Devices for regulation of blood pressure and heart rate

A blood pressure and regulator technology, applied in applications, cardiovascular system diseases, treatment, etc., can solve problems such as insufficient control of blood pressure or heart rate

Inactive Publication Date: 2015-02-11
RESHAPE LIFESCIENCES INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many therapies have unwanted side effects, or do not achieve adequate control of blood pressure or heart rate

Method used

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  • Devices for regulation of blood pressure and heart rate
  • Devices for regulation of blood pressure and heart rate
  • Devices for regulation of blood pressure and heart rate

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0234] Materials and methods / experimental design

[0235] An open-label, prospective, baseline-controlled, four-center clinical study was conducted to evaluate the feasibility and safety and efficacy of a device as described herein that induces intermittent electrical blockade of the anterior and posterior vagal trunks . Participating centers include Flinders Medical Centre, Adelaide, Australia; Circle of Care, Sydney, Australia; University Hospital, Basel , Switzerland; and St. Olavs University Hospital, Trondheim, Norway.

[0236] patient

[0237] Male or female obese subjects (BMI31.5-55kg / m) aged 25-60 years (inclusive) were recruited at four centers 2 ). The study evaluated device safety and efficacy for up to 6 months.

[0238] The ability to complete all study visits and procedures is an eligibility requirement. Relevant exclusion criteria included: current type 1 diabetes mellitus (DM) or type 2 DM poorly controlled with oral hypoglycemic agents or with associate...

Embodiment 2

[0295] Materials and methods

[0296] Research design

[0297] This study is a prospective, open-label, multicenter study evaluating the safety and efficacy of a high-frequency electrical algorithm applied to the intra-abdominal vagal trunk to promote weight loss and improve glycemic control in type 2 diabetes control and blood pressure. Subjects' pre-implantation baseline measurements were used as controls.

[0298] The study was carried out at the following sites: National Institute of Nutrition (Instituto National de la Nutricion, INNSZ), Mexico City, Mexico; Trondheim University Hospital, Trondheim, Norway; University Hospital, Basel, Switzerland; Flinders Medical Centre, Adelaide, Australia; and Institute of Weight Control , Sydney (Sydney), Australia. This study is registered with clinicaltrials.gov (NCT00555958).

[0299] research subjects

[0300] Obese female and male subjects with type 2 diabetes (body mass index (BMI) 30-40kg / m 2 (endpoints inclusive), age 25...

Embodiment 3

[0332] This study was a multicenter, prospective, randomized, double-blind, controlled, parallel-group trial with a 12-month post-randomization follow-up period. All subjects in both groups received Maestro at implantation (EnteroMedics Inc, St. Paul, MN) for all implantable components. Obese subjects without diabetes at initial therapy were randomized in a 2:1 allocation to treatment and control groups. A limited number of patients with type 2 diabetes were randomized with a 1:1 allocation. At the end of the blinded 1-year follow-up period, all subjects received open-label VBLOC therapy and continued to be followed for an additional 4 years.

[0333] Research center

[0334] Fifteen academic and / or private practice clinics participated in the EMPOWER study (see list of contributing centers). All surgeons involved in the VBLOC feasibility study or have received Maestro placement in the classroom and in the animal laboratory under the supervision of a laparoscopic surgeon ...

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Abstract

A method and apparatus for treating a condition associated with impaired blood pressure and / or heart rate in a subject comprising applying an electrical treatment signal, wherein the electrical treatment signal is selected to at least partially block nerve impulses, or in some embodiments, to augment nerve impulses. In embodiments, the apparatus provides a first therapy program to provide a downregulating signal to one or more nerves including renal artery, renal nerve, vagus nerve, celiac plexus, a splanchnic nerve, cardiac sympathetic nerves, spinal nerves originating between T10 to L5. In embodiments, the apparatus provides a third therapy program to provide an upregulating signal to one or more nerves including a glossopharyngeal nerve and / or a tissue containing baroreceptors.

Description

[0001] cross reference [0002] This application was filed as a PCT International Patent Application on March 4, 2013, and claims priority to U.S. Provisional Patent Application No. 61 / 607,701, filed March 7, 2012, the disclosure of which is incorporated herein by reference in its entirety . Background technique [0003] It is estimated that about 50 million people in the United States have high blood pressure. The criteria used to diagnose hypertension have changed: blood pressure of 120 / 80mmHg is considered normal; 120-139 / 80-89mmHg is defined as prehypertensive; greater than or equal to 140-159mmHg systolic / 90-99mmHg diastolic It is stage I hypertension; and greater than or equal to 160mmHg in systole / greater than or equal to 100mmHg in diastole is stage II hypertension (The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure, ( JNC7), NHLBI publication, Hypertension 42:1206, 2003). Of those who have b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61N1/36A61N1/378A61N1/372A61B5/296
CPCA61N1/3787A61N1/36114A61N1/36167A61N1/37252Y10T29/49002A61P9/04A61P9/12
Inventor A.P.唐德斯K.S.特威登M.B.克努森A.W.桑顿
Owner RESHAPE LIFESCIENCES INC
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