Patent Application
20240050024
The present invention relates to vaginal devices and more specifically to devices as well as methods and systems for the retention of such devices, the devices being for measurement, diagnostics, therapy, or treatment.
For women pelvic organ prolapse (POP) and urinary incontinence (UI) are common and often distressing conditions. Research indicates that in the United States alone there are 3.3 million women with pelvic organ prolapse and approximately 300,000 surgeries are performed annually in the United States. Additionally, approximately 25% of all women, 33% of older women, have some degree of urinary incontinence. Further, male urinary incontinence whilst it exists has only recently become perhaps evident to the general population with the advent of advertisements for male and female incontinence underwear. An aging population at this point would not indicate any reduction in such figures in the near term whilst a massive expenditure and ease of availability of ultra-thin liners for women's underwear, male and female incontinence underwear and emerging products such as liners for male underwear within supermarkets and pharmacies indicate that the demand and market are high enough for multinational household product and pharmaceutical enterprises to have product lines and brands in this area.
Today, a range of surgical treatment options for POP as well as non-surgical treatments exist. Non-surgical treatment options include Kegel exercises, Kegel assist devices, pessaries, core/floor strengthening exercises, biofeedback, electrical stimulation, hormone replacement therapy, tibial nerve stimulation and support garments. At present, physical non-surgical devices such as Kegel assist devices and pessaries are fitted by best guess, trial-and-error. Pessaries being prosthetic devices that can be inserted into the vagina to support its internal structure as a remedy for urinary incontinence, fecal incontinence, cervical incompetence and/or pelvic organ prolapse. Whilst the literature is replete with information explaining to medical personnel how to fit a pessary or users how to tell if their pessary fits correctly, this potentially exacerbates the situation as there are at least 20 designs of pessary alone each available in multiple sizes, in some instances 10 or more. So, type of pessary and size both need to be factored into addressing the correct device for a user.
As discussed by the inventors previously, see for example World Patent Application 2019/051,579 entitled “Methods and Systems for Vaginal Therapeutic Device Fitting”, it would be beneficial to replace the current manual processes of sizing, fitting etc. as well as pessary design with a personal pelvic health characterization and provisioning approach that factors user specific anatomy and physiology, user life style, user experiences, automated assessments etc. into provisioning custom vaginal therapeutic devices.
Accordingly, the user specific anatomy and physiology should be obtained in a reproducible manner with devices and systems that remove measurement artifacts, errors, bias etc. whilst providing the patient with an improved experience and the medical personnel with ergonomic, efficient, and easy to use systems exploiting combinations of dedicated multi-patient measurement equipment with user specific consumable items for cleanliness etc.
Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.
It is an object of the present invention to mitigate limitations within the prior art relating to vaginal devices and more specifically to devices as well as methods and systems for the retention of such devices, the devices being for measurement, diagnostics, therapy, or treatment.
In accordance with an embodiment of the invention there is provided a balloon comprising a first balloon disposed at a first position on a catheter; a second balloon disposed adjacent the first balloon on the catheter; wherein each of the first balloon and second balloon is filled with a predetermined fluid independent from the other of the first balloon and second balloon; the first balloon is either attached at both ends to the catheter or attached at a first end of the catheter and extends beyond the catheter at a second distal end to the first end; and the second balloon is attached at both ends to the catheter.
In accordance with an embodiment of the invention there is provided a method comprising providing an outer cushion formed from a low elastic modulus material for conforming to a predetermined portion of a patient's body; providing a structural shield formed from a high elastic modulus material disposed with the outer cushion between it and the patient; providing a manometry balloon for establishing first data relating to the patient; and providing a probe for establishing second data relating the patient having one or more transducers generating and/or receiving signals of a predetermined type; wherein the outer cushion and structural shield maintain the manometry balloon in position within a cavity of the patient; the manometry balloon is filled to a predetermined pressure and/or volume with a predetermined fluid; the body of the manometry balloon and the predetermined fluid have high contrast against the patient's body to the signals of the predetermined type; and the probe can be positioned against or in close proximity to the outer cushion.
In accordance with an embodiment of the invention there is provided a method comprising providing a structural shield formed from a high elastic modulus material; providing a manometry balloon for establishing first data relating to the patient; and providing a probe for establishing second data relating the patient; wherein the structural shield maintains the manometry balloon in position within a cavity of the patient; the manometry balloon is filled to a predetermined pressure and/or volume with a predetermined fluid; the body of the manometry balloon and predetermined fluid present a high contrast against the patient's body to the probe; and the probe can be positioned against or in close proximity to a window within the structural shield.
In accordance with an embodiment of the invention there is provided a method comprising providing a cushion formed from a low elastic modulus material for conforming to a predetermined portion of a patient's body; wherein providing a manometry balloon for establishing first data relating to the patient; providing a probe for establishing second data relating the patient; and providing a seat within an opening; wherein the cushion is disposed between patient's body and the seat; the cushion maintains the manometry balloon in position within a cavity of the patient; the manometry balloon is filled to a predetermined pressure and/or volume with a predetermined fluid; the body of the manometry balloon and predetermined fluid present a high contrast against the patient's body to the probe; and the probe is positioned in or in close proximity to the opening within the seat to acquire the second data.
In accordance with an embodiment of the invention there is provided a method of performing measurements with respect to a patient comprising: providing a balloon for insertion within a cavity of the patient; providing a probe exploiting signals of a predetermined type; providing a manometry system coupled to the balloon; providing a support for the patient.
In accordance with an embodiment of the invention there is provided a device comprising:
In accordance with an embodiment of the invention there is provided a method comprising automatically identifying a pubic symphysis (PS) of a patient and an anorectal angle (ARA) of the patient from a plurality of transperineal ultrasound images.
In accordance with an embodiment of the invention there is provided a device comprising:
In accordance with an embodiment of the invention there is provided a device comprising:
In accordance with an embodiment of the invention there is provided a method of establishing a user specific therapeutic device (USTD) comprising:
Other aspects and features of the present invention will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments of the invention in conjunction with the accompanying figures.
Embodiments of the present invention will now be described, by way of example only, with reference to the attached Figures, wherein:
The present invention is directed to vaginal devices and more specifically to devices as well as methods and systems for the retention of such devices, the devices being for measurement, diagnostics, therapy, or treatment.
The ensuing description provides representative embodiment(s) only, and is not intended to limit the scope, applicability, or configuration of the disclosure. Rather, the ensuing description of the embodiment(s) will provide those skilled in the art with an enabling description for implementing an embodiment or embodiments of the invention. It being understood that various changes can be made in the function and arrangement of elements without departing from the spirit and scope as set forth in the appended claims. Accordingly, an embodiment is an example or implementation of the inventions and not the sole implementation. Various appearances of “one embodiment,” “an embodiment” or “some embodiments” do not necessarily all refer to the same embodiments. Although various features of the invention may be described in the context of a single embodiment, the features may also be provided separately or in any suitable combination. Conversely, although the invention may be described herein in the context of separate embodiments for clarity, the invention can also be implemented in a single embodiment or any combination of embodiments.
Reference in the specification to “one embodiment”, “an embodiment”, “some embodiments” or “other embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiments is included in at least one embodiment, but not necessarily all embodiments, of the inventions. The phraseology and terminology employed herein is not to be construed as limiting but is for descriptive purpose only. It is to be understood that where the claims or specification refer to “a” or “an” element, such reference is not to be construed as there being only one of that element. It is to be understood that where the specification states that a component feature, structure, or characteristic “may”, “might”, “can” or “could” be included, that particular component, feature, structure, or characteristic is not required to be included.
Reference to terms such as “left”, “right”, “top”, “bottom”, “front” and “back” are intended for use in respect to the orientation of the particular feature, structure, or element within the figures depicting embodiments of the invention. It would be evident that such directional terminology with respect to the actual use of a device has no specific meaning as the device can be employed in a multiplicity of orientations by the user or users. Reference to terms “including”, “comprising”, “consisting” and grammatical variants thereof do not preclude the addition of one or more components, features, steps, integers, or groups thereof and that the terms are not to be construed as specifying components, features, steps, or integers. Likewise, the phrase “consisting essentially of”, and grammatical variants thereof, when used herein is not to be construed as excluding additional components, steps, features integers or groups thereof but rather that the additional features, integers, steps, components, or groups thereof do not materially alter the basic and novel characteristics of the claimed composition, device, or method. If the specification or claims refer to “an additional” element, that does not preclude there being more than one of the additional element.
“Artificial intelligence” (AI, also machine intelligence, MI) as used herein may refer to, but is not limited to, intelligence exhibited by machines rather than humans or other animals which exhibit so-called natural intelligence (NI). Colloquially, the term AI is employed when a machine mimics “cognitive” functions which humans associate with other human minds, such as “learning” and “problem solving”. AI may employ one or more tools, including, but not limited to search and optimization, logic, probabilistic methods for uncertain reasoning, classifiers and statistical learning methods, neural networks, deep feedforward neural networks, deep recurrent neural networks, and control theory.
A “portable electronic device” (PED) as used herein and throughout this disclosure, refers to a wireless device used for communications and other applications that requires a battery or other independent form of energy for power. This includes devices, but is not limited to, such as a cellular telephone, smartphone, personal digital assistant (PDA), portable computer, pager, portable multimedia player, portable gaming console, laptop computer, tablet computer, a wearable device, an electronic reader, a vaginal therapy device (VTD), and a user specific therapeutic device (USTD).
A “fixed electronic device” (FED) as used herein and throughout this disclosure, refers to a wireless and/or wired device used for communications and other applications that requires connection to a fixed interface to obtain power. This includes, but is not limited to, a laptop computer, a personal computer, a computer server, a kiosk, a gaming console, a digital set-top box, an analog set-top box, an Internet enabled appliance, an Internet enabled television, and a multimedia player.
An “application” (commonly referred to as an “app”) as used herein may refer to, but is not limited to, a “software application”, an element of a “software suite”, a computer program designed to allow an individual to perform an activity, a computer program designed to allow an electronic device to perform an activity, and a computer program designed to communicate with local and/or remote electronic devices. An application thus differs from an operating system (which runs a computer), a utility (which performs maintenance or general-purpose chores), and a programming tools (with which computer programs are created). Generally, within the following description with respect to embodiments of the invention an application is generally presented in respect of software permanently and/or temporarily installed upon a PED and/or FED.
A “user” as used herein may refer to, but is not limited to, an individual exploiting a vaginal therapeutic device according to an embodiment or embodiments of the invention. As such an individual may be employing a vaginal therapeutic device with respect to one or more conditions, requirements, and/or preventions. As such an individual may include, but not be limited to, a person with a vagina, an animal with a vagina, a recipient of gender affirming surgery (also known as sex reassignment surgery, gender confirmation surgery, gender specific reconstruction surgery, and sex realignment surgery). In its broadest sense the user may further include, but not be limited to, mechanical systems, robotic systems, android systems, etc. that may be characterised by a requirement to exploit one or more embodiments of the invention. A user may be associated with biometric data which may be, but not limited to, monitored, acquired, stored, transmitted, processed and analysed either locally or remotely to the user. A user may also be associated through one or more accounts and/or profiles with one or more of a service provider, third party provider, enterprise, social network, social media etc. via a dashboard, web service, website, software plug-in, software application, and graphical user interface.
