RU2401052C2 - Systems and methods for disease intelligence with using dental examination device and ambient light management systems (alms) - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: system (ALMS) is designed to fit tight to a segment of a patient's body comprising an examined tissue, and to screen off the examined tissue from the entire ambient light essentially. The system contains essentially a lightproof vestibular device containing at least one barrier sized and configured so that to make it possible to form a vestibule to cover at least a segment of the body and to allow at least one hand of the user or an instrument manipulated by the user manipulates to contact the examined segment of the body inside the vestibule. The vestibular device additionally contains a passage opening arranged so that to ensure the visual accessibility of the examined object, and is essentially designed to that to enable the lightproof attachment of the examination device designed to be in working communication between the examiner and examined object. Besides the system contains a light source to deliver light to the examined object.

EFFECT: invention allows for diagnosis within routine medical examination.

42 cl, 52 dwg

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the priority of provisional application for US patent No. 60/562469, filed April 14, 2004; provisional patent application US No. 60/618287, filed October 12, 2004; and provisional application for US patent No. 11/016567, filed December 16, 2004, each of which is fully incorporated into this description by reference, and in relation to all principles, information and goals.

BACKGROUND

The detection of cancer, including precancerous and cancerous cells at an early stage of the disease, has always been a complex and controversial process. One way to recognize cancer cells was to measure the autofluorescence characteristics of cells, since cancer cells have an autofluorescence characteristic different from healthy cells. Other diseases are also characterized by their changes in autofluorescence characteristics. However, the detection of autofluorescence in traditional conditions for dentistry and medicine was problematic, since the characteristic of autofluorescence is very weak compared to the external illumination that is usually present in the examination room, operating room, etc.

Below are some links regarding the detection of cancer in the oral cavity. As for all other references cited in the present description, including cross-references to related applications, these links are included in the present description in full all of their principles and objectives. The inclusion of these links in the present description does not mean that any of these links are or are not prototypes for this application. Zheng, W., et al., Detection of squamous cell carcinomas and pre-cancerous lesions in the oral cavity by quantification of 5-aminolevulinic acid induced fluorescence endoscopic images, Lasers Surg. Med. 31: 151-157, 2002; Utzinger U, et al., Optimal visual perception and detection of oral cavity neoplasia, Cancer 2003 Apr 1; 97 (7): 1681-92; Muller, MG, et al., Spectroscopic detection and evaluation of morphologic and biochemical changes in early human oral carcinoma, Cancer 2003; 97: 1681-92; Majumder, S., Nonlinear pattern recognition for laser-induced fluorescence diagnosis of cancer, Lasers Surg. Med. 33: 48-56, 2003; Tsai, T., et al., In vivo autofluorescence spectroscopy of oral premalignant and malignant lesions: Distortion of fluorescence intensity by submucous fibrosis, Lasers Surg Med 2003; 32 (1): 17-24; Ebihara, A, Detection and diagnosis of oral cancer by light-induced fluorescence. Lasers Surg. Med. 32: 17-24, 2003, PMID: 12516066; Zheng W, Detection of neoplasms in the oral cavity by digitized endoscopic imaging of 5-aminolevulinic acid-induced protoporphyrin IX fluorescence, Int J Oncol 2002 Oct. 21 (4): 763-8, PMID: 12239614; Wang CY, Autofluorescence spectroscopy for in vivo diagnosis of DMBA-induced hamster buccal pouch pre-cancers and cancers, J Oral Pathol Med 2003 Jan; 32 (l): 18-24, PMID: 12558954; Onizawa K, Characterization of autofluorescence in oral squamous cell carcinoma, Oral Oncol 2003 Feb; 39 (2): 150-6, PMID: 12509968.

Therefore, the need to improve the ability of a doctor, dentist or other person to diagnose cancer and precancerous cells in the tissue under examination under typical dental and medical conditions remained unmet. The present invention provides this and other advantages.

SUMMARY OF THE INVENTION

The present invention relates to the detection of diseases such as oral cancer in a patient using a patient examination device. In some embodiments, systems and methods excite and detect tissue fluorescence. Fluorescence can then be evaluated and the possibility of certain diseases, such as cancer, can be determined. The devices include an ambient light control system (ALMS, often referred to as a “vestibular or vestibular device”): a system for regulating the background from lighting in a practitioner's office. This device can be used with the aforementioned viewing systems to detect pathological tissue by fluorescence. The present description also relates to the detection of pathological tissues in the oral cavity and to various elements of systems and methods. The description covers the patient being diagnosed and the testing practitioner, be it a dentist, therapist or hygienist.

Accordingly, true innovations relate to methods and systems, etc. to detect pathological tissues in the oral cavity and other openings of the body and other places by observing the measurement of tissue fluorescence or other optical properties. This can be done in a dental or doctor's office under normal lighting conditions. Since tissue fluorescence (autofluorescence) is characterized by a very low light intensity, pathological tissue detection by fluorescence is preferably performed at very low levels of background or external illumination so that there is no interference with the measurement. Therefore, methods and systems are provided to prevent external exposure to light and to absorb the scattered light that enters the field of view for proper operation of the system.

Solutions include pre-door devices such as bedspreads, aprons and masks. The vestibular devices are worn or otherwise fixed on the face or head of the patient, for example below the eyes, so that the examination light does not go into the patient's eyes and capture the oral cavity. If desired, the pre-door device can be fixed to a chair or other accessible structures with or without accession to the patient himself and then the patient can be equipped with protective glasses if desired.

In embodiments with appropriately designated dimensions, a viewing passage or gap is provided at the mouth through which the physician may pass the viewing device. The coverlet can be held on the head or other part of the patient’s body with elastic ribbons or ribbons on the back of the head or behind the ears, ear arches, or some other comparable method or system. It is also possible to use a part made of aluminum or other ductile material on the nose to fit the patient's face. In other embodiments, the physician and / or patient is enclosed within a bedspread or other pre-door element.

Exemplary examination techniques include the following:

1. During the examination, the patient sits right in the chair. The patient will usually not be in a supine position, although this position can be applied if desired. The supine position causes the patient's tongue to sink into the throat and, accordingly, restrict the view of the tissue.

2. Light source, viewing device, etc. preferably move freely, while the pre-door device either does not significantly limit movement or does not obstruct the view of the dentist or other doctor.

3. The doctor, if desired, can capture and move the tongue without introducing scattered light and without interrupting the study.

Exemplary device designs take into account the following:

4. The pre-door device may consist of a curtain material or other suitable enclosing material, which can be rigid or freely hanging, or intermediate rigid / free, if desired, and depending on this embodiment it is possible to include compliant devices, for example, internal stiffeners, in the design for shaping. Systems and methods for attaching to a viewing device, to a separate light source (if one exists) and to an instrument (if one exists). Systems and methods for attaching to a patient may also be included.

a. Attaching a pre-door device to a viewing device: A viewing device or other examination device passes into the pre-door device through a passage or opening in the blind, usually along a line coinciding with the mouth or other tissue being examined, and thereby becomes part of ALMS in some embodiments. Mounting and / or sealing improves shading and the ability to confidently manipulate the vestibule and other elements of the system without introducing unwanted light.

b. Fastening the pre-door device to the patient. It is possible to provide a part from a compliant / shaping material that corresponds to the curvature of the nose and cheeks, for example, an elastic product that extends around the patient’s head or ear clips similar to the frames of glasses. Mounting to the patient’s head can give the dentist more freedom to move the device from different angles. Molding around the nose and cheeks acts as a seal that improves the attenuation of external exposure.

5. In some embodiments, the vestibule device is disposable to prevent the spread of bacteria, viruses, or the exchange of materials between patients.

6. In particular, in embodiments where the pre-door device may be disposable, the device should be cheap.

Exemplary pre-door materials include the following:

7. The curtain material may be any predetermined, typically opaque, material, for example, non-woven synthetic material. A material may also be more than one sheet of a given material or other combinations of materials.

8. The specific composition of the curtain material can be determined by the drapery properties necessary for convenient sheltering of the patient without interfering with the doctor’s work process.

9. The material from which ALMS is made preferably meets the safety rules for flammability of materials.

10. In the interest of patient health, the materials are preferably tested for cytotoxicity and skin irritation under short-term exposure.

11. The materials preferably do not exhibit pyrogenic / allergic properties.

12. The materials are preferably not polyvinyl chloride (PVC) so that their use in Europe is possible.

13. In order not to impede or alter the measurement performed in some examinations, the materials preferably do not fluoresce or give at least less fluorescence than a typical measurement of pathological tissue within the visible optical spectrum.

14. The materials are preferably opaque enough so that external light under normal lighting conditions (for example, under normal conditions for reading and observation) of the dentist / doctor’s office does not significantly affect the observation of fluorescence or other predetermined examination / response light.

15. The materials on the surface can be dark in color (for example, black, grass-green or dark blue) and non-reflective to improve measurements due to the absorption of scattered light, which nevertheless passes through and / or under the ALMS.

The approximate dimensions for the pre-door device take into account the following:

16. Pre-door devices preferably do not interfere with the patient and the doctor; for example, do not interfere with movement during the examination.

17. The vestibular device is usually large enough to cover the patient’s mouth and, possibly, the body to block light that can penetrate at various points, for example on the shoulders (in embodiments where the shoulders are taken into account). The pre-door device, which may be disposable in whole or in part, is large enough to prevent light from entering when the device is moved during the examination.

eighteen.  In some embodiments, the pre-door device will be attached to the patient, and thus, in some embodiments, the implementation should not have a noticeable tangible or uncomfortable weight, for example, should be less than 100 g.

