JPH0572818B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to diagnostic and/or therapeutic tools.

[Background Art] In general, accurately understanding the tissues and component concentrations of circulating plasma and extracellular fluids (hereinafter also referred to as body fluids) is essential for understanding the pathology of many diseases and proceeding with treatment. This is extremely important.

For example, not only drugs, but also fluid movement, specifically the components that form edema, the differences between the composition of edema and the composition of interstitial fluids, and pathobiochemical changes in cells within internal organs such as the liver , requires early and safe diagnosis to allow treatment with simple means.

Diagnosis of such pathobiochemical changes can be made at an extremely early stage by examining body fluids secreted from the organ in question.

However, because the measurement method is complicated and the normal range is wide, it has not been widely used in daily clinical practice to date.

The first known method for understanding such pathobiochemical changes is to extract organs and analyze drug concentrations. However, although this method is effective in considering the effects and side effects of drugs, it cannot currently be applied to the human body because it cannot be performed without removing the organs of animals other than humans. This is not an appropriate method. Therefore, methods of monitoring blood levels of drugs have been substituted.

Second, methods are known for taking small tissue samples directly from organs. However, in this method, not only the desired tissue sample but also a large amount of undesired tissue is mixed in. In addition, the known method uses a large tube, which is prone to bleeding and infection, causing pain to the patient, which limits its use.

Various body fluid sampling tools are known as methods for detecting pathological biochemical changes such as those described above.

For example, in Utility Model Application Publication No. 58-95841, the main pipe and
first and second pipes having a smaller inner diameter than this main conduit;
Two auxiliary pipes are provided integrally or separately, and the two auxiliary pipes are
The auxiliary pipe is branched from the main pipe at the top.
A series of holes are opened in the side surface of the main conduit near the tip, the first auxiliary tube opens into the main conduit at the distal end, and a filter is attached near the upper branch end. The body fluid discharge tube is described as having a structure in which the auxiliary tube opens into the main conduit and/or outside the conduit at its tip, and is equipped with an opening/closing mechanism such as a cap near the upper branch end.

Furthermore, in Japanese Patent Application Laid-open No. 50-103194, a section filled with an X-ray absorbing substance such as barium sulfate is provided at the tip of a catheter body made of a small diameter tube made of rubber or soft synthetic resin, and a section filled with an X-ray absorbing substance such as barium sulfate is provided at the tip of the catheter body, which is made of a small diameter tube made of rubber or soft synthetic resin. The catheter body has a number of scattered small holes for injecting and discharging contrast media, gastric juice, etc., and the tip of the catheter body is made of rubber, etc., which is more flexible than the tube body, and has a diameter that gradually decreases toward the tip. A catheter is described which is fitted with an insertion guide cap having a circular end and an arcuate end.

The catheter constructed as described above can be easily inserted into the patient due to the arc-shaped insertion guide cap made of flexible rubber, etc., and there is little insertion feeling, minimizing the physical and psychological burden on the patient. The system is designed to allow contrast media, gastric fluid, etc. to be injected and discharged quickly and efficiently.

Furthermore, in JP-A-60-54710, a thin tube that is more rigid than the hollow fibrous membrane is inserted into the hollow part of the hollow fibrous membrane, and the thin tube protrudes outward from the hollow fibrous membrane. A fluid separator is described, which is characterized in that the thin tube and the hollow fibrous membrane are joined together.

[Problems to be Solved by the Invention] Generally, in order to test for pathological biochemical changes using conventional body fluid collection tools, the smaller the amount of body fluid collected, the better. In particular, for patients who undergo body fluid tests every day, body fluid collection significantly exhausts their physical strength, so it is necessary to keep the amount of body fluid collected as small as possible.

In addition, in hospital laboratories, where a large number of body fluids are handled, it takes a considerable amount of time from collecting the body fluids to actually testing them. This is not preferable in terms of separation operation and efficiency of body fluid testing.

However, conventional body fluid sampling tools have the drawback of not being able to adequately respond to these needs.

