An adjustable laser treatment suit for lymphedema

Abstract

The present application relates to the field of medical devices. An adjustable lymphedema laser treatment sleeve includes a sleeve body, the sleeve body includes a covering part covering the periphery of the limb, and the two ends of the covering part are detachably connected to form a ring structure; the covering part includes a cloth layer, a reflective layer, a light-emitting layer, a flexible light-transmitting upper layer, and a flexible light-transmitting lower layer arranged in sequence from outside to inside; a medicine storage bag is clamped between the flexible light-transmitting upper layer and the flexible light-transmitting lower layer, a medicine delivery channel is provided on the flexible light-transmitting lower layer and is in conductive connection with the medicine storage bag, and a temperature control opening and closing structure that opens when heated is provided in the medicine delivery channel. The present application optimizes the structure of the sleeve body, facilitates the realization of temperature control automatic drug delivery effect, and at the same time, through the light-emitting layer, facilitates the realization of light wave thermotherapy, and improves the treatment effect on lymphedema.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a laser treatment device for lymphedema. Background Technology

[0002] Lymphedema compression sleeves or compression pants are commonly used products for treating lymphedema. They can provide additional power for lymphatic drainage, promote drainage, and reduce edema.

[0003] However, the existing clinical lymphedema pressure sleeves or lymphedema pressure pants can only provide a certain amount of pressure and cannot be combined with heat therapy to further promote microcirculation and improve lymphatic return; they also cannot have the function of drug delivery while being worn; at the same time, they do not have the ability to regulate temperature autonomously; and they do not have the function of sensing temperature and pressure.

[0004] A search revealed the following patents in existing public patents related to the treatment of lymphedema using laser thermotherapy:

[0005] CN209548535U discloses a lymphedema radiation therapy device, which includes a shell, the shell being U-shaped; several elongated irradiation lamps, including a set of far-infrared lamps and a set of 904nm laser emitters, the far-infrared lamps and the 904nm laser emitters being evenly spaced on the inner wall of the shell, and several lamp tube sockets corresponding to the irradiation lamps being provided on the inner sides of both ends of the shell; and an infrared transmission layer, the infrared transmission layer being parallel to the shell and disposed inside the irradiation lamps.

[0006] CN106823155A discloses a far-infrared radiation therapy device for treating lymphedema of the limbs. The device includes an upper and a lower housing, each with a semi-circular cavity. The semi-circular cavities work together to form a heat therapy space for the limb. Each of the upper and lower housings has a far-infrared heating tube, which is evenly arranged along the circumference of the heat therapy space. The surface of the cavity wall of the semi-circular cavity is a reflective surface, and the far-infrared heating tube is a far-infrared heating tube that emits low-temperature far-infrared rays.

[0007] Although the aforementioned patents disclose devices for treating lymphedema with thermotherapy, none of them can deliver medication.

[0008] Currently, there is a lack of a lymphedema treatment device that can achieve both thermotherapy and drug administration. Summary of the Invention

[0009] In view of the problems existing in the prior art, the present invention provides an adjustable lymphedema laser treatment kit, which solves at least one of the above-mentioned technical problems.

[0010] The technical solution of the present invention is: an adjustable lymphedema laser treatment sleeve, comprising a sleeve body, characterized in that the sleeve body includes a covering part covering the periphery of the limb, and the two ends of the covering part are detachably connected to form a ring structure;

[0011] The covering includes, from the outside to the inside, a fabric layer, a reflective layer, a light-emitting layer, a flexible light-transmitting upper layer, and a flexible light-transmitting lower layer;

[0012] The light-emitting layer is a laser light-emitting layer;

[0013] A drug storage sac is sandwiched between the flexible, light-transmitting upper layer and the flexible, light-transmitting lower layer.

[0014] The flexible, light-transmitting lower layer is provided with a drug delivery channel that connects and communicates with the drug storage sac. The drug delivery channel is provided with a temperature-controlled opening and closing structure that opens when heated.

[0015] This invention optimizes the structure of the sleeve to facilitate temperature-controlled automatic drug delivery. At the same time, the luminescent layer facilitates photothermal therapy, improving the treatment effect on lymphedema.