Exemplary pre-door pairings take into account the following:

19. The vestibular device can be connected / combined with the device for examination so that it does not accidentally fall out of the device for examination.

20. The vestibule device may contain a passage opening or other access site allowing its device to be examined in the oral cavity or to another examined part of the patient’s body.

21. The vestibular device can be paired with the patient by shaping him so that a seal is created with the face or other part of the patient’s body. In one embodiment, this is achieved using a compliant / shaping part in the mask.

22. The curtain material can be large enough and flexible enough so that the practitioner can capture and manipulate the tongue or other part of the body from under the curtain material without introducing external illumination.

23. A space is usually created between the patient and the light source. For this, for example, the curtain material can be relatively rigid, reinforced with another material, a large amount of the same material and / or overlapping stitches, or it will contain fields or another space-forming structure.

In the above and other embodiments (unless otherwise expressly indicated or not obvious from the context), all embodiments, aspects, features, etc. The innovations described in the present description can be mixed and combined, combined and rearranged by any suitable method.

Mentioned and other aspects, features and options for implementation are presented in this application, including in the following detailed description and in the accompanying drawings. In addition, various references are provided in this application, including in the above section of cross-references to related applications, in which certain systems, devices, methods, and other information are presented; all these links are included in the present description by reference in their entirety and in relation to all their principles and information, regardless of where in the present application the link may be given.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 presents a schematic view of ALMS (external light control system), made with the possibility of medical use.

2 is a schematic side view of an ALMS in accordance with the present invention.

FIGS. 3 and 4 show an embodiment essentially similar to the embodiment of FIG. 2, it being assumed that the guard is essentially black and the device is adapted to be held under the eyes of the patient.

5 and 6 are schematic front and side views of an ALMS containing fields.

7 is a schematic side view of an ALMS embodiment suitable for use by a patient in supine position.

On Fig presents a schematic view of the vestibule in the form of an apron.

Figure 9 presents a schematic view of a device containing a protruding and behind-the-ear parts.

10-12 schematically depict various embodiments of seals suitable for use in fixing ALMS to a patient.

On Fig.13-13A presents a number of different geometric shapes that can be applied to the through hole for the viewing device, backlight, tool or something else, if desired.

On Fig schematically shows a feed-through insert that detachably secures the viewing device.

FIGS. 15A-C are schematic views of a feedthrough that can be used to attach a sighting device to a substantially lightproof ALMS pre-door device.

On Fig schematically shows another embodiment of the pre-door device.

On Fig presents a schematic top view of various geometric shapes that can be used for pre-door device to create pre-door space.

On Fig shows a lot of different geometric shapes that can be applied to protruding parts or other space-forming vestibule devices.

On Fig shows a plate suitable for use in the protruding part of the pre-door device.

On Fig presents an additional embodiment for fastening the viewing device and the pre-door device.

On Fig presents a side view of a viewing device attached to a multilayer fence and a through hole, shown in Fig.20.

On figa-C presents the installation slot and the tubular passage hole 151 for the tube in the shutter together with the corresponding distal end of the sighting device.

On Fig presents one variant of implementation before the manufacture of fencing 68, for example, shown in figa.

On Fig presents a front view of a guard containing a passage hole, in the embodiment of the type of surgical mask.

On Fig presents an enlarged image of a front view of the fence and the through hole shown in Fig.24.

On Fig presents a cutout in side view of the installation mechanism of the pre-door device, for example, shown in Fig.24 and 25.

On Fig.28-2 presents a front view of the rotary locking configuration of the plug-in bore.

On Fig presents an enlarged side view of the passage opening and the pre-door device containing several layers of tissue and having passages of different shapes for the formation of the passage hole with a fixed fit into it of the viewing device.

On Fig presents a front view in perspective of a sighting device in accordance with one embodiment of the innovations proposed in this application.

On Fig presents a partially exploded side view of the viewing device.

On Fig presents a side view in section of a viewing device.

On Fig presents a side view in section of the head of the viewing device shown in Fig, and Fig-34 shows schematic side views in section of a number of different connecting mechanisms for connecting various devices in the system.

On Fig presents an additional embodiment of the adapter, in which inside the adapter is provided as a power source and a light source.

On Fig presents a side view in section of a manual embodiment of a viewing device, and the viewing device contains a light source and a power source in the handle.

On Fig presents a perspective view of a schematic representation of ALMS.

On Fig presents a top view in perspective of a viewing device with a conduit that is disconnected from an external power source and light.

On Fig presents a viewing device connected by a conduit and a removable adapter to an external power source and light.

On Fig presents a tool 288 containing a cantilever part 290 with a protrusion 300, made with the possibility of fastening to the distal end of the viewing device.

On Fig presents a side view of the device shown in Fig. 49.

On Fig presents a perspective view with a spatial separation of the details of the viewing device.

On Fig presents a binocular embodiment of ALMS in accordance with the innovations proposed in the present description.

DETAILED DESCRIPTION

The present invention relates to viewing devices referred to in some embodiments as “Velscopes” (“optical inspection devices”) suitable for examining light, such as fluorescent light emitted by a patient. In some embodiments, innovations relate to viewing devices for detecting pathological changes such as cancer in the oral cavity or vaginal region. Inspection devices are usually capable of detecting fluorescence or other very weak light emitted by the tissue being examined, and are used in combination with ALMS, such as a guardrail or vestibule, which essentially obscure the region of interest and essentially prevent any unwanted light from entering, for example the light of general cabinet lighting, into the inspection area.

In addition, the vestibule usually contains at least one passage opening made with a size and a configuration that provides a working attachment of the viewing device in it, usually at the distal end (or at least one device connected to the viewing device and extending between viewing device and fencing). Below are presented and explained various embodiments of the viewing device and fencing.

FIGURES EXPLANATION

Figure 1 presents a schematic view of ALMS (external light control system), made with the possibility of use by a practitioner. In short, ALMS is adapted to fit snugly against a portion of a patient’s body (oral cavity in FIG. 1) containing tissue to be examined, for example, tongue, cheeks or gums in the illustrated embodiment, or, for example, cervical, vaginal, related to the hearing organs or epidermal tissue, in other embodiments, and even tissue opened during examination during surgery, especially if these tissues are suspected for the presence of cancer-related cells or tissues, such as neoplasia, malignancy Nogo development of benign tumors, dysplasia, etc.

In figure 1, the ALMS 50 comprises a passage opening 52 and a guard or curtain 68. The guard or curtain is mounted (on) so as to block essentially all external illumination from entering the tissue being examined, and is configured (on) to form a vestibule, which covers at least a portion of the body that is being examined. In addition, the fence 68 is made with a size and configuration that allows at least one hand of the user and / or the instrument that the user manipulates to be allowed to come into contact with the body part to be examined inside the vestibule. The term instrument means a real physical device, for example a mechanical protrusion that extends from the distal portion or even from the distal end of the viewing device, but may also mean a mechanical device that extends into the examined area through a separate passage hole and / or observation hole, even without being connected with a sighting device. The term instrument does not include what is emitted by a sighting device, such as light or electricity. As noted, the pre-door device 50 of the ALMS system 51 further comprises a passage opening 52 arranged so as to provide accessibility for the subject to be examined for visual observation and configured to provide substantially opaque viewing of the viewing device configured to communicate suitable for performing a working function between the observer and the object being examined. As shown in other figures discussed herein, ALMS in some embodiments further comprises a light source configured to provide light, such as fluorescence excitation light, for directing to an object to be examined. In some preferred embodiments, the implementation of the light source can provide many different types of light, such as excitation light, standard white light, IR (infrared) light, photodynamic exposure light (PDT), and the like.

ALMS 51 also contains a seal 80, which in this embodiment is shown in the form of a thin metal strip of small mass, which can be shaped into the shape of the nose bridge (above or below the eyes) of the patient to substantially transmit light to the examined area from the patient’s eye area.

Figure 2 shows an ALMS 51 containing a pre-door device 50 containing a passage opening 52. In the embodiment shown in figure 2, the shutter 68 is combined with an operating (OR) mask 63. The OR mask also provides fastening mechanisms (not shown) that simplify attaching ALMS 51 to the patient.

FIGS. 3 and 4 show an embodiment substantially similar to the embodiment of FIG. 2, except that the guard 68 is essentially black and the device is adapted to be held under the eyes of the patient. In the present embodiment, the blind or railing 68 comprises two interconnected square pieces of medical grade polypropylene (in one embodiment, the mass may be 1.91 ounces / sq. Yard ² ). In addition, an elastic braid and a molded metal strip 80 are attached, which help to keep the mask in a predetermined position on the patient's face and prevent unwanted light from entering the examined area. As noted elsewhere in this application, in this and most other embodiments, the material is dark and, moreover, is neither fluorescent nor reflective, so that essentially all of the light within the examined area, in some embodiments, is essentially only from any backlight / excitation light provided by the user and any autofluorescence, Raman scattering, or other light emitted by the patient.

Figures 5 and 6 are schematic views of the ALMS proposed in this application, in which the ALMS further comprises a protruding part 82 that forms fields 83. As shown, the protruding part 82 and fields 83 are substantially rigid (in one embodiment the fields may have a shape substantially similar to a duck nose nose mask No. 95) cut out in any given shape. The protruding part 82 improves the size and rigidity of the pre-door region within the pre-door device 50 ALMS 51.

