US20110190689A1

US20110190689A1 - Intravaginal therapy device

Info

Publication number: US20110190689A1
Application number: US12/890,811
Authority: US
Inventors: James D. Bennett; Andrew W. Ziarno
Original assignee: Illuminare Holdings Ltd
Current assignee: Illuminare Holdings Ltd
Priority date: 2009-09-28
Filing date: 2010-09-27
Publication date: 2011-08-04
Also published as: EP2525702A1; US20110190580A1; MX2012003742A; US20110190595A1; EA201200543A1; US8679014B2; WO2011038310A4; EP2525702A4; CN103068299A; WO2011038310A1; US20110190581A1; US20130053657A1; US20110190582A1; US8679013B2; US20110188716A1; US20110190579A1

Abstract

An intravaginal treatment device (ITD) provides therapeutic light and fluid treatments. Vision systems throughout supporting networks and devices allow for directed control of the treatment processes. The ITD uses illumination to gather various types of imager data that is used to identify and conditions, monitor the treatment process, and evaluate treatment efficacy. Specific frequency light emissions and associated fluids are used to reduce overabundant flora, at least assist in elimination of fungal, viral and bacterial invaders, and enhance the detection process. Several configurations and sizes of ITDs with light and fluid therapy, also have a built in optics assembly (camera, light sources, etc.) for capturing intravaginal still images and video of vaginal channels, cervix, cervical channels, uterus and fallopian tubes. Some ITD configurations are also wearable and include full fluid delivery infrastructure unlike some other ITDs with external components. Supporting devices include local and remotely located computing devices such as laptops, smart phones, and independent monitors. ITDs can be fully or partially inserted via the vaginal channel, and operate in a stand-alone mode or pursuant to remote control. Therapy procedures may be preset or programmed to deliver continuous, periodic and scheduled performance with various underlying parameters defined in the preset or programming processes.

Description

CROSS REFERENCES TO RELATED APPLICATIONS

This application incorporates by reference herein in their entirety and makes reference to, claims priority to, and claims the benefit of:
a) U.S. Provisional Application Ser. No. 61/246,375 filed Sep. 28, 2009, entitled “Intravaginal Monitoring Device” by Ziarno et al.;
b) U.S. Provisional Application Ser. No. 61/246,405 filed Sep. 28, 2009, entitled “Network Supporting Intravaginal Monitoring Device, Method and Post Harvesting Processing of Intravaginally Processed Data” by Ziarno et al.;
c) U.S. Provisional Application Ser. No. 61/246,396 filed Sep. 28, 2009, entitled “Network Supporting Intravaginal Monitoring Device” by Ziarno et al.
d) U.S. Provisional Application Ser. No. 61/290,792 filed Dec. 30, 2009, entitled “Network Supporting Intravaginal Monitoring Device, Method and Post Harvesting Processing of Intravaginally Processed Data” by Ziarno et al.; and
e) U.S. Provisional Application Ser. No. 61/263,416 filed Nov. 23, 2009, entitled “Intravaginal Monitoring Architecture” by Ziarno et al.
Also incorporated herein by reference in their entirety are:
a) U.S. patent application Ser. No. ______ filed on even date herewith by Ziarno et al., entitled “Intravaginal Monitoring Device” client docket number PUS-L019-001;
b) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Network Supporting Intravaginal Monitoring Device” client docket number PUS-L019-002;
c) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Analysis Engine within a Network Supporting Intravaginal Monitoring” client docket number PUS-L019-003;
d) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Monitoring Support Architecture” client docket number PUS-L019-004;
e) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Therapy Device” client docket number PUS-L019-006;
f) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Dimensioning System” client docket number PUS-L019-007; and
g) U.S. patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Optics Targeting System” client docket number PUS-L019-008; and
h) PCT patent application Ser. No. ______ filed on even date herewith by Bennett et al., entitled “Intravaginal Monitoring Device and Network” client docket number PW0-L019-001.

BACKGROUND

1. Technical Field
The present invention relates generally to monitoring and providing a diagnosis and/or therapy for intravaginal and/or sex organ infections and diseases using therapeutic light sources, pharmaceutical fluid deliveries, diagnostic agent, and video image capturing devices.
2. Related Art
Very often, the reproductive organ diseases have been one of the major health hazard faced by many a women. Some of these diseases are of sexual origin caused by microorganisms that invade into womens reproductive organs, some are habit related, and some others are hereditary related diseases. The diseases which are of sexual origin are often caused by invasion of microorganisms such as bacteria, viruses, fungus, etc., into reproductive organs of women through unhygienic sexual practices. When once disease causing microorganisms invade the sensitive reproductive organs of women, it becomes virtually impossible to check their growth and get rid of them from the body by normal surgical and medication techniques. This becomes even more challenging to treat, when a woman is pregnant.
Conventionally, antibiotics which kill or inhibit the growth of microorganisms are used to cure the womens reproductive organ related diseases. But antibiotics are known to cause side effects, causing harmful effects to the body of the patient. Therefore the antibiotic treatments result in complications in vital organs such as kidneys, heart, lung, livers, brain, and so forth.
The complications of antibiotic treatment are severe when a woman is pregnant; the reason for this being that the risk of side effects is very real for both the mother and fetus when treated with antibiotics. In some extreme cases abortion becomes inevitable. This is really shocking for parents who are expecting to have a baby through unconventional and expensive means, such as vitro fertilization and artificial insemination. There are no proven safety medical techniques to save the pregnancy if there are severe side effects due to antibiotics.
Some of the techniques currently practiced for birth control or any other surgery on the reproductive organs, which becomes inevitable due to complications, leads to permanent damage to uterus and the associated organs. This easily leads to permanent pregnancy failures (infertility), which is a known risk during inadvertent surgery or drug treatments. There are no obvious means of finding the cause of pregnancy failures in such patients. The pregnancy failure may be due to simple cause of abrasion of the cervical channel, chronicle lesions, or infections. Lack of precise detection of the causes is another limitation of the current treatment practices during treatment of reproductive organ of women.
Some of the diseases are normally asymptomatic, that is, do not manifest at very early stages, making it very hard to diagnose at the early stages (e.g., STD infections, precancerous conditions, etc.). Such diseases are often only diagnosed through doctor's visits which unfortunately occur on an infrequent basis, or, for example, when the disease or related condition becomes outwardly noticeable or intolerable to a patient.
Currently used techniques, such as colposcopy for detecting cancerous growth, are invasive techniques meant to cure diseased parts of female reproductive organs. In these techniques, the health care professional carries on biopsies in areas considered to be cancerous or infected. This is discomforting surgical procedure and causes severe pain to the patient under treatment. In addition, the colposcopy detects cancer on probabilistic basis, since the health care professional is not certain of cancer or infections until the region is tested through biopsy, in detail. When the invasive or surgical techniques are used on a woman who is undergoing the treatment, it causes severe pain, most of the time, particularly when the anesthesia is not advised or not administered properly. The anesthesia used can have severe side effects, and can even be fatal if not controlled properly during its administration into the body.
The present techniques, such as endoscopy and exploratory biopsy, cause permanent damages to the sensitive tissues in the vaginal and cervical regions. This will lead to permanent infertility in woman. Often, this discourages the patient from undergoing such treatments, due to fears of the likely negative consequences.
When endoscopy or colposcopy is performed on a woman, any random and unpredictable errors may result in inaccurate diagnosis of the illness. This leads to wrong medication to be given, which may further complicate the condition of the patient. In addition, conventional endoscopy and colposcopy are performed in a doctor's facility (office or hospital, for example) with shared equipment. Failing to follow strict hygienic procedures can lead to disastrous spreading of the very bacteria and viruses at issue. Moreover, because of the typically low frequency of use of colposcopy equipment and such equipment's limited functionality, even patients diagnosed and subject to ongoing treatment have few means to evaluate treatment efficacy.
Conventional techniques of localized drug deliveries often cause allergic reactions in the areas of the infections, in the vaginal or cervical channels, such as itching, burning, or inflammations effects, especially when the drugs are not administered properly. This may subject a patient to tolerable discomfort or cause more significant complications, the cause and impact not fully appreciated for long periods of time.
These and other limitations and deficiencies associated with the related art may be more fully appreciated by those skilled in the art after comparing such related art with various aspects of the present invention as set forth herein with reference to figures.

BRIEF SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods of operation that are further described in the following Brief Description of the Drawings, the Detailed Description of the Invention, and the claims. Other features and advantages of the present invention will become apparent from the following detailed description of the invention made with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional diagram illustrating insertion of an intravaginal treatment device (ITD), built in accordance with various aspects of the present invention, placed inside a vaginal channel, wherein the ITD assists in the identification, diagnosis and treatment of conditions within female reproductive systems.

FIG. 2 is a cross-sectional diagram illustrating a snake-like intravaginal treatment device (ITD) with slender stem guided through vaginal and cervical channels and into a uterus, wherein the ITD also assists in the identification, diagnosis and treatment of conditions within female reproductive systems, in accordance with the present invention.

FIG. 3 is a perspective diagram of a wearable type of intravaginal treatment device (ITD) that can be controlled through wireless communication links or via pre-programmed settings, wherein the ITD has an optics assembly with two imager and light source assemblies disposed thereon, and each imager and light source assembly being used for image capture and for delivery of light therapy.

FIGS. 4 a-b are perspective diagrams that illustrate a structure of a snake like intravaginal treatment device (ITD) with a segmented stem that is flexible to support guidance deep into uterus, fallopian tube, and ovarian region and carries an imager and light source assembly for capturing images and video, selectively delivering light therapy, and, in FIG. 4 b, a fluid delivery nozzle, all in accordance with various aspects of the present invention.

FIG. 5 is a perspective diagram illustrating a fluid delivery embodiment for an intravaginal treatment device (ITD) with a fluid nozzle and an imager and light source assembly, both disposed within a cervical cap, that selectively delivery fluids and light therapies, respectively, and wherein squeeze ball and tube for manual fluid injection via the nozzle.

FIG. 6 is a perspective diagram illustrating another embodiment of an intravaginal treatment device (ITD) having a built-in fluid reservoir, a fluid nozzle and dual imager and light source assemblies, and built in accordance with various aspects of the present invention, to capture imager data and deliver fluid and light source therapy.

FIG. 7 is a perspective diagram illustrating a tethered interconnect between one embodiment of an intravaginal treatment device (ITD) and a laptop computer running support software, wherein via the tether, collected data may be process, reviewed and forward, and control signals generated and delivered to the ITD.

FIG. 8 is a conceptual block diagram illustrating many possible configurations and embodiments of intravaginal treatment devices (ITDs) and supporting systems that can be built in accordance with the present invention.

FIG. 9 is perspective diagram of an exemplary intravaginal treatment device (ITD) interfaced with a hand held device (with a display and diagnosis software) through, for example, a universal serial bus (USB) port in accordance with one embodiment of the present invention.

FIG. 10 is a perspective diagram of another embodiment of an intravaginal treatment device (ITD) tethered to a supporting hand held device illustrating that more or less of functionality carried out by the ITD can be moved to or from the domain of such supporting hand held device.

FIG. 11 is a perspective diagram of a further embodiment of an intravaginal treatment device (ITD) that has a wireless transceiver circuitry for communicating to a supporting hand held device, wherein the circuitry and an antenna is integrated within the tail end of the ITD to attempt to minimize any negative effects that may be caused by transmissions within or near body tissues.

