JP5681162B2 - Disease detection system and method including an oral mirror and an ambient light processing system (ALMS) - Google Patents

Description

  The present invention relates to a system and a method for detecting a disease such as oral cancer using a spectroscopic means for examining a patient tissue.

Related Applications This application includes US Provisional Patent Application 60/562469 filed on April 14, 2004, US Provisional Patent Application 60/618287 filed on October 12, 2004, and US Patent Application 11 filed on December 16, 2004. Claim priority of / 016567.

  Including detection of precancerous cells and early cancer cells, detection of cancer has always been difficult and uncertain. One way to identify cancer cells was to measure the cell's autofluorescence signature. This is because cancer cells have a unique autofluorescent label that is different from healthy cells. Other diseases also have changes in autofluorescent labels. However, detection of autofluorescence in traditional dental and medical environments has been problematic. This is because the autofluorescent label itself is very weak compared to the ambient light provided in the laboratory, operating room, etc.

  The following are documents related to the detection of cancer in the oral cavity. The content of these documents is incorporated into the text, as are other references cited in the text. Zen, W. Other "Detection of oral squamous cell carcinoma and precancerous lesions by quantification of 5-aminolevulinic acid-induced fluorescence endoscopic images" (Lasers Surg. Med., 31: 151-157, 2002), Atginger et al. “Best visual recognition and detection of oral tumors” (Cancer, April 1, 2003; 97 (7): 1681-92), Murler, MG et al. “Morphological and biological changes in early human oral cancer. Spectral detection and evaluation "(Cancer, 2003; 97: 1681-92), Majumuder, S" Nonlinear pattern recognition of laser-induced fluorescence diagnosis of cancer "(Lasers Surg. Med., 33: 48-56, 2003), Tsai, T.A. Other "In vivo autofluorescence spectroscopy of oral precancer and cancer lesions: Distortion of fluorescence density due to submucosal fibrosis" (Lasers Surg. Med., 2003; 32 (1): 17-24), Ebihara, A, "Light Detection and diagnosis of oral cancer by induced fluorescence "(Lasers Surg. Med., 32: 17-24, 2003, PMID: 12516066), Zen, W. et al. “Detection of oral tumors by digitized endoscopic imaging of 5-aminolevulinic acid-induced protopolyphyllin IX fluorescence” (Int. J. Oncol, October 2002, 21 (4): 763-8; PMID: 12239614), Wan, CY “Automated fluorescence spectroscopy for in vivo diagnosis of DMBA-induced hamster cheek pouch pre-cancer and cancer” J. Oral. Pathol. Med, January 2003; 32 (1): 18-24, PMID: 12558954), Onizawa, K.A. “Characterization of autofluorescence of oral squamous cell carcinoma” (Oral. Oncol, February 2003; 39 (2): 150-6, PMID: 12509968).

  Therefore, there is a need to enhance the diagnostic ability of target intracellular cancer cells or precancerous cells of doctors, dentists or laboratory technicians in a typical medical or dental environment. The present invention provides these as well as other advantages.

  The present invention relates to the detection of diseases such as oral cancer using examination mirror means to examine patient tissue. In some embodiments, the system and method excite and detect fluorescence emission in tissue. Fluorescence is then evaluated to determine the likelihood of a disease such as cancer. The device includes an ambient light processing system (referred to as ALMS or “pre-device”). This is a background light processing system for medical facilities. This device can be used with such a speculum system for fluorescence detection of abnormal tissue. The following description extends to the detection of abnormal oral tissue and the various elements of this system and method. The description also includes medical personnel such as dentists, general practitioners or hygienists who manage the patient to be diagnosed and the test.

  Accordingly, the present invention relates to a method and system for detecting abnormal tissue in the mouth and other body pores and other sites by observing and measuring tissue fluorescence or other light-based properties. This practice is possible under normal lighting conditions in dental clinics and general clinics. Since the fluorescence generated by the tissue (spontaneous fluorescence) is very low light, fluorescence-based abnormal tissue detection is preferably performed at very low levels of background or ambient light conditions and does not interfere with the measurement . Accordingly, a method and system for preventing the intrusion of ambient light and absorbing diffuse light entering the field of view is provided for proper operation of the system.

  A system that solves the problem includes pre-devices such as bales, bibs, and masks. The pre-device is placed or attached to the patient's face or head. For example, it is attached under the eye so that the examination illumination is not directed directly at the patient's eye and covers the mouth. If desired, the pre-device can be attached to a chair or other available structure and nothing can be attached to the patient himself. If desired, the patient can be put on an eye covering that protects the eyes.

  In a suitably sized embodiment, a port hole or slit is provided at the patient's mouth and the examination mirror is inserted. The veil can be secured to the patient's back of the head, behind the ear, or other body part with a band or string. Ear hooks can also be used. Aluminum and other extensible materials can be processed to secure the nasal space and comfortably cover the patient's face. In other embodiments, the laboratory technician and / or patient may be covered with a veil or the like.

  Exemplary usage methods include:

  1. During the procedure, the patient sits with his back straight on a chair. Typically, the patient does not take a supine position, but this is possible if desired. The supine posture pulls the patient's tongue into the back of the throat and limits tissue exposure.

  2. Preferably, the light source, inspection mirror, etc. are free to move without restriction of movement and without obstructing the view of the dentist or other inspector.

  3. If desired, the inspector can move the tongue without intruding stray light and without interfering with the inspection.

  An exemplary device structure includes:

  4). The pre-device can be provided with drape material or other suitable covering material.

This may be a rigid material, a flexible material, or a material having intermediate properties thereof, and is appropriately selected according to the embodiment. Rigid materials can also be reinforced to maintain shape. A system and method for attaching to an examination mirror, a system and method for attaching to a separate light source or instrument, and a system and method for attaching to a patient are also provided.

  a. Attaching the pre-installation device to the inspection mirror: The inspection mirror or other inspection device can be attached to the mouth part of the patient provided in the drape or through a port provided at a site corresponding to another target tissue. And becomes part of ALMS in some embodiments. Mounting and / or sealing enhances the darkness and allows the use of pre-devices and other components of the system without the inconvenience of extraneous light.

  b. Attaching the device to the patient: An extensible material is available that can be shaped along the curvature of the patient's nose and cheeks. It is also possible to have a structure in which this is wrapped around the patient's head or hung around the ear like a spectacle frame. By attaching the pre-device to the patient's head, the dentist is free to move the pre-device to different angles. Intrusion of ambient light can be further reduced by molding according to the shape of the nose and cheek.

  5. In some embodiments, the pre-device is a disposable device that prevents diffusion of bacteria, viruses, and other substances between patients.

  6). When the pre-device is disposable, it is important that the pre-device is inexpensive.

Exemplary materials for the pre-installation device include:
7). The drape material is a material such as a non-woven fabric and is generally an opaque material.

The drape material may be a sheet of multiple layers or a combination of multiple materials.

  8). The drape material is determined in consideration of characteristics that do not interfere with the examination and provide comfort to the patient.

  9. The material from which the ALMS is made is preferably selected from those in line with national combustion characteristics guidelines.

10. For patient health, the ALMS material is preferably selected from those that have passed the cytotoxicity and skin irritation tests.

11. The ALMS material is preferably selected from those that are not pyrogenic / allergenic.

12 The ALMS material is preferably selected from non-PCV materials that do not interfere with use in Europe.

13. To avoid interfering with or modifying the measurement, the ALMS material is preferably selected from those that do not fluoresce or that have a fluorescence emission that is at least significantly weaker in the visible light spectrum than at least typical tissue-generated fluorescence.

14 The ALMS material is preferably sufficiently opaque and normally lit (eg for normal reading etc.) to select clinic room light from one that does not affect tissue autofluorescence or other light observations. .