[Object of the Invention] The present invention has been made in view of the above-mentioned drawbacks of the prior art, and it is possible to perform a series of operations from collection of body fluid to separation and fractionation of desired components with a single device. , to provide a diagnostic and/or therapeutic tool that can safely separate and fractionate only the desired components with simple operations without contaminating the separated and fractionated desired components with unnecessary components. The purpose is to

Furthermore, the present invention is applicable not only to body fluids but also when a mixed liquid is separated into a liquid layer and a solvent layer, and when one of the layers is required, the collection of the mixed liquid allows the separation and separation of only the necessary layer. The purpose of the present invention is to provide a tool that can perform the removal with a single device.

[Means for Solving the Problems] The present invention includes a hollow part of a small diameter tube in which a plurality of small holes are bored in the side wall of the outer circumferential surface, and a blockage tapered toward one end of the hollow part of the small diameter tube. a plurality of hollow fiber filters, each of which is a homogeneous hard or soft synthetic resin thin tube integrally formed with the hollow portion, and which is more flexible than the thin tube and has a large number of fine through holes; It is configured to be inserted into the hollow interior of the small diameter tube.

[Example] Next, an example of the present invention will be described in detail using the drawings.

FIG. 1 is a plan view showing the entire body fluid sampling device according to an embodiment of the present invention, FIG. 2 is a front view of FIG. 1, and FIG. 3 is a cross section taken along the line A-A in FIG. 4 is an enlarged sectional view taken along the line BB in FIG. 2, FIGS. 5 and 6 are enlarged left and right side views of FIG. 2, respectively, and FIG.
FIG. 3 is an enlarged sectional view taken along line CC in FIG. 2;

In the figure, the main body 1 includes a small diameter tube main body 2 and a small diameter tube holding cap 3 that holds the small diameter tube main body 2.
and a hollow fiber filter holding cap 4 which is inserted and fitted from the open end face of the small diameter tube holding cap 3.

The small diameter tube main body 2 is made of homogeneous hard or soft synthetic resin and has a predetermined diameter, and is hollow inside, and has a small diameter tube hollow portion 2a formed with a predetermined length. , and a small diameter tube closing portion 2 integrally formed in a tapered shape at the distal end of this small diameter tube hollow portion 2a is constituted by b. This small diameter tube body 2
It is preferable that the tube be made of a transparent material so that the amount of liquid inside the tube can be confirmed. In addition, as shown in FIG. 2, the small diameter tube hollow portion 2a is formed in a tube portion _2a1 having a predetermined length, and a large number of small diameter tube hollow portions 2a are bored on the outer circumferential side wall of the small diameter tube hollow portion 2a. Pipe portion 2a ₂ in which discharge or introduction small holes 2c (2c ₁ to 2c _o ) are formed
It is formed of.

The length of the tube portion _2a1 is variable. Further, the diameter of the discharge or introduction small holes 2c is formed to be a constant size, and a large number of these small holes 2c are bored in a scattered manner. Further, the diameter of the small hole 2c can be changed as appropriate. The small diameter tube closing portion 2b is formed in a tapered shape from the end of the tube portion 2a ₂ of the small diameter tube hollow portion 2a toward the tip. Since the tip of this obstructing part is formed into a sharp needle shape, it can be directly pierced into an organ or subcutaneously.

On the other hand, as shown in the exploded perspective view of FIG. 8, an annular ring 5 is fitted and fixed to the other end of the small diameter tube body 2, and a small diameter tube holding cap 3 is inserted through the annular ring 5. is inserted and fitted into the opening 3a of.

The small diameter tube holding cap 3 has a hollow interior, and has a stepped portion 3b tapered from the opening 3a toward the other end. By narrowing down the stepped portion 3b into a tapered shape, the rigidity is increased and the small diameter tube main body 2 is reliably supported and fixed. In addition, this small diameter tube holding cap 3
is preferably made of a transparent material.

