WO1994020022A1

WO1994020022A1 - Transillumination apparatus

Info

Publication number: WO1994020022A1
Application number: PCT/US1994/002442
Authority: WO
Inventors: Myron A. Baker; Robert C. Gray; F. Scott Kenneth; Laurence Polley
Original assignee: Medhealth Imaging, Inc.
Priority date: 1993-03-09
Filing date: 1994-03-08
Publication date: 1994-09-15
Also published as: AU6398294A

Abstract

A transillumination device (10) includes at leat one fiber optic light source (32) and a fiber optic cable (40) that delivers light to a hand held wand (42) having a light emitting surface (44). The wand is placed against breast or other tissue to transilluminate it, and the patient experiences no discomfort because the light emitting surface is cool. A camera (18) sensitive to infrared and near infrared radiation is aimed at the tissue during the transillumination procedure, and the physician observes the transilluminated tissue through a high resolution video monitor (16). Frames of interest may be frozen and high resolution photographs are made on demand by a video printer (52). Ultrahigh resolution copies may also be produced through the use of image enhancing software.

Description

TRANSILLUMINATION APPARATUS

BACKGROUND OF THE INVENTION

1. Field of the invention

This invention relates, generally, to devices that perform transillumination of body tissue so that cancerous or other abnormal growths may be detected.

2. Description of prior art

Transillumination is a diagnostic technique used by physicians to determine whether or not a patient has a condition that requires further study; thus, it is a

screening tool. A bright light held against the human body will illuminate it, at least to some degree; the illumination is known as transillumination because the light travels through the tissue being illuminated. Dark objects that appear when the tissue is transilluminated may or may not be cancerous growths, but the detection of a dark abject alerts the physician to the need for further testing.

The earliest clinical trials of transillumination devices were performed in the 1920s, but the technique was not widely accepted within the medical community because the early devices were believed to lack the high degree of reliability required of screening tools. Patient discomfort was also a problem; light bulbs generate heat, of course, and patient comfort therefore required the use of low wattage bulbs to transilluminate the tissue under inspection. The low wattage provided lower light levels, and the devices were thus unable to detect dark spots at an acceptable level of reliability.

Although transillumination devices can be used to transilluminate any body tissue, they are used primarily to transilluminate breast tissue. Breast tissue grows less dense with age; as a result, even the low wattage light bulbs of the early devices can be used with some success in the screening of older persons for breast cancer. In younger people, the wattage required to adequately transilluminate the tissue, when using the heretofore known transillumination devices, generates excessive heat.

The screening tool of choice in 1993 is the mammogram. It includes a source of X-rays, and therefore cannot be used with some patients and should not be used with any patient on a frequent basis. Recent reports recommend against the use of mammograms for any individual less than fifty years of age. Moreover, mammograms are not acceptable for use during pregnancy. Significantly, mammogram devices share a feature with early transillumination devices: the denser the tissue in the breast, the less reliable the mammogram. Thus, mammograms, like the early transillumination devices, are more effective as a diagnostic tool for older individuals than for younger people.

A physician may purchase basic mammogram equipment for about sixty thousand dollars, but an additional expenditure of about fifty thousand dollars is needed to convert an examination room into a shielded room suitable for use with X-ray equipment. Another large sum will be required if the physician desires to have a developer so that he or she can develop the pictures taken by the mammogram machine. Thus, in 1993 dollars, a physician can spend about one hundred eighty thousand dollars in setting up a mammogram screening

operation.

Nor are mammogram devices one hundred per cent reliable. As mentioned above, their reliability drops off with

increasing tissue density. Advertisements contending that mammograms have one hundred per cent reliability do not advise the consumer that the one hundred per cent detection rate is for tumors having a diameter of at least five

centimeters; such large tumors can also be found through palpitation. The reliability of a mammogram decreases as tumor size diminishes.