15. The ALMS surface material is dark (eg, black, dark green, dark blue) and is non-reflective to absorb transmitted stray light.

  Exemplary dimensions for the pre-device include:

16. The pre-device is preferably provided in a size that does not cause discomfort to the patient or interfere with the examination.

17. The pre-device is typically large enough to cover the patient's mouth or body, and is sized to shield intrusion light from various sites such as the shoulder (an embodiment involving shoulders). The pre-device, which may be wholly or partly disposable, is large enough so that external light does not enter when the device moves during the examination.

18. Since the pre-installation device is directly attached to the patient in some embodiments, it is provided with a weight of, for example, 100 g or less so as not to cause discomfort to the patient.

  An exemplary interface of the vestibular device includes:

19. The pre-device can be combined / integrated with the inspection device so that it will not accidentally fall off the inspection device.

20. The pre-device is provided with a port or other access that allows the testing device to access the patient's mouth or other body part to be examined.

21. The pre-device is shaped and provided to the patient to provide a sealed state with the patient's face and other body parts. In one embodiment, this sealing property is achieved by providing the mask with a progressive and shapeable material.

22. The drape material should be sufficiently large and flexible so that the patient's tongue and other body parts can be manipulated under the drape without introducing ambient light.

23. A space is provided between the patient and the light source. For this purpose, for example, the drape material is made relatively stiff and reinforced with another material or the same material, or a space is provided by sewing or edging.

  In these and other embodiments, all embodiments, features, etc. of the invention are free to be combined and replaced.

  These and other features and embodiments of the present invention are illustrated in the following detailed description and drawings.

FIG. 1 is a schematic perspective view of an ALMS (Ambient Light Processing System) designed for medical use. FIG. 2 is a schematic side view of an ALMS according to the present invention. FIG. 3 is a schematic perspective view of an ALMS substantially similar to the embodiment of FIG. 2 except that the cover is black and the device is placed under the patient's eye. FIG. 4 illustrates an embodiment similar to that of FIG. 2 except that the cover is black as in FIG. 3 and the ALMS device is provided under the patient's eye. FIG. 5 is a schematic perspective view of a trimmed ALMS. FIG. 6 is a schematic perspective view of an ALMS that is edged as in FIG. FIG. 7 is a schematic perspective view of an ALMS suitable for application to a supine patient. FIG. 8 is a schematic perspective view of a front-hanging front device. FIG. 9 is a schematic perspective view of the front device in the form of being put on an ear. FIG. 10 is an exemplary schematic of an ALMS patient attachment seal. FIG. 11 is an exemplary schematic diagram of an ALMS patient attachment seal. FIG. 12 is an exemplary schematic of an ALMS patient attachment seal. FIG. 13 and FIG. 13A are illustrations of various shapes of ports of the pre-device used for insertion of inspection mirrors, illumination light, instruments, and the like. FIG. 14 is a schematic perspective view of a port device that is detachably attached to the inspection mirror. 15A to 15C are schematic views of a port device used for connection of an inspection mirror to an opaque front device. FIG. 16 is a schematic perspective view of another embodiment of the front device. FIG. 17 is a schematic plan view of various shapes of space creation tools that can be used in the front device to provide space for the front device. FIG. 18 is a schematic plan view of various shapes of space creation tools that can be used in the front device to create space in the forehead. FIG. 19 is a schematic plan view of another space creation tool suitable for use in the forehead of the front device. FIG. 20 illustrates another embodiment of a fixture for attaching the inspection mirror to the pre-device. FIG. 21 is a side view of the multilayer cover of the fixture shown in FIG. 20 and the inspection mirror attached to the port. 22A to 22C illustrate a cover port tool and port 151 to which the corresponding tip of the inspection mirror is attached. FIG. 23 illustrates an embodiment of the cover 68 prior to manufacture as illustrated in FIG. 22A. FIG. 24 is a perspective view of an embodiment of a cover surgical mask embodiment having a port. FIG. 25 is a front view of the cover and the port as shown in FIG. FIG. 26 is a side view illustrating the connecting mechanism of the front device as illustrated in FIGS. 24 and 25. FIG. 27 is a front view illustrating the lock structure of the sliding port. FIG. 28 is a front view illustrating the lock structure of the sliding port. FIG. 29 is a perspective view of a portion of a pre-device that includes a side view port as well as a plurality of fabric layers to form a port for an inspection mirror and having differently shaped passages. FIG. 30 is a perspective view of an inspection mirror according to one embodiment of the present invention. FIG. 31 is an exploded perspective view of an inspection mirror according to another embodiment. FIG. 32 is a cross-sectional side view of an inspection mirror according to one embodiment. FIG. 33 is a cross-sectional side view of the head portion of the inspection mirror according to one embodiment. FIG. 34 shows an exemplary connection structure for attaching an inspection mirror to a conduit or for attaching a detachable eyepiece structure. FIG. 35 illustrates another connector in which the male end of the conduit is attached to the female end of the handle portion. FIG. 36 illustrates a fitting form of the band-like protrusion and groove functioning in the same manner as the above-described drawing embodiment. FIG. 37 illustrates another simple pull-away fit configuration. FIG. 38 illustrates a removable eyepiece for illumination and light collection components. FIG. 39 illustrates a similar embodiment focused on optical components. FIG. 40 is a cutaway view of the adapter. FIG. 41 shows a light guide in which an adapter bends light from an inspection mirror (not shown) and irradiates and collects light through respective condensing components and irradiation optical components. FIG. 42 is a side view of two flexible adapters. FIG. 43 is a side view of two flexible adapters. FIG. 44 is a cross-sectional side view of an adapter according to one embodiment in which the power source and light source are maintained within the adapter. FIG. 45 is a cross-sectional view of a hand-held inspection mirror according to one embodiment, and the inspection mirror includes a light source and a power source in a handle. FIG. 46 is a schematic perspective view of an ALMS according to one embodiment. FIG. 47 is a perspective view of an inspection mirror according to an embodiment having a cord body that can be detached from an external power source and a light source. FIG. 48 is a perspective view of an inspection mirror according to one embodiment connected to an external power source and a light source via a cord body and a plug adapter. FIG. 49 is a perspective view of an instrument 288 having an extension 290 with a connecting shape 300 designed to be attached to the tip of an inspection mirror. FIG. 50 is a side view of the instrument shown in FIG. FIG. 51 is an exploded perspective view of an inspection mirror according to one embodiment. FIG. 52 illustrates an eyeglass type embodiment of ALMS according to the present invention.

  The present invention relates to an inspection mirror. In some embodiments, this is referred to as a “bell scope”. This is suitable for examining faint light such as fluorescence emitted from a patient. In some embodiments, the invention relates to a speculum for the detection of lesions such as cancer in the oral cavity or vaginal region. Typically, the inspection mirror is designed to detect fluorescence or other faint light emitted from the target tissue, substantially covering the target area and directing the viewing area to inconvenient light such as ambient room light. Used in combination with ALMS such as a covering device or a front device to prevent intrusion.

  Also, the pre-device typically includes at least one port having a size and design that is attached to the examination mirror. The port is typically attached to the tip of the pre-device (or attached to the device attached to the examination mirror and provided between the examination mirror and the covering device). Various embodiments of the inspection mirror and covering device will be described in detail below with reference to the drawings.

  FIG. 1 is a schematic diagram of an ALMS (Ambient Light Processing System) designed for use in medical institutions. Briefly, ALMS fits around a part of a patient's body (target tissue such as tongue, cheek or gum) (oral cavity in FIG. 1). Alternatively, it fits around the neck, vagina, ear or epithelial tissue, or tissue that was incised for examination during surgery. In particular, such a tissue is used when it is suspected to be a cancer-related cell or tissue such as a tumor, malignant tumor, benign tumor, or dysplasia.

