Disposable cervical HPV (human papillomavirus) photodynamic automatic therapeutic apparatus

Abstract

The invention provides a disposable cervical HPV (human papilloma virus) photodynamic automatic therapeutic apparatus which comprises a cervical cover for applying medicine and performing light treatment and an insertion main body connected with the cervical cover, a light-emitting element is arranged on the end face, facing the illumination direction, of the cervix uteri cover, a cone made of light-transmitting materials is arranged outside the light-emitting element, and a medicine film is attached to the outside of the cone. At least one part of the cervical cover is made of a light-transmitting material, and the at least one part is a part between the light-emitting element and the vertebral body, so that light emitted by the light-emitting element can be transmitted to the vertebral body in a barrier-free manner; and moreover, one side, opposite to the illumination direction, of the cervical cover is connected to the insertion main body through a connecting shaft, so that the cervical cover and the insertion main body can relatively rotate through the connecting shaft.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a disposable cervical HPV photodynamic automatic therapeutic device. Background Art

[0002] Cervical HPV (human papillomavirus) infection is extremely harmful to women's lives. According to statistics, the HPV infection rate in women is 60% in their lifetime, and 20% of them may turn into cervical cancer.

[0003] Currently, there is no drug that can kill the HPV virus for cervical HPV infection. Laser and electrocautery for cervical cone biopsy are the only viable treatment options, but the consequence is inability to get pregnant, which many young women cannot accept.

[0004] Endocervical photodynamic therapy is a new, non-invasive treatment technology for gynecological HPV infection. The treatment principle is to apply a photosensitizer, such as 5-aminolevulinic acid (5-ALA), to the HPV-infected endocervical area in advance. The photosensitizer penetrates into the tissue and reacts with the enzyme to produce protoporphyrin (Pp IX) with photosensitizing effect. Experiments have shown that when Pp IX encounters light of a specific wavelength (400nm-700nm), it undergoes a photochemical reaction in the body, releasing singlet oxygen ( 1 O2) can kill HPV viruses without harming normal cells, thus achieving selective killing of viruses without harming cells in normal tissues, thereby achieving selective treatment goals.

[0005] In the prior art, in order to achieve the coating of photosensitizer, medical workers need to pre-saturate the gauze soaked in photosensitizer water solvent, use tweezers or cervical dilator to insert the gauze into the cervical canal, and take it out after staying in the cervical canal for 2-3 hours. After that, the cervical canal and cervix are irradiated with a laser or LED light of a specific wavelength to achieve photodynamic therapy. The above-mentioned treatment method not only has the problems of complicated operation and poor patient experience, but also is prone to uneven coating of photosensitizer, which greatly affects the treatment effect. For this reason, those skilled in the art are in urgent need of an injector that can realize the illumination function while completing the photosensitizer coating work, and then simply and conveniently realize the uniform coating and illumination function of the photosensitizer, and realize photodynamic therapy. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a cervical HPV photodynamic therapy device that is easy to operate and can achieve uniform application of medicine and light irradiation in view of the above-mentioned defects in the prior art.

[0007] According to the present invention, a disposable cervical HPV photodynamic automatic therapy device is provided, comprising: a cervical cover for performing medication and light treatment, and an insertion body connected to the cervical cover; wherein a light-emitting element is arranged on the end face of the cervical cover facing the light-irradiation direction, a vertebral body made of a light-transmitting material is arranged outside the light-emitting element, and a drug film is adhered to the outside of the vertebral body; and at least a portion of the cervical cover is made of a light-transmitting material, and the at least a portion is the portion from the light-emitting element to the vertebral body, so that the light emitted from the light-emitting element can be transmitted to the vertebral body without hindrance; and, the side of the cervical cover opposite to the light-irradiation direction is connected to the insertion body by a connecting shaft, so that the cervical cover and the insertion body can rotate relative to each other via the connecting shaft.

[0008] Preferably, the connecting shaft connects the cervical cover and the insertion body in a hinged connection.

[0009] Preferably, the cervical cover and the insertion body can be rotated along the extension direction of the cervical canal via the connecting shaft.

[0010] Preferably, the cervical cover is made of transparent soft latex, and the side in contact with the cervix is ​​a spherical concave surface.

[0011] Preferably, the cone is located at the center of the end surface, and the cone length is 20-30 mm.

