Erythropoeitin production by electrical stimulation

• US 9,610,444 B2
• Filed: 03/18/2014
• Issued: 04/04/2017
• Est. Priority Date: 03/15/2013
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories Incorporated)
• Inventors: Bharmi, Rupinder, Rosenberg, Stuart, Rooke, Ryan, Karst, Edward, Farazi, Taraneh Ghaffari
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US14/218,740
• Publication Number:
  US 20140288551A1
• Time in Patent Office: 1,113 Days
• Field of Search: None
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 5/02 Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/021 Measuring pressure in heart or blood vessels A61B5/0205 takes precedence
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61N 1/36031 using physiological parameters for adjustment
• CPC Class Codes: A61N 1/36034 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36121 Production of neurotransmitters; Modulation of genes expression
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/3702 : Physiological parameters A61N1/365 takes precedence; evoked response A61N1/371

Abstract

Described herein are methods, devices, and systems for treating human anemia. The methods, devices, and systems generally include monitoring a patients hemoglobin level and at least one of autonomic balance and inflammatory state to determine the etiology of the anemic state, modulating at least one of a sympathetic or parasympathetic nerve based on the cause of the anemia, monitoring for changes in the patients cardiac activity and state of inflammation, and hemoglobin level. An external neurostimulation system is describes, and well as a chronic implantable system. A method for treating a patient for anemia in conjunction with a renal denervation ablation catheter is also disclosed.

Claims

1. A method of treating anemia in a human patient, the method comprising:

monitoring a hemoglobin level of the patient on a periodic basis;

determining an anemic condition based on the hemoglobin level;

determining one or more characteristics of the anemic condition;

selecting electrical stimulation parameters of a neurostimulation device based on the one or more characteristics of the anemic condition;

generating one or more stimulation signals to stimulate the patient'"'"'s nervous system using the selected electrical stimulation parameters;

monitoring at least one of an autonomic balance or an inflammatory state of the patient resulting from the neurostimulation using the selected electrical stimulation parameters;

monitoring the patient'"'"'s cardiac activity resulting from the neurostimulation using the selected electrical stimulation parameters; and

adapting the stimulation parameters of the neurostimulation device based on at least the patient'"'"'s cardiac activity.

2. The method of claim 1 further comprising determining whether to provide stimulation of parasympathetic innervation, sympathetic innervation, or a combination of the two based on the anemic condition of the patient.

3. The method of claim 1, further comprising:

monitoring changes in at least one of;

a severity of the anemic condition, a patient'"'"'s heart rate, a quantity or severity of observed PVCs, or cardiac integrity; and

modifying stimulation parameters of the neurostimulation device if there is a change in at least one of;

a severity of the anemic condition, the patient'"'"'s heart rate, a quantity or severity of observed PVCs, or a cardiac integrity.

4. The method of claim 1, wherein determining an anemic condition based on the hemoglobin level comprises determining the patient'"'"'s EPO observed/predicted (O/P) ratio.

5. The method of claim 1, wherein determining an anemic condition based on the hemoglobin level comprises determining the patient'"'"'s EPO observed/predicted O/P ratio, transferrin saturation, and ferritin level.

6. A method of treating anemia in a human patient, the method comprising:

surgically implanting a pulse generating source comprising an electrode in communication with at least one predetermined site selected from the group consisting of one or more brain regions, a renal vessel, a carotid sinus nerve, one or more areas of the spinal cord, and one or more vagus nerves;

therapeutically treating anemia by generating an electrical signal with the pulse generating source, wherein said signal electrically stimulates the at least one predetermined site;

determining an amount of inflammation caused by the electrical signal; and

automatically adjusting at least one of;

one or more control parameters of the pulse generating source or the predetermined site of stimulation of the pulse generating source, based on at least the determined amount of inflammation.

7. The method of claim 6, wherein the at least one predetermined site comprises a NF-κ

B pathway of the patient'"'"'s hypothalamus, and wherein the electrical signal blocks the NF-κ

B pathway of the patient'"'"'s hypothalamus.

8. The method of claim 6, wherein the at least one predetermined site comprises at least one:

an area of the patient'"'"'s spinal cord at T10-L2, the patient'"'"'s renal artery, the patient'"'"'s paraventricular nucleus of the hypothalamus, the patient'"'"'s cervical vagus nerve, or a NF-κ

B pathway of the hypothalamus of the patient.

9. A method of treating anemia in a human patient, the method comprising:

monitoring a hemoglobin level of the patient on a periodic basis;

determining an anemic condition based on the hemoglobin level, wherein determining an anemic condition based on the hemoglobin level comprises determining the patient'"'"'s EPO observed/predicted O/P ratio, transferrin saturation, and ferritin level;

determining one or more characteristics of the anemic condition;

selecting electrical stimulation parameters of a neurostimulation device based on the one or more characteristics of the anemic condition;

generating one or more stimulation signals to stimulate the patient'"'"'s nervous system using the selected electrical stimulation parameters;

monitoring at least one of an autonomic balance or an inflammatory state of the patient resulting from the neurostimulation using the selected electrical stimulation parameters.

10. The method of claim 9 further comprising determining whether to provide stimulation of parasympathetic innervation, sympathetic innervation, or a combination of the two based on the anemic condition of the patient.

11. The method of claim 9, further comprising:

monitoring changes in at least one of;

a severity of the anemic condition, a patient'"'"'s heart rate, a quantity or severity of observed PVCs, or cardiac integrity; and

modifying stimulation parameters of the neurostimulation device if there is a change in at least one of;

a severity of the anemic condition, the patient'"'"'s heart rate, a quantity or severity of observed PVCs, or a cardiac integrity.