  The ALMS 50 shown in FIG. 1 includes a port 52 and a cover or drape 68. The covering or drape 68 is fixed to shield substantially all ambient light from the target tissue and is designed to form at least a pre-device that covers the body part to be examined. Furthermore, the cover 68 allows at least one hand of the user and / or an instrument operated by the user to contact the body part to be examined in the pre-device. Such an instrument is a device that can be physically operated, such as a protruding device that extends from the front or tip of the inspection mirror. It may be a device that extends into the target area via a port. It may be a separate device from the inspection mirror. Such instruments do not generate light or electricity from the inspection mirror. As described above, the front light device 50 of the ambient light processing system (ALMS) 51 includes a port 52 arranged to provide visual access to a target body part. This port 52 allows operative access to the target body part. In some embodiments, the ALMS further includes a light source designed to provide light, such as fluorescence excitation light, to the target site. In a preferred embodiment, such a light source can provide a plurality of different forms of light, such as excitation light, standard white light, IR light, photodynamic therapy light (PDT), and the like.

 ALMS 51 also includes a seal 80. The seal 80 is a thin and lightweight adhesive metal strip in this embodiment, and around the patient's nasal bridge (above or below the eye) to prevent light from entering the target area from the patient's periocular area. Glued to.

  FIG. 2 illustrates an ALMS 51 that includes a pre-device 50 having a port 52. In FIG. 2, drape 68 is combined with an operating room (OR) mask. The OR mask also provides a locking mechanism (not shown) that simplifies attachment of the AKMS 51 to the patient.

  3 and 4 illustrate an embodiment similar to that of FIG. 2 except that the covering 68 is substantially black and the ALMS device is provided under the patient's eye. In this embodiment, the drape or cover 68 includes two bonded medical quality polypropylene (in one embodiment, weighs 1.9 ounces / square yard). In addition, an elastic band and moldable metal band 80 are provided to hold the mask around the patient's face and prevent unwanted light from reaching the target area. In this embodiment, as well as most other embodiments, the material is dark, non-fluorescent, non-reflective, and all light in the area of interest is generated from the illumination / excitation light provided by the device user and the patient. Only fluorescent light, Raman light or other light.

  5 and 6 are schematic views of the ALMS described here. The ALMS further includes a raised body 82 that provides an edge 83 (on the orbit). As shown, the ridges 82 and the edges 83 are substantially rigid (in one embodiment, the edges 83 are substantially similar in shape to an OR duckbill type N95 mask) and can be in any desired shape. Can be cut. The raised body 82 enhances the size and rigidity of the head region within the head device 50 of the ALMS 51.

  FIG. 7 illustrates a pre-device 50 for the ALMS 51. The pre-installation device 50 includes a port 52 of size and design for light, inspection mirror, instrument, etc., and a tip sheet 53. In the illustrated embodiment, the tip sheet 53 is substantially circular, but may have any desired shape such as an oval, square, hexagon, octagon, and the like. A cylindrical body 54 is provided by the front end sheet 53 and the reinforcing material 55. In the cylindrical body 54, the user of the apparatus can operate the inspection target using an inspection mirror. The reinforcement 55 can be seen through the cut. The reinforcing material 55 may have any shape. Furthermore, since the shape of the ALMS 51 is maintained, the material can be made seamless or accordion sewing. The pre-device 50 can further include an open end 56 disposed around a target site, such as the patient's oral cavity. However, it may be around other parts such as colposcopy, skin part, or inside or outside of the surgical part.

  The longitudinal length 57 of the front device 50 may be any length as long as it is suitable for blocking inconvenient light such as ambient light. If desired, the pre-device 50 can include an adhesive or adhesive material that causes the pre-device to adhere to the patient 60. Further, the side edges of the pre-device (and other parts) can be provided with a shapeable material 61. Of course, the drape 68 material 62 reduces light transmission in the interior space of the pre-device and is non-luminous. The tubular portion can be an accordion shape 59.

  FIG. 8 is a schematic view of a front-end device 64 made of a substantially opaque material 66 and having a drape 68 that includes a port 70. The drape 68 includes an adhesive element 72 provided with an adhesive or the like. As the drape 68 is moved up onto the patient's 60 face, the adhesive element 72 can be utilized to hold the pre-device 64 in the desired position on the patient's 60 face. In the illustrated embodiment, a neck string 74 is included that attaches the sag shape ALMS 51 around the patient's neck.

  FIG. 9 shows the pre-installation device 76 of the ALMS 51 including the ridge 82, the port 84 and the drape 86. The pre-device 76 includes an ear hook 78 that helps attach the pre-device to the patient and hold it in the desired position. This device 76 is particularly suitable for a patient's supine tilt upright examination. This embodiment also includes a seal 80. This is typically extensible and allows the pre-device 76 to be held on the patient.

  FIGS. 10-12 schematically illustrate an example of a seal 80 that can be shaped along the patient's nose 88. Other shapes are preferred for other body parts. As shown in FIG. 11, the seal 80 may be V-shaped or corrugated. Furthermore, although this embodiment uses only one seal, multiple seals can be used that are used sequentially or simultaneously. As shown in FIG. 12, the seal 80 is typically flexible and the seal portion 92 is bent approximately 90 ° and can be moved to a desired angle. Furthermore, the seal 80 can be manufactured in a flat shape to facilitate transportation, storage, etc., and can be made non-planar when used.

  13 and 13A illustrate various shapes that can be used for the port 94 for inspection mirrors, illumination light, instruments, and the like. The port 94 has a shape that can be mounted and held at the front portion of the inspection mirror, typically at the tip. As shown in the figure, the port 94 may be circular, but it may be rectangular, elliptical, diamond-shaped, etc., and is of the lock-key type (locking key relationship) that can be snap-locked to the tip of the inspection mirror. Furthermore, the port shape is symmetrical and can be securely attached to the inspection mirror.

  FIG. 14 illustrates an end member 96 that can be detachably mounted on an inspection mirror, a light source, or the like. Preferably, the removable end member is disposable or is disinfectable that can be used multiple times to prevent infection between patients.

  15A-15C illustrate an embodiment of a coupling device 97 suitable for coupling an inspection mirror, light source or other device 104 to an ALMS port. In this embodiment, the tip 99 of the coupling device 97 includes a port key portion 98 that is shaped to provide a locking connection to the port. Other shapes may be used. The detachable end member 96 includes a receiving structure 100 adapted to receive a projection or a thread groove of the inspection mirror 104. End member 96 can be provided in a disposable or reusable form. If the end member 96 is reusable, the end member is provided in a shape suitable for sterilization techniques such as autoclaving and sterilization cleaning. As shown, the inspection mirror 104 includes a protrusion 102 at its distal end region and is connected to an end member 96.

  FIG. 16 is a schematic diagram of another embodiment of the pre-device 108 in which the pre-device 108 includes a batten 110. Such battens are substantially rigid members and are typically made of plastic, aluminum or other material stitched or bonded to a drape or cover 68. In the illustrated embodiment, the battens hold the anterior device a predetermined distance away from the patient's head and neck. As described in the embodiment of FIG. 16, the front device 108 is mounted on the head with a string 109 wound around the head.

  Returning from FIG. 15A to FIG. 15C. The removable end member 96 further includes a window 106. Window 106 is particularly advantageous in embodiments of the present invention for intraoral examination. This is because the patient's breath exhales contaminating particles that adversely affect the microscope itself or other mechanisms. If desired, the device can be manufactured without providing a window. In certain embodiments, the window can simply function as a transparent shield and reduce contaminant movement between components of the pre-device. Alternatively, the window can be provided with a filter function including illumination light or detection light. In some embodiments, the window is non-fluorescent and non-reflective so as not to adversely affect the functions of observation, examination, tissue excitation, treatment, etc. that can be provided by the system or apparatus of the present invention.

