Pressure sensitive device

Inventors

Verkaik, Josiah

Assignees

RTM Vital Signs LLC

Publication Number

US-11529100-B2

Publication Date

2022-12-20

Expiration Date

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Abstract

A pressure sensitive device including a body having a proximal portion and a distal portion opposite the proximal portion, the distal portion being made of a shape memory alloy, a flexible diaphragm at least partially surrounding the body and defining a fluid chamber between the flexible diaphragm and the distal portion of the body, and a non-compressible fluid disposed within the flexible diaphragm and exhibiting a hydraulic pressure in communication with the flexible diaphragm.

Core Innovation

The invention provides a pressure sensitive device including a body having a proximal portion and a distal portion opposite the proximal portion, the distal portion being made of a shape memory alloy, a flexible diaphragm at least partially surrounding the body and defining a fluid chamber between the flexible diaphragm and the distal portion of the body, and a non-compressible fluid disposed within the flexible diaphragm and exhibiting a hydraulic pressure in communication with the flexible diaphragm. In another aspect the non-compressible fluid is fluidly coupled to a pressure measuring system remote from the body, the pressure measuring system being configured to measure the hydraulic pressure exerted by a force on the flexible diaphragm. The pressure measuring system may be disposed within a housing and include a MEMS device configured to be in communication with the hydraulic pressure exhibited by the non-compressible fluid.

The disclosure addresses limitations of known pressure transducers and transvascular devices by providing a device configured to be at least partially implanted in a blood vessel for communicating a hydraulic pressure within the blood vessel to a pressure measuring system outside of the blood vessel. The background describes known pressure transducers having manufacturing difficulties where a deflection of the diaphragm at the diaphragm's center should be no greater than a thickness of the diaphragm for accuracy, and that metal diaphragms present problems such as lack of sensitivity and various manufacturing limitations. The background further describes that known transvascular devices typically necessitate significant hardware inside the blood vessel that may be hazardous including blood flow obstructions and the potential for thrombus formation.

Claims Coverage

The independent claims recite six main inventive features across two independent claims.

Distal portion made of a shape memory alloy

A body including a proximal portion and a distal portion opposite the proximal portion, the distal portion being made of a shape memory alloy.

Flexible diaphragm defining a fluid chamber surrounding the distal portion

A flexible diaphragm surrounding the distal portion of the body and defining a fluid chamber between the flexible diaphragm and the distal portion of the body.

Non-compressible fluid exhibiting hydraulic pressure in communication with the diaphragm

A non-compressible fluid disposed within the flexible diaphragm and exhibiting a hydraulic pressure in communication with the flexible diaphragm.

Tubular body with transition region including plurality of expandable arms

A tubular body having a transition region including a plurality of expandable arms extending therefrom, each arm from the plurality of expandable arms defining a length and each arm from the plurality of expandable arms defining a planar region extending at least partially along the length.

Diaphragm and fluid chamber with non-compressible fluid around expandable arms

A diaphragm surrounding the plurality of expandable arms, the diaphragm defining a fluid chamber between the diaphragm and the tubular body; and a non-compressible fluid disposed within the fluid chamber and configured to exhibit a hydraulic pressure on the diaphragm.

Housing remote with pressure measuring system including MEMS device

A housing remote from and in communication with the pressure sensitive device, the housing including a pressure measuring system disposed therein, and the pressure measuring system including a Micro-Electro-Mechanic Systems (MEMS) device configured to be in communication with the hydraulic pressure exhibited by the non-compressible fluid.

The independent claims focus on a shape memory alloy distal portion, a surrounding flexible diaphragm forming a fluid chamber with a non-compressible fluid that communicates hydraulic pressure, a tubular body with a transition region and expandable arms, and a remote housing containing a pressure measuring system including a MEMS device.

Stated Advantages

A relatively larger surface area upon implantation than prior art devices configured as a pole or post.

Maintain the sensitivity of the device with respect to pressure measurements despite relatively small changes in mechanical properties or small changes in the volume of the fluid.

Increased capacity of the fluid chamber to provide for added fill volume and thus account for fluid volume depletion over cycles of the fluid.

Documented Applications

Implantation in a blood vessel to communicate a hydraulic pressure within the blood vessel to a pressure measuring system outside of the blood vessel.

Communicating the hydraulic pressure to a pressure measuring system upon dilation and constriction of the blood vessel.

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