FIG. 12 is a perspective diagram of an embodiment of an optics assembly having a stem, mounting structures and two mounted imager and light source assemblies that may be used in some embodiments of an intravaginal treatment device (ITD) in accordance with the present invention to delivery light therapy and capture imager data.

FIG. 13 is a perspective diagram of another embodiment of an optics assembly that may be used in constructing an intravaginal treatment device (ITD) in accordance with the present invention, wherein the optics assembly has a stem, mounting structure, and an array of radial imager and light source assemblies for capturing a variety of types of images and producing light source therapy.

FIG. 14 is a perspective diagram illustrating another approach for integrating light sources into an imager and light source assembly of an overall optics assembly, wherein one light source is used for illumination and the other for delivering light therapy.

FIG. 15 is a perspective diagram of an optics assembly having an imager and light source assembly that employs optical fiber through which a variety of frequencies of light can be delivered from light sources either within or outside of the intravaginal treatment device (ITD).

FIG. 16 is a schematic block diagram illustrating exemplary components and circuitry that may be found in whole or in part within the many embodiments of an intravaginal treatment device (ITD) of the ITDs set forth herein and built in accordance with various aspects of the present invention.

FIG. 17 is a schematic block diagram of a monitoring and treatment architecture built in accordance with aspects of the present invention, and which an intravaginal treatment device (ITD) couples with various control and monitoring devices distributed physically across many locations.

FIG. 18 is a perspective and cross-sectional diagram illustrating an inserted ITD having a radial illumination mechanism to support delivery of light therapy along the length of the vaginal channel.

FIG. 19 is a cross-sectional diagram illustrating use of a plurality of light emitting diodes (LEDs) disposed along a snake-like stem of an intravaginal treatment device (ITD) for delivering light treatment deep within a female's reproductive organs in accordance with various aspects the present invention.

FIG. 20 is a perspective diagram of a scanning optics assembly inside the head end of intravaginal treatment device (ITD) of one embodiment of the present invention wherein light therapy can be scanned across an overall scanning region of the scanning optics, or directed only to an area of interest within the overall scanning region using laser light duty cycle control.