[0016] The two ends of the cover can be detachably connected to form a ring structure, which makes it easy to adjust the size of the ring structure to fit the patient.

[0017] More preferably, the temperature control opening and closing structure includes a heat-deformable stretching layer, the heat-deformable stretching layer having a structure that is narrow at both ends and wide in the middle, and the top of the heat-deformable stretching layer being connected to the inner wall of the drug delivery channel;

[0018] The heat-deformable stretching layer includes an inner and outer flexible silicone layer and a silk protein layer. The bottom of the flexible silicone layer is fish-mouth shaped and includes a closed portion disposed opposite to each other.

[0019] When not under stress, the relatively closed portions are brought together, and the drug delivery channel is in a closed state.

[0020] Once the luminescent layer emits light, the silk protein layer senses the heat emitted by the luminescent layer and contracts. During the contraction process, the silk protein layer pulls on the closed part, opening it up, thereby delivering the medicine.

[0021] At the same time, when the temperature rises, the skin pores open, which can promote the penetration of these medicinal solutions through the skin barrier into the skin and subcutaneous tissue for treatment.

[0022] This invention achieves a combination of phototherapy and physical drug delivery, which greatly improves the treatment effect.

[0023] In a further preferred embodiment, when the relatively arranged closed portions are brought together, they form a conical inner cavity that is wider at the top and narrower at the bottom.

[0024] More preferably, the bottom of the silk fibroin layer is located in the central region of the heat-deformed stretching layer.

[0025] This facilitates the compression of the inner cavity of the heat-deformed stretching layer through the contraction of the silk protein layer, further improving the liquid extraction effect.

[0026] More preferably, a pressure sensor is installed on the flexible, light-transmitting lower layer, the pressure sensor including an air bladder, and an air pressure sensor installed inside the air bladder.

[0027] It allows for easy assessment of the tightness of the protective sleeve by detecting the air pressure inside the airbag. This increases comfort during contact with the patient and avoids the foreign body sensation caused by exposed pressure sensors.

[0028] Further preferably, it also includes a temperature sensor for measuring body surface temperature, the temperature sensor being mounted on the light-emitting layer, and both the flexible light-transmitting upper layer and the flexible light-transmitting lower layer having perforations through which the temperature sensor passes.

[0029] The temperature sensor can be replaced without replacing the flexible light-transmitting upper layer and the flexible light-transmitting lower layer.

[0030] More preferably, the light-emitting layer includes an optical fiber, the optical fiber is connected to a light-emitting device, and the light-emitting device includes a laser emitter;

[0031] When the temperature sensor detects a temperature below 38 degrees Celsius, the laser emitter power is automatically adjusted to 4W.

[0032] When the temperature sensor detects a temperature of 38 degrees Celsius, the laser emitter power is automatically adjusted to 3W;

[0033] When the temperature sensor detects a temperature of 39 degrees Celsius, the laser emitter power is automatically adjusted to 2W;

[0034] When the temperature sensor detects that the temperature reaches 40 degrees Celsius, the laser emitter power is automatically adjusted to 1W;

[0035] When the temperature sensor detects a temperature of 41 degrees Celsius, the laser emitter power automatically and gradually decreases, dropping to 0W within 10 minutes.

[0036] This allows for adjustment of the laser emitter's power based on body surface temperature, enhancing the user experience.

[0037] A further preferred embodiment includes a dimming layer, which is located between the light-emitting layer and the flexible light-transmitting upper layer;

[0038] The dimming layer includes an upper light-transmitting film and a lower light-transmitting film arranged vertically. Transparent airbags are arranged in a matrix between the upper and lower light-transmitting films, and adjacent transparent airbags are connected.

[0039] The transparent airbag is connected to an inflation / deflation mechanism;

[0040] When the temperature sensor detects a temperature higher than the set value, the temperature sensor transmits the detected signal to the processor. The processor controls the inflation and deflation mechanism, thereby controlling the transparent airbag to be in an inflated state, reducing the light transmittance of the dimming layer.

[0041] When the temperature sensed by the temperature sensor is lower than the set value, the temperature sensor transmits the sensed signal to the processor. The processor controls the inflation and deflation mechanism, thereby controlling the light-transmitting airbag to be in a deflated and compressed state, which improves the light transmittance of the dimming layer.

