Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
  • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
  • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable

Definitions

• This disclosure relates generally to a medical device having an inflatable member and a pressure calibration system.
• an inflatable member or portion is used to apply pressure to a portion of the body.
• an inflatable member or portion is used to apply pressure to a urethra of a patient.
• pressure can be applied to the urethra of the patient to help resolve continence issues.
• the medical device may include a pump, such as an electric pump, to inflate or deflate the inflatable member.
• a pump such as an electric pump
• it can be important to not overinflate or over deflate the inflatable member so as to conserve battery power and/or have an otherwise efficient system.
• an apparatus includes a bodily implant configured to be implanted into a body of a patient.
• the implant having an inflatable member, a sensor, and a calibration module.
• the inflatable member is configured to be disposed proximate a portion of the body of the patient.
• the sensor is operatively coupled to the inflatable member and is configured to detect a fluidic pressure within the inflatable member.
• the calibration module calibration module is configured to receive pressure data from the sensor and determine when the inflatable member is placing a pressure on the portion of the body of the patient.
• the inflatable member is configured to be disposed in an inflated configuration and a deflated configuration. In some embodiments, the inflatable member is configured to be disposed in an inflated configuration and a deflated configuration, the inflatable member being configured to place a first pressure on the portion of the body of the patient when the inflatable member is in its inflated configuration and a second pressure on the portion of the body of the patient when the inflatable member is in its deflated configuration.
• the inflatable member is configured to be disposed in an inflated configuration and a deflated configuration, the inflatable member being configured to place a first pressure on the portion of the body of the patient when the inflatable member is in its inflated configuration and a second pressure on the portion of the body of the patient when the inflatable member is in its deflated configuration, the first pressure being greater than the second pressure.
• the bodily implant includes a pump, the pump being operatively coupled to the inflatable member and configured to pump a fluid out of the inflatable member.
• the bodily implant includes a pump, the pump being operatively coupled to the inflatable member and configured to pump a fluid into the inflatable member.
• the bodily implant includes a first pump and second pump.
• the bodily implant includes an electric pump. In some embodiments, the bodily implant includes a first electric pump and a second electric pump.
• the bodily implant includes a reservoir configured to hold fluid.
• the calibration module includes an evaluation module, the evaluation module being configured to evaluate pressure data.
• the calibration module includes a smoothing module, the smoothing module being configured to smooth pressure data received from the sensor.
• the inflatable member is configured to be disposed proximate a urethra of a patient. In some embodiments, the inflatable member is configured to be disposed in a circular configuration. In some embodiments, the inflatable member is configured to be disposed in a circular configuration and is configured to surround a urethra of a patient.
• an apparatus includes a bodily implant configured to be implanted into a body of a patient, the implant including an inflatable member, a reservoir, a first electrical pump, a second electrical pump, a sensor, and a calibration module, the inflatable member being configured to be disposed proximate a portion of the body of the patient, the first electrical pump being configured to pump fluid from the inflatable member to the reservoir, the second electrical pump being configured to pump fluid from the reservoir to the inflatable member, the sensor is operatively coupled to the inflatable member and is configured to detect a fluidic pressure within the inflatable member, and the calibration module calibration module is configured to receive pressure data from the sensor and determine when the inflatable member is placing a pressure on the portion of the body of the patient.
• the inflatable member is configured to be disposed proximate a urethra of a patient. In some embodiments, the inflatable member is configured to be disposed in a circular configuration and is configured to surround a urethra of a patient.
• a method includes deflating an inflatable member that is disposed within a body of a patient; sensing the pressure applied by the inflatable member to a portion of the body of the patient; and determining when the inflatable member is no longer applying a pressure to the portion of the body of the patient.
• the method includes smoothing pressure data received from a pressure sensor. BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 schematically illustrates an apparatus according to an embodiment of the invention.
• FIG. 2 is a schematically illustrates an apparatus according to another embodiment.
• FIGS. 3-6 are graphs illustrating pressure over time of an apparatus according to an embodiment.
• FIG. 7 is a flow chart of a method according to an embodiment.
• the terms “a” or “an,” as used herein, are defined as one or more than one.
• the term “another,” as used herein, is defined as at least a second or more.
• the terms “including” and/or “having”, as used herein, are defined as comprising (i.e., open transition).
• the term “coupled” or “moveably coupled,” as used herein, is defined as connected, although not necessarily directly and mechanically.
• the embodiments are directed to bodily implants.
• the term patient or user may hereafter be used for a person who benefits from the medical device or the methods disclosed in the present disclosure.