FIG. 21 is a perspective and cross-section diagram illustrating a wearable snake-like intravaginal treatment device (ITD) inserted into the cervical channel for capturing imager data, delivering light treatment, and wirelessly communicating to deliver such imager data and, in some embodiments, to receive control signals, e.g., regarding treatment delivery.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cross-sectional diagram illustrating insertion of an intravaginal treatment device (ITD), built in accordance with various aspects of the present invention, placed inside a vaginal channel, wherein the ITD assists in the identification, diagnosis and treatment of conditions within female reproductive systems. The ITD is guided into the vaginal channel 131. The ITD of present invention is also used in the cervical region 145 to detect infection and to treat them. The ITD 161 is a tubular structure with 3 distinguished parts; the end which is inserted into the reproductive organ of women is called as head end 115. The tubular extension of the head end 115 is called the stem 139 of the ITD 161. The extension of the stem 139 to the other end of ITD 161 to which an external cable assembly 137 is connected is called tail end 111 in the present invention.
Inside the head end 115 is an optics assembly 113; the optics assembly 113 is electrically tethered to a “control and monitoring system” 153 having computing capability with built in display screen. The computing capability of the control and monitoring system 153 is required to process the video images captured and sent by the optics assembly 113. The display (screen) is required to project the video image sent by the optics assembly 113. The optics assembly 113 transmits the video images captured through the cable assembly 137 or through any wireless link (discussed later) into the control and monitoring system 153.
The tethering cable assembly 137 comprises a set of wires. A set of wire in the tethering cable assembly 137 are used to convey electric power (supply) to optics assembly 113 and to energize associated circuitry; and to convey video frames from optics assembly 113 to the control and monitoring system 153. In another embodiment of present invention, the ITD 161 will have rechargeable battery built in for supplying the optics assembly 113. The term control and monitoring system herein refers to any devices like PCs, laptops, cell phones, and PDAs or any other devices that are coupled through wire or wireless channel which are assisting in analyzing and displaying video image data. Using the control and monitoring system 153 doctors performs remote controlling operation of optics assembly 113 inside the ITD 161.
Doctors can control various components of the optics assembly 113 instantaneously by observing the movie pictures of internal view of reproductive organ. The video image helps the doctors in guiding the ITD 161 head end into deeper regions 145 of the reproductive organ for diagnosis and treatment purpose. During this process the doctors have various control options in a Graphical User Interface (GUI) on the display. They can control the orientation of the optics assembly 113 and they can also control orientation of the individual components on the optics assembly 113, e.g., light sources. Controllable components on optics assembly 113 include a plurality of video image capturing devices, light sources of different colors, fluid pump, etc., discussed below. This feature provides a quick means diagnosis and an easier means of and treating the diseases
A plurality of light sources of different colors (or frequencies): IR (infrared) light, UV (ultraviolet) light, red light, blue light, monochromatic light, and laser are generated internally using low power LEDs (light emitting diodes) built in to optics assembly 113 (inside ITD head end 115) in one embodiment of the present invention. Light sources of required color and intensity is also conveyed from an external source using optical fiber cable into the optics assembly 113 in the case where footprint of the optics assembly 113 needs to be minimized by removing internal light sources in another embodiment of the present invention.
In the present invention, the light sources are used for two main purposes; for illuminating the wall of reproductive organ during the video image capturing, and for light therapy in treating the infections of reproductive organ region of a woman under diagnosis. For example, the use of blue light in treating the acne vulgaris is known; similarly the use of lasers and X-rays for treating cancer. That knowledge is used to treat diseases in the deeper invisible parts of women.
The ITD 161 has built in fluid pump for delivering the various fluids supplementing the light treatment. The fluid pump has many chambers, with each chamber containing specific fluid which is injected into the reproductive organ region using pumping (like a squeeze ball) or injecting mechanism (like a syringe), electrically or manually actuated. The integration of the optical light sources, imagers, and fluid pump into the ITD 161 facilitates a multi functional capability of imaging, light treatment, and drug therapy. Fluid injection mechanism for injecting the fluids into the reproductive organ is discussed in detail in subsequent figures, FIG. 4-6. Different configurations of optics assembly 115 in accordance with various embodiments of present invention are discussed with relevant figures in subsequent paragraphs. Different ITD structures and light sources for light therapy are also discussed in detail. Various ITD functionality mapping options over different blocks of implementations, and various communication interface or communication standard options with remote control and monitoring system are discussed in detail, later.
For example, a woman, in conjunction with a doctor, purchases an ITD, upon detection of a viral infection (such as STDs—Sexually Transmitted Diseases). Then, the woman inserts the device as per the doctors advice, and based upon remote execution of firmware codes by a doctors remote device or manual control by the woman herself, applies medication or light sources to the regions affected . . . .
FIG. 2 is a cross-sectional diagram illustrating a snake-like intravaginal treatment device (ITD) with slender stem guided through vaginal and cervical channels and into a uterus, wherein the ITD also assists in the identification, diagnosis and treatment of conditions within female reproductive systems, in accordance with the present invention. In particular, within a monitoring and therapy environment 201, an ITD 265 with slender stem has been routed and is located within a uterus 275. Therein, identification and diagnosis of conditions can be observed via video and image feeds communicated to a control, monitoring, and fluid source system 253. Light or fluid therapies can also be delivered via the ITD 265.
At a head end of the ITD 265, an imager and light source assembly 269 and a fluid nozzle 273 can be found. Snap shot images and video can be displayed (on a screen associated with the control, monitoring, and fluid source system 253) in real time, or reviewed later via storage associated with the control, monitoring, and fluid source system 253. Some of the light sources associated with the imager and light source assembly 269 are dedicated to illumination for purposes of imager data capture. Others, under the control of the control, monitoring, and fluid source system 253, are used for delivery of light therapy. Similarly, the control, monitoring, and fluid source system 253 manages the flow of fluids from a container via a pump (not shown but both located within the system 253), and through a tube located within a flexible stem 279 that leads to the fluid nozzle 273. Fluids for therapy, e.g., douches or pharmaceutical constructs, can be disposed with the container in advance or during the monitoring process.
Control, power and data exchange signaling between the system 253 and the electrical components of the ITD 265 utilize a communication pathway (e.g., wiring) also located within the flexible stem 279. The control, monitoring, and fluid source system 253 can be a single or multi-piece, dedicated unit, or may comprise (i) a general purpose computing device (e.g., a PC, laptop, cell phone, PDA, tablet computer, etc.); (ii) a tailored software application running thereon; and (iii) a fluid pumping reservoir with electrical and fluid interfaces for attaching the stem 279 and communicatively coupling with the computing device.
Each portion of the functionality underlying the control, monitoring, and fluid source system 253 can also be migrated in whole or in part into the ITD 265 and into local and remote computers, servers, systems and equipment. Using the functionality of the control, monitoring, and fluid source system 253, a doctor or patient may manage the overall process.
The fluid nozzle 273 is connected to fluid pump which controls the timing, dosage, and intensity of the spraying events. Such events can be monitored visually via a display screen associated with the control, monitoring, and fluid source system 253.
Imagers include an array of photodiodes, such as a charge coupled device array (a “CCD array”) or a complementary metal oxide semiconductor array (a “CMOS array”). Imager assemblies typically include lensing mounted within an optical mounting element (often a hollow tube) that attaches to orient the lensing with the imager. Integrating or attaching light sources for purposes of illumination in support of imager data capture are known.
In addition, light sources that provide therapy can also be integrated upon or within the optical mounting element of an imager assembly and/or anywhere else within or on the ITD. Exemplary light from the imager and light source assembly 269, includes typical white light of the illuminators for image capture, and therapeutic light such as infrared (IR), ultraviolet (UV), and particular frequencies of red, blue, etc. Laser diodes can be tuned and used for a variety of such light although other sources are contemplated. In some embodiments, such as were no internal light sources are used, optical fiber can be used to route the light from external sources and through an ITD to the target regions.
FIG. 3 is a perspective diagram of a wearable type of intravaginal treatment device (ITD) that can be controlled through wireless communication links or via pre-programmed settings, wherein the ITD has an optics assembly with two imager and light source assemblies disposed thereon, and each imager and light source assembly being used for image capture and for delivery of light therapy. In particular, a wearable type of ITD 335 with a stem 303, an optics assembly 305, and a transparent cap 307. The optics assembly 305 consists of a mounting structure 337 on which axial and radial imager assemblies 309 and 313, respectively, affixed thereon. The axial imager assembly 309 captures imager data (e.g., snap shot images and video) along an axial direction along a channel of a reproductive organ. The radial imager assembly 313 captures the imager data along the radial direction.
Imager data from the imager assembly 309 can be used to assist in real time guidance of the ITD 335 along the intravaginal channel to and in an appropriate orientation near a cervix, for example. A finger ring 323 can be used not only during insertion, but, importantly, during extraction of the ITD 335. The optics assembly 305 is protected by the transparent cap 307 surrounding the optics assembly 305. Within the stem 303, all the required processing circuitry, batteries, and wireless and wired communication interfaces supporting the functionalities of the ITD 335 can be found.
As the ITD 335 is a wearable type, communication to deliver imager data or to receive control instructions involves deployment of internal wireless communication circuitry such as that supporting low power and short range proprietary or industry standard approaches, e.g., cellular, Bluetooth, Zig-bee, or Wi-Fi standards. Internet and cellular infrastructures can be also used to extend delivery of imager data and receive control signals from well beyond the local premises wherein the patient is using the ITD 335.
The radial imager assembly 313 is mounted on the mounting structure 337. The mounting structure 337 helps maintain orientation of the radial imager 313 in the mostly radial direction relative to the axis of the ITD 303. A plurality of the light sources 325 placed at the periphery of the axial imager assembly 309 emit light in the mostly axial direction. Similarly, a plurality of light sources 311 are placed at the periphery of the radial imager assembly 313 to emit light in a mostly radial direction. Some of the lights in the plurality of light sources 325 and 311 provide illumination in a white light range to assist in imager data capture by the underlying imagers housed within the imager assemblies 309 and 313. In addition, others of the lights in the plurality of light sources 325 and 311 support light therapy by delivering light of various other often monochromatic frequencies that are selected for their therapeutic affects. Outer lenses 315 and 333 of lensing systems within the imager assemblies 333 and 309 assist in focusing reflected illumination from the imager target onto the imagers within the imager assemblies.
The embodiment of FIG. 3 supports remote monitoring functionality for disease or infection reactions (or responses) for a particular drug or light therapy administered remotely. The patient under diagnosis will be treated as an outpatient but will be under the supervision of the doctors through remote wired and wireless links. The patient can be admitted to hospital as an outpatient or in some cases the she can even stay at home, but still be under regular supervision of doctors.
FIGS. 4 a-b are perspective diagrams that illustrate a structure of a snake like intravaginal treatment device (ITD) with a segmented stem that is flexible to support guidance deep into uterus, fallopian tube, and ovarian region and carries an imager and light source assembly for capturing images and video, selectively delivering light therapy, and, in FIG. 4 b, a fluid delivery nozzle, all in accordance with various aspects of the present invention.
FIG. 4 a illustrates a snake like ITD 401 with a segmented stem 407 carrying an imager assembly at the head end. The segments 405 of the stem 407 makes the ITD of 401 very flexible. The components of the ITD 401 are mounted such that they conform to the bending of the stem 407.
A plurality of light source emitters 417 of the imager assembly 409 provide illumination and therapy lighting. The imager assembly also contains lensing 415 and an underlying imager (not shown). The emitters 417 are LEDs specifically chosen for their illumination or therapeutic performance, e.g., IR, UV, blue, red, and other monochromatic or polychromatic light. Alternatively, some or all of the emitters 417 may merely comprise optical fiber and dispersion lensing, and wherein such fiber is routed along side of or within the stem 407 to a lower portion of the ITD 401 (not shown). Particular light sources of the emitters 417 can be selected depending upon the requirement. For example, to disrupt a certain infection, perhaps blue LED's might be turned on continuously, while illumination for image capture occurs once per hour for a snap shot session, and all the while with an infrared LED turned off.
The imager assembly 409 communicates with associated circuitry in a supporting portion of the ITD 401 (not shown) via wired cabling running within the stem 407. Such other portion may also be inserted at least in part into the vaginal channel or remain entirely outside thereof. Some circuitry in addition to the present imager may also be embedded in or near the imager assembly 409.
In FIG. 4 b, a fluid delivery system has been piggybacked onto an ITD 301 which, other than the fluid delivery components, is identical to the ITD 401 (FIG. 4 b). In particular, a fluid delivery head 423 has a plurality of nozzles 419 for various fluids to areas within and beyond a vaginal channel via a tube 42. Such fluids include cleaning solutions and various solutions containing drugs, dyes, bio-markers, or other pharmacological, biological or biochemical fluids. Other fluids include fluids used to assist in diagnosis. Exemplary fluids include acetic acid test solutions, cervical cancer screening solutions, cervical abnormality screening solutions, and the like.
In some embodiments, the tube 421 routes inside a segmented stem 427, but in the present embodiment, it runs alongside (and may be affixed to) the segmented stem 407. The tube 421 is connected to the nozzle fluid delivery head 423 on one end, and to fluid reservoirs and a pumping mechanism on the other. The pumping mechanism can be a manual mechanism such as a squeeze ball or syringe. Alternatively, such pumping mechanism can be electro-mechanical, comprising a fluid pump. A fluid pump responds to control signaling by deliver all or a fixed amount of the fluid within a reservoir through the tube 421 and out the plurality of nozzles 419. The pumping pressure can also be adjusted via such control signaling.
Such pump control signaling can be generated directly via direct interaction with a supporting user interface by the patient, doctor, or other assistants located locally or remotely. Alternatively, pump control signaling can be automatically produced according to preprogrammed settings. Such settings might define parameters for and invoke one or more of: (i) scheduled one time delivery; (ii) periodic repeating deliveries per schedule; (iii) series of unrelated deliveries per schedule; (iv) slow, continuous “drip” delivery; (v) fluid volume per delivery; and (vi) type of fluid (where multiple fluid reservoirs and supporting pumping arrangements are available).
For example, via a setup screen associated with a wearable ITD, 10 ml of a first type of fluid might be automatically delivered at a rate of 1 ml per second, once per hour for three days. Alternatively through such setup screen, beginning at midnight, a 30 ml of a first cleaning fluid is delivered at a 3 ml per second rate, followed 30 minutes thereafter by delivery of a second fluid in a continuous, 3 hour “drip.”