  FIG. 17 illustrates a ridge 112 that can be used in a drape 114 of a pre-device that creates a space in the pre-device between the pre-device and the patient. The raised body 112 can have a single structure, a two-piece structure, or other structure.

  FIG. 18 illustrates a plurality of example space-providing members suitable for use in an orbital ridge or other body part within an ALMS pre-device according to the present invention. The member leg 118 raises the raised member 116. The shapes of the raised members 116 and the legs 118 are variable and can be deformed according to various shapes of the face and other body parts.

  FIG. 19 illustrates another embodiment of the raised body 120. The raised body 120 includes a batten 122 to provide a space creation structure that keeps the raised body in the desired shape.

  FIG. 20 illustrates another embodiment of the removable port of the cover. In the embodiment shown in FIG. 20, the port structure 124 includes a port 126 provided by an O-ring 128 sandwiched between at least two layers provided by a covering material. In particular embodiments, the sheets of materials 134 and 136 weigh less than about 2 ounces per square yard. It may be lighter or heavier than this. In another embodiment, port 126 is approximately 1 inch in diameter. It may be about 1 mm to 1 cm, 3 cm to 5 cm, or more. If desired, at least one cloth sheet can be provided with a slit 130 for introducing a tube, such as the tip of an inspection mirror, into the port. The layers of the material 134 and 136 may be bonded together by stitching or may be bonded by, for example, bonding (detachable resin ARc / o, AS-124M) of Glenlock (Pennsylvania). Furthermore, other layers may be transparent if at least one cover layer is sufficiently opaque. For example, one layer may be a backing material or a 2 mil siliconized clear polyester.

  FIG. 21 illustrates an examination mirror 104 having an optical path 142 that transmits light between the light source and the patient and between the patient and the sensor. This optical path 142 also serves to send observation light directly from the target tissue to the eyes of a user such as an examiner. The user can observe through the eyepiece device 145. The port structure 124 in the cover 138 preferably removably engages the protruding edge 140 or other attachment mechanism of the inspection mirror 104. The inspection mirror 104 includes an eyepiece device 145, a two-color reflecting mirror 141, and a hand holding unit 147. Typically, the direct viewing end of the inspection mirror includes a filter in one or both of the illumination light path and the detection light path.

  22A to 22C show the keyhole shape portion of the cover 68 and the tubular port 151 together with the corresponding key shape portion and the distal end portion of the inspection mirror 104. The cover 68 includes a keyhole and a tubular port 151 that includes a window 150 provided in the upper port 152 in the keyhole shape 148. As illustrated, the keyhole-shaped portion 148 has a rhombus shape, but may have any shape including a symmetrical shape. FIG. 22B is a side view of the keyhole-shaped portion and the tubular port 151 that are partially slid into the distal end portion 155 of the inspection mirror 104. The inspection mirror 104 includes a retaining ring 146 that is complementary to the shape of the keyhole-shaped portion 148. An exemplary shape of the retaining ring 146 is illustrated in FIG. 22C. The retaining ring 146 can include both shapes simultaneously. For example, a circular ring is positioned on the diamond so as to extend into and pass through the port 152, and the diamond ring is removably engaged with a corresponding diamond keyhole 148.

  FIG. 23 illustrates an embodiment of the cover 68 as shown in FIG. 22A prior to manufacture. In this example, a first material 156 having a diamond keyhole shape 148 is combined with a second material 158 having a circular port 152. Typically, the second material 158 is the side of the drape 68 that faces the patient. These two materials may be combined by any method. For example, it may be bonded by the stitching portion 160 or an adhesive may be used.

  FIG. 24 illustrates a front device formed of a mask body 162 including a vertex connection port 166 and a plurality of reinforcing bodies 164. The reinforcing body 164 can be made of aluminum, plastic or other lightweight material that maintains the shape of the mask body 162. If desired, the mask can be provided without the use of additional stiffeners. In general, if the number of reinforcing bodies is large and / or the rigidity of the reinforcing bodies is high, the mask body 162 will maintain its shape more robustly. On the other hand, if the number of these reinforcing bodies is reduced or removed, the mask body becomes flexible. FIG. 25 is an enlarged view of the vertex connection port 166 shown in FIG. The connection port 166 has a main body 170, and in the illustrated embodiment, has a bar code 173. Port 171 fits closely with nozzle 168. In this embodiment, such a close fit is provided with two protrusions 175 that receive the nozzle 168 and hold the nozzle 168 in the desired position in front of the port 171. In FIG. 25, the passage 172 of the main body 170 is turned upside down, and the front device of FIG. 25 is a bottom insertion type, which is opposite to the upper insertion type device of FIG. Of course, a side insertion type or another type of insertion type can be used.

  The identification symbol 173 is a barcode in this example, but a 3D barcode, other scanable display means, a mechanical fit type identification system, or other identification system can be employed. A special mechanical fit between the pre-device and the detachable end device is advantageous for a variety of reasons. For example, end devices and / or pre-devices and / or inspection mirrors, etc. have identification means so that specific filter combinations are used properly or other specific embodiments are used properly. Can be provided. For example, an ALMS system in which an anti-infection window is located within the cover itself is steadily used with a removable end device and an inspection mirror that does not have such a window to prevent unwanted optical interference from being introduced into the system. It is ensured that such a pre-device with Otherwise, an open passage will occur between the patient and the relatively expensive optical and observation equipment. In addition, the manufacturer's filter is properly used with other carefully selected filters, so that the system used in the fluorescence test is properly provided throughout the system and is not confused with that for IR testing. The identification symbol 173 can be placed at any desired position. For example, on the connection port surface, somewhere else in the pre-device, in the ring, or at other connection sites of the pre-device. The pre-device fits a specific desired inspection device, instrument, etc., or fits a removable end device.

  FIG. 26 illustrates a connection port 166 that includes a body portion 170, a keyhole shape portion 174, and a backing 176 that may be made of mylar, cardboard, or any desired material. They are all attached to the cover 178. 27 and 28, the inspection mirror is initially rotated as shown in FIG. 27, the oval nozzle 168 is pushed into the passage 172, and the entire light source 180 is rotated 90 ° clockwise to move the oval nozzle 168 into position. A state in which the nozzle is not pulled out until it is engaged with the protrusion 175 of the main body 170 and the light source 180 is rotated in the opposite direction to return to the original position and pulled out. FIG. 29 illustrates another embodiment of the connection port. The outer fabric 184 of the port 182 provides an elliptical hole and the inner fabric 186 provides a circular hole. Each passage is provided with a seam or lip 188 that can provide rigidity.

  28 and 28 illustrate a rotation lock type slide port.

  FIG. 29 illustrates a front view device having a side view port and a passage that includes multiple fabric layers and provides an interference fit port for an inspection mirror.

  FIG. 30 is a perspective view of the inspection mirror 104 having a distal end portion 190 and a proximal end portion 192. The near end 192 includes an eye cup body 194 that acts as an eyepiece and provides a comfortable eyepiece that does not interfere with ambient light usage by the user. The tip 190 includes a connecting region that includes a circular flange and a lip body. The tip 190 may have other shapes. The inspection mirror 104 further leads to a power source, light source, CCD, CID, CMPOS or other digital or analog camera, imaging equipment such as an imaging device, and external equipment such as a spectrum analyzer such as a spectrometer, spectroradiometer, spectrograph, etc. A handle portion 198 with a conduit 200 attached thereto is included. In this embodiment, the head portion 201 of the inspection mirror 104 is smaller than the handle portion 198. Providing the short head 201 is advantageous in some embodiments. This is because a short head unit allows a user such as a doctor or a dentist to approach the target tissue and enables wide-angle observation during a colposcope or a mouth examination. Further, although the inspection mirror is connected to an external power source or other device in the illustrated embodiment, the entire system can be housed in a single portable device if desired. FIG. 31 is a partially exploded view of the inspection mirror 104.

