JP2002200089A - Hemostatic material filling instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a hemostatic material filling instrument which can securely fill a hemostatic material into a target position without deviating from a puncture hole during operation corresponding to a case. SOLUTION: This hemostatic material filling instrument 1 is equipped with a holder 2 with a tubular holder main body 21 insertable into a guiding sheath 10, a hemostatic material 3 retained in the tip end part of the holder 2, an ejecting member 4 with an inserting part 41 insertable into the holder 2, a positioning member 5 with a support part 51 and a body abutting part 52 equipped on the tip end of the support part 51. A pin 44 equipped on the base end part of the ejecting member 4 is inserted into any of plural holes 53 formed in the base end part of the positioning member 5 to position the ejecting member 4 on the body surface 200 via the positioning member 5. A hole 53 to be inserted with the pin 44 is selected so as to enable a position of the ejecting member 4 to be adjusted along the longitudinal direction for positioning.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

TECHNICAL FIELD The present invention relates to a hemostatic filling device.

[0002]

2. Description of the Related Art For example, when performing cardiac catheterization, cardiac and angiography, His bundle electrocardiography, and the like, a catheter is percutaneously inserted into a blood vessel to perform treatment. After the treatment is completed, it is necessary to stop the puncture hole from hemostasis. In order to easily and surely perform the hemostasis, a method of filling (inserting) a hemostatic material for closing the puncture hole is known.

[0003] Conventionally, as a hemostatic filling device used for filling (inserting) such a hemostatic material, a cylinder (cylindrical member) loaded with the hemostatic material and a hemostatic material that can be inserted into the cylinder are used. And a plunger capable of extruding the plunger from the tip of the cylinder.

[0004] The operation of filling a hemostatic material in such a conventional hemostatic material filling instrument is as follows. That is, the distal end side of the cylinder is inserted into the puncture hole, and the cylinder and the plunger are relatively moved. Thereby, the hemostatic material is extruded from the tip of the cylinder, and is filled (placed) in the puncture hole.

In such a hemostatic filling operation, particularly when the cylinder and the plunger are relatively moved, the position of the hemostatic filling instrument relative to the living body (puncture hole) tends to shift. For this reason, filling the hemostatic material at the correct position (detention)
It is difficult to insert the hemostatic material too far, and the hemostatic material penetrates into the blood vessel and obstructs blood flow.On the contrary, the insertion position of the hemostatic material is too shallow to achieve a sufficient hemostatic effect. In some cases, they could not be obtained.

[0006]

SUMMARY OF THE INVENTION It is an object of the present invention to fill a hemostatic material into a target position reliably without causing a displacement of a puncture hole during operation according to a case. It is to provide a device.

[0007]

This and other objects are achieved by the present invention which is defined below as (1) to (12).

(1) A holder having a main body that can be inserted into an introduction sheath, a hollow portion penetrating from a base end to a distal end, a hemostatic material held by the holder, and a hollow portion of the holder. A discharge member having an elongated insertion portion that can come into contact with the hemostatic material in an inserted state, an engagement portion provided on a proximal end side of the insertion portion, a long support portion, and a distal end side of the support portion. A positioning member having a living body contacting portion that comes into contact with the provided living body surface, wherein the engaging portion of the discharging member and the supporting portion of the positioning member engage with each other, so that the discharging member is attached to the living body surface. An apparatus for filling with a hemostatic material, characterized by having an adjusting means which can be positioned with respect to the living body surface at the time of positioning, and which can be positioned by adjusting the position of the discharging member with respect to the living body surface along the longitudinal direction of the discharging member.

(2) The hemostatic filling device according to the above (1), wherein the position of the discharge member with respect to the surface of the living body can be adjusted stepwise or continuously to be positioned.

(3) The adjusting means is formed on one of the engaging portion of the discharge member and the supporting portion of the positioning member, and is formed on the other, and the convex portion is selectively provided. The above (1) having a plurality of insertable holes or recesses.
Or the hemostatic filling device according to (2).

(4) The adjusting means is capable of connecting the discharge member and the positioning member so as to be relatively movable along the longitudinal direction of the discharge member. The hemostatic filling device according to 2).

(5) A restricting means for restricting movement of the discharge member in the proximal direction with respect to the positioning member in a state where the engaging portion of the discharge member is connected to the support portion of the positioning member. The hemostatic filling device according to (4).

(6) The adjusting means includes a serrated rack formed on one of the discharging member and the positioning member, and a claw formed on the other and engaging with a tooth portion of the serrated rack. The device for filling a hemostatic material according to the above (4) or (5), comprising:

(7) The above-mentioned (1) to (1) to (4), further comprising positioning means for positioning the distal end of the hemostatic material held by the main body of the holder inserted into the introduction sheath so that the distal end substantially coincides with the tip of the introduction sheath. The hemostatic filling device according to any of (6).

