System and method for improved and enhanced expansion devices for targeted expansion diagnostics and therapeutics

Abstract

A system and method for an improved expansion device for targeted diagnosis and targeted expansion therapy is conceived. The improved expansion device has multiple expansion lumens that expand and contract via multiple pumps that operate to pressurize expansion fluid in and out of multiple expansion lumens to contact the diagnostic area of ​​the patient's expanded orifice, in order to derive diagnostic states, aggregated diagnostic profiles and treatment methods for multiple areas of the patient's expanded orifice. The diagnostic device may also include a scanner with an emitter that operates to emit energy toward the diagnostic area of ​​a body cavity into which the diagnostic device may be inserted, and a sensor that operates to detect the effect of the energy to generate one or more regional diagnostic states that characterize the body cavity.

Description

Technical Field

[0001] This application relates to the field of dilation devices for therapeutic, diagnostic, and recreational purposes. More specifically, this application relates to improved dilation devices and methods of achieving targeted dilation treatment using such devices.

Background Art

[0002] There are several reasons why an individual may use a device configured to be inserted into the vagina or anus. Medically, there are several disorders involving the pelvic region, including the bladder, vagina, pelvic floor muscles, rectum, and cervix, for which the insertion of a device for therapeutic treatment is a common procedure. Similarly, such devices are often used for sexual stimulation purposes. In particular, the disclosures of U.S. Patent Application No. 17 / 655,761, filed earlier by the applicant, titled "Improved Dilatation Device Incorporating Inflatable Balloon," U.S. Patent Application No. 17 / 646,309, filed earlier by the applicant, titled "Enhanced Prophylactics for Vacuum Therapy," U.S. Patent Application No. 17 / 809,357, filed earlier by the applicant, titled "Improved Dilatation Devices Incorporating Enhanced Features," and U.S. Patent Application No. 17 / 931,411, filed earlier by the applicant, titled "Resilient Adhesive Sheath for Use with Dilation Device" are important for a complete understanding of the disclosure made herein, and accordingly, the entire disclosure of each is incorporated herein as if fully rewritten.

[0003] The pubococcygeal muscles, commonly known as the pelvic floor muscles, play a role in supporting all the pelvic organs within the pelvic cavity. The pelvic floor muscles consist of deep and superficial layers, which work together to maintain the pelvic organs in a healthy and functional state. The muscles are suspended at the base of the pelvis and surround the vagina and rectum. The pelvic floor muscles can be damaged or weakened through childbirth, lack of use, aging, disease, or as an incidental result of surgical procedures. One symptom associated with weakness of these muscles is urinary incontinence.

[0004] Other pelvic disorders include chronic pelvic pain and vulvodynia (pelvic muscle dysfunction), which can sometimes be experienced by young adult women. These disorders can be caused by involuntary contractions (spasms) of the levator ani and perineal muscles. This condition is often called vaginismus or pelvic floor tonic and can cause difficulty or pain during vaginal penetration (dyspareunia), often resulting in pain and other difficulties that substantially reduce a woman's quality of life, not only in terms of participation in and enjoyment of penetrative sex, but also in other aspects of life such as the use of menstrual products like tampons or the use of a microscope during gynecological examinations.

[0005] Dilatation devices are generally prescribed for the treatment of such conditions and generally include products such as vaginal dilators and Kegel exercisers. Similarly, dilatation devices for insertion into the anus may also be prescribed to assist in the treatment of conditions such as anal stenosis, where the treatment involves progressively stretching and adapting the rectum to an ideal size in order to improve comfort and function after an anorectal procedure, such as surgery for the prostate or hemorrhoids.

[0006] Similarly, expansion devices are also used to enhance sexual pleasure, and in this context, such devices are generally referred to as sex toys. Furthermore, there can be substantial overlap between the structure and function of devices adapted for therapeutic and recreational use, and often a single device can serve both purposes, particularly when pelvic disorders can directly affect the ability to enjoy sexual intercourse and pleasure. Many types of sex toys are known. Some of the most popular sex toys are designed for vaginal or anal insertion and include items such as dildos, prostate stimulators, and anal plugs. Many of these devices may also include other stimulating elements, such as vibration or rotation functions.

[0007] Conventional dilation devices have many drawbacks. For example, conventional treatments for vaginismus or anal stenosis typically involve the gradual insertion of progressively larger sequences of dilators until the vagina or anus adapts to the desired size. Therefore, it is desirable to have improved dilation devices that, for example, offer adaptive forms of dilation therapy, potentially taking biofeedback mechanisms into consideration and even allowing them to be measured to provide the optimal treatment for the user. Similarly, similar shortcomings exist in the field of sex toys, and as a result, overall sexual pleasure can be enhanced by applying similar techniques to manufacture improved insertable sex toys.

[0008] Therefore, the applicant has developed an innovation in the field of dilation devices that enables adaptive dilation therapy using a single complex device, where conventional treatment methods may require the use of multiple devices. [Overview of the project]

[0009] To address these and other issues, an improved dilation device is envisioned that can apply techniques developed in catheter-based balloon techniques such as angioplasty, and other dilation or deocclusion procedures, to conventional devices in novel ways. In particular, a tubular balloon may be positioned around the shaft of a conventional rigid dilation device (e.g., vaginal or anal dilators, penetrating sex toys (dildos), pelvic floor / Kegel trainers, and stimulators), and the reservoir inside the body of the dilation device is filled with an expansion fluid such as helium gas. Inflation and deflation may be observed along multiple expansion fluid pathways to multiple internal lumens within the balloon, formed from an elastic but flexible material, via the action of a pump that transfers the expansion fluid to and from the internal fluid reservoir, resulting in improved, controllable dilation beyond that provided by the insertion of a rigid dilation device alone. Furthermore, the enhanced control mechanism is envisioned to allow the inflation and deflation of one or more balloon portions of the device by selectively controlling the inflation and deflation of the balloon's expansion lumen. When inserted into a user's body cavity, this effect can be used to create a diagnostic profile characterizing the cavity and to apply specific treatment methods to that diagnostic profile. To determine the diagnostic profile characterizing the body cavity, the scanner unit may be integrated into an enhanced extension device or used in a separate diagnostic device.

[0010] An improved dilation device for targeted dilation therapy may comprise a rigid, elongated member having a proximal end, a distal end, and a shaft region between the proximal and distal ends, and a sheath fixed to at least a portion of the outside of the shaft region and at least partially surrounding it, the sheath having an outer surface and a plurality of expansion lumens, each of the individual expansion lumens being transitionable between at least a contraction configuration and an expansion configuration. Transitioning each individual expansion lumen to an expansion configuration operates to expand each expansion portion of the outer surface corresponding to that expansion lumen away from the outside of the shaft region, and transitioning each individual expansion lumen to a contraction configuration operates to retract each expansion portion of the outer surface corresponding to that expansion lumen toward the outside of the shaft region.