  FIG. 31 is a side perspective view of the inspection mirror 104. A part of the head part is removed from the handle part so that the inside of the head part can be observed. Tube 206 is provided at the distal end of inspection mirror 104, wavelength selective optical elements such as beam splitter 204 are provided in the head portion of the inspection mirror, and filter 202 is provided at the proximal end of the head portion. Also shown is a handle component 208 that is maintained in the handle portion.

  FIG. 32 is a sectional view of the inspection mirror 104 including the distal end portion 190 and the proximal end portion 192. The apparatus further includes an eye cup 194 and a beam splitter 204. The beam splitter 204 projects light onto the internal space 207 of the inspection mirror 104 via the conduit 200. The light is then projected upward through the optical element 209 and sent to the beam splitter 204. The beam splitter reflects light through the path of the tip 190. The light can include excitation light suitable for inducing fluorescence, white light, infrared light, or other types of light. Furthermore, the light can be selectively adjusted or changed by the user, and can be provided to be switchable between the observation mode and the irradiation mode. Furthermore, the light can be provided for use in reflection-based irradiation, fluorescence excitation-based irradiation, therapeutic purposes, diagnostic purposes, and the like. In the illustrated embodiment, the patient's vaginal area is examined by the user. Light returning from the patient is collected in projection / collection tube 206. Projection / collection tube 206 detachably engages pre-device 50 at port 52. Light generated from the patient is sent to the user's eye through the selectable optical element 204. If desired, the light from the patient can be sent back by the beam splitter 204 through the handle to an analytical device such as a camera, spectrograph or other analytical element. Further, if desired, the inspection mirror 104 can include filters such as filters 211 and 213, for example. If desired, the filter can only remove illumination light or generated light. In this case, the filter is installed in front of or behind the beam splitter. If desired, the filter can remove both the emitted and generated light. In that case, the filter is placed in front of the beam splitter as in this example.

  33 is a sectional view of the head portion of the inspection mirror 104 shown in FIG. Further, the third filter 215 and the fourth filter 217 installed before and after the beam splitter 204 are specified.

  34 to 43 are cross-sectional views of connection mechanisms for connecting various devices of the system.

  FIG. 34 shows an exemplary connection structure for attaching the inspection mirror 104 to the conduit 200 or attaching a tip removable eyepiece structure. FIGS. 34A and 34B include an optical path 210, a male end 219 and a female receiving end 221. In FIG. 34A, the male end 219 is maintained in a connected state with a female end 221 and a compressible O-ring 211 fitted in the receiving notch 223 interposed. Both ends can be pushed and connected to each other and pulled apart. Similarly, in FIG. 34B, the male end 219 is maintained via a wide complement 214 that fits snugly within the complementary wide notch 225 to the female end 221. O-rings, supplements, etc. can be provided with suitable materials such as plastic, sponge, rubber and the like. As shown, in the preferred embodiment, the optical paths are aligned for connection.

  FIG. 35 illustrates another connector in which the male end 219 of the conduit 200 is attached to the female end 221 of the handle portion. The connection is provided via a screw groove 218. If desired, the device can further include a window 216. This is typically non-fluorescent, transparent and non-reflective.

  FIG. 36 illustrates a fitting form of the band-like protrusion and groove functioning in the same manner as the above-described drawing embodiment. In this embodiment, a snap-on on the band-like protrusion 220 is provided to hold the two ends together.

  FIG. 37 illustrates another simple pull-away fit configuration. The latch lever 22 cooperates with the spring load pin 226 to stably hold both the male and female ends in a detachable manner. In this embodiment, the O-ring 224 held on the female end 221 interacts with a notch 227 in the male end 219. The spring load pin 226 and the latch lever 227 cooperate to lock the two ends and provide a stable holding function so that it does not come off when a considerable unexpected pressure is applied.

  FIG. 38 illustrates a removable eyepiece 96 for illumination and light collection components. The detachable eyepiece 56 slides on a suitable protrusion 229 of the inspection mirror 104. The irradiation path 111 may be a hollow cylinder, an optical fiber cable, an optical fiber bundle, a liquid light guide, or any other desired light guide. The irradiation light is sent from the inspection mirror 104 to the irradiation path 228, followed by a bandpass filter 232, a collimation lens. 234 and the output lens 240. The light is then sent to the patient's arm, and fluorescence, reflection, Raman signals, or other generated light from the patient's arm is sent to the condenser lens 236, through the high pass filter 238 and the collimation lens 234, and the light receiving path 230. Sent to. In this embodiment, the filter 234 is a bandpass filter and is substantially suitable for inducing fluorescent action on a phosphor in the target (a spontaneous phosphor or a phosphor provided by a drug, a fluorescent agent, etc.). Send only the excitation light. The high pass filter 238 substantially blocks all excitation light and sends only fluorescence generated from the patient.

  In the embodiment of FIG. 38, the bandpass filter 232 protrudes from the protruding portion 229 into the complementary receiving portion 221 of the adapter 96 to provide an appropriate identification and device management system, and does not confuse the irradiation light path and the light collection path when in use. FIG. 39 illustrates a similar embodiment focused on optical components.

  In FIG. 39, the optical component includes an optical fiber bundle. Other suitable light guides, output lens 240, band pass filter 232, condenser lens 236 and high pass filter 238 may also be used. In this embodiment, the device does not include the protective bandpass filter 232 and the corresponding receiver 231 of FIG. 38, and the optical connections in the various elements of the device will be determined by the user confirming the operating signal.

  FIG. 40 is a cutaway view of the adapter 96. Adapter 96 includes a lens and a mirror and provides side inspection capability. The irradiation optical path 228 passes through the receiving unit 231 beyond the collimation lens 234 and is sent to the inclined mirror 244. Mirror 244 directs light from output lens 240 located on the side of adapter 96. The condensing path 230 condenses the light through the condensing lens 236. The light passes through the tilt mirror 234 and is sent from the collimation lens 234 to the inspection mirror. FIG. 41 illustrates another side test adapter. In FIG. 41, the adapter 96 includes light guides 246 and 248 that bend light from an inspection mirror (not shown) and irradiate and collect light through respective condensing components 246 and irradiation optical components 248.

  42 and 43 are side views of two flexible adapters. In FIG. 42, a corrugated gooseneck 250 is provided. This gooseneck can be bent or twisted as desired as the material allows. FIG. 43 illustrates a flexible rubber hose 252 that can be freely bent and twisted. Also provided is a link structure 254 that stiffens the adapter and maintains its shape.

  FIG. 44 is a cutaway side view of an adapter including a power source and a light source. The protrusion 229 of the adapter 96 includes a battery 266 coupled to a light source such as an LED 264. As shown, the wire 258 passes through the current limiting resistor 260 so that the intensity and color of the light generated by the light source 264 can be controlled according to the design. Battery 266 and light source 264 are activated and controlled by switch 256. The light generated from the light source 264 is sent from the adapter to the patient via the filter 262. Then, the return light is condensed through the condensing path 268. In this embodiment, light is sent from the adapter to the OS for cervical examination, and return light returns from the OS. In some embodiments, the side inspection device is particularly advantageous for such inspection.

  FIG. 45 is a cutaway view of an inspection mirror 104 having a proximal end portion 102 and a distal end portion 90. Handles, power supplies, optical components, etc. are designed to be provided on the hand-held structure that forms the actual inspection mirror or attached to the inspection mirror at the tip.

