Device for tissue regeneration

Abstract

A device for tissue regeneration includes: a blood flow constrictor; a heat source; and a controller, coupled to the blood flow constrictor and the heat source, for applying a combination of blood flow restriction and thermal therapy that cause hypoxia to the treated body part to cause tissue regeneration in the treated body part.

Description

Technical Field

[0001] The present invention generally relates to tissue regeneration through a combination of blood flow restriction and thermal therapy. Background Art

[0002] Tissue regeneration (the terms "regeneration" and "regeneration" are used interchangeably throughout) involves restoring or regenerating damaged or aged tissue, such as by stimulating the body's natural healing mechanisms to repair and renew cells, resulting in improved tissue structure and function. Promoting tissue regeneration includes medical interventions, lifestyle changes, and regenerative medicine techniques.

[0003] Regenerative medicine focuses on the use of stem cells, growth factors, and other biomaterials to stimulate tissue regeneration.

[0004] Platelet-rich plasma (PRP) therapy involves injecting a concentrate of a patient's own platelets (containing growth factors) into injured or aged tissue.

[0005] Heating by optical, electromagnetic or ultrasonic energy can also be used to regenerate the skin by promoting collagen production and stimulating the growth of new, healthier skin cells. Skin rejuvenation can be used to reduce wrinkles, improve skin texture and treat scars or blemishes.

[0006] A healthy diet and appropriate supplementation can support tissue regeneration by providing the necessary nutrients for cell growth and repair. For example, collagen supplements are often used to promote skin elasticity and joint health.

[0007] Regular exercise and physical therapy can help stimulate blood flow, increase oxygenation, and promote tissue healing. These activities can improve muscle strength, flexibility, and overall tissue health.

[0008] Adopting a healthy lifestyle, including proper sleep, stress management and avoiding harmful habits like smoking or excessive drinking, among other lifestyle changes, can help tissue regeneration. Chronic stress and unhealthy habits can adversely affect tissue health and hamper the body's healing process.

[0009] The key elements of tissue regeneration are angiogenesis and collagen production. Angiogenesis, in which new blood vessels are formed from existing ones, plays a vital role in various physiological and pathological processes, including wound healing and tissue regeneration. Heat has been shown to induce the release of various growth factors and cytokines involved in angiogenesis. For example, thermal stress can stimulate the production of vascular endothelial growth factor (VEGF), which is a potent inducer of angiogenesis; it acts on nearby blood vessels, promoting their growth and sprouting. In addition, hyperthermia-induced vasodilation can lead to the recruitment of endothelial progenitor cells involved in angiogenesis.

[0010] Heat stimulates the production of collagen, the main structural protein in skin, tendons, ligaments and other connective tissues. Hyperthermia activates fibroblasts, which are cells responsible for producing collagen. Thermal stress triggers the release of certain growth factors that can activate fibroblasts and promote collagen production. Hyperthermia induces the production of heat shock proteins, which play a key role in collagen synthesis, and can enhance collagen cross-linking, which is the formation of chemical bonds between collagen molecules.

[0011] Restricted blood flow leads to hypoxia (defined as insufficient oxygen supply), which is known to promote angiogenesis by triggering physiological responses aimed at restoring oxygen delivery. One of these responses is the release of certain signaling molecules (such as VEGF) by cells in the hypoxic zone.

[0012] The vascular network delivers oxygen and nutrients to all cells in the body. Most transcriptional responses to hypoxia are mediated by hypoxia-inducible factor (HIF), a highly conserved transcription factor that controls the expression of many angiogenic, metabolic, and cell cycle genes. Therefore, the HIF pathway is currently considered to be a major regulator of angiogenesis. HIF regulation can provide therapeutic benefits for a wide range of pathologies, including cancer, ischemic heart disease, peripheral arterial disease, wound healing, and neovascular eye disease. Hypoxia promotes blood vessel growth by upregulating multiple pathways that promote angiogenesis, wherein the multiple pathways that promote angiogenesis mediate key aspects of endothelial, matrix, and vascular support cell biology.