[0011] The improved expansion device may further comprise a reservoir that operates to contain an expansion fluid, a plurality of conduits that define each expansion fluid path between the reservoir and each corresponding expansion lumen, and a plurality of pumps, at least one of which is associated with each expansion fluid path, and each of the at least one pump operates to regulate the net flow of expansion fluid between the reservoir and each expansion lumen along its respective expansion fluid path. The net flow of expansion fluid from the reservoir into each expansion lumen is associated with the transition of that expansion lumen to an expanded configuration, and the net flow of expansion fluid from each expansion lumen into the reservoir is associated with the transition of that expansion lumen to a contracted configuration. The improved expansion device may further comprise a plurality of pressure sensors, with each of the expansion lumens having at least one respective pressure sensor associated with it for measuring the pressure within that expansion lumen. The improved expansion device may further comprise a control unit that operates to control the operation of the plurality of pumps and to receive measurements from the plurality of pressure sensors.

[0012] The improved expansion device can operate to perform a diagnostic sequence for characterizing a patient's body cavity into which a rigid, elongated member is inserted, the diagnostic sequence including one or more of a plurality of expansion lumens, each expansion portion of the outer surface corresponding to one or more of these expansion lumens expands toward each corresponding diagnostic region of the body cavity, and transitions to an expansion configuration such that each at least one pressure sensor associated with one or more of the plurality of expansion lumens that have transitioned to an expansion configuration detects at least one pressure measurement within that expansion lumen. Based on at least one detected pressure measurement, a regional diagnostic state is determined for each diagnostic region of the body cavity.

[0013] The regional diagnostic state may also be determined by a combination of at least one detected pressure measurement and the net flow of expansion fluid flowing into one or more of the expansion lumens via the operation of a pump associated with an expansion fluid path between one or more of the expansion lumens and a reservoir. The regional diagnostic state may be further determined based on multiple detected pressure measurements taken at different times during the transition of the expansion lumen to its expansion configuration. Each of the diagnostic states determined for each diagnostic region of a body cavity may be used to generate an aggregated diagnostic profile corresponding to the body cavity.

[0014] Following the execution of any of the aforementioned diagnostic sequences, the improved expansion device may operate to perform a procedure on the patient via a rigid, elongated member that remains inserted into or is re-inserted within the patient's body cavity in substantially the same spatial arrangement as the diagnostic sequence, and the control unit operates to control the operation of at least one of the pumps to perform a procedure method derived from at least an aggregated diagnostic profile corresponding to a body cavity. The procedure method may include transitioning at least one of a plurality of expansion lumens into an expansion configuration so that targeted expansion is delivered to at least one of the diagnostic areas of the patient's body cavity.

[0015] The procedure may include transitioning one or more specific selected expansion lumens to an expansion configuration; transitioning one or more expansion lumens to an expansion configuration to achieve a predetermined specific measurement in one or more pressure sensors associated with those expansion lumens; transitioning one or more expansion lumens between an expansion configuration and a deflation configuration a specific number of times over a specific period of time; transitioning expansion lumens to an expansion configuration or a deflation configuration over a specific time rate; or one or more combinations thereof. Following the execution of one or more procedure methods, the improved expansion device may operate to evaluate the results of the execution of one or more procedure methods and to repeat the execution of the diagnostic sequence to generate a new regional diagnostic state for each of the diagnostic regions of the body cavity. The repeated execution of the diagnostic sequence may be performed by leaving a rigid, elongated member inserted into the patient's body cavity in substantially the same spatial arrangement as in the previous diagnostic sequence, or by reinserting it.

[0016] Methods for performing diagnostic sequences to characterize a patient's body cavity are also contemplated, which may include providing an improved expansion device with the first exemplary improved expansion device described above, inserting a rigid elongated member into a patient's body cavity, transitioning one or more of a plurality of expansion lumens into an expansion configuration so that each expansion portion of the outer surface corresponding to one or more of those expansion lumens expands toward each corresponding diagnostic region of the body cavity, and so that each at least one pressure sensor associated with one or more of the plurality of expansion lumens that have transitioned into an expansion configuration detects at least one pressure measurement within that expansion lumen, and determining the regional diagnostic state of each diagnostic region of the body cavity from the at least one detected pressure measurement.

[0017] It is intended that at least one regional diagnostic state for at least one of the diagnostic regions of a body cavity may be determined based on a combination of at least one detected pressure measurement in the expansion lumen corresponding to that at least one diagnostic region and the net flow of expansion fluid flowing into that expansion lumen via the operation of a pump associated with the expansion fluid path between the expansion lumen and the reservoir. Each regional diagnostic state for each of the diagnostic regions of a body cavity may be determined based on multiple detected pressure measurements in the expansion lumen corresponding to that diagnostic region, taken at different times during the transition of the expansion lumen to the expansion configuration. Each of the regional diagnostic states determined for each diagnostic region of a body cavity may be used to generate an aggregated diagnostic profile corresponding to the body cavity.

[0018] Furthermore, a method is envisioned in which the rigid, elongated member of the improved expansion device remains inserted into the patient's body cavity in substantially the same spatial arrangement as the diagnostic sequence, or is reinserted, and the control unit can operate to control the operation of at least one of the pumps to perform a treatment method derived from at least an aggregated diagnostic profile corresponding to the body cavity. The treatment method may include transitioning at least one of a plurality of expansion lumens to an expansion configuration so that targeted expansion is delivered to at least one of the diagnostic areas of the patient's body cavity. The treatment method may also include transitioning one or more specific selected expansion lumens to an expansion configuration, transitioning one or more expansion lumens to an expansion configuration to achieve a predetermined specific measurement in one or more pressure sensors associated with those expansion lumens, transitioning one or more expansion lumens between an expansion configuration and a deflation configuration a specific number of times over a specific period of time, transitioning expansion lumens to an expansion configuration or a deflation configuration over a specific time rate, or one or more combinations thereof.

[0019] Furthermore, a diagnostic device for characterizing a patient's body cavity is intended to comprise a rigid elongated member having a proximal and distal end, one or more emitters within the rigid elongated member that operate to emit energy, and one or more sensors within the rigid elongated member that operate to detect the effect of the energy emitted by the one or more emitters. The diagnostic device can operate to perform a diagnostic sequence for characterizing a patient's body cavity into which the rigid elongated member is inserted, the diagnostic sequence including at least one emitter that emits energy toward at least one diagnostic region of the body cavity, and at least one sensor that detects the effect of the energy emitted toward at least one diagnostic region of the body cavity by at least one emitter and determines the regional diagnostic state of each of the at least one diagnostic region of the body cavity based on the detected effect. The emitters may be configured to emit one or more of the following: electromagnetic waves having a specific wavelength, electromagnetic waves having a specific polarization, sound wave energy having a specific frequency, sound wave energy having a specific amplitude, or a combination thereof. One or more emitters may comprise at least one emitter configured to transition along the longitudinal axis of a rigid elongated member between its proximal and distal ends. One or more emitters may comprise at least one emitter configured to rotate about the longitudinal axis of a rigid elongated member between its proximal and distal ends. Each of one or more determined regional diagnostic states for each of one or more diagnostic regions of a body cavity may be used to generate an aggregated diagnostic profile corresponding to the body cavity.