Early transillumination devices were also real time devices in that the physician was required to make the diagnostic observations in real time, i.e., as the tissue was being transilluminated. Due to the complexity of diagnosis in general, this placed a heavy burden on the physician to carefully note all abnormalities as they appear. For example, the detection of a clearly defined dark spot normally

indicates a non-cancerous growth, but such a spot will merit further testing. Dark spots that are somewhat amorphous in shape usually indicate a cancerous growth and the detection of such a spot will cause the physician to consider

post-screening courses of action. An apparent discontinuity in a vein also indicates the need for further scrutiny, and so forth. It is beyond the scope of this disclosure to describe everything a physician looks for during a

transillumination screening process, of course; the point is that a real time examination may be unrealistic in view of the volume of information conveyed to the physician during the procedure. Accordingly, workers in the field of

transillumination devices have developed camera arrangements whereby the procedure is filmed for later study. However, the quality of the pictures produced by the known

transillumination devices is quite poor. Moreover, if the physician observes a possible abnormality during a review of the film, no means are provided for freezing a frame that the physician would like to study in more detail, nor are any means provided whereby the physician could obtain an

enlarged, computer-enhanced photograph of such a frame.

In view of the very high expense of establishing a screening operation that relies on mammogram equipment, there is a need for an alternative screening tool that is more affordable to physicians so that screening of patients for cancerous or other abnormal growths in tissue may become more widespread. There is also a need for a screening tool that does not rely on high frequency radiation such as X-rays. Many members of the general population refuse to see a physician for a mammogram because they understandably fear the adverse effects of radiation.

A need also exists for a screening tool that may be used with patients who are pregnant.

still another need exists for a screening tool that may be used effectively and comfortably with younger patients having dense tissue.

Moreover, there is a need for a transillumination device capable of comfortably transilluminating tissue of low as well as high density.

A need also exists for a transillumination device that does not force the physician to make diagnostic decisions in real time, and which provides very high resolution pictures of individual frames for the physician's use.

However, when the prior art is viewed as a whole, there are no teachings or suggestions as to how to build a device that could fulfill all of these needs. Importantly, the failure of the early transillumination devices as effective screening tools has caused those of ordinary skill in that art to abandon its further development. Thus, most

developmental work in the field of cancer screening is in mamroography. SUMMARY OF THE INVENTION

An important breakthrough has been achieved in the field of transillumination, and the present invention embodies that breakthrough. Unlike early transillumination devices, which were limited in the amount of wattage that could be applied to the light bulbs employed to perform the transillumination due to the excessive heat generated thereby, as aforesaid, the present invention is not so limited. In a preferred embodiment, four hundred and fifty watts may be applied to the light source or sources, without discomfort to the patient. Much higher wattages may also be employed in view of the breakthrough that has been made, but four hundred and fifty watts of power will provide sufficient light to

transilluminate even very dense tissue so higher wattages will not be needed in most applications.

Since four hundred and fifty watts, when applied to a light source, may cause over-transillumination of low density tissue, means are provided for reducing the wattage as needed. The early devices also provided such power-reducing means, but since the maximum power to the bulbs was about seventy five watts, such earlier devices became even more ineffective when the power was reduced below said seventy five watts.

The invention incorporates numerous advances, but perhaps the most significant breakthrough is the means found for enabling the physician to substantially increase the power applied to the light source without causing discomfort to the patient. The solution to this longstanding problem has been found in the unrelated field of fiber optics. Employing fiber optic technology, the light source is positioned remote from the patient so any heat generated thereby is not sensed by the patient. A fiber optic cable, or a plurality thereof, is extended from the remote light source to a hand-held probe or wand that includes a light outlet surface that remains cool due to its remoteness from the light source. The wand is manipulated by the physician in the same way as the early wands, i.e., the tissue is transilluminated from different positions, and diagnostic decisions can be made in real time.

In a broad sense, then, the invention may be understood as a transillumination apparatus, comprising:

a light source;

a wand having a light-emitting surface; and

a fiber optic cable having a proximal end disposed in open communication with said light source and having a distal end disposed in open communication with said wand.

The procedure is recorded on film and displayed in real time on a very high resolution video monitor so that the physician may observe the tissue in greater detail than possible with the unaided eye by simply observing the

monitor. Moreover, the physician may obtain a high resolution hard copy photograph of any frame at any time on demand.