[0013] If some tissues do not receive enough oxygen (hypoxia), cells in the affected area send out chemical signals that cause angiogenesis to begin.

[0014] In summary, hypoxia promotes angiogenesis by releasing signaling molecules such as VEGF, which stimulate the growth of new blood vessels from existing ones. Acute hypoxia lasts from a few minutes to a few hours. Utility Model Content

[0015] The present invention attempts to provide a method and apparatus for tissue regeneration by combining heat therapy and hypoxia-inducing blood flow restriction (hereinafter referred to as "flow restriction"). The prior art does not suggest combining flow restriction and heat therapy. In addition, it is surprisingly found that the combination of flow restriction and heat therapy provides synergistic results; that is, the effect of the combination of flow restriction and heat therapy is significantly better than the combined effect of flow restriction alone and heat therapy alone.

[0016] According to one non-limiting embodiment of the present invention, a method for tissue regeneration is provided, the method comprising using a combination of flow restriction and thermal therapy applied to the treated body part to induce tissue regeneration in the treated body part, the flow restriction being accomplished by impeding blood circulation to the treated body part, and the thermal therapy being accomplished by applying heat to the treated body part.

[0017] According to one non-limiting embodiment of the present invention, the treated body part is a hand, arm, foot, leg, neck, face, scalp, vagina, skin part, penis, penis crus, or pelvic muscles.

[0018] According to one non-limiting embodiment of the present invention, flow restriction and application of thermal therapy to the treated body part are performed consecutively over several cycles, and blood circulation to the treated body part is restored between consecutive cycles while the thermal therapy continues.

[0019] According to one non-limiting embodiment of the present invention, thermal therapy is applied using more than one type of energy including electromagnetic energy, optical energy, radiofrequency energy, acoustic energy, or fluid-conducted thermal energy.

[0020] According to one non-limiting embodiment of the present invention, the thermal therapy is assisted by another type of energy, including electromagnetic energy, optical energy, radiofrequency energy, acoustic energy, or fluid-conducted thermal energy.

[0021] According to one non-limiting embodiment of the present invention, the treated body part is the penis, and the method further comprises stretching the penis or erecting the penis, blocking blood circulation to the penis, and applying heat therapy to the penis, and the method is used to treat erectile dysfunction.

[0022] According to one non-limiting embodiment of the present invention, the body part being treated is the face, and the method includes blocking blood circulation to the face by applying external pressure using a pressure-applying mask, and applying pressure by pulling and / or pushing the mask toward the face using, for example, springs, elastic bands, gravity, pneumatic assemblies, or electric motors.

[0023] According to one non-limiting embodiment of the present invention, the treated body part is a skin part, and the method further comprises blocking blood circulation to the skin part by applying a pressure skin mask, and forcing the treatment lotion into the skin part by external pressure applied on the skin part by the skin mask.

[0024] According to a non-limiting embodiment of the present invention, a device for tissue regeneration is provided, the device comprising: a blood flow constrictor; a heat source; and a controller, the controller being coupled to the blood flow constrictor and the heat source, for applying a combination of hypoxia-inducing blood flow restriction and heat therapy to a treated body part to induce tissue regeneration in the treated body part. Preferably, the heat source comprises at least one of electromagnetic energy, optical energy, radio frequency energy, acoustic or fluid-conducted thermal energy sources.

[0025] According to a non-limiting embodiment of the present invention, a device for tissue regeneration is provided, which includes: a pressure-applying body part mask for flow restriction; a heat source; and a controller, which is connected to the body part mask and the heat source, and is used to apply a combination of flow restriction and heat therapy to the treated body part to induce tissue regeneration in the treated body part.