[0020] Another method of administering targeted dilation therapy using the diagnostic device described above may include providing a dilation device comprising a rigid, elongated member for insertion into a patient's body cavity according to a specific predetermined spatial arrangement derived from a diagnostic sequence performed by the diagnostic device, and configured to perform a procedure derived from an aggregated diagnostic profile corresponding to the patient's body cavity, and inserting the rigid, elongated member into the patient's body cavity according to a specific predetermined spatial arrangement derived from a diagnostic sequence performed by the diagnostic device.

[0021] All of these embodiments are intended to be within the scope of the invention disclosed herein. These embodiments and other embodiments will be readily apparent to those skilled in the art from the following detailed description of the preferred embodiments, with reference to the accompanying drawings, and the invention is not limited to any particular preferred embodiment disclosed.

[0022] These and other features and advantages of the various embodiments disclosed herein will be better understood with reference to the following description and drawings.

Brief Description of the Drawings

[0023] [Figure 1] A front view of an improved and extended device according to a first exemplary embodiment of the present disclosure. [Figure 2] A side cross-sectional view of the improved and extended device according to the first exemplary embodiment of the present disclosure along line 2 of FIG. 1. [Figure 3] A front cross-sectional view of the improved and extended device according to the first exemplary embodiment of the present disclosure along line 3 of FIG. 1. [Figure 4] An exemplary block diagram of a control unit according to a second exemplary embodiment of the present invention. [Figure 5] A front view of an improved and extended device according to a third exemplary embodiment of the present disclosure. [Figure 6] A front view of an improved and extended device according to a fourth exemplary embodiment of the present disclosure for use in a cavity. [Figure 7] A front view of an improved and extended device according to a fifth exemplary embodiment of the present disclosure controlled by a mobile device.

Modes for Carrying Out the Invention

[0024] Throughout the drawings and the detailed description, common reference numerals are used to indicate the same elements. According to various aspects of the present disclosure, novel and improved modified expansion devices for targeted diagnosis and targeted extended treatment are contemplated. The modified expansion device may comprise a rigid elongate member defining a longitudinal axis that defines a proximal end, a distal end, and a shaft region therebetween, the rigid elongate member having a sheath, the sheath being fixed to and at least partially surrounding at least a portion outside the shaft region. A tubular inflatable balloon can serve as a sheath disposed around the shaft of a conventional rigid device such as a dildo, dilator, or pelvic floor relaxer for insertion into a body cavity of a patient or user including the vagina or anus. Also contemplated is that the modified device may be configured to be used in or inserted into other regions of the user, such as blood vessels and the esophagus for use in angioplasty after atherectomy. The tubular balloon may define a plurality of internal lumens therein. A reservoir may be included inside the body of the device and may be filled with helium gas or another suitable fluid for inflating the balloon, which may be referred to as an inflation fluid. A plurality of pumps may be associated with a plurality of inflation fluid paths defined by a plurality of conduits between the reservoir and each of the plurality of inflation lumens.

[0025] The design may be configured such that each inflation lumen has a specific inflation fluid path associated with a specific pump. The plurality of pumps may operate to expand and contract one or more of the inflation lumens by pumping inflation fluid into or out of one or more of the inflation lumens. Each of the inflation lumens of the plurality of inflation lumens may be capable of transitioning at least between an expanded configuration and a contracted configuration. When in the expanded configuration, a particular inflation lumen can operate to expand an opposing expanded portion of the outer surface of the balloon outwardly, while when in the contracted configuration, a particular inflation lumen can operate to retract an opposing expanded portion of the outer surface of the balloon inwardly. A plurality of pressure sensors may be associated with each of the inflation lumens to measure the pressure inside the inflation lumen.

[0026] Multiple expansion lumens can operate to perform specific expansion effects and / or procedures to be performed when one or more of the lumens are inflated into the expansion configuration. These procedures may include therapeutic methods or sexual stimulation. Depending on the device configuration, the control mechanism may be implemented to enable automatic or manual inflation and deflation of the multiple expansion lumens by controlling the operation of one or more of the pumps. The control mechanism may enable selective inflation / deflation of one or more specific expansion lumens by controlling the operation of specific pumps. Pressure readings from one or more of the multiple pressure sensors may be received by the control mechanism.

[0027] Because the multiple expansion lumens are separated from each other, the expansion fluid contained in a particular expansion lumen cannot directly move into or leak into another expansion lumen, even if the expansion lumens are adjacent to each other. This allows a particular expansion lumen to contain more or less expansion fluid than others, which in turn allows each expansion lumen to expand outward to a certain degree. Thus, in some embodiments, the multiple expansion lumens can operate to transition between a spectrum of expansion configurations between contraction and expansion configurations, which may depend on the amount of expansion fluid pumped into the interior of the expansion lumens. The degree to which each expansion lumen is expanded may determine the expansion / retraction of the expansion portion corresponding to each particular expansion lumen.

[0028] The control mechanism of the improved expansion device may be provided with information for determining the degree to which each individual lumen of a plurality of expansion lumens is expanded. For example, each of the plurality of expansion lumens may be expanded so that each pressure sensor reads a specified pressure value.

[0029] Multiple expansion lumens do not need to be identical to one another, and therefore the expansion lumens may be of different sizes and shapes. Using different expansion lumens throughout the device requires that the expansion lumens expand and contract differently from each other, requiring that different amounts of expansion fluid be pumped into them before reaching the expansion configuration and different amounts of expansion fluid be pumped out of them before reaching the contraction configuration, and that they may have completely unique expansion and contraction configurations (for example, having two expansion lumens in an expansion configuration, but one being half the size of the other and having a quarter of the volume of expansion fluid inside as an expansion lumen). It can be seen that one or more expansion lumens of a particular improved expansion device may be molded and sized to target one or more specific diagnostic areas of a body cavity.

[0030] The ability of each individual lumen among multiple expansion lumens to be selectively expanded from a deflated configuration to an expanded configuration, and optionally expanded to an expansion configuration between these two, enables unique and novel procedures to be performed on the patient's or user's body cavities. The device may be inserted into the patient's body cavities, and one or more of the multiple expansion lumens may operate to expand their corresponding expansion portions for each corresponding diagnostic area of ​​the body cavity. If the expansion lumens are expandable between a spectrum of expansion configurations, one or more specific expansion lumens may be expanded or deflated to a certain degree to allow a specific level of pressure to be applied and / or the expansion effect to one or more specific diagnostic areas. It can be found that unique expansion effects or procedures can be performed by expanding or retracting specific expansion portions of the sheath, and these can be easily adjusted. A control mechanism may utilize one or more pressure readings from multiple sensors to set one or more of the expansion lumens to the appropriate expansion configuration.