Software may also be employed to enhance the images, and individual frames requiring further study may be reproduced in the form of an ultra high resolution photograph for further study. Photographic data may also be transmitted over a modem for review by a remote radiologist.

The present invention is preferably embodied in a modular unit that incorporates various components that are commercially available but which have never before been arranged in the combination disclosed herein to provide a transillumination device that fulfills the above-mentioned needs. The device may be carried on a frame having caster wheels at its lowermost end to facilitate its movement within a physician's office, and the various components may be stacked in said frame. An auxiliary frame may also be

employed to house auxiliary components.

A high resolution television monitor is movably mounted to the top of the frame, as is a movably mounted camera that is sensitive to the infrared and near-infrared regions of the electromagnetic spectrum. The camera includes a light source and a lens system that produces a pencil-thin light beam that is directed toward the tissue under study so that a

technician may aim the camera before beginning the

transillumination procedure; a first control means is

provided for panning the camera and a second control means is provided for aiming the light beam, once the patient has been properly positioned and the camera has been properly aimed, the light beam is switched off and the transillumination procedure begins.

The television monitor displays the images captured by the camera in real time as aforesaid; moreover, the camera sends electrical signals to a Betamax or equivalent recorder and means are provided whereby the physician may obtain high resolution hard copy video print of any desired frame from said recorder on demand. The infrared camera sends electrical signals to a high resolution super VHS recorder as well, and said recorder stores the images on super VHS video tape to enable the physician to view the tape whenever desired. The super VHS recorder sends electrical signals to a matrix camera or to a laser camera; frame grabber and image

enhancement means are provided so that ultra high resolution photographs of individual frames may also be obtained.

The highest position within the frame itself is occupied by a modular box having three halogen fiber optic light sources therein, each of which has a wattage of one hundred fifty watts. Other quantities and types of light sources and other wattages are within the scope of this invention.

Various control means and outlet plugs are provided on the front surface of the topmost modular box. For example, in the preferred embodiment, three plugs are provided for releasable connection of fiber optic cables. More

particularly, a single fiber optic cable terminates at its distal end in a hand-held wand having a light-emitting surface that is placed directly against the tissue to be transilluminated, and its proximal end is trifurcated for connection to said outlets. A light source is associated with each plug so that the light emitted by each light source enters its associated branch of the fiber optic cable. Thus, the light from all three light sources is combined where the trifurcated cable joins the main cable and said light escapes from the aforesaid surface of the wand to provide the

transillumination.

The front surface of the uppermost module also includes dials or other suitable control means for independently adjusting the power output of each of the light sources; in this manner, the total amount of light that enters the fiber optic cable may be throttled from the maximum amount to any minimum.

The uppermost module also houses the above-mentioned Betamax or similar eight millimeter recorder and a video printer as well; the video printer is built into said Betamax recorder. The recorder receives electrical signals from the above-mentioned high resolution super VHS video recorder and records the data on film. The Betamax recorder delivers said signals to the video printer so that a high resolution hard copy video print can be provided to the physician on demand.

A computer keyboard is positioned in the frame below the topmost module; the keyboard is mounted on a sliding shelf so that it may be stored within its module when not in use. When a screening procedure is begun, the keyboard is slid out into a cantilevered position relative to the frame so that it is positioned at a convenient level for use by a seated

individual; the name of the patient, or a code number

assigned to said patient, the date of the screening

procedure, and other identifying information is entered into the computer memory through the keyboard, and means are provided for displaying such information on the video monitor and upon any photographs that may be produced upon command of the physician.

Just above the keyboard, within the same module but not slideably mounted, is a panel that contains various control buttons, switches, joysticks, and the like. A first button, in a first position, activates a character generator to cause the words "left breast" to appear on the video monitor and upon all copies of any photographs made of individual frames; a second position of the first button causes the words "right breast" to appear on said monitor and photographs. A joystick adjacent said first button provides macro control of the position of the infrared and near infrared camera, i.e., said joystick enables the operator to pan the camera. Another switch or joystick, adjacent said camera pan joystick, controls the aiming of the pen light emitted by said camera. Additional buttons control camera focus, zoom, and the like. A matrix or laser camera may be mounted in the module below the keyboard module, or either of said cameras may be mounted in an auxiliary frame similar to the main frame.