  The handle portion 198 includes a plurality of elements that provide power and light. They include a power register battery 274, a cooling fan 272, and a heat sink 270 that aids cooling. The power register battery 274 supplies power to the light source 264. The light source sends the irradiation light to the filter 262. The filter 262 provides light to the illumination light guide 242 and sends it to the tip 90. The power source, light source, and the like are controlled by a switch 256. The switch 256 is preferably installed on the front side of the handle portion in the same manner as the trigger, but may be located elsewhere. FIG. 46 is a schematic perspective view of ALMS. In this embodiment, the housing 277 includes a light source, a power source, a camera, and other analysis or image elements. The front side 276 includes a port 279. From there extends a conduit containing light guides, electrical wiring, and other elements. The conduit 200 sends the desired signal, light, etc. to the inspection mirror 104 including the light want 278 and the adapter 96. In this embodiment, a power source 282 is provided adjacent to the housing 277 and has a power cable extending from the power guide to the inspection mirror 104. The light source and power source are each plugged into a wall outlet 284.

  FIG. 47 illustrates the inspection mirror 104 having a distal end 190 and a proximal end 192 and a conduit 200 extending from the base of the handle portion 198. The conduit is fairly long (about 4 to 15 feet) and extends to the end of an adapter 284 that is removably plugged into an external power source and light source. FIG. 48 illustrates the inspection mirror of FIG. 47 and a conduit attached to an external power source and light source.

  FIG. 48 illustrates the inspection mirror 104 connected to an external power source and light source 286 by a plug of conduit 200 and adapter 284. The external power source and light source 286 includes a holder 288 that is complementary to the shape of the inspection mirror 104. The holder 288 has a size and a shape for holding the inspection mirror at a desired position of the holder.

  FIG. 49 illustrates a member 288 that includes an extension 290 having a ridge 300 designed to be attached to the tip of the inspection mirror. FIG. 49 is a perspective view of a member 288 attached via the port ring 302. The port ring 302 is attached to the inspection mirror at the tip by slip, slide, click, or other means. Member 288 includes an extension 290 designed to reject inconvenient problem areas from the inspection passage. Thus, the extension 290 can be a tongue compressor, vaginal sidewall compressor, or other shape. Member 288 can be designed to rotate when attached to an inspection mirror. Alternatively, it can be designed to be attached to the inspection mirror and remain in one place or remain in a movable position, with friction or other forces holding it in place and moving the user. Further, the extension 290 can be extended and contracted, or can have a fixed length as shown.

  50 is a side view of the apparatus of FIG.

  FIG. 51 is an exploded view of the inspection mirror 104. The handle 198 is held by the head unit 201 via a bolt 304. The bolt is covered with a bolt cover 306 for appearance and dust resistance. The side handle is an inner foundation 308 that holds the various elements in the desired position and also provides additional strength. Typically, the inner base, handle, head, etc. are made of plastic or other lightweight material, but may be made of metal or other medically available material, typically an autoclave, sterilizing solution It is processed so that it can be sterilized or maintain the integrity of the medical or dental environment. Inspection mirror 104 is shown in combination with member 288. The member 288 comprises two members in this embodiment and includes a ring 302 that snaps into the distal end 190 of the inspection mirror 104 using a plug-in lock 316 connection system.

  The extension 290 of the member 288 is snap-held on the retaining ring 300. The retaining ring 300 includes a plurality of retaining ridges 318 that snap to the extension 290 to hold the extension 290 in place. As shown, the extension 290 is removably attached adjacent to virtually any location on the retaining ring 302.

  The inner base 308 includes a plurality of optical elements such as filters and mirrors as can be understood from their holding structure. For example, the short pass filter 314 is held between the light source and the holding structure portion of the dichroic mirror 141. The short pass filter 314 passes only blue light, that is, light having a wavelength of about 450 to 500 nm. This light is almost harmless to the human body (no harmful effect of UV light), but has sufficient energy to induce spontaneous fluorescence or fluorescence from the provided phosphor. Other filters with other characteristics are also available at this location. Interchangeable gutters or other structures can be provided, and different filters can be inserted into or removed from one inspection mirror.

  The dichroic mirror 141 reflects light from the light source through the distal end portion 190 of the inspection mirror 104 and the window 303 of the member 288. Return light from the patient returns through the window 303 and the dichroic mirror 141. In this embodiment, the dichroic mirror 141 functions as a long pass filter having a shielding power of about 475 to 480 nm. That is, it shields short wavelengths and transmits long wavelengths of light. In this embodiment, the dichroic mirror 141 shields all the excitation light that has passed by the short pass filter 314. In front of the dichroic mirror 141, the dichroic mirror 141 provides a maintenance structure for the second long-pass filter 310 that eliminates substantially all unwanted light that has passed through. In such an embodiment, almost all inconvenient light is eliminated for the observer. If desired, additional filters such as a notch filter 312 held by a holding structure downstream of the second long pass filter 310 can be provided. In one embodiment, the notch filter passes substantially all light except light between 585 and 595 nm. This particular embodiment is particularly advantageous for the detection of oral cancer, cervical cancer, and other cancers. The reason is that, in part, such exclusion of light helps the observer distinguish between sick and non-sick cells. Such a notch filter is particularly advantageous for the detection of other diseases. It is particularly advantageous for diseases involving fluorescent identifiers that are red-shifted in the presence or state of the disease.

  FIG. 52 is a schematic view of the binocular structure 326. The binocular structure 326 includes a binocular observer 320. In this embodiment, the binocular observer 320 includes an independent lens 330 for each eye and an ear hanger 328. The binocular observer 320 is detachably connected to the binoculars port at the junction 323. The adapter 324 combines the optical paths of the respective binocular lenses into one interrogation optical path exiting through one port 332. In other embodiments, the binocular viewing ability of this embodiment can extend to the interrogation region. Thus, it typically includes separate observation ports and, if desired, separate irradiation areas. In some cases this is very advantageous. This is because different wavelengths of light as well as different rays of light, with other different characteristics such as different polarities, can be provided for independent examination of different or the same area by each user eye. .

Further Overview Description In some embodiments, the inspection mirror is beyond a filter that passes only fluorescence excitation light, eg, white light, eg, substantially only in the excitation wavelength range of 400 to 450 nm (eg, transmission or reflection). (In some embodiments, it may be desirable to use light of 400 nm or more to avoid the inclusion of dangerous UV light). Exemplary filters include a short pass filter and a band pass filter.

  The excitation light contacts the target. Reaction light is generated from the target, typically via fluorescence. Reflected light or other light such as IR light or Raman light can sometimes be used in addition to or instead of fluorescence. The inspection mirror device itself processes the radiated light collected by the inspection mirror and sends it to the observer (if desired, a video detection device such as a camera, CCD, CID, CMOS, or other device such as a computer or spectrometer, or others. To the spectrum measurement device).

  The detection optical path of the inspection mirror typically has at least one long pass filter or other desirable filter that substantially blocks the excitation light and processes it so that only low wavelength light is seen. In one embodiment, such a shielding process provides a dichroic mirror that provides shielding of about 475 to 480 nm (ie, shielding light of shorter wavelengths and passing light of longer wavelengths), and 475 to 480 nm or less. Is provided by the subsequent use of a “green glass” filter that shields light of light and transmits light of longer wavelengths.

  In some embodiments, the inspection mirror processes at least one of the light so that different wavelength bands of the detection light remain visible and other wavelength bands are substantially eliminated or their power or intensity is reduced. It further includes one filter. For example, the inspection mirror can have a notch filter downstream of the long pass filter that allows substantially all light other than about 585 to 595 nm to pass through. This particular embodiment is particularly effective in detecting oral cancer and certain other diseases.

  Other suitable notch filters can also be provided. For example, to enhance the difference between oxygenated blood and deoxygenated blood (eg, oxyhemoglobin and deoxyhemoglobin), or to enhance the difference between activated and inactivated drugs, or between diagnostic markers is there. If desired, variable or non-variable ratio wavelength scale filters such as those introduced in US Pat. No. 6,110,106 can also be provided, and in a preferred embodiment, the ratio of each of the different delivered wavelength bands can be varied. Additional examples of multiple bandpass filter combinations are disclosed in US Pat. No. 6,021,344.