The terms “woman” or “female” as used herein, and throughout this disclosure, refers to a human having a vagina or surgically formed vaginal structure and optionally a clitoris or clitoral region, uterus, bladder, a urethra, rectum, and/or an anus. The terms “woman” and “female” are used interchangeably herein.
“User information” as used herein may refer to, but is not limited to, user behavior information and/or user profile information. It may also include a user's biometric information, an estimation of the user's biometric information, or a projection/prediction of a user's biometric information derived from current and/or historical biometric information.
A “vaginal therapeutic device” (VTD, commonly referred to as a pessary) refers to a medical device and is a specific form of a user specific therapeutic device (USTD). A USTD may be used to support the uterus, vagina, bladder, or rectum. A USTD may be employed to treat a pelvic organ prolapse (POP), such as prolapse of the uterus for example, treat an intestinal issue, an enterocele (essentially a vaginal hernia), reduce the impact of an evolving POP, treat and/or reduce the impact of urinary incontinence (UI), treat and/or reduce the impact of stress UI, and treat and/or reduce the impact of urge UI. Alternatively, a USTD may be employed during pregnancy to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early) as an alternative to cervical cerclage since there are fewer potential complications. A USTD may also be used to address constipation, fecal incontinence, retroverted uterus, address cystocele, address rectocele, manage menstruation, induce an abortion, or provide and/or support contraception. A USTD may be placed temporarily or permanently. A pharmaceutical USTD may provide an effective means for the delivery of one or more pharmaceutical substances which are easily absorbed through the mucosa of the vagina, or intended to have action in the locality, for example to delivery hormones or act against inflammation or infection, or on the uterus. An occlusive USTD may perform similarly to a cervical cap and may be used in combination with spermicide as a contraception. A stem USTD, a type of occlusive USTD, is an early form of the cervical cap shaped like a dome to cover the cervix but with a central rod or “stem” entering the os to hold it in place. USTD's within the prior art are offered in a variety of forms including, but not limited, ring USTDs, lever USTDs, Gehrung USTDs, inflatable USTDs, doughnut USTDs, cube USTDs, Gellhorn USTDs, and incontinence USTDs. USTDs according to embodiments of the invention are designed in dependence upon the user for custom fitting and/or applications including, but not limited to, prolapse, urinal incontinence, and fecal incontinence.
“Gender affirming surgery” (also known as gender reassignment surgery, gender confirmation surgery, genital reconstruction surgery, gender-affirming surgery, or gender realignment surgery) as used herein may refer to, but is not limited to, one or more surgical procedures that adjust a user's physical appearance and function with respect to their genitalia which may require the user to use a vaginal therapeutic device according to an embodiment of the invention.
A “wearable device” or “wearable sensor” relates to miniature electronic devices that are worn by the user including those under, within, with or on top of clothing and are part of a broader general class of wearable technology which includes “wearable computers” which in contrast are directed to general or special purpose information technologies and media development. Such wearable devices and/or wearable sensors may include, but not be limited to, smartphones, smart watches, e-textiles, smart shirts, activity trackers, smart glasses, environmental sensors, medical sensors, biological sensors, physiological sensors, chemical sensors, ambient environment sensors, position sensors, neurological sensors, drug delivery systems, medical testing and diagnosis devices, and motion sensors. The wearable devices and/or wearable sensors may include, but not be limited to, devices that can stimulate and/or measure parameters related to the function of the vagina, urethra, uterus, bladder, cervix, rectum, anal sphincter, urethral sphincter, and abdominal cavity. It may also be used to measure intra-abdominal pressure which can be correlated to the amount of force that the USTD will need to support.
“Biometric” information as used herein may refer to, but is not limited to, data relating to a user characterised by data relating to a subset of conditions including, but not limited to, their environment, medical condition, biological condition, physiological condition, chemical condition, ambient environment condition, position condition, neurological condition, drug condition, and one or more specific aspects of one or more of these said conditions. Accordingly, such biometric information may include, but not be limited, blood oxygenation, blood pressure, blood flow rate, heart rate, temperate, fluidic pH, viscosity, particulate content, solids content, altitude, vibration, motion, perspiration, EEG, ECG, energy level, etc. In addition, biometric information may include data relating to physiological characteristics related to the shape and/or condition of the body wherein examples may include, but are not limited to, fingerprint, facial geometry, baldness, DNA, hand geometry, odour, and scent. Biometric information may also include data relating to behavioral characteristics, including but not limited to, typing rhythm, gait, and voice.
A “profile” as used herein, and throughout this disclosure, refers to a computer and/or microprocessor readable data file comprising data relating to a USTD according to an embodiment of the invention and/or biometric data of a user.
A “scaffold” or “scaffolds” as used herein, and throughout this disclosure, refers to a structure that is used to hold up, interface with, or support another material or element(s). This includes, but is not limited to, such two-dimensional (2D) structures such as substrates and films, three-dimensional (3D) structures such as geometrical objects, non-geometrical objects, combinations of geometrical and non-geometrical objects, naturally occurring structural configurations, and manmade structural configurations. A scaffold may be solid, hollow, and porous or a combination thereof. A scaffold may contain recesses, pores, openings, holes, vias, and channels or a combination thereof. A scaffold may be smooth, textured, have predetermined surface profiles and/or features. A scaffold may be intended to support one or more other materials, one or more films, a multilayer film, one type of particle, multiple types of particles etc. A scaffold may include, but not be limited to, a spine of a device and/or a framework, for example, which also supports a shell and/or a casing.
A “shell” as used herein, and throughout this disclosure, refers to a structure that is used to contain and/or surround at least partially and/or fully a number of elements within devices according to embodiments of the invention. A shell may include, but not limited to, a part or parts that are mounted to, attached to, and/or surround all or part of a scaffold or scaffolds that support elements within a device according to an embodiment of the invention.
A “casing” or “skin” as used herein, and throughout this disclosure, refers to a structure surrounding a scaffold and/or shell. This includes structures typically formed from an elastomer and/or silicone to provide a desired combination of physical tactile surface properties to the device it forms part of and other properties including, but not limited to, hermeticity, liquid ingress barrier, solid particulate ingress barrier, surface sheen, and colour. A casing may include, but not limited to, a part or parts that are mounted to a scaffold or scaffolds and/or a casing or casings forming part of a device according to an embodiment of the invention.
A “resin” as used herein may refer to, but is not limited to, a solid or highly viscous substance which is typically convertible into polymers. Resins may be plant-derived or synthetic in origin.
A “polymer” as used herein may refer to, but is not limited to, is a large molecule, or macromolecule, composed of many repeated subunits. Such polymers may be natural and synthetic and typically created via polymerization of multiple monomers. Polymers through their large molecular mass may provide unique physical properties, including toughness, viscoelasticity, and a tendency to form glasses and semi-crystalline structures rather than crystals.
A “polyester” as used herein, and throughout this disclosure, refers to a category of polymers that contain the ester functional group in their main chain. This includes but is not limited to polyesters which are naturally occurring chemicals as well as synthetics through step-growth polymerization, for example. Polyesters may be biodegradable or not. Polyesters may be a thermoplastic or thermoset or resins cured by hardeners. Polyesters may be aliphatic, semi-aromatic or aromatic. Polyesters may include, but not be limited to, those exploiting polyglycolide, polylactic acid (PLA), polycaprolactone (PCL), polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyethylene adipate (PEA), polybutylene succinate (PBS), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PTT), and polyethylene naphthalate (PEN).
A “thermoplastic” or “thermosoftening plastic” as used herein and throughout this disclosure, refers to a category of polymers that become pliable or moldable above a specific temperature and solidify upon cooling. Thermoplastics may include, but not be limited, polycarbonate (PC), polyether sulfone (PES), polyether ether ketone (PEEK), polyethylene (PE), polypropylene (PP), poly vinyl chloride (PVC), polytetrafluoroethylene (PTFE), polyimide (PI), polyphenylsulfone (PPSU), polychlorotrifluoroethene (PCTFE or PTFCE), fluorinated ethylene propylene (FEP), and perfluoro alkoxy alkane (PFA).
An “aramid” as used herein, and throughout this disclosure, refers to an aromatic polyamide. Aramids are a class of materials fibers in which the chain molecules are highly oriented along the fiber axis, so the strength of the chemical bond can be exploited. Examples include but are not limited to fibers distributed under brand names such as Kevlar™, Technora™, Twaron™, Heracron™, Nomex™, Innegra S™ and Vectran™ as well as nylon and ultra-high molecular weight polyethylene.
A “silicone” as used herein, and throughout this disclosure, refers to a polymer that includes any inert, synthetic compound made up of repeating units of siloxane.
An “elastomeric” material or “elastomer” as used herein, and throughout this disclosure, refers to a material, generally a polymer, with viscoelasticity. Elastomers may include, but not be limited to, unsaturated rubbers such as polyisoprene, butyl rubber, ethylene propylene rubber, silicone rubber, fluorosilicone rubber, fluoroelastomers, perfluoroelastomers, and thermoplastic elastomers.
The term “flexible,” as used herein, refers to the ability of a body that is capable of being bent or flexed and refers to the ability of a body that has been subjected to an external force to return to its original size and/or shape once the external force has been removed or reduced to below a particular level. Something that is flexible can be, for example, resilient or malleable. A “flexible” material, such as a rubber for example, may be characterised by a low Young's modulus.
The term “resilient,” as used herein, refers to the ability of a body that has been subjected to an external force to recover, or substantially recover, its original size and/or shape, following deformation. The term “malleable,” as used herein, refers to the ability of a body that has been subjected to an external force to deform and maintain, or substantially maintain, the deformed size and/or shape. Accordingly, a malleable material supports plastic deformation. A resilient material, such as polytetrafluorethylene for example, may be characterised by a moderate Young's modulus. A rigid material, for example steel, may be characterised by a high Young's modulus but may under appropriate conditions undergo plastic deformation.
A “CAD model” as used herein may refer to, but is not limited to, an electronic file containing information relating to a component, piece-part, element, assembly to be manufactured. A CAD model may define an object within a two-dimensional (2D) space or a three-dimensional (3D) space and may in addition to defining the internal and/or external geometry and structure of the object include information relating to the material(s), process(es), dimensions, tolerances, etc. Within embodiments of the invention the CAD model may be generated and transmitted as electronic content to a system providing manufacturing according to one or more embodiments of the invention. Within other embodiments of the invention the CAD model may be derived based upon one or more items of electronic content directly, e.g. a 3D model may be created from a series of 2D images or extracted from electronic content.
A “fluid” as used herein may refer to, but is not limited to, a substance that continually deforms (flows) under an applied shear stress. Fluids may include, but are not limited to, liquids, gases, plasmas, and some plastic solids.
