Subcutaneous device for monitoring and/or providing therapies

• US 10,716,511 B2
• Filed: 11/11/2019
• Issued: 07/21/2020
• Est. Priority Date: 07/31/2018
• Status: Active Grant

• Current Assignee: Calyan Technologies, Inc.
• Original Assignee: Manicka Institute, LLC
• Inventors: Manicka, Yatheendhar D.
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US16/680,360
• Publication Number:
  US 20200077953A1
• Time in Patent Office: 253 Days
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/0536 Impedance imaging, e.g. by tomography
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6878 Bone
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0563 specially adapted for defibrillation or cardioversion
• CPC Class Codes: A61N 1/059 : Anchoring means
• CPC Class Codes: A61N 1/37512 : Pacemakers
• CPC Class Codes: A61N 1/37518 : Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3756 : Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3956 : Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
• CPC Class Codes: A61N 1/3968 : Constructional arrangements, e.g. casings A61N1/375 takes precedence

Abstract

A subcutaneously implantable device includes a housing, a clip attached to a top side of the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue, and a first prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a first lung. A first electrode on the device is configured to contact the first lung, and a second electrode on the device is configured to contact the first lung or a second lung. Sensing circuitry in the housing in electrical communication with the first electrode and the second electrode is configured to measure an impedance in the first lung and/or the second lung, and/or a transthoracic impedance across the first lung and the second lung.

Claims

1. A subcutaneously implantable device comprising:

a housing;

a clip attached to a top side of the housing that is configured to anchor the device to a muscle, a bone, and/or a first tissue;

a prong and electrode structure comprising;

a first prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a first lung;

a first electrode on the first prong that is configured to contact the first lung; and

a second electrode on the first prong that is configured to contact the first lung;

or

a first prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a first lung;

a second prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a second lung;

a first electrode on the first prong that is configured to contact the first lung; and

a second electrode on the second prong that is configured to contact the second lung; and

sensing circuitry in the housing in electrical communication with the first electrode and the second electrode that is configured to measure an impedance in the first lung and/or the second lung, and/or a transthoracic impedance across the first lung and the second lung.

2. The device of claim 1, wherein the clip is configured to attach the device to a xiphoid process and/or a sternum of a patient.

3. The device of claim 1, wherein the clip further comprises:

a top portion;

a bottom portion; and

a spring portion extending between and connecting the top portion to the bottom portion, wherein the spring portion is curved and is configured to act as a spring for the clip to push the top portion of the clip onto the bone, the muscle, and/or the first tissue to which it is anchored.

4. The device of claim 1, wherein the clip is configured to be positioned around the muscle, the bone, and/or the first tissue to anchor the device to the muscle, the bone, and/or the first tissue without piercing the muscle, the bone, and/or the first tissue.

5. The device of claim 1, wherein the first electrode and the second electrode are positioned on the first prong and are configured to contact the first lung.

6. The device of claim 1, wherein the prong and electrode structure comprises:

the first prong with its proximal end attached to the housing and its distal end extending away from the housing that is configured to contact the first lung;

the second prong with its proximal end attached to the housing and its distal end extending away from the housing that is configured to contact the second lung;

the first electrode on the first prong that is configured to contact the first lung; and

the second electrode on the second prong that is configured to contact the second lung.

7. The device of claim 6, and further comprising:

a third electrode on the first prong that is configured to contact the first lung; and

a fourth electrode on the second prong that is configured to contact the second lung.

8. The device of claim 1, wherein the sensing circuitry is configured to sense a baseline impedance in the first lung and/or the second lung.

9. The device of claim 1, wherein the sensing circuitry is configured to sense impedance in the first lung and/or the second lung over a period of time.

10. The device of claim 1, and further comprising:

a sensor in electrical communication with the sensing circuitry and selected from the group consisting of a temperature sensor, an accelerometer, a pressure sensor, a proximity sensor, an infrared sensor, an optical sensor, an ultrasonic sensor, a data storage device, and combinations thereof.