Further, inside the small diameter tube hollow part 2a, a large number of fine through holes 6b (6b ₁ to 6b _o ), which are made of a material more flexible than that of the small diameter tube, as shown in FIG. Multiple hollow fiber filters 6a (6a ₁ to 6
a _o ) is inserted. There are five hollow fiber filters 6a (6a ₁ to 6
_a5 ) There is a gap of Δl between the hollow fiber filter _6a5 and the nearest _6a1 , _6a2 , _6a3 or _6a4 , respectively, as shown in FIG. are spaced apart to form a The material of the hollow fiber filter 6a is usually one that is widely used in the medical/pharmaceutical industry, food industry, electronic industry, etc., such as hemodialysis membranes, ultrafiltration membranes, reverse osmosis membranes, or gas separation membranes. You can use what you have. Further, the diameter of the fine through-holes 6b of the hollow fiber filter 6a ranges from several tens of angstroms to several tens of μm depending on the purpose.
The number of a and the diameter of the fine through holes 6b formed in the hollow fiber filter 6a can be changed as appropriate.

The end of the hollow fiber filter 6a is inserted and held in the opening 4a of the hollow fiber filter holding cap 4, and a seventh filter is inserted into the opening 4a.
As shown in the figure, adhesive 7 is filled. Stepped portion 4b of this hollow fiber filter holding cap 4
The outer periphery of the cap 3 is tapered so that it can be inserted and fitted while being in sliding contact with the inner circumferential surface of the cap 3 for holding a small diameter tube. Therefore, when the small diameter tube holding cap 3 and the hollow fiber filter holding cap 4 are fitted and fixed, the opening of the hollow fiber filter holding cap 4 other than the open end 4c is sealed. In addition, flanges 4 are provided at both ends of the open end 4c to prevent the tube from coming off when a tube (not shown) is attached when separating, fractionating, or introducing a desired component.
d is formed.

Next, a method of operating the body fluid sampling tool having the above configuration will be explained.

A method of separating and dispensing the desired components by puncturing the tissue inside the organ or subcutaneously.

By sequentially inserting the small diameter tube body 2 into the body cavity through the small diameter tube closing portion 2b of the main body 1, the continuous small diameter tube body 2 can be smoothly guided into the body cavity. When the small holes 2c, which are scattered in large numbers on the side wall of the outer peripheral surface of the tube portion _2a2 of the main body 1 inserted into the body cavity, are introduced into the body cavity, the pressure inside the body cavity is higher than the external pressure. Due to the pressure difference, body fluid is discharged through the small hole 2c into the tube of the small diameter tube hollow section 2a. From this discharged body fluid, only the desired components are separated and fractionated by the hollow fiber filter 6a, and the components sequentially permeate into the small diameter tube holding cap 3 and the hollow fiber filter holding cap 4, where they are separated and fractionated. (Components other than the desired components are not mixed in because they are prevented from entering by the fine through holes 6b of the hollow fiber filter 6a).

A method of introducing the desired drug component by puncturing the tissue inside an organ or subcutaneously.

Cap 4 for holding hollow fiber filter of main body 1
A tube (not shown) is connected to flanges 4d formed at both ends of the open end 4c, and a drug supply section is connected to the other end of the connected tube.
Then, by sequentially inserting the small diameter tube main body 2 into the body cavity through the small diameter tube closing portion 2b of the main body 1, the continuous small diameter tube main body 2 can be smoothly guided into the body cavity. At this time, the pressure inside the small diameter tube hollow section 2a is set to be higher than the pressure inside the body cavity. When the drug is introduced from the other end of the connected tube, the drug is introduced through the small holes 2c that are scattered in large numbers on the side wall of the outer peripheral surface of the tube section _2a2 of the main body 1 inserted into the body cavity. Desired components can be introduced into the body cavity (components other than the desired components are prevented from being introduced by the fine through holes 6b of the hollow fiber filter 6a, so they are not mixed).

Note that a large number of small discharge or introduction holes 2c bored in the outer circumferential side wall of the tube portion _2a2 of the small diameter tube main body 2 are open in a scattered manner.
Even if the hole c ₁ is adsorbed and blocked by the body cavity wall, the small hole 2c ₂ is opened in a different direction from the small hole 2c ₁ , so it will not be blocked and the discharge or introduction operation will not be hindered.