Fluid delivery may also automatically initiate in response to detected conditions. For example, via a setup screen, pump initiation of fluid delivery may be tied to sensor data. If for example, a pH sensor determines that the acidity level is beyond a desired threshold, a pump control signal can be delivered which causes the pump to deliver one or more quantities of a pH balancing fluid at once or over multiple delivery events. Similarly, upon determining natural yeast particulates above a threshold as identified from periodic images captures, such and other types of fluids might be similarly automatically delivered. Likewise via other settings, upon the ITD 401's detecting an onset of ovulation, fluid containing concentrations of spermatozoa could be dispensed every fifteen minutes while a patient sleeps at night. Such detection could involve an analysis of imager data while the ITD 401 is being worn, and the fluid delivery triggering could occur only when such event is detected and associated timing is met. Confirmation of timing such as during nighttime sleep is accomplished via one or more of clock circuitry and orientation and/or motion sensors disposed within the ITD).
Basically, output of any one or more sensors (including imagers) can be analyzed within an ITD or outside thereof (on supporting computing systems) to determine whether thresholds have been exceeded or a condition or event has occurred. Such analyses may yield pump control signals automatically or via confirmation by the patient or supporting medical staff. Moreover, such sensor data analysis may be completely performed by: (i) the ITD's and/or supporting system's software and hardware; (ii) the patient or supporting medical staff; or (iii) a both of the above working together.
Similarly, decisions regarding light therapy can be made via the same setup procedures and using the same infrastructures. In fact, light therapy and fluid delivery procedures can be intertwined into an overall therapy approach.
Light therapy signaling to the one or more light therapy sources of the plurality of light source emitters 417 can also be generated directly via direct interaction with a supporting user interface by the patient, doctor, or other assistants located locally or remotely, and in a manner similar to that of the pump control signaling. Alternatively, as with the pump control signaling, the light therapy signaling can be automatically produced according to preprogrammed settings. Such settings might define parameters for and invoke one or more of: (i) scheduled one time delivery; (ii) periodic repeating deliveries per schedule; (iii) series of unrelated deliveries per schedule; (iv) continuous delivery; (v) power intensity per delivery; and (vi) type or types of light being delivered.
Also as with fluid delivery, events or conditions detected (via various types of on board sensors) can (alone or with patient or medical staff assistance, initiation or confirmation) trigger one or more of the aforementioned preprogrammed settings. For example, based on colorization changes (via image data analysis) and pH level variations, automatically and without requirement of confirmation, a first preprogrammed cleansing wash process triggers, followed immediately thereafter by both a continuous red light therapy and a short duration UV therapy process, wherein both light therapy processes are defined via preprogrammed settings. Many other types of triggering events with automatic and/or manual causation and intermixed sequential and/or parallel fluid and light therapy regimes are contemplated. For example, some fluids may be delivered for causing responses that are emphasized or fully activate when exposed to light, and thus the resulting performance requires a controlled overall procedure manageable by the ITD, patient or medical staff, and/or supporting systems.
FIG. 5 is a perspective diagram illustrating a fluid delivery embodiment for an intravaginal treatment device (ITD) with a fluid nozzle and an imager and light source assembly, both disposed within a cervical cap, that selectively delivery fluids and light therapies, respectively, and with a squeeze ball and tube for controlling manual fluid injection via the nozzle. Therein, an ITD 501 has a cervical cap 511 covering an imager assembly 509 and fluid nozzles 517 at a head end (or anterior end of the ITD 501), and has a squeeze ball 503 at the tail end (or posterior end of the ITD 501).
A silicone rubber tube 505 may be detached from a housing stem 503 of the ITD 501 for convenience when the fluid system is not being used or during the process of cleaning and filling the squeeze ball 503 with fluids. Although a squeeze ball 503 is illustrated, other shapes and manual injections configurations such as a syringe may replace the squeeze ball 503 temporarily or permanently. That is, a variety of types of injection mechanisms, some purely mechanical and some electro-mechanical can replace (for all or some types of fluid deliveries) the squeeze ball 503 and the tube 505, if needed.
A fluid nozzle assembly 519 has the fluid nozzles 517 disposed thereon. The fluid nozzle assembly 519 provides a fluid pathway to the fluid nozzles 517 and there through to a target area with a vaginal channel such as a cervical area. In other words, when the squeeze ball 503 is squeezed, fluid will be forced from the interior of the squeeze ball 503 and, in sequence, through the tube 505, an internal pathway 521 within the housing stem 507, the assembly 519, and, finally, through the nozzles 517.
The cervical cap 511 is sized to cover (and perhaps even contain portions of) a cervix. With illuminators for the imager, light sources for therapy, and nozzles for fluid delivery being disposed within the cervical cap 511, a more controlled treatment environment within the cervical region can be maintained. More specifically, along with the fluid nozzle assembly 519, the imager assembly 509 can is disposed within the cervical cap 511. As illustrated in detail with reference to various other figures herein, the imager assembly contains a imager, lensing and a housing with illuminating white light supporting imager data capture (images and/or video data) as well as various therapeutic light sources. Although integrated into the housing as illustrated, all or some of such light sources may be disposed at other locations within the ITD 501. As can be seen, the fluid nozzles 517 are designed for delivery of fluids to at least partially encompass the imager's field of view. In other words, fluids injected should contact at least part the target area being (or to be) imaged. Additionally, an extra nozzle can be added that targets the head end of the imager assembly so that cleaning thereof can be carried out without having to remove the ITD 501 once it has been inserted and in operation.
The squeeze ball 503 can also be used to deliver fluid during the insertion or the removal process so as to coat the entire vaginal channel. Likewise, when only partially inserted, fluid deliver can be invoked to, for example, target a specific artifact at a particular location perhaps midway into the vaginal channel that is not cervix related.
The size and angle of the cervical cap 511 can be changed by merely selecting and installing an alternate one of a plurality of differing sized and oriented counterpart cervical caps (not shown). The cervical cap can be made of any bio-compatible material such as soft, medical-grade silicone rubber. It may also comprise a reflective inner surface 515 to assist in the illumination and light therapy process.
FIG. 6 is a perspective diagram illustrating another embodiment of an intravaginal treatment device (ITD) having a built-in fluid reservoir, pump, a fluid nozzle and dual imager and light source assemblies, and built in accordance with various aspects of the present invention, to capture imager data and deliver fluid and light source therapy. Therein, an ITD 601 has a fluid reservoir and pumping system 605 disposed with a housing stem 619. Because a cap 603 fully encloses an optics assembly 617, fluid nozzles 609 are disposed on the outside surface of the cap 603 and aimed in a typical direction where a cervix may be found, which differs greatly from female to female.
As can be appreciated, the target of the nozzles 609 and a mostly radial imager assembly 613 have at least substantial overlap. Thus, the nozzles 609 are provided to mostly service the area of the interest to the mostly radial imager assembly 613 and not that of a mostly (if not fully) axial imager assembly 611. An additional nozzle set servicing the imager assembly 611 could be added at a different location on the cap 603 with service from the fluid reservoir and pumping system 605 or an independent counterpart thereof, if so desired.
As in other embodiments, the size and shape of the cap 603 can be changed by merely replacing the cap 603 with another and reattaching the new fluid nozzles to a fluid carrying pipe 607. Although the fluid reservoir and pumping system 605 as illustrated only contains a single fluid reservoir, multiple reservoir chambers can be added and serviced by one or more pumps for delivering a corresponding multiple types of fluids.
The ITD 601 may comprise a wearable ITD (with a relatively short version of the housing stem 619) or have a hand maneuverable length (i.e., with a relatively long version of the housing stem 619) that can be grasped even when the ITD 601 is fully inserted. Triggering of light and fluid therapy approaches are identical to that discussed in relation to the ITD of FIG. 5. For example, the fluid injection process may be triggered after automatically detecting a condition that is confirmed remotely by a doctor at a certain hour of the day during the generation of video and with before and after images. A preprogrammed process associated with the above triggering might be terminated mid sequence upon determining that enough fluid has reached the target. That is, process initiation might not only be started (triggered) by conditions or events detected (by sensor data analysis by the ITD, associated support systems and/or staff) but may be stopped due to identification of the lack of such condition or event or yet another condition or event entirely. Moreover, with a real time video feed from the imager 613 (for example) along with twisting, torquing and adjusting insertion depth of the ITD 601, a patient or medical staff can direct the delivery of fluid to more accurately and effectively hit a target. The aforementioned applies equally to directing the light therapy emitters within the imager assemblies 611, 613 as well.
As mentioned before, fluids that may be delivered include almost any hopefully non-toxic and beneficial solutions such as: (i) drug suspensions; (ii) pH balancing and other cleaners; (iii) anti-coagulants; (iii) birth control (including “morning after”) suspensions; (iv) anti-bacterial, anti-viral or anti-fungal solutions; (v) preparatory solutions to assist any ITD sensor (optical or otherwise) such as those including acids, dyes, markers, conductive materials, etc.; and (vi) preparatory or enhancing solutions to assist the light therapy process such as with solutions containing selective binding agents having light activated responses.
In addition, although only light sensing imager arrays (sensors) that are contained within the imager assemblies 611, 613 are illustrated, the ITD 601 can be fitted with a wide variety of additional sensors such as those described for example with reference to FIGS. 16 and 17 herein. Such other sensors can benefit from various types of fluids as mentioned above. In addition, they can be fully responsive to reflections from the light therapy sources directly. For example, if an ultraviolet (UV) light emitter might be used to provide a particular therapy via (i) direct tissue interaction (ii) activation resulting from a delivered fluid, or (iii) direct interaction with viral, bacterial or fungal constructs. In addition, reflections of such UV lighting may also be detected by a sensor (such as an imager array) that is tuned to sense UV frequencies, and which produces imager data (images and video) that can be translated into the visible range for viewing by patients and medical staff in real time or reviewed post facto.
FIG. 7 is a perspective diagram illustrating a tethered interconnect between one embodiment of an intravaginal treatment device (ITD) and a laptop computer running support software, wherein via the tether, collected data may be process, reviewed and forward, and control signals generated and delivered to the ITD. In an overall architecture 701 supporting intravaginal therapies, an ITD 711 is connected to a local laptop computer 731 running software to process data, control and support targeting of the ITD 711. Such software supports analysis, diagnosis and treatment of infections and conditions as mentioned with reference to previous figures.
The laptop 731 in the present embodiment acts much like the control and monitoring system 153 (FIG. 1). It receives imager data from an optics assembly 713, analyzes the imager data, draws conclusions, and, for such imager data, provides an analysis, confirmation, and review environment for a user of the laptop 731. To provide such functionality, the laptop computer 731 runs application software tailored to support the ITD 711. The software provides a graphical user interface (GUI) acting as a workbench from which, for example, a patient or doctors can control setup and operation of the ITD 711.
In addition, the ITD 711 can be placed into modes of operation that have been predefined to provide specific treatment and functionality. These modes may include predefined treatment sequences and regimens that instruct a user regarding even fluid type acquisition, optimal physical orientations, and operating schedules and durations.
The ITD 711 operates much the same of the ITD 161 (FIG. 1), and thus at least most of the description related thereto applies equally here. The ITD 711 is guided along and through reproductive organ channels assisted by real time viewing of video and snap shot images extracted from imager data. Such viewing takes place on a display 741 of the laptop computer 731, and supports the guiding of the ITD 711 into an adequate position for both capturing imager data from and delivering light therapy to a target area within such channels. As a side benefit, providing such viewing to a patient while a medical practitioner performs the guidance and diagnosis or therapy process will help to calm the patient during the entire process and provide a more rational frame of reference in which to evaluate a diagnosis.
For example, after self guiding the ITD 711 into position using real time video displayed on the laptop computer 731, a patient captures a fixed, snap shot image (with or without fluid enhancing support) of her cervix by interacting through the keyboard of the computer 731. Through colorization analysis tools and/or comparison with prior images, for example, she may recognize that a fluid and/or light therapy seem to be reducing a diagnosed condition. In a note and associated electronic delivery to remote medical personnel, such at home analysis can be confirmed. This is possible due to such medical personnel having a copy of such software running within their remote premises and which receive not only the note but also have access to all of the sensor and treatment data collected from and delivered by the ITD 701.
Likewise, growths, rashes or expelled fluids can be at least initially “home diagnosed” in a similar way. For example, with dyes, marker fluids, etc., and/or other sensor or colorization analysis techniques, chlamydia versus a yeast product or seminal fluids might be at least tentatively confirmed.
Potentially cancerous cells could be visualized at early stages via current high resolution images as compared to similar images captured some time ago to reveal growth. Such visualization can be performed “manually” by the patient or doctor or automatically as a normal process performed by the laptop computer 731 via software direction.
Other diseases for example venereal warts, sores, vitiligo, etc. can also be detected at their early stages, simplifying the treatment process, which can be treated at least in part via fluid and light therapy delivery via an ITD such as the ITD 701.
Other noninvasive diagnosis techniques via other sensors disposed on the ITD 701 (not shown) can supplement the visualization process, or can be used independent thereof when visualization offers no discernible value. For example, other types of sensors can be used to detect or assist in detecting a variety of characteristics that reveal indications of reproductive system health, including for example, pH levels, salt levels, viscosity of intravaginal fluids, colors of uterine fluid discharge, body temperature, cervical temperature contours, EKG (of mother and fetus), fetal movement or inactivity, fetal position and size, etc. Thus, other embodiments of the ITD 711 can include corresponding sensors beyond merely a visual light sensor array (visual light imager) illustrated.
In addition, the ITD 711 as illustrated is tethered to a universal serial bus (USB) port 773 using a cable assembly 719. The USB dongle 771 provides an interface between ITD 711 and the laptop 731. For example, the USB dongle 771 provides temporary storage facility for sensor data (including imager data) collected by the ITD 711. It also may provide a variety of functionality via circuitry and firmware therein that assists the optical assembly 713 and the software of the laptop computer 731 in carrying out all of the aforementioned operations by not only forwarding data and control signaling, but also via internal processing.
In some embodiments of the ITD 701, instead of having illumination and/or therapy lighting within the optical assembly 713, corresponding one or more light sources may be located within the dongle 771 with optical fiber routing and delivery via the cable assembly 719.
Thus, as may be appreciated, overall ITD functionality described throughout the present application may, as a matter of design choice, be incorporated in whole or in part within one or more of the ITD 711, a supplemental intermediary unit such as the dongle 771, and local and remote, dedicated and general purpose computing devices such as the laptop computer 731.
FIG. 8 is a conceptual block diagram illustrating many possible configurations and embodiments of intravaginal treatment devices (ITDs) and supporting systems that can be built in accordance with the present invention. Configurations of ITDs and supporting architecture distributed over the various blocks illustrated can be grouped, divided and placed into a distinct physical forms involving ITDs, local supporting devices, remote supporting devices, servers, etc., and via wired, wireless point to point and networked links in accordance with various embodiments of the present invention.
The illustrated configuration consists of 4 conceptual blocks, although more could be added and others subdivided. In particular, a block 803 comprises various imager assemblies supported by various monochromatic, polychromatic or panchromatic light frequencies, illuminating light emitters of such frequencies, therapy light emitters, fluid nozzles in or out of alignment of various ones of the imagers' field of views, fluid nozzles aiming at optics system components for cleaning purposes, and systems for containing and selectively delivering ones of pluralities of fluids to such nozzles. Although not shown, other types of sensors can be provided by the block 803. From these options, at least an insertable portion of a single or a multi-element ITD can be constructed.
