WO2015145768A1

WO2015145768A1 - Subcutaneous penetrating instrument for guiding catheter

Info

Publication number: WO2015145768A1
Application number: PCT/JP2014/059317
Authority: WO
Inventors: 秀治狩谷; 昇谷川; 重義長尾; 宗和西川
Original assignee: テルモ・クリニカルサプライ株式会社
Priority date: 2014-03-28
Filing date: 2014-03-28
Publication date: 2015-10-01
Also published as: JPWO2015145768A1; JP6286688B2

Abstract

The subcutaneous penetrating instrument (1) for guiding a catheter is provided with: a rod-shaped body section (2); a sloped flat section (3), which is provided at one end (21) of the rod-shaped body section (2) and is formed with a slant of a specified angle with respect to the rod-shaped body section (2); and a flat section sloped surface recognition marker, which is provided at a position that is a specified distance from the sloped flat section (3), in other words, a position that is closer to the base end of the rod-shaped body section (2) than the sloped flat section (3) by a specified distance, and on the surface that is in the direction that the sloped flat section (3) slopes and which can be confirmed by touch. The sloped flat section (3) also has: a catheter insertion/holding part, which is provided so as to pass through the sloped surface of the sloped flat section (3), into which a catheter can be inserted, and which is for holding the inserted catheter; and an end (6) for insertion into a living body, the end having a rounded overall shape.

Description

Subcutaneous penetration tool for catheter guidance

The present disclosure relates to a catheter-guided subcutaneous penetration device (tunneler device) used to penetrate a catheter subcutaneously under a patient's skin.

In the treatment of cancer and the like, a chemical solution injection therapy in which a chemical solution is injected into the body is performed.
A drug injector has been proposed for use in such drug injection therapy. The chemical injection device includes a main body, an internal space formed in the main body, a chemical injection port communicating with the space, a flow path for outflow of the chemical solution, and a rubber plug attached to the chemical injection port ( A chemical solution injection port having a septum) and a catheter in which a lumen for chemical solution injection is formed.
The medical solution injector inserts the catheter into the body, positions its distal end at the target site (for example, central vein), cuts the excess portion on the proximal end side of the catheter, and injects the cut end portion with the chemical solution. After connecting to the port, the drug solution injection port is fixed in the subcutaneous tissue and placed in the living body.

When the catheter is implanted subcutaneously in the patient, one end of the catheter is inserted through the incision in the patient's skin and inserted into the intended vein, and the other end is connected to, for example, the above-described drug injection port Implanted subcutaneously with a drug injection port. A tunneler device is used to penetrate the proximal portion of the catheter under the patient's skin. As a tunnel device, for example, a device disclosed in Japanese Patent Application Laid-Open No. 2012-75890 (Patent Document 1) has been proposed.

JP2012-75890

The tunneler device of Patent Document 1 is formed on a proximal end of the tunneler device and is configured for operable engagement by a user, a shaft extending distally from the handle, A collet supported on the distal end and a connector configured for operative engagement with the collet, wherein the collet includes a plurality of distally extending fingers defining a longitudinal opening. And the opening is configured to receive the end of the catheter tube, and the connector is configured to bias the collet fingers radially inward upon engagement of the connector with the collet. . In one embodiment, the collet includes four fingers. In one embodiment, each of the plurality of fingers includes at least one prong extending radially inward.

And in the tunnel device of patent document 1, as shown in FIG. 6 of patent document 1, the distal end of the tunnel 100 is extended from the phlebotomy site “V” so that the collet 130 is exposed. After being positioned, the end of the catheter tube 52 is received through the passage 151 of the connector 150 and inserted into the longitudinal opening 135 formed by the finger 136 of the collet 130. After receiving the end of the catheter tube 52 into the opening 135 of the collet 130, the connector 150 is slid onto the catheter tube 52 and engages the collet 130, as shown in FIGS. 8, 9A and 9B. . As shown in FIGS. 10A and 10B, rotation of the connector 150 relative to the collet 130 causes the threaded engagement of the portion 154 (FIG. 5) threaded inside the connector 150 with the portion 134 threaded outside the collet 130. cause. The progressive engagement of the threaded portions 134, 154 causes the longitudinally extending fingers 136 of the collet 130 to engage the tapered portion 156 of the connector 150. As the finger 136 engages the tapered portion 156, the finger 136 is gradually biased radially inward to securely engage the outer surface of the catheter tube 52.

Once the catheter tube 52 is secured to the tunnel device 100 via engagement of the collet 130 and connector 150, the tunnel device 100 is pulled through the tunnel “T”. Once the tunnel device is fully retracted from the tunnel “T”, the connector 150 is disengaged from the collet 130, and the catheter tube 52 is from within the longitudinal opening 135 formed by the finger 136 of the collet 130. Removed. Alternatively, the tube 52 is cut to disengage the tunnel device 100 from the remainder of the tube 52.

However, in Patent Document 1, in order to connect the catheter, the connector is attached to the end of the catheter, the cap 140 is detached from the tunnel device 100, the tunnel device is attached to the collet 130 of the tunnel end, A procedure such as screwing the connector 150 to the collet 130 is necessary.
Therefore, an object of the present invention is to provide a catheter guiding subcutaneous penetration tool that facilitates the catheter connection operation and facilitates the penetration of the catheter into the patient's skin.

What achieves the above object is as follows.
The catheter guiding subcutaneous penetration device of the present invention is used for placing a catheter under the skin. The subcutaneous penetration tool includes a rod-shaped main body portion, an inclined flat plate portion provided at one end of the rod-shaped main body portion and formed obliquely with respect to the rod-shaped main body portion, and an inclination direction side of the inclined flat plate portion of the rod-shaped main body portion. And a flat plate portion inclined surface confirmation marker that can be confirmed by tactile sensation provided at a portion that is a predetermined distance from one end to the other end, and the inclined flat plate portion penetrates the inclined surface of the inclined flat plate portion. And a catheter insertion holding portion for holding the inserted catheter, and an in vivo insertion end portion that is rounded as a whole.

FIG. 1 is a front view of an embodiment of a catheter-guided subcutaneous penetration device according to the present invention. FIG. 2 is a plan view of the catheter guiding subcutaneous penetration device shown in FIG. FIG. 3 is an enlarged plan view of the distal end portion of the catheter guiding subcutaneous penetration device shown in FIG. FIG. 4 is an explanatory diagram for explaining a state in which the catheter is held by the catheter guiding subcutaneous penetration device shown in FIGS. 1 to 3. FIG. 5 is a front view of another embodiment of the catheter guiding subcutaneous penetration device of the present invention. FIG. 6 is a plan view of the catheter guiding subcutaneous penetration device shown in FIG. 7 is a longitudinal sectional view of the catheter guiding subcutaneous penetration device shown in FIG. FIG. 8 is an enlarged cross-sectional view taken along line AA of FIG. FIG. 9 is an explanatory diagram for explaining a catheter insertion holding portion of a catheter guiding subcutaneous penetration device according to another embodiment of the present invention. FIG. 10 is an explanatory view for explaining a catheter insertion holding part of a catheter guiding subcutaneous penetration device according to another embodiment of the present invention. FIG. 11 is an explanatory diagram for explaining a state in which the catheter is held by the catheter guiding subcutaneous penetration device shown in FIG. FIG. 12 is a front view of another embodiment of the catheter-guided subcutaneous penetrating device of the present invention. FIG. 13 is a plan view of the catheter guiding subcutaneous penetration device shown in FIG. FIG. 14 is a longitudinal sectional view of the catheter guiding subcutaneous penetration device shown in FIG. FIG. 15 is a front view of another embodiment of the catheter guiding subcutaneous penetration device of the present invention. FIG. 16 is a plan view of the catheter guiding subcutaneous penetration device shown in FIG. FIG. 17 is a plan view of another embodiment of the catheter guiding subcutaneous penetrating device of the present invention. FIG. 18 is an enlarged front view of the distal end portion of another embodiment of the catheter guiding subcutaneous penetration device of the present invention. FIG. 19 is an enlarged front view of the distal end portion of another embodiment of the catheter guiding subcutaneous penetration device of the present invention. FIG. 20 is an explanatory diagram for explaining the operation of the catheter guiding subcutaneous penetration device of the present invention. FIG. 21 is an explanatory diagram for explaining the operation of the catheter guiding subcutaneous penetration device of the present invention. FIG. 22 is an explanatory diagram for explaining the operation of the catheter-guided subcutaneous penetration device of the present invention. FIG. 23 is an explanatory diagram for explaining the operation of the catheter-guided subcutaneous penetration device of the present invention.