Matrix and laser cameras, like the Betamax camera mentioned earlier, are not conventional cameras in that they do not collect light from the environment to produce pictures, as is well-known; they receive electrical signals and employ software to enhance said signals to create what are commonly known as computer-enhanced images. The matrix or laser camera receives its signals from the high resolution super VHS video recorder which in turn receives its signals from the infrared and near infrared camera as pointed out above.

The above-mentioned high resolution super VHS video cassette recorder (VCR), capable of producing high quality freeze frames, is positioned within the module disposed below the matrix or laser camera module, (which module is

unoccupied if the matrix or laser camera is positioned on an auxiliary frame, as aforesaid), and an empty module for storage of cassette tapes, wands, and the like is positioned below said VCR module.

Of course, the invention is not limited to the

above-disclosed physical arrangement of parts, nor is the invention limited to modular transillumination devices. The various components could be horizontally arranged, instead of vertically stacked, for example, it being understood that the preferred embodiment disclosed herein is one of many forms the invention could take.

For example, in a commercial embodiment of the

invention, the matrix or laser camera is not positioned within one of the modules on the above-described frame, but is carried, along with additional auxiliary equipment, in an auxiliary frame, as mentioned above. The additional auxiliary equipment may also include the above-mentioned modem so that the physician may send data to a remote radiologist for further review, a film developer, and a personal computer for the freeze frame or frame grabber and image-enhancement software. Obviously, the modem may also be built into the computer, and the main and auxiliary frames could be

combined. Numerous mechanical arrangements of the components which collectively form this invention are within the

ordinary skill of machine designers, and all such

arrangements of components are within the scope of this invention.

The hand held wand at the distal end of the fiber optic cable is also releasably attached to said distal end and differing sizes of wands are provided so that the physician may change wand sizes. In the above-mentioned commercial embodiment, small, intermediate, and large wands will be provided so that the physician may match the wand size to the size of breast under examination. It is therefore understood that the primary object of this invention is to revolutionize the art of

transillumination by providing the first transillumination apparatus, anywhere in the world, capable of

transilluminating tissue of any density in the absence of patient discomfort.

Another object is to provide a screening device having a cost αf about one third that of mammogram devices.

Still another important object is to make screening available to patients without subjecting them to X-rays so that more patients are encouraged to undergo the screening process.

These and many other important objects, features and advantages of the invention will become apparent as this description proceeds.

The invention accordingly comprises the features of construction, combination of elements and arrangement of parts that will be exemplified in the construction

hereinafter set forth, and the scope of the invention will be indicated in the claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the nature and objects of the invention, reference should be made to the following detailed description, taken in connection with the

accompanying drawings, in which: Fig. 1 is a perspective view of the main frame used in an illustrative embodiment of the invention;

Fig. 2 is a perspective view of an auxiliary frame used in said illustrative embodiment; and

Fig. 3 is a diagrammatic depiction of said illustrative embodiment.

DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring now to Fig. 1, it will there be seen that the reference numeral 10 denotes a first illustrative embodiment of the invention as a whole. In this embodiment, the

above-mentioned matrix or laser camera, the film developer, and the personal computer with modem are not included because the system may operate satisfactorily without such auxiliary equipment.

A frame, generally denoted 12, is preferably supported by a plurality of caster wheels 14. A high resolution

monochrome video monitor 16 is movably mounted atop frame 12; link arms 15 and 17 provide adjustability so that the

physician can easily position said monitor in a desired deployment.

An infrared and near infrared-sensitive camera 18 is similarly mounted atop pivot member 20. Camera 18 preferably includes a high resolution charge coupled device (CCD) and includes lens opening 22 the position of which is adjustable so that the light beam emitted through said lens opening may be aimed at a preselected location on the tissue under examination. Cameras of this type are known as light

directional assist cameras. The technician assisting the physician aims the light on a preselected part of the breast to be transilluminated to thereby aim camera 18 prior to use of the wand. Thus, when the wand and camera are activated, the breast will appear in greatly enlarged size on the monitor and no further aiming of the camera will be required.

