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Title:
A LOCAL TREATMENT KIT IN THE FORM OF AN INTRA-ORGAN CAPSULE ALLOWING LOCAL TREATMENT IN SOLID AND HOLLOW ORGAN CANCERS
Document Type and Number:
WIPO Patent Application WO/2023/211394
Kind Code:
A1
Abstract:
The invention relates to a local treatment kit (A) for use in the treatment of solid and hollow organ cancers, which is configured to apply a drug in an appropriate dose to be administered to a cancerous organ of a patient without hospitalization, so that the cancer treatment may be realized in the comfort of a home, wherein the kit eliminates the possible systemic side effects and consists of an intra-organ capsule (100) and a programmable control unit (200).

Inventors:
DEĞİRMENCİ EVREN (TR)
TEK MESUT (TR)
ERAT SELMA (TR)
YUYUCU KARABULUT YASEMIN (TR)
Application Number:
PCT/TR2022/050478
Publication Date:
November 02, 2023
Filing Date:
May 25, 2022
Export Citation:
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Assignee:
MERSIN UENIVERSITESI (TR)
DEGIRMENCI EVREN (TR)
TEK MESUT (TR)
ERAT SELMA (TR)
YUYUCU KARABULUT YASEMIN (TR)
International Classes:
A61M31/00; A61P35/00
Domestic Patent References:
WO2019120489A12019-06-27
WO1992005822A11992-04-16
Other References:
VADLAPATLA RAJESH, WONG EVA Y., GAYAKWAD SANJAYKUMAR G.: "Electronic drug delivery systems: An overview", JOURNAL OF DRUG DELIVERY SCIENCE AND TECHNOLOGY, ED. DE SANTé, FR, vol. 41, 1 October 2017 (2017-10-01), FR , pages 359 - 366, XP093107182, ISSN: 1773-2247, DOI: 10.1016/j.jddst.2017.08.008
Attorney, Agent or Firm:
TERCIH PATENT A.Ş. (TR)
Download PDF:
Claims:
CLAIMS A kit developed for the use in treatments of solid and hollow organ cancers, characterized by: a local treatment kit (A) for use in the treatment of solid and hollow organ cancers, which is configured to apply a drug in an appropriate dose to be administered to a cancerous organ of a patient without hospitalization, so that the cancer treatment may be realized in the comfort of a home, wherein the kit eliminates the possible systemic side effects,

— wherein the kit administers the medicine to the cancerous organ by separately opening the spring-loaded doors (120) at a desired period of time with a magnetic effect from the control unit (200), or an instruction from a controller therein and an electrical signal obtained from a biocompatible power unit, which doors are in a closed state by means of a locking system (130) in the front of each chamber (1 10) in which a medicine is present in a solid or liquid form in a determined dose for treatment in a body (1 10), which is made of a biocompatible material, of a capsule (100) disposed using a catheter with a local administration to the cancerous organ, wherein the kit is removed from the organ by a physician upon local delivery of the medicine in each chamber (1 10) to a patient, respectively, wherein the kit eliminates the possible systemic side effects due to the local treatment and allows the cancer treatment to be performed at the comfort of a home, wherein the kit consists of an intra-organ capsule (100) and a programmable control unit (200). The local treatment kit (A) according to claim 1 , characterized in that the local treatment kit (A) comprises:

— a capsule (100) made of a biocompatible material, which is disposed in the cancerous organ using a catheter with a local administration and has a body (110) on which the chambers exist in a number as much as the appropriate predetermined doses of a chemotherapeutic agent to be used in the treatment and the number of doses planned to be administered. The local treatment kit (A) according to claim 1 or 2, characterized in that in the local treatment kit (A), the capsule (100) disposed in the organ using a catheter comprises:

— a body (1 10) made of a biocompatible material with rounded ends/corners/edges, on which there are chambers (1 1 1 ) in a number as much as the appropriate predetermined doses of a chemotherapeutic agent to be used in the treatment and the number of doses planned to be administered and a slide (1 12) on which the spring-loaded door (120) is moved in the lateral front sides of each chamber (1 11 ), wherein the chambers (11 1 ) are sealed when the spring-loaded door (120) thereof is closed. The local treatment kit (A) according to claim 1 or 2, characterized in that in the local treatment kit (A), the capsule (100) disposed in the organ using a catheter comprises:

— a door (120) made of a biocompatible material which does not lead to destruction in the organ during opening, which door is connected to the front side of each chamber (1 11 ) located in the body (110) so as to move on the slides (112). The local treatment kit (A) according to claim 1 or 2, characterized in that in the local treatment kit (A), the capsule (100) disposed in the organ using a catheter comprises:

— a locking system (130) which enables the spring-loaded door (120) to remain in a closed state upon placement of the chemotherapeutic agent in each chamber (1 11 ) and allows the drug in the chamber (1 10) to be released by opening the spring-loaded door (120) during the course of the treatment, wherein the locking system has an electromagnetic structure creating a magnetic effect at a frequency/code value obtained when the programmable control unit (200) is got closer tothe capsule (100) extracorporeally, or an electromechanical structure which transmits an electrical signal to a biocompatible power unit and controller circuitry which is integrated into the capsule (100). The local treatment kit (A) according to claim 1 , characterized in that the local treatment kit (A) comprises:

— a programmable control unit (200) which enables the spring-loaded doors (120) of the chambers (1 10) to be opened in a contactless manner at a desired period of time, wherein the control unit creates an electro-magnetic effect at a frequency/code value which is same as the locking system (130) of the spring-loaded door (120), or sends an electrical signal to the biocompatible power unit and controller circuitry which is integrated into the locking system (130).

Description:
A LOCAL TREATMENT KIT IN THE FORM OF AN INTRA-ORGAN CAPSULE

ALLOWING LOCAL TREATMENT IN SOLID AND HOLLOW ORGAN CANCERS

TECHNICAL FIELD

The invention relates to a kit developed for use in the treatments of solid and hollow organ cancers.

In particular, the invention relates to a local treatment kit for the use in treatments of solid and hollow organ cancers, which is configured to apply a drug in an appropriate dose to be administered to a cancerous organ of a patient without hospitalization, so that the cancer treatment may be realized in the comfort of a home, wherein the kit eliminates the possible systemic side effects,

- wherein the kit administers the medicine to the cancerous organ by separately opening the spring-loaded doors at a desired period of time with a magnetic effect from the control unit, or a command from a controller therein and an electrical signal obtained from a biocompatible power unit, which doors are in a closed state by means of a locking system in the front of each chamber in which a medicine is present in a solid or liquid form in a determined dose for treatment in a body, which is made of a biocompatible material, of a capsule disposed using a catheter with a local administration to the cancerous organ, wherein the kit is removed from the organ by a physician upon local delivery of the medicine in each chamber to a patient, respectively, wherein the kit eliminates the possible systemic side effects due to the local treatment and allows the cancer treatment to be performed at the comfort of a home, wherein the kit consists of an intraorgan capsule and a programmable control unit.

PRIOR ART

Surgery, radiotherapy and chemotherapy are the most commonly used methods for cancer treatments. As the invention is for the administration of chemotherapy drugs to the body by an easy method, the state of the art will be explained only by considering the chemotherapy method and the disadvantages thereof. In the treatment of cancer, chemotherapy drugs are delivered to a patient by means of a serum by a vascular access in the current art, or invasively (with a surgical procedure). The disadvantages of this are as follows:

- The patient suffers while receiving each chemotherapy drug, the more the dose frequency of chemotherapy increases, the more the patient suffers, and the patient often does not want drug treatment,

- The patient should be hospitalized while receiving each chemotherapy drug, thus, both the burden of the hospitals and the risks for a cancer patients further increases especially during the pandemic period.

- These chemotherapy drugs and the other chemical agents administered by a vascular access are distributed not only to the cancerous organ but also to the whole body through the circulatory system. These drugs and agents, which are used for cancer treatment and eliminate malignant cells, unfortunately also damage healthy cells due to their toxic effects, thus it damages not only the cells around the healthy tissue of the cancerous organ, but also especially the bone marrow, skin and skin appendages, and especially the tissues with a high regeneration and proliferation capacity. Many cancer patients are known to die not due to the cancer, but due to the side effects of the chemotherapy drugs and chemical agents spreading throughout the body.

In the treatment of hollow organ cancer, the bed patient has to perform different physical movements in order to distribute the chemotherapy drugs administered to the organ homogeneously within the organ by a surgical method. For example, for the treatment of bladder cancer, chemotherapy drugs are administered into the bladder by inserting a catheter (a painful and aching procedure). For homogeneous distribution of the drug administered into the bladder, the patient should move his/her legs in the air and move in different positions. This causes the suffering patient to further suffer as long as he/she moves.