[0012] Preferably, the film is a gel film made of photosensitizer ALA which is solid at room temperature and melts at body temperature.

[0013] Preferably, the shape of the medicine film is the same as the shape of the convex surface of the cervical mask cone.

[0014] Preferably, the insertion body includes: a power box connected to the connecting shaft for supplying power to the cervical mask, a handle arranged at the end of the power box opposite to the connecting shaft, and an airbag for fixing the position; wherein the airbag is arranged at the outermost side of the insertion body, and the airbag is equipped with an inflation tube and an inflation switch for inflation and deflation.

[0015] Preferably, the power box is a closed cylindrical shape made of metal or hard plastic sheet, one end of the power box is provided with a power switch and connected to the handle, and the other end is connected to the cervical cover through a connecting shaft.

[0016] Preferably, the power box includes a battery and a timing power board, the timing circuit board is respectively connected to the power switch, the battery and the wire, and the wire is connected to the light-emitting unit; wherein when the power switch is turned on, the power box starts to provide electrical energy to the light-emitting unit when the delay time preset in the timing circuit board is reached to illuminate the cervical canal; when the illumination time preset in the timing circuit board is reached, the power box disconnects the power supply so that the light-emitting unit is extinguished to complete the illumination of the cervical canal.

[0017] Therefore, according to the present invention, when using, by pressing the switch button at the rear end of the power box, the timer can connect the LED wick on the lamp panel at a preset time, and turn off the power at the set time, extinguish the LED light, and complete the photodynamic therapy; in order to prevent the cervical HPV photodynamic therapy device from sliding and slipping out of the vagina during treatment, the present invention also coats the power box with a latex ring-shaped airbag. During treatment, the airbag is inflated by an external air pump through the connected inflation tube, so that the airbag expands and is fixed in the vagina, ensuring that the cervical HPV photodynamic therapy device is tightly covered on the cervix and does not slide or shift. When the treatment is completed, the timer in the circuit board in the power box starts to turn off the LED power supply, the switch on the inflation tube is turned on to deflate, the airbag shrinks, and the patient grabs the handle at the rear end of the power box with his hand, slowly pulls the cervical HPV therapy device out of the vagina, and completes the cervical photodynamic therapy process.

[0018] The present invention can effectively save the step of manually applying photosensitizers in the cervical canal with gauze, thereby solving the problems of complicated operation, poor patient experience, and uneven application of photosensitizers in existing treatment methods. It can perform both drug coating and cervical irradiation treatment at one time without the need for separate coating and irradiation, thus reducing two insertion treatments to one insertion treatment, effectively reducing the pain of patients.

[0019] In summary, compared with the prior art, the technical solution of the present invention has at least the following advantages:

[0020] 1. The patient of the present invention can perform the treatment by himself without going to the hospital, which is convenient and time-saving;

[0021] 2. The medicine and device are integrated, which realizes the one-time operation of cervical canal medication and light treatment, saving time and effort;

[0022] 3. The cervical cover rotates through the hinge shaft to ensure that the cervical cover and the cervix fit closely, so that the medicine application and light exposure are accurate, thereby ensuring the efficacy. Moreover, more importantly, the position rotation of the cervical cover is achieved through the above-mentioned shaft structure, and the above-mentioned hinge structure can ensure that the cervical cover and the cervical head fit accurately, because the cervical cover with a hinge structure will not generate rebound force due to the elastic deformation of the connecting part, ensuring that the connection position of the cervical cover and the cervical head is completely fitted, and there will be no fitting gap, the medicine film has a good fitting effect, and the light can completely cover the fitting position of the cervical cover and the cervical head and cervical canal.

[0023] 4. The airbag ensures the fixed position of the treatment device to prevent the device from sliding and affecting the efficacy;

[0024] 5. The present invention has a built-in power supply and can be turned on and off according to the set time, eliminating the need for an external power supply and light source and not affecting the patient's activities. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] A more complete understanding of the present invention and its attendant advantages and features will be more readily appreciated by reference to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0026] Figure 1 The overall schematic diagram of a disposable cervical HPV photodynamic automatic therapy device according to a preferred embodiment of the present invention is schematically shown.

[0027] Figures 2 to 5 Various exploded views of a disposable cervical HPV photodynamic automatic therapy device according to a preferred embodiment of the present invention are schematically shown.

