JPH06501401A - Device for administering bioactive substances to the gastrointestinal tract - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Technical field of device invention for administering bioactive substances to the gastrointestinal tract The present invention provides a method for delivering bioactive substances or diagnostic substances to predetermined locations in a patient's gastrointestinal tract. Regarding devices for introduction. This device contains the above substances and is administered by the patient. It consists of a capsule to be used.

Background of the invention In some cases, administering bioactive substances to specific parts or locations of the gastrointestinal tract is sometimes desirable. One reason for this is, for example, local treatment of local inflammation in the intestines. Another reason is to continue to perform blood tests to test local intestinal permeability. A possibility is to administer substances to the intestine to induce a decrease in blood pressure. This maximizes systemic effects. This may be particularly important if it is desired to keep the limit to a minimum.

Such devices for local application of drugs or substances to the gastrointestinal tract are DE- It is disclosed in ^-2928477.

This prior art device can be inflated by the patient and opened at a specific location in the gastrointestinal tract. Discloses capsules containing substances obtained. Trigger mechanism for opening the capsule The system includes a first wire that can be heated by a radio frequency field applied from outside the patient's body. It may be configured from The first wire melts when the second wire is heated. It is connected to a second plastic wire that is made of plastic. The second wire is It is connected to a spring that is released when the layer melts. The compression force of this spring is It is used to open the capsule, thereby releasing the substance.

However, this prior art device is associated with several drawbacks. one drawback The treatment is performed using ultrasound or X-rays until the target position is reached each time the target position is treated. The point is that it may be necessary to track the capsule. Another drawback is the cap As the cell continues to move along the gastrointestinal tract with the normally released substance, the substance The point is that it does not remain in the vicinity of the area to be treated when it is being released. this child and, when this prior art device is used for treatment, each relatively This means that it is suitable for carrying out several treatments over a short period of time. treatment time Short and sometimes relatively high doses must be used to obtain a pharmacological effect may be absent and may be associated with undesirable systemic effects. In addition, X-ray equipment, etc. It would be difficult to perform these treatments outside the hospital, as they require several hospital facilities. It will be done.

A brief explanation of the inventive idea The invention relates to a device of the type stated in the introduction of the attached main claim, comprising: In addition, each treatment can be carried out over a relatively long period of time, so it is possible to For repeated local treatment of the gastrointestinal tract, allowing the substance to act on the area for the required amount of time. The aim is to create devices that are easy to use.

This allows the capsule to be held outside the patient's body apart from its end. both connected to a line or wire that is lowered by the patient, thereby enabling the capsule to be stopped and held at said predetermined location; It can be obtained by The capsule is then left in it for as long as necessary to complete the treatment. keep it in place.

The wire can then be cut, and the wire and capsule exit the patient's body through the anus. I'm going to go.

In a preferred embodiment, the capsule is initially sealed and the capsule is provided with a suitable triggered by a signal transmitted through said wire, preferably electrically conductive. sometimes to open the capsule at said predetermined location(s). means are provided.

Detailed description of one preferred embodiment In this preferred embodiment, the capsule is made of relatively hard plastic material or made of metal. The capsule material must be opaque to X-rays, at least to some extent. should be. This capsule is inserted one inside the other and therefore both A typical oblong shape consisting of two halves with some overlap. It has the general shape of a pharmaceutical gelatin capsule. Approx. 2ml size is suitable for drinking It was found to have a true length of 2-3c and a diameter of about 1c11, corresponding to a capacity of Ta.

There are many holes equiangularly arranged around each half of their overlapping region.

The distance between the holes is larger than the hole diameter, which means that the holes are half-closed. Means to be sealed in one rotational position. those holes connect one half to the other Rotate to align the position (register) L or match ), thereby opening the capsule and exposing its contents. Ru. When this capsule is further triggered, the relative rotation of the half-rest is performed. It includes a spring that can be pre-biased. The spring is an electrical signal by any kind of conventional trigger mechanism that can respond to and also be miniaturized. can also be triggered.

Attached to one end of the capsule is a thin, highly flexible thread or wire.

The striae are thin and flexible enough to not cause nausea when laid down. It is soft and smooth. Furthermore, the filaments are made of conductive material and are Preferably, it should be made at least in part of a material that is opaque to X-rays. this line The strips are preferably made of Teflon-coated thin material such as copper, silver or stainless steel. It may be a long wire and may have two leads for signals if necessary. stomach. This second lead can be used, for example, if the trigger device requires a relatively high voltage to react. This may be necessary for safety reasons if the product is of a certain type. 1cl outside the striae A scale may be provided for each I.

In use, the capsule is fitted with a certain amount of wire, e.g. to allow passage of the capsule through the pylorus. be swallowed with sufficient quantity to The capsule is then capped by the normal spiral movement of the intestine. The cell will travel along the intestine with its wire. reach the point of treatment The wire would then be locked inside or outside the patient, for example to the patient's teeth; This means that the capsule will stop at this location. Needs less precision If not, this location measures the length of the patient's lowered wire on the scale of that wire. The force may be determined by measuring at (, otherwise the capsule is moved to the desired location It may be necessary to use an x-ray machine to properly position the Once the Once the capsule is correctly positioned, the capsule position should be adjusted if repeating the treatment on the same patient. In order to repeat the determination correctly, pay attention to the position of the scale relative to a certain part of the patient's body. It is sufficient to do so.

