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Title:
LED LIGHT SOURCE DEVICE FOR PHOTODYNAMIC THERAPY
Document Type and Number:
WIPO Patent Application WO/2019/088938
Kind Code:
A1
Abstract:
Swallowable, suppository or implantable LED light source device (1) in different sized capsule/spherical form according to the application with or without a safety retraction cord mechanism to perform photoinitiated procedures or treatments namely, photodynamic therapy at in vivo mammalian gastro intestinal tract without a safety retraction cord and at bodily cavities mainly at rectum, vagina, uterus and at oral, laryngeal, nose, ear cavities with a safety retraction cord or with a perforated capsule carrier chain (9) and its special holders.

Inventors:
BENLİOĞLU MÜŞFIK (TR)
Application Number:
PCT/TR2017/050532
Publication Date:
May 09, 2019
Filing Date:
October 31, 2017
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
BENLIOGLU MUESFIK (TR)
International Classes:
A61N5/06
Foreign References:
CN106902468A2017-06-30
US6273904B12001-08-14
US20050192478A12005-09-01
CN106237533A2016-12-21
US20140005758A12014-01-02
US20140081360A12014-03-20
US8786689B12014-07-22
US20160231494A12016-08-11
Attorney, Agent or Firm:
ANKARA PATENT BUREAU (TR)
Download PDF:
Claims:
CLAIMS

The LED light source device (1) for being inserted in the body of a living organism for photodynamic therapy comprising,

- at least one biocompatible outer sealed case (2),

- at least one LED (3) for emitting light at wavelengths that at least one photosensitizer material in the body is susceptible with,

- at least one battery cell (4) for supplying energy to LEDs (3) and a first control circuit (5),

- first control circuit (5) comprising an on/off switch for activating/deactivating the LEDs (3).

The LED light source device (1) according to claim 1, comprising a second control circuit (6) for communicating with a user interface.

The LED light source device (1) according to claim 2, wherein the second control circuit (6) is a Bluetooth circuit.

The LED light source device (1) according to claim 2 wherein the second control circuit (6) is adapted to control the LEDs (3) to radiant according to a predetermined pattern.

The LED light source device (1) according to claim 1, according to claim 1, wherein the device is a swallowable capsule.

The LED light source device (1) according to claim 1, wherein the device is a suppository capsule.

The LED light source device (1) according to claim 1, wherein the device is an implantable capsule.

8. The LED light source device (1) according to claim 1, comprising an outer sealed case (2) is made from a tissue-friendly polymeric material.

9. The LED light source device (1) according to claim 1, comprising an outer case (2) made from an elastomeric material.

10. The LED light source device (1) according to claim 1, comprising an outer sealed case (2) consists of two parts which are combined with ultrasonic welding.

11. The LED light source device (1) according to claim 1, comprising an outer sealed case (2) consists of two parts which are combined with medical adhesives. 12. The LED light source device (1) according to claim 1, comprising a battery cell (4) which is a lithium, lithium-ion, zinc alloy battery.

13. The LED light source device (1) according to claim 1, comprising a battery cell (4) which is a chargeable battery.

14. The LED light source device (1) according to claim 1, comprising a safety pin (7) which allows removal of the device (1) from the body.

15. The LED light source device (1) according to claim 1, comprising a perforated capsule carrier chain (9) to allow the capsule arranged in a row to enter the deep cavities of the body.

16. The LED light source device (1) according to claim 1, comprising a perforated capsule carrier chain (9) is produced from an elastic and transparent elastomer.

17. The perforated capsule carrier chain (9) according to the claim 15, comprising a chain holder (10) to penetrate the elastic chain (9) to rectum and vagina. 18. The LED light source device (1) according to claim 1, comprising a chain holder (10) is produced from an elastic and transparent elastomer.

19. The LED light source device (1) according to the claim 1, implanted into a tissue and connected to the surrounding tissues by sutures from the half rings (8) on both sides of the capsule.

Description:
LED LIGHT SOURCE DEVICE FOR PHOTODYNAMIC THERAPY Field of the invention

The present invention relates to a swallowable, suppository or implantable LED light source device in different sized capsule/spherical form according to the operation in vivo at all mammalians with or without a safety retraction cord mechanism and special holders.

Background of the invention

Photodynamic therapy has roots going to ancient Egypt and Hellenistic civilizations. People noticed the curing ability of sun light for skin diseases. During 19. Century some treatment methods used as using sun light passing behind the red coloured window glasses before washing the patient skin.