A block 807 conceptually contains processing and interface circuitry 807 that at least assists in managing all of the functionality described in the various specific embodiments found in this application. Typically, the content of the block 807 is distributed in various ways between an ITD, supporting local units or dongles, supporting local or remote computing (client or server) devices via communication links supported by various interface circuitry.
For example, processing circuitry can be built into an ITD which performs a vast amount of functionality to operate independently, or which may performs few functions and thus be heavily reliant on external processing circuitry support. Beyond blocks 807 and 803, it is typical to find at least a local display device to be used at a minimum to calm or educate an examined patient or provide ITD insertion guidance assistance. Lastly, a block 815 is also typically present to, for example, at least allow a remote doctor gain access to ITD data and operations.
More particularly, in the block 815, a remote networked server or a remote client device may be configured to connect through a link 813 to a local display device at the block 811. The link 813 may represent either or both of wired or wireless links connecting the local system display device (e.g., a control and monitoring system) with a remote networked server/client device. From a remote site, doctors may control the modes and functionalities of the ITD inside vaginal channel and cervical region in real-time, or merely monitor the condition of the patient post facto or in real-time depending on the embodiment.
Brackets within FIG. 8, indicate several possible grouping of various functionalities distributed over different blocks 803, 807, 811, and 815. In one embodiment, for example, an ITD consists of a single block 803 and the associated component functionality as indicated by the bracket 817. In another embodiment, the functionality of the block 803 and a part of the functionality of the block 807 are merged into an ITD as indicated by the bracket 819. At least a portion of the communication link 805 in this case will be a local connectivity internal to such ITD.
In yet another embodiment, complete functionality of the blocks 803, 807 are built within an ITD as indicated by the bracket 821. In such configuration, the link 805 represents internal connectivity. Similarly, an overall intravaginal therapy architecture can be built wherein the functionality of the block 807 and the functionality of the block 811 are merged together as indicated by the bracket 823, perhaps within the laptop computer 731 of FIG. 7, while the block 817 comprises the ITD. In another overall architecture option, the functionalities of all the 3 blocks 807, 811, and 815 can be merged together as indicated by the bracket 825. This is equivalent to embodying the functionality of all the 3 blocks, 807, 811, and 815 into a remote control and monitoring system at the remote doctors site that connects via an Internet network pathway to a very simplistic ITD embodiment supporting not much more that the functionality of the block 817.
Merging of the functionalities in this manner as indicated in FIG. 8 provides high degree flexibility during the complete control and monitoring system design and implementation. It also provides easy testability of the ITD functionalities along with the associated software tools.
FIG. 9 is perspective diagram of an exemplary intravaginal treatment device (ITD) interfaced with a hand held device (with a display and diagnosis software) through, for example, a universal serial bus (USB) port in accordance with one embodiment of the present invention. For ease of use and carrying, an ITD 911 is configured with a dongle 931 and tethered interconnect 919 there between is supported by an application program downloaded into a hand held device 933 such as a smart phone. Both the hand held device 933 and the ITD 911 form at least a part of an overall intravaginal therapy architecture 901 which can be extended, for example, through a wireless cellular network via antenna 939 to some remote servers or client devices, e.g., devices used by a remotely located doctor.
The hand held device 933 has a display 935 on which imager data can be displayed in real time or reviewed at any time thereafter. Analysis procedures coded in software support imager data review. Similarly, if other sensors are present, other analysis procedures that are independent or supplemental thereto can be found. The hand held device has a connector 941 that accepts in a “plug-in” like mating, the dongle 931. The connector 941 may comprise a proprietary or industry standard serial or parallel, electrical or optical link that may be available. It may also be replaced with a wireless link. The dongle 931 itself may merely comprise a communication pathway if additional circuitry and functionality associated with the communication standard therefore is built within the ITD 911. Otherwise, such circuitry and functionality may be built within the dongle 931 itself.
The hand held device 933 facilitates video image processing and display functions, and, for example, diagnosis and treatment of a condition or disease by directing operation of light and fluid therapy delivery. Because of the hand held sizing, a woman can easily insert and guide the ITD 911 into position with one hand, while viewing to support or initiate such guidance, analysis, and therapy delivery.
The software that runs on the hand held device 933 provides a simple GUI environment via the screen 935 and a keypad 937. The GUI acts can also act as a workbench from which doctors or the patient can setup, program, or pre-program the functionality of the ITD 911. It can also be used to launch analysis procedures, route collected sensor data for remote storage or review, and facilitate doctor-patient communications relating thereto.
The ITD 911 itself consists of the optics assembly 913 within an enclosure 943, a stem 917, a tethered cable assembly 919, and the dongle 931. The cable assembly 919 carries wires, optical fibers and/or fluid pathways (not shown) for conveying or exchanging power, data and control signaling, and light (if any of the light sources are disposed within the dongle 931 for example).
The dongle 931 may also provide temporary storage of battery power or data and control signals such that the ITD 911 can be operated even when the hand held device 933 is powered down or performing another unrelated function. The dongle 931 may also be integrated in whole or in part into the ITD 911. As such, attachment of an interconnecting cable (between the integrated dongle and the hand held) or substituting such wired link with a wireless approach can allow for an overall operation between the ITD 911 and the device 933. Other such variations are also contemplated including, for example, having some or most of the functionality of the hand held device 933 migrated to (or duplicated at) a remotely located device (client or server, for example).
FIG. 10 is a perspective diagram of another embodiment of an intravaginal treatment device (ITD) tethered to a supporting hand held device illustrating that more or less of functionality carried out by the ITD can be moved to or from the domain of such supporting hand held device. Carrying on with the migration concepts set forth in FIG. 9 above, an ITD 1011 communicates through a direct link, i.e., a cable 1019, to a hand held device 1033, wherein all functionality that might otherwise be located in a dongle (and possibly more functionality that would otherwise be performed by the hand held device 1033) can be found to be performed by a circuit 1031.
As before, the hand held device 1033 has a display 1035, keyboard 1037, socket 1041, and an antenna 1039. The ITD 1011 consists of an optics assembly 1013, an optics cover 1043, a stem 1017, the circuit 1031 and the cable 1019.
The hand held device 1033 runs application software tailored for interacting with the ITD 1011. Such software provides a simple (graphical user interface) GUI environment on the display 1035. A user (patient or medical staff) through the GUI may set both the software and the ITD 1011 in one of a plurality of different modes of operation. Such setup can also be conducted by remote support devices via the antenna 1039. Modes and specific settings related thereto can be accessed, for example, via tabs, drop-down menus, etc., presented on the display 1035. Components within the ITD 1011 may be represented in the form of an icon or a tab in the GUI window. Any operation defined via the icon or tab will in-turn assist in a physical configuration of the respective component inside the ITD 1011.
Defined modes may include testing modes, monitoring modes, diagnosis modes, and treatment modes. During one treatment modes, for example, selection of a fluid along with a volume, rate or duration and schedule, will trigger a confirmation and subsequent, appropriate fluid delivery. Light therapies independent thereof or integrated therewith may also be so set up via a treatment mode.
The circuit 1031 may contain digital signal processing (DSP) functionality that may process sensor (including imager) data in advance of delivery to the hand held device 1033. The circuit 1031 may also manage all control signals received from the hand held device 1033 (pursuant to its application software) to carry out control of the components of the ITD 1011. The circuitry 1031 may also comprise communication and power regulation circuitry. As shown, the circuitry 1031 may be placed within the stem 1017 at one particular location. Alternatively, it may be distributed in one or more other locations within the ITD 1011.
The optics assembly 1013 may contain multiple imager assemblies, multiple light treatment emitters, and multiple illuminators assisting such multiple imager assemblies. Fluid therapy infrastructure (although not shown) can also be integrated within the ITD 1011 and perhaps under the control of the circuitry 1031.
FIG. 11 is a perspective diagram of a further embodiment of an intravaginal treatment device (ITD) that has a wireless transceiver circuitry for communicating to a supporting hand held device, wherein the circuitry and an antenna is integrated within the tail end of the ITD to attempt to minimize any negative effects that may be caused by transmissions within or near body tissues. Therein, an ITD 1111 and its underlying components and structures perform with identical operations and have nearly identical possible variations as the ITD 1011 (FIG. 10). One clear difference in the illustration can be found in the location of radio circuitry at the base of and within a stem 1117 which replaces the cable 1019 (FIG. 10)
More specifically, within the ITD 1111, with a wireless transceiver chip 1133 integrated in its tail end. The wireless transceiver chip communicatively couples with a hand held device 1141 via a wireless link 1135 to a radio antenna 1137 of the hand held device 1141. The radio antenna 1137 connects to a transceiver circuit (not shown) within the hand held device 1141 to provide communication flow between an application program running thereon that is tailored for interacting with the ITD 1111. The same transceiver circuitry and the radio antenna 1137 or additional counterparts therefor and within the hand held device 1141 support additional wireless communication via wireless link 1143 which leads to other local or remote supporting systems.
The power for the various components inside the ITD 1111 is provided by batteries encapsulated in the tail end of the ITD 1111 (not shown). All the raw or preprocessed imager data and control signals can be exchanged wirelessly (in real time or post facto from storage) between the hand held device 1141 and the ITD 1111. As illustrated, the ITD 1111 contains a processing circuitry 1131, the transceiver circuitry 1133, and the optics system 1113. The optics system 1113 includes light therapy emitters and illuminators supporting various imagers. Although not shown, fluid therapy infrastructure can also be integrated therein.
As mentioned, the antenna 1137 facilitates wireless coupling between the ITD 1111, the hand held device 1141, and possibly remote supporting devices (not shown). Using the antenna 1137 and any counterparts, the hand held device 1141 can consume, process and/or forward sensor data, control signals, textual notes in upstream (to other supporting devices) or downstream (to the ITD 1111). Such wireless communication may involve wireless cellular, WAN, WLAN, WPAN, or direct wireless point to point links.
FIG. 12 is a perspective diagram of an embodiment of an optics assembly having a stem, mounting structures and two mounted imager and light source assemblies that may be used in some embodiments of an intravaginal treatment device (ITD) in accordance with the present invention to delivery light therapy and capture imager data. In particular, an optics assembly 1201 contains a radial imager assembly 1207 (containing a mostly-radial oriented imager 1206) and the axial imager assembly 1215 (containing a mostly-axial oriented imager—not shown). The imager assemblies 1207 and 1215 are attached to a mounting structure 1203 of optics assembly 1241. The optics assembly 1241 can be moved in an axial direction 1239 and a rotational direction 1237.
To increase focal distance in a mostly radial direction, the radial imager assembly 1207 is mounted slightly off center and upon a flexible portion 105 of the mounting structure 1203. The imager assembly 1207, in addition to the imager 1206, has a lensing system 1227, a plurality of light therapy sources capable of emitting light at any specified one or more frequencies, i.e., via an IR light source 1223, UV light source 1225, monochromatic blue light source 1219, and monochromatic red light source 1221. The light therapy sources 1219, 1221, 1223 and 1225 are switched off or on at various power levels or duty cycles pursuant to local or remote control. In addition to continuous emission and fixed power levels, active and continuously power level variations (or other modulation techniques) over time may be employed to provide better therapeutic results.
The axial imager assembly 1215 is mounted slightly off center of the cylindrical base 1203 to allow mounting space for the radial imager assembly 1207. The axial imager assembly 1215 is attached to a flexible vertical portion 1217 of the mounting structure 1203. The axial imager assembly 1215 also has lensing 1213 (supporting the underlying imager) and a plurality of light therapy sources mounted thereon, including: an IR light source 1211; UV light source 1213; blue light source 1233; and red light source 1229. Power, power level and duty cycle control as with the light therapy sources of the imager assembly 1207, can be fully controlled by internal processing circuitry, devices outside of the ITD, or by a combination of both.
Light source illuminators supporting image data capture by the imagers within the imager assemblies 1207 and 1215 are not shown but may also be incorporated into the imager assemblies 1207 and 1215 or into either another location within the optical assembly 1201 or at some other location within an ITD that includes such optical assembly 1201. Light source illuminators and their corresponding imagers may be selected or tuned to operate in any electromagnetic wave frequency including in the white light range.
The radial imager assembly 1207 can be moved in the direction indicated by the arrow 1235 by perhaps ±20° to fit a particular female's anatomy. Similar adjustments may be made to the axial imager assembly 1215. The complete optics assembly 1241 can be axially moved along the direction of a stem of an ITD, or rotated for better alignment as illustrated by arrow 1237.
FIG. 13 is a perspective diagram of another embodiment of an optics assembly that may be used in constructing an intravaginal treatment device (ITD) in accordance with the present invention, wherein the optics assembly has a stem, mounting structure, and an array of radial imager and light source assemblies for capturing a variety of types of images and producing light source therapy. Therein, an optics assembly 1301 has a mechanical structure 1303 with a flexible mounting portion 1307 that supports an attached plurality of imager assemblies. The radial, axial and rotational adjustability of the optics assembly 1201 (FIG. 12), applies equally herein, e.g., via radial 1305, axial 1339 and rotational 1337 adjustments.
The plurality of imager assemblies 1309, 1311, 1313 and 1315 each contain an imager for capturing images of an intravaginal target such as a region of a cervix. But instead of having all such imagers operate solely in the white light region, each imager is directed to capturing images in differing electromagnetic wave frequencies or ranges. Specifically, the imager within the imager assembly 1309 is designed for use in the white (visible) light range and with RGB filter elements that assist in the imager's ability to capture high resolution color imager data (i.e., color images and video). To assist in this process, all four periphery light sources disposed in the imager assembly 1309 emit white light.
Similarly, an imager located within the imager assembly 1315 is selected for infrared (IR) image capture at a frequency range typically associated with cervical temperature ranges. When capturing images of the cervix within such temperature range, no other emitter but the cervix itself is needed. Even so, the four periphery mounted light sources of the imager assembly 1315 may selected to cover various other therapeutic frequencies or frequency ranges. Likewise, the imager within the imager assembly 1311 is directed to UV frequencies for image capture and includes a corresponding four periphery mounted UV light sources which can not only be used to assist in image capture, but can also be used for therapeutic light delivery.
The imager within imager assembly 1311 may operate at any other frequency range or for binocular pairing with any other of the imager assemblies with the peripheral light sources mounted thereon assisting in such purpose as illuminators and, if desired, in providing light therapy as well.
FIG. 14 is a perspective diagram illustrating another approach for integrating light sources for light therapy or for illumination for imager data capture into an optics assembly 1401. In particular, a light source 1409 constitutes an illuminator as it operates to produce reflections from an intravaginal target to assist an imager 1407 in capturing imager data. The light source 1415 produces light for therapy, i.e., produces light at a therapeutical frequency or frequency range.