7, a pre-door device 50 for ALMS 51 is shown. As shown, the pre-door device 50 comprises a passage opening 52 configured with a size and configuration for transmitting light, a viewing device, an instrument, and the like, and includes a space-forming upper mold 53. In the shown embodiment, the space-forming topsheet 53 is substantially circular, but any desired configuration can be used, for example, oval, square, hexagonal, octagonal, and the like. Due to the upper shape 53, stiffeners (for example, essentially rigid rod-type elements that can optionally be connected together to form a frame) form a tube 54 through which the user can inspect using a viewing device (not shown) and in which the user can manipulate the object being examined, if desired. The stiffening elements 55 can be observed in the cutout and they can be made to give them any desired shape or configuration. In addition, the material can be made with the possibility of the absence of seams or a single combined knit weave with alternating full, incomplete and press stitches to help maintain the shape of ALMS 51, if desired. The pre-door device 50 further comprises an open edge 56, which is located around the object being examined, which, as indicated elsewhere in this application, in this particular embodiment, is the patient’s oral cavity, but may be any other desired cavity, for example, an area suitable for colposcopy, place on the skin or even the internal or external surface of the surgical field.

The length 57 of the pre-door device 50 can be of any desired value, provided that the length is sufficient to provide the desired obstacle to unwanted light, such as external lighting. If desired, the pre-door device 50 may further comprise an adhesive or other adhesive or sticky substance to support the pre-door device and its adhesion to the patient 60. In addition, the edges of the pre-door device (and other areas, if desired) can be made of plastic profiled material 61, and Of course, the material 62 of the shutter 68 reduces the transmission and formation of light inside the vestibule. The designs of the seams and rods, if desired, can be given a corrugated shape 59.

Fig. 8 is a schematic view of a pre-door device 64 containing substantially opaque material 66 for forming a shutter 68 containing a passage opening 70 in which the pre-door device 50 is in the form of an apron. The apron comprises an attachment member 72, for example an adhesive or other sticky composition, which is located on the outside of the apron when the apron is hanging, as shown, but when the apron is lifted and applied to the face 60 of the patient, the sticky element helps fix the pre-door device 64 in a predetermined position on face of 60 patient. The illustrated embodiment also includes a loop 74, which secures the ALMS 51 in the form of an apron on the patient.

Fig. 9 shows an ALMS 51 pre-door device 76 comprising a protruding part 82, an aperture 84, and a shutter 86. The pre-door device 76 includes an ear piece 78 that secures the pre-door device to the patient and also helps to maintain the device in position. This device is especially useful for examining a patient in a supine position, at an angle, and fully standing. The embodiment also includes a seal 80, which is usually malleable and helps fix the vestibular device 76 to the patient and / or at a predetermined location on the patient.

10-12 schematically depict angular and curved embodiments of the seals 80, which can be configured to shape the nose 88 of the patient. Of course, other configurations would be preferable for other parts of the body. As shown in FIG. 11, the device may be angular or curved, or both. In addition, although in the shown embodiments, only one sealing mechanism is used, if desired, multiple mechanisms can be used either sequentially, or in parallel, or otherwise. As shown in FIG. 12, the seal 80 is typically pliable so that the seal portion 92 can be moved at an angle of 90 to a predetermined position. In addition, if desired, the seal 80 can be made to be manufactured or otherwise flattened to facilitate transportation, storage, etc. and then give a non-flat shape when used.

On Fig.13-13A presents a number of different geometric shapes that can be used for a through hole for a viewing device, a backlight, an instrument or something else, if desired. In the embodiments shown, the passage openings are shaped to allow locking in connection with a distal portion, typically the distal end of the sighting device. As can be seen, the apertures 94 may be round, but may also have other various shapes, for example, rectangular, oval, diamond-shaped, etc., so that the aperture allows it to snap and lock in place and in a lock-type configuration with a viewing device. In addition, as shown in some embodiments, the geometric shapes must be exactly symmetrical, which can help to eliminate the undesired attachment of the sighting device to the passage opening.

On Fig schematically shows the end piece 96, which can be removably mounted on a viewing device, a light source, etc. In a preferred embodiment, the removable end piece is either disposable or sterilizable so that it can be repeatedly used for several patients or disposed of after use by one patient, both of which reduce the likelihood of infection of the following patients by one patient.

On figa-C depicts one embodiment of a connecting device 97, suitable for attaching a sighting device or a light source, or other specified tool 104 to the through hole in the ALMS. In the depicted embodiment, the distal end 99 of the connecting device 97 comprises the shape of a passage 98 to provide a fixable connection to the passage. As shown in other figures in the present application, many other geometric shapes are also suitable. The removable end piece 96 also includes a receiving part 100 adapted to receive a connecting protrusion or thread or other suitable attachment device for the sighting device 104. The removable end piece 96 may be configured to be either disposable or reusable. In particular, if the end piece is intended to be reused, it is usually preferable that the end piece is suitable for sterilization by methods such as autoclaving, sterilizing washing, etc. As shown, the viewing device 104 includes connecting tabs 102 in the distal portion of the viewing device 104 for connection to a removable end piece 96.

Fig. 16 schematically shows an additional embodiment of the pre-door device 108, where the pre-door device 108 comprises plates 110. These plates are essentially rigid devices, usually made of plastic, aluminum or other predetermined material, that are sewn or otherwise bonded or engage with the shutter or guard 68. In the shown embodiment, the plates are located in the middle of the pre-door device 108 and serve to hold the pre-door device at a distance from Tin and the patient's neck. As also shown in the embodiment of FIG. 16, the pre-door device is fixed to the head by a head ribbon 109, which essentially covers the head.

As shown in FIGS. 15A-C, the removable end piece 96, in the present embodiment, further comprises a window 106. The window is particularly useful in embodiments of the present invention for observing the oral cavity, since the patient’s breathing can introduce contaminants that can damage the sighting device itself or other mechanisms. If desired, the device for the oral cavity or other part of the body can be performed without a window. In some embodiments, the window can act solely as a transparent barrier, reducing the likelihood of contamination or other transfer of material from one side of the pre-door device to its other side, and / or the window can provide a filtering function, including either backlight or diagnostic light. In some embodiments, the window is selected to be substantially non-fluorescent, non-reflective, and, in another respect, substantially inert with respect to the functions of observation, control, tissue excitation, adjunctive therapy, and the like. functions that can be performed using the systems and devices offered here.

17 is a schematic top view of a plurality of protruding parts 112 that can be used with the shutter 114 of the pre-door device to create space within the pre-door device between the pre-door device and the patient. If desired, the protruding parts may have an integral structure consisting of one part, or a structure consisting of two parts, or another structure.

FIG. 18 is a plan view from above of a plurality of different embodiments of space-forming elements suitable for use in a raised or other place as part of an ALMS pre-door device in accordance with the present description. As you can see, the shelves 118 of the device can serve as a support for the protruding element 116, as shown in this side view. The protruding elements 116 and the shelves 118, like many other other constructions of the present description, can be useful and warrantable for modification with the creation of a wide variety of geometric shapes, at the request of the user, for example, to more closely match or fit to the facial features or other parts of the patient’s body.

FIG. 19 shows another embodiment of the protruding part 120, where the protruding part comprises plates 122 to create a space-forming structure that helps to hold the protruding part in a predetermined position.

On Fig presents another variant of implementation for creating a removable bore in the shutter, shown elsewhere in this application. In the embodiment of FIG. 20, the passage opening assembly 124 comprises a passage opening 126 formed by an annular seal 128 sandwiched between at least two layers of curtain material 132. In some embodiments, different sheets of material 134, 136 are made of material that has the mass is less than about 2 ounces per square yard, although lighter or heavier material can also be used if desired. In a preferred embodiment, the bore 126 has a diameter of about one inch, although, if desired, a bore can also be provided with any given size from about 1 mm to 1 centimeter (cm) to 3 cm to 5 cm or more. If desired, at least one of the sheets of fabric may include slots 130 designed to insert a tube, for example, the distal end of the viewing device, into the passage opening. The layers of material 134, 136 can be bonded to each other by any desired method, for example, crosslinking, adhesives such as adhesives from Adhesive Research Com, Glenrock, PA, including, for example, Removable Adhesive Systems, AR c / o 8561, AS- 124M. In addition, provided that at least one of the layers is sufficiently opaque, the other layer can be transparent or translucent, for example, one of the layers can be made in the form of a gasket containing a transparent silicone polyester plastic with a thickness of 2 mils (1 / 1000 inches).

On Fig presents a viewing device 104 containing an optical path 142, along which the light passes in both directions between the light emitting source and the patient or patient and the sensor, as well as, usually, the optical path 143 direct observation along which the light during operation from the tissue being examined into the eye of a user, for example, a dentist or doctor, while the user can observe the tissue through the eyepiece 145. As you can see, the node 124 of the passage opening in the bedspread or curtain 138 is preferably detachable flange 140 or other attachment device of the viewing device 104, while the viewing device, as noted, contains an eyepiece 145, the dichroic mirror 141 shown and a handle 147. Typically, the end of the device intended for direct observation will contain at least one light filter in any one of backlight paths and paths of light for diagnostics or in both of these paths.

On figa-C presents the installation slot and the tubular passage hole 151 in the guard 68 along with the corresponding insert and the distal end of the sighting device 104. The guard 68 is simplified shown in a torn form and contains the installation slot and a tubular passage hole 151 containing a window 150 located in the passage hole 152, which, in turn, is located in the mounting slot 148. As shown, the mounting slot 148 has a diamond shape, but you can apply any given shape, including a symmetrical shape y. FIG. 22B is a side view of a mounting slot and a tubular bore 151 partially pushed against the distal end 155 of the viewing device 104. The viewing device 104 includes a holding ring 146 that is complementary in shape to the mounting slot 148. Exemplary shapes of the holding ring 146 are shown in FIG. .22C. In addition, the retaining ring 146 may contain both shapes, for example, a circular shape distal to the diamond shape so that the circular shape extends into and through the aperture 152, and the diamond shape may come into detachable engagement with the corresponding diamond-shaped mounting slot 148.

On Fig presents one variant of implementation before the manufacture of fencing 68, for example, shown in figa. In this embodiment, the first piece of material 156 containing a diamond-shaped insertion slot 148 is combined with a second layer of material 158 containing a substantially circular passage 152. Typically, the second piece of material 158 is on the side of the shutter 68 facing the patient. Two pieces of material can be combined by any desired method, for example, using stitches 160 or gluing, a fixed fit or other required fastening method.

On Fig schematically presents the pre-door device, made in the form of a mask 162, containing the mounting part 166 with an input from above and many elements 164 stiffness. Additional stiffening elements can be made of aluminum, plastic, other material with a small mass, i.e. any material deemed suitable for shaping the mask 162. If desired, the mask can be made without additional stiffening elements. Generally speaking, the greater the number of stiffeners and / or the greater the stiffness of the stiffeners, the more reliable the mask will be to stiffly stiffen regardless of external pressure or other influences. On the other hand, reducing or eliminating said stiffening elements or weakening their stiffness provides a more flexible mask. On Fig presents a closeup view of the mounting part 166 shown in Fig.24. In a simplified form, the mounting part 166 includes a housing 170 and, in the shown embodiment, a barcode 173. The passage hole 171 is made in size for a snug fit of the nozzle 168. In the shown embodiment, this tight fit is achieved thanks to two protrusions 175 configured to receive the nozzle 168 and holding the nozzle 168 in the desired position in front of the passage opening 171. In FIG. 25, the passage 172 in the housing 170 is turned upside down so that the device shown in FIG. 25 is a device with a bottom entry in contrast the top entry device shown in FIG. 24. Naturally, you can use the device with input from the side and from a different direction.

Identification mark 173, which in the embodiment shown is a barcode, but a 3-dimensional barcode is also possible, another scanable identification index and another system for identifying a mechanical landing or something else, for example, mechanically landing a particular light source or viewing device in a pre-door device or a removable end piece may be especially useful for a number of reasons. For example, an end piece and / or a pre-door device, and / or viewing devices, etc. can be equipped with these identification devices to ensure the correct use of specific combinations of light filters or the correct use of other special embodiments, for example, to ensure that the AMLS system, in which the window that prevents cross-contamination, is located in the enclosure itself, is used with a removable end piece (if presence) and a viewing device that does not contain such a window, to prevent excessive optical interference in the system while ensuring at the same time the scope of the use of a pre-door device with a window, since, otherwise, a clear passage would be created between the patient and the relatively expensive optics and mechanisms of the direct observation device, etc. In addition, the identification mark mentioned can serve to confirm that the manufacturer’s filters are used appropriately with carefully selected other filters so that a system suitable for use in fluorescence studies is properly provided with all parts of the system and does not mix with a system specifically designed for testing infrared light. Identification mark 173 may be placed in any desired location, for example, as shown, on the front surface of the mounting hole, in any other location on the pre-door device, inside a ring or other mounting area of the pre-door device, so that the pre-door device is only mated to the specific required examination device tool, etc. or on the instrument or device for examination, or on a removable end piece, or on several of the mentioned structures, or, if desired, otherwise.

On Fig presents mounting part 166, comprising a housing 170, which can be made of Mylar (polyethylene terephthalate), cardboard or any other required material, mounting cut-out 174 and substrate 176, which are attached to the bedspread 178. Figs. 27 and 28 show the installation procedure of the light source 180 (or a viewing device, etc.) in which the viewing device is first rotated, as shown in FIG. 27, so that the elongated pipe 168 can be moved through the passage 172, and the entire light source 180 is rotated 90 ° clockwise for clutch the elongated pipe 168 for the protrusions 175 of the housing 170, so that the pipe cannot be removed until the light source 180 is turned back to its original position and extended. FIG. 29 shows another embodiment of such an installation system in which the outer fabric 184 of the passage opening 182 forms a substantially oval hole, while the inner fabric 186 forms a substantially circular hole. Each of the passages is formed by a seam or edge 188, which may, if desired, be configured to provide rigidity.

On Fig.28-2 presents a front view of the rotary locking configuration of the plug-in bore.

On Fig presents an enlarged side view of the passage opening and the pre-door device containing several layers of tissue and having passages of different shapes for the formation of the passage hole with a fixed fit into it of the viewing device.

FIG. 30 is a front perspective view of a viewing device 104 comprising a distal end 190 and a proximal end 192. The proximal end 192 includes an eyecup 194, which serves as an eyepiece frame and provides the user with a convenient stop for eye placement and at the same time does not allow a larger parts of the external light interfere with the user during the examination. The distal end 190 includes a connection region, which, as shown, contains essentially annular flange and edge; other configurations are also suitable. The viewing device 104 further comprises a handle 198, which in the depicted embodiment is connected to a conduit 200, which passes to any external products, such as a power source, a light source, imaging equipment, such as CCD (CCD) cameras, CID (injection devices charge), CMOS (CMOS structures) or other digital or analog cameras, imaging devices, etc., as well as devices for spectral analysis, such as spectrophotometers, spectroradiometers , Spectrographs, etc. In the depicted embodiment, the head 201 of the viewing device 104 is substantially shortened relative to the handle. Other configurations are also suitable, but providing a substantially short head 201 provides some advantages in some embodiments, since the relatively small head length allows the doctor, dentist, or other user to get as close to the tissue being examined as possible and may further facilitate viewing in different directions in confined spaces. for example, colposcopy and examination of the oral cavity. In addition, although in the presented embodiment, the viewing device is connected to external power or other devices, if desired, the entire system can be provided in the form of one fully portable device that is not connected to anything. On Fig presents partially exploded side view of the viewing device 104.

On Fig presents a partially exploded side view of the sighting device 104, in which some elements of the head and handle are removed to allow observation of the internal elements. In the present embodiment, the objective / collecting tube 206 is located in the direction of the distal portion of the viewing device 104, with the optical element selective to wavelengths, for example, a beam splitter 204, essentially located mainly in the head of the viewing device 104, and the filter 202 is located on the proximal portion of the head. Shown are also components of the handle 208 located inside the handle.

On Fig presents a side view in section of a viewing device 104 containing the distal end 190 and the proximal end 192. The device further comprises an eyecup 194 and a beam splitter 204. The beam splitter 204 allows light to pass through the conductor 200 into the interior 207 of the viewing device 104. Then, the light is projected upward through the optical element 209 to a beam splitter 204 that reflects light into the passage at the distal end 190. As noted elsewhere in this application, the light may include excitation light suitable for excitation I fluorescence, white light, infrared light or light of other categories, at the request of the user. In addition, if desired, it is possible to provide such a light so that it is possible to selectively control or change it by the user and / or switch between different viewing or lighting modes. In addition, light can be used for illumination on reflection, illumination for excitation of fluorescence, for therapeutic purposes, for diagnostic purposes or other illumination, if desired. In the illustrated embodiments, the user examines the colposcopic portion of the patient. The light returning from the patient is collected by the projection / collecting tube 206. As can be seen, the projection / collecting tube 206 is connected with the possibility of a connector with a pre-door device 50 in the passage hole 52. The light emanating from the patient is transmitted through the selective optical element 204 and into the eye user. Optionally, the light coming from the patient can also be sent by the beam splitter 204 back through the handle to at least one camera, an analytical device such as a spectrograph, or other analytical elements. In addition, if desired, the viewing device 104 may contain at least one filter, for example filters 211 and 213. If desired, the filters can filter only the backlight or only the emitted light, and, in this case, in the shown embodiment, the filters they would usually be located either in front of or behind the beam splitter, or, if desired, the filters can perform the function of filtering both the backlight and the emitted light, and, in this case, the filters would usually be located in front of the beam splitter Telem, as shown in the present embodiment.

On Fig presents a side view in section of the head of the viewing device 104 shown in Fig. In addition, a third light filter 215 and a fourth light filter 217 are shown located in front of and behind the beam splitter 204.

On Fig-43 presents schematic side views in section of a number of different connecting mechanisms for connecting various devices in the system.

On Fig presents one exemplary connecting node, suitable for mounting a sighting device 104 to the conduit 200 or for mounting a distal removable end element. In both FIGS. 34A and 34B, the optical path 210 is shown, the male end 219 and the female receiving end 221. In FIG. 34A, the male end 219 is fixed in operative connection with the female end 221 by means of a compressible ring seal 212 that is installed in the receiving groove 223. The ends You can connect and separate just by moving them with effort and stretching. Similarly, in FIG. 34B, male end 219 is secured in female end 221 by means of a wide malleable material 214 that is crimped into the mating wide groove 225. O-ring, malleable material, and the like. can be made of any suitable material, for example plastic, sponge, rubber, etc. As you can see, in the desired embodiment, the conductive path of the optical beam is aligned according to the working connection.