A “powder” as used herein may refer to, but is not limited to, a dry, bulk solid composed of a large number of very fine particles that may flow freely when shaken or tilted. Powders may be defined by both a combination of the material or materials they are formed from and the particle dimensions such as minimum, maximum, distribution etc. A powder may typically refer to those granular materials that have fine grain sizes but may also include larger grain sizes depending upon the dimensions of the part being manufactured, the characteristics of the additive manufacturing system etc.
“Additive manufacturing” (AM) as used herein may refer to, but is not limited to, a process or processes used to create a three-dimensional object in which layers of material are formed under computer control. Commonly referred to as “3D printing” the processes of AM are currently defined in ISO/ASTM52900-15, which defines several categories of AM processes although others may also be viewed as AM processes. These categories being binder jetting, directed energy deposition, material extrusion, material jetting, powder bed fusion, sheet lamination and vat photopolymerization. “3D printers” exploiting custom “inkjet” print heads are a special application of plastic extrusion known as fused deposition modelling. AM processes may be applied to plastics, ceramics, and metals. AM processes for AM sintering or melting include selective laser sintering, direct metal laser sintering, and selective laser melting whilst those for deposition may include microcasting and sprayed materials. In some instances, sacrificial and/or support materials may be employed in conjunction with AM processes to achieve the desired geometry and/or combination of materials.
“Non-additive manufacturing” (NAM) as used herein may refer to, but is not limited to, a process or processes used to create a three-dimensional object by subtractive or transformative manufacturing. NAM processes may include, but not be limited to, hydro-forming, stamping, injection molding, casting, machining, and welding.
As noted above a range of surgical treatment options for POP as well as non-surgical treatments exist. Non-surgical treatment options include Kegel exercises, Kegel assist devices, pessaries, core/floor strengthening exercises, biofeedback, and support garments. Electrical stimulation, hormone replacement therapy and tibial nerve stimulation provide non-surgical treatment options to other pelvic floor disorders (PFDs). At present, physical non-surgical devices such as pessaries are fitted today by best guess, trial-and-error. Whilst the literature is replete with information explaining to medical personnel how to fit a pessary or users how to tell if their pessary correctly fits this potentially exacerbates the situation as there are at least 20 designs of pessary alone each available in multiple sizes, in some instances 10 or more. So, type of pessary and size both need to be factored into addressing the correct device for a user.
As discussed by the inventors previously, see for example World Patent Application 2019/051,579 entitled “Methods and Systems for Vaginal Therapeutic Device Fitting”, it would be beneficial to replace the current manual processes of sizing, fitting etc. as well as pessary design with a personal pelvic health characterization and provisioning approach that factors user specific anatomy and physiology, user life style, user experiences, automated assessments etc. into provisioning custom vaginal therapeutic devices.
Accordingly, the inventors have established custom USTD processes wherein core advantages include simplifying the fitting process as well as establishing a new paradigm between the two characteristics of support and comfort which runs counter to prior art USTDs the more support the less comfortable, less prone to expulsion during exercise, or tissue erosion over long term. Accordingly, the process established by the inventors resets this paradigm through a custom fitting and manufacturing process with a single material or multiple material USTD design allowing support to be established from a scaffold within the device whilst a shell and/or skin around the scaffold provide for increased comfort. Further, adoption of additive manufacturing processes allows the custom USTD manufacturing to be established in multiple locations with a city, state, province, country allowing improved delivery, responsiveness and supporting exploitation of custom USTDs with reduced usage duration as they exploit anti-microbial coatings, contraceptive coating, etc.
Accordingly, the user specific anatomy and physiology should be obtained in a reproducible manner with devices and systems that remove measurement artifacts, errors, bias etc. whilst providing the patient with an improved experience and the medical personnel with ergonomic, efficient, and easy to use systems exploiting combinations of dedicated multi-patient measurement equipment with user specific consumable items for cleanliness etc.
Accordingly, referring to
An ongoing monitoring and cyclic process may be appropriate for a variety of USTD use cases including, but not limited to:
Accordingly, as depicted M&C 110 comprises three sub-processes, these being:
Within embodiments of the invention the custom USTD may be employed in combination with other therapies and/or pharmaceutical coatings etc. in order to combine a custom USTD with regenerative medicine. Accordingly, within other embodiments of the invention a USTD according to an embodiment of the invention may exploit an energy delivery system such as electrical stimulation, infrared irradiation or ultraviolet irradiation for example. A custom USTD may also be employed in conjunction with other medical procedures and/or treatment regimens including, for example, exploitation of biological therapies including recombinant proteins, recombinant peptides, and stem cells for example.
Structural 112 may comprise one or more measurements of the user's anatomy and/or measurements of the user's physical characteristics such that one or more characteristics such as the dimensions of the user's major anatomical structures, anatomical geometry, etc. are defined. For example, a Pelvic Organs Prolapse Quantification (POP-Q) may be performed, this being a standardized tool for documenting the examination findings recognized by International Continence Society (ICS) and International Urogynecological Association (IUGA). Within the POP-Q system six principal landmarks are defined to describe the degree (quantity) of Pelvic Organ Prolapse (POP). These points (Aa, Ba, C, D, Ap, Bp) are located on vaginal walls and cervix and are related to the hymen which is considered a fixed point of reference. Another three distances (GH, TVL, and PB) may also be defined for more detailed description. The “stage” of prolapse is typically defined according to the evaluation of these points. These nine points are defined by letters Aa, Ba, C, D, Ap, Bp, GH, TVL, and PB respectively, these being:
All measurements are taken on Valsalva except TVL. A clinician may employ a manual procedure to measure the basic six or full nine points Aa, Ba, C, D, Ap, Bp, GH, TVL, and PB, respectively. This may be via the use of a ruler, swab, or other mechanical measuring device. The necessary user-specific structural/anatomical parameters may also be derived from one or more imaging techniques including, but not limited to, ultrasound imaging, magnetic resonance imaging (MRI), elastography, acoustic analysis, tactile imaging, photoacoustic (optoacoustic) imaging, tomography, echocardiography, functional near-infrared spectroscopy, and electrical impedance tomography. Alternatively, mechanical based devices may be employed to perform measurements and/or support one or more transducers for one or more imaging techniques, manual processes etc. Further these measurements may be at least one intravaginal, translabial, and transperineal.
For example, within an embodiment of the invention, ultrasound imaging may be used to determine specific anatomic parameters such as cross-sectional diameter of the vagina at various cross-sections along its length. Distances between various anatomical structures may also be used to determine specific anatomical parameters including but not limited to distances between any of the following anatomical structures: pubic symphysis, cervix (anterior lip, posterior lip, or os), urethra, bladder neck, bladder, rectum, anus, or levator ani and other pelvic floor musculature. Importantly, mobility of the various anatomical structures may also be measured by obtaining measurements at rest and on maximum Valsalva and contraction. These mobility measures help characterize the prolapsing compartment(s) and have been correlated with patient's symptoms. For example, bladder descent greater than 1 cm below the pubic symphysis on Valsalva is correlated with symptoms of prolapse. In one embodiment, these data may be used to generate a prosthetic that optimally fits within the vagina and limits bladder descent and thereby minimizes patients' symptoms. In addition to distances, thicknesses, surface area, and shape of the vaginal wall may also be assessed using ultrasound. Thickness data may be used to customize the mechanical properties and shape of the prosthetic device such that it minimizes the risk for vaginal ulcerations and erosions.
Force, Strain and Distension 114 may comprise one or more measurements of characteristics of the user's anatomy and/or measurements of the user's physical characteristics such as compliance/resilience of the user's tissues, the movement(s) and strength of user's musculature within the appropriate anatomical regions. These may involve mechanical and/or imaging testing discretely or in combination with other tests. Such tests may include, but not be limited to:
Techniques may include those identified supra and others including, but not be limited, leak point pressure, vaginal manometry, ultrasound, elastography, strain sensor array, acoustic analysis, tactile imaging, and photoacoustic (optoacoustic) imaging. The measurements performed within Structural 112 and Force, Strain and Distension 114 may be statically acquired, i.e. with the user sitting/laying/standing within a clinic or another environment and/or dynamically acquired with the user performing one or more routine aspects of their life such as Valsalva effort, walking, exercising, running, lifting, bending, etc.
In contrast to the Structural 112 and Force, Strain and Distension 114 the Quality of Life 116 is user reported assessment. Accordingly, Quality of Life (QoL) 116 may include, but not limited to:
Accordingly, QoL 116 establishes baseline QoL data which may be employed subsequently for the monitoring, QoL and performance of the USTD once manufactured and employed according to embodiments of the invention. Accordingly, for one user a QoL goal may be the elimination of a symptom that occurs only during sexual activity whilst for another it may be during a specific exercise, sporting activity, etc. or for another over specific periods of time and/or generally monitored etc. Additionally, the USTD in terms of being permanent, semi-permanent, or temporary is established wherein for temporary use at least the installation/removal means and/or mechanisms are established with the user. For permanent and semi-permanent the installation/removal means are geared primarily to the clinician rather than the user.
In establishing the QoL 116 a user may employ an application upon a PED and/or FED in order to track the user's (patient's) perceived QoL, to monitor and/or log occurrences such as incontinence, pain, prolapse symptoms, pessary fall out, etc.
From M&C 110 the process proceeds to A&M 120 wherein sub-processes of Assessment 122 and Performance Goals 124 are undertaken. Within Assessment 122 the data obtained within the M&C 110 step are analysed, for example, through their entry into a human body (anatomical) model (HBM) to define a series of two-dimensional (2D) and/or three-dimensional (3D) perspectives of the user's anatomy. These 2D and 3D perspectives and modelling/analysis with the HBM may exploit one or more machine learning processes and/or algorithms and/or systems. Additionally, other parameters and/or aspects including, but not limited to, the following may be included:
Within Performance Goals 124 the QoL 116 data is established as specific static and dynamic performance goals for the USTD. These may include, but not be limited to, whether the USTD is to address urinary and/or fecal incontinence, number of episodes and volume, degree of comfort level required, will or can the user perform self-removal/cleaning/insertion etc., will this require periodic visits to a physician or clinic, and will any coatings require the user periodically dispose of the USTD and use a new USTD. Additionally, additional characteristics may be established with respect to providing an antimicrobial coating, providing controlled pharmaceutical product release(s) such as combinations of estrogen and progesterone for contraception, estrogen for treatment of genitourinary syndrome of menopause, spermicide, proteins, regenerative medicine(s) or other drugs for the user. These together with the data from Assessment 122 are employed in defining the custom USTD for the user in terms of physical geometry, e.g. dimensions of any ring structure, knob, support etc. Additionally, the mechanical properties of the custom USTD are defined in respect of the flexibility, dimensional stability, installation/removal means, physical characteristics of the USTD such as smooth/contoured surfaces and/or regions, etc. as well as other aspects such as any locking and/or release mechanisms.
