Oxygen regulation and control photodynamic therapy equipment and use method

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to oxygen regulation and control photodynamic therapy equipment and a use method, which can be used for treating nevus flammeus, skin precancerous lesions and other skin diseases. The equipment comprises a bonding layer, a shading layer and an oxygen regulator, the device can regulate the oxygen concentration or temperature of a treatment part by coordinating the irradiation time and controlling the oxygen regulator, so that the photodynamic treatment effect is improved, and the adverse reaction is reduced. The oxygen concentration of the epidermal layer and the nipple layer of the skin can be regulated and controlled, so that the photodynamic reaction rate is regulated, and the chemical damage of photochemical reaction to the epidermal layer and the nipple layer is reduced. The temperature of the skin epidermal layer can be regulated and controlled, the photochemical reaction rate in the capillary wall is improved by improving the light irradiance, and the heat damage of the epidermal layer is reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and specifically relates to an oxygen-regulated photodynamic therapy device and a use method thereof, which can be used to treat skin diseases such as port-wine stains and skin precancerous lesions. Background Art

[0002] Photodynamic therapy is a new method of using photosensitive drugs and laser activation to treat tumors, precancerous lesions, and vascular diseases. Irradiating the lesion with a specific wavelength can activate the photosensitive drugs accumulated in the lesion tissue, triggering a photochemical reaction to destroy the lesion, achieving the purpose of selective damage.

[0003] Since the selective effect of photodynamic therapy depends on the selective temporal and spatial distribution of light, oxygen and photosensitizer in tissues, accurate regulation of its influencing factors is conducive to improving the treatment effect and reducing adverse reactions.

[0004] Taking the photodynamic therapy of port-wine stains as an example, under typical circumstances, the photosensitizer is injected intravenously into the patient's body. The treatment effect is closely related to the time interval between the start of illumination, the irradiance, and the patient's skin lesions. Due to the lack of control over oxygen penetration on the skin surface, there is severe photochemical damage to the epidermis during the treatment, which makes the capillary targeted damage to the targeted treatment target of port-wine stains insignificant and leads to serious adverse reactions. During the photodynamic therapy of precancerous lesions of the skin, due to the increased oxygen consumption of the photochemical reaction, there is often a problem of insufficient oxygen concentration supply, and it is necessary to increase oxygen supply through the epidermis. Summary of the invention

[0005] The technical problem solved by the present invention is: to overcome the shortcomings of the prior art and to propose an oxygen-regulated photodynamic therapy device and a control method thereof. The device includes an adhesive layer, a light-shielding layer, and an oxygen regulator, which can be attached to the skin lesions by an adhesive method. By controlling the oxygen concentration, temperature, and illumination time sequence of the oxygen regulator connected to the skin side, the targeted treatment effect of the photodynamic therapy is improved and the adverse reactions of the photodynamic therapy are reduced.

[0006] In order to achieve the above object, the present invention adopts the following specific technical solutions:

[0007] An oxygen-regulated photodynamic therapy device, the device comprises an adhesive layer, a light-shielding layer, and an oxygen regulator, and therapeutic light is transmitted through the therapeutic device to treat the skin lesion;

[0008] The adhesive layer is bonded to the skin lesion;

[0009] The adhesive layer has a plurality of micropores to form a breathable and water-blocking structure;

[0010] The light shielding layer is formed into a hollow area by laser cutting or other methods, and the periphery of the light shielding layer is pasted on the adhesive layer to protect the skin lesion area, that is, to prevent the treatment light from irradiating normal skin tissue, so that the treatment light penetrates and irradiates the skin lesion area;

[0011] The oxygen regulator is a covering film including a supporting structure, and the covering film has an epitaxial structure around it; the supporting structure is used to support the covering film so that the covering film is raised, that is, a raised covering film is formed;

[0012] The bottom of the epitaxial structure is bonded above the light shielding layer, and a closed cavity structure is formed between the raised covering film and the skin lesion. The supporting structure is located between the covering film and the skin lesion, so that the raised covering film forms an internal cavity for gas or liquid to flow, which is used to adjust the oxygen concentration of the skin lesion and cool the skin.

[0013] The oxygen regulator is made of optically transparent materials; weakly absorbing light scattering materials can also be used, so that the oxygen regulator also has the ability to provide uniform illumination. After the light from the light source passes through the oxygen regulator, more uniform illumination is formed on the skin lesion site.