• the patient can be a person whose body is implanted with the medical device or the method disclosed for operating the medical device by the present disclosure.
• the patient may be a human male, a human female, or any other mammal.
• FIG. 1 illustrates an apparatus 100 according to an embodiment of the invention.
• the apparatus or a bodily implant 100 The bodily implant 100 is configured to be disposed or otherwise placed within a body of a patient.
• the bodily implant is configured to be placed within a pelvic region of a patient.
• the bodily implant is a configured to be placed within a pelvic region of a patient and is configured to address or help treat continence issues of the patient, such as urinary incontinence or fecal incontinence.
• the bodily implant 100 includes an inflatable or inflation member 110, a sensor 120, and a calibration module 130.
• the inflatable member 110 is configured to be placed in an inflated configuration and a deflated configuration.
• the inflatable member 110 is configured to place pressure on a portion of the body of the patient when the inflatable member 110 is in its inflated configuration.
• the inflatable member 110 is configured to be disposed proximate a urethra of a patient and is configured to serve as an artificial sphincter.
• the inflatable member 110 applies a pressure to the urethra when the inflatable member 110 is in its inflated configuration and does not apply a pressure (or applies less of a pressure) when the inflatable member 110 is in is deflated configuration.
• the inflatable member 110 is formed of a material that is configured to expand.
• the inflatable member 110 is a balloon or other inflatable type device.
• the inflatable member 110 is or forms a loop or circle and is configured to surround a portion of the body of the patient, such as a urethra of a patient.
• the sensor 120 is operatively coupled to the inflatable member 110. The sensor 120 is configured to sense or detect a pressure within the inflatable member 110.
• the calibration module 130 is operatively coupled to the sensor 120.
• the calibration module 130 is configured to receive pressure data of the inflatable member 110 from the sensor 120.
• the calibration module 130 is configured to determine when the inflatable member 110 is applying pressure to the body of the patient.
• the calibration module 130 is configured to determine when the inflatable member 110 is not applying pressure to the body of the patient.
• the calibration module 130 is configured to determine when the inflatable member 110 is applying pressure to the body of the patient and when it is not applying pressure to the body of the patient.
• the calibration module 130 is configured to determine the atmospheric pressure of the location of the patient. For example, the calibration module 130 is configured to determine if the local atmospheric pressure is greater than normal (patient is diving in the ocean) or if the local atmospheric pressure is less than normal (patient is hiking a tall mountain).
• FIG. 2 schematically illustrates a bodily implant 200 according to an embodiment.
• the bodily implant 200 is configured to be disposed within a body of a patient.
• the bodily implant 200 includes an inflatable or inflation member 210.
• the inflatable member 210 is configured to be placed in an inflated configuration and a deflated configuration.
• the inflatable member 210 is configured to place pressure on a portion of the body of the patient when the inflatable member 210 is in its inflated configuration.
• the inflatable member 210 is a cuff that is configured to surround a urethra of a patient.
• the inflatable member 210 applies a pressure to the urethra when the inflatable member 210 is in its inflated configuration and does not apply a pressure (or applies less of a pressure) when the inflatable member 210 is in is deflated configuration.
• the inflatable member 210 is formed of a material that is configured to expand. In some embodiments, the inflatable member 210 is a balloon or other inflatable type device.
• the bodily implant 200 includes a first pump 212, a first valve 214 and a reservoir 216.
• the inflatable member 210 is operatively coupled to the first pump 212.
• a tubular member such as a kink-resistant tubular member, may be coupled to and extend from the inflatable member 210 to the first pump 212.
• the first pump 212 is configured to pump fluid out of the inflatable member 210.
• the first pump 212 is configured to pump fluid out of the inflatable member 210 and towards or into the reservoir 216.
• the first pump 212 is an electric pump or a pump that operates on an electrical power source.
• the first pump 212 is operatively coupled to the first valve 214.
• a tubular member such as a kink-resistant tubular member, may be coupled to and extend from the first pump 212 to the first valve 214.
• the first valve 214 is configured to allow fluid to pass in the direction towards the reservoir 216.
• the first valve 214 is operatively coupled to the reservoir 216.
• a tubular member such as a kink-resistant tubular member, extends between and couples the first valve 214 to the reservoir.
• the reservoir 216 is configured to hold fluid.
• the reservoir 216 may be a pressure-regulating inflation balloon or element.
• the reservoir 216 may be constructed of polymer material that is capable of elastic deformation to reduce fluid volume within the fluid reservoir 216 and push fluid out of the fluid reservoir 216.
• the reservoir 216 is made from an elastic material and is configured to expand when fluid is disposed in the reservoir 216.
• the fluid reservoir 216 is implanted into the abdominal space.
• the bodily implant 200 also includes a second pump 222 and a second valve 224.
• the reservoir 216 is operatively coupled to the second pump 222.
• a tubular member such as a kink-resistant tubular member, may be coupled to and extend from the reservoir 216 to the second pump 222.
• the second pump 222 is configured to pump fluid into the inflatable member 210.
• the second pump 222 is configured to pump fluid out of the reservoir 216 and towards or into the inflatable member 210.
• the second pump 222 is an electric pump or a pump that operates on an electrical power source.