The accumulated data from the Analysis & Modelling 120 as defined within Assessment 122 and Performance Goals 124 is coupled to an Artificial Intelligence (AI) Engine 160 which employs a plurality of algorithms which may exploit one or more approaches including, but not limited to, those based on symbol manipulation, cognitive simulation, logic-based programming, anti-logic programming, natural language processing, knowledge based, sub-symbolic, embodied intelligence, computational intelligence and soft computing, and statistical either individually or in combination such as within methodologies such as the intelligent agent, multiple interacting agents in a multi-agent system, and a hybrid intelligent system.
The AI Engine 160 may employ a hierarchal control system to bridge between sub-symbolic AI and symbolic AI. Tools exploited by the AI Engine 160 may include, but are not limited to, search and optimization, evolutionary computation, swarm intelligence algorithms, evolutionary algorithms, logic programming, fuzzy systems, subjective logic, default logics, non-monotonic logics, circumscription, probabilistic methods for uncertain reasoning, Bayesian networks, Hidden Markov models, utility theory, decision theory, Kalman filters, dynamic decision networks, classifiers and statistical learning methods, classifiers, neural networks, kernel methods, k-nearest neighbour algorithm, naive Bayes classifier, decision tree, neural networks, artificial neural networks, acyclic or feedforward neural networks, recurrent neural networks, perceptrons, multi-layer perceptrons, radial basis networks, backpropagation networks, deep feedforward neural networks, convolutional neural networks, reinforcement learning, deep recurrent neural networks, recurrent neural networks, and gradient descent training.
The output of the AI Engine 160 is coupled to Custom Device Manufacturing and Fitting (CUDEMAF) 130 which proceeds with a sequence comprising Manufacture 132 and Fitting 134. Within Manufacture 132 the custom USTD is defined in respect of the materials providing its physical geometry with the desired mechanical properties as well as external characteristics. Accordingly, the custom USTD may be defined by one or more aspects including, but not limited to:
Accordingly, a CAD model is established from which the Manufacture 132 process is undertaken. Within an embodiment of the invention an initial CAD model may be established by combining three-dimensional (3D) modelling with computational fluid dynamics (CFD), finite element analysis (FEA), and/or multi-organ free-body diagram models. The CAD model may be simplified to reduce the required computational power and complexity of the processing applied prior to the AI Engine 160 executes. The AI Engine 160 may process based upon this initial pre-processing solely or may apply the pre-processing to a more complete human body (anatomical) model and USTD model in order to define the USTD design, CAD, and materials requirements. Optionally, the pre-processing may be bypassed where appropriate levels of computing resources are available. Within an embodiment of the invention the AI Engine 160 generates the specifications for design of the USTD in dependence upon the computational modelling, FEA analysis, 3D modelling either individually or in combination.
Accordingly, a USTD as designed and manufactured may range from a passive USTD through to an active USTD, with lock-release structure, anti-microbial coating, and wireless interface for transmitting and logging data relating to the user. An active USTD may incorporate one or more sensors or stimulation mechanisms, such as electrostimulation, for example.
Within Fitting 134 the custom USTD is provided to the user and either fitted by themselves, e.g. for temporary use USTD that the user will insert/remove as desired, or by a clinician, e.g. semi-permanent or permanent use. At this point one or more assessments may be carried out such as outlined previously in respect of Structural 112 and/or Force, Strain and Distension 114 whereby, for example, mechanical, imaging, static and/or dynamic assessment etc. are performed to assess the USTD fit against the target design/user physiology etc. Optionally, the Structural 112 and/or Force, Strain and Distension 114 may be device based assessments and/or non-device based (e.g. clinical) assessments. This stage may also include device-acquired user monitoring, e.g. via internal sensors to the USTD, as well as user-reported monitoring, e.g. by personally noting performance of the USTD etc. Based upon these results a determination is made as to whether the USTD meets the initial requirements wherein if yes, the process proceeds to step 140. If not, then the process proceeds to loop back to either A&M 120 or CUDEMAF 130 according to the nature and/or complexity of the modifications/amendments required.
In step 140 the user employs the USTD on an ongoing basis wherein device-acquired monitoring, e.g. via internal sensors to the USTD, as well as user-reported monitoring, e.g. by personally noting performance of the USTD etc. are performed wherein periodically this data is employed in determining whether the objectives for the USTD were met in step 150. If yes, then the process loops back to step 140 otherwise it proceeds back to step 110. For example, a young user may require multiple USTDs within the space of a few years/decade during their childhood, puberty, adolescence, etc. with evolving dimensions and requirements whereas an elderly user may require a single adjustment or no adjustment according to their circumstances.
Within the description supra monitoring of the user has been described and discussed with respect to the fitting, assessment, and performance monitoring of a USTD or USTD according to an embodiment of the invention. Whilst this may exploit one or more sensors embedded within the body of the USTD or upon its surface as discussed below it would be evident that the assessment may employ and exploit data acquired from a range of other wearable devices and biometric sensors in order to enhance, for example, the assessment, fitting, and monitoring of USTDs and/or USTDs according to embodiments of the invention wherein the additional data obtained, e.g. biometric data, environmental data, activity data, body position data, etc., provides correlation data and/or additional data For example, a patient suffering UI may experience incontinence when bending over and/or walking but not during sitting and/or being prone. Further, the ongoing acquisition of data from a range of other wearable devices and biometric sensors may also be employed in association with or without sensors within the USTD to provide ongoing quality of life (QoL) data to assess the effectiveness of the USTD.
Now referring to fourth to sixth images 240 to 260 respectively then, for a second patient, Patient B, there are similarly depicted:
Table 1 presents some characterizations of the 3D CAD model where the ultrasound images in first and fourth images 210 and 240 respectively were obtained in the supine position at 100% vaginal capacity.
Now referring to
Within Patient 320 the user through a Patient Portal enters data relating, for example, to Quality of Life 116 in
The data once stored upon the remote Cloud Server 330 from the Clinic 310 and Patient 320 is employed by a combination of Off-the-Shelf (OTS) applications and custom applications to generate the data required for the Manufacturing Facility 340 as well as any communications required to the R&D—Operations Staff 350. The remote Cloud Server 330 based upon the processing by the OTS applications and custom applications may also send communications to the Clinic 310 and the Patient 320. Data provided to R&D—Operations Staff 350 may include data for reporting and/or queries. The data provided to the Manufacturing Facility 340 from the remote Cloud Server 330 would be stored upon an internal server of the Manufacturing Facility 340 and would comprise USTD tracking data to associate the USTD to the Patient 320, manufacturing data for the USTD specific to the Patient 320, etc. This is then employed to schedule the manufacturing and control the manufacturing process using additive and/or non-additive manufacturing processes. The Cloud Server 330 may include an AI Engine, such as AI Engine 160 in
After QA processes etc. the Clinic 310 and Patient 320 are advised the USTD has been manufactured and the USTD shipped to the Clinic 310 or the Patient 320. Accordingly, measurements from the Manometry System 360 together with Manometer Balloon 370 and an embodiment of the invention, a Manometry Cap 380, which is employed with an instrument such as two-dimensional (2D) ultrasound Probe 390A,a three-dimensional ultrasound Probe 390B, or endoscopic Probe 390C for example, are employed by the Cloud Server 330 to generate the USTD specific manufacturing data including dimensions, design, material(s), etc. employed by the Manufacturing Facility 340. This conversion from patient centric data to USTD design data are described and depicted in more detail in
Accordingly, the USTD Platform and System 300 provides for collection of data from several sources including, but not limited to:
Accordingly, the USTD Platform and System 300 stores data within one or more cloud services wherein this stored data is exploited to provide analysis and prediction software methods and applications including, but not limited to:
Accordingly, several software applications and/or portals as depicted within USTD Platform and System 300 transfer data to/from the Cloud Server 330. Accordingly, referring to
Also depicted is Imaging or Clinical Data Integration (CDI) 2820 wherein acquired imaging and/or clinical data is communicated to another Cloud Server Instance 2850, Data Validation 2850B, wherein the acquired data is processed to ensure it is valid before it is stored within one or more Data Lakes 2870C. As depicted the Imaging or CDI 2820 communicates directly with Data Validation 2850B via secure links, data tunnels, etc. as known in the art. Optionally, this data may also be pushed via one or more Web Servers 2840. The data stored within Clinical RDS 2870A and Data Lakes 2870C is archived/backed up within Cold Storage and Backup 2870B. The data from Clinical RDS 2870A and Data Lakes 2870B is accessed by Analysis Applications 2850C representing yet further Cloud Server Instances 2850.
The Analysis Applications 2850C may access Other RDS 2870D storing data including, but not limited to, analysis software, design databases, material databases, quality of life databases etc. The Analysis Applications 2850C or a specific application within the Analysis Applications 2850C also communicate with an E-Commerce Portal 2860 allowing a Clinician 2810 to initiate an analysis, design, and manufacturing process through an e-commerce process. During this e-commerce process the Clinician 2820 may be provided with data prior to their review and approval of the manufacturing process. This data may include, but not be limited to, the USTD device geometry and dimensions, patient data, patient quality of life data, CDI data and predictions of USTD quality of life. Similarly, the Other RDS 2870D may be archived/backed up within Cold Storage and Backup 2870B.
Within embodiments of the invention the E-Commerce Portal 2860 provides one or more functions (features) to a clinician/physician as well as to other third parties. For example, the E-Commerce Portal 2860 may provide for:
Referring to
Optionally, first step 411 may be replaced with translabial ultrasound. Optionally, first step 411 may comprise an initial determination of vaginal capacity to define distension(s). Within the first branch third to fifth steps 413 to 415 are executed, these comprising
Within the second branch sixth and seventh steps 416 and 417 are executed, these comprising
Within the second branch the outputs from the first and second branches are employed in eighth and ninth steps 418 and 419 respectively, these comprising:
Referring to second MIA process Flow 400B this relates to measurements made using a Vaginal Manometry (VAMA) system. As depicted second MIA process Flow 400B comprises first to eighth steps 421 to 428 respectively. Initially, the process executes first and second steps 421 and 422. Subsequently a first branch comprising third to fifth steps 423 to 425 is executed in parallel to a second branch comprising sixth and eighth steps 426 and 428 respectively. Accordingly, first and second steps 421 and 422 comprising:
Within the first branch third to fifth steps 423 to 425 are executed, these comprising:
Within the second branch sixth and seventh steps 426 and 427 are executed, these comprising
Referring to third MIA process Flow 400C this relates to measurements made using a Vaginal Manometry (VAMA) system but now rather than static 3D ultrasound images a 2D video ultrasound is acquired and processed. These 2D video ultrasound images may then be processed to generate 3D ultrasound images. As depicted third MIA process Flow 400C comprises first to fourth steps 431 to 434 respectively, these comprising.
First MIA process Flow 400A and/or second MIA process Flow 400B may exploit 3D transverse plane ultrasound (TPUS).