As a result, due to the drawbacks encountered in the state of the art and described above, it is necessary to make improvements in the related technical field.

OBJECT OF THE INVENTION Due to the disadvantages in the prior art, the object of the invention is to solve all the disadvantages described.

The object of the invention is to provide the production of a local treatment kit for use in the treatments of solid and hollow organ cancers, which is configured to apply a drug in an appropriate dose to be administered to a cancerous organ of a patient without hospitalization, so that the cancer treatment may be realized in the comfort of a home, wherein the kit eliminates the possible side effects,

- wherein the kit administers the medicine to the cancerous organ by separately opening the spring-loaded doors at a desired period of time with a magnetic effect from the control unit, or an instruction from a controller therein and an electrical signal obtained from a biocompatible power unit, which doors are in a closed state by means of a locking system in the front of each chamber in which a medicine is present in a solid or liquid form in a determined dose for treatment in a body, which is made of a biocompatible material, of a capsule disposed using a catheter with a local administration to the cancerous organ, wherein the kit is removed from the organ by a physician upon local delivery of the medicine in each chamber to a patient, respectively, wherein the kit eliminates the possible systemic side effects due to the local treatment and allows the cancer treatment to be performed at the comfort of a home, wherein the kit consists of an intraorgan capsule and a programmable control unit.

Another object of the invention is to provide the production of a capsule having chambers as much as the dose of the chemotherapeutic agent (drug) to be used in the treatment suitable for the relevant type of cancer. Therefore, each dose of a drug can be administered into the organ at a specified period of time, and the treatment may be performed.

Another object of the invention is to enable the spring-loaded door in front of each chamber in the capsule containing the drug in the determined dose to be used in the treatment to move on the slide without causing any damage to the organ during the opening thereof.

A further object of the invention is to enable the electro-magnetic lock maintaining the closed state of the spring-loaded door in front of each chamber in the capsule containing the drug in the determined dose to be used in the treatment to be opened by an electromagnetic effect at a frequency value resulting from an external programmable control unit being got closer to the capsule extracorporeally, or by a command of the controller therein and an electrical signal obtained from the biocompatible power unit. Thus, the spring-loaded door of each chamber in the capsule is able to be opened independently, so the drug performing the treatment may be administered separately into the organ at specified time intervals without overdose.

BRIEF DESCRIPTION OF THE INVENTION

The invention is a local treatment kit for use in the treatment of solid and hollow organ cancers, which is configured to apply a drug in an appropriate dose to be administered to a cancerous organ of a patient without hospitalization, so that the cancer treatment may be realized in the comfort of a home, wherein the kit eliminates the possible side effects, wherein the kit consists of a capsule disposed in an organ and a programmable control unit which releases the spring-loaded door locally delivering the chemotherapeutic agent in each chamber in the capsule and opens the locking system by its electro-magnetic frequency/code, or an instruction from a controller located in the capsule and the power obtained from the biocompatible power unit.

The preferred chemotherapeutic agent suitable for the relevant cancer type is prepared in the appropriate doses determined in the tool that will enable local treatment and placed in the chambers in the body of the capsule as much as the number of doses planned to be administered, and each of the spring-loaded doors in a closed state, which are locked by the locking system in front of the chamber is opened for appropriate period of times by an electro-magnetic effect at a frequency/code value obtained from the control unit, or an command obtained from a controller located in the capsule and an electrical signal from the biocompatible power unit, during the course of the treatment.

For example, bladder cancers are the sixth most common type of cancer. Urothelial carcinoma is the most common histological type with a rate of 90%, and 70-80% of this group of patients constitutes the group of noninvasive bladder cancer. As there is no muscle invasion in this group of patients, there is no indication for cystectomy, and the treatment of frequently recurring relapses is provided by a transurethral resection. Intravesical immunotherapy is applied to prevent recurrent relapses. For this treatment, the patient is hospitalized for the 1 st month after the first TUR operation and every week for at least 6 weeks thereafter, and this treatment is possible with urethral catheterization, which is a highly invasive method. For the bladder, the capsule will be placed in the bladder only in the first urethral catheterization application thanks to the capsule of the invention, and the drug will be released into the bladder lumen at appropriate doses every week, allowing the patient to be treated in the comfort of a home without a need for hospitalization.