Fig. 35 shows an alternative connector in which the male end 219 of the conduit 200 is attached to the female end 221 of the handle 198. The connection is achieved by means of a fastening thread 218. If desired, the device may further comprise a window 216 that normally does not fluoresce, is transparent and does not reflect.

On Fig presents landing using protrusions and grooves, which acts similarly to the options for implementation presented in the previous figures. In this embodiment, snapping is provided on the protrusion 220 to improve the mutual fixation of the two ends.

On Fig presents another quick fit, in which the lever-latch 22 acts in conjunction with a spring-loaded pin 226 for reliable mutual fixation of the male and female ends with the possibility of their connector. In the shown embodiment, the O-ring 224 held at the female end 221 interacts with a groove 227 at the male end 219. The spring pin 226 and the latch lever 227 cooperate to fix the ends of one to the other and thereby provide a mechanism for more secure holding which is significantly less likely to plug in if unintentional application of significant pressure.

On Fig presents an embodiment of a removable end piece 96, designed for illuminating and collective optics. Briefly, a removable end piece 96 is pushed onto a suitable protrusion 229 of the sighting device 104. The backlight path 111, which may be a hollow tube, a fiber optic cable, a fiber optic bundle, a liquid fiber, or any other desired fiber, conducts the backlight from the viewing device 104 along the pathway 228 of the backlight, then through the band-pass filter 232, a collimating lens 234 and an output lens 240. Then the light is sent to the patient’s shoulder and then the fluorescence signals, reflection, combination ion (Raman) scattering or other light emitted from the patient’s hand is distributed into a collecting lens 236, passing through a high-pass filter 238 and collimating lenses 234, and into a receiving optical path 230. In the shown embodiment, the filter 234 is a band-pass filter that transmits essentially, only excitation light suitable for inducing fluorescence in fluorophores (either autofluorophores or fluorophores required by this fluorescent drug means, etc.) in the object being examined, while the high-pass filter 238 cuts off essentially all the excitation light and transmits only the fluorescence light emitted by the patient.

In the embodiment shown in Fig. 38, the band-pass filter 232 protrudes from the protrusion 229 into the mating socket 221 in the adapter 96, which provides a suitable identification system and organization of work with devices, such that the optical path of the backlight and the optical path of the collected light do not create mutual interference. On Fig presents a similar variant of implementation, which relates to optics.

In Fig. 39, the optics comprise fiber beams 232, but of course other suitable optical fibers can also be used, as well as an output lens 240, a band pass filter 232, a collective lens 236, and a high pass filter 238. In this embodiment, the device lacks a protective band-pass filter 232 and a corresponding socket 231, as in FIG. 38, so that the optical connection with different elements of the device will usually be determined by the user, confirming the valid signals.

On Fig presents a view in section of the adapter 96, containing lenses and mirrors to enable lateral viewing. The optical path 228 of the backlight light passes through a socket 231, a collimating lens 234 and to an angled mirror 244, which directs the light outwardly from the output lens 240, which is located on the side of the adapter 96. In the optical path 230 of the collected light, light is collected through the collective lens 236, which it is transmitted by an inclined mirror 234 and then in the proximal direction through a collimating lens 234 into the viewing device. On Fig presents an alternative adapter for side viewing. 41, the adapter 96 comprises optical fibers 246, 248 that deflect light at an angle from a viewing device (not shown) and then project and collect the light from the respective collecting optics 246 and illuminating optics 248.

On Fig and 43 presents side views of two flexible adapters. On Fig presents a grooved flexible sleeve 250, and this flexible sleeve can be bent and rotated by the user according to the requirements to the extent permitted by the materials selected for the manufacture of the device. On Fig presents a flexible rubber pipe 252, which can be freely bent and rotated, and a connecting mechanism 254, which serves to increase the rigidity of the adapter according to the requirements and to fix it in a predetermined position.

On Fig presents a side view in section of an adapter containing both a power source and a light source. Briefly, the protrusion 229 of the adapter 96 comprises a battery 266 connected for operation to a light source, for example an LED (light emitting diode) 264. As shown, the wires 258 pass through a current limiting resistor 260, so that depending on the configuration, the intensity can be continuously adjusted and, possibly, the color of the light emitted by the light source 264. The battery 266 and the light source 264 are turned on and controlled by a switch 256, the light emitted from the light source 264 is discharged from the adapter through the filter 262 to the patient, and then the return light is collected in a collective light path 268 similar to the paths described elsewhere in this application, or having a different configuration according to the requirements. In the embodiment shown, light is projected from the adapter into the OS (optical system) for examining the neck and, likewise, the return light is returned from the OS. In some embodiments, the side view devices described herein may be particularly useful for survey data.

On Fig presents a side view in section of a viewing device 104 having a proximal end 102 and a distal end 90. The handle, power source, optical system, etc. shown in Fig, can be provided either in the form of a manual unit, which, in fact, forms the viewing device itself, or in the form of a manual unit, which is configured to be attached to the viewing device, usually at the distal end.

The handle 198 comprises a plurality of elements for providing power and light, a power battery 274, a fan 272 for cooling, and a heat sink 270, which also aids in cooling. The battery pack 274 supplies power to the light source 264, which emits backlight to the filter 262, which in turn supplies light to the backlight 242 to pass to the distal end 190. Power source, light source, etc. they are operated by a switch 256, which, as shown, can preferably be placed on the proximal side of the handle like a trigger element, but can also be placed in any other desired location. On Fig presents in perspective view a schematic representation of ALMS. In this embodiment, the housing 277 comprises a light source, a power source, a camera, and other required analytic or imaging elements, if any. On the proximal side 276 contains port 279, from which the conduit continues, containing optical fibers, electric wires and other required elements. The conduit 200 passes the required signals, lights, etc. into a viewing device 104, which contains a light pencil 278 and an adapter 96. In the shown embodiment, the power source 282 is located next to the housing 277 and contains a power cable extending from the power source to the viewing device 104. The light source and power source each include your wall outlet 284.

On Fig presents a viewing device 104 having a distal end 190 and a proximal end 192 and containing a conduit 200 extending from the base of the handle 198. As you can see, the conduit is quite long (usually about 4-15 feet long) and ends with a male connector an adapter 284 configured to be plugged into an external power and light source. On Fig presents a viewing device and conduit shown in Fig, but connected to an external power source and light.

On Fig presents a viewing device 104 connected by conduit 200 and a removable adapter 284 to an external source 286 of power and light. External power and light source 286 comprises a holder 288 that is responsive in shape to the viewing device 104 and sized to hold the viewing device in the desired position on the holder.

On Fig presents a tool 288 containing a cantilever part 290 with a protrusion 300, made with the possibility of fastening to the distal end of the viewing device. Fig. 49 is a perspective view of a tool 288 suitable for fastening by a passage ring 302. The passage ring 302 is slidably mounted, snap-fit, snap-fastened or otherwise attached to a viewing device, typically at the distal end. Tool 288 includes a console portion 290 that is designed to prevent unwanted selections from entering the viewing path. Accordingly, the cantilever part 290 can be made with the possibility of tightening the tongue, tightening the wall on the vaginal side or other possibility in accordance with the requirements. The tool 288 may be rotatable after it is attached to the viewing device, or it may be configured to be fixed and held in one position or in a movable position in which friction or other force holds it in a predetermined position, into which the user moves him. In addition, if desired, the cantilever portion 290 may be configured to extend and retract, or, as shown, may be of the same length.

On Fig presents a side view of the device shown in Fig. 49.

On Fig presents a perspective view with a spatial separation of the parts of the viewing device 104. The handle 198 is attached to the head 201 by bolts 304, which for aesthetic and hygienic purposes are closed by caps 306. The handle contains an internal frame 308, which supports various elements in the required position and also provides extra strength. Usually the frame, handle, head, etc. made of plastic or other low-density material, but can also be made of metal or other material acceptable in medicine, and are usually made so that they can be autoclaved, sterilized with liquid sterilizing liquids, or otherwise processed to maintain a clean medical or dental environment . A viewing device 104 is shown in combination with a tool 288. The tool 288 is a detachable tool in the present embodiment, comprising a ring 302 that is mounted by a bayonet lock system 316 to the distal end 190 of the viewing device 104.

Then, the cantilever portion 290 of the tool 288 is snapped onto the ring 300. The retaining ring 300 includes a plurality of locking tabs 318 that snap onto the cantilever portion 290 and lock it in a predetermined location. As can be seen, the cantilever portion 290 can be connected and disconnected and installed end-to-end in almost any position on the ring 302.

The frame 308 contains many optical elements, such as filters and mirrors, which can be seen from their mounting structures. For example, the short-wave filter 314 is held in the structure between the light source and the mounting structure for the dichroic mirror 141. In the shown embodiment, the short-wave filter 314 transmits essentially only blue light, i.e. light with wavelengths less than about 450-500 nm, which is light that is essentially safe for human illumination (without the potentially harmful effects of ultraviolet light), but has enough energy to excite fluorescence, such as autofluorescence or added fluorescence fluorophores. Other filters with different characteristics can also be installed in this place, and, if desired, a changeable gap or other design can be provided so that the insertion and removal of different filters are allowed in one sighting device. Alternatively, it is possible to provide several viewing devices with different combinations of light filters.

