JPS6111111B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a device for collecting cytological specimens from the human or animal body. In this embodiment, the device is for taking specimens of the esophagus for the detection of cancerous or pre-cancerous lesions.

During actual treatment in both humans and animals, specimens are extracted from internal canals, organs, or cavities (hereinafter referred to as the vascular system) that can be accessed through natural or surgically created orifices or passageways in the body. It is often necessary to collect.

However, these orifices or passageways are typically narrow and sensitive, making it difficult to introduce tubing devices to remove the appropriate test strips, depending on the shape and configuration of such devices. Additionally, such tubing is typically muscular and contracts and relaxes, changing shape in an irregular manner, making specimen collection more difficult. This is especially true when it is necessary to take specimens from all surfaces of the tubing. Yet another problem is that the walls of the tubing must not be excessively damaged or perforated when taking the specimen. Furthermore, once
Once the test specimen is removed from the tubing, the sample collection device must be transferred with the test specimen without contaminating or damaging the specimen.

A device for collecting specimens of the esophagus was introduced in the Proceedings of the 2nd International Symposium on Cancer Detection and Prevention (April 1973).
(held in Bologna from 9th to 12th May 1974)
It is explained on page 321 of Volume 2 of 2010 (Published in 2013). The device consists of a double hollow tube with a scraping balloon at the end. The tube is swallowed until the balloon passes through the stomach. The balloon then swells and the dislodged cells collect on the surface of the balloon, which is removed for examination when the tube is pulled out. Other balloon-containing medical devices are known, such as U.S. Pat. No. 3,896,815 to Fetztel et al., which relates to an expandable tip catheter.

Medical professionals also recommend devices that allow instruments to be introduced into the tubing system and minimize contamination when withdrawn.
I know. One example of such a device is the U.S. Patent No. 1 granted to W. C. Kalayan entitled “Instrument for Harvesting Body Cultures.”
It is number 3513830.

Although the aforementioned devices for obtaining esophageal specimens have been used with some success, there are deficiencies and problems that have been identified early on. In fact, the amount of test pieces retained is small.

It is thus an object of the invention to improve said device so as to overcome the aforementioned problems.

The first object of the present invention is to minimize trauma to the patient, to be easy to introduce into the ductal system, easy to use, and safe, and to collect representative test pieces without damaging the ductal system. The specimen is taken from the entire surface of the tubing and is removed from the tubing with minimal damage to the specimen when it is pulled out of the tubing and with minimal contamination or damage to the specimen. It is an object of the present invention to provide a device for collecting cytological specimens from an internal tubing system that is easily withdrawn.

The invention therefore provides a device for taking cytological specimens from the internal ductal system of a human body or an animal, which is formed by a balloon of suitable elastic material, which has a large flexible section towards the distal end. and a plurality of specimen collection elements fixed around the flexible portion thereof and spaced circumferentially from each other, the elements comprising a suitable scrape collection material. Become.

These elements must be made of sufficient scraping material to remove the surface layer of the epithelium of the ductal system, but not so much that the epithelium is injured, the underlying mucosa bleeds, or the ductal system perforates. Must not be. Similarly, the material must be sufficiently absorbent to retain virtually all of the splintered material, as loss of even a small portion can have disastrous consequences. For example, the specimen collection element may be comprised of a collection of discrete fibers, such as provided by a non-woven synthetic plastic system. The specimen collecting element is in particular in the form of a brush.

By this means, the tubular member has virtually constant lateral dimensions so that when unexpanded it is relatively small and easy to introduce, and when expanded it is relatively large to allow contact with the tubing. Additionally, the scraping and absorbent properties of the specimen collection elements remain unchanged when they are expanded since they are made of non-intumescent material.

Conveniently, the bulk of the tubing consists of a balloon of elastic material, to which the specimen collection element is secured.

In order to provide the specimen collection elements with sufficient surface area, they are elongated strips and are arranged in either a longitudinal direction (FIG. 2) or a helical direction (FIG. 3). Instead of using continuous pieces for the element, it is also possible to use small segments, which are arranged in vertical groups (see Figure 4.2).
2), or spirally arranged in groups (Fig. 4, 24).

Another feature is that the distal end of the tubular member having an expandable portion is removable.
Therefore, multiple tip sections can be used with a stable and reusable main section of the tubular member, reducing the cost of the device. Furthermore, once the device is withdrawn from the patient, the end portion containing the test strip can be removed and sent to a cytologist or pathologist for examination.

