JPS63246178A - Apuncture needle equipped with dilator for imaging blood vessel - 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 <Industrial Application Field> The present invention relates to a dilator-equipped puncture needle for catheter insertion used in angiography.

<Conventional technology and its problems> In DSA and other computer image-based angiography tests, a puncture hole is opened in the femoral artery or cubital artery, and a catheter is inserted through the catheter introduction guide wire. , it is necessary to inject a contrast agent.

Conventionally, as a tool for this purpose, a puncture needle consisting of a needle body (1) and a sheath (2) that can be freely inserted into and removed from the needle body (1) as shown in Figure 8.9 has been used. In use, a puncture hole is first opened into the blood vessel using the assembled puncture needle, and then the needle body (1) is removed from the sheath (2), and only the sheath (2) is inserted into the puncture hole. Usually, the guide wire is inserted into the blood vessel along this line while remaining inserted and held.

However, as is clear from both figures, the puncture sheath (2) is in the form of a simple straight hollow round pipe, and its opening diameter (d) is such that the guide wire can be inserted through it. However, not only the catheter is thicker than the wire, but also the catheter introduction guide source forming the catheter sheath introducer is not sized to be large enough to allow the catheter to be inserted therethrough.

Therefore, after inserting the guide wire, the puncture sheath (2) is completely removed from the wire, and the catheter is guided by the remaining wire. Since the puncture hole opened by the sheath (2) is small, the opening edge of the puncture hole and the catheter being fed directly and repeatedly rub against each other, giving physical stimulation to the blood vessel, As a result, a blood clot forms and blocks blood flow. This occurs particularly in small blood vessels such as the cubital artery.

From this point of view, direct rubbing between the opening edge of the puncture hole and the catheter can be prevented by inserting and holding a separate introduction guide source into the puncture hole in a stationary state and feeding the catheter into the hollow interior of the guide source. However, in the case of the above-mentioned conventional product, the puncture hole once opened by the middle sheath (2) of the puncture needle must be opened by a separate dilator (dilator) to expand the puncture hole to a size large enough to insert the catheter introduction guide source. Now we have to expand it again.

It is clear that this process is extremely complicated and cannot be carried out instantaneously and efficiently, and that it also causes difficulty in stopping the bleeding later on.

Means for Solving the Problems> The present invention aims to provide a new dilator-equipped puncture needle that is useful for fundamentally solving these problems. A puncture needle for angiography consists of a sheath that can be inserted into and pulled out from the needle body, and the front part of the sheath is a small diameter tube part through which a catheter introduction guide wire can be inserted, and the rear part is a small diameter tube part through which a catheter introduction guide wire can be inserted. The catheter to be guided or the introduction guide source of the catheter is a large-diameter tube section that can accept it, and the boundary position between the small-diameter tube section and the large-diameter tube section is a smoothly continuous tapered conical tube section. , the sheath is integrally formed into an overall stepped shape, and together with the needle body, the puncture hole opened into the blood vessel by the small diameter tube part of the sheath is continuously formed by the conical tube part and the large diameter tube part of the sheath. The first feature is that it is set to expand on its own, and it also consists of a needle body for puncturing a blood vessel and a sheath that can be attached to and pulled out from the needle body. In the puncture needle, the front part of the sheath is a small-diameter tube through which a catheter introduction guide wire can be inserted, and the rear part is a catheter guided and guided by the wire, or a large-diameter tube capable of receiving the catheter's introduction guide source. The sheath is integrally formed into an overall stepped shape, with the boundary position between the small diameter tube section and the large diameter tube section being a smoothly continuous tapered conical tube section, and the sheath is integrally formed in the overall stepped shape. A slit of a certain length extending along the line is carved, the sheath is opened and split through the slit, and in combination with the needle body, a puncture hole opened into the blood vessel by the small diameter tube part of the sheath is continuously inserted. The second feature is that the conical tube and large diameter tube of the sheath are designed to expand automatically.
The characteristics of

<Example> Hereinafter, the configuration of the present invention will be specifically described in detail based on the illustrated example. Fig. 1.2 shows the assembled state and disassembled state of the puncture needle with dilator for angiography. However, this consists of a metal puncture needle body (10) of a certain length, and a hollow metal or synthetic resin puncture sheath (11) that is attached to the body, and the sheath (11) and Needle body (
10) can be inserted and removed from each other.