[0028] Figure 6 A cross-sectional view of a disposable cervical HPV photodynamic automatic therapy device according to a preferred embodiment of the present invention is schematically shown.

[0029] Figure 7 A cross-sectional view schematically shows a power box of a disposable cervical HPV photodynamic automatic therapy device according to a preferred embodiment of the present invention.

[0030] Reference Mark Description:

[0031] 1. Power box; 2. Light board; 3. LED chip; 4. Link shaft; 5. Power switch; 6. Battery; 7. Circuit board; 8. Wire; 9. Handle; 10. Cervical mask; 11. Medicine film; 12. Air bag; 13. Inflatable tube; 14. Inflatable switch; 15. Vertebral body; 16. Light board cavity

[0032] It should be noted that the drawings are used to illustrate the present invention, rather than to limit the present invention. Note that the drawings showing the structures may not be drawn to scale. In addition, in the drawings, the same or similar elements are marked with the same or similar reference numerals. DETAILED DESCRIPTION

[0033] In order to make the contents of the present invention clearer and easier to understand, the contents of the present invention are described in detail below in conjunction with specific embodiments and drawings.

[0034] <Overall Structure>

[0035] Figure 1 The overall schematic diagram of a disposable cervical HPV photodynamic automatic therapy device according to a preferred embodiment of the present invention is schematically shown. Figures 2 to 5 Various exploded views of a cervical HPV photodynamic therapy device according to a preferred embodiment of the present invention are schematically shown.

[0036] like Figures 1 to 5As shown, the disposable cervical HPV photodynamic automatic therapy device according to a preferred embodiment of the present invention includes: a cervical cover 10 for performing medication and light treatment, and an insertion body connected to the cervical cover 10; wherein, a light-emitting element is arranged on the end face of the cervical cover 10 facing the light irradiation direction, a vertebral body 15 made of a light-transmitting material is arranged outside the light-emitting element, and a drug film 11 is adhered to the outside of the vertebral body 15; and at least a portion of the cervical cover 10 is made of a light-transmitting material, and the at least a portion is the portion from the light-emitting element to the vertebral body 15, so that the light emitted from the light-emitting element can be transmitted to the vertebral body 15 without obstacles.

[0037] Furthermore, the side of the cervical cover 10 opposite to the light irradiation direction is connected to the insertion body through the connecting shaft 4, so that the cervical cover 10 and the insertion body can rotate relative to each other via the connecting shaft 4.

[0038] Preferably, the connecting shaft 4 connects the cervical cover 10 and the insertion body in a hinged connection. In addition, preferably, the cervical cover 10 and the insertion body can be rotated along the extension direction of the cervical canal via the connecting shaft 4.

[0039] Therefore, the present invention provides an integrated medicine-device device, which realizes simultaneous cervical canal medication and light therapy through a single insertion operation; and because there is a bending angle between the cervical canal and the vaginal axis, and users generally cannot determine the specific bending conditions between each person's cervical canal and vaginal axis, it is advantageous to adjust the cervical cover with a movable connecting shaft; and, compared with the angle adjustment with rebound force performed by soft materials such as latex, the angle adjustment of the connecting shaft avoids the defect that the rebound force is difficult to maintain positioning in the cervical environment.

[0040] As for the specific structure of the cervical cover 10, preferably, the cervical cover 10 is made of transparent soft latex, and the side in contact with the cervix is ​​a spherical concave surface with a diameter as large as the cervix. Figure 6 The vertebral body 15 shown is located at the center of the end face, and the length of the vertebral body 15 is preferably 20-30 mm; the vertebral body 15 is inserted into the cervical canal during treatment, and its function is to bring the drug film 11 into the cervical canal for applying the medicine, and another function is to guide the light of the LED chip into the cervical canal to illuminate the cervical canal endothelium and implement the purpose of photodynamic therapy.

[0041] <Medicine film>

[0042] Preferably, the film 11 is a gel film made of photosensitizer ALA which is solid at room temperature and melts at body temperature.

[0043] Specifically, Figure 2As shown, the thickness of the drug film 11 can be, for example, 1-2 mm, and it is solid at normal temperature (room temperature, 16°C-22°C). The shape of the drug film 11 is the same as the convex surface of the vertebral body of the cervical cover 2, and it can be firmly covered on the vertebral body. When the cervical cover is covered on the cervix and the vertebral body is partially inserted into the cervical canal, the body temperature (36-37°C) can melt the drug film 11, so that the photosensitizer ALA is coated on the cervix and the endothelium of the cervical canal. After a period of time (2-3 hours), the photosensitizer (ALA) that penetrates into the endothelium of the cervical canal will produce protoporphyrin with photosensitizer characteristics in the cells infected with HPV, laying the foundation for the next step of light-induced photodynamic therapy.