The light sources 1409 and 1415 are mounted on the outside of an imager assembly 1406, but could be mounted anywhere else in the optics assembly 1401 or outside thereof in association with some other construct of an ITD. By being co-mounted, however, targeting using real time displays generated from image capture data allow for co-targeted exposure areas for light therapy treatment.
All other aspects regarding the optics assembly 1401 can be found with reference to corresponding parts and functionalities described with reference to FIGS. 12 and 13.
FIG. 15 is a perspective diagram of an optics assembly 1501 having an imager assembly that employs optical fiber through which a variety of frequencies of light can be delivered from light sources either within or outside of an intravaginal treatment device (ITD). The optics assembly 1501 is fitted with two optical fibers 1511 and 1513. The fibers 1511 and 1513 are attached and in mostly optical alignment with an optical pathway of an imager assembly 1507.
Connected at the opposite end of the fibers 1511 and 1513, a plurality of light sources (not shown) can be found. Such light sources, depending on the configuration, could be located within the housing of an ITD or be found outside of an ITD in a supporting device. Either way, such plurality of light sources include light sources that provide (i) illumination light of a frequency or frequencies to be used to support image capture by an imager 1506 of the imager assembly 1507 such as white light, and (ii) therapeutic light of a frequency or frequencies to be used in providing light therapy. In this way, a variety of light can be delivered to serve various purposes and as needed without significantly impinging on the limited space within the optics assembly 1501.
The ends of the fibers 1513 and 1511 can also be formed, polished, abraded or otherwise processed to provide better dispersion of light or adjust a coverage area (e.g., such as mapping the illumination area to the field of view of the imager 1506). Alternatively, the fibers 1513 and 1511 can be fitted with end caps providing the same or other optics functions with elements therein such as polarizers, apertures, filters, diffusers, etc. Moreover, both fibers 1511 and 1513 may operate to deliver identical types of light or work separately and simultaneously for two types of therapy delivery or to deliver therapy while capturing imager data.
FIG. 16 is a schematic block diagram illustrating exemplary components and circuitry that may be found in whole or in part within the many embodiments of an intravaginal treatment device (ITD) of the ITDs set forth herein and built in accordance with and to illustrate various aspects of the present invention. In particular, circuitry 1601 includes an interface and control circuitry 1607 which arbitrates and prioritizes data acquisition and transmission to and from various ITD components and supporting devices and systems outside of the ITD.
For example, the interface and control circuitry 1607 directs the capture of imager data via control signals delivered to imager devices 1603 and retrieves resultant captured imager data therefrom. The circuitry 1607 may store such image data locally within a memory 1609 and/or route to devices outside of the IDT via wired and/or wireless communication interfaces 1619 and 1621. The circuitry 1607 is responsive to incoming commands and controls via the communication interfaces 1619 and 1621 as well. Such commands and control are translated by circuitry 1607 into sequences of digital control signals delivered to various underlying components to carry out the specified functionality, e.g., activation selected ones of the imager devices 1603 and providing illumination therefore, activating fluid pump 1623, delivering stored information via the wireless communication interface 1621, etc.
Other activities of the circuitry 1607 include activation, retrieval, storage and forwarding of other sensor data from a microphone 1615 and supplemental sensors such as orientation and motion indicators, fluid level indicators (fluid reservoir), pH sensors, thermometers, sonograms, EKGs, and a variety of other bio-sensors, for example.
Sensor data retrieved may also be processed or preprocessed by the circuitry 1607 in preparation for display or analysis. If so, even further, automatic analysis could lead to conclusions all possibly performed by the circuitry 1607 or by an external support device. The circuitry 1607 also manages directly (or indirectly via remote control) the application of light and fluid therapies.
Each of the imager devices 1603 responds to control signals to capture and forward imager data. The imager assembly 1603 may contain one or more of a monochromatic light sensitive imager 1631, a UV light source sensitive imager 1633, an IR light sensitive imager 1635, MRI (magnetic resonance imaging) imager 1637 and other source sensitive imagers 1651, such as sonogram imaging elements (not shown) or a select frequency of light that reveals venous growth to provides an early indication of potential cancerous cell activity.
The light therapy block 1605 indicates a various selection of light sources that may be employed to treat a wide spectrum of conditions within a female reproductive organ. The UV source 1639 may be used for example to kill bacteria which respond to a specific frequency or frequencies in the UV spectrum. A red light source 1641 may be used to illuminate lesions, abrasions and cuts, by inducing tissue healing. A blues light source 1643 may be used against bacteria or virus infected tissues. The other light sources 1645 pertain to any therapy that involves light energy such as X-rays, laser, IR light, etc.
The internal light sources 1649 are the sources of light of specific frequencies and frequency ranges housed within an ITD of the present invention. An external light source 1647 are those light sources located outside of the ITD that produce light conveyed via fiber optics into the optics assembly of the ITD for imaging (illumination) and light treatment.
As mentioned, the supplemental sensors 1613 are any of a variety of sensors that may be included in a particular ITD, e.g., bio-sensors, thermal sensors, pressure sensors, glucose sensors, IR sensors, position sensor, velocity sensors, gene chips, etc. The microphone 1615 is an audio range sensor that can be used to capture fetal or female heart rate(s), movement, etc.
The user interface 1617 may be fairly simplistic and comprise only a power button and relying on external support devices for more complex input and display interaction. Alternatively, an ITD can be configured with a more complex input device and display supporting vastly superior interaction, and perhaps without the need for a supporting external device to operate and even display internally generated data or conclusions. For example, a user can inject fluids using injection syringe or squeeze ball (discussed in FIG. 5) or automatically direct such functionality via internal pumps and reservoirs via the user interface(s) 1617. Such user could be the patient, doctor, medical assistants, etc.
The wired communication interface 1619, if present, may utilize proprietary and industry standard communication protocols compatible with external support devices, e.g., USB, firewire, ethernet, etc. Similarly, if present, the wireless communication interface 1621 may also offer proprietary and industry standard communication, such as Bluetooth, Zig-bee, or Wi-Fi.
A fluid pump 1623 associated with a fluid reservoir 1625 may contain any number of fluids as described in detail relating to the preceding figures.
The power regulator unit 1611 manages power delivery to ITD components and circuitry. Depending on the construct, power can be delivered wirelessly, via wire, replaceable or rechargeable batteries 1629, etc. Power charging and regulation circuitry 1627 manages the delivery to insure stable and sufficient power is distributed and, if employed, the rechargeable batteries 1629 receive adequate recharging.
FIG. 17 is a schematic block diagram of a monitoring and treatment architecture 1701 built in accordance with various aspects of the present invention, and which an intravaginal treatment device (ITD) 1703 couples with various control and monitoring devices distributed physically across many locations. At locations within the same premises of the ITD 1703, local support devices 1705 can be found that assist the ITD 1703 in detecting, monitoring and treating reproductive system issues.
The local support devices 1705 include, for example, a cell phone 1733, PDA 1735, laptop 1737, and other local supporting systems 1739, such as: (i) local medical diagnostics equipment, external sensors (e.g., microphones, cameras, blood pressure, heart monitors, glucose measurement devices, etc.); (ii) other local computing devices (e.g., tablet computers, desk top units, servers, etc.); and (iii) imager data display devices (e.g., dedicated monitors and television screens).
Similarly, at locations remote from the ITD 1703, such as at a health care center, on a home of medical staff member (e.g., via a tablet computer or smart phone), and/or any other remote facility or location, remote support devices 1707 such as a supporting computer system 1741 and supporting medical diagnostic equipment 1743 can be found.
Another supporting system, a server or access point 1709 may be located locally or remotely (or both via comprising two independent units). As a local server (perhaps running on one of the patient's local computing devices) or remote server (e.g., an Internet server), the server or access point 1709 provides both direct and indirect support to the ITD 1703. For example, the direct support might involve captured data processing and/or analysis. The indirect support includes the provision of real time and delayed routing pathways (via postings and delayed, subsequent retrievals) between the various components of the monitoring and treatment architecture 1701.
At the same premises as the ITD 1703, either during direct interaction with the ITD 1703 during a monitoring and treatment procedure or after the fact to extract information related thereto, the ITD 1703 interacts with one or more of the local support devices 1705 via a wired or wireless link 1763 or 1765, respectively, for communication exchange. For example, the ITD 1703 delivers collected imager data (e.g., still images and/or video image data, each at one or more resolutions) for real time display on the laptop 1737 for use by a patient in such patient's insertion guidance, condition detection, therapy targeting and management, and determining treatment efficacy. Other sensor data may be similarly delivered and utilized. Such deliveries may involve point to point communication (via the links 1763 or 1765) or via routing through ones of links 1745, 1755, 1747 and 1749 and the server or access point 1709.
The ITD 1703 also receives a variety of types of control signals that may originate in local support devices 1705, the server or access point 1709 (when comprising a server), or the remote support devices 1707. Such control signals may also or alternatively originate with the external server 1709 or the remote support devices 1707. They may be conveyed directly to the ITD 1703 via a point to point link, or indirectly via routing infrastructures that may or may not involve ones of the underlying local support devices 1705, the external server 1709 and the remote support devices 1707.
The controls signals are used, for example, to direct operations of light sources (on, off and intensity), imager other sensor's data collection, collected data (pre)processing and delivery, fluid injection, local memory management, etc. That is, the control signals at least assist if not fully control the management of one or more functional procedures performed by the ITD 1703.
The communication protocol for wireless local and remote communication could be selected from one or more proprietary or industry standard approaches, such as Bluetooth, Zig-Bee, Wi-Fi, etc. Similarly, wired communications defined by one or more proprietary or industry standards, such as USB, Ethernet, firewire, etc., might also be included.
The local support devices 1705 are communicatively coupled with the ITD 1703. The local support devices 1705 are also coupled indirectly through the server or access point 1709 with the ITD 1703. The use of direct or indirect coupling may depend on functionality goals or communication link availability.
The computer systems 1741 of the remote support devices 1707 might similarly comprise the same types of the local support devices 1705. Moreover, remote and local labeling is relative to the current location of the ITD 1703. For example, when the ITD 1703 is used in the locality of the support devices 1705, such devices earn the illustrated label “local.” Similarly, when using the ITD 1703 locally at the premises of the support devices 1707, the label “remote” should be changed to “local” and so on. Thus, the labels “remote” or “local” are based on the location of the ITD 1701 at the time of use thereof. For example, when at the doctor's facilities, the local support devices 1705 might all be doctor's devices, and the remote support devices 1707 might comprise patient's devices within the patient's home.
The local and remote support devices 1705 and 1707 may comprise proprietary and dedicated support devices or general purpose devices that each execute application software that directs ITD support. Such devices 1705 and 1707 may intercommunicate directly or via the server or access point 1709, and may be highly portable. For example, doctors using one such device (e.g., a tablet computer) may freely move within a “local” facility and to “remote” locations, while continuing to interact with the ITD 1703 or captured data therefrom.
The computer systems 1741 and the medical diagnostic equipment 1743 may intercommunicate via a local area network (LAN) within the remote location (e.g., a health care center). The computer systems 1741, in general, provide for primary interaction with the ITD 1703. The medical diagnostic equipment 1743, in general, provide supplemental information and analysis for the computer systems 1741. For example, the equipment 1743 might include an analysis system that responds to an input (such as data or tissue), and might output measurements and conclusions based thereon, and wherein such measurements and conclusions being delivered to the computer systems 1741 and being for integration into the condition identification, therapy selection and delivery, and efficacy determination processes. Such analysis might be in real time, based on real time data from the various sensors within the ITD 1703, or post facto.
The input to the equipment 1743 might comprise data from the ITD 1703 or, based thereon, post processed information from the local or remote support devices 1705 and 1707. Such data might be derived from any of the sensors within the ITD 1703, e.g., pH, glucose, temperature, imager, ultrasound, magnetic resonance, microphone, or any other bio-mechanical, bio-electrical or bio-chemical sensors disposed inside the ITD 1703. In addition, such data might be generated from the other local supporting systems 1739. For example, other sensors (including, but not limited to, those types disposed in the ITD 1703) may be integrated into independent devices, i.e., into one or more of the other supporting systems 1739 outside of the ITD 1703. The input to the equipment 1743 may also comprise manually collected input of tissues, bio-fluids or other bio-material collected without assistance from the ITD 1703.
The medical device equipment 1743 may involve merely direct computer analysis of input data, and may involve a complex manual and automated process using cultures, marking or other biochemical operations to produce the measurements, further data and conclusions to be delivered to the computer systems 1741.
The ITD 1703 of the present embodiment has sensor/instruments 1711, fluid container and pump 1713, imagers/photodetector 1715, light sources 1717, communication interfaces 1719, user interfaces 1727, memory 1729, processing circuitry 1731, and power regulator and management circuitry 1721.
The other sensor/instruments 1711 is a plurality of supplemental sensors like pH sensors, temperature sensor, biochemical sensors, and so on. They may directly measure or provide indications of the current state of a female's reproductive system, such a pH value, body temperature, yeast levels, fetal heart rate, etc. The fluid container and pump 1713 is a fluid reservoir component (discussed in FIG. 4-6) having multiple fluid chambers; in each fluid chamber, fluids of specific type is stored. The fluid container and pump 1713 provides a smooth injection of these fluids into the reproductive organs of the woman under diagnosis.
The imagers 1715 are optical imagers discussed earlier, for example, with reference to FIG. 12-15, that captures imager data (still image data and/or video data) of various intravaginal targets within the female's reproductive system. The light sources 1717 include both illuminators supporting the imagers 1715, and therapy delivery light sources. For therapy lighting, the light sources 1717 include a plurality of adjustable intensity, (mono-, pan-, and poly-chromatic) light sources of different frequencies or frequency ranges. The processing circuitry 1731 may direct such intensity to deliver modulation, duty cycling, etc., to optimize and otherwise manage therapy. Such direction may be initiated by the processing circuitry 1731 itself, or in response to external control signals from the local or remote support devices 1705 and 1707.
The ITD 1703 has user interfaces 1727 which provides a mean of user interaction with ITD 1703. For example, for delivering user input, buttons, touch pads, keyboards, microphones, motion detection sensors, switches, etc., might be included in or on a housing of the ITD 1703. For communications from the ITD 1703 to a user, speakers (for delivering voice, beeps, vibrations, music, etc.), displays (presenting a GUI and/or imager data, for example), LED indicators, etc., might similarly be disposed within the ITD 1703. Overall, the user interface 1727 provides a mechanism through with a user can configure, control and receive feedback from the ITD 1703.
The processing circuitry 1731 of ITD 1703 may comprise a signal processing circuitry for processing imager data captured by the imager 1715 for display by the ITD 1703 or by a supporting device 1705 or 1707. Such processing may also involve analysis used to assist in identification of a gynecological event, artifact or condition.
