Systems, methods, and devices for reducing the pain of glucose monitoring and diabetes treatment

• US 10,149,641 B2
• Filed: 02/16/2015
• Issued: 12/11/2018
• 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.
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US14/623,185
• Publication Number:
  US 20150157250A1
• Time in Patent Office: 1,394 Days
• 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 lancet housing disposed at a first end of the body, the lancet housing comprising;

(i) an opening defined in the lancet housing;

(ii) a first stimulation component disposed on the lancet housing, wherein the first stimulation component comprises a first electrode configured to be capable of delivering at least one of electrical stimulation and vibration stimulation; and

(iii) a lancet disposed at least partially within the lancet housing;

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

(d) a second stimulation component disposed along a bottom portion of the body, wherein the second stimulation component comprises a second 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 first and second stimulation components.

2. The device of claim 1, further comprising a testing strip opening defined in the second 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 bottom portion of the body comprises a concave shape, 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. The device of claim 1, further comprising a controller operably coupled to the stimulation generating unit.

7. The device of claim 6, further comprising a display operably coupled to the controller.

8. The device of claim 6, further comprising at least one actuation button operably coupled to the controller.

9. The combination blood testing and pain reduction device of claim 1, wherein the lancet comprises a retracted position disposed within the lancet housing and a deployed position wherein at least a distal portion of the lancet extends out of the lancet housing through the opening.

10. The device of claim 1, further comprising at least one actuation button disposed on the body.

11. The device of claim 1, further comprising at least one intensity adjustment button disposed on the body.

12. The device of claim 1, further comprising a slidable lever operably coupled to the lancet.

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

(a) the device of claim 1; and

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

14. 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 skin, the pain reduction device comprising;

(a) a body;

(b) a lancet housing disposed at a first end of the body, the lancet housing comprising;

(i) an opening defined in the lancet housing;

(ii) a first stimulation component disposed on the lancet housing; and

(iii) a lancet disposed at least partially within the lancet housing;

(c) a concave-shaped second end of the body, the second end defining an injection site adjacent to the second end;

(d) a second stimulation component disposed along a bottom portion of the body; 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 first and second stimulation components;

piercing skin at a testing site with the lancet or a separate lancet;

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

injecting insulin at the injection site; and

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

15. The method of claim 14, wherein the device further comprises a testing strip opening defined in the second end of the body, the testing strip opening configured to receive a testing strip.

16. The method of claim 15, further comprising positioning a testing strip in the testing strip opening.

17. The method of claim 16, 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.

18. The method of claim 17, wherein the positioning the device further comprises advancing the second end toward a target testing area on the patient.

19. The method of claim 14, further comprising measuring skin attributes prior to actuating the stimulation generating unit.

20. The method of claim 19, further comprising controlling an amount of the at least one of electrical energy and vibration energy based on the skin attributes.

21. The method of claim 14, further comprising actuating a button, wherein actuating the button causes the actuating of the stimulation generating unit or the piercing the skin with the lancet or the separate lancet.

22. The method of claim 21, wherein the actuating of the stimulation generating unit is timed randomly in relation to actuating the button.

23. The method of claim 21, wherein the piercing the skin with the lancet or the separate lancet is timed randomly in relation to actuating the button.

24. The method of claim 14, further comprising contacting the patient'"'"'s skin with one of the first and second stimulation components, wherein the contacting the patient'"'"'s skin actuates the stimulation generating unit to transmit at least one of electrical energy and vibration energy to the one of the first and second stimulation components.

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

(a) a body;

(b) a lancet housing disposed at a first end of the body, the lancet housing comprising;

(i) an opening defined in the lancet housing;

(ii) a first electrical and vibration stimulation component disposed on the lancet housing; and

(iii) a lancet disposed at least partially within the lancet housing;

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

(d) a second electrical and vibration stimulation component disposed along a bottom portion of the body;

(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 first and second stimulation components; and

(f) a controller operably coupled to the stimulation generating unit.

26. The device of claim 25, further comprising at least one actuation button operably coupled to the controller.

27. The device of claim 25, further comprising a slidable lever operably coupled to the lancet.