WO2019088940A2

WO2019088940A2 - Drainage catheter with integrated led light source

Info

Publication number: WO2019088940A2
Application number: PCT/TR2017/050534
Authority: WO
Inventors: Musfik BENLIOGLU
Original assignee: Benlioglu Musfik
Priority date: 2017-10-31
Filing date: 2017-10-31
Publication date: 2019-05-09
Also published as: WO2019088940A3

Abstract

The drainage catheter with integrated LED light source (13) that can be used in all mammals and can be produced in various sizes according to the target organ/tissue to be used and can be integrated into the any type of catheter, mainly at urinary catheters. The device with battery cell (12), control unit (2) or simple on/off switching (9) and LED light source (4) which can be used easily by both experienced medical personnel or patient itself. With this invention, drainage and anti-infective treatment namely Photo Dynamic Therapy and many other photo initiated treatments can be performed at the same time without requirement of skilled medical personnel.

Description

DRAINAGE CATHETER WITH INTEGRATED LED LIGHT SOURCE Field of the invention

The present invention relates to a drainage catheter with integrated led light source that can perform both drainage and infection-relieving treatment namely Photo Dynamic Therapy and many photo initiated treatments at the same time at a tissue or organ of the body mainly at urinary system and bladder.

Background of the invention

Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (frequently a drug that becomes activated by light exposure) and a light source to activate the administered drug. The procedure is easily performed in a physician's office or outpatient setting. PDT is also referred to as blue light therapy. PDT is currently used in numbers of medical fields, including oncology (cancer), dermatology (skin), cosmetic surgery, ophthalmology, surgery, edema therapy and oral medicine.

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 colored 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.

PDT essentially has three steps. First, a light-sensitizing liquid, cream, or intravenous drug (photosensitizer) is applied or administered. Occasionally, a photosensitizing molecule that is already part of the body can be activated. Second, there is an incubation period of minutes to days. Finally, the target tissue is then exposed to a specific wavelength of light that then activates the photosensitizing medication. The mechanism by which tissue is destroyed seems to depend on the presence of activated oxygen molecules.

Although first used in the early 1900s, PDT in the modern sense is a new, evolving science. Current PDT involves a variety of incubation times for different the light- sensitizing drugs and a variety of light sources depending on the target. The basic premise of PDT is selective destruction.

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. PDT light sources include laser light, intense pulsed light, light-emitting diodes (LEDs), blue light, red light, and many other visible lights (including natural sunlight). Photosensitizer drugs may become activated by one or several types of light. The optimal light source depends on the ideal wavelength for the particular drug used and target.

Bladder/urinary catheterisation also dates to ancient Greek civilization. Numerous natural materials have been used as catheter material. Silver hard catheters were used in 1800s. 1844 rubber vulcanized and flexible catheters were used. Latex was obtained synthetically in the 1930s. LaTeX balloon urinal soda (catheter) was used by Frederic Foley. In urinary catheterization a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection. It may be used to inject liquids used for treatment or diagnosis of bladder conditions. A clinician, often a nurse, usually performs the procedure, but self-catheterization is also possible. The catheter may be a permanent one (indwelling catheter), or an intermittent catheter removed after each catheterization.

The Chinese utility model numbered CN204121577U discloses an ureteral catheter provided with an optical fiber and capable of emitting light passively comprises an LED light source device, the optical fiber, an adapter and a ureteral catheter body. One end of the optical fiber which is connected with the LED light source device, and the other end of the optical fiber is fixed into the ureteral catheter body through the adapter. The ureteral catheter is simple in structure and convenient to operate, after the optical fiber emits the light in the ureteral catheter, an operator can accurately determine the position of a ureter, and accordingly damage to the ureter is avoided.

In the state of the art, the use of catheters causes infection in the bladder and urinary tract and increased body temperature in patients. To prevent this, careful attention must be paid to sterilization rules when inserting the catheter. In addition, skilled and qualified medical personnel is required to operate and also equipment is expensive.

Objects of the invention

The present invention can perform both drainage and infection-relieving treatment namely Photo Dynamic Therapy at the same time at a tissue or organ of the body. Photodynamic therapy can be applied with a drainage catheter with integrated LED light source without the need for an external light source designed for clinical use and need for skilled medical personnel.

The present invention, includes battery, control unit, simple on / off control and LED light source, can be used in all mammals, by any type of catheter designed properly according to the intention of use during manufacturing.