[0031] The diagnostic sequence may be performed by an improved expansion device by determining one or more regional diagnostic states corresponding to one or more diagnostic regions of a body cavity. Regional diagnostic states may be determined by one or more pressure measurements from one or more pressure sensors and / or by measurements of the net flow of expansion fluid into or from one or more expansion lumens. Alternatively, regional diagnostic states may be determined by scanners as described later in this disclosure. Diagnostic states can provide information about the corresponding diagnostic region of the cavity, such as muscle strength, muscle condition, nerve density, nerve stretch diagnostic region imaging or mapping, and the response of the diagnostic region to pressure applied by the corresponding expansion portion. These regional diagnostic states can be combined to form an aggregated diagnostic profile of the body cavity.

[0032] This aggregated diagnostic profile may be read and used by a control unit to operate a pump in order to perform a specific treatment method for that body cavity. The improved expansion device may remain inserted in the body cavity or may be reinserted into the patient's body cavity in substantially the same spatial arrangement as the diagnostic sequence to ensure that the treatment method is performed correctly. The treatment method may include transitioning one or more of the expansion lumens to an expansion configuration so that the targeted expansion effect is delivered to at least one of the diagnostic areas of the body cavity. The treatment method may further include time-based expansion / contraction of the expansion lumens, such as expansion rate, circulation between multiple configurations, and sudden or gradual expansion / contraction of one or more expansion lumens. For example, if a particular diagnostic area is injured or bruised, the treatment method may include inflating the expansion lumens corresponding to the diagnostic area surrounding this particular injured diagnostic area to an expansion configuration and maintaining the expansion lumens corresponding to this particular diagnostic area in a contracted configuration. Another example of a treatment method is to slowly inflate the expansion lumen corresponding to the damaged diagnostic area over time to the desired expansion configuration, avoiding a sudden reaction that may be caused by rapidly applying pressure to the diagnostic area. The expansion and contraction of multiple expansion lumen, along with the operation of auxiliary features such as a vibrator, can also be used to exert a crushing effect on one or more diagnostic areas.

[0033] The improved extension device may further comprise a scanner, which itself may comprise one or more emitters that operate to emit energy, and one or more sensors that operate to detect the effect of the energy emitted by these one or more emitters. The emitters and sensors can scan, diagnose, detect, and / or measure one or more conditions on a diagnostic area, such as muscle conditions (pain, bruise, laceration, etc.), to form one or more regional diagnostic conditions, either on their own or in combination with other data (such as the aforementioned one or more pressure readings from pressure sensors). This may be done via at least one sensor that detects the effect of the energy emitted by the emitters toward one or more diagnostic areas of the patient's or user's body cavity. The emitters and scanner can also operate to image the body cavity into which the improved extension device is inserted. This image can be analyzed by the scanner or by other means to provide further information about the regional diagnostic conditions. This information may include, for example, nerve density in a certain area, or nerve extension in a particular direction, which may prove useful in determining an appropriate treatment method for treating the body cavity.

[0034] The scanner, its emitter, and sensors may further operate to scan a diagnostic area and measure the composition and presence of specific species on or within the diagnostic area. For example, the scanner may detect the presence and / or amount of calcium in a blood vessel corresponding to the diagnostic area, and the treatment method may include operating an improved expansion device to exert a grinding effect to remove this undesirable calcium accumulation. This information may also be used to determine the presence / amount of calcium outside the blood vessel and then used to treat the calcium accumulation via other means, such as by applying an ultrasonic frequency.

[0035] The device may be configured such that each emitter corresponds to a specific diagnostic region, or one or more emitters can correspond to two or more diagnostic regions. In the latter case, one or more emitters can move relative to the enhanced augmentation device and / or scanner to emit energy toward two or more diagnostic regions. In this case, the sensors can operate to determine which detected radiant energy effect corresponds to which diagnostic region, which may be via positioning of which sensor corresponds to which radiant energy detected by the sensor. The emitters may be provided in various forms such as cameras, electromagnetic wave emitters, acoustic wave emitters, radio frequency emitters, laser emitters, electrical stimulation emitters, and combinations thereof. This data may be fed to a control unit to form an aggregated diagnostic profile, which may then be used by the control unit to selectively inflate / deflate multiple expansion lumens via the operation of one or more pumps to treat one or more diagnostic regions.

[0036] The improved expansion device may instead function as a diagnostic device that primarily houses one or more emitters and one or more sensors, thereby enabling them to generate one or more regional diagnostic states of a diagnostic area inserted into a body cavity. In this type of diagnostic device, features that contribute to expansion effects or procedures, such as multiple expansion lumens, may be omitted. Regional diagnostic states or aggregated diagnostic profiles generated from diagnostic states may be used to fabricate or configure expansion devices that may be particularly suitable for performing procedures targeting specific body cavities. This may enable providing patients or users with highly personalized procedures related to them and any conditions they may have, which may enable results far greater than those obtainable from prior art methods.

[0037] Any of the improved dilation devices discussed herein are based on the applicant's prior applications, specifically, U.S. Patent Application No. 17 / 655,761, titled "Improved Dilation Device Incorporating Inflatable Balloon," U.S. Patent Application No. 17 / 646,309, titled "Enhanced Prophylactics for Vacuum Therapy," U.S. Patent Application No. 17 / 809,357, titled "Improved Dilation Devices Incorporating Enhanced Features," and U.S. Patent Application No. 17 / 931,411, titled "Resilient Adhesive Sheath for Use with Dilation Devices." Features of "SHEATH FOR USE WITH DILATION DEVICE" may be incorporated, and each disclosure as a whole is incorporated herein as if it were a complete paraphrase.

[0038] Referring here to Figure 1, a front view of an improved expansion device according to a first exemplary embodiment of the present disclosure is shown. The improved expansion device 100 comprises a plurality of expansion lumens 102 and corresponding expansion portions. In the illustrated embodiment, the array of expansion lumens 102 is arranged around the outside of a shaft portion of a rigid elongated member, with 20 shown and a total of 32 (12 not shown) in the particular device shown. However, according to other embodiments, more or fewer expansion lumens 102 may be present along the horizontal axis or at any other arbitrary location throughout the improved expansion device 100. The plurality of expansion lumens 102 are shown here in a regular array, but in different embodiments they may be arranged in an irregular configuration and / or abstract arrangement. The plurality of expansion lumens 102 can operate to expand, and each can be seen to have a corresponding outer surface 104 that expands outward from the improved expansion device 100. This outward expansion can operate to cause the outer surface 104 to apply pressure to a contacting external surface, such as a diagnostic area of ​​a body cavity.