Uppermost module 30 houses three halogen fiber optic light sources, collectively denoted 32. Each light source, in a commercial embodiment, will have one hundred fifty watts of power applied thereto, and will be near infrared-enhanced.

Module 30 includes a front panel 34 having, in this embodiment, three sockets, collectively denoted 36, for releasably receiving the respective proximal ends,

collectively denoted 38, of a trifurcated fiber optic cable 40 so that said proximal ends are in open communication with their respective light sources. A hand-held wand 42 having light-emitting surface 44 is releasably connected by suitable connector means 46 to the distal end of said cable 40 and is therefore also in open communication with said light sources. In a commercial embodiment, plural wands of differing sizes are provided as mentioned earlier; connector means 46 is of the quick release type.

Dimmer means 43 on wand 42 enables the physician to dim the light available at the wand. Dimmer switches 47, 48, and 49 on front panel 34 are also provided for individual

adjustment of the halogen light sources.

A Betamax hard copy camera 50 is also housed within upper module 30 and its front surface is flush with an opening formed in front panel 34 of said module. When the physician desires a hard copy photograph of a suspicious dark spot, apparent vein discontinuation, or the like, camera 50 is employed to provide said photograph. The photo is printed by a high resolution monochrome video printer 52 (Fig. 3) which is built into the camera 50 and which produces a high resolution hard copy video print 53 (Fig. 3). More particularly, printer 52 receives electrical signals from recorder 54 which in turn receives signals from high

resolution super VHS video cassette recorder 102; those signals drive printer 52 which produces a hard copy

photograph (print 53); the resulting print 53 is dispensed from camera 50 in substantially the same way as photographs are dispensed by Polaroid cameras. More particularly, the photograph, i.e., the high resolution hard copy video print 53, is dispensed through slot 56 (Fig. 1). In the claims that follow, the Betamax camera or its equivalent is referred to as the first video recorder.

Button 60 has two positions and is the above-mentioned "left breast" and "right breast" button, joystick 62 is the camera pan joystick, joystick 64 is the light directional assist, buttons 66 and 67 control the focus of camera 13 by moving the lens in and out, and buttons 68 and 69 are in and out buttons for controlling zoom. The unnumbered buttons are reserved for future use.

Keyboard 72 is mounted atop drawer 74 and is housed within module 70 when in storage. Said keyboard is the input means for personal computer 82, shown in Fig. 2; computer 82 includes a modem 84 for sending data to a remote radiologist, frame grabber software for freezing frames produced by video camera 18, software for enhancing the frozen or grabbed frames, and a video titler character generator 86. Patient data is thus input at keyboard 72, and character generator 86 places such information on the monitor 16 and on the

photographs produced by Betamax camera 50, the matrix camera, or the laser camera.

Module 90 (Fig. 1) may be reserved for storage space or future use.

Module 100 houses the high resolution super VHS video recorder 102 that uses super VHS video tape 104 (Fig. 3), and lowermost module 110 may be used for the storage of such tapes, wands that are not in use, and the like.

Significantly, as mentioned above, video recorder 102

provides the electrical signals for the matrix or laser camera, as well as for recorder 54 that drives the video printer 54 of Betamax camera 50. In the claims that follow, recorder 102 is referred to as the second video recorder. Auxiliary frame 120 is shown in Fig. 2; it is also preferably supported by caster wheels 122. Its top wall 130 supports a matrix or laser camera 132; said camera 132 receives electrical signals from recorder 102 and, under the control of the above-mentioned image-enhancing software, produces computer-enhanced images on film.

That film is developed in film developer 142. Thus, the physician, if not satisfied with the relatively small

photograph produced by hard copy camera 50, may obtain a much larger, highly enhanced photograph of the frames that require a detailed examination by employing said matrix or laser camera. It should be understood that the frame grabber software enables the physician to freeze the frames to be enhanced by said camera 132. In lieu of developing the film in house, the physician may transmit the output signals of camera 132 over the modem to a remote radiologist for

development and analysis at the remote location of said radiologist.

