ES3037764A1 - BIOCOMPATIBLE MAGNETIC ACTIVATION CAPSULE, MAGNETICALLY ACTIVATED DRUG RELEASE SYSTEM AND METHOD FOR DRUG RELEASE BY MAGNETIC ACTIVATION - Google Patents

Abstract

Magnetically activated biocompatible capsule comprising a first compartment: with a power source, a motor connected to it, a piston, connected to the motor, which moves it linearly; a Reed switch, configured to activate a current flow from the power source to the motor; and a second compartment comprising holes and is intended to house a medication; the piston being configured to generate pressure in the second compartment, releasing the medication through the holes. Drug release system comprising: the biocompatible capsule and beacons with magnetic properties. Method for drug release comprising: placing the beacon on a target soft tissue, activating the Reed switch by magnetic activation, activating a current flow from the power source to the motor so that it acts on the piston; and expelling the medication from the capsule by pressure generated by the piston. (Machine-translation by Google Translate, not legally binding)

Description

DESCRIPTION

BIOCOMPATIBLE MAGNETIC ACTIVATION CAPSULE SYSTEM FOR

MAGNETICALLY ACTIVATED DRUG RELEASE AND METHOD

FOR DRUG RELEASE BY ACTIVATION

MAGNETIC

OBJECT OF THE INVENTION

The object of the present invention is a biocompatible magnetically activated capsule and a magnetically activated drug delivery system comprising said capsule. The system of the invention enables the reliable and precise delivery of a drug to a specific area of a patient's body.

The invention also relates to a method for drug delivery that allows the drug to be delivered to the specific location where it is needed by means of magnetic activation.

BACKGROUND OF THE INVENTION

The use of capsules for the protection of a drug and its release at a specific point in the human body is a subject of study in the state of the art.

In general, many different approaches have been made in this field, using mechanisms that control drug delivery using principles of dissolution or pressure, among others.

Electronic drug delivery systems are also known in the state of the art in various applications, such as cardiac devices.

Many of these systems use wireless communication mechanisms and activate drug delivery based on radiofrequency signals, ultrasound, or images or videos obtained.

However, most of the systems located in the state of the art are large, complex and/or have very limited accuracy in relation to the place where the drug should be delivered.

DESCRIPTION OF THE INVENTION

The invention relates to a biocompatible magnetically activated capsule comprising two compartments, a first compartment and a second compartment.

The first compartment comprises: an electronic control module which in turn comprises: a power supply, a motor, preferably a stepper motor which is more precise, a piston and a Reed switch.

The second compartment comprises: one or more holes and is intended to hold a medication.

The holes are configured with a size small enough to achieve a high surface tension that prevents unwanted losses of the drug located in the second compartment, which breaks due to the pressure generated at the time of drug expulsion.

Alternatively, the second compartment may comprise a sealing element or mesh that temporarily covers the holes until the moment of expulsion of the drug from the second compartment, by pressure.

The motor is connected to the power supply via a reed switch. When activated, the reed switch allows current to flow from the power supply to the motor. The reed switch's small size and high sensitivity enable precise and efficient drug delivery. The motor is connected to the piston, causing it to move linearly. This linear movement of the piston into the second compartment increases the pressure, releasing the drug through the orifices. This magnetic delivery mechanism ensures more reliable and controlled release at a more precise location.

Preferably, the first compartment may also include a hold module, which may comprise one or more relays connected between the power supply and the motor and configured to maintain the flow of current from the power supply to the motor. More preferably, the one or more relays are compact, solid-state hold relays. The hold module enables the motor to remain active even after a magnetic beacon has been removed, i.e., when the reed switch is deactivated, until the power is interrupted or the batteries are depleted.

Preferably, the piston may comprise a rod and a washer attached to the rod. More preferably, the piston may be made of aluminum alloys, cast iron, ceramic, or any metallic alloy.

On the other hand, the power source can be a Silver Oxide, Galvanized Copper-Zinc, Mg-MoO3 or Sodium Ion battery.

The biocompatible capsule can be made of rigid, biocompatible materials that do not degrade.

The invention also relates to a magnetically activated drug delivery system comprising a biocompatible capsule as described and one or more beacons with magnetic properties. Preferably, the beacons may be made of gold, steel, platinum, carbon, or any other magnetic material.

The invention's system offers a unique combination of simplicity and effectiveness. This system has proven to be precise while also being significantly compact. The system's accuracy is crucial for meeting required standards and ensuring reliable results. Its key feature is its ability to release fluid in a controlled manner to the specific desired area, making it a versatile tool adaptable to a variety of applications.

On the other hand, the invention also relates to a method for drug delivery by magnetic activation that makes use of the described drug delivery system.

The method of the invention comprises the following steps:

- Place a magnetic beacon in a target soft tissue, preferably within the digestive system.

- activate the Reed switch by proximity of the biocompatible capsule to the beacon after ingestion by a patient, activating a current flow from the power supply to the motor;

- to activate the engine's movement by acting on the piston; and

- expel the medication from the capsule by pressure generated by the piston.

