System and method for a drug delivery and biosensor patch

• US 9,636,457 B2
• Filed: 09/26/2016
• Issued: 05/02/2017
• Est. Priority Date: 07/19/2015
• Status: Active Grant

• Current Assignee: Trilinear Bioventures LLC
• Original Assignee: Sanmina-SCI Corporation
• Inventors: Newberry, Robert Steven, Rodencal, Matthew
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US15/276,760
• Publication Number:
  US 20170014572A1
• Time in Patent Office: 218 Days
• Field of Search: 604 65- 67, 604131, 604151, 128DIG 12, 128 13, 600558, 600316
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/8206 battery-operated
• CPC Class Codes: A61M 2205/8268 Fuel storage cells
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• CPC Class Codes: A61M 2230/20 Blood composition characteristics
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/145 using pressurised reservoirs, e.g. pressurised by means of pistons
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61M 5/3298 Needles arranged in parallel

Abstract

An integrated drug delivery and biosensor (IDDB) system is implemented on a patch or arm band. The drug delivery system includes needles adapted to pierce the skin and direct injection of a predetermined dosage of medication through the needles into the epidermis of the skin of a patient. The integrated biosensor monitors absorption of the medication into the epidermis of the skin of the patient and may also monitor concentration of the medication or other relevant substances in arterial blood flow of the patient. The integrated biosensor may also monitor a patient'"'"'s vitals in response to the medication. The integrated biosensor may then alter dosage or frequency of administration of dosages or even halt a dosage of medication in response to the patient'"'"'s vitals or absorption of the medication.

Claims

1. An integrated drug delivery and biosensor (IDDB) system, comprising:

a patch configured for attaching to a patient;

a drug delivery system coupled to the patch, wherein the drug delivery system is configured to administer a dosage of medication at an administration rate at an upper epidermal layer of skin to the patient;

a biosensor system coupled to the patch, wherein the biosensor system is configured to;

monitor biosensor data of the patient, wherein the biosensor data includes one or more of;

respiratory rate, heart rate or blood pressure;

continuously monitor an absorption rate of the medication into the upper epidermal layer of skin and surrounding tissue and in arterial blood flow of the patient; and

continuously monitor a concentration of a substance in the arterial blood flow, wherein the concentration of the substance corresponds to a concentration of the medication;

wherein the drug delivery system is configured to alter the dosage of the medication and the administration rate of the medication in response to;

the biosensor data;

the absorption rate of the medication into the upper epidermal layer of skin and surrounding tissue and in the arterial blood flow; and

the concentration of the substance in the arterial blood flow.

2. The IDDB system of claim 1, wherein the drug delivery system includes one or more needles and is configured to administer the dosage of the medication at the administration rate through the one or more needles into the upper epidermal layer of the skin.

3. The IDDB system of claim 2, wherein the biosensor includes at least a PPG circuit, wherein the PPG circuit includes:

a light source configured to emit light directed at skin of the patient at a plurality of frequencies;

a photodetector circuit configured to detect spectral responses of reflected light from the skin and surrounding tissue at the plurality of frequencies; and

a processing circuit configured to;

process the spectral response at a plurality of frequencies; and

obtain an absorption rate of the medication into the surrounding tissue and the arterial blood flow using the spectral response.

4. The IDDB system of claim 3, wherein the drug delivery system is configured to alter at least one of the dosage of the medication or the administration rate of the medication or frequency of dosage of the medication in response to the absorption rate of the medication into the surrounding tissue and the arterial blood flow.

5. The IDDB system of claim 1, wherein the biosensor system is further configured to:

determine one or more of;

respiratory rate, heart rate or blood pressure has exceeded a predetermined threshold indicating an allergic reaction; and

transmit instructions to the drug delivery system to halt the administration of the dosage of the medication.