(8) The holder according to any one of (1) to (7), wherein the holder has a fixing portion that can be fixed to a base end portion of the introduction sheath in a state where the main body portion is inserted into the introduction sheath. The hemostatic filling device according to any one of the above.

(9) The hemostatic filling device according to any one of (1) to (8), wherein the living body contact portion of the positioning member has a space through which the introduction sheath can penetrate.

(10) The hemostatic filling device according to any one of (1) to (9), wherein the living body contact portion of the positioning member has a substantially horseshoe shape.

(11) The hemostatic filling device according to any one of (1) to (10), wherein the living body contact portion of the positioning member is provided to be inclined with respect to the support portion.

(12) The device for filling a hemostatic material according to any one of (1) to (11), further comprising the introduction sheath.

[0020]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, a hemostatic filling device according to the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment> FIG. 1 is a longitudinal sectional view showing a holder and a hemostatic material held by the holder in the first embodiment of the hemostatic material filling device of the present invention, and FIG. 2 is a hemostatic material of the present invention. FIGS. 3 and 4 are perspective views of a discharge member and a positioning member in the first embodiment of the filling device, and FIGS. 3 and 4 are diagrams for sequentially explaining how to use the hemostatic filling device shown in FIGS. 1 and 2. is there. In the following description,
The upper side in FIG. 1 and the upper right side in FIG. 2 are referred to as “proximal end”, and the lower side in FIG. 1 and the lower left side in FIG. 2 are referred to as “distal end”.

The hemostatic filling device 1 shown in these figures comprises a holder 2 having a tubular (tubular) holder body 21;
Hemostatic material 3 held by holder 2 and discharge member 4 having insertion portion 41 that can be inserted into hollow portion 23 of holder 2
And a positioning member 5 that can position the discharge member 4 with respect to the surface of the living body. Hereinafter, the configuration of each unit will be described.

As shown in FIG. 1, the holder 2 comprises a holder main body (main body) 21 formed of a tubular (tubular) member, and a hub 22 mounted on the base end of the holder main body 21. ing.

At substantially the center of the holder body 21, a hollow portion (inner cavity) 23 is formed over the entire length of the holder body 21. This hollow portion 23 is open to the base end and the front end of the main body 2.

The outer diameter of the holder main body 21 is set to be equal to or less than the inner diameter (minimum inner diameter) of the introduction sheath 10 described later.
0 can be inserted. A suitable value of the outer diameter of the holder body 21 depends on the inner diameter of the introduction sheath 10 and the like, but is usually preferably about 1 to 5 mm.
More preferably, it is about 3 to 4.5 mm.

The cross-sectional shape of the holder body 21 is as follows.
Although the shape is circular in the present embodiment, the shape may be elliptical or the like. The introduction sheath 10 will be described later.

At the distal end of the holder body 21, a hemostatic material 3
Is loaded (held). This hemostatic material 3 is, for example,
It is composed of a bioabsorbable material such as a cellulosic polymer material or collagen. When the hemostatic material 3 is filled in the puncture hole 400 formed in the living body, the hemostatic material 3 comes into contact with blood and becomes wet and gel, and closes the puncture hole 400 to exhibit a hemostatic function.

The length and diameter of the hemostatic material 3 held by the holder body 21 are not particularly limited, and the preferable values vary depending on the use and the case, but are usually as follows. That is, the length of the hemostatic material 3 is preferably about 5 to 100 mm, and more preferably about 10 to 70 mm. And the diameter of the hemostatic material 3 is 0.5 to 1
It is preferably about 0 mm, more preferably about 1 to 5 mm.

In the illustrated configuration, the entire hemostatic material 3 is housed in the hollow portion 23 of the holder main body 21. However, the hemostatic material 3 only needs to be held by the holder main body 21 and is exposed from the holder main body 21. There may be some parts.

At the base end of the holder body 21, a hub 22 is mounted. Inside the hub 22, a hollow portion 23 is provided.
And at least a distal end of the passage 25 preferably has an inner diameter substantially equal to the inner diameter of the hollow portion 23, and has an inner surface at a base end of the hollow portion 23.
It is continuous without any step.

A fixed portion 24 is formed on the outer peripheral portion of the distal end of the hub 22 so as to protrude in the distal direction. A protrusion 242 is formed on the inner periphery of the fixing portion 24.
2 can be inserted into a concave portion 105 formed on the outer periphery of the proximal end of the hub 102 of the introduction sheath 10.
Thereby, the sheath 1 for introduction is provided on the inner side 241 of the fixing portion 24.
The hub 102 of FIG.
reference). With such a configuration, the hub 22 of the holder 2
Can be fixed to the hub 102 of the introduction sheath 10 with the holder main body 21 inserted into the introduction sheath 10.