The dichroic mirror 141 reflects the light from the light source to the distal end 190 of the viewing device 104 and the window 303 of the instrument 288. The return light from the patient passes back through the window 303 and the dichroic mirror 141. In the shown embodiment, the dichroic mirror 141 acts as a long-wave filter with a boundary wavelength about 475-480 nm, i.e. This filter does not transmit light with shorter wavelengths and transmits light with longer waves. In the shown embodiment, the dichroic mirror 141 blocks essentially all of the excitation light transmitted by the short-wavelength filter 314. On the proximal side of the dichroic mirror 141 is the mounting structure of the second long-wavelength filter 310, which cuts off essentially all of the unwanted light transmitted by the dichroic mirror 141 In this embodiment, substantially all unwanted light is cut off from the user. If desired, other additional filters can be provided, a narrow-band filter 312 inserted into the installation structure behind the second long-wave filter 310. In one embodiment, the narrow-band filter transmits essentially all of the light except for light in a band of approximately 585-595 nm. This particular embodiment is particularly useful for detecting cancer of the oral cavity, cervical cancer and other types of cancer, in particular because suppressing said light helps an observer to distinguish between diseased and non-diseased tissues. The mentioned narrow-band light filter can also be especially useful for detecting other pathological changes, in particular pathological changes, causing a shift in the fluorescence characteristics in the red region of the spectrum in accordance with the existing disease or condition.

On Fig presents a schematic view of a binocular site 326 containing binocular viewing devices 320, which in the shown embodiments are made essentially in the form of glasses containing independent lenses, one for each eye, lenses 330 and eyepieces 328. Binocular viewing devices 320 are detachably connected to binocular through-holes 322 at the junction 323, after which the adapter 324 combines the optical paths for each of the binocular lenses into a single optical light pathway exiting through the aperture 332. In other embodiments, the possibility of binocular observation of this embodiment can be extended to the actual examination area and therefore usually with separate viewing apertures and, if desired, separate backlight zones. This can be especially useful in some cases, since it is possible to provide different wavelengths of light or different light rays having other different characteristics, for example different polarization characteristics, for examining different areas or one area independently with each eye of the user.

Additional general description

In some embodiments, the viewing device provides light to excite fluorescence, for example, by transmitting white light through (e.g., a transmission or reflective) filter that transmits essentially light only within the excitation range, e.g., 400-450 nm (in some embodiments, it is advisable to use only light that is substantially longer than approximately 400 nm so that ultraviolet light, which can be dangerous, is not part of this light). Exemplary filters contain short-wave and band-pass filters.

Then the excitation light comes into contact with the object being examined. Then, response light is emitted from the object being examined, usually as a result of fluorescence, although it is sometimes possible to use reflected light or other light, such as infrared light or Raman light, either in addition to or instead of fluorescence light. Then the viewing device itself processes the emitted light collected by the viewing device and directs it to the observer (and, if desired, to another device (s), for example, a camera, a video signal detection device, for example CCD (CCD), CID (device with charge injection), CMOS (CMOS device), etc., either into a computer, or a spectrometer, or other spectral measuring device).

The optical path of the diagnostic light of a sighting device typically contains at least one long wavelength filter or other desired filter, which essentially blocks the excitation light so that only light in the longer wavelength range can be seen. In one embodiment, such blocking is accomplished by using a dichroic mirror with a boundary wavelength of about 475-480 nm (i.e., this filter does not transmit light with shorter wavelengths and transmits light with longer waves), followed by a green glass »A filter that also does not transmit light with wavelengths shorter than approximately 475-480 nm, and transmits light with wavelengths greater than the reduced wavelengths.

In some embodiments, the viewing device further comprises at least one light filter that processes the light so that the bands of different wavelengths of the diagnostic light remain visible, while the band (s) of the other wavelengths are substantially cut out or substantially attenuated in power or intensity. For example, behind a long-wavelength filter (s) along the beam, a viewing device may comprise a narrow-band filter that transmits essentially all of the light except for light in a band of approximately 585-595 nm. This particular embodiment is particularly useful for detecting oral cancer and some other pathological changes.

You can also apply other (s) suitable narrow-band (s) light filter (s), for example, to increase the visibility of oxygenated and non-oxygenated blood (i.e., oxyhemoglobin and deoxyhemoglobin), or to distinguish between activated and deactivated drugs or diagnostic markers. If desired, it is also possible to provide at least one filter with a variable or unchanged non-uniform spectral transmittance, for example, the filter described in US Pat. No. 6110106, so that the corresponding relationship between different bands of transmitted wavelengths can be changed in the desired embodiments. Further examples of multi-band bandpass filter combinations are also proposed in US Pat. No. 6,221,344. As noted earlier, both of the above references are incorporated by reference in their entireties and information, including descriptions of endoscopes, filters, suitable sensors, and sources. light etc.

If desired, the viewing device of the present invention may be a substantially hollow body containing filters, typically placed on the handle for ease of use. In some embodiments, the device may further comprise an elongated element for attaching to the distal end of the viewing device (or to another location according to the requirements), and this elongated element can be used to squeeze interfering tissue or body structures, such as cheeks, tongue or vaginal walls , from the observation line of the sighting device so that observations can be improved. Examples of some embodiments of this device, sometimes called a "retractor", are presented in the figures in this application. In one preferred embodiment, the tissue transfer device is rotatably mounted to a viewing device so that it can be much easier or more efficient to move within the oral cavity or other body cavity being examined.

The physical composition of the viewing device can be significantly changed depending on the specific intentions and needs of the user. For example, as noted above, a viewing device can be essentially only a hollow body with the required optics, which simply conducts light from an external (usually proximally located) light source to the tissue being examined and then returns the light from the tissue being examined to the eyepiece of the viewing device ( the eyepiece is usually an eyecup, but may also be another suitable ocular device, for example frosted glass, and may be monocular or binocular as required). If desired, the viewing device, either alternatively or additionally, can be performed with at least one internal light source, a distally located light source (for example, an LED (light emitting diode) and / or a proximally located light source and at least one optical fiber, fiber optic cable or other light guide element, in addition to or instead of the optical fiber, formed by a hollow body containing suitable optical elements described in this boiling application.

An inspection device typically contains a power source to provide light. The power source may be an external power source, such as a battery connected by a wire, a battery contained in a handle or elsewhere in the viewing device itself, or a plug or other suitable device for connection to a wall outlet or other power source. The figures show exemplary combinations of power / light sources. In some embodiments, the implementation of the housing of the light source contains an installation structure made with the possibility of fixing the sighting device when it is not used.

As noted earlier, if desired, the viewing device may contain at least one material sensitive device, for example, sensors containing CCD (CCD), CID (devices with charge injection), CMOS (CMOS structures), etc., and / or at least one display device, for example CRT (CRT), flat panel display, computer display screen, etc. In addition, if desired, the viewing device system may include at least one computer that controls, processes and / or interprets various functions of the viewing device, including, for example, diagnostic, research and / or therapeutic functions.

By "computer" is meant a device that is capable of controlling a light filter, a selective light modulator, a sensor or other elements of the devices and methods proposed in this application. For example, the controller can control the light transmission characteristics of a selective light modulator, control the on / off state of the elements of a light sensor composed of elements (e.g., a charge coupled device (CCD) or a charge injection device (CID)), and / or collect data from the sensor , including the use of the above data for the formation or reconstruction of images, in the form of feedback data for controlling the backlight or other elements of the devices and methods proposed in this application, for example Imer, for diagnosis or treatment. Typically, the computer contains a central processing unit (CPU) or a logical device, such as a stand-alone computer such as a desktop or laptop computer, a computer with peripheral devices, hand-held, local or network, etc. Computers are widely known and the selection of the desired computer for a particular property or feature can be made by a person skilled in the art in light of the disclosure of the present invention.

In one exemplary embodiment, the system provided herein comprises a light source, a manual viewing device, a pre-door device (ALMS), a retractor or (cheek presser), an optical conductive path, a light unit (light source), a light guide and an eyepiece at the proximal end of the viewing device. The optical path continues from the optical path of the illumination light to the object under examination, to the user and inside the manual viewing device, contains, in the indicated order, a collimator, a 430-nm ± 30-nm filter (filter 1), a dichroic filter (filter 2), a light absorber, glass window, mucous tissue or other tissue being examined, dichroic filter (filter 2 (light passes back the same dichroic filter), 475-nm long-wave filter (filter 3), 590-nm narrow-band filter (filter 4), oculus The filters can be either separate (discrete) or combined (for example, reflective coatings) .The systems can also, or instead, contain binocular eyepieces, such as magnifiers / filter glasses or sunglasses / glasses with / without magnification and a curing light source. curing light may contain a multi-wave system (for example, a second head with a separate filter), and the wavelength of the curing light can be adjusted by independent filters and / or interchangeable filters, etc. . Some other features that may be included include a light pencil, a mirror and / or fiber optics, usually with a collimation, or an LED (light emitting diode) in the pencil, or an oral insertion chamber, which may include a tube with a light filter on end to provide, in particular, the required light and therefore act as a light pencil and thereby as a light source or as an additional light source for fluorescence or other desired purpose.

Designs of cameras for insertion into the oral cavity may include multiwave optical processing inside and outside the camera. The light may be transmitted through the system, or the light source may be turned on, or there may be a separate tube (or other suitable light emitter) emitting its own light. The tube may comprise appropriate filters for radiation / excitation wavelengths. The position of the filter and other optical element may vary within the optical path, provided that the required functions are provided.