[0039] The improved expansion device 100 may also have multiple expansion lumens 102, each configured differently from the others, and each corresponding outer surface 104 may be configured to expand outward in different ways. For example, a particular expansion lumen 102 may be in an expansion configuration in which a particular corresponding outer surface 104 expands outward to a considerable extent, while another expansion lumen 102 may be configured so that its outer surface 104 expands to an intermediate extent when expanded into the expansion configuration, while a further expansion lumen 102 may be configured so that its outer surface 104 expands outward to a reduced extent when transitioned to the expansion configuration. Similarly, the transition between an expanded configuration and a contracted configuration may be a matter of degree, and it may be possible to partially transition between maximum and minimum expansion, or to expand with greater elasticity, and such expansion may also be resisted by the presence of an external elastic surface which may have different levels of elasticity, and thus the extent to which any given expansion lumen 102 transitions to an expanded configuration may depend on the circumstances in which it is placed, and such transitions may occur further under circumstances in which more or less compressible fluid is used to pressurize the expansion lumen and cause such expansion. Similarly, it may be found that when an expansion lumen 102 is expanded with a compressible fluid (such as a gas) and placed under external pressure, the volume of the lumen itself may decrease. Thus, it may be found that the concept of any expansion lumen 102 transitioning to or from an expanded or default configuration is relative and should not be interpreted as any specifically defined change in the internal volume of the expansion lumen 102, but rather should be understood as referring to a relative action of actively pumping the expansion fluid into or out of the expansion lumen and into or from the reservoir via the action of the pump according to this disclosure. Thus, it can be seen that the expansion lumen 102 can transition to an expanded configuration even if, for example, its internal volume does not substantially change (e.g., via a net flow of compressible expansion fluid into the expansion lumen 102 under external pressure, which results in an increase in pressure but not an increase in volume). It can also be seen that the expansion lumen can transition to a contracted configuration by any net action of the corresponding pump to remove the expansion fluid from the expansion lumen.The expansion lumen 102 does not need to be completely expanded or contracted in order to become an expansion or contraction configuration, and such language refers to the most recent relative net change of the expansion fluid in that particular lumen via the action of the pump, and it can be seen that, for example, a lumen that has recently transitioned to an "expansion configuration" may still have less expansion fluid in it than a different lumen that has recently transitioned to a "contraction configuration".

[0040] The improved dilation device 100 shown in Figure 1 has a substantially linear oval shape, similar to many conventional dilators or dildo products currently on the market. However, it can be seen that the shape, size, and external features of the improved dilation device in any embodiment, including size, shape, curvature, color, etc., can be substantially modified or customized, similar to how many conventional dilators or dildo products are also modified. Furthermore, multiple expansion lumens in any embodiment can be molded and configured in a variety of different ways, and it is intended that each expansion lumen on a particular improved dilation device does not need to be the same shape, size, or configuration. For example, one expansion lumen may be larger than another expansion lumen positioned adjacent to it, which would allow the larger expansion lumen to expand into a larger diagnostic area of ​​the body cavity. Thus, it can be seen that even if similar amounts of expansion fluid are pumped into a particular set of expansion lumens 102, different types of expansion lumens will expand differently, and therefore expand into different sized areas of the diagnostic area in different ways.

[0041] Referring here to Figure 2, a side section view along line 2 in Figure 1 of an improved expansion device according to a first exemplary embodiment of the present disclosure is shown. The multiple expansion lumens 102 of the improved expansion device 100 can accommodate an expansion fluid in and from a reservoir 118. The expansion fluid may be pumped in and out of the multiple expansion lumens 102 to transition the multiple expansion lumens 102 into a spectrum of expansion and contraction configurations. Multiple pumps 120, which may take the form of bidirectional pumps positioned on multiple expansion fluid paths 122, operate to pump the expansion fluid from the expansion fluid reservoir 118 to and from the multiple expansion lumens 102. Although the multiple expansion fluid paths 122 are depicted here as being of equal size and shape, it is intended that the multiple expansion fluid paths 122 may be configured to be different from one another, such as having a larger cross-section or having a shape that varies through the expansion fluid paths 122.

[0042] In addition, each of the multiple expansion fluid paths 122 is described here to correspond to one specific expansion lumen 102, but in a separate embodiment, it is intended that two or more expansion fluid paths 122 may converge into a specific expansion lumen 102, or that the expansion fluid paths 122 may branch into two or more expansion fluid paths 122, each leading to a different expansion lumen 102. In these types of embodiments, the pump 120 may be located on an expansion fluid path 122 before or after the point where the expansion fluid paths 122 converge or branch, which may allow a particular pump 120 to pump expansion fluid into or from two or more expansion lumen 102. The control unit 132 can control the operation of the pump 120, as well as other auxiliary features such as a vibrator 128, and can receive pressure measurements from a pressure sensor 130 in the expansion lumen 102.

[0043] Multiple pumps 120 can operate independently of each other, so that some pumps 120 can pump expansion fluid into or from several expansion tubules 102 while other pumps 120 may be idle. A power supply 126 may be provided to power one or more of the multiple pumps 120 and any other additional features such as a vibrator 128. Multiple pressure sensors 130 may be placed inside the multiple expansion tubules 102 to measure the pressure inside a particular expansion tubule 102.

[0044] Referring now to Figure 3, a front cross-sectional view along line 3 in Figure 1 of an improved expansion device according to a first exemplary embodiment of the present disclosure is shown. Here, it can be seen that the multiple expansion lumens 102 completely enclose the rigid elongated member of the improved expansion device 100. However, the multiple expansion lumens 102 do not need to completely enclose the shaft region of the improved expansion device 100 shown herein. In this embodiment of the improved expansion device 100, each of the multiple expansion lumens 102 may expand outward in different directions, which can be utilized by this particular embodiment of the improved expansion device 100 to expand the outer surface 104 over a large portion of the available diagnostic area of ​​the body cavity. Depending on the level of expansion / contraction of the multiple expansion lumens 102, different outward expansion effects can be delivered to each outer surface 104 of each of the multiple expansion lumens 102, for example, to produce different expansion effects. Therefore, different pressure measurements are obtained at each pressure sensor 130 within each of the expansion lumens 102, according to the elasticity of the diagnostic region corresponding to that expansion lumen 102. A more elastic diagnostic region will result in a higher pressure measured within the expansion lumen 102 for a given amount of expansion fluid being pumped into it, and a less elastic diagnostic region will result in a lower pressure measured. Thus, for example, by inserting the improved expansion device 100 into the patient's orifice, and then expanding multiple substantially identical expansion lumens 102 with a predetermined amount of expansion fluid, and measuring the resulting difference in pressure measurements from each pressure sensor 130, it is possible to determine the difference in elasticity of various diagnostic regions of the patient's orifice.