Fig. 3 shows the novel system in diagrammatic form. All of the components shown therein have already been discussed, so no further description thereof is required; note that all of the components are commercially available and that their interconnection, in view of this disclosure, will be apparent to those of ordinary skill in the art, there being no special filtering, shielding, or other special devices required to make said components operate as a whole in the manner herein described.

This invention is clearly new and useful. Moreover, it was not obvious to those of ordinary skill in this art at the time it was made, in view of the prior art considered as a whole as required by law.

This invention pioneers the art of transillumination devices having a fiber-optic light source. Accordingly, the claims that follow are entitled to broad interpretation, as a matter of law, to protect from piracy the heart or essence of this breakthrough invention.

It will thus be seen that the objects set forth above, and those made apparent from the foregoing description, are efficiently attained and since certain changes may be made in the above construction without departing from the scope of the invention, it is intended that all matters contained in the foregoing construction or shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.

It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all

statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

Now that the invention has been described.

Claims

WHAT IS CLAIMED IS:

1. A transillumination apparatus, comprising:

at least one light source;

a wand having a light-emitting surface; and

a fiber optic cable having a proximal end disposed in open communication with said at least one light source and having a distal end disposed in open communication with said wand.

2. The apparatus of claim 1, further comprising:

a video camera; and

a video monitor that receives electrical signals from said video camera;

whereby a physician may see the images produced by said video camera in an enlarged size by observing said video monitor.

3. The apparatus of claim 2, further comprising:

a first video recorder;

said first video recorder including a video printer for producing hard copy video prints and a dispensing slot for dispensing said hard copy video prints;

a second video recorder;

said second video recorder electrically connected to said video camera and being adapted to receive electrical signals from said video camera;

said second video recorder electrically connected to said first video recorder, said first video recorder being adapted to receive electrical signals from said second video recorder; and

control means for activating said video printer so that hard copy video prints may be produced and dispensed on demand.

4. The apparatus of claim 3, further comprising:

a computer having frame grabber and image-enhancing software;

a modem for transmitting images enhanced by said camera means to a remote location;

a camera means electrically connected to said computer; said camera means adapted to freeze preselected frames of the images captured by said video camera and to enhance said images.

5. The apparatus of claim 4, further comprising:

a character generator for placing identifying characters on images captured by said video camera.

6. The apparatus of claim 4, further comprising:

a film developer;

said film developer electrically connected to said camera means so that images enhanced by said camera means ma be developed and examined.

7. The apparatus of claim 1, wherein said at least one light source is a near infrared-enhanced fiber optic light source.

8. The apparatus of claim 1, wherein said at least one light source includes a plurality of light sources, and wherein said proximal end of said fiber optic cable is divided into as many branches as there are light sources so that each light source of said plurality of light sources is in open communication with an associated branch of said fiber optic cable, said fiber optic cable being, unbranched at its distal end so that light from all of said light sources is delivered to said light-emitting surface of said wand.

9. The apparatus of claim 1, further comprising a control means associated with said wand for controlling the amount of light emitted from said light-emitting surface.

10. The apparatus of claim 8, further comprising

individual control means associated with each of said light sources for independently controlling the level of power delivered thereto.

11. The apparatus of claim 1, further comprising quick release means for enabling facile attachment and detachment of said wand to and from said distal end of said fiber optic cable, respectively.

12. The apparatus of claim 2, wherein said video camera is infrared and near-infrared sensitive.

13. The apparatus of claim 11, wherein said video camera includes a charge-coupled device and provides high resolution images.

14. The apparatus of claim 2, further comprising light directional assist means associated with said video camera so that said video camera may be properly aimed prior to the commencement of a transillumination procedure.

15. The apparatus of claim 2, further comprising control means for means for controlling the pan, focus, and zoom of said camera.

16. The apparatus of claim 2, wherein said video monitor is a high resolution monochrome monitor.

17. The apparatus of claim 3, wherein said first video recorder is a high resolution video tape recorder.

18. The apparatus of claim 3, wherein said second video recorder is a high resolution super VHS video recorder.

19. The apparatus of claim 4, wherein said camera means is a matrix camera.

20. The apparatus of claim 4, wherein said camera means is a laser camera.