[0044] For example, the preparation process of the drug film is as follows: the photosensitizer can be 15-20% of aminolevulinic acid or any one of aminolevulinic acid methyl ester, aminolevulinic acid ethyl ester or aminolevulinic acid propyl ester, carbomer 20-30%, and mixed fatty acid glyceride with a thermosensitive temperature (35-36° C.) 40-50%. The above raw materials are heated to 36°-39° to melt, stirred evenly, poured into a cervical cover mold, cooled and solidified, and taken out to complete the preparation of the drug film 11 of the cervical cover.

[0045] Although the present invention is described by taking ALA as an example, the present invention is not limited to this combination. The present invention can also treat cervical-related viruses other than HPV viruses. In this case, the photosensitizer coating can use corresponding drug ingredients.

[0046] <Light Emitting Element>

[0047] Preferably, for example, the light emitting element includes: a lamp board 2 arranged in the lamp board cavity 16 of the cervical cover 10 and an LED chip 3 placed on the lamp board 2. For example, the lamp board 2 is made of metal aluminum, one side of which is connected to the power box through the connecting shaft 4, and rotates along the extension direction of the cervical canal to ensure that the cervical cover 10 can tightly cover the cervix without a fitting gap. The other side of the lamp board 2 is used as a light source, and 10-20 LED chips with a power of 100-200mW and a wavelength of 600-700nm are selected and evenly attached to the lamp board in a circularly symmetrical manner. The LED chips are connected in series with metal wires and connected to the power supply of the power box 1 through the wire 8.

[0048] <Insert body>

[0049] Further, as shown in the figure, the insertion body includes: a power box 1 connected to the connecting shaft 4 for supplying power to the cervical mask 10, a handle 9 arranged at the end of the power box 1 opposite to the connecting shaft 4, and an airbag 12 for fixing the position; wherein the airbag 12 is arranged at the outermost side of the insertion body, and the airbag 12 is equipped with an inflation tube 13 and an inflation switch 14 for inflation and deflation.

[0050] Preferably, the airbag 12 is a tire-like annular bag structure made of soft latex or rubber film. Preferably, the material of the inflation tube 13 is the same as that of the airbag 12.

[0051] Specifically, for example, during operation, one end of the inflation tube 13 is connected to the airbag, and the other end of the inflation tube 13 is provided with an inflation switch 14. When the device is accurately inserted into the vaginal cervix, the inflation switch can be turned on, and the air relies on pressure to expand the diameter of the airbag 12 to ensure that the cervical HPV photodynamic therapy device will not shift or slide out, and then the inflation switch 14 can be turned off; when the treatment is completed, the inflation switch is turned on again to release the air in the airbag and shrink the airbag, and the handle 9 can be held to slowly pull the cervical HPV photodynamic therapy device out of the vagina to complete the treatment.

[0052] Preferably, if Figure 1 and Figure 7 As shown, the power box 1 is a closed cylindrical shape made of metal or hard plastic sheet. One end of the power box 1 is provided with a power switch 5 and connected to a handle 9, and the other end is connected to the cervical cover 10 (especially the light board 2 of the cervical cover 10) through a connecting shaft 4, for example.

[0053] Preferably, the power box 1 includes a battery 6 and a timing power board 7 (for example, the battery 6 and the timing power board 7 are contained inside the power box 1), and the timing circuit board 7 is respectively connected to the power switch 5, the battery 6 and the wire 8, and the wire 8 is connected to the light-emitting unit; wherein when the power switch 5 is turned on, the power box 1 starts to provide electrical energy to the light-emitting unit to illuminate the cervical canal when the delay time preset in the timing circuit board 7 (for example, 2-3 hours, used to allow the drug film to fully dissolve into the skin) is reached; the power box 1 disconnects the power supply when the illumination time preset in the timing circuit board 7 (for example, 20-30 minutes) is reached, so that the light-emitting unit is extinguished to complete the illumination of the cervical canal.

