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Patent Issued for Implantable Fluid Management Device for the Removal of Excess Fluid

July 26, 2014



By a News Reporter-Staff News Editor at Obesity, Fitness & Wellness Week -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventor Burnett, Daniel R. (San Francisco, CA), filed on March 7, 2013, was published online on July 8, 2014 (see also Sequana Medical AG).

The patent's assignee for patent number 8771221 is Sequana Medical AG (Zug, CH).

News editors obtained the following quote from the background information supplied by the inventors: "Various medical conditions result in pathologic collections of bodily fluids. One such conditions is congestive heart failure (CHF), which causes the heart to be unable to effectively meet the oxygen needs of other organs. CHF usually occurs in adults after an injury to the heart, for example, after myocardial infarction, which causes the pumping action of the heart to be ineffective. CHF may also occur in the presence of a near-normal cardiac function under conditions of hi) 11 demand, for example, because of an increase of blood volume due to retention of salt and water or because of tachycardia. These compensatory changes burden the cardiac function, leading to progressive CHF.

"In terms of incidence, prevalence, morbidity, and mortality, the epidemiologic magnitude of CHF is staggering. In the United States, the estimated annual cost of heart failure is $60 billion. Approximately one million U.S. hospital admissions per year are attributable to a primary diagnosis of acutely decompensated heart failure and the estimated annual cost of inpatient care for CHF patients is $23 billion.

"Until recently, the only therapies for delaying progress of this illness were diuretics and heart-assist devices. Fluid accumulation related to CHF is typically treated by diuretics in the early stages of the condition, but over time the body builds resistance to diuretics and the patient then begins to retain fluid. Fluid and salt restrictions may be imposed, but despite these measures, most patients continue to accumulate fluid with cardiac function deteriorating over time, which results in further fluid accumulation until the patient receives a heart transplant or succumbs to his illness.

"In three recent publications, the use of peritoneal dialysis was explored in the treatment of refractory CHF: COSTANZO ET AL., Early Ultrafiltration in Patients with Decompensated Heart Failure and Diuretic Resistance, J. Am. Coll. Cardiol. 2005; 46: 2047-2051, HOULBERG ET AL., Terminal right heart failure due to complex congenital cardiac disease successfully managed by home peritoneal drainage, Cardiol. Young 2003; 13: 568-570, and ORTIZ ET AL., Long-term automated peritoneal dialysis in patients with refractory congestive heart failure, Advances in Peritoneal Dialysis, 2003; 19; 77-80. In each of these publications, the patients were subjected to standard peritoneal dialysis and their conditions stabilized or even improved. This treatment requires the patients to undergo peritoneal dialysis exchanges, with the use of an external catheter and great risk of infection.

"Various devices have been disclosed in the prior art for removing excess fluid from different body organs, for example, in U.S. Pat. No. 4,610,658 to Buchwald et al.; U.S. Pat. No. 4,850,955 to Newkirk; U.S. Pat. No. 6,132,415 to Finch et al.; U.S. Pat. No. 6,264,625 to Rubenstein et al.; and in U.S. Patent Application Publication 2005/0273034 to Burnett. The devices of the prior art, however, exhibit different shortcomings, for example, provide no system for preventing an excessive removal of fluids from a bodily cavity, or for preventing accumulation of tissue ingrowth into an implanted fluid collection system, which would cause the system to fail to operate properly over time."

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventor's summary information for this patent: "The present invention relates to a device and its method of use for periodically, or on an as needed basis, removing fluid from a first bodily cavity, for example, from the peritoneal cavity or the lungs, and for transferring that fluid to a second bodily cavity, for example, the bladder. By the use of a device constructed according to the principles of the present invention, risk of infection is avoided fluid removal may be limited to the extent necessary to treat a specific aliment without unnecessarily dehydrating the cavity producing the excessive fluid. Therefore, the present invention provides the benefits but avoids the drawbacks of peritoneal dialysis to treat CHF and other pathological conditions, and also provides an improvement over devices of the prior art that cause excess fluid removal from a target bodily cavity.

"In one embodiment, an implantable fluid management device according to the present invention includes an uptake tube having a proximal end in fluid communication with a first cavity in the body of a patient and a distal end in fluid communication with a pump, and further includes an outflow tube having a proximal end in fluid communication with the pump and a distal end in fluid communication with a second cavity in the body of the patient. The distal end of the uptake tube is coupled to a reservoir that is configured to expand upon ingression of fluid into the reservoir and to contract upon removal of the fluid caused by a negative pressure applied on the reservoir by the pump.

"The reservoir has an outer surface with perforations that provide fluid communication between the first cavity and the reservoir, and may be manufactured with different shapes, for example, hemispherical or cylindrical. The uptake tube may be coupled to the reservoir in different point, for example, centrally or laterally.

"The reservoir may be supported by a support structure, which may provide a basic frame to the reservoir or may be made from a material that causes the support structure of the reservoir to recoil after contracting and to reacquire its expanded configuration. Therefore, the reservoir may be refilled and expand gently due to ingression of the fluid from the cavity, or expansion may be promoted by a recoil of the support structure. Backflow from the outflow tube to the uptake tube may be prevented with different unidirectional systems, for example, by adding a unidirectional valve to the device or by employing a unidirectional pump.

"The reservoir may also include a plurality of recesses on a portion of its outer surface, which promote flow of the fluid towards at least some of the perforations. The surface spanning between those recesses may be made or coated with a material favoring tissue ingrowth within that surface, so to anchor the reservoir to the cavity. Moreover, to prevent clogging of the perforations, or a blockage of the perforation by contact with a wall of the bodily cavity, at least some of the perforations may be disposed in recessed positions in relation to the outer surface of the reservoir.

"A dehydration prevention element may be included in the reservoir for preventing an actuation of the pump when the reservoir is in the contracted condition, so to avoid an excess removal of fluid from the bodily cavity by forcing a flow of fluid from the cavity into the reservoir. A weight may also be disposed in the reservoir to force the reservoir to acquire a desired position within the cavity after implantation of the device.

"In one embodiment, the perforations on the surface of the reservoir may be semi-permeable, in order to prevent ingression into the reservoir and to filter out certain undesirable components of the fluid.

"In one embodiment, the device includes a reservoir formed by a first reservoir element and a second reservoir element in fluid communication one with the other. Each of the first and second reservoir elements is configured to hold fluid and to contract upon actuation of the pump. An annular surface couples the first element to the second element and is configured like a groove defined by a portion of the first element and by a portion of the second element. Openings in the annular surface enable ingression of the fluid into the reservoir.

"In one embodiment, the first and second elements are each shaped like expandable disks having circumferential perimeters one parallel to the other, and the annular surface is disposed parallel to the first and second elements. Recesses are disposed radially on the outer face of the annular surface, promoting flow of the fluid to the openings in the annular surface. Those recesses also define ribs along the inner face of the annular surface, stiffening a portion of the reservoir and favoring expansion and contraction of the reservoir along predetermined directions."

For additional information on this patent, see: Burnett, Daniel R.. Implantable Fluid Management Device for the Removal of Excess Fluid. U.S. Patent Number 8771221, filed March 7, 2013, and published online on July 8, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8771221.PN.&OS=PN/8771221RS=PN/8771221

Keywords for this news article include: Sequana Medical AG.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2014, NewsRx LLC


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Source: Obesity, Fitness & Wellness Week


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