[0042] More preferably, the light-emitting layer includes an optical fiber;

[0043] The sleeve includes sub-sleeves that can be spliced ​​together. The fabric layers of adjacent sub-sleeves are detachably connected by zippers, and the light-emitting layers of adjacent sub-sleeves are connected by light guides. The light guides are provided with sockets for inserting optical fibers of the light-emitting layers of adjacent sub-sleeves, and the inner wall of the sockets is coated with a reflective film layer.

[0044] More preferably, the light-emitting layer is used to emit near-infrared light with a wavelength of 1270nm, and the irradiation intensity is less than 0.4W / cm². 2 And greater than 0.2 W / cm 2 . Attached Figure Description

[0045] Figure 1 This is a partial schematic diagram of a specific embodiment 1 of the present invention;

[0046] Figure 2 This is a partial schematic diagram of the dimming layer in specific embodiment 5 of the present invention;

[0047] Figure 3 This is a schematic diagram of the rat tail growth rate in specific embodiment 7 of the present invention.

[0048] In the diagram: 1 is the fabric layer, 2 is the reflective layer, 3 is the light-emitting layer, 4 is the flexible light-transmitting upper layer, 5 is the flexible light-transmitting lower layer, 6 is the drug storage bladder, 7 is the flexible silicone layer, 8 is the silk protein layer, 9 is the drug delivery channel, 11 is the upper light-transmitting membrane, 12 is the lower light-transmitting membrane, and 13 is the transparent airbag. Detailed Implementation

[0049] The present invention will now be further described with reference to the accompanying drawings.

[0050] See Figure 1Specific embodiment 1: An adjustable laser treatment sleeve for lymphedema includes a sleeve body. The sleeve body includes a covering portion that covers the periphery of the limb, with the two ends of the covering portion detachably connected to form a ring structure. The covering portion includes, from the outside to the inside, a fabric layer 1, a reflective layer 2, a light-emitting layer 3, a flexible light-transmitting upper layer 4, and a flexible light-transmitting lower layer 5. The light-emitting layer is a laser light-emitting layer. A drug storage sac 6 is sandwiched between the flexible light-transmitting upper layer 4 and the flexible light-transmitting lower layer 5. The flexible light-transmitting lower layer 5 has a drug delivery channel 9 that connects and communicates with the drug storage sac 6. The drug delivery channel 9 has a temperature-controlled opening and closing structure that opens upon heating. This invention optimizes the structure of the sleeve body, facilitating temperature-controlled automatic drug delivery. Simultaneously, the light-emitting layer 3 facilitates photothermal therapy, improving the treatment effect on lymphedema. The detachable connection of the two ends of the covering portion to form a ring structure allows for adjustment of the ring size to fit the patient. The detachable connection can be achieved by using bristles to detachably connect the two ends of the covering portion.

[0051] The temperature-controlled opening and closing structure includes a heat-deformable traction layer, which has a structure that is narrow at both ends and wide in the middle. The top of the heat-deformable traction layer is connected to the inner wall of the drug delivery channel. The heat-deformable traction layer includes a flexible silicone layer 7 and a silk protein layer 8 arranged inside and outside. The bottom of the flexible silicone layer 7 is fish-mouth shaped and includes opposing closed portions. In the unstressed state, the opposing closed portions are closed, and the drug delivery channel is in a closed state. Once the light-emitting layer 3 emits light, the silk protein layer senses the heat emitted by the light-emitting layer 3 and contracts. During the contraction process, the silk protein layer pulls the closed portions, opening them and thus delivering the drug. At the same time, when the temperature rises, the skin pores open, which can promote the penetration of these liquid drugs through the skin barrier into the skin and subcutaneous tissue for treatment. This invention realizes a combination of phototherapy and physical drug delivery, greatly improving the treatment effect.

[0052] The heat-deformable tensile layer includes a connecting part that is wider at the top and narrower at the bottom. The top of the connecting part is connected to the inner wall of the drug delivery channel, and the bottom of the connecting part is connected to the top of the structure that is narrow at both ends and wide in the middle.