6. The IDDB system of claim 1, wherein the biosensor includes at least a photoplethysmograpy (PPG) circuit, wherein the PPG circuit includes:

a light source configured to emit light directed at skin of the patient at a plurality of frequencies;

a photodetector circuit configured to detect spectral responses of reflected light from the skin and surrounding tissue at the plurality of frequencies; and

a PPG circuit configured to;

emit light having at least a first wavelength responsive to the substance directed at an outer epidermal layer of skin tissue of a patient;

emit light having at least a second wavelength with a low absorption coefficient for the substance directed at the outer epidermal layer of skin tissue of the patient;

generate a first spectral response for light around the first wavelength responsive to substance levels reflected from the outer epidermal layer of the skin tissue of the patient;

generate a second spectral response for light around the second wavelength with a low absorption coefficient for substance reflected from the outer epidermal layer of the skin tissue of the patient;

a processing circuit configured to obtain an indicator of a concentration level of substance of the patient by;

isolating a systolic point and a diastolic point in the first spectral response and obtain a value L<sub>λ

1</sub> using a ratio of the systolic point and the diastolic point in the first spectral response;

isolating a systolic point and a diastolic point in the second spectral response and obtain a value L <sub>λ

2</sub> using a ratio of the systolic point and diastolic point in the second spectral response;

obtaining a value R <sub>λ

1, λ

2</sub> from a ratio of the value L<sub>λ

1</sub> and the value L<sub>λ

2</sub>, wherein the value R<sub>λ

1, λ

2</sub> is the indicator of the concentration level of substance of the patient;

obtaining a arterial blood medication concentration level in the arterial blood flow of the patient from a calibration table using the value R <sub>λ

1, λ

2</sub>, wherein the calibration table includes a range of R <sub>λ

1, λ

2</sub> values with substance and correlated medicine concentration levels; and

a processing circuit configured to;

process the spectral responses at the plurality of frequencies; and

configure the system to calculate and process the absorption amount of only the upper epidermal layer of skin of at least one substance and/or obtain a concentration level of at least one substance in arterial blood flow of the patient.

7. The IDDB system of claim 6, wherein the processing circuit is configured to process the spectral responses at the plurality of wavelengths by:

isolating a systolic point and a diastolic point in a first spectral response and obtain a value L<sub>λ

1</sub> using a ratio of the systolic point and the diastolic point in the first spectral response;

isolating a systolic point and a diastolic point in a second spectral response and obtain a value L<sub>λ

2</sub> using a ratio of the systolic point and diastolic point in the second spectral response; and

obtaining a value R<sub>λ

1, λ

2</sub> from a ratio of the value L<sub>λ

1</sub> and the value L<sub>λ

2</sub>.

8. The IDDB system of claim 1, wherein the IDDB system is further configured to:

obtain position information of the biosensor and activity level; and

adjust operation of the biosensor system and the drug delivery system in response to the position information of the biosensor and the activity level.

9. The IDDB system 100 of claim 1, further comprising:

a wireless transceiver coupled to the patch for transmitting biosensor data and the dosage and the administration rate of the medication to one or more devices in an EMR network.

10. An method operable by an integrated drug delivery and biosensor (IDDB), comprising:

administering a dosage of medication at an administration rate from a drug delivery system integrated onto the patch for attaching to a patient;

monitoring biosensor data of the patient using a biosensor integrated onto the patch, wherein the biosensor data includes one or more of;

respiratory rate, heart rate or blood pressure;

monitoring absorption rate using the integrated biosensor of the medication into surrounding tissue and arterial blood flow;

monitoring concentration by the integrated biosensor of a substance in arterial blood flow, wherein the concentration of the substance corresponds to a concentration of the medication; and

altering the dosage of the medication and the administration of the medication by the drug delivery system in response to the biosensor data, the absorption rate of the medication into the surrounding tissue and into the arterial blood flow, and the concentration of the substance in the arterial blood flow.

11. The method of claim 10, further comprising:

administering the dosage of the medication at the administration rate through one or more needles protruding from the patch into at least an upper epidermal layer of the skin.

12. The method of claim 10, further comprising:

determining one or more of;

respiratory rate, heart rate or blood pressure has exceeded a predetermined threshold indicating an allergic reaction; and

transmitting instructions to the drug delivery system to halt the administration of the dosage of the medication.

13. The method of claim 10, further comprising:

emitting light directed at skin of the patient at a plurality of frequencies by a photoplethysmograpy (PPG) circuit of the biosensor;

detecting spectral responses of reflected light from the skin and surrounding tissue at the plurality of frequencies by a photodetector circuit of the biosensor;

processing the spectral responses at the plurality of frequencies; and

obtaining a concentration level of at least one substance in arterial blood flow of the patient.