The front end of the needle body (10) is sharpened with an inclined cut surface (10a) for smooth puncturing into the blood vessel CM), and a cap tube (12) is attached and fixed to the rear end. ing. (13) is a handle that is preferably inserted into and removed from the base tube (12);
2) may be omitted and the synthetic resin handle (13) may be directly attached and integrated with the rear end of the needle body (10). Although the figure shows a hollow round pipe shape as the needle body (10), it is also possible to adopt a solid round bar shape instead.

The puncture sheath (11) is formed to have an overall length that does not cover the sharp front end of the needle body (10) when it is attached to the needle body (10). Furthermore, as is particularly clear from Figure 3.4, about half of the front end of the guide wire (15) is thinner than the catheter (14).
), and is set as a small diameter tube portion (11a) that functions to puncture the blood vessel (M) while cooperating with the needle body (10).

On the other hand, approximately half of the rear end side of the sheath (11) is a large-diameter tube (11b) whose opening diameter (d2) is the catheter (14) itself or a larger introduction guide source (16). ). The boundary position between the small diameter tube portion (11a) and the large diameter tube portion (11b) is the tapered conical tube portion (II).
C) and is smoothly continuous with the needle body (1).
The puncture hole (S) opened into the blood vessel (M) by the small diameter tube part (11a), which is connected to the conical tube part (11c)
) and the large-diameter tube portion (11b) allow for easy expansion.

In that case, in the basic example shown in Figures 1 to 4, the puncture sheath (11
) is engraved with a slit (17) of a certain length extending along its longitudinal direction so that it can be opened and split later. Alternatively, the slit (17) may be omitted as shown in the modification shown in Fig. 5.6.

However, if the slit (17) is carved in advance, the sheath (11) is cut by cutting only a certain length L) remaining in the front wheel part of the sheath (11) with a cutter or the like.
), the catheter introduction guide wire (15) can be removed even from the middle of the guide wire (15).
It is now possible to feed the catheter (14) as it is along the wire (15) without having to completely pull it out backwards from the wire (15), which can be said to be significantly beneficial to workability. It goes without saying that the slit (17) is not limited to the solid line shape as shown in the figure, but may also be engraved with a so-called broken line or chain line, or even have a concave groove shape with a closed opening.

<Operation> When performing an angiographic examination using the basic puncture needle configured as described above, first, as is clear from FIG. 7(1), the puncture needle body (10 ) to sheath (11)
The puncture needle is inserted into a blood vessel (femoral artery or cubital artery) (M) while the needle remains in the assembled state.

Then, the conical tube part (I) of the puncture sheath (11)
IC) and the large diameter tube section (11b) that follows this is the blood vessel (
The blood vessel (M) is large enough to safely accept not only the catheter (14) but also the introduction guide source (16) of the catheter (14) while acting as a dilator for the blood vessel (M). The puncture hole (S) will be opened without any difficulty in its expanded state, so after opening the puncture hole (S), insert the puncture sheath (11) into the blood vessel CM and hold it as shown in Figure (II). and its sheath (1
Remove the needle body (10) from 1).

On the other hand, the above guide source (
Using the catheter sheath introducer (A) on which the dilator (16) has been set in advance, insert the dilator (18)
) and insert the guide wire (15) into the puncture sheath (11).
After inserting the sheath (M) into the blood vessel (M) based on the guidance of
11) is also extracted as shown in the same figure (I [I), and removed by cutting it through the slit (17).

The guide wire (15) used in that case is:
Since a relatively short one is sufficient, even if the puncture sheath (11) shown in the modified example of Fig. 5.6 is adopted,
Instead of opening and splitting the sheath (11),
It can be easily pulled out backwards from the wire (15).

Next, the above introducer (A) is shown in FIG. 7 (IV).
Insert the blood vessel (M) along the guide wire (15) as shown.
The dilator (18) and guide wire (15) are removed while leaving only the guide source (16) in a stationary state as shown in FIG. As described above, the puncture hole (S) is opened in an expanded state by the puncture needle before inserting the introducer (A), so the guide source (16) in the introducer (A) The insertion action becomes extremely smooth.

Then, along the remaining guide source (16),
Subsequently, as shown in the same figure (Vl), the catheter (14) is sent in, and finally the guide source (16) is also removed, and the contrast medium is poured into the catheter (14) as shown in the same figure (■). This involves photographing and examining blood vessels. The catheter (14) is inserted into the blood vessel (M) through the guide source (16) of the introducer (A), so as to rub against the opening edge of the puncture hole (S).
There is no danger of direct physical stimulation, and as a result, the contraction phenomenon of the blood vessel (M) can be effectively prevented, and the puncture hole (S)
) will not cause difficulties in hemostasis due to subsequent forced expansion.

