion configured to be easily grasped by a patient.

5. The device of claim 1, wherein the concave shape of the bottom portion is configured to allow the bottom portion to be positioned over a patient'"'"'s finger such that contact between the stimulation component and the patient'"'"'s finger is maximized.

6. A combination blood testing and pain reduction system comprising:

(a) the device of claim 1; and

(b) a lancet configured to pierce skin at the testing site.

7. The device of claim 1, further comprising a controller operably coupled to the stimuliation generating unit.

8. The device of claim 7, further comprising a display operably coupled to the controller.

9. A combination blood testing and pain reduction device, the device comprising:

(a) an elongate body;

(b) a concave-shaped distal end of the body, the distal end defining a testing site adjacent to the distal end;

(c) a testing strip opening defined in the distal end of the body, the testing strip opening configured to receive a testing strip;

(d) a bottom portion of the body comprising a concave shape extending along a length of the bottom portion;

(e) a stimulation component disposed along the bottom portion of the body, the stimulation component comprising an electrode configured to be capable of delivering at least one of electrical stimulation and vibration stimulation;

(f) a stimulation generating unit disposed within the body, the stimulation generating unit configured to transmit at least one of electrical energy and vibration energy to the stimulation component; and

(g) a controller operably coupled to the stimulation generating unit, the controller configured to control the stimulation generating unit.

10. The device of claim 9, further comprising a testing component operably coupled to the testing strip opening and a display operably coupled to the testing component.

11. The device of claim 9, wherein the body comprises a rounded top portion configured to be easily grasped by a patient.

12. The device of claim 9, wherein the concave shape of the bottom portion is configured to allow the bottom portion to be positioned over a patient'"'"'s finger such that contact between the stimulation component and the patient'"'"'s finger is maximized.

13. A combination blood testing and pain reduction system comprising:

(a) the device of claim 9; and

(b) a lancet configured to pierce skin at the testing site.

14. The device of claim 9, further comprising a display operably coupled to the controller.

15. A method of testing blood and reducing pain relating to the blood testing, the method comprising:

positioning a pain reduction device on a patient'"'"'s finger, the pain reduction device comprising;

(a) a body;

(b) a concave-shaped distal end of the body, the distal end defining a testing/injection site adjacent to the distal end;

(c) a bottom portion of the body comprising a concave shape;

(d) a stimulation component disposed along the bottom portion of the body, the stimulation component comprising an electrode configured to be capable of delivering at least one of electrical stimulation and vibration stimulation; and

(e) a stimulation generating unit disposed within the body, the stimulation generating unit configured to transmit at least one of electrical energy and vibration energy to the stimulation component;

piercing skin at the testing/injection site with a lancet; and

actuating the stimulation generating unit to generate at least one of electrical energy and vibration energy to the stimulation component during the piercing of the skin, thereby reducing the pain of the piercing of the skin.

16. The method of claim 15, wherein the device further comprises a testing strip opening defined in the distal end of the body, the testing strip opening configured to receive a testing strip

17. The method of claim 16, further comprising positioning a testing strip in the testing strip opening.

18. The method of claim 17, further comprising positioning the device such that the testing strip contacts blood forming at the testing/injection site, such that the blood is taken up by the testing strip.

19. The method of claim 18, wherein the positioning the device further comprises advancing the device distally.

20. The method of claim 15, further comprising injecting insulin at the testing/injection site and actuating the stimulation generating unit to generate at least one of electrical energy and vibration energy to the stimulation component during the injecting, thereby reducing the pain of the injecting of the insulin.