The catheter guiding subcutaneous penetration device of the present invention will be described with reference to the illustrated embodiment.
The catheter guide subcutaneous penetration tool 1 of the present invention is a catheter guide subcutaneous penetration tool used for placing the catheter 15 subcutaneously. The subcutaneous penetration device 1 includes a rod-shaped main body portion 2, an inclined flat plate portion 3 provided at one end 21 of the rod-shaped main body portion 2 and formed obliquely with respect to the rod-shaped main body portion 2, and the rod-shaped main body portion 2. A flat plate portion inclined surface confirmation marker 5 that can be confirmed by a tactile sensation provided on the surface on the inclined direction side of the inclined flat plate portion 3 and on the other end side at a predetermined distance from one end. Furthermore, the inclined flat plate portion 3 is provided so as to pass through the inclined surface of the inclined flat plate portion 3, and can be inserted into the catheter, and the catheter insertion holding portion for holding the inserted catheter, and the living body rounded as a whole. It has an end 6 for insertion.
The catheter-guided subcutaneous penetration device of the present invention is of a type in which a catheter is connected to a person who advances the subcutaneous. For this reason, it is particularly effective for the connection procedure between the catheter in which the tip is inserted into the jugular vein (external jugular vein) and the drug injection port. This catheter-guided subcutaneous penetration device can also be used for a connection procedure between a catheter having a distal end inserted into a central vein and a drug injection port.

First, the catheter guiding subcutaneous penetration device 1 of the embodiment shown in FIGS. 1 to 3 will be described.
The catheter guiding subcutaneous penetration device 1 of this embodiment is provided with a rod-shaped main body 2 and one end 21 of the rod-shaped main body 2, and an inclined flat plate portion 3 formed obliquely with respect to the rod-shaped main body 2 by a predetermined angle. And a position that is a predetermined distance away from the inclined flat plate portion 3, in other words, a position that is the base end side of the predetermined long rod-shaped main body portion 2 from the inclined flat plate portion 3, and the inclined direction side of the inclined flat plate portion 3. And a flat plate inclined surface confirmation marker that can be confirmed by a tactile sensation provided on the surface. Further, the inclined flat plate portion 3 is provided so as to penetrate the inclined surface of the inclined flat plate portion 3, and is inserted into the catheter insertion holding portion for holding the inserted catheter and holding the inserted catheter. It has a living body insertion end 6.

The catheter guide subcutaneous penetrating device 1 of this embodiment is a rod-like body that extends substantially in a straight line.
The catheter-guided subcutaneous penetration device 1 includes a rod-shaped main body portion 2 extending a predetermined length and an inclined flat plate portion 3 provided at one end 21 of the rod-shaped main body portion 2.
In the subcutaneous penetration tool 1 of this embodiment, the rod-shaped main body 2 is substantially cylindrical. The rod-shaped main body 2 may be a narrow flat plate whose upper surface and lower surface are flat surfaces, or a kamaboko shape whose only upper surface is a flat surface. The length of the rod-shaped main body 2 is preferably 100 to 350 mm, and particularly preferably 150 to 250 mm. The width of the rod-shaped main body 2 is preferably 3.0 to 8.0 mm, and particularly preferably 4.0 to 6.0 mm.

The inclined flat plate portion 3 is provided at one end 21 (tip) of the rod-shaped main body portion 2. The inclined flat plate portion 3 is formed obliquely at a predetermined angle with respect to the rod-shaped main body portion 2. The inclination angle of the inclined flat plate portion 3 with respect to the rod-like main body portion 2 is preferably 1 to 30 degrees, and particularly preferably 5 to 20 degrees. The length of the inclined flat plate portion 3 is preferably 15 to 100 mm, and particularly preferably 20 to 50 mm. The width of the inclined flat plate portion 3 is preferably 3.0 to 10.0 mm, and particularly preferably 4.0 to 6.0 mm. In the subcutaneous penetration tool 1 of this embodiment, the inclined flat plate portion 3 is formed to have the same width as the rod-shaped main body portion 2 as shown in FIG.
The inclined flat plate portion 3 provided in the catheter guiding subcutaneous penetrating device 1 of this embodiment is thinner than the main body portion 2. The thickness of the inclined flat plate portion 3 is preferably 1.5 to 5.0 mm, and particularly preferably 2.0 to 4.0 mm. The thickness of the inclined flat plate portion 3 is preferably 1.5 to 6.5 mm thinner than the thickness (or outer diameter) of the rod-like main body portion 2.