In Fig. 7, an angiography method using the introducer (A) was explained, but this is omitted and the guide wire is inserted into the puncture hole (S) of the blood vessel (M) opened in an expanded state by the puncture needle. It is also possible to directly insert the catheter (14) through the catheter (15) and inject the contrast medium. In other words, the guide wire (15) to be inserted in the process shown in FIG.
After removing the puncture sheath (11) in the subsequent step (II [) in the same figure, the catheter (14) is immediately inserted into the blood vessel (M) along the wire (15).
), and finally the wire (15) is removed and a contrast agent is injected into the remaining catheter (14).

Even in that case, the puncture hole (S) is connected to the sheath (11) of the puncture needle.
Since the catheter (14) is opened at both fronts in an expanded state that is considerably larger than the outer diameter of the catheter (14), there is no risk of rubbing against the opening edge of the puncture hole (S) when the catheter (14) is inserted. Therefore, the safety is maintained and the catheter (14) can be inserted smoothly.

<Effects of the Invention> In summary, the present invention includes a needle body (10) for puncturing a blood vessel (M), and a base (11) that is attached and set so as to be able to be inserted into and removed from the needle body (10). In the puncture needle for angiography, the front part of the sheath (11) is a small diameter tube part (11a) through which a catheter introduction guide wire (15) can be inserted, and the same (the rear part is a small diameter tube part (11a) through which a catheter introduction guide wire (15) can be inserted). a catheter (14), or a large-diameter tube portion (
Ilb), and the boundary position between the small diameter pipe part (11a) and the large diameter pipe part (11b) is a smoothly continuous tapered conical pipe part (IIc).
), the sheath (11) is integrally formed in an overall stepped shape, and together with the needle body (10), the small diameter tube part (11a) of the sheath (11) opens into the blood vessel (M). Puncture hole (S
) is set to expand automatically by the conical tube section (11c) and the large diameter tube section (11b) of the sheath (11), so all the problems of the prior art described at the beginning can be reliably solved. It has the effect of eliminating the problem.

Further, a slit (17) of a certain length extending along the longitudinal direction is also cut into the puncture sheath (11) as described above, and the sheath (11) is inserted through the slit (17).
), the catheter (1
The insertion workability (4) can also be further improved. Furthermore, the necessary configuration for this purpose is extremely simple and the mass production effect can be expected to the maximum, so it can be said that this ring is extremely superior in practice as a disposable medical device.

[Brief explanation of drawings]