The principle of photodynamic action was first described by Oscar Raab in 1890 when he noted the toxic effects of acridine orange, which showed activity as a photosensitizer when combined with light and oxygen by destroying Paramecium caudatum cells without apparent damage to the protozoa when used alone. Von Tappeiner discovered in 1903 that the administration of eosin following irradiation with light led to oxygen-dependent tissue reactions and improvements in skin diseases such as condylomata lata, lupus vulgaris, psoriasis, syphilis, and skin cancers. He termed this activity a "photodynamic reaction". In the late 1970s, photodynamic therapy (PDT) with hematoporphyrin derivative (HPD) was developed by Thomas Dougherty and his co-workers. They purified HPD to some extent and discovered that the administration of HPD followed by irradiation with red light resulted in oxygen-dependent tissue reactions. Today, it is known that PDT relies on the absorption of harmless visible light by a photosensitizer, which then produces reactive oxygen species (ROS) such as singlet oxygen that destroy cancer cells, blood vessels, and pathogenic microorganisms. Generally, PDT requires three essential components for the biochemical process to proceed: a photosensitizer, an appropriate light source, and tissue oxygen. The photosensitizer is a photosensitive molecule that is localized within the target tissue and is activated by a specific wavelength or energy of light. When the photosensitizer is exposed to light of the appropriate wavelength, it is activated from the ground state, SO, to the first excited state, S 1.

The excited photosensitizer goes from SO to S 1 and undergoes intersystem crossing to the long-lived metastable triplet state that then transfers hydrogen or energy to ground state 0 2 . This activated photosensitizer can then undergo two types of reaction in which the energy released can mediate selective cell killing. First, it can react directly with a substrate, such as intracellular molecules or cell membrane components, to form radicals, which then interact with oxygen to generate ROS (type I reaction); Second, the activated photosensitizer can transfer its energy directly to oxygen to form the ROS singlet oxygen (102), which further oxidizes various substrates (type II reaction). These species can oxidize various substrates and initiate cytotoxic effects by inducing necrosis and apoptosis.

The generation of singlet oxygen species by type II photochemical reactions is believed to be the predominant reaction in PDT. At low levels of PDT, biological systems may be positively stimulated by low enhancement of ROS levels.

The United States patent document numbered US8786689 discloses an optical medical diagnostic system is disclosed comprising a LED light assembly, a controller portion and a power portion where the modular LED light assembly can switch from one operating wavelength LED light assembly to another wavelength LED light assembly. The generated fluorescence image may be viewed through a fluorescence band pass filter assembly mounted on the light handle and viewing angle can be adjusted through its tilt arm. The band pass filter blocks the excitation wavelength and passes the fluorescence wavelength.

The United States patent document numbered US2016231494 discloses an external endoscope light source system includes light emitting diodes for providing a light output to an endoscope. The light is provided to a fiber optic cable for transmission to the endoscope.

In the state of the art, treatment like a photodynamic treatment at GI tract requires an invasive endoscopic, retroscopy or colposcopy methods require very expensive and sophisticated medical equipment and should be performed by experienced medical team costs very expensive and time consuming, while carrying risks like perforation, bleeding, risks related to anaesthetic procedures and being extremely disturbing to patient.

To overcome these problems and able to apply photodynamic therapy at GI tract and bodily cavities to the millions of people need a simple yet efficient method of treatment that can be performed by themselves. Objectives of the invention

One objective of the invention is to realize a swallowable, suppository or implantable light/radiation source device in capsule/spherical form can perform multiple functions during its naturally going travel inside the gastrointestinal tract starting from the oral cavity to the rectum in vivo at all mammalians

Another objective of the invention is to realize a safety retraction cord to the LED light source device, it can be also used at bodily cavities like vagina, rectum, oral cavity, laryngeal opening, stomach, lungs, nose, ear and on to the skin.

The shape and dimensions of the LED light source device can be prearranged during the manufacturing stage of the sealed device and start stop function may performed with an external control mechanism of mechanical, magnetically, with an electronic RF signal. Capsules can be synched with smartphones, meaning progress easily accessible by users and doctors online. The LED light source device can surgically be inserted into an organ, bone, muscle or bodily cavity during the surgery to left in the body to radiate according to a predetermined pattern and wavelengths to apply a photo initiated treatment of any kind described above including one time or repetitive photodynamic therapy or photo bio stimulation post operatively or may performed for only this purpose for a period of time before taken out from body according to the IV infused photosensitive material upload and treatment plan of the medical performers.