By providing such a fixing portion 24, the holder 2 and the introduction sheath 10 can be combined, and when the holder 2 and the introduction sheath 10 are removed from the puncture hole 400 together. In addition, only the holder 2 is prevented from being separated from the introduction sheath 10 and pulled out. Therefore, the operability is excellent, and the position of the hemostatic material 3 does not shift during the operation.

The fixing part 24 of the holder 2 and the sheath 1 for introduction
The method of fixing the “0” to the hub 102 is not limited to the fitting, and may be a configuration in which the “0” is fixed by a method such as screwing, engaging with a claw portion, or the like.

Such a holder 2 includes an introduction sheath 1
Positioning means is provided for positioning the distal end 31 of the hemostatic material 3 held by the holder main body 21 inserted into the guide sheath 10 so as to substantially coincide with the distal end 103 of the introduction sheath 10.

That is, as shown in FIG. 3, the distal end 31 of the hemostatic material 3 is introduced while the holder body 21 is inserted into the introduction sheath 10 and the hub 22 is fixed to the hub 102 of the introduction sheath 10. The length of the holder main body 21 and the position of the hemostatic material 3 are set so as to substantially coincide with the distal end 103 of the sheath 10 for use. As a result, the distal end 31 of the hemostatic material 3 can be positioned and inserted into the blood vessel wall 110 as described later.

The preferred value of the length of the holder body 21 varies depending on the length of the introduction sheath 10 and the like, but is usually preferably about 300 to 800 mm.
More preferably, it is about 350 mm.

The constituent materials of the holder body 21 and the hub 22 are not particularly limited.
Polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, polyvinyl chloride, polyurethane, polystyrene, polymethyl methacrylate, polycarbonate, polyamide, polyester such as polyethylene terephthalate, polybutylene terephthalate, acrylic resin, ABS resin, Various resin materials such as AS resin, ionomer, polyacetal, polyphenylene sulfide, and polyetheretherketone, and a combination of two or more of them (polymer alloy, polymer blend, laminate)
Is mentioned.

In addition, the holder body 21 may be constituted by a laminated body in which two or more layers are laminated, in addition to the case where the holder main body is constituted by one layer. Further, a reinforcing material may be provided in or between the layers. As the reinforcing material, for example, a reinforcing member formed of a linear or spiral (coiled) linear body,
One composed of a net-like body is exemplified.

In the present invention, the holder 2 is not limited to the one having the tubular main body, but has a hollow part penetrating from the base end to the front end, and can hold the hemostatic material 3. Any configuration may be used, for example, a frame shape,
It may have a coil shape, a mesh shape, a net shape, or the like.

As shown in FIG. 2, the discharge member 4 is composed of an elongated insertion portion 41 which is substantially linear, and an engagement portion 42 attached to the base end of the insertion portion 41.

The outer diameter of the insertion portion 41 is set to be equal to or less than the inner diameter (minimum inner diameter) of the hollow portion 23 of the holder 2, whereby the insertion portion 41 can be inserted into the hollow portion 23 of the holder 2. .

Then, as shown in FIG.
The distal end 43 can be brought into contact with the proximal end 32 of the hemostatic material 3 when inserted into the hollow portion 23 of the holder 2. By moving the holder 2 and the discharge member 4 relatively from such a state, the hemostatic material 3 is moved to the holder 2.
Can be discharged from the tip.

The length of the insertion portion 41 is the same as the length when the holder 2 is inserted into the introduction sheath 10 and the two are combined (the length indicated by L in FIGS. 3 and 4). It is preferably of the order or longer. Thus, the hemostatic material 3 can be completely discharged from the holder 2 or the distal end of the introduction sheath 10, and the hemostatic material 3 can be discharged in the discharging operation.
Of the puncture hole 400 without displacement.
Therefore, the hemostatic material 3 can be more reliably filled at the target position.

A pin (convex portion) 44 is formed on the engaging portion 42 attached to the base end of the insertion portion 41 so as to project in a direction perpendicular to the longitudinal direction of the insertion portion 41. The pin 44 can be inserted (fitted) into a hole 53 formed in a support portion 51 of the positioning member 5 described later.

As shown in FIG. 2, the positioning member 5 includes a long support portion 51 formed of a plate-like member, and the support portion 51.
And a living body contact part 52 installed at the tip of the body.