Now referring
The Prediction Model 520 exploits parallel threads of Statistical Analysis 520A and Deep Learning Algorithms 520B using Input 510 and Pessary Registry 540. The resulting outputs from the parallel threads in Prediction Model 520 are coupled to Pessary 530A and USTD 530B in the Prediction and Design Output 530. Pessary 530A comprises data relating to the success of the modelling, type of pessary selected, and size of pessary selected. This data, may for example, be the data transmitted back from the Cloud Server 330 to the Patient 320 and/or Clinic 310. USTD 530B comprises the CAD modelling parameters which, may for example, be passed from the Cloud Server 330 to the Manufacturing Facility 340 directly or be processed further prior to being passed to the Manufacturing Facility 340 in
The Pessary Registry 540 comprises data obtained through a process such as described with respect to exemplary Flow 500B in
Accordingly, Flow 500A in
Pathway 1: Clinician Design. In this pathway the USTD device may be designed based upon physical examination by the clinician, such as taking anatomical measurements, using a Pelvic Organs Prolapse Quantification (POP-Q) and the patient's pessary history. Accordingly, the USTD Platform and System 300 and/or Cloud Infrastructure 2800 result in the clinician being presenting with a list of available USTD devices including options for dimensional customization.
Pathway 2: POP-Q+. In this pathway a physician enters anatomical measurements which results in the USTD Platform and System 300 and/or Cloud Infrastructure 2800 recommending patient specific USTD device design(s) for the physician's review and approval using a clinical decision confirmation system (CDCS), for example. In this pathway, a clinician will review, edit, and approve the USTD device prior to providing the device to the patient.
Pathway 3: Clinical Data Integration (CDI). Within this pathway a physician/clinician employs, for example, colpodynamic imaging, to obtain ultrasound images of patient's pelvic floor, as well as manometry data of the vaginal cavity for example. The USTD Platform and System 300 and/or Cloud Infrastructure 2800 recommending patient specific USTD device design(s) for the physician's review and approval using clinical decision support software for example. In this pathway, a clinician will review, edit, and approve the USTD device prior to providing the device to the patient.
Now referring to
Referring to second image 600B the dimension identified is the Bead Depth F which defines the distance from the centre of the bead to the centre of the ring at its maximum depth so that the ring may vary from flat, i.e. F=0, be concave, i.e. F>0 along the Y-axis, or convex, i.e. F<0 along the Y-axis. Third image 600C defines the thickness of the support, this being the portion of the pessary within the periphery of the ring which is a membrane of thickness G.
Fourth image 600D defines:
Fifth image 600E defines:
As noted within
The Manometer Balloon 360, Manometry Cap 380 and 2D probe 390A and/or 3D probe 390B allow the measurements required for diagnosis of Pelvic Organ Prolapse, dimensional determination of the vagina at various stages of distention, monitoring pelvic muscle strength and tissue elasticity, or for surgical planning to be obtained. Within the description of embodiments of the invention 2D ultrasound and 3D ultrasound are described with respect to imaging the vagina at different distensions, under different user conditions (e.g. seated, supine, dynamic, static etc.), etc. to be obtained. However, it would be evident that other imaging methods may be employed without departing from the scope of the inventions described and depicted. Further, the descriptions presented are with respect to vaginal measurements, but it would be evident that other embodiments of the invention may exploit rectal, urethral, or other measurements.
Referring to
Now referring to
Referring to
Referring to
Now referring to
Referring to
An alternate balloon is depicted in second image 1100B wherein the Balloon 1110 is attached to a pair of Fluid Seals 1130 and 1140 to the Catheter 1120 and is a single opening design rather than a dual opening balloon requiring attachment to the Catheter 1120 at each end by fluid seals, such as Fluid Seals 1130 and 1140 respectively. Also depicted are the Fluid Port 1150 for filling the Balloon 1110 through a first bore of the Catheter 1120 and the Pressure Port 1160 which is coupled to the external pressure transducer via a second bore of the Catheter 1120. Optionally, within other embodiments of the invention the Pressure Port 1160 and external pressure transducer are replaced by one or more pressure transducers integrated into the Catheter 1120 and coupled to external monitoring circuitry via one or more electrical connections. Third image 1100C is depicting an exemplary dual bore of the Catheter 1120 whilst fourth image 1100D depicts a Catheter 1180 and attached Balloon 1190 (of a configuration as depicted in first image 1100A) coupled to a Lumen 1170 which provides connections to the two bores from the pump and fluid source and to the external pressure transducer respectively. Within embodiments of the invention the catheter may be of an external diameter between 2.0-5.0 mm (approximately 0.08-0.20″) with an inner fill bore of 1.5 mm (approximately 0.06″), for example. It would be evident that these dimensions are exemplary and that other dimensions may be employed without departing from the scope of the invention.
Now referring to
Considering second Balloon Assembly 1110F then a single Balloon 11150 is employed with an interior wall 11160 to form first and second Chambers 11150A and 11150B respectively. It would be evident that other configurations with N balloons, N being a positive integer, may be employed where increasing N may lead to the integration of microelectromechanical systems (MEMS) pressure monitors and electrical interfaces rather than additional bores within the catheter.
Now referring to
As depicted in
Referring to
Now referring to
Within second Cushioned Shield design 1400B the Balloon 1450 and Outer Cushion 1440 are separate elements. Also depicted are the Probe 1420 and Structural Shield 1430B. Referring to third Cushioned Shield design 1400C the Balloon and Outer Cushion are again depicted as a single Cushioned Balloon 1410B in conjunction with a Probe 1460 and Structural Shield 1430C. The opening, for example Opening 1480 in Image 1400D within the Structural Shield 1470 may be dimensioned to retain a specific probe in a predetermined position or it may be dimensioned to allow positioning of the probe to be varied either during an initial configuration step prior to measurements or during the measurements. Optionally, multiple openings may be provided such that, for example, Probe 1420 can be initially employed and then Probe 1460 employed or vice-versa.
Accordingly, within embodiments of the invention:
Referring to
Second Shielded Cushion 1500B comprises a Cushion 1540A with Filler Tube 1550A and Structural Shield 1560A with integral Opening 1570A. Accordingly, in this variant the Cushion 1540A is essentially another balloon but formed from a medium or high elastic modulus material which is filled with a fluid via the Filler Tube 1550A. Whilst the Filler Tube 1550A is depicted upon the upper surface of the Cushion 1540A which would be disposed towards the patient's body it would be evident that it may be upon another surface of the Cushion 1540A in a region of the Cushion 1540A exposed relative to the Structural Shield 1570A but not passing through the Structural Shield 1570A. Optionally, the Filler Tube 1550A may connect to the Cushion 1540A through the Structural Shield 1570A. Optionally, the Filler Tube 1550A may be a fluidic connector rather than a tube allowing a tube with mating fluidic connector to be connected to it for filling the Cushion 1540A. The fluid for filling the Cushion 1540A may be water, a low viscosity silicone oil, nitrogen, air, or another fluid which may or may not be the same as that employed to inflate the manometry balloon. The Structural Shield 1570A incorporating an Opening 1560A for insertion of a measurement probe through the Structural Shield 1570A into contact with or in proximity to the Cushion 1540A.
Third Shielded Cushion 1500C comprises a Cushion 1540B with Filler Tube 1550B, and a Structural Shield 1570B with Opening 1560B. These being similar to the corresponding elements in second Structural Cushion 1500B denoted by common identifiers with an “A” instead of a “B.” Third Structural Cushion 1500C also incorporates a first Fluidic Connector 1580, a second Fluidic Connector 1585 and a Tube 1590 connecting the first Fluidic Connector 1580 to the second Fluidic Connector 1585. Accordingly, a balloon may be connected to the first Fluidic Connector 1580 prior to placement of the Structural Cushion 1500C against the user and the external fluid source and pump/pressure transducer etc. connected to the second Fluidic Connector 1585. For simplicity, a single connector supporting two or more fluidic channels may be employed or alternatively multiple connectors may be employed each for fluid flow into or pressure monitoring etc.
Whilst the Filler Tube 1550A is depicted upon the upper surface of the Cushion 1540B which would be disposed towards the patient's body it would be evident that it may be upon another surface of the Cushion 1540B in a region of the Cushion 1540B exposed relative to the Structural Shield 1570B but not passing through the Structural Shield 1570B. Optionally, the Filler Tube 1550B may connect to the Cushion 1540B through the Structural Shield 1570B. Optionally, the Filler Tube 1550B may be a fluidic connector rather than a tube allowing a tube with mating fluidic connector to be connected to it for filling the Cushion 1540B. The fluid for filling the Cushion 1540B may be water, a low viscosity silicone oil, nitrogen, air, or another fluid which may or may not be the same as that employed to inflate the manometry balloon.
Now referring to
Referring to second image 1600B there is depicted a variant region of an item such as Fitting 1610 wherein the Region 1660 provides for transparency of the signals from the Probe 1670 when the material forming the majority of the item absorbs, reflects, or highly attenuates the signals from the probe. As such Region 1660 acts as a window within the Structural Element 1650 but now the Structural Element 1620 supports attachment of the Probe 1670 to the Structural Element 1620. For example, the Structural Element 1650 may be formed from an elastic material such that an opening within it supports insertion and removal of the Probe 1670 and maintains the Probe 1670 in position through the Structural Element 1650 fitting around it. Optionally, within other embodiments of the invention the Probe 1670 may be attached to the Structural Element 1650 via other demountable attachments means including, but not limited, hook-and-loop, hooks, snap fasteners etc. Optionally, the Probe 1670 may be attached to the Structural Element 1650 via an intermediate fitting which attaches to standard locations on the Structural Element 1650, but different intermediate fittings allow different Probes 1670 to be employed with a common Structural Element 1650.
Referring to
The Front Seat Portion 1740 and Rear Seat Portion 1750 being defined relative to the user's body and forward/back from an opening within the seat of which they form part that allows insertion of the Probe 1760 for measurements. Optionally, the Plug 1770 is integral to the Balloon 1720 so that it remains in position relative to the patient as they move and moves with them. Optionally, the Cushion 1710, Plug 1770 and Balloon 1720 are a single piece part. Optionally, the Plug 1770 may be inflatable independent of the Balloon 1720, where inflating the Plug 1770 would grip the catheter tighter and push against the Cushion 1730 and/or Front Seat Portion 1740 providing support to hold the manometry bag inside but without a rigid element pushing against the user causing discomfort or impacting the measurements. Optionally, the Catheter 1710 may be between the patient and the Cushion 1730 or between the Cushion 1730 and the Front Seat Portion rather than through the Cushion 1730 as depicted.
Now referring to
This concept is extended in
Referring to
Optionally, the item of clothing may include or be coupled to all or a subset of a pump, a fluid reservoir, and a pressure transducer to provide a mobile manometry system for obtaining pressure/volume data of the user in a variety of activities either within a specific clinical environment or within everyday life. The plugs depicted in
Now referring to
Such an item of membrane underwear may be employed discretely, or it may be employed in conjunction with embodiments of the invention such as described and depicted in
Within other embodiments of the invention the Frame 2420 may have limited or no compliance whilst the Membrane 2410 is pulled taught either due to automatic or manual expansion of the Frame 2420 or other elements attached to the Frame 2420. Optionally, the Membrane 2410 may be adjusted through the Frame 2420 and/or other elements in order to provide different levels of tension of the Membrane 2410. The Membrane 2410 is described with respect to
For example, the Membrane 2410 may be formed from a silicone. Optionally, referring to fourth Image 2400D the Membrane 2410 may be designed to retain an Internal Device 2430 within a cavity of the user, e.g. vaginal canal. Internal Device 2430 may, for example, be a 2D probe, 3D probe, other measurement/data acquisition device and/or system.