[0014] The constituent material of the oxygen regulator is preferably liquid silicone or PVC;

[0015] A control method for an oxygen-regulated photodynamic therapy device, the method comprising the following steps:

[0016] When performing vascular targeted photodynamic therapy for port wine stains, the oxygen regulator uses N 2 or CO 2 The gas or liquid flow reduces the oxygen concentration on the surface of the skin lesion to a low oxygen concentration state (oxygen partial pressure lower than 30 mmHg), and the temperature of the oxygen regulator is reduced to below body temperature. Preferably, the oxygen regulator keeps the temperature of the skin surface at a low temperature of 5 to 10°C. After the above conditions are met, turn on the light source for photodynamic therapy.

[0017] Preferably, the delay interval Od from the oxygen concentration of the oxygen regulator decreasing to a low oxygen concentration state to the start of illumination is not less than 30s, and the delay interval Td from the temperature decreasing to a low temperature state to the start of illumination is not less than 5s; the light irradiation power is not less than 100mW / cm 2 .

[0018] When performing non-vascular targeted photodynamic therapy for skin precancerous lesions, the oxygen regulator uses a high oxygen concentration operation mode;

[0019] The oxygen regulator uses O 2The gas increases the oxygen concentration on the surface of the skin lesion to a high oxygen concentration state (oxygen partial pressure is not less than 200 mmHg), and the temperature of the oxygen regulator is reduced to below body temperature. Preferably, the oxygen regulator keeps the temperature of the skin surface at a low temperature of 5 to 10°C. After the above conditions are met, turn on the light source for photodynamic therapy.

[0020] Preferably, the delay interval time Od from the oxygen concentration being raised to a high concentration state to the start of illumination is not less than 30s, and the interval time from the temperature being dropped to a low temperature state to the start of illumination, i.e. the delay time Td, is not less than 5s.

[0021] Compared with the prior art, the technical solution of the present invention has the following beneficial effects:

[0022] 1. It can regulate the oxygen concentration in the epidermis and papillary layer of the skin, thereby adjusting the rate of photodynamic reaction and reducing the chemical damage of photochemical reaction to the epidermis and papillary layer.

[0023] 2. The temperature of the epidermis can be regulated, the photochemical reaction rate around the capillary wall can be increased by increasing the light irradiance, and the thermal damage of the epidermis can be reduced.

[0024] 3. The present invention discloses a photodynamic therapy device with oxygen regulation capability and a control method thereof. The device includes an adhesive layer, a light shielding layer, and an oxygen regulator. The device can adjust the oxygen concentration or temperature of the treatment site by coordinating the illumination time with the control of the oxygen regulator, thereby improving the photodynamic therapy effect and reducing adverse reactions. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 An exploded view of the oxygen-regulated photodynamic therapy device provided by the present invention;

[0026] Figure 2 A three-dimensional diagram of the oxygen regulator provided by the present invention;

[0027] Figure 3 Three-dimensional image of adhesive layer with microporous structure added to the skin lesion area

[0028] Figure 4 Parameter control method of oxygen-regulated photodynamic therapy equipment for vascular-targeted photodynamic therapy of port-wine stains

[0029] Figure 5 Parameter control method of oxygen-regulated photodynamic therapy device for non-vascular targeted photodynamic therapy of skin precancerous lesions

[0030] Among them, 1 is an adhesive layer, 2 is a light shielding layer, 3 is an oxygen regulator, 31 is an oxygen regulator inlet, 32 is an oxygen regulator outlet, 33 is an oxygen regulator epitaxial structure, and 34 is an oxygen regulator supporting structure. DETAILED DESCRIPTION

[0031] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] like Figure 1 , Figure 2 and Figure 3 As shown in the structure, this embodiment provides an oxygen-regulated photodynamic therapy device, including an adhesive layer 1, a light-shielding layer 2, and an oxygen regulator 3; therapeutic light is transmitted through the above components to treat skin lesions;

[0033] The adhesive layer is bonded to the skin lesion area, and the upper part thereof is connected to the light shielding layer; the adhesive layer can be processed with a plurality of micropores 11 at the skin lesion treatment position to form a breathable and water-blocking structure;