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 drainage catheter with integrated LED light source which is the subject matter of the invention.

Figure 2. shows a perspective view of cross-section of the body of the drainage catheter with integrated LED light source which is the subject matter of the invention.

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

13. Drainage catheter with integrated LED light source

1. Body

l.A. Inner body

l.B. Outer body

l.C. Main sheath

2. Control unit

4. Integrated LED light source

5. First port

6. Second port

7. Third port 9. On / off switch

10. Connection button

11. Warning lights

12. Battery cell

The drainage catheter with integrated LED light source (13) comprises,

at least one body (1) comprising;

- an inner body (l.A), having at least one hollow tube in its center, extruded from a hard, semi-flexible material,

- an outer body (l.B), produced from dielectric, soft and transparent material, with the circuit inside,

a main sheath (l.C) produced from bright, slippery, transparent, flexible and hygienic material by injection molding, covers the inner body (l.A) and outer body (l.B) and combine altogether by sealing,

- at least one control unit (2) comprising an on/off switch for activating and deactivating the system,

at least one integrated LED light source (4), placed on a flexible printed circuit in the outer body (l.B) in a helical position with a 60, 90 or 120 degree angles with the flexible printed circuit,

- at least one first port (5), to introduce any medicine/solution into the organ or tissue that the catheter can be reached,

at least one second port (6), to take out the accumulated edema from the organ or tissue,

at least one third port (7), to allow the air flow through the device, at least one third port (7), to allow the air flow through the device, to inflate the balloon to fix the catheter inside the target organ or tissue,

at least one on / off switch (9) to control the operation of system,

at least one connection button (10), to control the LED lights (4) through a phone or a tablet,

- at least one warning lights (11), to shows the current actions to the operator during operation by emitting lights,

at least one battery cell (12) to provides power supply to the LEDs. The drainage catheter with integrated LED light source (13) has body (1) comprising three parts, an inner body (l.A), an outer body (l.B) and a main sheath (l.C). The inner body (l.A) have at least one hollow tube in its center, extruded from a hard, semi-flexible material. Hardness material of body (1) allows the force to be applied to push the catheter. The outer body (l.B), produced from dielectric, soft and transparent material, with the circuit inside. This circuit has integrated LED light sources (4) and a flexible printed circuit that transmits electric current to LEDs. Integrated LED light sources (4) are arranged in such a way that they may radiate 360 degrees around the circuit. The main sheath (l.C) produced from bright, slippery, transparent, flexible and hygienic material by injection molding, covers the inner body (l.A) and outer body (l.B) and combine all three together by sealing.

The control unit (2) may control the first activation of the device (13) by an on/off switch (9) and may also comprise means for current and voltage regulation of the LED light sources (4).

The control unit (2) may also comprise means for temperature sensing. As the device (13) is used in the body of a living organism, the circuit means and the LED light source (4) may be overheated during the operations. When the temperature sensing means detects overheat or overcurrent situation caused from any other reasons, the control unit (2) can deactivate the LED light source (4) for example by a fuse.

The control unit (2) may also comprise means for short circuit protection.

The drainage catheter with integrated LED light source (13) may also comprise a control unit (2) for communicating with a user interface (i.e. smartphone, tablet etc.). This communication allows the LED light source (4) 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 LED light source (4)). Depending on the purpose of use, the LED light source (4) 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 control unit (2) may comprise an antenna that receives signal from a smart mobile phone or tablet. The control unit (2) can preferably a Bluetooth circuit.

The integrated LED light sources (4), which are arranged to radiate on three different regions and are placed on a flexible printed circuit in the outer body (l.B) in a helical position with a 60, 90 or 120 degrees' angle with the flexible printed circuit. These integrated LED light sources (4) are placed on axial position at the end of the drainage catheter with integrated LED light source (13) and on the lateral surfaces for the remaining parts. In special applications, such as bladder catheters, a narrow angle- integrated LED light sources (4) are selected to reach deeper regions (such as prostate gland) and provide the light energy. The integrated LED light sources (4) may produce the light with identical wavelengths or in multiple different wavelengths on the same strip.

Generally, integrated LED light sources (4) emits the light in the wavelength where the photosensitized material is sensitive (between 350 nm, ultraviolet and 800 nm, infrared). They are placed on a flexible printed circuit in the outer body (l.B) in a helical position with a 60, 90 or 120 degree angles with the flexible printed circuit.