Within embodiments of the invention the membrane underwear may be designed to provide one or more of the following:
Optionally, the Membrane 2410 and Frame 2420 may be a disposable element of membrane underwear employed with a reusable attachment and adjustment means. Referring to
As evident from
An alternate design is depicted in
Within embodiments of the invention the Body 2640 may be completely detachable from the Waistband 2510 rather than permanently attached at the rear and demountably attachable at front (or vice-versa). Optionally, the Membrane Underwear 2600 as well as Membrane Underwear 2400 and 2500 in
Optionally, the Membrane Underwear such as membrane underwear depicted in
Referring to
Referring to Table 1 below are surface anatomy measurements for different populations based upon age range where these surface anatomy measurements are depicted in
Now referring to
However, in fourth Schematic 2300D the Cup 2310 is employed in conjunction with a Gasket 2320 so that the periphery of the Cup 2310 formed from a high elastic modulus material is softened by the low or medium modulus elastic material employed for the Gasket 2320. The Cup 2310 is also depicted with a Hole 2330 for insertion of a tube, catheter etc. The Gasket 2320 around the entire top surface in addition to enhancing patient comfort also seals where it makes contact with the patient's skin. The Hole 2330 may be one of several holes or other mechanical structures to the Cup 2310 either for tubing interface, fluid connectors etc. or to secure various outer inserts in place such as the cushion, plug etc.
As discussed above embodiments of the invention support the design and implementation of custom USTD devices tailored to a patient's physiology, symptoms, etc. Within embodiments of the invention this includes the use of VAMA systems, 2D ultrasound, 3D ultrasound etc. However, within other embodiments of the invention it may be appropriate to employ a pessary to establish patient related data. Accordingly, referring to
The PSS 2920 provides a force/pressure sensing system integrated within a pessary or size-adjustable tool or structure that functions to monitor the pressures and/or forces in distinct regions of the fitted USTD device. As depicted in the insert in
Within other embodiments of the invention the number of sensors may be varied from four. Within other embodiments of the invention the sensors may comprise those providing force/pressure data as well as other sensors providing additional data such as temperature, pH, humidity, etc. The inventors refer to such devices as PSS 2920 as Smart Fitting USTD devices.
Referring to
Disposed around the Body 4880 of the USTD are Sensors 4810 such as providing, for example, temperature, pH, humidity, blood oxygenation, pressure, vibration, etc. These are coupled to Microprocessor 4840 which is powered from Battery 4850. The Microprocessor 4840 also connected to a Wireless Transceiver 4860 which transmits data through Antenna 4870. For example, the Wireless Transceiver 4860 may be Bluetooth or LoRa (Long Range, low-power wide-area network protocol) which provide for transmission through short distances of aqueous media. Alternatively, the Antenna 4870 may a connection from the USTD to an antenna element which is within the user's vagina with an end external to their body. Accordingly, the USTD may acquire data and transmit it to an external logging system.
Optionally, a subset of the Sensors 4810 may include or be transducers such as acoustic transducers, heaters, etc. such that the USTD may acquire or execute specific actions and monitor the resulting effects etc. For example, the USTD may adjust the internal periphery until the Sensors 4810 register a certain pressure is being applied. Optionally, the USTD may include another Distributed Element 4820 around the external periphery of the device to adjust its external peripheral dimension or distort the geometry of the USTD from circular. Similarly, the inner periphery may be distorted through the action of the one or more elements within the Distributed Element 4820. It would be evident that piezoelectric elements may be employed to adjust the dimensions/geometry of the USTD and provide sensor feedback to subsequent pressure etc. applied to them through the Body 4480 of the USTD.
Within embodiments of the invention the length of the Arms 4920 may be fixed or within other embodiments of the invention the length of the Arms 4920 may be adjustable wherein these may be extended and/or retracted from the Body 4910 using techniques as known in the art. In retracted and/or extended but undeployed scenarios the Pads 4930 may be towards the axis of the Body 4910. Accordingly, the Arms 4920 may be retracted when the Sensor Device is shipped/stored etc. but extended when measurements are to be taken of a patient. The Arms 4920 may be flexible but semi-rigid such that their relative positions may vary according to the patient's anatomy, but they are retained against the patient's body through their spring like nature seeking to return them to a resting position along the axis of the Body 4910.
Optionally, the Pads 4930 may be coated with a gel to promote adhesion to the user's body when deployed.
Optionally, within embodiments of the invention each Arm 4920 may be extended or retracted discretely from the other Arms 4920 so that they may have different lengths.
Optionally, within embodiments of the invention all Arms 4920 are extended or retracted together so that they have the same length at all times.
Optionally, a subset of the plurality of Pads 4930 comprise sensors, each Pad 4903 of the predetermined subset of the plurality of Pads 4930 comprising a predetermined sensor. Accordingly, each sensor within the plurality of Pads 4930 may be same, different or each Pad 4930 may have differing subsets of multiple sensor types.
Accordingly, as described above embodiments of the invention allow for the collection of patient centric data together with the analysis, design, and manufacture of USTD devices. These embodiments of the invention being directed to predicting and determining USTD device geometries and dimensional parameters in order to optimize the success rate for patients wearing the USTD devices for POP treatment. Accordingly, embodiments of the invention provide for systematically defining each dimensional setting (or variable) through quantifiable input relating to the patient and/or processes relating to analysis etc. Further, another goal for the exemplary processes described and depicted may include minimize the amount of materials employed within the USTD device while providing sufficient supporting forces for each patient's unique individualized POP condition. It a further goal for the exemplary processes described and depicted to facilitate self-management of USTD devices by designing features that facilitate insertion, removal, and cleaning by the patient without dependence on a clinician. Referring to Table 2 exemplary relationships for different components of systems according to embodiments of the invention are presented.
Accordingly, referring to
Now referring to
Now referring to
Now referring to second Image 3100B in
However, to remove the Gellhorn as depicted in
Within the embodiments of the invention described above one potential issue is the difficulty in establishing the appropriate probe placement with respect to location, angle, and pressure in order to establish a good ultrasound image. Accordingly, the inventors have established a system/methodology wherein ultrasound images are processed to detect the patient's pubis symphysis and establish the patient's anorectal angle in order to provide feedback, either to a clinician or a robotic system, as to how to adjust placement of the probe. Accordingly, as depicted in first Image 3600A in
It would be evident that the probe may be mounted to a robotic system such that the position of the probe head is automated wherein pressure sensor(s) allow the contact pressure of the probe head against the patient's body to be monitored/controlled/set. Further, by processing the ultrasound images the robotic system can establish the locations of the patient's pubis symphysis as well as the Probe Marker 3660. Subsequently, the robotic system may adjust the probe position such that the Probe Marker 3660 is central within the acquired images by moving the probe under control of a controller of the robotic system. Once positioned the automated system can proceed to automatically acquire the required ultrasound images, e.g. 2D or 3D, as well as direct the patient to undertake specific movements, e.g. rest, contract, Valsalva.
Now referring to
Also depicted in
As outlined above ultrasound imaging of the pelvic floor can be obtained transvaginally or transperineally, with the latter being more widespread at this point, mainly due to its non-invasive nature and the advantage of reducing tissue distortion. 3D and 4D transperineal ultrasound images are often obtained in the supine position, using a curvilinear volumetric probe, for example. To acquire a transperineal 3D image of the pelvic floor, the probe is placed vertically on the central perineum and pubic symphysis, such that in the mid-sagittal view, the following anatomical structures are visualized ventrally to dorsally, namely the symphysis pubis, urethra, bladder neck, vagina, and anorectal junction. The levator ani muscles and genital hiatus can then be visualized on the plane of minimal hiatal dimensions (PMHD), defined as the plane where the distance between the posterior aspect of the pubic symphysis and the anorectal angle (i.e. anterior border of the pubovisceral muscle) is minimal.
However, the PMHD does not fall on any of the orthogonal ultrasound image planes. Therefore, to visualize the PMHD, the transverse plane needs to be rotated so that it goes through the inferior border of the pubic symphysis and the apex of the anorectal angle. This is performed by first, identifying the pubic symphysis and the apex of the anorectal angle landmarks on the midsagittal plane, and then rotating the transverse image plane clockwise until both landmarks lie along a straight line on the oblique image plane.
Multiple biometric indices are described for the PMHD, including levator ani muscle thickness, the anteroposterior and lateral hiatal diameter, and the pelvic floor hiatus inner area. Within the prior art significant correlations between levator hiatus area and pelvic organ descent have been reported. Hiatal enlargement of ≥25 cm2 on Valsalva is defined as an abnormal distensibility (or “ballooning”) and is strongly associated with detecting prolapse and symptoms of prolapse. In addition, the shape of the levator ani muscle on the PMHD is associated with increased pelvic floor symptoms.
As the PMHD is an oblique angle, obtaining these measurements is challenging and require manual manipulation of the image to visualize the PMHD. While several techniques have been developed to automate the segmentation of the PMHD to obtain its area, identification of the PMHD is performed manually. Accordingly, the inventors have established a novel algorithm to identify the PMHD automatically wherein the inventive fully automated pipeline also obtains the area of the PMHD. Further, the pipeline(s) according to embodiments of the invention exploit novel methods to robustly estimate the locations of the pubic synthesis (PS) and the anorectal angle (ARA) from the input 3D transperineal ultrasound volume, despite all the challenges mentioned above. The PMHD can then be extracted based on the detected landmarks.
Since clinicians are used to working with pelvic floor ultrasound images in 2D sagittal view to detect PS and ARA, the inventors developed their inventive landmark detection algorithm accordingly, in order to incorporate clinicians' expertise and experience. The pipeline, in summary, exploits a 2D landmark detection algorithm for a given mid-sagittal plane to estimate the locations of PS and ARA. The 2D landmark detection is performed on all the mid-sagittal planes within the volume of interest and the 3D location is then identified via a neighborhood consistency check. The inventors automatic landmark detection algorithm comprises the steps of pre-processing, pubic symphysis detection, anorectal angle detection, and a consistency check.
With respect to pre-processing the generally low quality of pelvic floor ultrasound image, due to image noise, low-contrast, and blurry boundaries, significantly reduces the effectiveness of landmark identification. Therefore, image pre-processing prior to landmark detection is typically required so that the pelvic floor ultrasound image quality can be improved by enhancing the contrast and smoothing the image while preserving the major edges. To achieve this, within an embodiment of the invention, the inventors initially apply an unsharp filter, for contrast enhancement, followed by the fast weighted median filter, for edge preserved smoothing. The reason for using the weighted median filter is due to its power to remove large outliers while incorporating local intensity distribution for edge preservation. From the pre-processed midsagittal image, the structural edge information can then be extracted as an edge map E, using the Canny edge detector.