The support portion 51 has a substantially linear shape, and is disposed substantially parallel to the insertion portion 41 of the discharge member 4 when the hemostatic filling device 1 is used. The position of the support portion 51 with respect to the living body surface 200 is defined by the contact of a living body contact portion 52 described below with the living body surface 200.

The length of the support portion 51 is not particularly limited, but is preferably equal to or longer than the length of the insertion portion 41 of the discharge member 4.

A plurality of holes (recesses) 53 are formed on the base end side of such a support portion 51 along the longitudinal direction.
The pins 44 of the discharge member 4 can be inserted (fitted) into these holes 53, respectively.

The number of holes 53 is not particularly limited, but is preferably about 1 to 80, and more preferably about 2 to 50. In the configuration shown, the holes 53
Are formed at regular intervals along the longitudinal direction of the support portion 51.

As shown in FIG. 3, by inserting (fitting) the pins 44 of the discharge member 4 into any of these holes 53, the discharge member 4 is brought into contact with the body surface 200 via the positioning member 5. Positioned. Thereby, the position of the discharge member 4 with respect to the living body surface 200 does not shift during the operation of discharging the hemostatic material 3 from the holder 2, and therefore,
The hemostatic material 3 can be discharged from the holder 2 without impairing the state where the hemostatic material 3 is positioned at the target position with respect to the puncture hole 400.

Further, by selectively inserting (fitting) the pins 44 of the discharging member 4 into any of the plurality of holes 53, the position of the discharging member 4 with respect to the living body surface 200 in the longitudinal direction of the discharging member 4 is adjusted. Can be adjusted and positioned in a stepwise manner. That is, in the present embodiment, the pin 44 of the discharge member 4 and the plurality of holes 53 of the positioning member 5
When positioning the discharge member 4 with respect to the living body surface 200, an adjusting means capable of adjusting the position along the longitudinal direction of the discharge member 4 to perform positioning is configured.

In the hemostatic filling device 1, the provision of such an adjusting means allows the blood vessel wall 110 to extend from the living body surface 200 near the puncture hole 400, as described later.
The hemostatic material 3 with respect to the puncture hole 400 in accordance with the difference in the thickness W (see FIG. 3) of the subcutaneous tissue 300 and the inclination angle β (see FIG. 3) of the introduction sheath 10 with respect to the living body surface 200 up to the target position. Can be reliably filled.

The width (distance between the most proximal hole 53 and the most distal hole 53 in this embodiment) that can be adjusted by this adjusting means is not particularly limited, but is preferably about 2 to 80 mm. preferable. The range that can be adjusted by this adjusting means preferably includes a state where the distal end 43 of the insertion portion 41 is positioned so as to be located near the living body contact portion 52.

The pitch of the holes 53 (the adjacent holes 5
3) is not particularly limited, but 1 to 10 mm
About 1 mm, and more preferably about 1 to 5 mm.

It should be noted that, unlike the configuration shown in the figure, a plurality of pins 44 may be provided, and these pins 44 may be inserted (fitted) into a plurality of holes selected from the plurality of holes 53.
Also, contrary to the configuration shown, a pin (convex portion) is formed on the positioning member 5, and a plurality of holes (or concave portions) into which the pin (convex portion) can be selectively inserted are formed on the discharge member 4. May be used.

At the tip of the support portion 51, a living body contact portion 52 is provided. The living body contact part 52 is a part that comes into contact (contact) with the living body surface 200 when the hemostatic filling device 1 is used.

In the illustrated configuration, the living body contact portion 52 has a space 54 through which the introduction sheath 10 can pass. That is, the living body contact portion 52 has a substantially horseshoe shape (U-shape), and a space 54 is formed at the center thereof.

As a result, the living body contact portion 52 is
The living body surface 2 around the introduction sheath 10 inserted in the
00, the supporting portion 51 is stabilized, and the discharge member 41 can be positioned more stably. In addition, since the living body contact portion 52 does not interfere, it can be used in a wide range of the living body regardless of the shape of the living body surface 200.

When the living body contact portion 52 is applied to the living body surface 200 around the introduction sheath 10,
The introduction sheath 10 can be inserted into the space 54 through the defective portion 55, so that the positioning member 5 can be easily set and excellent in operability.

In the present invention, the shape of the living body abutting portion 52 having a space through which the introduction sheath 10 can penetrate is not limited to a horseshoe shape (U-shape) as shown in the figure, but may be, for example, a C-shape. It may be U-shaped or ring-shaped.

In the present embodiment, the living body contact portion 52 is provided at a predetermined angle with respect to the support portion 51. As a result, the following effects can be obtained.