The wire then sends an electrical signal to the capsule to pre-energize the spring. When triggered, the spring also pushes one of the two halves of the capsule to the other. rotate against the capsule to expose the capsule contents to the inside of the intestine. capsule in capsule contains a contrast agent mixed with a substance, the substance is being released correctly. It can be easily checked by X-ray whether the

Once the capsule is held in the desired location for a sufficient period of time to complete the treatment , the wire is simply cut, and the capsule passes naturally through the anus along with the wire. Excreted.

The advantages of this device are obvious. Treatment can be done for as long as needed and is simple. doses can be kept low per hour, thus minimizing systemic effects. You can stop it. The capsule can be held without limit (so the release rate can be can be changed freely.

Once the exact length of wire needed to reach the destination is determined, the The treatment can be repeated on the patient as many times as necessary without the need for Therefore, X-ray exposure can be kept to a minimum. Transmission through insulated wire The possible harmful effects of trigger signals can be avoided from sending signals. Ru.

Possible variants of the invention The invention may of course be modified in various ways within the scope of the appended claims. . The above system is, for example, an optical fiber that enables the transmission of optical signals instead of electrical signals. It may be configured as follows.

In a preferred embodiment, the capsule consists of two halves, and the two halves Open the capsule by rotation between the halves, but also by any other suitable method You can open it. The capsules are moved longitudinally relative to each other, e.g. under the action of a spring. It may consist of two slidable halves, or it may be held by a lever system. It may also include a cap that can be lifted up.

Additionally, the capsule opens automatically, independent of any signals from outside the patient's body. It can also be done. One of the ways to do this is to place capsules where they should be treated. After sufficient time to ensure that the capsule has been reached, the signal to open the capsule is activated. The capsule may also be provided with a timer for feeding. Another option is to A portion of the well may be comprised of a material that dissolves in the gastrointestinal tract, such as gelatin.

The time it takes for the capsule to open depends on the thickness of these shell parts and/or Depending on the material, these factors may The capsules are selected so that they have sufficient time to reach the location to be treated. Ru. However, the capsule portion to which the filament is attached is preferably dissolvable and smooth. It's not possible. This is because this part is the line that will pass through the gastrointestinal tract when the treatment is completed. This is because it facilitates the movement of the strips.

Additionally, the shell of the capsule may be made of a material that dissolves at a certain pH.

Additionally, in these latter cases, the system or wire should be removed from materials that are dissolved in the gastrointestinal tract. It is also easy to make. This is because the system does not need to be designed for signal transmission. It is the body. In this case, the parameters governing striatal dissolution are Do not melt any part of the filament until sufficient time has elapsed to ensure completion. should be selected so that it is not interpreted.

international search report international search report PCT/SE　91100651 Continuation of front page (81) Designated countries EP (AT, BE, CH, DE.

DK, ES, FR, GB, GR, IT, LU, NL, SE), 0A (BF, BJ, CF, CG, CI, CM, GA, GN, ML, MR, SN, TD , TG), AT, AU, BB, BG, BR, CA, CH, C3, DE, DK.

ES, FI, GB, HU, JP, KP, KR, LK, LU, Ni C, MG, MW, NL, No, PL, RO, SD, SE, SU, US (72) Inventor: Monoson, Vikkik Sweden Varnish - 23700 Vinyl Red, Stoudentveien 11 (72) Inventor: Newberg, Laas, Sweden, Nis-22252 Lund .

Jagdsteigen 3

Claims (9)

[Claims] 1. Consisting of a capsule containing a physiologically active or diagnostic substance that is swallowed by the patient. device for introducing the substance into a predetermined location in a patient's gastrointestinal tract. Thus, the capsule further includes one end thereof that is retained within or outside the patient's body. and is connected to a striatum or wire that is swallowed by the patient along with the capsule; means for stopping and holding the capsule at said predetermined location; A device characterized by: 2. The capsule is initially sealed, but when triggered by a signal 2. The device according to claim 1, further comprising means for opening at a predetermined location. device. 3. said filament or wire is electrically or optically conductive, thereby Electrically or optically the capsule is opened from outside the patient's body through the striae or wires. A claim characterized in that a signal for mechanically triggering can be transmitted. 2. The device according to 1 or 2. 4. The capsule may be magnetically, electromagnetically, ultrasonically or in any other suitable manner transmits a signal through the patient's body to trigger the capsule to open. Claims 1 to 3 include a receiving device for receiving. device. 5. The capsule has a shell, at least a portion of which gradually dissolves in the gastrointestinal tract; thereby releasing the substance after a certain time depending on the dimensions and material of the shell. 2. A device according to claim 1, characterized in that: 6. A signal for opening the capsule is included in the capsule after a predetermined time. 3. The device according to claim 2, wherein the device is obtained from a timed device that chair. 7. such that the capsule or its contents are at least to some extent opaque to X-rays; The device according to any one of claims 1 to 6, characterized in that: 8. The wire or filament is made at least to some extent opaque to X-rays. A device according to any one of claims 1 to 8, characterized in that: 9. A scale indicating the length of the filament or wire is provided on the filament or wire. A device according to any one of claims 1 to 8, characterized in that: