This application claims the benefit of European Patent Office Patent Application serial number 15154180.2, filed Feb. 6, 2015, entitled “Intravaginal Camera,” which is incorporated by reference herein in its entirety.
The present invention relates to medical imaging, and more particularly, is related to an intravaginal imaging device.
Colposcopy is a medical diagnostic procedure to examine an illuminated, magnified view of the cervix and the tissues of the vagina and vulva. There are known methods and instrumentation used to observe changes of the cervix mucosa. Inspection of the cervix has generally been performed by insertion of medical devices inside in the vagina. The medical devices, such as a speculum 100, as shown in
However, use of a speculum 100 with an external light source has undesirable qualities, such as excessive expansion of the vagina wall throughout the entire length of the vagina, rather than just in the vicinity of the cervix. The result is unnecessary deformation of the vagina and cervix region, as well as unnecessary discomfort for the patient. In addition, the colposcope and additional standalone examination unit are expensive, and may not be practically used in combination with other diagnostic tools, such as ultrasound systems.
For some intravaginal cameras, focus adjustment is performed by manually adjusting the distance between the lens and sensor. But this method is not convenient for intravaginal applications. Some intravaginal cameras have a small numerical aperture (NA) that can provide a large depth of field (DOF) to replace focus adjustment. But small NA optical systems are generally unsuitable to provide high resolution and may increase the luminous flux.
A liquid lens camera, for example, an intraoral camera as disclosed in patent applications such as EP 2161607 A1, EP 1780757 A1, and PCT/CN2008/001900, generally includes a first liquid and a second liquid of equal density sandwiched between two transparent windows in a conical vessel. The first liquid is generally conductive, while the second liquid is generally insulating. A variable voltage can be selectively applied to electrodes in electrical communication with the conductive liquid. The interface between the first and second liquid changes its shape depending on the voltage applied across the conical structure. In this way, the liquid lens can attain the desired refraction power by means of changing the voltage applied on the electrodes. The variation of voltage leads to a change of curvature of the liquid-liquid interface, which in turn leads to a change of the focal length of the lens. However, several factors including the orientation of the camera in relation to the housing and potential buildup of mucus around the lenses make the intraoral camera unsuitable for intravaginal use. Therefore, there is a need in the industry to address some of the abovementioned shortcomings.
Embodiments of the present invention provide an intravaginal imaging device, system and method. Briefly described, an aspect of the present invention is directed to an intravaginal imaging device. The imaging device is housed within an elongated housing having a proximal end and a distal end. The distal end includes a sealing endcap window, an objective disposed behind the window having first lens group and a second lens group configured to focus on a target, an image detector disposed behind the objective configured to detect an image from the objective, and a LED light source disposed behind the window configured to illuminate the target. A connecting portion in communication with the image detector is disposed at the proximal end. The connecting portion is configured to convey an image from the image detector to an external device. The intravaginal imaging device is configured to be used in conjunction with a speculum where the intravaginal imaging device is inserted within jaws of the speculum and positioned within the spacers of the speculum.
Other systems, methods and features of the present invention will be or become apparent to one having ordinary skill in the art upon examining the following drawings and detailed description. It is intended that all such additional systems, methods, and features be included in this description, be within the scope of the present invention and protected by the accompanying claims.
The accompanying drawings are included to provide a further understanding of the invention, and are incorporated in and constitute a part of this specification. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present invention. The drawings illustrate embodiments of the invention and, together with the description, serve to explain the principals of the invention.
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used in the drawings and the description to refer to the same or like parts.
Exemplary embodiments of an intravaginal imaging device are intended to perform intravaginal acquisition, cervix acquisition, and the like. It is therefore desirable for a lens module of the camera to have a large depth of field (DOF) and wide field of view (FOV) in a large range of working distances, for example, from under 1 mm to infinity. The camera may be used in a large working distance range with a big DOF. The intravaginal imaging device may focus at a far distance, for example, when positioned at the entrance of the vagina, or at a near distance, for example, when positioned adjacent to the cervix. Focus adjustment is used to provide appropriate image quality.
Generally, a first embodiment of an intravaginal imaging device includes a housing enclosing an illumination system, a lens system, attachment means for a vagina expander, and electrical components. The illumination system is used to provide enough light to illuminate the cervix and vagina interior. Polarized illumination may be used to limit reflections. For example, one or more white light emitting diodes (LEDs) may be used in the illumination system, which may be preferable due to small size, long lifetime and high luminous flux. Similarly, illumination in one or more specific wavelengths or bands of wavelengths may be used to directly or indirectly illuminate the target, for example via a fluorescence effect. For example, the illumination system may include LEDs with different colors, such as red/green/blue or other color combinations in order to produce a better tissue image, or to highlight or discern certain features in the image.
A first embodiment of the invention is explained in detail with reference to
Here, the fixed lens groups 240, 241, and 242 are positioned between the target object (not shown) and the image detector 207. The first fixed lens group 240 is located behind an ingress window 238 (
As shown in
A variable lens 208 is positioned between the second fixed lens 241 and the third fixed lens 242. In alternative embodiments, the variable lens 208 may be positioned elsewhere with respect to the fixed lens groups, such as behind the third lens group 242. The liquid lens is preferably located near the aperture 210. The variable lens 208 under the first embodiment is a liquid lens. However, other variable lenses are possible in alternative embodiments. For example, rather than a liquid lens, one or more conventional solid lenses may be configured to be movable along an optical axis of the distal end 205 of the elongated housing 206, behaving as a classical focusing system. The fixed lens groups 240, 241, 242, the variable lens 208 and the ingress window 238 share a common optical axis. In general, the illumination provided by the illumination system is aligned with the common optical axis.
The imaging characteristics of the variable liquid lens 208 are controllable with electrical voltage as provided to electrodes (not shown) via an electrical lead 209 from an electrical controller 211. The electrical controller 211 may be housed within the elongated housing 206, as shown, or may be external to the elongated housing in alternative embodiments.
Further, the elongated housing 206 of the intravaginal imaging device 200 includes a variable aperture 210, the diameter of which is adjustable in a specified ratio to the focal position. The variable aperture 210 may be implemented as a liquid crystal panel (LCD), which is controlled by a further electrical voltage via an additional electrical connection (not shown). In alternative embodiments a mechanical aperture may be used.
The image detector 207 may be trained with the controller 211 to control the image sharpness. The controller 211 may further control the voltage for the variable liquid lens 208 via the electrical lead 209. The processor may be implemented as a computer, as described further below. An image at the image detector 207 may further include a scale configured to indicate a size of a region of interest. For example, a scale may be blended with the image at the image detector 207, or the controller 211 may superimpose upon the image of the image detector. The scale may be faded into the image at a desired intensity.
A sheath 260 may surround the proximal end 204 of the elongated housing 206. The center axis of the proximal end 204 of the elongated housing 206 may not be aligned with the center axis of the distal end 205 of the elongated housing 206. As a result, merely rotating the proximal end 204 around its axis outside the vagina may reposition the distal end 205 near the cervix, for example, allowing the user to more easily locate the portio of the cervix.
A connecting portion 290 may be located at the proximal end 204 of the elongated housing. The connecting portion may provide physical connections, for example, electrical connections and or gas/fluid connections, for example, for expanding/deflating the vagina expander 310 (
The elongated housing 206 may be formed of a biocompatible plastic, such as a medical grade biocompatible plastic. Alternatively, other materials may be used for the housing that are suitable for sterilization, such as, but not limited to silicone, latex, or metal such as medical grade titanium.
Under the first embodiment, the elongated housing 206 is approximately 293 mm in length, has a maximum diameter of approximately 25.7 mm, and a minimum diameter at the distal end 205 of approximately 12.7 mm (without the vagina expander 310). Of course, these dimensions are provided as a non-limiting example, and dimensions of alternative embodiments may vary significantly.
A vagina expander 310 may be removably fastened to the distal end 205 of the elongated housing 206. The vagina expander 310 may be configured as a generally ring shaped tube structure substantially surrounding the distal end 205 of the distal end 205 of the elongated housing 206, such that the soft tissue is held apart to allow a clear field of view in front of the distal end 205 of the elongated housing 206. The optical path of the intravaginal imaging device 200 passes through an aperture in the vagina expander 310.
The vagina expander 310 may be removably attached to the distal end 205 of the elongated housing 206 by one or more of several attachment means 335, for example, a threaded attachment, a tongue in groove attachment, a friction fit attachment where the vagina expander is attached by friction to an otherwise smooth external surface of the distal end 205 of the elongated housing 206, or other means familiar to persons having ordinary skill in the art. The attachment means 335 are generally disposed at an inner diameter D1 of the vagina expander, and mate with corresponding means at or near the distal end 205 of the elongated housing 206, in particular, around an outer diameter at or near of the distal end 205 of the elongated housing 206.
Under the first embodiment, the vagina expander 310 includes a mucus trap 330, formed as a recessed region in a forward facing portion of the vagina expander. The mucus trap 330 may extend entirely around the distal end 205 of the elongated housing 206, such that mucus collects within the recess rather than collecting in front of the ingress window 230, thereby keeping the optical and/or illumination path of the intravaginal imaging device 200 unobstructed and unobscured.
While different embodiments of the vagina expander 310 may have different fixed sizes, the interior diameter DI is substantially the same, being configured to mate to the distal end 205 of the elongated housing 206. However, in alternate embodiments the vagina expander 310 may have differently sized outer diameters, for example, but not limited to in the range of 10 mm up to 50 mm.
While the intravaginal imaging device 200 distal end 205 of the elongated housing 206 includes means for connecting to an optional vagina expander 310, the intravaginal imaging device 200 may be operated without a vagina expander 310. For example, the intravaginal imaging device 200 may be used in conjunction with a speculum 100 (
Alternatively, the intravaginal imaging device 200 may be used in combination with a speculum 100 using a suitable holder provided by the speculum 100 or/and intravaginal imaging device 200 so as to affix the intravaginal imaging device 200 to the speculum 100, or provide a movable connection so that the intravaginal imaging device 200 is moveable along the speculum, for example, along a rail or slot.
In a second embodiment the intravaginal imaging device 200 may include a variably sized vagina expander 310. For example, the intravaginal imaging device 200 may include means for expanding or contracting the outer diameter DO of the vagina expander 310. Such expansion/contraction means may include inflation/deflation of gasses and/or fluids in an expanding/contracting tube within the vagina expander 310. Control of the amount of expansion/contraction may be controlled by the controller 211 located within the housing 206, or external to the housing 206.
In alternative embodiments, the vagina expander 310 may be implemented as a disposable or cleanable tube or cover pulled over the elongated housing 206.
As previously mentioned, the controller 211 (
The processor 502 is a hardware device for executing software, particularly that stored in the memory 506. The processor 502 can be any custom made or commercially available single core or multi-core processor, a central processing unit (CPU), an auxiliary processor among several processors associated with the present system 500, a semiconductor based microprocessor (in the form of a microchip or chip set), a macroprocessor, or generally any device for executing software instructions.
The memory 506 can include any one or combination of volatile memory elements (e.g., random access memory (RAM, such as DRAM, SRAM, SDRAM, etc.)) and nonvolatile memory elements (e.g., ROM, hard drive, tape, CDROM, etc.). Moreover, the memory 506 may incorporate electronic, magnetic, optical, and/or other types of storage media. Note that the memory 506 can have a distributed architecture, where various components are situated remotely from one another, but can be accessed by the processor 502.
The software 508 defines functionality performed by the system 500, in accordance with the present invention. The software 508 in the memory 506 may include one or more separate programs, each of which contains an ordered listing of executable instructions for implementing logical functions of the system 500, as described below. The memory 506 may contain an operating system (O/S) 520. The operating system essentially controls the execution of programs within the system 500 and provides scheduling, input-output control, file and data management, memory management, and communication control and related services.
The I/O devices 510 may include input devices, for example but not limited to, a keyboard, mouse, scanner, microphone, etc. An input device may include a switch or actuator configured to start the autofocus procedure, for example, implemented as a switch on the housing, an external wired or wireless footswitch or by a keyboard, keypad, touchscreen, or other mechanism. Furthermore, the I/O devices 510 may also include output devices, for example but not limited to, a display, et cetera, which may be connected via a USB connector, or the illumination means 345 (
When the system 500 is in operation, the processor 502 is configured to execute the software 508 stored within the memory 506, to communicate data to and from the memory 506, and to generally control operations of the system 500 pursuant to the software 508, as explained above.
When the functionality of the system 500 is in operation, the processor 502 is configured to execute the software 508 stored within the memory 506, to communicate data to and from the memory 506, and to generally control operations of the system 500 pursuant to the software 508. The operating system 520 is read by the processor 502, perhaps buffered within the processor 502, and then executed.