That is, as shown in FIG. 3, a catheter (not shown) is usually used for the introduction sheath 10.
The blood vessel 100 (the body surface 20) is smoothly introduced into the blood vessel 100.
0) is placed at an angle. Thereby, the supporting portion 51 of the discharging member 4 and the positioning member 5 is also
Although it is used in a posture inclined with respect to 0, in this case, the living body contact portion 52 becomes close to being parallel to the living body surface 200, and a large contact area can be secured. Therefore, the discharge member 4 can be positioned more stably with respect to the living body surface 200.

The inclination angle α of the living body contact portion 52 with respect to the support portion 51 (see FIG. 3) is not particularly limited.
It is preferably from 0 to 180 °, and more preferably from 100 to 165 °.

In the present invention, a mechanism that can adjust the inclination angle α of the living body contact portion 52 with respect to the support portion 51 may be provided.

The constituent materials of the discharge member 4 and the positioning member 5 are not particularly limited. For example, polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer, polyvinyl chloride,
Polyester such as polyurethane, polystyrene, polymethyl methacrylate, polycarbonate, polyamide, polyethylene terephthalate, polybutylene terephthalate, acrylic resin, ABS resin, AS resin, ionomer, polyacetal, various resin materials such as polyphenylene sulfide, polyether ether ketone, stainless steel Various metal materials such as steel, aluminum or an aluminum alloy, titanium or a titanium alloy, copper or a copper-based alloy, and the like can be used, and further, two or more of them can be used in combination.

Next, an example of how to use (action) the hemostatic filling device 1 will be described in detail. [1] First, the introduction sheath 10 will be described. As shown in FIG. 3, the introduction sheath 10 includes a tubular sheath body 101, a hub 102 attached to the proximal end of the sheath body 101, and a hemostatic valve made of an elastic material fixed in the hub 102. 104.

Such an introduction sheath 10 is used in a state where it penetrates a subcutaneous tissue 300 and a puncture hole 400 formed in a blood vessel wall 110 and its distal end is percutaneously inserted into the blood vessel 100. You. That is, a catheter (not shown) or the like is introduced into the blood vessel 100 through the lumen of the introduction sheath 10 indwelled in such a state, for example, a cardiac catheterization method, a heart and angiography method, a His bundle electrocardiogram method, or the like. Such as medical treatment and examination.

When such a procedure is completed, the catheter (not shown) is removed from the introduction sheath 10. At this time, bleeding from the introduction sheath 10 is suppressed by closing the hemostatic valve 104.

[2] Next, a state in which the distal end 103 of the introduction sheath 10 substantially matches the blood vessel wall 110 (FIG. 3)
Until the state shown in FIG.
Pull out from 00. In this operation, the introduction sheath 1
In order to position the leading end 103 with respect to the blood vessel wall 110, an introduction sheath positioning device (not shown) can be used.

[3] The holder main body 21 of the holder 2 holding the hemostatic material 3 is inserted into the positioned introduction sheath 10, and the hub 102 of the introduction sheath 10 is fitted to the fixing portion 24 of the hub 22. Then, the two are united. In this state, as described above, the distal end 31 of the hemostatic material 3 substantially coincides with the distal end 103 of the introduction sheath 10, and thus is located substantially coincident with the blood vessel wall 110.

[4] Next, the insertion portion 41 of the discharge member 4
Is inserted into the hollow portion 23 through the passage 25 of the holder 2, and the distal end 43 of the insertion portion 41 is brought into contact with the proximal end 32 of the hemostatic material 3.

[5] Next, the positioning member 5 is arranged. That is, the living body contact portion 52 of the positioning member 5 is applied to the living body surface 200 such that the introduction sheath 10 is inserted into the space 54, and the support portion 51 is substantially parallel to the insertion portion 41 of the discharge member 4. To hold.

[6] In this state, the pin 4
4 is inserted (fitted) into the closest hole 53. Thus, the discharging member 4 is positioned with respect to the living body surface 200 via the positioning member 5.

[7] Next, while supporting the positioning member 5 and the discharging member 4 so that the living body contact portion 52 does not separate from the living body surface 200, the united introduction sheath 1 is supported.
Both the 0 and the holder 2 are pulled out (pulled out) from the puncture hole 400 (subcutaneous tissue 300) along the insertion section 41 of the discharge member 4.

Then, as shown in FIG.
Since the base end 32 is pressed by the insertion portion 41 of the discharge member 4, the position relative to the puncture hole 400 (the subcutaneous tissue 300) does not change, and is relatively discharged from the distal end of the holder 2. To remain. Then, the hemostat 3 comes into contact with the blood to be moistened and gelled, closes the puncture hole 400, and exhibits a hemostatic function.

If an excess portion of the hemostatic material 3 has protruded from the surface of the living body 200, it is cut as necessary.