• the second pump 222 is operatively coupled to the second valve 224.
• a tubular member such as a kink-resistant tubular member, may be coupled to and extend from the second pump 222 to the second valve 224.
• the second valve 224 is configured to allow fluid to pass in the direction towards the inflatable member 210.
• the second valve 224 is operatively coupled to the inflatable member 210.
• a tubular member such as a kink-resistant tubular member, extends between and couples the second valve 224 to the inflatable member 210.
• the calibration module 230 is configured to determine the atmospheric pressure of the location of the patient. For example, the calibration module 230 is configured to determine if the local atmospheric pressure is greater than normal (patient is diving in the ocean) or if the local atmospheric pressure is less than normal (patient is hiking a tall mountain).
• the pressure applied by the inflatable member 210 levels out for a period of time (the plateau region). In this region, the inflatable member 210 is no longer applying pressure to the portion of the body of the patient. Accordingly, the calibration module 230 can determine when the pump 212 can cease pumping fluid from the inflatable member 210. Specifically, in some embodiment, the pump 212 can cease pumping fluid from the inflatable member 210 at the beginning of the plateau region so as to conserve power resources.
• the pressure data received from the first sensor 220 oscillates.
• the oscillation may make the plateau region difficult to identify.
• the oscillating data may be smoothed to more easily and more accurately identify the plateau region.
• FIG. 6 also illustrates pressure data over time.
• the smoothing module 234 may use any number of methods for smoothing the oscillating data.
• the smoothing module uses a standard deviation method to smooth the data.
• the standard deviation of a subset of the data points will be the smallest at the plateau region.
• the smoothing module uses a subtraction method to generate a smoothed curve.
• the value of the previous point is subtracted from the value of the current point to smooth the curve.
• the inflection point or points of the oscillating curve may be identified to identify the plateau region.
• the inflatable member 210 when the inflatable member 210 is being inflated, there may be a higher pressure on at the reservoir 216 than at the inflatable member 210. In such cases, passive filling of the inflatable member 210 may be used. For example, in such cases, the second valve 224 may be opened to allow fluid to flow from the reservoir 216 to the inflatable member 210 without having to operate the second pump 234.
• FIG. 7 is a flow chart of a method 300 according to an embodiment of the invention.
• the method 300 includes at 310 deflating an inflatable member that is disposed within a body of the patient.
• the fluid pressure of the inflatable member is sensed or detected.
• Various implementations of the systems, modules, and other units described herein, and techniques described here can be realized in digital electronic circuitry, integrated circuitry, specially designed ASICs (application specific integrated circuits), computer hardware, firmware, software, and/or combinations thereof.
• ASICs application specific integrated circuits
• These various implementations can include implementation in one or more computer programs that are executable and/or interpretable on a programmable system including at least one programmable processor, which may be special or general purpose, coupled to receive data and instructions from, and to transmit data and instructions to, a storage system, at least one input device, and at least one output device.
• Methods discussed above may be implemented by hardware, software, firmware, middleware, microcode, hardware description languages, or any combination thereof.
• the program code or code segments to perform the necessary tasks may be stored in a machine or computer readable medium such as a storage medium.
• a processor(s) may perform the necessary tasks.
• references to acts and symbolic representations of operations that may be implemented as program modules or functional processes include routines, programs, objects, components, data structures, etc., that perform particular tasks or implement particular abstract data types and may be described and/or implemented using existing hardware at existing structural elements.
• Such existing hardware may include one or more Central Processing Units (CPUs), digital signal processors (DSPs), appbcation- specific-integrated-circuits, field programmable gate arrays (FPGAs) computers or the like.
• CPUs Central Processing Units
• DSPs digital signal processors
• FPGAs field programmable gate arrays
• the software implemented aspects of the example embodiments are typically encoded on some form of non-transitory program storage medium or implemented over some type of transmission medium.
• the program storage medium may be magnetic (e.g., a floppy disk or a hard drive) or optical (e.g., a compact disk read only memory, or CD ROM), and may be read only or random access.
• the transmission medium may be twisted wire pairs, coaxial cable, optical fiber, or some other suitable transmission medium known to the art.
• the example embodiments not limited by these aspects of any given implementation.
• Detailed implementations are disclosed herein. However, it is understood that the disclosed implementations are merely examples, which may be embodied in various forms.

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• Health & Medical Sciences (AREA)
• Urology & Nephrology (AREA)
• Cardiology (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)
• Measuring And Recording Apparatus For Diagnosis (AREA)
• Measuring Fluid Pressure (AREA)

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• 2022
  • 2022-03-03 AU AU2022231183A patent/AU2022231183A1/en active Pending
  • 2022-03-03 EP EP22714095.1A patent/EP4301281A1/de active Pending
  • 2022-03-03 CA CA3212494A patent/CA3212494A1/en active Pending
  • 2022-03-03 WO PCT/US2022/070940 patent/WO2022187840A1/en active Application Filing

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