To further facilitate the introduction and manipulation of the tubular member, it has a rounded end and is resiliently flexible.

Appropriate equipment can be provided for dilating the end portion. Thus, if the end portion consists of a balloon, a pumping device may be provided for discharging fluid into it to inflate it.

A valve arrangement is also provided to control fluid flow. Conveniently, the pumping device consists of a cylinder connected to or integral with the central end of the tubular member. The valve device is therefore a tap at the end near the center of the tubular section. It is also possible to include a stop device for stopping the plunger of the cylinder at a desired position.

Another feature is that the end portion of the tubular member is
The distal end first becomes enlarged, and then gradually swells toward the center.

A hollow introduction member is provided to facilitate insertion of the tubular member into the tubing and to minimize contamination of the specimen. Such a hollow introduction member also facilitates the desired longitudinal and rotational movement of the tubular member. The distal end of the introduction member is closed with a centrally removable plug, which has a suitably rounded distal tip.

The tubular member rotates when it is positioned longitudinally so as to cover the entire surface of the tubing. this is,
This can be done manually or automatically. Thus, interconnection means can be provided within or on the tubular member and the introducer. Also, the specimen collection elements are arranged in a helical manner, as described above.

The invention will now be described with reference to the accompanying drawings.

Referring first to FIG. 1, a test strip collector is indicated at 10. The collector 10 consists of a single lumen tube 12 made of synthetic plastic material;
The tube 12 is resiliently flexible, but sufficiently rigid so that it can be inserted into and manipulated within a person's esophagus. The tube 12 has a length of about 50 cm and an outer diameter of about 3 mm. The tube 12 is closed at its distal end 12,1 and has a rounded tip, as is clearly seen in FIG. Furthermore, at the distal end 12,1, approximately 5 mm from the distal end 12,1, for example polystyrene,
A sleeve 16 of a suitable resilient material such as latex or polybutadiene is provided and its ends are joined to the tube 12. This part of the tube 12 is provided with an opening 18 and is covered by a sleeve 16, so that the sleeve 16 forms a balloon. The sleeve 16 has a length of approximately 6 cm and is pre-stretched at its distal end so that it initially expands laterally and progresses toward the center. The surface of the sleeve 16 has three strips of non-woven nylon attached by a suitable adhesive to a suitable base such as formaldehyde resin with a mineral surface. Each strip has a length of about 5 cm and its width is about 1/3 of the circumference of the tube, or about 5 mm. As shown, the strips 20 are arranged longitudinally and spaced around the sleeve or 16. Thus, the sleeve 16 with the strip 20 is no thicker than the tube 12 in its contracted state.

When the sleeve 16 expands, the portions of the sheath 16 between the strips 20 stretch, but the strips 20 themselves do not. The distal end of the tube 12 is removable;
A male and female threaded joint is provided at 25.

Another form of specimen collection element is the third,
This is shown in Figure 4. In FIG. 3, the strips 20,1 are arranged in a pitched spiral, and in FIG.
The segments 20,2 are shown aligned longitudinally 22 or arranged in pitched helical groups 24.

Referring again to FIG. 1, tube 12
The ends 12,2 near the center are provided with a tap 26, which end 12,2 receives the nozzle of a syringe 28. Positioned towards its ends 12,2 are two arms 30 having small holes 32 in their free ends.

As shown in FIG. 5, the collector 10 is used with a cannula or introduction tube 34. The canyule 34 is also made of synthetic plastic material and has an outer diameter of approximately 8 mm and a body length of approximately 25 cm.
It is. The cannula 34 is slightly flexible, cannot be bent, and is open at both ends. Its distal end 36 is rounded and closed by a removable internal trocar or stylet 38, the distal portion 40 of which is smooth and conical. The plug part 40 is the canyule 3
4 closes its distal end representing a smoothly contoured end with a closure fitted within. Kanyur 3
At the end 42 near the center of the tube 4 are two helical coils 44 which fit into the small holes 32 in the arms 30 of the tube 12 so that the tube 12 moves vertically in use. When it rotates.

In use, internal trocar 38 is placed within cannula 34 with its distal end 36 closed, and cannula 34 is passed through the patient's mouth, through the oropharynx, and through the circumpharyngeal sphincter. This is plug 4
This is facilitated by the smooth edges of the 0. The trocar 38 is then removed, creating a smooth passageway through which the specimen collector 10 is inserted into the esophagus. The tube 12 is inserted into the cannula 34 with the sleeve 16 deflated and inserted down the esophagus and into the lower esophageal sphincter.