The LED device can surgically insert into an organ, blood vessel, vein, bone, muscle, skeletal joint, a bodily cavity, nearby an implant or inside a purpose made implant itself via attached to an endoscope, laparoscope, retractor, stent, needle, catheter or attached to a surgical instrument to be used during an operation, diagnosis or treatment as a light source to illumination, photodynamic treatment to prevent infection or bio stimulation of surrounding cells around the surgical site. Detailed description of the invention

A realized to fulfil the objective of the present invention is illustrated in the accompanying figures, in which: Figure 1. shows a perspective view of the LED light source device for photodynamic therapy which is the subject matter of the invention.

Figure 2. shows a perspective view of the chain of the LED light source device for photodynamic therapy which is the subject matter of the invention.

Figure 3. shows a perspective view of the chain form of the LED light source device holder that is a hollow pipe just to be used as a directing handle for photodynamic therapy at deeper cavities of the body like throat, trachea, oesophagus, bronchus and lungs to be performed by a directing medical applicant which is the subject matter of the invention. Figure 4. shows a perspective view of the chain form of the LED light source device holder that is a hollow pipe in a special form just to be used as a directing handle for photodynamic therapy at rectum or vagina and uterus to be performed by a directing medical applicant or patient his/her self which is the subject matter of the invention. Figure 5. shows a perspective view of the chain form of the LED light source device holder that is a hollow pipe just to be used as a directing handle for photodynamic therapy at deeper cavities of the body like throat, trachea, oesophagus, bronchus and lungs to be performed by a directing medical applicant which is the subject matter of the invention.

The parts illustrated in the figure are individually numbered where the numbers refer to the following:

1. LED light source device

2. Outer sealed case

3. LED light sources

4. Battery cell

5. A first control circuit

6. Second control circuit

7. Safety pin

71. Ring

72. Rope

8. Half ring

9. Chain

10. Chain holder The LED light source device (1) for being inserted in the body of a living mammalian organism for photodynamic therapy comprising;

at least one biocompatible outer sealed case (2),

at least one LED (3) for emitting light at wavelengths that at least one photosensitizer material in the body is susceptible with,

at least one battery cell (4) for supplying energy to LEDs (3) and a first control circuit (5),

first control circuit (5) comprising an on/off switch for activating/deactivating the LEDs (3).

The device (1) has an outer sealed case (2) is made of a transparent colourless or coloured material according to the specific operation to be used. The material is preferably a tissue-friendly polymeric material suitable for medical sterilization systems. The outer sealed case (2) consists of two parts and the joint of these two parts is sealed with ultrasonic welding and / or medical adhesives. In this case, the outer sealed case (2) does not leak fluids into the body. It is also not affected by body fluids. This case may be fulfilled with an elastomeric material to prevent any kind of short circuit or electrical failure due to air, acid, body liquids or any other penetration as a second protection layer to make a perfectly sealed unit against outer gases or liquids of any kind.

The device (1) comprises multiple LEDs (3). These LEDs (3) are placed facing the inner axial and lateral faces of the case (2). In general, axially positioned LEDs (3) are chosen to have narrower radiation angles, while laterally placed LEDs (3) are chosen to have a wider angle of radiation.

The wavelength of the light emitted by different LEDs (3) can be the same. However, LEDs (3) which are emitting in different wavelengths could be in the same device (1). LEDs (3) selected due to the wavelength to which the photosensitizer materials in the body of a living organism are susceptible, depending on the type of light to be applied. The device (1) has a battery cell (4) that supplies electricity to the LEDs (3) and the first control circuit (5). The battery cell (4) can be a lithium, lithium-ion or zinc alloy chargeable or disposable battery. The first control circuit (5) may control the first activating for use of the device (1) by mechanical or magnetic on/off switch and may prevent the battery cell (4) from being spent until the moment of use.

The first control circuit (5) may also comprise means for current and voltage regulation of the LEDs (3).

The first control circuit (5) may also comprise means for temperature sensing. As the device (1) is used in the body of a living organism, the circuit means and the LEDs (3) may be overheated during the operations. When the temperature sensing means detects overheat or overcurrent situation caused from any other reasons, the first control circuit (5) can deactivate the LEDs (3) for example by a fuse.

The first control circuit (5) may also comprise means for short circuit protection.