In order to detect the pubic symphysis (PS) efficiently and reliably, the inventors have focused on two important features. First, assuming the 3D transperineal pelvic ultrasound image is acquired following the standard convention, the PS should always appear roughly on the top left corner of the midsagittal image. Second, since the PS is a cartilaginous joint and the urethra is soft tissue, the PS should always appear to be a higher intensity region on the left side of the urethra. The distinctly different ultrasound properties of the PS and the urethra results in a large intensity change between these two landmarks, which creates an edge, allowing delineation of the boundary of the PS, as shown in
Utilizing the high localization of the PS from conventional transperineal image acquisition, a probability map can be created to provide a strong prior information for PS detection. Within an embodiment of the invention this probability map for PS was created as an average atlas of hand labeled PS from the inventors' data set, convolved with a Gaussian kernel. The edge of urethra, adjacent to the PS, is then detected using a negative gradient flow defined as decreasing intensity from left to right as depicted for example in
From the previously extracted edge map E, the edges with a negative gradient flow are then identified using Equation (3) where · is an element-wise product operator and 537 ┘0 is a threshold operator, such that the positive product will be assigned label 1, and the negative product will be assigned label 0. Knowing that the urethra edge is within the negative edge map, the urethra edge can then be detected by selecting a segment within the negative edge map, which maximizes the following discrete cost function given by Equations (4) and (5) where ei∈E− is a disjoint edge segment belonging to the negative edge map, and P(x) is the probability map of PS. The edge segment yielding the highest cost will be selected as the urethra edge. Finally, from the urethra edge, we now select the point with the highest curvature as our initial landmark for PS.
E
−
=└E·G
−┘0 (3)
E
ps=arg maxCps(ei) (4)
C
ps(ei)=Σxe
Subsequently, anorectal angle detection is performed. Similar to the PS identification, we mainly focus on two features for the detection of the anorectal angle (ARA). First, as shown in
To further emphasize the intensity changes across the rectum edge, we use another convolutional kernel hnormal to estimate the intensity differences along the normal of the ARA edge as given by Equation (9). We then detect the ARA edge Eara by selecting an edge segment within the positive edge map, which maximizes the following discrete cost function, Cara (ei), as given by Equation (10) where ei∈E+ is a disjoint edge segment belonging to the positive edge map and D(x) is a Euclidian distance map, measuring the distance between every pixel to the PS. α is a joint parameter to balance the distance term and the intensity term in the cost function.
For I(x) ∈[0,1] with a resolution of 150 250 then α was chosen as a constant 0.01 for all test cases. From the extracted edge, Eara, we now select the point which is closest to the PS as our landmark for the ARA. An exemplary illustration of the aforementioned positive and negative edge maps, detected urethra and rectum edges, as well as the extracted PS and ARA landmarks, are shown in
Within an exemplary embodiment of the invention the automated process employed exploits a consistency check. The described landmark detection is based on an input of the optimal mid-sagittal 2D image plane. To improve the automation and avoid the need of manually selecting the optimal image plane, the inventors have established consistency check method to integrate their methodology within a 3D system.
The optimal mid-sagittal plane is defined as a sagittal image plane, which captures all the important anatomies, including the PS, urethra, vagina, rectum, and ARA. Assuming centered image acquisition. We know the optimal mid-sagittal plane is somewhere in the middle of the ultrasound volume. Hence, the proposed 2D landmark detection algorithm can be used for a range of para-sagittal slides in the middle section of the ultrasound volume to extract the most locally consistent landmark positions as the final output. When the final positions of the PS and the ARA landmarks are identified, the rotation angle for the PMHD extraction can be calculated. The PMHD is on an oblique image plane, which contains the detected landmarks. The PMHD extraction procedure is identical to the manual approach explained previously. The overall workflow of our automatic landmark detection algorithm and PMHD extraction method is described in
As depicted in
In order to validate the proposed method the inventors performed two sections of validation. In the first section, the performance of the landmark detection algorithm according to an embodiment of the invention was validated by comparing the predicted landmarks and the groundtruth landmarks, which were manually labeled by experts. In the second section, as a demonstration of the complete clinical workflow, we extracted the PMHD based on the predicted landmarks and performed automatic segmentation of the levator hiatus using U-Net (convolutional neural network for biomedical image segmentation at the University of Freiburg). The resulting automatic segmentations were compared with the manual segmentations of the PMHD, which were also manually extracted by the experts.
The dataset included 108 3D transperineal ultrasound images of the pelvic floor obtained using a GE Voluson-I ultrasound system with RAB4-8 probe. For each image volume, the PMHD was manually extracted by the experts and the levator hiatal area manually segmented to create the groundtruth dataset. Among the total images in the dataset, 35 images were randomly selected as training set and the rest 73 images were used as the test dataset. To train the U-Net for the levator hiatus segmentation, the PMHD of the 35 training images were used as inputs, and the corresponding segmentations were used as labels. Although our landmark detection algorithm doesn't require training sets, all test results were obtained using the testing dataset for consistency purposes.
The landmark and PMHD extraction algorithms were implemented in MATLAB R2018b and the U-Net was implemented with Keras (v2.2.4) using Python (v.3.6.10). An Adam solver was used with a fixed learning rate of 0:001, and a total number of 20 epochs were used with 300 iteration steps per epoch.
The effectiveness of the presented automatic landmark detection algorithm was evaluated against groundtruth manual segmentation. Compared to the groundtruth for both the landmarks and PMHD, the inventive automatic algorithm according to an embodiment of the invention produced highly accurate results on female pelvic ultrasound images with various pathologies and physiologies. As an example, the qualitative comparisons are presented in
As shown in the automatically detected and manually identified landmarks in second Column 4300B in
Quantitatively, three metrics were used to evaluate the accuracy of the landmarks and their impacts on the PMHD extraction. They include the absolute landmark distance, the effective landmark distance, and the plane angle difference. The absolute landmark distance was calculated as the Euclidean distance between the predicted landmarks and the corresponding groundtruth landmarks, as illustrated in first Image 4400A in
Based on the proposed metrics, we evaluated the performance of the landmark detection algorithm using 73 test images. As shown in Table 6, the average effective distance for PS was 5.03 pixels and the average effective distance for ARA was 4.93 pixels. Since the isotropic spatial resolution for pixels on sagittal plane is 0.5 mm by 0.5 mm, the PS effective distance and the ARA effective distance were roughly 2:5 mm on average. The average PS absolute distance and the average ARA absolute distance were 3.05 mm and 4.85 mm, respectively. Since the presented algorithm is the first automatic landmark detection algorithm for female pelvic floor 3D transperineal ultrasound images, these outcomes could not be compared with any previous study. Nevertheless, in similar studies, such as those on anatomical landmark detection in prostate and abdominal ultrasound images, landmark errors of 5 mm or less were considered to be highly accurate. The plane angle difference was less than 5° on average. Such a small rotational difference combined with the small effective landmark distances led to the accurate PMHD extraction in the ultrasound images as reflected in third Image 4400C in
To quantitatively assess the accuracy of the automatically extracted PMHD and to demonstrate the algorithm's value in clinical applications, the inventors also implemented a deep learning segmentation algorithm, to automatically extract the levator hiatus. Since the dimensions and area of the hiatus are of clinical significance, such an automatic segmentation algorithm would reduce the workload and enable computer assisted analysis.
To illustrate the performance of our PMHD extraction algorithm, the extracted PMHD and the segmentation results are shown in
To quantitatively assess the segmentations, we used mean boundary distance (MBD), the Sorensen-Dice Coefficient (DICE) coefficient, and levator hiata area to evaluate the overlap between our segmentations and the groundtruth. As shown in Table 7, the algorithm was able
to perform fairly accurate segmentation with an average DICE score of 0:89, an average MBD of 2:15 mm, and an average area difference of 1:75 cm2. Since the average area of the levator hiatus in the test dataset was 65 cm2, a small deviation of 1:75 cm2 would not have a significant impact clinically, especially due to the potential issues with low image quality.
Accordingly, the inventors have presented an automatic approach to identify landmarks from female pelvic floor 3D ultrasound images and also to extract the plane of minimal hiatal dimensions. Given the appropriate parameters, the presented algorithm can systematically estimate the locations of the pubic symphysis and anorectal angle. The inventors have utilized the fact that PS and ARA are relatively close to the urethra and rectum. By identifying the urethra and rectum edges, the locations of the PS and ARA landmarks were estimate robustly, despite the large variations of patient anatomy and ultrasound image qualities. For automation purposes, whilst the exemplary methodology does not explicitly search for the mid-sagittal slice, the landmark detection algorithm was executed for all midsection sagittal slices, where the PS and ARA landmarks were computed for every sagittal slice and the most locally consistent landmark positions within consecutive slices were chosen as the final output. For validation, the automatically extracted landmarks was compared with the manually extracted groundtruth and we focused our evaluation on the landmarks localization impact on identifying the PMHD. Experiments using 73 test images showed that, on average, this algorithm could accurately identify the landmarks with less than 5 mm of absolute distance, less than 2:5 mm of effective distance, and less than 5° of rotation error. To further evaluate the validity of the extracted PMHD and the usefulness of the proposed automated algorithm the inventors performed an automated segmentation of the levator hiatus and compared the results to the manually segmented levator hiatus from the PMHD groundtruth dataset. The automated segmentations were highly similar to the manual segmentation, with average DICE of 0:89 and average MBD of 2:15 mm. Consultation with clinicians indicates that the accuracy of this level is acceptable and the inventive automated PMHD extraction algorithm can replace the tedious manual work.
Within embodiments of the invention a balloon may be formed from medical grade silicone comprising an initial sticky soft silicone, e.g. 20 durometer, with a micro-layer (e.g. spray coated for example) of high durometer medical grade silicone, for example 70-90 durometer, to create a “slippery” surface. Alternatively, the balloon may be formed from a single later of high durometer medical grade silicone or a medium durometer medical grade silicone.
Within embodiments of the invention discrete pressure monitoring relative to the flow of fluid into a manometry balloon has been described and depicted with respect to
Within
Accordingly, upon expert review the AI Engine may perform revisions to the design of the USTD, cup, plug etc. In this case, a new virtual 3D model can be produced, tested, and re-evaluated. In some embodiments, only following approval by the expert or through a collaborative approval, such as the expert and/or a designer and/or manufacturing authority can a design be released for manufacture. In some embodiments of the invention the USTD may be designed in conjunction with either an intended surgical procedure or with a recommendation that a surgical procedure be performed. In other embodiments of the invention the design process and/or a clinical evaluation may determine that an area or areas of the user should be surgically manipulated, e.g. a re-alignment, sectioning, re-profiling, or morphological adjustment should be performed. Optionally, the design of the USTD may require that a portion or portions of the USTD are attached to the user's body through a surgical procedure in order to ensure appropriate placement and/or retention of the USTD.