[0053] When the opposing closed sections are closed together, they form a conical inner cavity that is wider at the top and narrower at the bottom. The bottom of the silk fibroin layer is located in the central region of the heat-deformed stretching layer. This facilitates the compression of the inner cavity of the heat-deformed stretching layer through the contraction of the silk fibroin layer, further improving the liquid extraction effect.

[0054] In specific embodiment 2, based on specific embodiment 1, a pressure sensor is installed on the flexible, translucent lower layer. The pressure sensor includes an air bladder, within which an air pressure sensor is installed. This allows for the determination of the tightness of the garment by detecting the air pressure within the air bladder. This increases comfort during contact with the patient and avoids the foreign body sensation caused by exposed pressure sensors.

[0055] In specific embodiment 3, based on specific embodiment 1, a temperature sensor for measuring body surface temperature is further included. The temperature sensor is mounted on the light-emitting layer, and both the flexible light-transmitting upper and lower layers have perforations through which the temperature sensor passes. This allows for replacement of the flexible light-transmitting upper and lower layers without replacing the temperature sensor.

[0056] In specific embodiment 4, based on specific embodiment 3, the light-emitting layer includes an optical fiber connected to a light-emitting device, which includes a laser emitter. When the temperature sensed by the temperature sensor is less than 38 degrees Celsius, the laser emitter power is automatically adjusted to 4W; when the temperature sensed by the temperature sensor reaches 38 degrees Celsius, the laser emitter power is automatically adjusted to 3W; when the temperature sensed by the temperature sensor reaches 39 degrees Celsius, the laser emitter power is automatically adjusted to 2W; when the temperature sensed by the temperature sensor reaches 40 degrees Celsius, the laser emitter power is automatically adjusted to 1W; when the temperature sensed by the temperature sensor reaches 41 degrees Celsius, the laser emitter power automatically and gradually decreases, reaching 0W within 10 minutes. This allows for easy adjustment of the laser emitter power based on body surface temperature, improving the user experience.

[0057] See Figure 2 In specific embodiment 5, based on specific embodiment 3, a dimming layer is further included. The dimming layer is located between the light-emitting layer and the flexible light-transmitting upper layer. The dimming layer includes an upper light-transmitting film 11 and a lower light-transmitting film 12 disposed vertically. Transparent airbags 13 are arranged in a matrix between the upper light-transmitting film 11 and the lower light-transmitting film 12, and adjacent transparent airbags 13 are connected and conductive. The transparent airbags are connected to an inflation / deflation mechanism. When the temperature sensed by the temperature sensor is higher than the set value, the temperature sensor transmits the sensed signal to the processor. The processor controls the inflation / deflation mechanism, thereby controlling the transparent airbags to be in an inflated state, reducing the light transmittance of the dimming layer. When the temperature sensed by the temperature sensor is lower than the set value, the temperature sensor transmits the sensed signal to the processor. The processor controls the inflation / deflation mechanism, thereby controlling the light-transmitting airbags to be in a deflated and compressed state, improving the light transmittance of the dimming layer.

[0058] In specific embodiment 6, based on specific embodiment 1, the light-emitting layer includes an optical fiber; the sleeve includes sub-sleeves that can be spliced ​​together, the fabric layers of adjacent sub-sleeves are detachably connected by a zipper, and the light-emitting layers of adjacent sub-sleeves are connected by a light guide, the light guide is provided with a socket for inserting the optical fiber of the light-emitting layer of the adjacent sub-sleeve, and the inner wall of the socket is coated with a reflective film layer.

[0059] In specific embodiment 7, based on specific embodiment 1, the light-emitting layer is used to emit near-infrared light with a wavelength of 1270nm, and the irradiation intensity is less than 0.4W / cm². 2 And greater than 0.2 W / cm 2 .

[0060] Treatment parameters using near-infrared radiation at a wavelength of 1270 nm: Twelve male SD rats were randomly divided into four groups (n=3): 0.1W, 0.2W, 0.3W, and 0.4W irradiation groups. Each group of rats was anesthetized with a 10% chloral hydrate solution, administered intraperitoneally at a rate of 0.3 mL per 100g of rat body weight using a 1 mL syringe. If anesthesia was unsatisfactory, chloral hydrate solution was added at 20% of the initial dose. After satisfactory anesthesia, the rats were fixed to a sterile operating table with their limbs extended, dorsiflexed, and the entire tail of each rat was irradiated with near-infrared radiation at a wavelength of 1270 nm at an intensity of 0.1 W / cm². 2 0.2W / cm 2 0.3W / cm 2 0.4W / cm 2 The irradiation was performed continuously for 1 hour. The temperature of the rat's tail was measured every 5 minutes from the start of irradiation until the end of the irradiation. Any abnormalities in the tails of the rats in each group during and after irradiation were observed.