[0045] Referring here to Figure 4, an exemplary block diagram of a control unit according to a second exemplary embodiment of the present invention is shown. Block diagram 200 represents the interconnections 220 and internal connections 224 of the control unit 202. Each of the interconnections 220 and internal connections 224 may be via direct wiring or via wireless connections. Power supply 204 can provide power to at least the controller 206. The controller 206 may operate to receive information from one or more pressure sensors 208 that operate to measure the pressure in one or more expansion lumens, and / or other devices such as an accelerometer 210 that operates to measure the direction and speed of movement of an improved expansion device. This information may be used to form one or more regional diagnostic states and aggregate diagnostic states. The controller 206 may then use the information from these sensors and / or information from the user via a Bluetooth® sensor 212 to control, for example, the operation of one or more bidirectional pumps 214 to inflate / deflate one or more expansion lumens 216. The controller 206 can further operate to transmit information to the user via the aforementioned Bluetooth® sensor 212. This information may include readings from one or more pressure sensors, one or more regional diagnostic states, and aggregate diagnostic states. The controller 206 can further operate to control the operation of additional features such as one or more vibrators 218.

[0046] Referring now to Figure 5, a front view of an improved extension device according to a third exemplary embodiment of the present disclosure is shown. In this improved extension device 300, a scanner 302 is built into the improved extension device 300. The scanner 302 comprises one or more emitters (not shown) that operate to emit energy, and one or more sensors (not shown) that operate to detect the effect of the energy emitted by the one or more emitters. The examples herein omit features shown in the previous figures, such as expansion tubular lumen, pump, and expansion tubular lumen, and such features may or may not be included in embodiments having the scanner 302. It is also noted that the improved extension device 300 functions only as a housing for the scanner 302, and that the improved extension device 300 may be used as an insertable diagnostic device capable of scanning, detecting, diagnosing, imaging, and / or measuring diagnostic areas, and is different from a device that can further function to perform procedures on these diagnostic areas.

[0047] Referring here to Figure 6, a front view of an improved extension device according to a fourth exemplary embodiment of the present disclosure is shown in use in a patient's cavity. This improved extension device 400, comprising a scanner 402, is inserted into a user's body cavity 404 having a plurality of diagnostic regions 406. One or more emitters (not expressly shown) of the scanner 402 may emit energy 408 originating from the emitters of the scanner 402 and transmitted toward the diagnostic regions 406 of the body cavity 404. The emitted energy 408 may then result in an effect 410 that can be received or detected by one or more sensors (not expressly shown) of the scanner 402. This effect can be analyzed to derive data to determine the regional diagnostic state of a particular diagnostic region 406. One or more emitters of the scanner 402 may include, but are not limited to, a camera, an electromagnetic wave emitter, a radio frequency emitter, a laser emitter, an electrical stimulation emitter, an acoustic energy emitter, or a combination thereof. The scanner 402's sensors may include any sensors that operate to determine the regional diagnostic state of the diagnostic region 406 by detecting the effect 410 of the energy 408 emitted by the emitter. It should be understood that the scanner 402 and its sensors and emitter may also include other scanning devices not expressly described herein, including scanners not yet discovered or conceived, that are suitable for and operate in such a manner as to determine the regional diagnostic state of at least one diagnostic region 406. Conditions that the scanner 402 may measure to determine the regional diagnostic state include, but are not limited to, injured muscle, torn muscle, muscle mapping, diagnostic region imaging, and combinations thereof.

[0048] As can be seen in Figure 6, the site from which energy 408 is emitted by the emitter and the site from which the effect 410 is sensed by the sensor may be spaced apart from each other, and thus the scanner 402 may be configured such that the sensor positioning can operate to detect the effect 410 from a specific emitter corresponding to a particular diagnostic region 406. The sensor or other features of the scanner 402 can operate to identify which diagnostic region 406 corresponds to a region diagnostic state determined by the sensor, which may be necessary in a device such as the one shown in Figure 6, where the sensor and emitter are offset from their respective diagnostic regions.

[0049] In addition, the emitter may be configured to move relative to the scanner 402 and / or the enhanced extension device 400 to scan multiple diagnostic areas 406. The emitter may transition along the longitudinal axis of the enhanced extension device 400 and / or the scanner 402, and / or rotate about the same longitudinal axis. In this way, the emitter can scan the diagnostic areas 406 of the body cavity 404 in a manner similar to how a scanner in a printer can scan a page. In this embodiment, multiple sensors may operate to detect the effect 410 of energy 408 emitted by one or more emitters, or a single sensor and a single emitter may be used to scan the entire surface of a patient's orifice, if they can move both longitudinally and rotationally.

[0050] A control unit 412 may be included that can control the operation of the emitter and sensors of the scanner 402. The control unit 412 can further receive and read data collected by the scanner 402 via a communication link 420 and operate to perform a cavity diagnosis 414 which can function as one or more regional diagnostic states or aggregated diagnostic states. The cavity diagnosis 414 may include raw data collected by the sensors of the scanner 402, or it may include a form of data processed into a format that can be used to more easily diagnose or measure one or more regional diagnostic states. Multiple expansion lumens are omitted from this embodiment, but if they are included, the control unit 412 can further operate to control the expansion / contraction of the multiple expansion lumens in order to perform a treatment method specific to that cavity diagnosis 414. The control unit 412 may achieve this, for example, through communication 420 with multiple pumps which operate to pump expansion fluid into and out of the multiple expansion lumens and expand them toward the diagnostic region 406.

[0051] The improved expansion device 400 may further comprise a scanner-friendly material 416 that operates to allow emitted energy 408 and / or effects 410 to pass through the improved expansion device 400, so that one or more regional diagnostic states may be determined without interference with the emitted energy 408 and / or effects 410, otherwise this could lead to the determination of incorrect regional diagnostic states. As will be understood by those skilled in the art, depending on the scanner 402 used, as well as the emitter and sensors found thereon, a particular scanner-friendly material 416 can be selected for the most accurate results. In some embodiments, multiple expansion lumens may be fabricated from this scanner-friendly material 416. The emitter of the scanner 402 may emit energy 408, and sensors may detect the resulting effects 410 through the scanner-friendly material 416 of the expansion lumens. In this case, the control unit 412 may be able to determine the regional diagnostic state of one or more diagnostic regions 406 of the body cavity 404 and then administer a treatment method by expanding / contracting the expansion lumens corresponding to the diagnostic regions 406.

