Control of body fluid condition using diuretics, based on biological parameters

Abstract

The system for controlling body fluids overcomes the limitations of the prior art by automatically infusing diuretic and / or other drugs into a human patient. In one approach, the rate of infusion of the diuretic is adjusted based on a measured biological parameter of the patient. For example, this biological parameter can be transmitted wirelessly to a portable diuretic infusion device attached to the patient.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims priority under 35 U.S.C. §119(e) to (a) U.S. Provisional Patent Application Ser. No. 60 / 967,025, “Apparatus and method to control body fluid balance,” filed Sep. 1, 2007, (b) U.S. Provisional Patent Application Ser. No. 60 / 979,634, “Controlling body fluid condition using diuretics,” filed Oct. 12, 2007, (c) U.S. Provisional Patent Application Ser. No. 60 / 986,974, “Controlling body fluid condition using diuretics,” filed Nov. 9, 2007, and (d) U.S. Provisional Patent Application Ser. No. 60 / 988,375, “Controlling body fluid condition using diuretics,” filed Nov. 15, 2007, and (e) U.S. Provisional Patent Application Ser. No. 61 / 048,113, “Controlling body fluid condition using diuretics,” filed Apr. 25, 2008. The subject matter of all of the foregoing is incorporated herein by reference in its entirety, including any appendices or attachments, for all purposes.BACKGROUND OF THE INVENTION[0002]1. Field of the Invention[00...

AI Technical Summary

Benefits of technology

[0014]In one aspect of the invention, a portable diuretic infusion device includes a reservoir, a pump and a controller. The reservoir can hold a diuretic or an antihypertensive drug to be infused into the patient. The pump is connected to the reservoir and is also connectable to the patient, for example using an infusion set. The pump is operated to infuse diuretic or other drug from the reservoir into the patient. The controller controls the pump based on some biological parameter(s), thereby controlling the rate of infusion of the diuretic or other drug.

[0021]These approaches allow the dose of diuretics to be controlled much more carefully than by patient instructions alone, resulting in many possible advantages. For example, early detection and early treatment of various body fluid related diseases may be possible. This can reduce hospitalizations and death from congestive heart failure, pulmonary edema and fluid overload. In addition, patients can now have continuous infusion of diuretics by using a portable, ambulatory infusion pump. Continuous infusion of diuretics may be more effective than bolus use of diuretics. These approaches may also be more effective in maintaining target weight and / or dry weight, compared with using oral diuretics. The automated approach is also easier for patients and allows the implementation of more complex protocols, while also reducing the risk of over- or under-treatment. The automated devices can also record diuretic use (and also body weight), thus providing a reliable medical history. This information can be sent over the internet to the healthcare providers or others, for analysis or remote monitoring of patients.

Problems solved by technology

Congestive heart failure in particular is a major cause of death and hospitalization.

Despite currently available treatment, mortality and hospitalization from congestive heart failure remains high.

As pump function of the heart deteriorates, body fluid often increases and may lead to complications such as pulmonary edema.

This results in retention and accumulation of body fluid because excessive body fluid is not delivered to the kidneys to be excreted.

This excessive body fluid often manifests as swelling of the legs.

If body fluid continues to expand, a weak heart may be no longer able to handle increased blood volume and finally fails to pump blood forward adequately.

Symptoms of congestive heart failure include shortness of breath, fatigue, swelling of legs, orthopnea, paroxysmal nocturnal dyspnea (not being able to breathe suddenly at night).

People do not breathe well when fluid builds up in the lungs.

However, use of oral diuretics often fails to prevent heart failure exacerbation.

When body fluid builds up in the digestive system, it may cause intestinal edema (swelling).

The body may not be able to absorb diuretics effectively.

Patients may need to take higher dose of diuretics when poor bioavailability occurs.

Second, poor compliance plays a role.

This poor compliance could result in heart failure.

Third, treatment delay plays a role.

These explanations are associated with many cases of heart failure.

However, conventional diuretic sliding scale titration has several significant drawbacks.

First, patients may not understand the sliding scale instruction or may not comply with it.

Poor understanding of the instruction may also lead to inappropriate use of medication.

Second, conventional instructions may be limited to instructions and sliding scale titration that are simpler than would be desired.

However, some patients may not be able to follow such complex instructions so instructions may be simplified at the cost of a less effective titration.

In addition, if the sliding scale diuretic titration changes frequently, some patients may not understand the change of sliding scale diuretic titration and may end up taking the wrong dose of medication.

This may lead to serious complications.

Taking too much medication may lead to complications such as dehydration, electrolyte imbalance, hypotension, and kidney failure.

Conventional sliding scale diuretic titration is also limited to oral diuretics, which may not be as effective as, for example, continuous infusion of diuretics.

More complex protocols generally have not been attempted because there is not a reliable way to carefully monitor and control the dispensing of diuretic or to adjust the dose according to varying conditions.

In addition, there are not reliable safety measures to safeguard against the possible inappropriate use of diuretics.

Without such controls and safety measures, more complex protocols can have a higher risk of inappropriate use of diuretics and possible adverse effects such as dehydration, electrolytes abnormalities, hypotension, and kidney failure.

Images