  If desired, the inspection mirror of the present invention can be substantially hollow and includes a filter. The filter is typically placed on the handle for convenience in use. In some embodiments, the inspection mirror device can further include an extension designed to be attached to the tip (or other location) of the inspection mirror. This can be used to obtain a good field of view by pushing the obstructing tissue or body structure such as the cheek, tongue or vaginal wall out of the field of view of the inspection mirror. Some examples of such devices are also referred to as “retractors” and are included in the drawings. In one preferred embodiment, the tissue transfer device is rotationally attached to the examination mirror and is more freely movable within the subject's oral cavity and other body pores.

  The physical configuration of the inspection mirror can vary greatly depending on the specific desires and needs of the user. For example, as described above, the inspection mirror is essentially just a hollow case that sends light from an external (typically near) light source to the target tissue, and from the target tissue to the inspection eyepiece structure (typically Is an ophthalmic cup body, but may be another suitable ophthalmic device such as frosted glass, which may be in the form of a telescope or binoculars) and is equipped with an optical device that returns light. If desired, the inspection mirror may alternately or additionally include an internal light source (light source (such as an LED) and / or a light source in the near position) and a fiber optic guide, fiber optic cable, or other light transmission guide, suitable optics. It can be included in addition to or instead of a light guide formed in a hollow case with elements.

  Typically, the inspection mirror includes a power source suitable for providing light. The power supply can be obtained from an external power supply such as a battery pack connected by electric wires, a battery pack held by the handle, a power supply inside the inspection mirror, or a wall outlet or other power supply by a plug or other appropriate connection device. Electric power is sufficient. The figure illustrates an exemplary power / light source combination. In some embodiments, the light source housing includes a holding structure designed to hold the inspection mirror when not in use.

  As described above, if desired, the inspection mirror can include a non-human detector such as a sensor including CCD, CID, CMOS, etc., and a display such as a CRT, flat panel display, computer screen, etc. . In addition, the speculum system can include a computer that controls, processes and / or interprets various functions of the speculum, for example, diagnostic, investigation and / or therapeutic functions.

  A “computer” is a device that can control a filter, light selective modulator, detector or other device element, as well as the method of the present invention. For example, the controller can control the optical communication characteristics of the light selective modulator, control pixel on / off of a pixelated photodetector (eg, CCD or CID), and / or compile data from the detector. It can be carried out. Such data is used to create or reconstruct an image as feedback to control the illumination light. In addition, other elements and methods of the apparatus of the present invention are used for diagnosis and treatment. Typically, a computer includes a central processing unit (CPU) or other logic execution unit, such as a desktop or laptop computer, a computer with peripherals, a handheld computer, an independent computer such as a local or internetwork. Yes. Computers are known and the choice of the desired computer is an expert decision.

  In one embodiment, the system of the present invention comprises a light source, a hand-held examination mirror, an in-place device (ALMS), a retractor or cheek pusher, a light path, a light box (light source), a light guide and an eyepiece structure at the proximal end of the examination mirror. Contains parts. The light path extends from the illumination light path to the target and the user, in a hand-held examination mirror, collimator, 430 ± 30 nm filter (filter 1), dichroic filter (filter 2), light avoiding the absorber, glass window, mucosal tissue or other target Includes tissue, dichroic filter (filter 2, light returns over the same dichroic filter), 475 long pass filter (filter 3), 590 NM notch filter (filter 4) and eyepiece structure. The filters can be separate or combined (eg, reflective coating). The system can also or alternatively include a binocular-shaped eyepiece structure and treatment light such as loop / filtered glasses or sunglasses / goggles with or without magnification. The therapeutic light can have a plurality of wavelength systems (eg, a second head portion with a separate filter), and the wavelength of the therapeutic light can be controlled by an independent filter and / or a filter wheel. Other features are light wands, mirrors and / or optical fibers, typically collimated, or LEDs on the wand or intraoral cameras, with a filter sleeve at the end, especially It provides the desired light, functions as a light wand, and functions as a light source or additional light source for fluorescence or the desired response.

  The intraoral camera design can have multiple wavelength light processing capabilities inside and outside the camera. Light is sent through the system. Alternatively, a light source can be incorporated. Alternatively, a separate sleeve (or other suitable light emitter) with its own light can be utilized. The position of the filter as well as other optical elements can be anywhere in the passage as long as the desired function can be achieved.

  The illumination light path and the observation path are combined. Alternatively, it can be separated as a light source with a loupe / eyepiece. These passages can enhance the user's ability to use equipment with standard methods of observation and irradiation. If two people are observing in the mouth at the same time, they have different viewing angles of the tissue being irradiated, so they are observing different tissues and may make different diagnoses. Tripods are used to reduce variation by standardizing height and angle. In some embodiments, the interrogation spot size is sized to allow comparison of diseased sites against surrounding normal tissue. This enhances observation and the ability to identify anatomical landmarks of location.

  In some embodiments, the intensity is optimized to irradiate the tissue with excitation light for diagnosis and excite the necessary phosphors to generate signals. In some embodiments, the wavelength is optimized to recognize specific cancers found in the mouth or other target tissues. Wavelength / fluorescence enhances the ability to recognize shifts in the fluorogenic spectrum that distinguishes between normal and cancer tissue abnormalities. For example, dual monitoring of two wavelength bands from about 475 to 585 nm and above about 595 nm enhances monitoring of cellular activity of metabolic cofactors NAD and FAD. NAD and FAD generate fluorescence with a peak level at such wavelengths.

  In some embodiments, the Stokes shift is prevented, the output spectrum is narrowed to exclude UV light, and the emission signal is not significantly contaminated to avoid illumination / excitation with light in the emission band (overlapping fluorescence). It is desirable to obtain as much power as possible.

  In some embodiments, the system can further include a diffuser that further normalizes the spot size, removes hot spots, and the like. Sometimes filters straighten the light, limit the divergence of the beam with increased power intensity, use liquid light guides instead of optical fibers, reduce wasted space between fibers, increase efficiency, cost and high numerical aperture It is desirable to include a collimator that achieves even better transmission per hit (contributes to good light collection). Furthermore, in another embodiment, the system further includes a metal halide light source that enhances the light intensity in a predetermined light emission range to allow overlap observation and illumination light path (simultaneously to remove illumination light from light emission from the light source and tissue. A dichroic filter or similar optical element can be included.

  In the intra-oral and other embodiments, the inspection mirror is used about 4 inches from the device to behind the mouth or behind other targets. Spacers can be provided if desired. The inside of the inspection mirror can be black to absorb stray reflection irradiation light and emitted fluorescence (unnecessary fluorescence feedback).

  The shape of the inspection mirror is preferably biologically comfortable and can be set to optimize the excitation and emission paths. The near-end eyepiece structure is designed so that the incident ambient light from behind the observer is reduced by the inclination of the near-end filter (eg, 590 nm notch filter) and the passing light can be reflected into the surface of the absorbent inner tube Designed. This reduces reflections and prevents users from observing themselves. For example, the near end filter can be tilted with its top approaching the viewer and its bottom close to the dichroic mirror, providing a reflective surface to reflect incident light into the bottom of the light path tube.

  The detachable eyepiece structure allows the camera adapter to be inserted. In some embodiments, the camera is as close to the dichroic as possible, reducing the camera's optical path inside the inspection mirror and reducing the probability of the camera autofocusing inside the VELScope. Autofocus tends to focus on the brightest of what you observe, so autofocus can be activated by other factors, but the generated fluorescence is low intensity light (high ISO film / setting, long shutter open time) This is also important as it may be.

  A cheek retractor or other tissue manipulator can be installed at the tip of the examination mirror. There are places in the patient's mouth that are difficult to access just by looking. Cheek and tongue retractors enhance the ability to access such tissues and provide a “third hand” to the physician. The first hand grabs the inspection mirror, the second hand holds the tongue, and the third hand retracts the cheek. This is particularly important when the clinician has to work alone.