[0052] Referring now to Figure 7, a front view of an improved expansion device according to a fifth exemplary embodiment of the present disclosure, controlled by a mobile device. Here, the improved expansion device 500 has a plurality of expansion lumens 502 which operate to allow their outer surfaces 504 to expand outward from the improved expansion device 500. The improved expansion device 500 includes a controller (not explicitly shown) which can operate to control the expansion / contraction of the plurality of expansion lumens 502, and thus the level and / or force of outward expansion. In this embodiment, a mobile device 506 communicates 508 with a control unit. This communication 508 may be, for example, via the aforementioned Bluetooth® connection. The mobile device 506 may be specifically designed to communicate with and control the operation of the control unit, or it may be a device that serves several other purposes, such as a smartphone, and a software application 510 residing on it enables communication with a transceiver on a rigid elongated member, the transceiver communicating with the control unit in the rigid elongated member, or, in certain embodiments, functioning as the control unit itself, independently of or in combination with another part of the control unit in the rigid elongated member of the improved extension device 500. As will be understood by those skilled in the art, the mobile device 506 may also be replaced with any other electronic device, such as a personal computer or a medical device. The mobile device 506 may enable the user to selectively select which of the multiple expansion lumens 502 to inflate / deflate, and to what extent to inflate / deflate the multiple expansion lumens 502, via communication 508 with the control unit. The mobile device 506 may also enable the user to review one or more of the area diagnostic status, aggregated diagnostic profile, or generated treatment methods. The mobile device 506 may also allow the user to select, generate, or edit specific treatment methods, or to trigger the execution of a diagnostic sequence or treatment method.

[0053] In addition, one or more treatment method profiles may be programmed into a user-selectable mobile device 506 and / or app 510, allowing the control unit to automatically inflate / deflate each of the multiple expansion lumens 502 to a configuration determined by its particular treatment method profile. The user can switch between different expansion profiles while the improved expansion device 500 is in a body cavity, thereby allowing the user to switch from one treatment method to the next when desired. The mobile device 506 may further operate to receive information collected from one or more types of sensors communicating with the control unit, enabling the user to monitor the operation of the improved expansion device 500 or collect and report data from sensors. The aforementioned diagnostic profiles, including one or more regional or aggregate diagnostic states, may also be collected and reported via the mobile device 506, which may further operate to transmit and share this data with other devices.

[0054] The above description is given as an example, not as an limitation. In consideration of the above disclosure, those skilled in the art can devise variations that fall within the scope and spirit of the invention disclosed herein. Furthermore, the various features of the embodiments disclosed herein can be used individually or in various combinations with respect to each other, and are not intended to be limited to any particular combination of each other, nor are they intended to be limited to any particular combination disclosed herein. Therefore, the claims should not be limited by the exemplary embodiments. Further modifications and improvements to the invention will also be apparent to those skilled in the art. Accordingly, specific combinations of parts and steps described and illustrated herein are intended to represent only specific embodiments of the invention and are not intended to serve as limitations on alternative devices and methods within the spirit and scope of the invention.

Claims

1. An improved expansion device for targeted expansion therapy, A rigid, elongated member having a proximal end, a distal end, and a shaft region between the proximal end and the distal end, A sheath fixed to at least a portion of the outside of the shaft region and at least partially surrounding the at least portion, the sheath having an outer surface and a plurality of expansion lumens, where one of each of the plurality of expansion lumens is transitionable between at least a contraction configuration and an expansion configuration, where transitioning each individual expansion lumen to the expansion configuration causes each expansion portion of the outer surface corresponding to the expansion lumen to expand away from the outside of the shaft region, and transitioning each individual expansion lumen to the contraction configuration causes each expansion portion of the outer surface corresponding to the expansion lumen to retract toward the outside of the shaft region, A reservoir that operates to contain the expanding fluid, A plurality of conduits defining each expansion fluid path between the reservoir and each corresponding expansion lumen, A plurality of pumps, each of which at least one pump is associated with each expansion fluid path, and each of the at least one pump operates to regulate the net flow of the expansion fluid along the corresponding expansion fluid path between the reservoir and the corresponding expansion lumen, wherein the net flow of the expansion fluid from the reservoir into each expansion lumen is associated with the transition of the expansion lumen to an expanded configuration, and the net flow of the expansion fluid from each expansion lumen into the reservoir is associated with the transition of the expansion lumen to a contracted configuration. A plurality of pressure sensors, wherein one of the corresponding expansion lumens of the expansion lumens is associated with at least one corresponding pressure sensor for measuring the pressure within the expansion lumen, A control unit that controls the operation of the plurality of pumps and receives measured values ​​from the plurality of pressure sensors. An improved expansion device equipped with the following features.

2. The improved expansion device according to claim 1, wherein the improved expansion device operates to perform a diagnostic sequence for characterizing a patient's body cavity into which the rigid elongated member is inserted, the diagnostic sequence includes one or more of a plurality of expansion lumens, and one or more of the plurality of expansion lumens are in a state of transition to the expansion configuration such that each corresponding expansion portion of the outer surface corresponding to one or more of the expansion lumens expands toward each corresponding diagnostic region of the body cavity, and each of at least one pressure sensor associated with the one or more of the plurality of expansion lumens that have transitioned to the expansion configuration detects at least one pressure measurement within the expansion lumen, and a regional diagnostic state is measured for each diagnostic region of the body cavity based on the at least one measurement.

3. The improved expansion device according to claim 2, wherein at least one regional diagnostic state relating to at least one of the diagnostic regions of the body cavity is determined based on a combination of at least one detected pressure measurement in one or more of the plurality of expansion lumens corresponding to the at least one diagnostic region and the net flow of expansion fluid flowing through one or more of the plurality of expansion lumens via the operation of the pump associated with the expansion fluid path between one or more of the plurality of expansion lumens and the reservoir.

4. The improved expansion device according to claim 2, wherein the diagnostic state of each of the corresponding diagnostic regions of the body cavity is determined based on a plurality of pressure measurements detected in one or more of the plurality of expansion lumens corresponding to the diagnostic region, which are acquired at different times while one or more of the plurality of expansion lumens are transitioning to an expansion configuration.

5. The improved extension device according to claim 2, wherein each of the regional diagnostic states determined for each diagnostic region of the body cavity is used to generate an aggregated diagnostic profile corresponding to the body cavity.

6. Following the execution of the diagnostic sequence, the improved expansion device operates to treat the patient via a rigid elongated member that remains inserted in the patient's body cavity in substantially the same spatial arrangement as the diagnostic sequence, or via a rigid elongated member that has been reinserted, and the control unit operates to control the operation of at least one of the pumps to perform a treatment method derived from the aggregated diagnostic profile corresponding to at least the body cavity, the treatment method comprising transitioning at least one of the plurality of expansion lumens to the expansion configuration so that a targeted expansion is delivered to at least one of the diagnostic areas of the patient's body cavity, according to claim 5.

7. The improved expansion device according to claim 6, wherein the treatment method includes transitioning one or more selected specific expansion lumens to the expansion configuration, transitioning one or more expansion lumens to the expansion configuration to achieve a predetermined specific measurement value in one or more pressure sensors associated with the expansion lumens, transitioning one or more expansion lumens between the expansion configuration and the contraction configuration a specific number of times over a specific period of time, transitioning an expansion lumen to the expansion configuration or the contraction configuration over a specific speed, or one or more combinations thereof.