Syringe 28 is also used to inflate sleeve 16 and tap 26 is closed. The sleeve 16 expands from its distal end toward its center.
Tube 12 is then moved up and down the esophagus, and the interaction of helical coil 44 and arm 30 causes tube 12 to rotate. This movement of tube 12 is facilitated by cannula 34. As the sleeve 16 moves up and down the esophagus, the epithelial skin layer is scraped away and retained between the nylon strips 20. Even though peristalsis occurs, virtually the entire inner surface of the esophagus is covered as it moves up and down the esophagus several times.

Tap 26 opens and sheath 16 retracts. When the sleeve is deflated, the strips 20 are not compressed, even if they were bulging, and retain the cell specimen. Tube 12 is then removed from the patient through cannula 34.
This prevents contamination of the specimen with oral or oropharyngeal secretions, mucosal cells, or saliva from the respiratory tract.

Additionally, since cannule 34 minimizes compression of strip 20, specimen loss is also kept to a minimum. Once the tube 12 is removed, the distal end is unscrewed and placed in a specimen container that is sent to a cytologist without handling by the operator. The main remainder of the tube 12 is sterilized and reused with a new or sterile used tip.

By these measures, the collector is cheap to manufacture and easy to use. Moreover, these measures minimize patient trauma and discomfort, increase safety and effectiveness, and allow for more reliable diagnosis.

[Brief explanation of the drawing]

FIG. 1 shows a test strip collector according to the invention;
The balloon is shown deflated. Figure 2 is the first
1 is a detailed view of the balloon shown in enlarged view; FIG. Figures 3 and 4 also show an inflated balloon with different shapes of specimen collection elements. Fifth
The figure shows a plugged introduction tube for use with the specimen collector of FIG. 10... Specimen collector, 12... Single hollow tube,
12, 1... Distal end of the tube, 14... Rounded tip of the tube, 16... Sleeve, 18... Opening, 2
0...Strip, 25...Male and female threaded joint, 20, 2...Segment, 26...Tap,
28...Cylinder, 30...Two arms, 32...
Small hole, 34...Canyule (introduction pipe), 38...
Internal trocar, 40...terminal plug part.

Claims (1)

Claims: 1. A tubular member having an inflatable portion towards its distal end formed by a balloon of a suitable elastic material, fixed around the inflatable portion and extending circumferentially from each other. a plurality of specimen collection elements spaced apart from each other, the elements being made of a suitable scraping material; A device that collects test pieces. 2. The apparatus of claim 1, wherein the test strip collection element is an elongated strip and is oriented longitudinally. 3. The apparatus of claim 1, wherein the test strip collection elements are elongated strips and are arranged in a helical manner. 4. The apparatus of claim 1, wherein the test strip collection element is comprised of a plurality of segments, each segment arranged in a longitudinal group. 5. The apparatus of claim 1, wherein the test strip collection element is comprised of a plurality of segments, each arranged in a group in a helical arrangement. 6. A device according to any one of claims 1 to 5, wherein the distal end portion of the tubular member containing the expandable portion is removable. 7. The device according to any one of claims 1 to 6, wherein the distal end of the tubular member is rounded. 8. The device according to any one of claims 1 to 7, wherein the tubular member is elastically flexible. 9. Claim 1 comprising a fluid discharge device for discharging fluid to the balloon to inflate it.
Apparatus described in section. 10. The apparatus of claim 9, further comprising a valve arrangement for controlling the flow of fluid into or out of the balloon. 11. The apparatus of any of claims 1-10, wherein the test strip collection element is made of compressed material. 12. The expandable portion is pre-stretched, expanding first at its distal end and then gradually expanding toward its central end. 12. The apparatus according to any one of paragraphs 11 to 12. 13. The device according to any one of claims 1 to 12, wherein the tubular member has a hollow introduction member for introduction into a human or animal. 14. The apparatus of claim 13, wherein the introduction member and the tubular member are interconnected to cause rotation of the tubular member as the tubular member is moved longitudinally through the introduction member. 15. The device of claim 13, further comprising a closure member for closing the distal end of the introduction member when the introduction member is inserted into a human or animal. 16. Apparatus according to any one of claims 1 to 15, wherein the test strip collection element is brush-shaped.