[0054] Moreover, for example, the treatment end timing circuit board can also emit a beeping alarm sound to prompt the patient to remove the cervical HPV photodynamic therapy device.

[0055] In summary, the present invention provides a cervical HPV photodynamic therapy device that is easy to operate and can even be operated by the patient himself. Since the cup of the device inserted into the cervical canal is coated with a photosensitizer film, when inserted into the cervical canal, the human body temperature will melt the photosensitizer gel, so that the photosensitizer (such as ALA) in the gel will penetrate into the HPV-infected cells of the cervical endothelial cells. After a period of time (2-3 hours), the enzymes in the cervical endothelial cells will cause ALA to produce enough protoporphyrin Pp IX. At this time, the LED light source of the cervical photodynamic therapy device will automatically emit light of a specific wavelength (400nm-700nm) at the set time, and evenly irradiate the cervix and cervical canal through the transparent cervical cover, thereby stimulating the singlet oxygen produced by Pp IX in the cervical endothelial cells to kill the HPV virus in the cervical canal, thereby achieving the purpose of treatment.

[0056] In addition, it should be noted that, unless otherwise specified, the terms "first", "second", "third", etc. in the specification are only used to distinguish the various components, elements, steps, etc. in the specification, and are not used to indicate the logical relationship or sequential relationship between the various components, elements, steps, etc.

[0057] It is to be understood that, although the present invention has been disclosed as a preferred embodiment, the above embodiment is not intended to limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, the technical content disclosed above can be used to make many possible changes and modifications to the technical solution of the present invention, or modified into equivalent embodiments of equivalent changes. Therefore, any simple modification, equivalent change and modification made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still falls within the scope of protection of the technical solution of the present invention.

Claims

1. A disposable cervical HPV photodynamic automatic therapy device, characterized in that include: A cervical cover for performing medication and light treatment, and an insertion body connected to the cervical cover; wherein a light-emitting element is arranged on the end face of the cervical cover facing the light irradiation direction, a vertebral body made of a light-transmitting material is arranged outside the light-emitting element, and a drug film is adhered to the outside of the vertebral body; and at least a portion of the cervical cover is made of a light-transmitting material, and the at least a portion is the portion from the light-emitting element to the vertebral body, so that the light emitted from the light-emitting element can be transmitted to the vertebral body without obstacles.

2. The disposable cervical HPV photodynamic automatic therapy device according to claim 1, characterized in that: The side of the cervical cover opposite to the illumination direction is connected to the insertion body through a connecting shaft, so that the cervical cover and the insertion body can rotate relative to each other via the connecting shaft.

3. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The connecting shaft connects the cervical cover and the insertion body in a hinged manner; The cervical cover and the insertion body can rotate along the extension direction of the cervical canal via the connecting shaft.

4. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The cervical cover is made of transparent soft latex, and the side that contacts the cervix is ​​a spherical concave surface.

5. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The vertebral body is located at the center of the end surface and the vertebral body length is 20-30mm.

6. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The film is a gel film made of photosensitizer ALA which is solid at room temperature and melts at body temperature; and / or, The shape of the medicine film is the same as the convex surface shape of the cervical mask cone.

7. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The insertion body comprises: a power supply box connected to the connecting shaft for supplying power to the cervical cover, and a handle arranged at an end of the power supply box opposite to the connecting shaft.

8. The disposable cervical HPV photodynamic automatic therapy device according to claim 7, characterized in that: The insertion body also includes: an airbag for fixing the treatment position of the cervical HPV photodynamic therapy device; wherein the airbag is arranged outside the insertion body, and the airbag is equipped with an inflation tube and an inflation switch for inflation and deflation.

9. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The power box is a closed cylindrical shape made of metal or hard plastic sheet. One end of the power box is equipped with a power switch and connected to the handle, and the other end is connected to the cervical cover through a connecting shaft.

10. The disposable cervical HPV photodynamic automatic therapy device according to claim 1 or 2, characterized in that: The power box includes a battery and a timing power board, the timing circuit board is respectively connected to the power switch, the battery and the wire, and the wire is connected to the light-emitting unit; when the power switch is turned on, the power box starts to provide power to the light-emitting unit when the delay time preset in the timing circuit board arrives to illuminate the cervical canal; when the illumination time preset in the timing circuit board arrives, the power box disconnects the power supply to turn off the light-emitting unit to complete the illumination of the cervical canal.

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