Within embodiments of the invention in a measurement and characterisation stage of determining the characteristics of the user they may be asked to wear a device which provides additional data relating to the user in addition to that identified supra. For example, the user may be asked to wear a device which provides for monitoring vaginal exercises, e.g. a Kegel exercise device, as well as providing for other parameters including, but not limited to, labial blood flow etc. for indications of whether their symptoms change according to initial stages of sexual arousal, during vaginal exercise etc.
Optionally, extended monitoring of the user's vulvar and/or vaginal temperature in conjunction with other biometric data, including vaginal pressure, etc. may allow enhanced determination of the user's exhibition of symptoms alignment with other physical and/or physiological characteristics. Optionally, within embodiments of the invention using photoplethysmography to provide vulvar/vaginal blood flow, but this may be replaced by another element with an electrical characteristic that is temperature dependent such as resistance, inductance, or capacitance for example.
Optionally, optical sensor elements may be employed for determining, for example, labial and vaginal blood flow using photoplethysmography (PPG) and/or laser Doppler imaging (LDI). Within PPG exploiting a reflective mode as depicted the volume of blood is determined in dependence upon the intensity of the reflected whilst each cardiac cycle appears as a peak within the reflected signal. As blood flow to the skin can be modulated by multiple other physiological systems, PPG can also be used to monitor breathing (respiration), medication effects, hypovolemia, and other circulatory conditions, especially where extended monitoring under a variety of conditions including rest and/or sleep provide enhanced baseline and/or early data. For example, the height of AC component of the PPG is proportional to the pulse pressure, the difference between the systolic and diastolic pressure in the arteries. Additionally, the shape of the PPG waveform differs from subject to subject, and varies with the location, providing additional options such as identification of user through PPG data and automatic adjustment of the ADDEV parameters/control program etc. in response therefrom.
Alternatively, Doppler imaging (LDI) wherein the OSAD is typically an infrared laser source in conjunction with a photodetector rather than a visible LED and photodetector in the instance of PPG. Accordingly, the pulsed laser light interacts with moving blood cells such that a small portion of it is reflected with a frequency shift, detected, and converted into an electrical signal. LDI can provide measurements without requiring physical contact and the signals are typically acquired at depth of 2-3 mm (approx. 1/8″) below the skin surface. Optionally, a device for characterization may employ an array of PPG and/or LDI sensors.
Within other embodiments of the invention a characterization and/or assessment device may exploit multiple electrical contacts (ELCOs) onto its surface. An array of ELCOs may be employed as well as a discrete ELCO and/or spatially separated ELCO pair(s). An ELCO may be employed to measure electrical activity and/or provide electrical stimulation to the user's vagina. Accordingly, the device may provide electrostimulation of the vaginal muscles with part of an exercise/training regime and then determine from user flexing the muscle strength/range of motion etc.
Within an alternate embodiment of the invention one or more of the ELCO elements may be replaced with a microphone such as one based upon capacitive thin film or microelectromechanical systems (MEMS) transducer, a piezoelectric transducer, accelerometer, hydrophone, or another type of microphone in order to measure the acoustic output of a contracting muscle. Accordingly, based upon such microphone placement a characterization device may support phonomyography (PMG) of the pubococcygeus muscle and/or other of the pelvic floor muscles. Typically, PMG has a frequency range of interest that is primarily 5-50 Hz.
Within embodiments of the invention in a measurement and characterisation stage of determining the characteristics of the user a device may be employed which can deform to fit into the vagina and recover to fit against the vaginal walls mapping the user's physiology wherein resistance sensors may map the deformation through strain and/or stress. Alternatively, the device may be a balloon of high elasticity material with stress and/or strain sensors which is filled with a fluid expanding the balloon and the deformation mapped from which the user's physiology is derived.
Within the descriptions supra embodiments of the invention have been described with respect to providing simulation and assessment of a user's vagina, vaginal muscles etc. Electrical control and monitoring have been described together with wired and wireless data connectivity of the USTD to the external world. Accordingly, the USTD may be wirelessly connected to a user's PED or FED and access/post content/data to one or more local and/or remote servers associated with different aspects of the user including, but not limited to, their personal USTD profile, personal health records, other PEDs/FEDs/wearables, physician's office, etc.
In some embodiments of the invention, current exercise parameters and the user's performance/progress are sent to a doctor, trainer, or therapist in real-time and/or periodically. In some embodiments of the invention the doctor, trainer or therapist may concurrently within a communication link, such as a phone call, in the reverse direction provide human, personalized instruction, communication, status, or feedback to the user as well as seek additional clarification/information.
The USTD, cup, plug, cushion etc. may be provided in a range of physical sizes such that, for example, the length of an inserted actuated member (e.g. for vaginal insertion) may be 50 mm, 65 mm, 75 mm, 100 mm, 125 mm, or 150 mm for example (2″, 2.5″, 3″, 4″, 5″, or 6″) or other values for this dimension and its lateral dimensions may be, for example, 40 mm, 50 mm, 65 mm, 75 mm or 100 m (1.6″, 2″, 2.5″, 3″, or 4″) or other values for this dimension. The construction of a USTD, cup, plug, cushion etc. may employ one or more central scaffolds which provides rigidity or structure to the required portions of the USTD, cup, plug, cushion etc. which may be surrounded by a shell and then a casing. Whilst the casing and shell may be transparent or semi-transparent over portions or all of the USTD, cup, plug, cushion etc. it is common for the USTD, cup, plug, cushion etc. to be opaque. An outer casing may be coloured based upon skin colour tones based upon ethnicity or personal preference, e.g. light, dark, etc. as well as single colour, binary colour, multiple colour etc. According to the complexity acceptable then the outer casing may be formed from a variety of colours and/or be patterned for a specific design. Typically, such colours will be part of a silicone or other elastomer employed in forming the casing although in other embodiments of the invention the casing may be coloured once formed and a protective fluid proof, non-toxic, non-abrasive coating formed atop these applied colours. Such instances of applied colours may include metallic lacquers, particulate lacquers for “sparkle”, etc.
Beneficially, medical grade silicone is clear thereby removing the requirement for any additional coating (e.g. food grade urethane) in conjunction with pigmented silicones. Accordingly, an USTD, cup, plug, cushion etc. may with medical grade silicone be clear and formed from an initial sticky soft silicone, e.g. 20 durometers, with a micro-layer (spray coated for example) of high durometer medical grade silicone, for example 70-90 durometer, to create “slippery” surface and avoid silky smooth surface that typically requires use of urethane coating.
Typically, the casing for the USTD, cup, plug, cushion etc. will be formed from a non-toxic, hypoallergenic silicone to provide a safe smooth surface although some regions of the USTD may be coated, textured and/or finished with a variation from that of the remainder of the casing in order to enhance or promote retention of the USTD, cup, plug, cushion etc. against the user's skin or clothing. Typically, the outer surface of the casing will be formed to provide low friction as well as resistance to lubricants, spermicides, and other chemicals that may or may not be employed by the user.
Embodiments of the invention with respect to the USTD, cup, plug, cushion etc. such as described within the embodiments of the invention supra may employ a “sticky” surface for a predetermined portion of the outer surface for engaging a recipient's body (e.g. being formed from a low durometer silicone for example) so that the surface is designed to “stick” to skin, so it stays in place or has higher resistance to motion. This “sticky” surface may be mirror surface, matt or textured for grip. Examples of materials may be those with durometer ideal Shore A10 or lower, Shore A5 or lower, or Shore A1. In some embodiments of the invention a region or regions of the casing may be formed from a gel such as the Ecoflex™ platinum catalyzed silicones for example certified to ISI 10993-10 for skin irritation/sensitization and having, for example, Shore 00-50 hardness (below the Shore A scale), Shore 00-30 hardness, Shore 00-20 hardness, or Shore 00-10 hardness. In embodiments of the invention the casing around the shell may act like a thin sheet (<<1 mm thick), like a fabric or material, like a sheet (˜1 mm), a thick sheet (>1 mm). Optionally, the lower surface of the casing designed for placement against a user's groin/stomach may be sticky and when washed recover this stickiness in its entirety or in different regions or areas.
Optionally, the outer surface which contact the user may be smooth with low friction to human skin, smooth with minimal friction to human skin, smooth with moderate friction to human skin, smooth with high friction to human skin in its entirety or in different regions or areas. Alternatively, the surface may be smooth, textured, and/or rough and have low friction, negligible friction, moderate friction, and/or high friction in its entirety or in different regions or areas. Optionally, the surface may be textured with low friction to human skin, textured with minimal friction to human skin, textured with moderate friction to human skin, or textured with high friction to human skin in its entirety or in different regions. Optionally, the surface of the casing in its entirety or in different regions or areas may be used in conjunction with disposable sheets that provide adhesion and/or friction in predetermined levels.
Within embodiments of the invention the casing, for example formed from silicone, is the only material surrounding the casing and the surface profile is derived from applying the casing to the contoured surface of the shell. In other embodiments of the invention the surface profile is derived from multiple applications of a single material forming the casing. In other embodiments of the invention an additional material or materials are disposed between the shell and the casing. This, may for example, be a preform formed from the same material as the casing such that the casing is applied as a single or multiple dip coating for example, a preform formed from another silicone of different characteristics to the casing, a preform formed from a plastic, a preform formed from a low density foam, from a medium density foam, or a high density foam. Alternatively, a combination of materials may be employed such as two or more plastics, two or more foams, a foam and a plastic, a foam and a silicone, a form and metal. The materials may be layered, inserted, embedded, etc. without departing from the scope of the invention. However, a characteristic of these materials is the transmission of vibratory motion arising from the active elements within the USTD according to embodiments of the invention. Within passive embodiments this characteristic of material selection is removed.
Optionally, the USTD, cup, plug, cushion etc. are formed through either one or more additive manufacturing (AM) steps and/or one or more non-additive manufacturing (NAM) steps.
The foregoing disclosure of the exemplary embodiments of the present invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Many variations and modifications of the embodiments described herein will be apparent to one of ordinary skill in the art in light of the above disclosure. The scope of the invention is to be defined only by the claims appended hereto, and by their equivalents.
Further, in describing representative embodiments of the present invention, the specification may have presented the method and/or process of the present invention as a particular sequence of steps. However, to the extent that the method or process does not rely on the particular order of steps set forth herein, the method or process should not be limited to the particular sequence of steps described. As one of ordinary skill in the art would appreciate, other sequences of steps may be possible. Therefore, the particular order of the steps set forth in the specification should not be construed as limitations on the claims. In addition, the claims directed to the method and/or process of the present invention should not be limited to the performance of their steps in the order written, and one skilled in the art can readily appreciate that the sequences may be varied and still remain within the spirit and scope of the present invention.
This application claims the benefit of priority to U.S. Patent Application 63/133,913 filed Jan. 5, 2021.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/CA2021/051893 | 12/29/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63133913 | Jan 2021 | US |