The LED light source device (1) may also comprise a second control circuit (6) for communicating with a user interface (i.e. smartphone, tablet etc.). This communication allows the LEDs (3) can be synchronized automatically or operate due to the desired radiation pattern (i.e. discrete or continuous radiation or sequential radiation for different kinds of LEDs (3)). Depending on the purpose of use, the LEDs (3) can emit light at various wavelengths or they can emit and be activated at a preferred time according to the desired pattern of radiation.

The second control circuit (6) may comprise an antenna that receives signal from a smart mobile phone or tablet. The second control circuit (6) can preferably a Bluetooth circuit.

In one embodiment of the invention, the LED light source device (1) can be a swallowable capsule and be used in the treatments of gastrointestinal tract. Photodynamic therapy in the gastrointestinal tract can be achieved by firstly taken a photosensitive material into the body orally / rectally or by intra venal injection. Photosensitive material selectively can be loaded into damaged cells. The LED light source device (1) in the form of a capsule is driven by the autonomous motion of the muscles in the gastrointestinal tract in living mammalian organisms, while providing the necessary light energy for photodynamic therapy. The capsule formed LED light source device (1) can be expelled out of the body naturally.

Swallowable LED light source device (1) for photodynamic therapy (1) can be selected the light in wavelength that the photosensitizer is sensitive with the specified algorithm predetermined lite/radiation modes like pulse, continuous, soft start, delayed start, stop or repeatedly radiate in a preadjusted patterns at precalibrated single or multiple wavelengths at visible light spectrum, UV or IR region as needed at the technique applied.

The LED light source device (1) in the form of a capsule can be removed from the body through the rectum, colorectal, vagina, uterus, mouth, throat, food tube, respiratory tract, lung, stomach, ear, nose or most exclusively on the skin from the outside of the body with the connection of the safety pin (7). The pin (7) comprises a ring (71) which is fixed to a rope (72). The ring (71) is also connected to a half ring (8) located on the case (2) of the device (1). Therefore, the device (1) can be removed from the body by pulling the rope (72).

LED light source device (1) can be used with a perforated capsule carrier chain (9) which is produced from an elastic and transparent elastomer, to allow the device to enter the deep cavities of the body in the shape of a row chain (9) and a chain holder (10) to penetrate the elastic chain easily to rectum, vagina and laryngeal opening.

Capsulated form LED device (1) can be implanted into organs, bone, muscle, vein, nerve, lymph tissue in an implant with surgical methods, endoscopy, laparoscopy, retractors, stents, needles, catheters, orthopedic implants. This invention resulted from a chronic need of searching a self-deployed treatment may performed by conventional methods by patients themselves at gastrointestinal diseases. This invention provides a system and method, a new way of doing photodynamic therapy at gastrointestinal track and offers a technical solution to a problem of bringing a light source by an endoscope, colonoscope, or similar device operating by an experienced clinician. This invention, brings a new solution to treatment of all kinds of inflammations, ulcers, gram positive-negative bacterial infections, cancers, tumors, all neoplastic cell activities and other diseases like fungus related illnesses or simply regulate, control the microorganisms at intestinal flora located at gastrointestinal (GI) tract from oral cavity to rectum or control, activate, deactivate the specific medicines to work at specific regions of GI tract to regulate or prevent diarrhea and constipation.

There are different diagnose and treatment techniques require a light/radiation source generating predetermined lite/radiation modes like pulse, continuous, soft start, delayed start, stop or repeatedly radiate in a preadjusted patterns at precalibrated single or multiple wavelengths at visible light spectrum, UV or IR region as needed at the technique applied, mainly at but not limited to; photodynamic therapy. There may different wavelength LEDs (3) lit at different wavelength and pattern at the same device (1). The device (1) may also use at the following applications; photoirradiation, photo biomodulation, photo bio stimulation, photo immune therapy, photo conversion of living cells and synthetic materials, photochemotherapy, photothermal therapy, photo activation of nanoparticles as anticancer nanotherapeutics, photo activation of molecularly targeted drugs, photocytotoxicity, techniques applied at the invivo mammalian gastrointestinal tract or other bodily outer cavities. The device may also use as an implanted device into blood vessels for photodynamic therapy of the infected blood cells and exhausted cancer cells originated from the primary cancer cells and body organs to use for preventing pain techniques or muscle relaxation by increasing blood circulation by applying visible light or IR radiation to the muscles, tendons, skeleton joints to relief from pain.