[0026] According to one non-limiting embodiment of the present invention, a temperature sensor and a pressure sensor are provided in operable communication with a controller, and the controller is configured to control operational parameters of the blood flow constrictor or body part mask and heat source as a function of feedback from the temperature sensor and the pressure sensor.

[0027] According to a non-limiting embodiment of the present invention, the blood flow constrictor comprises a constriction ring or a pressure-applying body part mask. Preferably, the pressure-applying body part mask comprises a pressure-applying skin mask or a pressure-applying face mask. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The present invention will be more fully understood and appreciated from the following detailed description in conjunction with the accompanying drawings, wherein:

[0029] Figure 1 is a simplified illustration of an apparatus for tissue regeneration by a combination of flow restriction and thermal therapy according to one non-limiting embodiment of the present invention, wherein the blood flow constrictor is a constriction ring or a pressure-applying body part mask.

[0030] Figure 2 is a simplified block diagram of a method for tissue regeneration by a combination of flow restriction and thermal therapy according to one non-limiting embodiment of the present invention. DETAILED DESCRIPTION

[0031] As described above, the present invention includes flow restriction-assisted hyperthermia and heat-assisted hypoxia.

[0032] Without limiting the invention to any theory, it is possible that the elimination or significant reduction of blood circulation in the organ, appendage or body part being treated results in the temperature distribution of the treated body part being determined solely by tissue parameters and deposited energy; the thermal energy of the blood flow does not affect the temperature distribution in the treated body part. Therefore, the steady-state temperature distribution in the treated body part is better achieved spatially (more uniform) and temporally (faster).

[0033] Likewise, without limiting the present invention to any theory, heating can help tissue regenerate hypoxia because the body part senses or detects the elevated temperature, which increases the demand for oxygen to be absorbed by the heated tissue. The increased oxygen demand can accelerate the triggering of the angiogenesis process.

[0034] The combination of flow restriction and thermal therapy provides a synergistic result due to mutual assistance; that is, the effectiveness of the combination of flow restriction and thermal therapy is significantly better than the combined effectiveness of flow restriction alone and thermal therapy alone.

[0035] Reference now Figure 1 , which shows a device 10 for tissue regeneration by a combination of blood flow restriction causing hypoxia and thermal therapy according to a non-limiting embodiment of the present invention.

[0036] The device 10 may include a blood flow constrictor 12, such as, but not limited to, a constriction ring for treating erectile dysfunction, an elastic band, a tourniquet, etc. The device 10 may include a heat source 14, such as, but not limited to, a resistive heater, a thermoelectric heater, a chemical heater, an optical heater (e.g., a laser, LED, or flashlight), infrared, acoustic, electromagnetic, radio frequency, a fluid conductor of thermal energy, etc.

[0037] According to another non-limiting embodiment of the present invention, the blood flow constrictor 12 can be a pressure-applying body part mask. For example, the pressure-applying body part mask can be a pressure-applying face mask, and the pressure is applied by pulling and / or pushing the mask toward the face using, for example, springs, elastic bands, gravity, pneumatic components, or electric motors. In this application of the present invention, the treated body part is the face, and the method includes blocking blood circulation to the face by applying external pressure using a pressure-applying face mask.

[0038] According to another non-limiting embodiment of the present invention, the pressure-applying body part mask (blood flow constrictor 12) can be a pressure-applying skin mask. In this application of the present invention, the treated body part is a skin part, and the method includes blocking blood circulation to the skin part by using a pressure-applying skin mask, and forcing the treatment lotion into the skin part by external pressure applied by the skin mask on the skin part.