Further, since the plurality of hollow fiber filters 6a inserted into the hollow portion 2a of the small diameter tube are made of a suitably flexible material, the flexibility of the tube body is not inhibited. Therefore, the hardness of the small diameter tube main body 2 is not affected.

Furthermore, the present invention is not limited to the above embodiments, and the selection of structural materials and the design of individual members may be modified in various ways without departing from the basic idea of the present invention. I can do it. For example, by changing the length of the tube portion 2a ₁ , it can be changed to use for the liver or subcutaneous use as appropriate.

[Effects of the Invention] As explained above, the present invention has the following effects.

That is, according to the present invention, it is possible to separate and collect only desired components from body fluids with simple operations, thereby solving the problem of drug concentration in organ tissues, shock substances, autocoids, etc. Elucidating the pathological condition from a general perspective, and comparing the ingredients to see what drugs will pass through and what drugs will not pass when the barrier to drugs is destroyed due to inflammation or shock. This can be explained using methods such as

Also, in compartment syndrome, for example, when edema becomes strong, various things such as circulation and nerves are squeezed out, leading to circulatory failure.
In such cases, the edema can be removed by inserting a large amount of the device of the present invention.

Furthermore, according to the present invention, there are no side effects, and depending on the drug, it is not only the drug concentration in the tissue of the organ, but also in which tissue of each tissue (for example, muscle, subcutaneous tissue, adipose tissue, etc.) that the drug is taken up. It is also very easy to determine whether the water is released or stored, that is, the volume of distribution. Knowing the drug concentration in tissues can have a significant effect not only on drug efficacy but also on side effects.

Furthermore, according to the present invention, by varying the size of the microscopic through-holes of the hollow fiber filter, so-called eye size, it is possible to separate and fractionate only the desired components. Depending on the disease state, it can be applied to the examination of various pathological changes, such as tissue concentration (for example, tissue concentration when the blood-brain barrier is destroyed). Furthermore, when there is no inflammation, certain drugs cannot be taken up into inflamed tissues, but when inflammation becomes very strong, they can reach those tissues. You can also check various things about inflammation.

Furthermore, according to the present invention, if it is inserted from the onset of the disease, it is known that edema will appear there, so at that point, changes in body fluids will occur, and trace substances will cause edema. If we can understand that the edema enters the area, it will be extremely effective in elucidating the edema itself.

Furthermore, according to the present invention, when muscles are in an ischemic state, they release various toxins or, depending on certain organs, shock substances.
Once a shock substance is released, it is possible to separate and collect it directly from the tissues and out of the body without passing it through the blood. Therefore, it is extremely useful for elucidating pathological conditions.

[Brief explanation of the drawing]

FIG. 1 is an embodiment of the present invention; FIG. 2 is a plan view showing the entire invention; FIG. 3 is a front view showing the entire invention; FIG.
FIG. 4 is an enlarged sectional view taken along line BB in FIG. 2, FIGS. 5 and 6 are enlarged left and right side views, respectively, and FIG. FIG. 8a is an exploded perspective view of the present invention, and FIG. 8b is a partially enlarged view of the hollow fiber filter. DESCRIPTION OF SYMBOLS 1...Main body, 2...Small diameter tube main body, 2a...Small diameter tube hollow part, 2b...Small diameter tube closing part, 2c...Small diameter hole for discharge or introduction, 3...Small diameter tube holding cap, 4...Hollow fiber filter Retaining cap, 5... annular ring,
6a...Hollow fiber filter.

Claims (1)

[Scope of Claims] 1. A small diameter tube hollow portion in which a plurality of small holes are bored in the side wall of the outer circumferential surface, and a tapered closing portion toward one tip of the small diameter tube hollow portion form the hollow portion. A homogeneous hard or soft synthetic resin thin tube integrally formed with a plurality of hollow fiber filters that are more flexible than the thin tube and having a large number of fine through holes are arranged in the hollow tube. A diagnostic and/or therapeutic tool characterized by having a structure inserted therein.