Subcutaneous device for monitoring and/or providing therapies

• US 10,471,251 B1
• Filed: 07/31/2018
• Issued: 11/12/2019
• 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:
  US16/051,451
• Time in Patent Office: 469 Days
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 5/142 Pressure infusion, e.g. using pumps
• 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 1/368 comprising more than one electrode co-operating with different heart regions A61N1/3622, A61N1/3627 take precedence
• CPC Class Codes: A61N 1/37512 Pacemakers
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3956 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, a first prong with a proximal end attached to the housing and a distal end extending away from the housing, and a first electrode on the first prong. The clip is configured to anchor the device to a muscle, a bone, and/or a tissue. The first prong is configured to contact a heart. The first electrode is configured to contact the heart. Sensing circuitry in the housing that is configured to sense an electrical signal from the heart, and therapeutic circuitry in the housing is in electrical communication with the first electrode and is configured to deliver electrical stimulation to the heart through the first electrode.

Claims

1. A subcutaneously implantable device comprising:

a housing;

a clip attached to a top side of the housing that is configured to be positioned around a muscle, a bone, and/or a tissue to anchor the device to the muscle, the bone, and/or the tissue without piercing the muscle, the bone, and/or the tissue;

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 heart;

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

sensing circuitry in the housing that is configured to sense an electrical signal from the heart; and

therapeutic circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation to the heart through the first electrode.

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 bias the top portion of the clip onto the bone, the muscle, and/or the tissue to which it is anchored.

4. The device of claim 1, wherein the sensing circuitry is in electrical communication with the first electrode and can sense the electrical signal from the heart through the first electrode.

5. The device of claim 1, wherein the sensing circuitry is in electrical communication with a second electrode on the first prong, the housing, and/or the clip and can sense the electrical signal from the heart through the second electrode.

6. The device of claim 1, wherein the first prong is configured to contact a right ventricle of the heart, a left ventricle of the heart, a right atrium of the heart, or a left atrium of the heart.

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

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 heart; and

a second electrode on the second prong that is in electrical communication with the therapeutic circuitry and is configured to deliver the electrical stimulation to the heart.

8. The device of claim 7, wherein the first prong is configured to contact a right ventricle of the heart and the second prong is configured to contact a left ventricle of the heart;

the first prong is configured to contact a left ventricle of the heart and the second prong is configured to contact a right atrium of the heart;

or the first prong is configured to contact a right ventricle of the heart and the second prong is configured to contact a right atrium of the heart.

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

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

a third electrode on the third prong that is in electrical communication with the therapeutic circuitry and is configured to deliver the electrical stimulation to the heart.

10. The device of claim 9, wherein the first prong is configured to contact the right ventricle of the heart, the second prong is configured to contact the left ventricle of the heart, and the third prong is configured to contact the right atrium of the heart.

11. A subcutaneously implantable device comprising:

a housing;

a clip attached to a top side of the housing that is configured to be positioned around a muscle, a bone, and/or a 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;

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 organ and/or a second tissue;

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 first organ, a second organ, the second tissue, and/or the third tissue;

a first electrode on the first prong that is configured to contact the first organ and/or the second tissue;

a second electrode on the second prong that is configured to contact the first organ, the second organ, the second tissue, and/or the third tissue;

sensing circuitry in the housing in electrical communication with the first electrode and the second electrode that is configured to sense an electrical signal from the first organ, the second organ, the second tissue, and/or the third tissue.

12. The device of claim 11, wherein the clip is configured to attach the device to a xiphoid process and/or a sternum of a patient.

13. The device of claim 11, 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 bias the top portion of the clip onto the bone, the muscle, and/or the first tissue to which it is anchored.

14. The device of claim 11, wherein the first prong is configured to contact the right lung and the second prong is configured to contact the left lung;

the first prong and the second prong are configured to contact the heart; and

/or the first prong and the second prong are configured to contact tissue surrounding the heart.

15. The device of claim 11, 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.

16. The device of claim 15, wherein the sensor is positioned on the housing, the first prong, or the second prong.

17. A subcutaneously implantable device comprising:

a housing;

a clip attached to a top side of the housing that is configured to be positioned around a muscle, a bone, and/or a tissue to anchor the device to the muscle, the bone, and/or the tissue without piercing the muscle, the bone, and/or the tissue;

a first prong made out of a stiff material with a proximal end attached to the housing and a distal end extending away from the housing that is configured to contact a heart;

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

sensing circuitry in the housing that is configured to sense an electrical signal from the heart; and

therapeutic circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation to the heart through the first electrode.

18. The device of claim 17, wherein the clip is configured to attach the device to a xiphoid process and/or a sternum of a patient.

19. The device of claim 17, 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 bias the top portion of the clip onto the bone, the muscle, and/or the tissue to which it is anchored.

20. The device of claim 17, wherein the sensing circuitry is in electrical communication with the first electrode and can sense the electrical signal from the heart through the first electrode.

21. The device of claim 17, wherein the sensing circuitry is in electrical communication with a second electrode on the first prong, the housing, and/or the clip and can sense the electrical signal from the heart through the second electrode.

22. The device of claim 17, and further comprising:

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 heart; and

a second electrode on the second prong that is in electrical communication with the therapeutic circuitry and is configured to deliver the electrical stimulation to the heart.

23. The device of claim 22, and further comprising:

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

a third electrode on the third prong that is in electrical communication with the therapeutic circuitry and is configured to deliver the electrical stimulation to the heart.

24. A subcutaneously implantable device comprising:

a housing;

a clip attached to a top side of the housing that is configured to be positioned around a bone to anchor the device to the bone without piercing the bone;

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 heart;

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

sensing circuitry in the housing that is configured to sense an electrical signal from the heart; and

therapeutic circuitry in the housing in electrical communication with the first electrode that is configured to deliver electrical stimulation to the heart through the first electrode.

25. The device of claim 24, wherein the clip is configured to attach the device to a xiphoid process and/or a sternum of a patient.

26. The device of claim 24, 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 bias the top portion of the clip onto the bone to which it is anchored.

27. The device of claim 24, wherein the sensing circuitry is in electrical communication with the first electrode and can sense the electrical signal from the heart through the first electrode.

28. The device of claim 24, wherein the sensing circuitry is in electrical communication with a second electrode on the first prong, the housing, and/or the clip and can sense the electrical signal from the heart through the second electrode.

29. The device of claim 24, and further comprising:

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 heart; and

a second electrode on the second prong that is in electrical communication with the therapeutic circuitry and is configured to deliver the electrical stimulation to the heart.

30. The device of claim 29, and further comprising:

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

a third electrode on the third prong that is in electrical communication with the therapeutic circuitry and is configured to deliver the electrical stimulation to the heart.