DESCRIPTION OF THE FIGURES

Fig 1 is a representative view of the local treatment kit of the invention,

Fig.— 2 is a representative view of the local treatment kit of the invention, with a door in the capsule being open,

Fig.— 3 is a representative view of mode of operation of the door in the capsule of the local treatment kit of the invention,

Fig.-4 is a representative view of the capsules having multiple chambers in the local treatment kit of the invention.

REFERENCE NUMERALS

A. Local treatment kit

100. Capsule

110. Body

111. Chamber

112. Slide

120. Spring-loaded door

130. Locking system

200. Control unit

DETAILED DESCRIPTION OF THE INVENTION

Fig. -1 and 2 shows the representative views of a local treatment kit A for use in the treatment of solid and hollow organ cancers, which is configured to apply a drug in an appropriate dose to be administered to a cancerous organ of a patient without hospitalization, so that the cancer treatment may be realized in the comfort of a home, wherein the kit eliminates the possible side effects. The local treatment kit A of the invention comprises:

- a capsule 100 made of a biocompatible material, which is disposed in the cancerous organ using a catheter with a local administration and has a body 110 on which the chambers exist in a number as much as the appropriate predetermined doses of a chemotherapeutic agent to be used in the treatment and the number of doses planned to be administered,

- a programmable control unit 200 which enables the spring-loaded doors 1 0 of the chambers 110 to be opened in a contactless manner at a desired period of time, wherein the control unit creates an electro-magnetic effect at a frequency/code value which is same as the locking system 130 of the spring- loaded door 120, or sends an electrical signal to the biocompatible power unit and controller circuitry which is integrated into the locking system 130.

In case that the locking system 130 has an electro-magnetic frequency/code structure, the programmable control unit 200 is got closer to the body extracorporeally, the locking system 130 is unlocked by an electromagnetic effect at an individual frequency/code value for the locking system 130 of each chamber 110, and the spring-loaded door 120 is opened, thereby releasing the drug in the chamber 1 10.

In case that the locking system 130 is with a power unit and a controller circuitry which are integrated into the capsule 100, the programmable control unit 200 is got closer extracorporeally, sends an electrical signal to the biocompatible power unit and controller circuitry for the locking system 130 of each chamber 110, thereby unlocking the locking system 130. When the locking system 130 is unlocked, the spring-loaded door 120 is opened and the drug in the chamber 1 10 is released.

In the local treatment kit A of the invention, the capsule 100 disposed in an organ by a catheter consists of:

- a body 110 made of a biocompatible material with rounded ends/corners/edges, on which there are chambers 11 1 in a number as much as the appropriate predetermined doses of a chemotherapeutic agent to be used in the treatment and the number of doses planned to be administered and a slide 1 12 on which the spring-loaded door 120 is moved in the lateral front sides of each chamber 1 11 , wherein the chambers 1 11 are sealed when the spring-loaded doors 120 are closed, - a door 120 made of a biocompatible material which does not lead to destruction in the organ during opening, which door is connected to the front side of each chamber 111 located in the body 1 10 so as to move on the slides 112,

- a locking system 130 which enables the spring-loaded door 120 to remain in a closed state upon placement of the chemotherapeutic agent in each chamber 1 11 and allows the drug in the chamber 1 10 to be released by opening the spring- loaded door 120 during the course of the treatment, wherein the locking system has an electromagnetic structure creating a magnetic effect at a frequency/code value obtained when the programmable control unit 200 is got closer to the capsule 100 extracorporeally, or an electro-mechanical structure which transmits an electrical signal to a biocompatible power unit and controller circuitry which is integrated into the capsule 100.

As mentioned above, the local treatment kit A of the invention consists of two parts: a capsule 100 disposed in an organ and a programmable control unit 200 which represents a hand unit operating the capsule 100.

The local treatment is conducted at the scheduled period of time by a biocompatible power unit and a biocompatible controller board, which are integrated into the capsule 100.

As specified, the programmable control unit 200 unlocks the locking system 130 by sending an electrical signal to an external biocompatible power unit and programmable controller circuitry located in the capsule 100, instead of sending an electro-magnetic effect to the locking system 130 of the spring-loaded door 120.