[0034] The light shielding layer is adhered to the adhesive layer through the adhesive layer, and is used to protect the skin lesion area, that is, to prevent the therapeutic light from irradiating normal skin tissue, and a hollow area can be formed by laser cutting or other methods to allow the therapeutic light to penetrate and irradiate the skin lesion;

[0035] The oxygen regulator is a covering film including an internal structure, and the covering film is surrounded by an epitaxial structure 33. The bottom of the epitaxial structure is bonded to the top of the light-shielding layer, and a closed cavity structure is formed between the raised covering film and the skin lesion. There is a supporting structure 34 between the raised covering film and the skin lesion, which is used to support the raised covering film and form an internal cavity for gas or liquid to flow, so as to adjust the oxygen concentration in the skin lesion and cool the skin. The oxygen regulator is made of an optically transparent material. A weakly absorbing light scattering material can also be used to make the oxygen regulator have the ability of uniform illumination. After the light from the light source passes through the oxygen regulator, more uniform illumination is formed on the skin lesion.

[0036] The constituent material of the oxygen regulator is preferably liquid silicone or PVC;

[0037] Preferably, to facilitate the doctor's operation, the oxygen regulator can be bonded to the light-shielding layer by a pressure-sensitive adhesive. The light-shielding layer can be formed by first performing a three-dimensional scan on the patient's skin lesion surface and projecting it onto a plane, and then cutting into holes in the light-shielding layer to form an illuminated area for the skin lesions.

[0038] Preferably, the light-shielding layer is made of medical flexible black rubber with a thickness of less than 1 mm and pressure-sensitive adhesive on both sides, which can be used to adhere to the patient's skin and fix the oxygen regulator.

[0039] The side of the oxygen regulator has an inlet 31 and an outlet 32, which can be used to circulate gases with different oxygen concentrations, or to circulate liquids dissolved with different oxygen concentrations;

[0040] A control method for an oxygen-regulated photodynamic therapy device, the method comprising the following steps:

[0041] When performing photodynamic therapy for port wine stains, the target of photodynamic therapy is the capillary network in the dermis, such as Figure 4 As shown, the oxygen regulator uses N 2 or CO 2 The oxygen concentration on the surface of the skin lesion is reduced to a low oxygen partial pressure state of less than 30 mmHg by gas or liquid flow, and the temperature of the oxygen regulator is reduced to below body temperature. Preferably, the oxygen regulator keeps the temperature of the skin surface at a low temperature of 5 to 10°C. After the above conditions are met, the light source is turned on for photodynamic therapy, and the light irradiation power is not less than 100 mW / cm 2 .

[0042] Preferably, the delay time Od between the oxygen concentration of the oxygen regulator decreasing to a low oxygen partial pressure state and the start of illumination is not less than 30 seconds, and the delay time Td between the temperature decreasing to a low temperature state and the start of illumination is not less than 5 seconds.

[0043] Preferably, in order to avoid the death of skin epidermal cells due to lack of oxygen, the tissue oxygen concentration of the skin epidermal layer and superficial papillary cells can be increased by intermittent oxygen supply, and this cycle is repeated, preferably the cycle period is 2-5 minutes.

[0044] A specific example is as follows: To increase the rate of photochemical reaction around blood vessels, 2 Compared with the existing photodynamic therapy dose with an irradiance of 20 minutes and a treatment time of 20 minutes, the device preferably increases the irradiance to 200-400 mW / cm 2 , and the treatment is completed within 10 minutes; the circulating water or air of the oxygen regulator reduces the skin surface temperature to a low temperature of 5 to 10°C, cools the skin epidermis, and avoids thermal damage to the epidermis and papillary layers; this dose adjustment scheme can make oxygen mainly consumed around the blood vessel wall, greatly reduce the tissue oxygen concentration away from the capillary area, and reduce the oxygen concentration in the superficial layer of the epidermis and papillary layer, thereby achieving the purpose of targeted damage to the capillaries.

[0045] When photodynamic therapy is performed on precancerous lesions of the skin, the target of photodynamic therapy is the cancerous tissue in the skin, such as Figure 5 As shown, the oxygen regulator adopts a high oxygen concentration operation mode; the oxygen regulator adopts O 2The oxygen concentration on the surface of the skin lesion is increased to a high oxygen partial pressure state of not less than 200 mmHg by the gases, and the temperature of the oxygen regulator is reduced to below body temperature. Preferably, the oxygen regulator keeps the temperature of the skin surface at a low temperature of 5 to 10°C. After the above conditions are met, the light source is turned on for photodynamic therapy.