When the system 500 is implemented in software 508, it should be noted that instructions for implementing the system 500 can be stored on any computer-readable medium for use by or in connection with any computer-related device, system, or method. Such a computer-readable medium may, in some embodiments, correspond to either or both the memory 506 or the storage device 504. In the context of this document, a computer-readable medium is an electronic, magnetic, optical, or other physical device or means that can contain or store a computer program for use by or in connection with a computer-related device, system, or method. Instructions for implementing the system can be embodied in any computer-readable medium for use by or in connection with the processor or other such instruction execution system, apparatus, or device. Although the processor 502 has been mentioned by way of example, such instruction execution system, apparatus, or device may, in some embodiments, be any computer-based system, processor-containing system, or other system that can fetch the instructions from the instruction execution system, apparatus, or device and execute the instructions. In the context of this document, a “computer-readable medium” can be any means that can store, communicate, propagate, or transport the program for use by or in connection with the processor or other such instruction execution system, apparatus, or device.
Such a computer-readable medium can be, for example but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, device, or propagation medium. More specific examples (a nonexhaustive list) of the computer-readable medium would include the following: an electrical connection (electronic) having one or more wires, a portable computer diskette (magnetic), a random access memory (RAM) (electronic), a read-only memory (ROM) (electronic), an erasable programmable read-only memory (EPROM, EEPROM, or Flash memory) (electronic), an optical fiber (optical), and a portable compact disc read-only memory (CDROM) (optical). Note that the computer-readable medium could even be paper or another suitable medium upon which the program is printed, as the program can be electronically captured, via for instance optical scanning of the paper or other medium, then compiled, interpreted or otherwise processed in a suitable manner if necessary, and then stored in a computer memory.
In an alternative embodiment, where the system 500 is implemented in hardware, the system 500 can be implemented with any or a combination of the following technologies, which are each well known in the art: a discreet logic circuit(s) having logic gates for implementing logic functions upon data signals, an application specific integrated circuit (ASIC) having appropriate combinational logic gates, a programmable gate array(s) (PGA), a field programmable gate array (FPGA), etc.
The above described embodiments of an intravaginal imaging device may be used for cervix inspection inside in the vagina with or without a speculum, because of the ergonomic shape including the vagina expander or inflatable bellow. This assists in observing the cervix regarding changes of the cervix mucosa. Advantages include lower costs compared with traditional colposcopy equipment and procedures, and no mandatory usage of a speculum, which is more comfortable and convenient for the patient. The intravaginal imaging device may be used in combination with ultrasound systems, for example via USB interface, providing a direct view and LED illumination on the region of interest (ROI) based on intravaginal use. The intravaginal imaging device may provide a digital image for recording and data transfer. In addition the ergonomic shape provides easy handling and avoids contamination of the internal optics.
As shown in
The image processor 420 may be configured to enhance and/or refine the images produced by the intravaginal imaging device 200 and/or the imaging system 410, either independently, or in concert. For example, the image processor 420 may be configured to overlay images from the intravaginal imaging device 200 and the imaging system 410, for example, by using registration techniques, or by manipulating either or both images to match/overlay features displayed by the images.
The image display 430 may represent a single display device, which may be capable of displaying multiple images simultaneously, for example, side-by-side or overlaid, or may be separate displays, for example, for independently displaying the output of the intravaginal imaging device 200 and the imaging system 410. The image display 430 may use cathode ray tubes, LED display screens, plasma display screens, and/or other display mechanisms, alone or in combination.
While
The software of the gynecological examination system 400 allows matching of the ultrasound, MRT or CT images with the visible image of the intravaginal imaging device 200. By this the gynecologist may obtain more information for his diagnosis than with either image alone. The ergonomic shape of the intravaginal imaging device 200 and the adapted interface makes the intravaginal imaging device 200 part of the combined gynecological examination system 400. The gynecological examination system 400 may be used, for example, to compare images produced during the examination by the intravaginal imaging device 200 with preoperative and/or intraoperative images from the imaging system 410, or other preoperative and/or intraoperative images.
The method is described with reference to
In summary, it will be apparent to those skilled in the art that various modifications and variations can be made to the structure of the present invention without departing from the scope or spirit of the invention. In view of the foregoing, it is intended that the present invention cover modifications and variations of this invention provided they fall within the scope of the following claims and their equivalents.
Number | Date | Country | Kind |
---|---|---|---|
15154180.2 | Feb 2015 | EP | regional |