Here, according to the present invention, the positioning position of the discharge member 4 with respect to the living body surface 200 can be adjusted along the longitudinal direction by the adjusting means.
The blood vessel wall 1 from the living body surface 200 near the puncture hole 400
The operation described above can be performed according to the difference in the thickness W (see FIG. 3) of the subcutaneous tissue 300 and the inclination angle β (see FIG. 3) of the introduction sheath 10 with respect to the living body surface 200 up to 10. it can.

For example, when the thickness W of the subcutaneous tissue 300 is larger than the state shown in the figure, or when the inclination angle β of the introduction sheath 10 is smaller, the pin 44 is inserted into the hole 53 located on the distal end side from the state shown in the figure. By inserting, the proximal end 3 of the hemostatic material 3
The discharge member 4 can be positioned with respect to the living body surface 200 in a state in which the distal end 43 of the insertion portion 41 is in contact with 2.
Conversely, when the thickness W of the subcutaneous tissue 300 is thinner than in the illustrated state, or when the inclination angle β of the introduction sheath 10 is large,
By inserting the pin 44 into the hole 53 located on the proximal side from the state shown in the figure, the insertion portion 41 is inserted into the proximal end 32 of the hemostatic material 3.
With the tip 43 of the body abutting, the discharging member 4 is
00 can be positioned.

Unlike the hemostatic filling device 1 of the present invention, the position of the discharging member 4 with respect to the living body surface 200 and the position of the discharging member 4 with respect to the living body surface 200 are changed along the longitudinal direction of the discharging member 4. When the hemostatic material 3 is filled by using a hemostatic material filling device that cannot be adjusted by the operator, the following inconvenience occurs.

For example, when there is no equivalent to the positioning member 5 and the discharge member 4 is used alone, it is difficult to perform an accurate operation in the following points. That is, the force required for the pull-out operation when pulling out the introduction sheath 10 and the holder 2 changes variously depending on the state (thickness, hardness, etc.) of the subcutaneous tissue 300, and thus the discharge member 4 is held at a fixed position. The adjustment of the force is very delicate, and if it is incorrectly performed, the detained position of the hemostatic material 3 positioned at an angle will be shifted.

In the case where the positional relationship between the discharging member 4 and the positioning member 5 cannot be adjusted (the two are integrated), the following inconvenience occurs. That is, depending on the thickness W of the subcutaneous tissue 300, the inclination angle β of the introduction sheath 10, and the like, the holder 2 is inserted into the introduction sheath 10.
Since the relative positional relationship between the proximal end 32 of the hemostatic material 3 and the living body surface 200 when the body is fixed changes, even if the living body contact portion 52 of the positioning member 5 is brought into contact with the living body surface 200, the discharging member 4 When the distal end 43 does not reach the proximal end 32 of the hemostatic material 3 or when the living body contact portion 52 of the positioning member 5 is
The distal end 43 of the discharge member 4 may push the base end 32 of the hemostatic material 3 before the contact is made. In the former case, when the introduction sheath 10 and the holder 2 are pulled out, the hemostatic material 3 rises to the proximal side from the position where it was initially positioned, and the positioning state of the hemostatic material 3 is impaired. Disappears. In the latter case, when the living body contact portion 52 of the positioning member 5 is applied to the living body surface 200, the discharging member 4 is pushed deeper (toward the blood vessel) from the position where the hemostatic material 3 is positioned.

On the other hand, in the present invention, since the discharge member 4 is accurately positioned with respect to the living body surface 200, the position of the discharge member 4 is shifted when the operation of pulling out the introduction sheath 10 and the holder 2 is performed. Therefore, the position of the hemostatic material 3 with respect to the puncture hole 400 does not occur.

As described above, it is possible to cope with the difference in the thickness W of the subcutaneous tissue 300, the inclination angle β of the introduction sheath 10, and the like.

Thus, according to the present invention, it is possible to fill the puncture hole 400 with the hemostatic material while reliably maintaining the state where the tip 31 of the hemostatic material 3 is positioned on the blood vessel wall 110.
For this reason, for example, the insertion position of the hemostatic material 3 is too deep, so that the hemostatic material 3 enters the blood vessel 100 and impedes the blood flow;
Conversely, the insertion position of the hemostatic material 3 is not so shallow that the hemostatic effect becomes insufficient, so that a high hemostatic effect is obtained and safety is high.