Power may be delivered via a tethered (wired) connection, via disposable batteries, or wirelessly. The power regulator and power management circuitry 1721 manages the stable delivery of power within the ITD 1703. As illustrated, the ITD 1703 is fitted with a rechargeable battery 1761 through which the circuitry 1721 derives power. The circuitry 1721 also manages charging of the batteries 1761 when wireless or wired external power sources become available.
FIG. 18 is a perspective and cross-sectional diagram illustrating an inserted ITD having a radial illumination mechanism to support delivery of light therapy along the length of the vaginal channel. As illustrated, within a reproductive system 1801, a therapy light 1813 built within a stem portion of an ITD 1809 to deliver light therapy to areas along the length of the vaginal channel. Similarly therapy lighting is also placed as described heretofore in an optics assembly 1815 of the ITD 1809. Both sources of therapy lighting are controlled by underlying circuitry within the ITD 1809, and may also be controlled via control signals originating outside thereof from external support devices.
Outside of the reproductive system domain, it is known that light of specific frequencies, frequency ranges, and under certain modulations and duty cycles, can at least assist in curing infections, e.g., the use of blue light for treating acne vulgaris, and UV lighting to destroy bacteria or deliver therapy for psoriasis and eczema. Also known outside of the reproductive system domain is the use of therapy lighting to promote healing, e.g., red light for healing skin roughness, cuts, etc. It is also known that the X-rays destroy both cancer and surrounding. High intensity laser light can be similarly useful.
If configured with appropriate therapy delivery and monitoring infrastructure, the ITD 1809 can not only follow a predefined therapy delivery procedure, but can also adjust the procedure based on sensor data (e.g., imager data) feedback so as to maximize the therapeutically effects while focusing in on the desired areas to be treated and to optimize the during and intensity of overexposure. Such feedback may be gathered during the therapy session and at some time after a session in a series of therapy sessions, to support such optimization. For example, overexposure might not be revealed until some time after exposure to the light therapy during a therapy session. In other cases, it might be revealed by sensor data during a session. Mid-session indications can then be used to adjust the intensity or duration of therapy given at a current session, while post session indications can be used to similarly adjust a subsequent therapy session. Either way, such indications may yield a decision to terminate all further therapy. And of course, this applies to any type of therapy delivered by the ITD 1809, including but not limited to the various light therapies illustrated, fluid therapies (used separately or in conjunction with the light therapies), and other types of therapies delivered by other bio-chemical, electrical or electro-mechanical sources installed within the ITD 1809.
For example, an x-ray source emitter can be controlled to target a particular optically discernible area on a cervix. During exposure, either x-ray reflections can be targeted or heat signatures from an infrared imager can be captured to produce real time images and feedback as to where and how effective treatments are proceeding. Intensity can be adjusted then to account for cancerous growth depths across the various locations of the surface region under treatment. With precise guidance of the x-ray or laser emitter (perhaps via on-off and intensity control via raster scanning arrangement similar to that of FIG. 20) such as an x-ray beam or laser beam, an optical image can be used to confine exposure of the emission to a specific target within the optical field of view. For targeting confirmation and efficacy, reflections to corresponding imagers or heat signature images from infrared imagers can be used. The surface area of three dimensional targets (artifacts) target can also require more or less overall intensity (via emission intensity or duration of exposure) at each point therein to correspond to the varying thickness of the underlying artifact. For example, often central areas with greater depth and treatment, and with lesser treatment at edges.
The therapy light 1813 may be a single or a plurality of incandescent or fluorescent lamp with or without appropriate filters (e.g., a “black light”) or any other lighting mechanism that provides a more radial light emission along the axis of the stem portion of the ITD 1809 as shown. As with the therapy lighting associated with the optics assembly 1815, the therapy light 1813 may produce light of one or more frequencies and/or one or more frequency ranges, and in a continuous or modulated approach for a specific therapeutic goal. Emissions from the therapy light 1813 impact organisms, viruses, fungus, fluids and tissues of or upon the vaginal walls 1805. For example, if the light therapy is directed to reduce an overabundant natural flora growth, such light tuned to such flora will be adversely effected and either illuminate or reduce the need for anti-fungal and anti-bacterial cremes.
Similarly, the ITD 1809 of present invention is also used for healing and enhancing the elasticity of the vaginal channel walls 1805, for example, using red light emissions. Moreover, if the optics assembly 1815 and end portion of the ITD 1809 are appropriately sized, the ITD 1809 can be inserted into further intravaginal areas such as through a cervical channel 1823 and beyond into the uterus, and to provide similar therapies for healing and to address therein viral, fungal and bacterial intruders, for example.
The guiding of the ITD 1809 inside the vaginal channel and cervical region and monitoring thereof is assisted by local or remote “control and monitoring system”, which have video display or screen showing the head end of ITD 1809. The optics assembly 1815 with axial imager assembly 1817 and radial imager assembly 1819 is used to capture video image (frames) of intravaginal channel/intracervical region walls.
FIG. 19 is a cross-sectional diagram illustrating use of a plurality of light emitting diodes (LEDs) disposed along a snake-like stem of an intravaginal treatment device (ITD) 1903 for delivering light treatment deep within a female's reproductive organs in accordance with various aspects the present invention. Within an intravaginal region of a reproductive system 1901, a snake-like ITD 1903 having an array of low power LEDs of specific color(s) used for light treatment deep inside reproductive organ of woman in accordance with the present invention. The LED array emitting optical frequencies: IR, UV, blue light, red light, monochromatic light, laser, etc. are used for light therapies for the reproductive system 1901.
A series of light therapy elements 1925, each element such as an LED (light emitting diode) 1927, may be either disposed on the surface the ITD 1903, or disposed entirely within the stem housing of the ITD 1903. In the latter case, the light therapy elements are supported by transparent or translucent light pathways of the housing of the ITD 1903. As illustrated, the light therapy elements 1925 are arranged in series (of course, each could been independently driven or connected in parallel). The ITD 1903, although usable within the vaginal channel 1923, is sized to be guided inside deeper intravaginal regions of the reproductive system 1901, such as within and beyond the cervix, i.e., cervical channel, uterus, fallopian tube, ovarian region, etc. For illustration purposes, the width of the stem portion of the ITD 1903 is exaggerated to allow details of the inner lighting structure to be identified. Similarly, the length of the stem of the ITD 1903 may be much longer so as to be able to reach the inner recesses of the reproductive system 1901 while perhaps simultaneously delivering therapy throughout.
The light therapy elements 1925 may be of a single frequency (or single frequency range) for delivery of one type of therapy, or comprise groupings of light elements with each group being directed to other frequencies or frequency ranges. Each such grouping may be spread and intermixed with other of such groupings within the ITD 1903.
A controller and driver 1911 of the ITD 1903 manages operations of the light therapy elements 1925 through a cable 1937 via electronic power and, depending on the embodiment, control signaling. In some embodiments, at least some of the sources of light for the light therapy elements 1925 originate from within the controller and driver 1911, e.g., via light elements attached to optical fibers associated with the cable 1937. In yet other embodiments, at least some of the controller and driver 1911 functionality is moved within the snake-like stem of the ITD 1903, possibly eliminating the need for the independent controller and driver unit 1911. In addition, the snake-like stem of the ITD 1903 may remain outside of the intravaginal regions or be sized for full or partial insertion therein. In the latter case, the cable 1937 might be replaced with a direct connection between the stem portion and the controller and driver element 1911. Lastly, the controller and driver unit 1911 might further comprise all or any part of the functionality described herein with relation to other ITDs embodiments set forth herein.
In addition, although not necessary to for therapy delivery, an optics assembly may be placed at the head end 1941 of the ITD 1903, such as in higher cost versions. Therein, such optics assembly may be configured and perform in the same ways described in relationship to the various optics assemblies described here.
FIG. 20 is a perspective diagram of a scanning optics assembly inside the head end of intravaginal treatment device (ITD) of one embodiment of the present invention wherein light therapy can be scanned across an overall scanning region of the scanning optics, or directed only to an area of interest within the overall scanning region using laser light duty cycle control. Therein, a scanning optics assembly 2033 within a head end 2003 of the ITD 2011 is illustrated. The scanning optics assembly 2033 has a mirrors 2007 and 2019 which are correspondingly driven by rocker motors 2009 and 2027. The mirrors are mounted on a motor shaft in an adjustable orientation. A light source 2029 is disposed in the scanning optics assembly 2033, and it emits light at a particular therapeutic frequency.
Although as illustrated, the light source 2029 is only a single laser diode, additional laser diodes and other directional light sources (e.g., sources of the same or different therapeutic frequencies or ranges, and/or sources for non-therapy purposes such as illuminators) can be added. If so, such other light sources can take advantage of the scanning functionality described herein.
Specifically, the light source 2029 emits a light beam 2005 toward the mirror 2007 which rocks back and forth in a scanning motion along a first axis. The scanning rate and range of the mirrors 2007, 2019 are controlled via both the design of the motors 2009, 2027 and to some extent by control signaling originating from within or outside of the ITD 2001.
The light beam 2005 reflects off the mirror 2007 in a first axis scanning fashion to impact the mirror 2019 which oscillates at a different rate and range in a second axis scanning fashion. As a result, the light beam 2005 is reflected (as illustrated by a light beam 2025) in a row and column scanning fashion across two axes. As with the motor 2009, the motor 2027 may be controlled via design and internally or externally originating control signals.
By turning on and off the light source 2029, a lesser area within a full scanning field can be exposed. By changing the rocker motors 2009, 2027 rocking angle, the full scanning area can be reduced or otherwise resized to correspond to a target area. By changing rocking frequencies, scanning resolutions can be changed. By changing the emission intensity of the light source 2029 or adjusting duty cycles, control over therapy or illumination can be exacted.
In other words, the optics assembly 2033 can be controlled in a precise way such that the light beam 2025 scans a two dimensional (2D) area in a manner similar to raster scanning in cathode ray television tubes. This scanning in 2D area is achieved for example when the mirror 2007 scans slowly along y-axis, while the mirror 2019 scanning relatively fast along an x-axis.
To either monitor a therapy process or wherein the light source 2029 also comprises an illuminator, a single photodetector or imager 2013 can be included. As illustrated, the reflections to the photodetector or imager 2013 return outside of the scanning process, but can also follow the same return path with proper re-orientation of the device 2013.
FIG. 21 is a perspective and cross-section diagram illustrating a wearable snake-like intravaginal treatment device (ITD) inserted into the cervical channel for capturing imager data, delivering light treatment, and wirelessly communicating to deliver such imager data and, in some embodiments, to receive control signals, e.g., regarding treatment delivery. The ITD 2109 is intravaginally inserted through the vaginal channel while operating to capture and display imager data in real time on supporting devices. Guidance into the cervical channel and beyond is greatly assisted by such real time imaging.
In particular, the snake-like portion of the ITD 2109, a segmented section 2107 along with the head end portion 2113, as illustrated is routed into a uterus 2111. A much larger portion relative to the snake-like portion, i.e., a base 2121, includes at least a majority of underlying circuitry and batteries. The base is remains inserted into the cervical channel for light (and, if so configured, with fluid) therapy deliveries, as well as imager data capture support, preprocessing and storage. Via wireless infrastructure, while within the intravaginal regions, the ITD 2109 communicatively couples with external devices. Such coupling involves both the exchange of such imager data as well as any other sensor data captures, and the exchange of control signals relating thereto.
The snake-like stem portion, the segmented section 2107, of the ITD 2109 is similar to that discussed with reference to FIGS. 2 and 4, and with much the same characteristics and functionality. As such, the segmented section 2107 is designed to be flexible enough to be guided along curvilinear intravaginal channels within the reproductive system 2101. In addition, on the tail-end of the ITD 2109, a finger ring 2115 provides finger grip that assists in insertion, removal and stabilization during wear.
The base 2121 of the ITD 2109 may be configured for relatively simplistic or advanced modes of operation, with corresponding functional components and circuits built inside such as those described with reference to FIG. 16 or 17. For example, within the base 2121, signal processing, communication interface, sensor, battery power and user interface circuitry and associated components can be found.
The cylindrical base 2121, if so configured, also contains a fluid reservoir and pump that injects fluids via the segmented section 2107 and nozzles mounted in the head end portion 2113.
Herein, often referenced throughout the present application, the female reproductive system of humans can be found. Even so, the present invention and various aspects thereof can be found in ITDs and associated supporting devices and networks designed to service any other species.
Throughout the present disclosure, various embodiments are used to illustrate some of various aspects of the present invention. It should be clear to one of ordinary skill in the art that yet other embodiments constructed based on elements extracted from several or more of the embodiments specifically described are contemplated.
As one of ordinary skill in the art will appreciate, the terms “operably coupled” and “communicatively coupled,” as may be used herein, include direct coupling and indirect coupling via another component, element, circuit, or module where, for indirect coupling, the intervening component, element, circuit, or module does not modify the information of a signal but may adjust its current level, voltage level, and/or power level. As one of ordinary skill in the art will also appreciate, inferred coupling (i.e., where one element is coupled to another element by inference) includes direct and indirect coupling between two elements in the same manner as “operably coupled” and “communicatively coupled.”
The present invention has also been described above with the aid of method steps illustrating the performance of specified functions and relationships thereof. The boundaries and sequence of these functional building blocks and method steps have been arbitrarily defined herein for convenience of description. Alternate boundaries and sequences can be defined so long as the specified functions and relationships are appropriately performed. Any such alternate boundaries or sequences are thus within the scope and spirit of the claimed invention.
The present invention has been described above with the aid of functional building blocks illustrating the performance of certain significant functions. The boundaries of these functional building blocks have been arbitrarily defined for convenience of description. Alternate boundaries could be defined as long as the certain significant functions are appropriately performed. Similarly, flow diagram blocks may also have been arbitrarily defined herein to illustrate certain significant functionality. To the extent used, the flow diagram block boundaries and sequence could have been defined otherwise and still perform the certain significant functionality. Such alternate definitions of both functional building blocks and flow diagram blocks and sequences are thus within the scope and spirit of the claimed invention.
One of average skill in the art will also recognize that the functional building blocks, and other illustrative blocks, modules and components herein, can be implemented as illustrated or by discrete components, application specific integrated circuits, processors executing appropriate software and the like or any combination thereof.
Moreover, although described in detail for purposes of clarity and understanding by way of the aforementioned embodiments, the present invention is not limited to such embodiments. It will be obvious to one of average skill in the art that various changes and modifications may be practiced within the spirit and scope of the invention, as limited only by the scope of the appended claims.