14. The method of claim 10, further comprising:

processing the spectral responses at the plurality of wavelengths by;

isolating a systolic point and a diastolic point in a first spectral response and obtain a value L<sub>λ

1</sub> using a ratio of the systolic point and the diastolic point in the first spectral response;

isolating a systolic point and a diastolic point in a second spectral response and obtain a value L<sub>λ

2</sub> using a ratio of the systolic point and diastolic point in the second spectral response; and

obtaining a value R<sub>λ

1, λ

2</sub> from a ratio of the value L<sub>λ

1</sub> and the value L<sub>λ

2</sub>.

15. The method of claim 10, further comprising:

emitting light directed at skin of the patient at a plurality of frequencies by a light source in the biosensor;

detecting spectral responses of reflected light from the skin and surrounding tissue at the plurality of frequencies by a photodetector circuit in the biosensor;

processing the spectral response at a plurality of frequencies; and

obtaining an absorption rate of the medication using the spectral response.

16. The method of claim 15, further comprising:

altering at least one of the dosage of the medication or the administration rate of the medication or frequency of dosage of the medication in response to the absorption rate of the medication.

17. The method of claim 10, further comprising:

obtaining at least one of;

position information and activity level; and

adjusting operation of at least one of the biosensor system or the drug delivery system in response to at least one of the position information or the activity level.

18. The method of claim 10, further comprising:

transmitting biosensor data and the dosage and the administration rate of the medication to one or more devices in an EMR network.

19. An integrated drug delivery and biosensor (IDDB) system, comprising:

a patch configured for attaching to a patient;

a drug delivery system coupled to the patch, wherein the drug delivery system is configured to administer a dosage of insulin at an administration rate to the patient;

a biosensor system coupled to the patch configured to continuously monitor a blood glucose concentration level in the arterial blood flow of the patient, wherein the biosensor system includes;

a PPG circuit configured to;

emit light having at least a first wavelength responsive to nitric oxide (NO) levels directed at an outer epidermal layer of skin tissue of a patient;

emit light having at least a second wavelength with a low absorption coefficient for nitric oxide (NO) directed at the outer epidermal layer of skin tissue of the patient;

generate a first spectral response for light around the first wavelength responsive to NO levels reflected from the outer epidermal layer of the skin tissue of the patient;

generate a second spectral response for light around the second wavelength with a low absorption coefficient for NO reflected from the outer epidermal layer of the skin tissue of the patient;

a processing circuit configured to obtain an indicator of a concentration level of NO of the patient by;

isolating a systolic point and a diastolic point in the first spectral response and obtain a value L<sub>λ

1</sub> using a ratio of the systolic point and the diastolic point in the first spectral response;

isolating a systolic point and a diastolic point in the second spectral response and obtain a value L<sub>λ

2</sub> using a ratio of the systolic point and diastolic point in the second spectral response;

obtaining a value R <sub>λ

1, λ

2</sub> from a ratio of the value L<sub>λ

1</sub> and the value L<sub>λ

2</sub>, wherein the value R<sub>λ

1, λ

2</sub> is the indicator of the concentration level of NO of the patient;

obtaining a blood glucose concentration level in the arterial blood flow of the patient from a calibration table using the value R <sub>λ

1, λ

2</sub>, wherein the calibration table includes a range of R<sub>λ

1, λ

2</sub> values and correlated blood glucose concentration levels; and

wherein the IDDB system is configured to alter the dosage of the insulin and the administration rate of the insulin in response to the blood glucose concentration level in the arterial blood flow.

20. The IDDB system of claim 19, wherein the drug delivery system includes one or more needles and is configured to administer the dosage of the insulin at the administration rate through the one or more needles into an upper epidermal layer of the skin.

21. The IDDB system of claim 20, wherein the PPG circuit is further configured to:

measure an absorption rate of the insulin into the upper epidermal layer of the skin and surrounding tissue; and

wherein the IDDB system is further configured to alter the administration rate of the insulin in response to the absorption rate of the insulin into the upper epidermal layer of the skin and the surrounding tissue.

22. The IDDB system of claim 21, wherein the PPG circuit is further configured to:

monitor biosensor data of the patient, wherein the biosensor data includes one or more of;

respiratory rate, heart rate or blood pressure; and

wherein the IDDB system is further configured to alter the administration rate of the insulin in response to the biosensor data of the patient.

23. The IDDB system of claim 22, wherein the drug delivery system further comprises:

a drug receptacle coupled to the one or more needles; and

a hydrogen fuel cell configured to pressurize the drug receptacle and force the dosage of the insulin at the administration rate through the one or more needles into the upper epidermal layer of the skin of the patient.