[0046] Preferably, after the oxygen regulator increases the oxygen concentration from a high oxygen partial pressure state, the illumination starts with a delay time Od of not less than 30 seconds, and the delay interval time Td between the temperature dropping to a low temperature state and the start of illumination is not less than 5 seconds.

[0047] Obviously, those skilled in the art can make various changes and modifications to the embodiments of the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

[0048] In summary, the above are only preferred embodiments of the present invention and are not intended to limit the protection scope of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention should be included in the protection scope of the present invention.

Claims

1. An oxygen-regulated photodynamic therapy device, characterized in that: The device includes an adhesive layer, a light shielding layer, and an oxygen regulator; The therapeutic light is transmitted through the therapeutic device to treat the skin lesions; The adhesive layer is bonded to the skin lesion; The adhesive layer is provided with a plurality of micropores; The light-shielding layer has a hollow area, and the periphery of the light-shielding layer is pasted on the adhesive layer to protect the area around the skin lesion; The oxygen regulator is a covering film including a supporting structure, and the covering film has an epitaxial structure around it; the supporting structure is used to support the covering film so that the covering film is raised, that is, a raised covering film is formed; the bottom of the epitaxial structure is bonded above the light-shielding layer, and a closed cavity structure is formed between the raised covering film and the skin lesion area, and the supporting structure is located between the covering film and the skin lesion area, so that the raised covering film forms an internal cavity for gas or liquid circulation, which is used to adjust the oxygen concentration in the skin lesion area and cool the skin.

2. The oxygen-regulated photodynamic therapy device according to claim 1, characterized in that: The oxygen regulator is made of optically transparent material or weakly absorbing light scattering material, so that the oxygen regulator also has the ability to provide uniform illumination. After the light from the light source passes through the oxygen regulator, more uniform illumination is formed on the skin lesion site.

3. The oxygen-regulated photodynamic therapy device according to claim 1, characterized in that: The oxygen regulator is made of liquid silicone or PVC.

4. A control method for oxygen-regulated photodynamic therapy equipment, characterized in that The steps of the method include: When performing vascular targeted photodynamic therapy for port-wine stains, the oxygen regulator uses refrigerated flowing gas or liquid to reduce the oxygen concentration on the surface of the lesion to a low oxygen concentration state, and the temperature of the oxygen regulator is lowered to below body temperature, and the light source is turned on for photodynamic therapy.

5. A control method for oxygen-regulated photodynamic therapy equipment, characterized in that: When non-vascular targeted photodynamic therapy is performed, the oxygen regulator uses a high oxygen concentration operation mode; After the oxygen regulator increases the oxygen concentration on the surface of the skin lesion to a high oxygen concentration state through gas or liquid flow, and the temperature of the oxygen regulator is lowered to below body temperature, the light source is turned on for photodynamic therapy.

6. The control method of an oxygen-regulated photodynamic therapy device according to claim 4, characterized in that: Hypoxia refers to a state where the oxygen partial pressure is less than 30 mmHg; Below body temperature means that the temperature of the skin surface is kept at a low temperature of 5 to 10 degrees Celsius.

7. The control method of the oxygen-regulated photodynamic therapy device according to claim 4, characterized in that: The delay interval Od between the oxygen concentration of the oxygen regulator decreasing to a low oxygen concentration state and the start of illumination shall not be less than 30s; The delay interval Td from the temperature dropping to a low temperature state to the start of illumination shall not be less than 5s.

8. The control method of an oxygen-regulated photodynamic therapy device according to claim 4, characterized in that: Light irradiation power is not less than 100mW / cm 2 .

9. The control method of the oxygen-regulated photodynamic therapy device according to claim 5, characterized in that: High oxygen concentration state means that the oxygen partial pressure is not less than 200mmHg; Below body temperature means that the temperature of the skin surface is kept at a low temperature of 5 to 10 degrees Celsius.

10. The control method of the oxygen-regulated photodynamic therapy device according to claim 5, characterized in that: The delay interval time Od from the oxygen concentration of the oxygen regulator being raised to a high concentration state to the start of illumination shall not be less than 30s, and the time interval from the temperature being dropped to a low temperature state to the start of illumination, that is, the delay time Td shall not be less than 5s.

Images