The conducting paths of the illumination and observation light can be combined, as in some figures, or separated, as in a light source with magnifiers / goggles. Optical conductive paths can improve the user experience when using the device using a standard surveillance and backlight method. From the point of view of two people observing the oral cavity at the same time, each of them observes the illuminated tissue at a different angle, and therefore they see different tissues and are likely to make different diagnoses. A tripod is sometimes used to reduce the likelihood of changes by standardizing height and angle. The size of the examined spot in some embodiments is assigned to compare the entire lesion with the surrounding normal tissue, which improves the observation and identification of anatomical landmarks to determine the location.

In some embodiments, the intensity is optimized to illuminate the tissue with excitation light for diagnosis to excite the necessary fluorophores to generate a signal. In some embodiments, the implementation of the wavelength (s) (s) optimized for the recognition of certain types of cancer detected in the oral cavity or other examined tissue. Fluorescence wavelengths increase the ability to recognize a shift in the fluorescence spectrum in order to create the possibility of determining the difference between normal and pathology for cancerous tissue. For example, double control in two bands of wavelengths within the range of approximately 475-585 nm and from approximately 595 nm and higher enhances the ability to control cell activity with respect to the metabolic cofactors NAD (nicotinamide adenine dinucleotide) and FAD (flavin adenine β-dinucleotide). The fluorescence maxima of NAD and FAD are for given wavelengths.

In some embodiments, it is desirable to obtain as much power as possible without unduly blurring the emitted signal to obtain a narrow output spectrum to prevent Stokes shift and eliminate ultraviolet light to avoid backlighting / excitation by light in the emission band (fluorescence superposition).

In some embodiments, systems may further comprise a diffuser to provide more uniform spot sizes, exceptions that are too bright spots, and the like. Sometimes it is also desirable to use a collimator to align the light rays on the filter and to limit the beam divergence in order to increase the power density, or to use a liquid fiber, rather than fibers, in order to achieve an increase in efficiency by reducing idle space between the filters and improving transmission at fixed costs and increase the numerical aperture (which further improves the collection of light). In other embodiments, the systems may further comprise metal halide light sources to increase power in certain emission ranges, dichroic filters or similar optical elements to improve the combined optical paths of observation and illumination (capable of simultaneously directing backlight from the source and the light emitted from the fabric). A glass or other transparent window on the front of the sighting device can protect against dust.

In some embodiments, for viewing the oral cavity and other purposes, a viewing device is used at a distance of about 4 inches from the device to the back of the oral cavity or other object to be examined; moreover, if desired, spacers can be provided. Viewing instruments can be blackened internally to absorb stray reflected illumination and emitted fluorescence light (unwanted fluorescence feedback).

The shape of the viewing device can, in a preferred embodiment, be made convenient, from an ergonomic point of view, with optimization of the conductive paths of the excitation light and the emitted light. The proximal eyepiece can be installed at such a distance that the inclination of the proximal filter (for example, a 590-nm narrow-band filter) creates such a geometry that it is possible to attenuate the external illumination coming from the back of the doctor, and the part that passes through can be rejected by absorbing inner surface of the pipe. This attenuates reflections and excludes the user from observing their reflections. For example, the proximal filter can be tilted upward closer to the doctor and downward closer to the dichroic mirror to create a reflective surface that directs incoming light to the bottom of the optical path.

The ability to remove eyepieces can allow the insertion of an adapter under the camera. In some embodiments, the camera is attached as close to the dichroic mirror as possible, which reduces the length of the optical conductive path inside the viewing device to the camera, which, in turn, reduces the likelihood / tendency of the camera to autofocus on the inner area of the VELScope. This solution may also be important, since fluorescence light may have a low intensity (require the use of high-sensitivity (according to ISO) films / settings, long shutter speeds), while autofocus can be triggered by other objects, since usually in this mode the camera focuses on an object with the greatest brightness in the field of view.

A cheek retractor or other tissue manipulation device may be located at the distal end of the viewing device. In the oral cavity of patients, there are areas that are difficult to access just for visual observation. A retractor of the cheeks or tongue facilitates access to these tissues and gives the doctor the so-called “third hand”, i.e. one hand holds the viewing device, the second holds the tongue and the "third" takes the cheek. This can be especially important if the doctor is forced to work alone.

The retractor can be made in the form of a base and a removable console and can also be configured to function as a cap to prevent contamination. In some embodiments, or for convenience, the retractor may occupy many positions around the end of the sighting device, for example, eight circumferential positions into which the retractor can be mounted if different angles are preferred. The console (s) of the retractor can be removable so that when they are not needed, they do not interfere with the procedure, for example, by clicking on the doctor and / or patient. A console may be required to access only 10% of the oral cavity.

The retractor console (s) can be tilted like a dental mirror. The console (s) may be structurally similar to other instruments that the doctor uses to prevent slippage of the lips and cheeks. The console can be shaped so that only a small part of the retractor can be observed to reduce the overlap of the observation line, but the doctor can always know where the tip is. External Light Control (ALMS) is also used for shielding against external light.

The cheek retractor may include a ratchet mechanism to provide for adjusting the angle of the cheek retractor without removing it from the device. Preset positions of the retractor can set certain positions for the device for documentation purposes, for example, "when the device was in the NW position (middle of the second quarter), an area was observed ...". The seal between the retractor and the rest of the VELScope can only be locked in position at the friction or in the grooves or grooves located around the circumference of the device. Instead of eight positions, it is possible to use a completely smooth ring on the VELScope device, which allows continuous positioning (an infinite number of positions), for example, if angular alignment is unimportant. Instead of eight positions, six positions are possible (for example, with top and bottom or without them), four positions (for example, if you needed a square plan that could be useful with a square window), or any other number of positions.

In some embodiments, the systems also comprise at least one removable treatment head, and the system can be modular with several heads for one light source, for example, to treat 476 nm light, excite fluorescence with 430 nm light to detect cancer, and excitation of fluorescence with 405-nm light to detect dental caries. Different components can be interconnected by any desired method, for example, with the possibility of quick disconnection, fit on friction, on threads, etc. The head may contain different filters according to the task, for example, diagnosis / treatment of caries / gingivitis.

For treatment, a combined optical observation / illumination path (or providing a truly optical observation path) may not be desirable in some embodiments, since the physician may not need to be able to observe the object being treated, but may provide some advantage, for example, because the backlight can be filtered out to protect the user's eyes from him (usually from harmful ultraviolet light), therefore, the filter after the light source can be represented by a combination of a glossy light filter and a narrow-band light filter for transmitting a wide range of wavelengths, including blue to red, and there is also a wide depression in the middle to remove all other light. In other words, they are exposed to blue light, observed in red light, and observation of fluorescence is not necessary.

In some embodiments, the systems also include a crosshair for the observer to aim at the observation site or contain another laser or side light source, such as a dual LED, to provide aiming light. In various embodiments, the treatment head may be a light filter that selects the desired backlight wavelength, and a treatment head to direct the backlight. The treatment head can be fixedly attached or a finished commercial (COTS) product that can be detachably attached to the filter head, if necessary. The treatment head may be a standard, fiber optic, free light tube, etc., using any desired method of delivering light from the filter to the tissue.

As noted elsewhere in this application, sometimes several light sources may be provided in one viewing device. When observing in white light, if desired, you can provide a wider band of output wavelengths. A wider band can be obtained due to an additional light source (LED, halogen, etc.) or by using different filters at the output of one light source. Systems can also be equipped with several maxima. For example, this solution can sometimes be used in pharmacological / physiological testing of biological markers when the emitted fluorescence (tissues, markers or chemicals) changes in the presence of different ions / molecules / pH. This solution can also be used to ensure normalization, since the fluorescence power produced by each wavelength can be compared with one another and normalized. In some embodiments, systems also include timers to turn off lights to withstand a specific treatment time or other purpose, such as saving energy.

In some embodiments, the viewing device comprises shock absorbing supports for isolating the optical conductive path in VELScope devices. This solution can be provided, for example, by a second exoskeleton winding on the first, but separated from it, air gap with contact along the rubber sealing ring shock absorbers laid between the tube of the optical conductive path and the outer shell. It also provides a convenient way to change the color of a device without resorting to expensive forming technologies. The internal optical pathway is usually black for absorbing light, and black cannot be the color commonly used in medical installations because of its depressing effect and because it looks dirty due to residues of cleaning solution and powder from latex gloves. The outer shell may be of a different color, for example, white, beige or commonly used colors to hide said impurities.

In some embodiments, the systems comprise a square window or passage opening, which is cheaper to manufacture than a round window due to process features, such as the use of circular saws compared to cutting in straight lines, and waste reduction. In addition, this configuration (or other non-circular configuration) may facilitate the user to manipulate the ALMS by creating friction / structural fit between the ALMS and the sighting device. A square window may also be desirable when using relatively inexpensive non-fluorescent glass / material in an optical conductive path, although this material can also be used with other geometries.

The distal end on the VELScope device may contain a female bore, which may be square at the very edge of the distal end, but, if desired, the optical conductive path may remain round. The through hole on the VELScope can be fixed or removable so that you can use windows of different shapes or the standard ALMS design. The ALMS form can be such that there can be more material on the distal sides - closer to the patient, further from the doctor. Thanks to this, ALMS interferes with the doctor less, the doctor provides an advantageous opportunity to block natural light, and ALMS may contain a cutout for the nose.