  The retractor can be composed of a base and a detachable arm, and can also function as a cap body to prevent contamination. In some embodiments, or for convenience, the retractor can take multiple positions around the end of the inspection mirror. For example, it is desirable that the retractor can be installed at eight peripheral positions at different angles. The retractor's arm can be detachable, and when not needed it sticks out towards the inspector or patient so as not to interfere with the work. Only about 10% access in the mouth will be required.

  The retractor arm can be tilted like a dental mirror. This can be designed like any other device used by the user to prevent slipping on the lips and / or cheeks. The arm can be designed to always let the user know where the tip is, see only a part of the retractor, and reduce the shielding of the observation path. An ambient light management system (AKMS) is also used to block ambient light.

  The cheek retractor can include a latch mechanism, and the angle of the cheek retractor can be adjusted without removing the cheek retractor from the device. The predetermined position of the retractor can provide a defined position of the device for recording purposes. For example, “When the device is in the position NW .... I looked into the space”. The seal between the retractor and the rest of the bell scope can be held simply by using friction around the device or by using notches and grooves. Instead of 8 positions, it can also provide a perfectly smooth ring for the bellscope. This allows continuous positioning (stepless position) if the registration of the angle is not important. Instead of 8 positions, 6 positions may be used (eg up / down presence / absence). Alternatively, it may be 4 positions (eg square front where square windows can be used). Alternatively, other numbers of positions may be used.

  In some embodiments, the system can also include a therapeutic detachable head. For example, a modular system with multiple heads of light sources that treat at 476 nm, excite fluorescence for cancer detection at 430 nm, and excite fluorescence for caries at 405 nm is possible. These various components can be attached to each other by any means. For example, a simple detachable type, a friction holding type, and the like. The head portion can include different filters depending on the purpose. For example, for diagnosis / treatment of caries / gingivitis.

  For treatment purposes, a combined observation / irradiation path is not preferred in some embodiments. This is because the user may not need to see the target. However, there may be some induction gains. For example, the illumination light can be filtered to prevent the user from seeing it (typically harmful UV light), and the light source filter can be from blue, for example, a combination of a bandpass filter and a notch filter. A wide range of wavelengths can be passed through to the red, and a large notch filter can be used in the center to remove all the rest. In other words, it is exposed to blue and viewed in red, but not necessarily for fluorescence observation.

  In some embodiments, the system also includes crosshairs that indicate where the observer is looking. Alternatively, it has a side light such as another laser or dual LED to provide aiming light. In various embodiments, the treatment head may be a filter that selects the treatment head that directs the desired illumination wavelength and illumination light. The treatment head part may be a permanent mounting type or may be detachably attached to the filter head part (COTS) when necessary. The treatment head portion may be a standard type, an optical fiber type, a free space type, a light pipe type, or the like, and any method for transmitting light from a filter to a tissue may be used.

  Sometimes one inspection mirror can be provided for multiple light sources. If desired, for white light viewing, it is possible to provide a larger bandwidth for the output. Greater bandwidth can be obtained by having additional light (LED, halide, etc.) or by using different filters at the output of one light source. The system can also provide illumination light having multiple peaks. For example, pharmacological / physiological testing of biomarkers sometimes uses this when the generated fluorescence (due to tissue, marker or chemical signal) changes in the presence of various ions / molecules / pH. This can also be used to provide standardization because the intensity of the fluorescence generated at each wavelength can be compared to each other and normalized to each other. In some embodiments, the system can include a timer that turns off the light for purposes such as defined treatment times or power savings.

  In some embodiments, the inspection mirror includes a shock mount to isolate the bellscope optical path. For example, this may be a second exoskeleton that wraps around the first exoskeleton, but is separated by air and is contacted by a rubber O-ring shock mount sandwiched between the passage tube and the outer shell. This is a convenient way to change the color of the device without using expensive molding techniques. The inner passage is typically black for light absorption. Black is a color that is not normally used in the medical setting because it looks dirty due to its melancholy tone and powder from cleaning residues and latex cloves. The outer shell may be different colors such as white, beige or other colors.

  In some embodiments, the system can include a square window or a square port. This can be made cheaper than a round window and can eliminate waste of materials. Furthermore, such a shape (or other non-circular shape) can assist the user in ALMS operation by providing a friction / structural fit between the ALM and the inspection mirror. Square windows are also desirable for relatively inexpensive non-fluorescent glass / material in the light path. Such materials can also be used in other forms.

  The tip of the bellscope can have a square female port at the tip, but the optical path can remain circular if desired. The bellscope port may be permanent, or it may be removable to allow different shaped windows or standard ALMS to be used. The ALMS shape is a shape that provides more material on the distal side of the patient away from the user. This can reduce ALMS interference to the user and use natural light shielding ability. The ALMS can have a nasal cut therein.

  In some embodiments, the system uses a low-strength, rewritable adhesive, such as “Post-It Memo”. The position can be adjusted if necessary, leaving no residue or permanent deposits on the glass. This makes it possible to reuse the protective glass and to dispose of used and dirty ALMS. Using this adhesive, it is also possible to provide a sheet-like ALMS in the form of a pad. The new ALMS can be stripped from the pad. The ALMS can be sized to cover the inspection mirror and hand. The material may be a black material or other dark material, which absorbs reflected illumination light and ambient light and absorbs autofluorescence emitted from ALMS. It can be manufactured from polypropylene or other inexpensive materials in consideration of cost and disposal. The material of the drape is selected considering that its weight does not become an obstacle.

  All terms used in this specification are used in their original meanings unless otherwise indicated.

The present invention includes not only devices, systems, etc., but also methods including methods of manufacturing them and methods of using them. In some embodiments, the present invention includes a diagnostic examination mirror and a dental care examination mirror. Example 1: Use of a speculum for identifying major formation disorders in the mouth A method for using a speculum for identifying major formation disorders in the mouth (N = 49) using autofluorescence.

The optical path of the inspection mirror is collimator, 430 ± 30 nm filter (filter 1), dichroic filter (filter 2), light avoiding the absorber, glass window, mucosal tissue or other target tissue, dichroic filter (filter 2) (light Includes a 475 nm long pass filter (Filter 3), a 590 nm notch filter (Filter 4), and an eyepiece structure. The inspection mirror is used with a pre-device. It is operatively linked to the inspection mirror and has a port that shields ambient light from reaching the target.

  For major disease sites in patients with no history of oral cancer, the speculum correctly identified most dysplasias (70%). Particularly advanced intraepithelial lesions were correctly identified (86%). Approximately 18% of non-plastic lesions were also confirmed using a speculum. The speculum also improved the physician's ability to recognize non-formed lesions. Nine of 11 such non-forming lesions were clinically diagnosed as oral precancerous lesions using standard techniques, but only 2 of these false positives used a speculum It was judged positive.

  Among other results, 10 biopsy samples of lesions that were judged positive using a speculum and were actually dysplastic lesions were adjacently normal and non-examined using a speculum. They also had biopsy samples in areas that were properly judged to be molding disorders.

Claims (1)

  A medical ambient light processing system (ALMS) designed to fit around a part of a patient's body that contains the tissue to be examined and prevents ambient light from reaching the target tissue. And includes an opaque pre-device, the pre-device includes at least one cover, the cover being provided in a size and shape covering at least the patient body part, At least one hand, or an instrument operated by a system user, is brought into contact with the target tissue in a pre-device, and the pre-device has a predetermined position on the covering so as to provide visual access to the target tissue And the port is coupled in a manner that does not allow light to enter a speculum that is designed to allow a user operative access to the target tissue. Is intended, the ALMS is characterized in that it further includes a light source designed to provide light to the target tissue ALMS.

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