FEEDBACK-BASED DIURETIC OR NATRIURETIC MOLECULE ADMINISTRATION

• US 20140031787A1
• Filed: 03/15/2013
• Published: 01/30/2014
• Est. Priority Date: 04/13/2012
• Status: Abandoned Application

• Current Assignee: Capricor Therapeutics, Inc.
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Burnes, John, Manda, VenKatesh, Van Antwerp, William, Williams, Jamie
• Application Number:
  US13/844,549
• Publication Number:
  US 20140031787A1
• Time in Patent Office: Days
• US Class Current: 604/505
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2210/1082 Kidney
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• 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: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 40/63 for local operation

Abstract

Devices, systems and methods using feedback from sensors for the treatment of pathological conditions such as Kidney Disease (KD) alone, Heart Failure (HF) alone, KD with concomitant HF or cardiorenal diseases syndrome (CRS) are described. The devices, systems and methods monitor and gather patient information and administer one or more diuretic or natriuretic molecules.

Claims

1. A medical device, comprising:

one or more sensors adapted to detect at least one physiologic parameter relating to any one of cardiac function, kidney function or fluid status of a patient,

a pump for delivering one or more diuretic or natriuretic molecules to a patient, and

an algorithm for determining the need for the patient to have an increased or decreased amount of a diuretic or natriuretic molecule.

2. The medical device of claim 1, wherein the pump is controlled by a control system, the control system applying the algorithm to data received from the one or more sensors.

3. The medical device of claim 2, wherein the control system has a data aggregation device function or has access to a data aggregation device function for receiving and storing data from the one or more sensors.

4. The medical device of claim 1, wherein the one or more sensors determine a physiological parameter selected from blood pressure, pulmonary artery pressure, left atrial pressure, central venous pressure, lung fluid volume, proteinuria, plasma renin, central venous pressure, right atrial pressure, cardiac output, and glomerular filtration rate (“

GFR”

).

5. The medical device of claim 1, wherein the algorithm decreases a rate of administration of the pump when a physiological parameter shows a value that indicates an improvement in cardiac function, kidney function or fluid status of the patient compared to a prior value, or increases a rate of administration of the pump when a physiological parameter shows a value that indicates a worsening in cardiac function, kidney function or fluid status of the patient compared to a prior value.

6. The medical device of claim 5, wherein the algorithm stops administration by the pump when the physiological parameter improves to reach a targeted level.

7. The medical device of claim 1, wherein the algorithm issues an alert when a physiological parameter has a value that indicates a worsening in cardiac function, kidney function or fluid status of the patient and the value has reached a critical level.

8. The medical device of claim 1, wherein the algorithm can set and adjust a maximum rate of administration of the pump.

9. The medical device of claim 8, wherein the algorithm increases the maximum rate of administration of the pump by an incremental amount when all of the following are present:

1) the medical device has operated the pump at a preliminary maximum dose, where the preliminary maximum dose is a present maximum rate of administration of the pump,

     2) the medical device has operated the pump at the preliminary maximum rate of administration for at least a predetermined period of time, and

     3) one or more physiological parameters of the patient has been stable over the predetermined period of time to indicate that homeostatis or near homeostatis of the physiological parameter is present.

10. The medical device of claim 1, wherein the algorithm initiates the delivery of a first diuretic or a second diuretic prior to initiating delivery of the natriuretic molecule to the patient.

11. The medical device of claim 1, wherein the one or more natriuretic molecules are selected from the group consisting of long-acting natriuretic peptide (LANP), kaliuretic peptide (KP), urodilatin (URO), atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), vessel dilator (VD) and chimeric natriuretic peptides including peptides selected from CD-NP, CU-NP, and BD-NP.

12. A system, comprising:

a sensor that generates an electrical signal that varies as function of a parameter associated with least one physiologic parameter relating to any one of cardiac function, kidney function or fluid status of a patient;

a processor that processes the electrical signal to detect a change in the cardiac function, kidney function or fluid status of a patient; and

a pump controlled by the processor for administering one or more diuretic or natriuretic molecules to the patient based upon the detected change in the cardiac function, kidney function or fluid status of the patient.

13. The system of claim 12, wherein the one or more sensors determine a physiological parameter selected from blood pressure, pulmonary artery pressure, left atrial pressure, central venous pressure, lung fluid volume, proteinuria, plasma renin, central venous pressure, right atrial pressure, cardiac output, and glomerular filtration rate (“

GFR”

).

14. The system of claim 12, wherein a protocol for controlling the pump is adjusted in an iterative process to improve the fluid status, cardiac function or kidney function of the patient while maintaining the cardiovascular stability of the patient.

15. The system of claim 12, wherein the one or more natriuretic molecules are selected from the group consisting of long-acting natriuretic peptide (LANP), kaliuretic peptide (KP), urodilatin (URO), atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), vessel dilator (VD) and chimeric natriuretic peptides including peptides selected from CD-NP, CU-NP, and BD-NP.

16. A method, comprising the steps of:

obtaining data from one or more sensors configured to measure one or more physiological parameters of a patient;

applying an algorithm to the data received from the one or more sensors, the algorithm determining the need for the patient to have an increased or decreased amount of a diuretic or natriuretic molecules; and

performing a treatment selected from at least one of;

a) administering one or more diuretic or natriuretic molecules at a rate determined by applying the algorithm, and b) stopping the administration of diuretic or natriuretic molecules as determined by applying the algorithm,

wherein the administration of the one or more diuretic or natriuretic molecules is performed by a pump for administering the diuretic or natriuretic molecules, the pump controlled by a control system for receiving data from the one or more sensors.

17. The method of claim 16, wherein the one or more physiological parameters is selected from the group consisting of blood pressure, pulmonary artery pressure, left atrial pressure, central venous pressure, lung fluid volume, proteinuria, plasma renin, central venous pressure, right atrial pressure, cardiac output, and glomerular filtration rate (“

GFR”

).

18. The method of claim 16, wherein a rate of administration of the diuretic or natriuretic molecules is increased if a physiological parameter measured by the one or more sensors indicates a deterioration in the fluid status, cardiac function or kidney function of the patient, or a rate of administration of the diuretic or natriuretic molecules is decreased if a physiological parameter measured by one or more sensors indicates a deterioration in the fluid status, cardiac function or kidney function of the patient.

19. The method of claim 16, wherein the data from the one or more sensors is received by a device acting as a data aggregation device for storing data received from the one or more sensors, and the data stored in the data aggregation device is accessible by the control system for controlling operation of a pump for administering the diuretic or natriuretic molecules.

20. The method of claim 16, wherein the one or more natriuretic molecules are selected from the group consisting of long-acting natriuretic peptide (LANP), kaliuretic peptide (KP), urodilatin (URO), atrial natriuretic peptide (ANP), brain natriuretic peptide (BNP), vessel dilator (VD) and chimeric natriuretic peptides including peptides selected from CD-NP, CU-NP, and BD-NP.