Claims

1. A therapeutic device that delivers therapy to areas within a female reproductive system via a vaginal channel, the therapeutic device comprising:

a housing that is sized to reach at least a partially inserted position within the vaginal channel;

a first light source disposed on the housing that delivers light within the female reproductive system when the housing is in the at least the partially inserted position within the vaginal channel; and

the light delivered by the light sources being selected to provide a therapeutic result.

2. The therapeutic device of claim 1, further comprising a therapy nozzle disposed on the housing and through which the therapy can be delivered within the female reproductive system.

3. The therapeutic device of claim 1, further comprising a light sensor.

4. The therapeutic device of claim 3, wherein the light sensor comprises an imager, and the therapeutic device further comprising a second light source disposed on the housing which delivers illumination to support the imager.

5. The therapeutic device of claim 1, further comprising a second light source disposed on the housing that produces a light of a different frequency from that of the first light source.

6. The therapeutic device of claim 2, wherein the therapy and the light delivered by the first light source are both used in the attempt to provide a therapeutic result, and the therapeutic result relating to a single gynecological condition.

7. A device that delivers a fluid to areas within a female reproductive system via a vaginal channel, the device comprising:

a nozzle, disposed on the housing, and through which a fluid is delivered into the female reproductive system when the housing is in the at least the partially inserted position within the vaginal channel; and

an light source disposed on the housing that produced light within the female reproductive system when the housing is in the at least the partially inserted position within the vaginal channel.

8. The device of claim 7, further comprising a reservoir disposed within the housing, and, wherein, the reservoir and the nozzle are connected via a fluid flow pathway.

9. The device of claim 7, wherein the light source provides light therapy.

10. The device of claim 7, further comprising an imager, and wherein the light source provides illumination for the imager.

11. The device of claim 8, further comprising a pump, and wherein the fluid flow pathway becomes active in response to control signaling delivered to the pump.

12. The device of claim 7, further comprising a fluid container disposed outside of the housing, and, wherein the fluid container and the nozzle are connected via a fluid flow pathway.

13. The device of claim 12, wherein the fluid flow pathway becomes active in response to a manual force exerted on the fluid container.

14. A method used by a device to deliver therapy, the device being sized for at least partial insertion into a female reproductive system via a vaginal channel, the method comprising:

delivering illumination lighting to a target area within the female reproductive system;

capturing imager data based on at least some reflections of the illumination lighting delivered; and

delivering therapy into at least a portion of the target area.

15. The method of claim 14, wherein the therapy comprising fluid therapy.

16. The method of claim 14, wherein the therapy comprising light therapy.

17. The method of claim 14, wherein the therapy comprising both fluid and light therapy.

18. The method of claim 14, wherein the capture of the imager data supports guidance of the device into the at least the partially inserted position.

19. The method of claim 14, wherein the capture of the imager data supports efficacy evaluations related to the therapy delivered.

20. The method of claim 14, wherein the at least the partially inserted position comprising a fully inserted position.