8. The improved extension device according to claim 6, wherein, following the execution of one or more treatment methods, the improved extension device operates to repeat the execution of the diagnostic sequence in order to evaluate the results of the execution of the one or more treatment methods and to generate new regional diagnostic states for each of the diagnostic regions of the patient's body cavity, the repeated execution of the diagnostic sequence is performed with the rigid elongated member remaining inserted in or re-inserted within the patient's body cavity in substantially the same spatial arrangement as in the previous diagnostic sequence.

9. A method for performing a diagnostic sequence to characterize a patient's body cavities, the method being: A step of providing an improved extension device, wherein the improved extension device is A rigid, elongated member having a proximal end, a distal end, and a shaft region between the proximal end and the distal end, A sheath fixed to at least a portion of the outside of the shaft region and at least partially surrounding the at least portion, the sheath having an outer surface and a plurality of expansion lumens, where one of each of the plurality of expansion lumens is transitionable between at least a contraction configuration and an expansion configuration, where transitioning each individual expansion lumen to the expansion configuration causes each expansion portion of the outer surface corresponding to the expansion lumen to expand away from the outside of the shaft region, and transitioning each individual expansion lumen to the contraction configuration causes each expansion portion of the outer surface corresponding to the expansion lumen to retract toward the outside of the shaft region, A reservoir that operates to contain the expanding fluid, A plurality of conduits defining each expansion fluid path between the reservoir and each corresponding expansion lumen, A plurality of pumps, each of which at least one pump is associated with each expansion fluid path, and each of the at least one pump operates to regulate the net flow of expansion fluid between the reservoir and each expansion lumen along each expansion fluid path. The net flow of expansion fluid from the reservoir into each expansion lumen is associated with the transition of the expansion lumen to the expansion configuration, and the net flow of expansion fluid from each expansion lumen into the reservoir is associated with the transition of the expansion lumen to the contraction configuration. A plurality of pressure sensors, wherein one of the corresponding expansion lumens of the expansion lumens is associated with at least one corresponding pressure sensor for measuring the pressure within the expansion lumen, A control unit that operates to at least control the operation of the plurality of pumps and to receive measured values ​​from the plurality of pressure sensors. To be equipped with, The rigid, elongated member is inserted into the patient's body cavity, and one or more of the plurality of expansion lumens are transformed into an expansion configuration, such that each of the corresponding expansion portions of the outer surface corresponding to one or more expansion lumens expands relative to each of the corresponding diagnostic areas of the body cavity, and each of the at least one pressure sensor associated with the one or more of the plurality of expansion lumens transformed into the expansion configuration detects at least one pressure measurement value within the expansion lumen. Based on at least one detected pressure measurement, the diagnostic status of each diagnostic region of the body cavity is determined. A method that includes this.

10. The method according to claim 9, wherein at least one regional diagnostic state relating to at least one of the diagnostic regions of the body cavity is determined based on a combination of the at least one detected pressure measurement in the expansion lumen corresponding to the at least one diagnostic region and the net flow of expansion fluid flowing into the expansion lumen via the operation of the pump associated with the expansion fluid path between the expansion lumen and the reservoir.

11. The method according to claim 9, wherein the diagnostic state of each corresponding diagnostic region of the body cavity is determined based on a plurality of detected pressure measurements within the expansion lumen corresponding to the diagnostic region, taken at different times during the transition of the expansion lumen to the expansion configuration.

12. The method according to claim 9, wherein each of the region diagnostic states determined for each diagnostic region of the body cavity is used to generate an aggregated diagnostic profile corresponding to the body cavity.

13. A method for administering targeted expansion therapy following execution of the method of claim 12, the method comprising a rigid elongated member remaining inserted in the patient's body cavity in substantially the same spatial arrangement as the diagnostic sequence, or a rigid elongated member being reinserted, the control unit operating to control the operation of at least one of the pumps to perform a treatment method derived from the aggregated diagnostic profile corresponding to at least the body cavity, the treatment method comprising transitioning at least one of the plurality of expansion lumens to the expansion configuration so that targeted expansion is delivered to at least one of the diagnostic areas of the patient's body cavity.

14. The method according to claim 13, wherein the treatment method includes transitioning one or more of the expansion lumens to an expansion configuration; transitioning one or more expansion lumens to an expansion configuration so as to achieve a predetermined specific measurement value in one or more pressure sensors associated with the expansion lumens; transitioning one or more expansion lumens between the expansion configuration and the contraction configuration a specific number of times over a specific period of time; transitioning an expansion lumen to the expansion configuration or the contraction configuration at a specific speed; or one or more combinations thereof.

15. A diagnostic device for characterizing a patient's body cavities, wherein the diagnostic device is A rigid, elongated member having a proximal end and a distal end, One or more emitters in a rigid, elongated member that operate to release energy, One or more sensors in a rigid, elongated member that operate to detect the effect of energy emitted by one or more emitters Equipped with, The diagnostic device operates to perform a diagnostic sequence for characterizing a patient's body cavity into which the rigid elongated member is inserted, the diagnostic sequence comprising: at least one emitter that emits energy toward at least one diagnostic region of the body cavity; and at least one of the sensors that detects the effect of the energy emitted toward the at least one diagnostic region of the body cavity by the at least one emitter and determines a regional diagnostic state relating to each of the at least one diagnostic region of the body cavity based on the detected effect.

16. The diagnostic device according to claim 15, wherein one or more emitters are configured to emit one or more of the following: electromagnetic waves having a specific wavelength, electromagnetic waves having a specific polarization, sound wave energy having a specific frequency, sound wave energy having a specific amplitude, or a combination thereof.

17. The diagnostic device according to claim 15, wherein the one or more emitters include at least one emitter configured to transition along the longitudinal axis of the rigid elongated member between the proximal end and the distal end.

18. The diagnostic device according to claim 15, wherein the one or more emitters include at least one emitter configured to rotate about the longitudinal axis of a rigid elongated member between the proximal end and the distal end.

19. The diagnostic device according to claim 15, wherein each of the one or more regional diagnostic states determined with respect to each of the one or more diagnostic regions of the body cavity is used to generate an aggregated diagnostic profile corresponding to the body cavity.

20. A method for administering targeted expansion therapy using the diagnostic device described in claim 19, wherein the method is: To provide an expansion device comprising a rigid, elongated member for insertion into the patient's body cavity according to a specific predetermined spatial arrangement derived from the diagnostic sequence performed by the diagnostic device, wherein the expansion device is configured to perform a procedure derived from the aggregated diagnostic profile corresponding to at least the patient's body cavity, Inserting the rigid, elongated member into the patient's body cavity according to a specific predetermined spatial arrangement derived from the diagnostic sequence performed by the diagnostic device. A method that includes this.

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