Fig. 1 is a side sectional view showing the assembled state of the dilator-equipped puncture needle according to the present invention, Fig. 2 is a plan view showing the disassembled state of the needle body and sheath, and Fig. 3 is the same (with the sheath extracted). FIG. 4 is a sectional view taken along the line IV-IV in FIG. 3, FIG. 5 is a perspective view showing a modified example of the sheath corresponding to FIG. 3, and FIG. -VI line, Fig. 7 ([)~
(■) is an explanatory diagram showing the insertion process of a catheter according to the present invention, and FIG. 8.9 is an assembled sectional view and an exploded plan view of a conventional product corresponding to FIG. 1.2. (10)...Puncture needle body (11)...Puncture sheath (11a)...Small diameter tube section (11b)...Large diameter tube section (11c)... ... Conical tube part (14) ... Catheter (15) ... Catheter introduction guide wire (1
6)・・・Catheter introduction guide source (17)・
...Slit (A) ...Catheter sheath introducer (M) ...Blood vessel (S) ...Puncture hole procedure NeiTi JE 1 ■, Incident display 1988 Patent Application No. 81727 2, Name of Invention Puncture needle with dilake for angiography 3?11i Person who performs correction [Relationship with the case] Patent applicant Isamu Furuyo, 2-112 Kamihama-cho, Tsu City, Sanshi Prefecture. 4. Agent 6, the specification to be amended (detailed description of the invention and brief description of the drawings 7, contents of amendment (1) page 3, line 20 of the specification, "Figure 8.9"), Correct it to "Figure 12.13." (2) In the same book, page 9, line 17 to page 10, line 3, it says, "In that case, -111...--I don't mind."
Correct as follows. ``In that case, in the basic example shown in Figures 1 to 4, the puncture sheath (1
The large diameter pipe part (11b) in 1) is set in a straight form with a uniform opening diameter (d2) over its entire length, but the boundary position between the small diameter pipe part (11a) and the large diameter pipe part (11b) Insofar as the tapered (downward) conical tube portion (11c) is interposed and coupled, the length of the large diameter tube portion (11b) is determined to be short as shown in FIG. The end may be formed into a conical shape with a downward slope, or the large diameter pipe portion (11b) may be formed as shown in Fig. 9.
The entire surface of the large-diameter pipe portion (11b) can be formed into a gently descending conical shape, as shown in FIG. It is also possible to define it as a form, etc. In addition, in the basic example shown in Figs. 1 to 4, the puncture sheath (11) is
A slit (17) of a certain length extending along the longitudinal direction is carved in order to allow the sheath (11) to open and split later, but if the sheath (11) can achieve the above purpose, As shown in Figure 5.6, the provision of the slit (17) may be omitted. ” (3) On page 10, lines 13-16 of the same book, “In addition,----
---Of course. ” is corrected as follows. ``Although in Figures 1 to 4, the above-mentioned slit (L7) is opened in a so-called solid line shape, but as long as it is useful for the overall opening operation of the sheath (11), it is possible to open the slit (L7) as shown in Figure 7.8. It is also possible to adopt the form of a groove with a non-penetrating opening, or the form of engraving with a so-called broken or chain line as shown in Fig. 9.'' (4) Ibid., page 10, lines 19-20, page 12. 9
In line 13, page 13, line 12, and lines 17 and 18, the words ``Figure 7'' are corrected to ``Figure 11.'' (5) In the same book, page 16, lines 7 to 12, “Figure 5 is one--
--It is an exploded plan view. ” is corrected as follows. 5 is a perspective view showing a first modification of the sheath corresponding to FIG. 3, FIG. 6 is a sectional view taken along the line Vl-1i11 in FIG. 5, and FIG. 7 is a plan view of the second modification, Figure 8 is the same as Figure 7.
- Enlarged sectional view along the line ■, Figure 9.10 is further shown in Figure 3.4.
Plan views of the modified examples, FIGS. 11(1) to (■) are action explanatory diagrams showing the catheter insertion process using the present invention, and FIGS. 12.13 are plan views of the conventional product corresponding to FIG. 1.2. They are an assembled sectional view and an exploded plan view. (6) In the drawings, figures 7 to 9 have been corrected as shown in the attached sheet, and figure 10 has been corrected.
Figure ~13 is added as shown in the attached sheet. Figure 7 Figure 8 Figure 9 Figure 70

Claims (1)

[Scope of Claims] 1. A needle body (10) for puncturing a blood vessel (M), and a sheath (
11), the front part of the sheath (11) is a small diameter tube part (11a) through which a catheter introduction guide wire (15) can be inserted, and the rear part is a small diameter tube part (11a) through which a catheter introduction guide wire (15) can be inserted. a guiding catheter (14) or the catheter (14);
The introduction guide source (16) is a large-diameter pipe section (11b) that can accept the guide source (16), and the boundary position between the small-diameter pipe section (11a) and the large-diameter pipe section (11b) is a smoothly continuous tapered conical pipe. Part (11c
), the sheath (11) is integrally formed in an overall stepped shape, and together with the needle body (10), the small diameter tube part (11a) of the sheath (11) opens into the blood vessel (M). Puncture hole (S
) is set to be automatically expanded by the conical tube portion (11c) and large diameter tube portion (11b) of the sheath (11). 2. A needle body (10) for puncturing a blood vessel (M), and a sheath (
11), the front part of the sheath (11) is a small diameter tube part (11a) through which a catheter introduction guide wire (15) can be inserted, and the rear part is a small diameter tube part (11a) through which a catheter introduction guide wire (15) can be inserted. a guiding catheter (14) or the catheter (14);
The introduction guide source (16) is a large-diameter pipe section (11b) that can accept the guide source (16), and the boundary position between the small-diameter pipe section (11a) and the large-diameter pipe section (11b) is a smoothly continuous tapered conical pipe. Part (11c
), the sheath (11) is integrally formed into an overall stepped shape, and a slit (17) of a certain length extending along the longitudinal direction of the sheath (11) is carved. 17)
The sheath (11) is opened and split from the needle body (10) and the small diameter tube part (11) of the sheath (11) is opened.
The puncture hole (S) opened into the blood vessel (M) in step a) is then inserted into the conical tube portion (11c) and the large diameter tube portion (
11b) A puncture needle with a dilator for angiography, characterized in that it is set to expand on its own.