In some embodiments, the implementation of the systems use weak adhesives with the ability to reinstall for exposure "after observation". The position can be adjusted on demand, with no residue or permanent attachment to the glass. This solution allows the reuse of safety glasses and the removal of contaminated ALMS. When using this adhesive, it is also possible to perform ALMS “sheets” combined into blocks, and a new sheet can be removed if necessary. The ALMS size can cover both the sighting device and the arm. The material may be black or other dark material for absorbing reflected light and external illumination and for absorbing autofluorescence emitted by ALMS itself. For the manufacture of polypropylene or other material, it is desirable from the point of view of low cost and possible removal. The mass can be selected so that the curtain does not create too much interference with the doctor.

All terms used in the present description are used in accordance with their usual meanings, unless otherwise clear from the context or clearly indicated in the description. Also, unless expressly stated otherwise, the term “or” includes the meaning of “and” and vice versa. Non-limiting terms cannot be interpreted as limiting unless otherwise expressly indicated or obviously follows from the context (for example, “comprising”, “having” and “including” usually means “comprising without limitation”). The singular forms, including in the claims, for example, the definite and indefinite articles of the singular, include the plural, unless otherwise expressly indicated or obviously does not follow from the context.

Viewing device in accordance with these systems and methods, etc. contains concepts of both means plus functions, and stages plus functions. However, the terms given in this application cannot be interpreted in the claims as meaning the relationship “means plus function” unless the word “means” is specifically presented in the claims, and should be interpreted in the claims as meaning the relationship “means plus function” if the word "remedy" is specifically presented in the paragraph of the formula. Similarly, the terms given in this application cannot be interpreted in the claims claiming a method or process as meaning a “step plus function” relationship unless the word “step” is specifically presented in a claim and should be interpreted in the claims as meaning a relationship “ stage plus function "if the word" stage "is specifically presented in the claim.

The innovations proposed in this application include not only the devices, systems, etc. described herein, but all related methods, including methods for manufacturing a system, manufacturing elements of systems, for example, specific devices such as ALMS or viewing devices, as well as methods of application devices and systems, for example, attaching ALMS to examination devices, and the use of systems for examining tissue (or other use of an examination device for diagnostics, treatment, etc. of tissue). In some embodiments, the present innovations include methods for using a viewing device for both diagnosis and treatment of teeth, for example, for curing cyanoacrylate adhesives used to attach or adhere dentures or other products to the oral cavity.

EXAMPLE

Example 1: Use of a viewing device to detect primary dysplasia in the oral cavity

The use of a viewing device to detect primary dysplasia in the oral cavity (number of patients N = 49) based on autofluorescence. The optical path of the viewing device contains the following order: collimator, 430-nm ± 30-nm light filter (filter 1), dichroic filter (filter 2), light absorber, glass window, mucous tissue or other examined tissue, dichroic filter (filter 2 ( the light passes back through the same dichroic filter), 475-nm long-wave filter (filter 3), 590-nm narrow-band filter (filter 4), eyepiece.The viewing device was used with a pre-door device with a through hole, which was connected for operation nyali with an inspection tool and is screened from the inspected object, substantially all ambient light.

As for the primary pathological changes in patients with a history of oral cancer, the examination device correctly detected the majority of cases of dysplasia (70%), in particular pronounced pre-invasive pathological changes (86%). About 18% of pathological changes not associated with dysplasia were also positive with the use of a viewing device. The examination device also increased the doctor's ability to distinguish pathological changes not associated with dysplasia. Nine out of eleven of these pathological changes not related to dysplasia were clinically diagnosed as precancerous pathological changes in the oral cavity using standard methods, but only two of these false positive reactions were also positive when using a viewing device.

From some other results for ten biopsies from pathological sites identified as positive using a viewing device that were actually dysplasias, biopsies were also taken from neighboring normal-looking areas that were correctly identified using a viewing device as not containing dysplasia.

Claims (42)

1. An external illumination control system (ALMS) for medical use, wherein the ALMS is adapted to fit snugly against a portion of the patient’s body that contains the tissue being examined, and to shield substantially all of the external light from contact with the tissue being examined, the system comprising a substantially opaque vestibule device comprising at least one rail made with a size and configuration that allows the formation of a vestibule that covers at least partly body, and the admission of at least one hand of the user or instrument that the user is manipulating, before contacting the body to be examined inside the vestibule, the vestibule device further comprises a passage opening located so as to ensure the accessibility of the examined object for visual observation, and made with the possibility of essentially opaque accession of the viewing device, made with the possibility of establishing a working connection between the observer and the object being examined, and ALMS d optionally contains a light source configured to deliver light to the object being examined. 2. The system according to claim 1, wherein the ALMS further comprises a viewing device fixed to the passage hole. 3. The system according to claim 2, in which the viewing device further comprises an eyepiece. 4. The system of claim 1, wherein the viewing device further comprises an imaging sensor. 5. The system according to any one of claims 1 to 4, in which ALMS further comprises a spectral measuring device. 6. The system according to any one of claims 1 to 4, in which ALMS contains a tool. 7. The system according to any one of claims 1 to 4, in which the tool is attached to a viewing device. 8. The system according to any one of claims 1 to 4, in which the tool is not attached to the viewing device. 9. The system according to any one of claims 1 to 4, in which the pre-door device is completely opaque and protects essentially all of the external illumination from contact with the object being examined. 10. The system according to any one of claims 1 to 4, in which the fence is essentially rigid. 11. The system according to any one of claims 1 to 4, in which the fence is semi-rigid. 12. The system according to any one of claims 1 to 4, in which the fence is flexible. 13. The system according to any one of claims 1 to 4, in which the fence contains both rigid and flexible sections. 14. The system according to any one of claims 1 to 4, in which the viewing device is removably attached to the passage opening of the pre-door device. 15. The system of claim 14, wherein the viewing device is removably attached to the passage opening of the pre-door device by means of a bayonet mount. 16. The system of claim 14, wherein the viewing device is removably attached to the passage opening of the pre-door device by means of a threaded frame. 17. The system of claim 14, wherein the viewing device is removably attached to the passage opening of the pre-door device by means of a snap frame. 18. The system of claim 14, wherein the viewing device is detachably attached to the passage opening of the pre-door device by means of a threaded frame. 19. The system according to any one of claims 1 to 4, in which the viewing device is permanently attached to the passage opening of the pre-door device. 20. The system according to any one of claims 1 to 4, in which at least the portion of the viewing device is integral with the passage opening of the pre-door device. 21. The system according to any one of claims 1 to 4, in which the light source is configured to emit light through a through hole for a viewing device. 22. The system according to any one of claims 1 to 4, in which the light source is configured to emit light from a viewing device. 23. The system according to any one of claims 1 to 4, wherein the ALMS is configured such that the light source emits light through a second through-hole of the backlight separate from the through-hole for the viewing device. 24. The system according to any one of claims 1 to 4, in which the light source is configured to emit essentially only the excitation light intended to excite fluorescent light from at least one tissue in the object being examined, and the viewing device contains a long-wavelength filter designed to block excitation light and transmit fluorescent light. 25. The system according to any one of claims 1 to 4, in which the light source is configured to emit essentially only light in the range of about 410 - 500 nm. 26. The system according to any one of claims 1 to 23, in which the light source is configured to emit white light. 27. The system according to any one of claims 1 to 4, in which the light source is configured to emit essentially only infrared light. 28. The system according to any one of claims 1 to 4, in which the excitation light is designed to cause fluorescence in at least one of the cancerous or precancerous cells. 29. The system according to any one of claims 1 to 4, in which the pre-door device contains a dark curtain, consisting of essentially non-fluorescent, essentially non-reflective material. 30. The system according to any one of claims 1 to 4, in which at least the inner surface of the dark curtain is dull black. 31. The system according to any one of claims 1 to 4, in which the pre-door device further comprises at least one supple support intended to be mounted on the patient’s nose and flexible for fitting according to the shape of the nose and adjacent region of the patient’s face. 32. The system according to any one of claims 1 to 4, in which the pre-door device further comprises at least one essentially rigid element located and having a configuration for holding the passage opening at least at a predetermined distance from the patient, so that the passage opening does not have contact with the patient. 33. The system of claim 32, wherein the pre-door device further comprises a plurality of connected substantially rigid elements configured to form a frame that holds the passage opening at least a predetermined distance from the patient so that the passage hole does not have contact with the patient. 34. The system according to p, in which at least one essentially rigid element is located and is designed to hold the fence entirely outside the optical path between the examined tissue and the passage hole. 35. The system of claim 33, wherein the at least one substantially rigid member protrudes from the compliant support. 36. The system of claim 33, wherein the at least one substantially rigid member is not attached to a compliant support. 37. The system according to any one of claims 1 to 4, in which the pre-door device is made with size and configuration, providing the possibility of a snug fit around the examined oral cavity of a person. 38. The system according to any one of claims 1 to 4, in which the pre-door device is made with a size and configuration that allows the patient to close his eyes. 39. The system according to any one of claims 1 to 4, in which the pre-door device is made with the size and configuration, providing the ability to not close the eyes of the patient. 40. The system according to any one of claims 1 to 4, wherein the ALMS is made with size and configuration, providing the possibility of a snug fit around the gynecological examined object on the patient. 41. The system according to any one of claims 1 to 4, wherein the ALMS is configured and sized to fit snugly around at least one examined eye on a patient. 42. The system according to any one of claims 1 to 4, wherein the ALMS is configured and sized to fit snugly around the epidermal object to be examined on the patient.

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