Apparatus, systems and methods for sensing bladder fullness
Inventors
Assignees
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Publication Number
US-11576598-B2
Publication Date
2023-02-14
Expiration Date
Abstract
Embodiments of the invention provide devices and systems to monitor fullness of a patient's bladder. One embodiment of a bladder fullness (BF) measure system comprises a sensor device (SD) and a controller. The SD generates an output signal (OS) based on the force exerted by the bladder against SD the wherein the OS corresponds to a degree of BF. The SD may be attached to the bladder wall or adjoining tissue and positioned between the bladder and the pubic bone such that the SD is not affected by tissues force other than that from the bladder. The controller connects to the SD and causes an associated implant to perform a function when the SD output signal exceeds a predetermined threshold. Embodiments are particularly useful for providing information on BF to patients suffering from spinal injury or other conditions whereby they have lost the ability to sense BF and/or voluntarily urinate.
Core Innovation
The invention describes a bladder fullness measurement apparatus that monitors fullness of a patient’s bladder. The apparatus includes a base comprising a flexible material configured to be positioned in and attached to tissue between the patient’s pubic bone and the patient’s bladder and to conform to a contour of the pubic bone so as to be mechanically supported by the pubic bone.
A rigid layer attached to the base includes a conductive material, and a deformable membrane is positioned over and hermetically sealed to the rigid layer along a perimeter. The membrane defines a cavity between the membrane and the rigid layer, and the cavity is filled with a fluid. The membrane is configured to deform from force exerted by the bladder against the membrane so as to exert a pressure on the fluid, and the pressure is correlated to a degree of fullness of the bladder.
The apparatus further includes a pressure sensor for measuring a pressure of the fluid within the cavity. The pressure sensor is positioned on a portion of the rigid layer within the cavity, electrically coupled to the conductive portion of the rigid layer, and configured to generate a signal correlated to a degree of distension of the bladder. The claims further include conductive traces, an insulative layer, and material properties that enable suturing while minimizing tearing.
Claims Coverage
The partial content includes four independent apparatus claims. Across these independent claims, the shared inventive subject matter comprises a pubic-bone mechanically supported, bladder-deformable, hermetically sealed, fluid-filled membrane producing a pressure-correlated signal via a pressure sensor electrically coupled to a conductive rigid layer, with additional coverage for layered conductive/insulative structure and specified base material properties.
Pubic-bone mechanically supported flexible base for bladder monitoring
A base configured to be positioned in and attached to tissue between the patient’s pubic bone and the patient’s bladder and to conform to a contour of the pubic bone so as to be mechanically supported by the pubic bone, wherein the mechanical support provided by the pubic bone to the base prevents the membrane from being substantially deformed by force from tissue other than the bladder.
Hermetically sealed deformable membrane defining a fluid cavity correlated to bladder fullness
A deformable membrane positioned over and hermetically sealed to a rigid layer along a perimeter of the membrane, the membrane defining a cavity between the membrane and the rigid layer, the cavity filled with a fluid, the membrane configured to deform from force exerted by the bladder against the membrane so as to exert a pressure on the fluid, the pressure correlated to a degree of fullness of the bladder.
Pressure sensor electrically coupled to conductive rigid layer to generate distension-correlated signal
A pressure sensor for measuring a pressure of the fluid within the cavity, the pressure sensor positioned on a portion of the rigid layer within the cavity, electrically coupled to a conductive portion of the rigid layer and configured to generate a signal correlated to a degree of distension of the bladder.
Layered rigid structure with insulating layer and conductive traces
A rigid layer having at least a portion comprising a conductive material, where the conductive portion includes conductive traces, an insulative layer positioned over at least a portion of the conductive traces or other conductive portion of the rigid layer, and a deformable membrane hermetically sealed to the rigid layer along a perimeter.
Suturable base material properties with specified tear strength
Material properties of the base configured to allow suturing through the base while minimizing tearing of the base from suturing, wherein the material properties comprise a tear strength of the base, and the tear strength of the base is in a range of about 1 lb/inch to about 10 lbs/inch.
Base tear strength range
A base comprising a flexible material configured to be positioned in and attached to tissue between the patient’s pubic bone and the patient’s bladder and to conform to a contour of the pubic bone so as to be mechanically supported by the pubic bone, and to have a tear strength in a range of about 1 to 20 lbs/inch.
The independent claims cover bladder-fullness monitoring using bladder-force-deformable, hermetically sealed membranes with internal fluid cavities that generate a fluid pressure correlated with bladder fullness, measured by a pressure sensor electrically coupled to a conductive rigid layer. The claims also require mechanical support by the pubic bone to prevent substantial deformation from non-bladder tissue forces, with additional coverage for layered conductive/insulative structures and specified base tear strength or suturing-related material properties.
Stated Advantages
Reduced infection risk versus Foley catheters.
Improved measurement accuracy from pubic-bone shielding.
Motion artifact mitigation.
Documented Applications
Monitoring bladder fullness (BFM) in patients lacking bladder sensation/voluntary voiding.
Using a bladder-fullness signal to send patient notifications and/or to trigger an implanted neuro-stimulation device to initiate/control urination when a predetermined threshold is exceeded.
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