11. The device of claim 10, wherein the sensor is positioned on the housing or the first prong.

12. The device of claim 1, and further comprising:

therapeutic circuitry in the housing in electric communication with the first electrode, the second electrode, and/or a third electrode, wherein the therapeutic circuitry is configured to deliver electrical stimulation to a nerve, an organ, and/or a second tissue through the first electrode, the second electrode, and/or the third electrode.

13. The device of claim 1, and further comprising:

a defibrillator prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a tissue surrounding a heart or a heart;

a defibrillator coil on the distal end of the defibrillator prong; and

therapeutic circuitry in the housing in electric communication with the first electrode, the second electrode, and/or the defibrillator coil, wherein the therapeutic circuitry is configured to deliver an electrical shock to the heart through the defibrillator coil.

14. The device of claim 1, and further comprising:

a drug pump having a drug reservoir in the housing;

a drug pump prong with a lumen extending through the drug pump prong and having a proximal end attached to the housing and the drug pump, and a distal end extending away from the housing that is configured to contact an organ, a nerve, and/or a second tissue; and

therapeutic circuitry in the housing in electrical communication with the drug pump that is configured to deliver a signal to the drug pump to provide a targeted or systemic therapeutic drug to the organ, the nerve, and/or the second tissue through the lumen extending through the drug pump prong.

15. A method of measuring an impedance in a first lung and/or a second lung, and/or a transthoracic impedance across the first lung and the second lung using a subcutaneously implantable device, the method comprising:

anchoring a clip of the device to a muscle, a bone, and/or a first tissue, wherein the device includes a housing and a first prong with a prong and electrode structure that is configured to contact the first lung and/or to contact the first lung and the second lung;

transmitting a current from a first electrode of the prong and electrode structure that is configured to contact the first lung to a second electrode of the prong and electrode structure that is configured to contact the first lung and/or the second lung; and

measuring an impedance between the first electrode and the second electrode using sensing circuitry in the housing to determine the impedance of the first lung and/or the second lung, and/or the transthoracic impedance across the first lung and the second lung.

16. The method of claim 15, wherein anchoring the clip of the device to a muscle, a bone, and/or a first tissue includes anchoring the clip of the device to a xiphoid process and/or a sternum.

17. The method of claim 15, wherein the prong and electrode structure comprises a first prong that is configured to contact the first lung, and the first electrode and the second electrode are positioned on the first prong and are configured to contact the first lung to determine the impedance of the first lung.

18. The method of claim 15, wherein the prong and electrode structure comprises:

a first prong that is configured to contact the first lung; and

a second prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact the second lung;

wherein the first electrode is positioned on the first prong and is configured to contact the first lung, and wherein the second electrode is positioned on the second prong and is configured to contact the second lung, and wherein the first electrode and the second electrode are configured to determine the transthoracic impedance across the first lung and the second lung.

19. The method of claim 15, and further comprising:

delivering, using therapeutic circuitry in the housing in electric communication with the first electrode, the second electrode, and/or a third electrode, electrical stimulation to a nerve, an organ, and/or a second tissue through the first electrode, the second electrode, and/or the third electrode.

20. The method of claim 15, wherein the device further includes a defibrillator prong with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a tissue surrounding a heart or a heart, and a defibrillator coil on the distal end of the defibrillator prong, wherein the method further comprises:

providing, using therapeutic circuitry in the housing in electric communication with the first electrode, the second electrode, and/or the defibrillator coil, an electrical shock to the heart through the defibrillator coil.

21. The method of claim 15, wherein the device further includes a drug pump having a drug reservoir in the housing, and a drug pump prong with a lumen extending through the drug pump prong and having a proximal end attached to the housing and the drug pump, and a distal end extending away from the housing that is configured to contact an organ, a nerve, and/or a second tissue, wherein the method further comprises:

providing, using therapeutic circuitry in the housing in electrical communication with the drug pump that is configured to deliver a signal to the drug pump, a targeted or systemic therapeutic drug to the organ, the nerve, and/or the second tissue through the lumen extending through the drug pump prong.