[0061] During the irradiation process, two rats in the 0.4W irradiation group showed redness and swelling in their tails, followed by the appearance of blisters. The next day, the red and swollen areas were found to be burn-like. The tails of rats in other groups showed no abnormalities.

[0062] Control group, 0.1W irradiation group ( Figure 3 (abbreviated as 0.1W group) and 0.2W irradiation group ( Figure 3 (referred to as 0.2W group) and 0.3W irradiation group ( Figure 3 A diagram illustrating the tail growth rate of the 0.3W group (see below). Figure 3 .

[0063] The comparison of the growth rate of rat tail volume in the control group, the 0.1W irradiation group, the 0.2W irradiation group, and the 0.3W irradiation group is shown in Table 1 below:

[0064] Table 1. Growth Rate of Rat Tail Volume

[0065] 7 26.21％±13.15％ 23.06％±10.64％ 24.86％±9.50％ 15.55％±8.99％ 14 39.54％±9.43％ 32.94％±9.84％ 29.91％±9.57％ 21.82％±12.20％ 21 46.34％±22.45％ 38.91％±14.68％ 32.66％±12.40％ 23.23％±5.64％ 28 45.43％±11.89％ 35.84％±8.72％ 31.62％±8.13％ 25.20％±5.56％ 35 45.31％±13.23％ 35.13％±9.90％ 27.99％±9.88％ 24.49％±7.04％ 42 40.25％±10.25％ 33.45％±10.44％ 25.48％±9.95％ 21.52％±9.68％

[0066] The p-values ​​for comparing the tail volume growth rates among the groups are shown in the table below:

[0067]

[0068] Normally distributed quantitative data are expressed as mean ± standard deviation. All results were analyzed using SPSS version 24.0. A p-value < 0.05 was considered statistically significant; * indicates p < 0.05, ** indicates p < 0.01, and ns indicates no statistical significance.

[0069] Rats in the 0.3W irradiation group showed significantly less swelling than the control group from day 14 post-surgery, a difference that persisted until day 42. Rats in the 0.2W irradiation group showed significantly less swelling from day 28 post-surgery, a difference that persisted until day 42. The 0.1W irradiation group showed no statistically significant difference. However, when comparing the 0.2W and 0.3W irradiation groups, no statistically significant difference in treatment effect was observed between the two groups. Based on our data, when using 1270nm wavelength near-infrared radiation to treat tail lymphedema in rats, an irradiation intensity of 0.2W / cm² was effective. 2 The above results can show certain therapeutic effects. The results were also verified by the detection of lymphatic drainage function in rat tails and histological examination. More compensatory lymphatic vessels with larger diameters were observed in the tail tissues of rats in the 0.2W irradiation group and the 0.3W irradiation group, which showed that the degree of edema was reduced, the degree of fibrosis was decreased, and the lymphatic drainage function was enhanced.

[0070] In this invention, it should be explained that terms such as "upper" and "lower" are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the purpose of facilitating the description of this invention and simplifying the description, and are not intended to indicate or imply that a specific orientation must be used, or that the invention must be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0071] The above are merely preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. An adjustable laser treatment sleeve for lymphedema, comprising a sleeve body, characterized in that, The sleeve includes a covering portion that covers the periphery of the limb, and the two ends of the covering portion are detachably connected to form a ring structure; The covering includes, from the outside to the inside, a fabric layer, a reflective layer, a light-emitting layer, a flexible light-transmitting upper layer, and a flexible light-transmitting lower layer; The light-emitting layer is a laser light-emitting layer; A drug storage bladder is sandwiched between the flexible light-transmitting upper layer and the flexible light-transmitting lower layer; The flexible, light-transmitting lower layer is provided with a drug delivery channel that connects and communicates with the drug storage sac, and the drug delivery channel is provided with a temperature-controlled opening and closing structure that opens when heated. The temperature-controlled opening and closing structure includes a heat-deformable stretching layer, which has a structure that is narrow at both ends and wide in the middle. The top of the heat-deformable stretching layer is connected to the inner wall of the drug delivery channel. The heat-deformable stretching layer includes an inner and outer flexible silicone layer and a silk protein layer. The bottom of the flexible silicone layer is fish-mouth shaped and includes a closed portion disposed opposite to each other. When not under stress, the relatively closed portions are brought together, and the drug delivery channel is in a closed state. Once the luminescent layer emits light, the silk protein layer senses the heat emitted by the luminescent layer and contracts. During the contraction process, the silk protein layer pulls on the closed part, opening it up, thereby delivering the medicine.