For use of the treatment kit A, the capsule 100 is easily disposed in the body using a catheter. As it has rounded ends/corners/edges, it does not damage the internal tissue of the organ in which it is disposed. A chemotherapeutic agent at a dose determined for the treatment in a solid or liquid form is placed in one or more chambers 1 10 on the capsule 100. Each chamber 110 has spring-loaded doors 120 which may be controlled individually and opened by a magnetic stimulation. The spring-loaded doors 120 will not leak the solids, liquids and gases around the capsule 100 into the chambers 1 11 and the drugs contained in the chambers 11 1 into the organ, when they are closed. Each of the spring-loaded doors 120 has a locking system 130 which has an electro-magnetic characteristic comprising a unique electro-magnetic frequency/code, or has an electromechanical characteristic comprising a biocompatible power unit and a controller board, which are integrated into the capsule 100, wherein said locking system 130 may be unlocked in a contactless manner by the programmable control unit 200 generating a magnetic effect that is the same as itself, or an electrical signal. A force is applied to the spring-loaded doors 120 in such a way that they are opened by springs of any of different types, including a pull member/a push member/a latch on both sides, when they are in a closed position. However, the spring-loaded doors 120 do not open due to the locking system 130.

As specified, the locking system 130 of each spring-loaded door 120 may be unlocked by a magnetic field having a separate frequency or a separate code and an electrical signal sent to a biocompatible power unit and a controller board, which are integrated into the capsule 100. The logic in which the passive (battery-free) magnetic key fobs called Mifare are energized when they are brought close to a magnetic reader, and send the code information therein to a magnetic reader terminal is an example. The spring- loaded doors 120 unlocked will not be closed again, and after all chambers 110 are brought to the open position, the capsule 100 is removed from the organ by the physician. The biocompatible capsule 100 may be left within the organ depending on the type of organ to be treated, for example solid visceral organs.

When the user presses the corresponding button of the programmable control unit 200, which is the second part of the local treatment kit A of the invention and forms the hand unit which is programmed before the intra-organ capsule 100 is placed, the corresponding spring-loaded door 120 is opened by means of the force generated by the springs. The control unit 200 generates an audible warning when the drug is released, and may also send a message to the user's phone. In this way, the user may effortlessly release drugs at a right time.

During use of the treatment kit A of the invention, firstly, the capsule 100 having chambers 11 1 in a number as much as the dose amount determined for treatment in a hospital environment is taken, the chemotherapeutic agent is disposed in each chamber 1 11 , and the spring-loaded door 120 is closed, (fig. 1 )

As soon as the capsule 100 is disposed in the organ, the spring-loaded doors 120 thereof are closed and locked by the locking system 130 which has an electromagnetic or electromechanical structure. The physician places the capsule 100 prepared in the cancerous organ by a local application using a catheter. The patient is enabled to become self-aware with training.

During the discharge of the patient, the patient is provided with the control unit 200. The control unit 200 provides a warning about the dose amount determined during the treatment process. After the patient receives the warning about the time to take the drug, the patient makes the control unit 200 get closer to the capsule 100 placed in the cancerous organ extracorpo really and presses the corresponding key/button of the control unit 200. In this step, the electromagnetic effect having the same frequency/code value as the locking system 130 which keeps the spring-loaded door 120 of the chamber 1 11 in which the corresponding dose is placed, or the electrical signal sent to the biocompatible power unit and the controller board, which are integrated into the capsule 100 is created by the control unit 200, and the locking system 130 is unlocked, so that the spring-loaded door 120 is released, thereby being opened moving on the slide 112 due to the springs located on the sides. When the spring-loaded door 120 is opened, the drug/chemotherapeutic agent in the chamber 1 11 is released into the organ, (fig. -3) Due to the correct movement of the spring-loaded door 120 on the slide 1 12, there is no damage to the surrounding tissue of the organ.

The indicated process is continued until the local release of the chemotherapeutic agent/drug in each chamber 11 1 is achieved throughout the specified treatment period. After the chambers 1 11 are completely emptied, that is, the entire dose is provided to the patient, the capsule 100 is removed from the organ by the physician. Thus, the drawbacks encountered in chemotherapy applications applied in the state of the art are eliminated, and the cancer treatment is performed locally in the comfort of a home without hospitalization.

The spring-loaded doors 120 may be opened by an external circuit board, a power unit, a communication unit and a processor, which are located on the body 1 10 of the capsule 100, instead of an electro-magnetic locking system 130 which keeps each chamber 1 11 in the capsule 100 of the local treatment kit A of the invention in a closed position. In this process, the control unit 200 may optionally be used/not used. During the treatment process, the programmed processor may open the spring-loaded doors 120 by means of an electronic coding when the dose amount determined by the timer arrives, and the chemotherapeutic agent in the chamber may be released into the organ.




 
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