In this embodiment, instead of pushing out the hemostatic material 3 from the tip of the holder 2, the position of the hemostatic material 3 with respect to the puncture hole 400 (subcutaneous tissue 300) is determined by the discharging member 4 and the positioning member. The hemostatic material 3 is relatively discharged from the distal end of the holder 2 by pulling out the holder 2 from the puncture hole 400 in a state where the holder 2 is fixed by 5. Accordingly, the position of the hemostatic material 3 with respect to the puncture hole 400 does not shift during the discharging operation, and the hemostatic material 3 can be reliably filled at the target position.

<Second Embodiment> FIG. 5 is a perspective view showing a discharge member and a positioning member in a second embodiment of the hemostatic filling device of the present invention.

Hereinafter, a second embodiment of the present invention will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and a description of similar items will be omitted.

This embodiment is the same as the first embodiment except that the structures of the engaging portion of the discharging member and the supporting portion of the positioning member are different.

That is, in the present embodiment, the discharge member 4 ′ comprises the insertion portion 41 and the engagement portion 45 fixed (fixed) to the base end of the insertion portion 41. The positioning member 5 ′ is composed of a long support portion 56 and a living body contact portion 52 fixed (fixed) to the tip of the support portion 56.

The support portion 56 of the positioning member 5 'has a substantially rectangular cross section, and a rack 57 is formed in a predetermined range on the base end side. This rack 57
Have serrated teeth.

The pitch of the teeth of the rack 57 is not particularly limited, but is preferably about 0.5 to 10 mm.
More preferably, it is about 5 mm.

Although the number of teeth of the rack 57 is not particularly limited, it is preferably about 1 to 160.
More preferably, the number is about 0.

The engaging portion 45 of the discharging member 4 ′ is
, And one end thereof is inserted into the insertion portion 4.
1 is fixed (fixed) to the base end.

At the other end of the engaging portion 45, a passage 46 through which the supporting portion 56 can be inserted (inserted) is formed. The passage 46 is formed in a direction in which the support portion 56 is inserted so that the support portion 56 and the insertion portion 41 are substantially parallel.

By inserting the support portion 56 into such a passage 46, the engagement portion 46 and the support portion 56 can be connected. In this connection state, the discharge member 4
Is relatively movable along the longitudinal direction with respect to the support portion 56 (positioning member 5).

In the passage 46, a pawl 47 which can be engaged with a tooth surface of a rack 57 formed on the support portion 56 is provided.
In a state where the engagement portion 46 and the support portion 56 are connected, the pawl 47 engages with each tooth of the rack 57, so that the discharge member 4 moves relative to the positioning member 5 in the proximal direction (the support portion 56). (Proximal end direction) is restricted (substantially prohibited). Then, by selecting a tooth with which the claw 47 is engaged from among the teeth on the rack 57, the position of the discharge member 4 is adjusted stepwise with respect to the positioning member 5 along the longitudinal direction thereof. Can be.

Next, an example of a method (operation) of using the hemostatic filling device of the present embodiment will be described.

The same operation as in the above [1] to [3] is performed.
Next, the support portion 56 is inserted into the passage 46 until the claw 47 is positioned at the base end of the rack 57, and the discharge member 4 and the positioning member 5 are connected.

Next, the insertion portion 41 of the discharge member 4 is inserted into the hollow portion 23 of the holder 2 and the positioning member 5 is inserted.
Is applied to the living body surface 200.

In this state, the discharging member 4 is moved in the distal direction with respect to the positioning member 5 by pressing the engaging portion 45 with a finger in the proximal direction, and the distal end 43 of the insertion portion 41 is moved to the position of the hemostatic material 3. It is brought into contact with the base end 32. Thereby, a state similar to the state shown in FIG. 3 is obtained.

Next, by performing the same operation as in the above [7], the hemostatic material 3 is filled in the puncture hole 400. In this operation, since the movement of the discharge member 4 in the proximal direction is regulated as described above, the discharge member 4 does not move in the proximal direction with the withdrawal operation of the introduction sheath 10 and the holder 2, Positioning is reliably performed with respect to the living body surface 200.

As described above, in the present embodiment, the positioning position of the discharge member 4 can be adjusted while the discharge member 4 and the positioning member 5 are connected, and the operability is particularly excellent. .

Further, the positioning of the discharge member 4 can be adjusted in more steps, and the puncture hole 400 of the hemostatic material 3 can be adjusted.
Can be particularly reduced.

The apparatus for filling a hemostatic material according to the present invention has been described with reference to the illustrated embodiment. However, the present invention is not limited to this, and each part constituting the apparatus for filling a hemostatic material exhibits the same function. Any configuration that can be used can be substituted.

For example, in the above-described embodiment, the adjusting means can adjust the position of the discharge member with respect to the surface of the living body in a stepwise manner. However, the present invention is not limited to this. It may be one that can continuously adjust the position with respect to the surface. As such an adjusting means, for example, one in which one of the discharge member and the positioning member is provided with a holding member such as a clip for holding the other, or the discharging member and the positioning member One that can be connected movably, and that can be fixed in its relative positional relationship by turning a handle and tightening a screw.