The catheter has at least three different ports. The first port (5) of the catheter (13), is used to introduce any medicine/solution into the target organ or tissue that the catheter can be reached. The end of the first port (5) of catheter (13) is used to deliver an antiseptic solution into the bladder or photosensitizing agent for photodynamic therapy. The second port (6), is used to take out the accumulated edema from the target organ or tissue. The medicine/solution which is flow out through the catheter (13) is collected in an externally separable collection container. The third port (7) is a closed ended pipe, allows the air flow through the catheter (13) to provide it to be fixed into the target organ or tissue. Fixing can be achieved with the help of swallowing balloon in the tip of catheter (13). The connection button (10) controls the LED lights (4) through a phone or a tablet.

The warning lights (11) which is controlled by the control unit (2), shows the current actions to the operator during operation by emitting lights.

The battery cell (12) provides power supply to the drainage catheter with integrated LED light source (13) to operate and can be lithium, lithium-ion or zinc alloy rechargeable or disposable battery. The present invention may be used in the treatment of diseases caused by inflammation, ulcers, gram-positive and negative bacteria caused by infections, adenomatous polyploids, benign formations, cancerous tissues, tumors, neoplastic tissues and fungi in various organs and tissues in the body but maybe used mostly at bladder and urinary tract due to most common usage of the catheters. At this application the device has a unique advantage of reaching to bladder and reaching to prostate glands with the light applied from urinary tract at the same time. This application makes PDT at prostate glands possible with this catheter after the photosensitive material applied intravenously. 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 lit at different wavelength and pattern at the same device The device 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, to prevent the exosom cancer cells metastases from a surgical site, techniques applied at the invivo mammalian organs and bodily cavities which had surgical operations or chronic infection sites.

Claims

1. The drainage catheter with integrated LED light source (13) comprising

at least one body (1) comprising;

- an inner body (LA), having at least one hollow tube in its center, extruded from a hard, semi-flexible material,

- an outer body (LB), produced from dielectric, soft and transparent material, with the circuit inside,

a main sheath (l.C) produced from bright, slippery, transparent, flexible and hygienic material by injection molding, covers the inner body (LA) and outer body (LB) and combine altogether by sealing,

at least one control unit (2) comprising an on/off switch for activating and deactivating the system,

at least one integrated LED light source (4), placed on a flexible printed circuit in the outer body (LB) in a helical position with a 60, 90 or 120 degree angles with the flexible printed circuit,

at least one first port (5), to introduce any medicine/solution into the organ or tissue that the catheter can be reached,

at least one third port (7), to inflate the balloon to fix the catheter inside the target organ or tissue,

at least one on / off switch (9) to control the operation of system,

at least one battery cell (12) to provides power supply to the LEDs.

2. The drainage catheter with integrated LED light source (13) according to claim 1, comprising a battery cell (12), being selected from the group consisting of lithium, lithium-ion or zinc alloy rechargeable or disposable battery.

3. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the communication and connection button (10) controls the LED light source (4) through a phone or a tablet.

4. The drainage catheter with integrated LED light source (13) according to claim 1, comprising an on/off switch (9), controlled by the control unit (2).

5. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the integrated LED light source (4) which are placed on axial position at one end and facing the lateral surfaces at the remaining parts.

6. Integrated LED light source (4), according to claim 5, emitting the light in the wavelength which is between 350 nm, ultraviolet and 800 nm, infrared.

7. Integrated LED light sources (4), according to claim 5, emitting the light in the wavelength where the photosensitized material is sensitive.

8. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the warning lights (11) which is controlled by the control unit (2).

9. The warning lights (11) according to claim 8, shows the current actions to the operator during operation by emitting lights.

10. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the inner body (l.A), having at least one hollow tube in its center, extruded from a hard, semi-flexible material.

11. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the outer body (l.B), produced from dielectric, soft and transparent material, with the circuit inside with integrated LED light sources (4).

12. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the main sheath (l.C) produced from bright, slippery, transparent, flexible and hygienic material by injection molding, to cover the inner body (l.A) and outer body (l.B) and combine all three together by sealing.

13. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the first port (5) to introduce any medicine/solution into the target organ or tissue that the catheter can be reached.

14. The drainage catheter with integrated LED light source (13) according to claim 1, comprising the second port (6), to take out the accumulated edema from the target organ or tissue.