Precise placement of the magnetic beacon allows the medication to be delivered to the exact location where it is needed, rather than to nearby healthy areas. Ideally, a needle is used to place the beacon in the target soft tissue. Additionally, computed tomography, ultrasound, or an endoscope can be used to guide the needle at this stage.

BRIEF DESCRIPTION OF THE DRAWINGS

To complement the description being made and to help in a better understanding of the characteristics of the invention, according to a preferred embodiment thereof, a set of diagrams is attached, in which, for illustrative and non-limiting purposes, the following has been represented:

Figure 1 shows a diagram representing the stages of a preferred embodiment of the method of the invention.

Figure 2 shows the drug release mechanism by magnetic activation of the biocompatible capsule of the invention.

Figure 3 shows the needle used to insert the magnetic beacon.

Figure 4 shows a Reed switch in its non-active and active positions, respectively.

Figure 5 shows the integrated circuit in the capsule of the system of the invention.

PREFERRED EMBODIMENTS OF THE INVENTION

The invention relates to a biocompatible capsule and a drug delivery system that make use of a magnetic activation mechanism that allows for a reliable and precise system.

Furthermore, magnetism is not harmful to the body and is one of the most advanced alternatives available today.

The system of the invention makes use of "Fiducial Markers," widely used in cancer localization for removal. Within this type of beacon, those with magnetic properties will be selected.

The system of the invention comprises a biocompatible capsule with two compartments: one intended to house the integral electronics of the system, and another designed to contain the drug (5) or substance (5) to be released into the body.

Figure 1 illustrates the high-level operation of the system, where the starting point is the placement (20) of a magnetic beacon in the area to be treated. Once the area where the substance (5) is to be released has been located and marked, the patient ingests (21) the capsule, which travels unaltered throughout the digestive system until it reaches the designated area. There, the system's capsule is activated (22) upon detecting the magnetic signals from the beacon and proceeds to release the substance (5). Finally, the capsule continues its course through the gastrointestinal tract until its expulsion (23).

Figure 2 illustrates the contents and operation of the biocompatible capsule of the invention. In one design, the capsule consists of two compartments: one for the electronic system and another for the substance to be released into the body. The main components of the electronic system are: a battery (1), a reed switch (2), a piston (4), a motor (3), and a magnetic beacon. Additionally, the electronic system may also include one or more sensors.

The beacon generates a magnetic field that activates a reed switch (2) once the capsule and the beacon come close enough together, allowing current to flow from the batteries (1) to the motor (3). This current activates a possible hold module, a position-hold relay, or a solid-state device, which keeps the system active even after the beacon has been withdrawn, until the current is interrupted or the batteries (1) are depleted.

After the system is activated, the motor (3) starts operating. This motor (3) moves a piston (4), in this case, a rod that, through a plunger, applies pressure to break the surface tension of the fluid contained in the second cavity of the capsule. The holes (6) in the capsule allow the medication to be released into the specific area to be treated.

Beacons, also called fiducial markers, are small metallic objects, which can be made of gold, steel, platinum, or carbon, approximately 1 mm x 5 mm in size. The radiation therapist uses them to locate the tumor and the treatment area. This ensures that the radiation is delivered to the tumor rather than the nearby healthy tissue.

The beacons are placed on different parts of the body:

• Lung or chest wall

• Liver, gallbladder, kidney, or pancreas

• Prostate

• Head and neck

• Digestive system

The beacons are placed in the soft tissue. They are inserted several days before radiotherapy begins and remain in the soft tissue permanently.

The placement of the beacons is often guided by computed tomography (CT) scans or ultrasound. In some cases, an endoscope—a flexible, lighted instrument used to view inside a body cavity or organ—is also used. The type of imaging used depends on the type and location of the tumor.

The beacons are placed using a needle-like tool (9), as shown in Figure 3. The needles (9) are placed through the skin and into the tumor.

In the present invention, the beacon is capable of radiating a magnetic field, so that interaction with the Reed switch (2) occurs.

Using the magnetic beacon, the medication must be released in the area where it is located.

The Reed switch (2), for its part, is widely used in sanitary products. This switch (2) has a very simple operation: it is a switch (2) that closes upon detecting magnetic fields, as shown in Figure 4. The Reed switch comprises a glass capsule (10) containing an inert gas (11). It also comprises two parallel plates (12) that pass through the wall of the glass capsule and overlap inside, defining a space (13) between them in the transverse direction.

By assembling an electrical circuit around the switch (2), we can activate our pressure system when the beacon comes into contact with the switch (2). The main feature of the Reed switches (2) is their high sensitivity and small size, providing very simple and effective communication between the switch (2) and the beacon.

The retention module keeps the pill active after magnetic activation. A constant power flow is required to ensure the stepper motor delivers all the medication (5) to the treatment area. To achieve this, the system maintains power to the motor even after the reed switch (2) is deactivated.