2. The adjustable lymphedema laser treatment kit according to claim 1, characterized in that: When the relatively closed parts are closed together, they form a cone-shaped inner cavity that is wider at the top and narrower at the bottom.

3. The adjustable lymphedema laser treatment kit according to claim 1, characterized in that: The bottom of the silk protein layer is located in the central region of the heat-deformed stretching layer.

4. The adjustable lymphedema laser treatment kit according to claim 1, characterized in that: A pressure sensor is installed on the flexible, light-transmitting lower layer. The pressure sensor includes an air bladder, and a pressure sensor is installed inside the air bladder.

5. The adjustable lymphedema laser treatment kit according to claim 1, characterized in that: It also includes a temperature sensor for measuring body surface temperature, the temperature sensor is mounted on the light-emitting layer, and both the flexible light-transmitting upper layer and the flexible light-transmitting lower layer have perforations through which the temperature sensor passes.

6. The adjustable lymphedema laser treatment kit according to claim 5, characterized in that: The light-emitting layer includes an optical fiber, which is connected to a light-emitting device, and the light-emitting device includes a laser emitter; When the temperature sensor detects a temperature below 38 degrees Celsius, the laser emitter power is automatically adjusted to 4W. When the temperature sensor detects a temperature of 38 degrees Celsius, the laser emitter power is automatically adjusted to 3W; When the temperature sensor detects a temperature of 39 degrees Celsius, the laser emitter power is automatically adjusted to 2W; When the temperature sensor detects that the temperature reaches 40 degrees Celsius, the laser emitter power is automatically adjusted to 1W; When the temperature sensor detects a temperature of 41 degrees Celsius, the laser emitter power automatically and gradually decreases, dropping to 0W within 10 minutes.

7. An adjustable lymphedema laser treatment kit according to claim 5, characterized in that: It also includes a dimming layer, which is located between the light-emitting layer and the flexible light-transmitting upper layer; The dimming layer includes an upper light-transmitting film and a lower light-transmitting film arranged vertically. Transparent airbags are arranged in a matrix between the upper and lower light-transmitting films, and adjacent transparent airbags are connected. The transparent airbag is connected to an inflation / deflation mechanism; When the temperature sensor detects a temperature higher than the set value, the temperature sensor transmits the detected signal to the processor. The processor controls the inflation and deflation mechanism, thereby controlling the transparent airbag to be in an inflated state, reducing the light transmittance of the dimming layer. When the temperature sensed by the temperature sensor is lower than the set value, the temperature sensor transmits the sensed signal to the processor. The processor controls the inflation and deflation mechanism, thereby controlling the transparent airbag to be in a deflated and compressed state, which improves the light transmittance of the dimming layer.

8. The adjustable lymphedema laser treatment kit according to claim 1, characterized in that: The light-emitting layer includes optical fibers; The sleeve includes sub-sleeves that can be spliced ​​together. The fabric layers of adjacent sub-sleeves are detachably connected by zippers, and the light-emitting layers of adjacent sub-sleeves are connected by light guides. The light guides are provided with sockets for inserting optical fibers of the light-emitting layers of adjacent sub-sleeves, and the inner wall of the sockets is coated with a reflective film layer.

9. The adjustable lymphedema laser treatment kit according to claim 1, characterized in that: The light-emitting layer is used to emit near-infrared light with a wavelength of 1270nm, and the irradiation intensity is less than 0.4W / cm². 2 And greater than 0.2 W / cm 2 .

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