[0106]

As described above, according to the present invention, the position of the discharge member with respect to the living body surface does not shift during the operation, and the puncture hole is reliably filled with the hemostatic material at the target position. be able to.

Further, the above effect can be achieved irrespective of the thickness of the subcutaneous tissue up to the blood vessel and the inclination angle of the introduction sheath.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view showing a holder and a hemostatic material held by the holder in a first embodiment of the hemostatic material filling device of the present invention.

FIG. 2 is a perspective view of a discharge member and a positioning member in the first embodiment of the hemostatic filling device of the present invention.

FIG. 3 is a view for sequentially explaining how to use the hemostatic filling device shown in FIGS. 1 and 2.

FIG. 4 is a view for sequentially explaining how to use the hemostatic filling device shown in FIGS. 1 and 2.

FIG. 5 is a perspective view of a discharging member and a positioning member in a second embodiment of the hemostatic filling device of the present invention.

[Explanation of symbols]

 Reference Signs List 1 hemostatic filling device 2 holder 21 holder main body 22 hub 23 hollow portion 24 fixing portion 241 inside 242 protrusion 25 passage 3 hemostatic material 31 front end 32 base end 4, 4 'discharge member 41 insertion portion 42 engagement portion 43 front end 44 pin 45 Engaging part 46 Passage 5, 5 ′ Positioning member 51 Support part 52 Living body contact part 53 Hole 54 Space 55 Defect part 56 Support part 57 Rack 10 Introduction sheath 101 Sheath body 102 Hub 103 Tip 104 Hemostatic valve 105 Depression 100 Blood vessel 110 Vessel wall 200 Body surface 300 Subcutaneous tissue 400 Puncture hole

Claims (12)

[Claims] A body portion insertable into an introduction sheath;
A holder having a hollow portion penetrating from a base end to a distal end; a hemostatic material held by the holder; an elongated insertion portion capable of coming into contact with the hemostatic material when inserted into the hollow portion of the holder; and the insertion portion A discharge member having an engagement portion provided on the base end side of the body, a positioning member having a long support portion, and a living body contact portion abutting on a living body surface provided on the distal end side of the support portion. By engaging the engaging portion of the discharging member and the supporting portion of the positioning member, the discharging member can be positioned with respect to the living body surface, and at the time of this positioning, the discharging member with respect to the living body surface An apparatus for filling a hemostatic material, comprising an adjusting means capable of adjusting a position along a longitudinal direction of the discharge member and positioning the discharge member. 2. The hemostatic filling device according to claim 1, wherein the position of the discharge member with respect to the surface of the living body can be adjusted stepwise or continuously to be positioned. 3. The adjusting means is formed on one of an engaging portion of the discharging member and a supporting portion of the positioning member, and is formed on the other, and the convex portion is selectively inserted. 3. A method according to claim 1, comprising a plurality of possible holes or recesses.
The device for filling a hemostatic material according to claim 1. 4. The adjusting device according to claim 1, wherein the adjusting means is capable of connecting the discharging member and the positioning member so as to be relatively movable along a longitudinal direction of the discharging member. Hemostatic filling equipment. 5. A restricting means for restricting movement of the discharge member in the proximal direction with respect to the positioning member in a state where the engagement portion of the discharge member and the support portion of the positioning member are connected. Item 5. The hemostatic filling device according to Item 4. 6. The adjusting means includes: a serrated rack formed on one of the discharge member and the positioning member; and a claw formed on the other and engaged with a tooth portion of the serrated rack. The hemostatic filling device according to claim 4 or 5, further comprising: 7. The positioning device according to claim 1, further comprising positioning means for positioning the tip of the hemostatic material held by the main body of the holder inserted into the introduction sheath so as to substantially coincide with the tip of the introduction sheath. The hemostatic filling device according to any one of the above. 8. The holder according to claim 1, wherein the holder has a fixing portion which can be fixed to a base end of the introduction sheath in a state where the main body is inserted into the introduction sheath. Hemostatic filling equipment. 9. The hemostatic filling device according to claim 1, wherein the living body contact portion of the positioning member has a space through which the introduction sheath can penetrate. 10. The hemostatic filling device according to claim 1, wherein the living body contact portion of the positioning member has a substantially horseshoe shape. 11. The device for filling a hemostatic material according to claim 1, wherein the living body contact portion of the positioning member is provided to be inclined with respect to the support portion. 12. The hemostatic filling device according to claim 1, further comprising the introduction sheath.