For this functionality, where size and complexity limitations are high, relays have been selected, specifically solid-state holding relays due to their smaller size.

A stepper motor (3) is a type of electric motor that performs discrete angular movements, or steps, in response to electrical pulses applied to its coils. These motors (3) are used in a variety of applications where precise positioning is required. They are used in the capsule of the invention to produce a progressive yet rapid release of the substance (5) or drug (5) with high reliability and accuracy.

The motor (3) and piston (4) can be approximately 2cm * 1cm in size to be similar to other capsules available on the market.

All the electronics are contained within the biocompatible capsule, which in this case is cylindrical to mimic the design of conventional oral tablets. The capsule is made of rigid, biocompatible materials to keep the entire internal system isolated from the body and prevent contact, ensuring patient safety and preventing capsule degradation as it passes through the digestive tract.

The capsule can have an approximate size of 11 mm x 26 mm, adjusting its dimensions to similar systems existing on the market.

The piston (4) is a mechanical component that moves within a cylinder in the drug cavity (5) inside the capsule. It can be made of durable materials, such as aluminum alloys, cast iron, or even ceramic in some specialized applications.

With the piston (4) we manage to apply sufficient pressure to the substance (5) or medicine (5) causing its release from the capsule through the holes (6).

The internal batteries (1) power the capsule. Different types of batteries (1) that could be used are shown below.

Types of batteries

• Silver oxide (0.68 x 0.26 cm).

• Galvanized copper-zinc

• Mg-MoO3

• Sodium ion

Figure 5 shows an example of the electronics implementation of the capsule of the invention. In this example, a power supply (1), a resistor (7), a stepper motor (3), a reed switch (2), and a controller (8) are used to ensure the correct operation of the motor (3).

To ensure the system's release capability, solutions of varying densities—60%, 70%, 80%, 90%, and 100%—were tested, progressing from lowest to highest density. Densities above 80% proved too high for the system to function, making it impossible to insert and release the capsule.

In this embodiment, when a magnet/magnetic system is brought near the Reed switch (2), the stepper motor (3) connected to the rod is activated. The rod rotates and moves downwards, applying pressure with a piston connected to it, releasing any fluid in the lower compartment of the capsule. Two millimeter-diameter holes (6) are located at the bottom through which the fluid will exit.

Claims (14)

1. Biocompatible magnetically activated capsule comprising: - a first compartment comprising an electronic control module comprising: a) a power supply (1), b) a motor (3) connected to the power supply (1), c) a piston (4), connected to the motor (3) and configured to move linearly by the action of the motor (3); d) a Reed switch (2), configured to activate a current flow from the power supply (1) to the motor (3); - a second compartment comprising one or more holes (6) and intended to house a drug (5); where the piston (4) is configured to generate pressure in the second compartment when it moves, releasing the medicine (5) through the holes (6). 2. A biocompatible capsule according to claim 1, wherein the first compartment further comprises a retention module comprising one or more relays connected between the power supply (1) and the motor (3) and configured to maintain active current flow from the power supply (1) to the motor (3). 3. A biocompatible capsule according to claim 2, wherein the one or more relays are solid-state holding relays. 4. A biocompatible capsule according to claim 1, wherein the motor (3) is a stepper motor or rotary motor. 5. A biocompatible capsule according to claim 1, wherein the piston (4) comprises a rod and a washer attached to the rod. 6. A biocompatible capsule according to claim 1, wherein the piston (4) is made of aluminum alloys, cast iron or ceramic. 7. A biocompatible capsule according to claim 1, wherein the power source (1) is a Silver Oxide, Galvanized Copper-Zinc, M g-MoO3 or Sodium Ion battery. 8. A biocompatible capsule according to claim 1, wherein the capsule is made of rigid, biocompatible, non-degradable materials. 9. A biocompatible capsule according to claim 1, wherein the holes (6) are configured with a size sufficiently small to prevent the drug (5) from escaping from the second compartment by surface tension. 10. A biocompatible capsule according to claim 1, wherein the second compartment comprises a sealing element or mesh that covers the holes (6) and is configured to break under pressure. 11. Magnetically activated drug delivery system comprising: - a biocompatible capsule according to claims 1 to 10; and - one or more beacons with magnetic properties. 12. The system according to claim 11, wherein the beacons are made of gold, steel, platinum or carbon. 13. A method for the release of drugs by magnetic activation that makes use of the drug delivery system according to any of claims 11 to 12 and comprising the steps of: - placing (20) a beacon in a target soft tissue, - activate (22) the Reed switch (2) by proximity of the biocompatible capsule to the beacon after ingestion (21) by a patient, activating a current flow from the power supply (1) to the motor (3); - activate the movement of the motor (3) by acting on the piston (4); and - expel the medicine (5) from the capsule by pressure generated by the piston (4). 14. Method for drug delivery by magnetic activation according to claim 13, wherein the step of placing the magnetic beacon in a target soft tissue is performed by means of a needle (2).