[0039] The device 10 may include a temperature sensor 16, such as but not limited to a thermistor or thermocouple, etc., which senses the temperature of the treated body part 18. The device 10 may include a pressure sensor 20, such as but not limited to a strain gauge, a piezoelectric pressure sensor, a piezoresistive strain gauge, a capacitive pressure sensor, etc., which senses the pressure applied to the treated body part 18 by the blood flow constrictor 12. The temperature sensor 16 and the pressure sensor 20 may communicate with a controller 22, which controls the operational parameters of the blood flow constrictor 12 and the heat source 14 as a function of feedback from the temperature sensor 16 and the pressure sensor 20. As is well known, the controller 22 may include a display and a user interface. The above-mentioned pressure-applying body part mask may also cooperate with a thermal therapy source, a temperature sensor, a pressure sensor, and a controller.

[0040] Reference now Figure 2 , which shows a non-limiting embodiment according to the present invention by using Figure 1 A method of combining flow restriction and hyperthermia to perform tissue regeneration.

[0041] It is expected that tissue regeneration treatment can be implemented in several courses during a treatment time of at least one week. In a course, treatment can include short cycles separated by interruptions to restore blood circulation and continuous heat therapy. Short cycles and associated interruptions allow safe and repeated hypoxia to be applied. The benefits of the cycles include expansion of tissues that circulate blood during interruptions, and safe and long treatment times in a course by increasing the number of cycles.

[0042] Thermal therapy can be achieved by using various energy delivery, such as, but not limited to, electromagnetic or optical (for non-contact delivery) and radiofrequency, acoustic or fluid-conducted thermal energy (for contact delivery). The relationship between the energy delivered and the organ temperature distribution is governed by the time-space bioheat equation, in which blood circulation is an important contributor to the energy flow to / from the organ. Impeded blood circulation eliminates or significantly reduces the circulation component in the bioheat equation, thereby effectively achieving the desired steady-state temperature distribution in the organ. The temperature range should be selected to prevent charring or other tissue damage, depending on which tissue is being treated.

[0043] Organ hypoxia can be achieved by reducing blood circulation to the organ. Appendicular hypoxia can be achieved by applying external pressure on the blood vessels to circulate blood to the appendage. An example of blocking blood circulation to the appendage is by placing a constriction ring at the base of the erect penis, which is used to trap blood in the penis in order to maintain the erection; for safety reasons, blood circulation must be restored in no more than 30 minutes.

[0044] When applying the method for ED treatment, an erect or stretched penis is preferred. Erection can be assisted by vasodilator drugs (such as, but not limited to, phosphodiesterase type 5 (PDE5) inhibitors), injection into the corpora cavernosa, or by applying a vacuum to fill the penis with blood and placing a contraction ring to capture blood in the penis. Maintaining a stretched penis can be mechanically implemented, for example, by pulling the penis with a stretchable cord or by rigidly supporting the stretched penis. Contraction and release of the base of the penis can be achieved by a tubular expandable ring, allowing contraction and release to be performed by controlling the pressure supplied to the tubular ring by a communicating pump. This function is particularly useful for achieving a cycle of blood flow obstruction and blood flow restoration during a course of treatment.

[0045] The device of the present invention can be a device for home use, clinic or hospital use based on cost, safety and ease of use.

Claims

1. A device for tissue regeneration, characterized in that: The device comprises: blood flow constrictor; Heat sources; and A controller is coupled to the blood flow constrictor and the heat source for applying a combination of hypoxia-inducing blood flow restriction and thermal therapy to a treated body part to induce tissue regeneration in the treated body part.

2. The device according to claim 1, characterized in that The heat source includes at least one of electromagnetic energy, optical energy, radio frequency energy, acoustic or fluid conduction thermal energy sources.

3. The device according to claim 1, characterized in that The device also includes a temperature sensor and a pressure sensor, which are in operable communication with the controller, and the controller is configured to control operational parameters of the blood flow constrictor and the heat source as a function of feedback from the temperature sensor and the pressure sensor.

4. The device according to claim 1, characterized in that The blood flow constrictor comprises a constriction ring or a pressure applying body part mask.

5. The device according to claim 4, characterized in that The pressure-applying body part mask comprises a pressure-applying skin mask or a pressure-applying face mask.

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