Thus, by making the inclined flat plate portion 3 thin, it is easy to insert the inclined flat plate portion portion, in other words, the distal end portion of the catheter guiding subcutaneous penetration device 1 into the living body. Further, in the catheter guiding subcutaneous penetration device 1 of this embodiment, the top surface 21a of the rod-like main body 2 connected to the inclined flat plate 3 is an inclined surface that becomes thinner from the main body 2 toward the flat plate. . For this reason, there is no step between the inclined flat plate portion 3 and the rod-shaped main body portion 2. Therefore, not only the inclined flat plate portion 3 but also the distal end portion of the rod-shaped main body portion 2 can be easily inserted into the living body.

In this embodiment, the catheter insertion holding part is formed by a first slit 14 a and a second slit 14 b provided in the inclined flat plate part 3. The number of slits may be one.
In particular, in this embodiment, the first slit 14a extends from one side surface of the inclined flat plate portion 3 to the other side surface and does not reach the other side surface. Further, the slit 14 a extends obliquely with respect to the longitudinal direction of the inclined flat plate portion 3. Specifically, it extends diagonally toward the tip 6 side. In addition, you may extend diagonally toward the base end direction. In this manner, the slit length can be increased by extending obliquely. The slit 14a includes a catheter introduction portion 41 formed by cutting out the proximal end side of the slit 14a, a slit main body 42 that is continuous with the introduction portion 41 and extends with substantially the same width, and a round slit end portion. 43. The catheter introduction part 41 is formed by a notch part 44.

The second slit 14b extends from one side surface of the inclined flat plate portion 3 to the other side surface and does not reach the other side surface, similarly to the first slit 14a. Furthermore, the slit 14 b extends obliquely with respect to the longitudinal direction of the inclined flat plate portion 3. Specifically, it extends diagonally toward the tip 6 side. In addition, you may extend diagonally toward the base end direction. The slit 14b includes a catheter introduction part 51 formed by cutting out the proximal end side of the slit 14b, a slit main body 52 that is continuous with the introduction part 51 and extends at substantially the same width, and a rounded slit end part 53. I have. The catheter introduction part 51 is formed by a notch part 54.

And in the penetration tool 1 of this embodiment, the first slit 14a and the second slit 14b are slightly different in size (length). As shown in FIG. 3, the first slit 14a is longer and wider than the second slit 14b. Thus, by providing slits having different sizes, it is possible to select the slit to be used in accordance with the outer diameter of the catheter to be used.

The width of the

slits

14a and 14b is preferably 0.30 to 0.90 mm, and particularly preferably 0.40 to 0.70 mm. The length of the

slits

14a and 14b is preferably 1.0 to 3.5 mm, and particularly preferably 2.0 to 3.0 mm. In the case where a plurality of slits having different widths and lengths are provided as described above, the difference in width between the first slit 14a and the second slit 14b is preferably 0.05 to 0.50 mm. 0.10 to 0.30 mm, and the difference in length is preferably 0.5 to 1.5 mm, particularly preferably 0.5 to 1.0 mm. The angle of the slit is preferably 30 to 90 degrees, particularly preferably 40 to 60 degrees, with respect to the axial direction of the main body.
The slit starting ends of the first slit 14a and the second slit 14b facing the

notches

44 and 54 forming the

catheter introduction portions

41 and 51 are rounded or open at a shallow angle. This prevents damage to the catheter inserted into the slit and facilitates insertion into the slit.

The other end of the rod-like main body 2 is provided with a flat plate portion inclined surface confirmation marker 5 that can be confirmed by a tactile sensation provided on the surface on the inclined direction side of the inclined flat plate portion 3.
In the subcutaneous penetration tool 1 of this embodiment, the marker 5 is a central portion of the rod-shaped main body 2 (specifically, a predetermined length proximal side from one end 21 of the rod-shaped main body 2 and a predetermined length from the other end 22 as well. It is formed by the recessed part provided in the position which becomes a front end side. In particular, the marker 5 of this embodiment is a recess having a flat bottom surface. Like the marker 5 in this embodiment, it is easy to pull the subcutaneous penetrating device 1 toward the hand side (the other end side) by having a depression that allows a finger to be placed on the other end side of the rod-like main body portion 2. It will be a thing.

In addition, since the one end side of the marker 5 has a dent for placing a finger, the operation of pushing the subcutaneous penetration tool 1 toward the distal end side (one end side) becomes easy. In addition, although the recessed part which has the above-mentioned one end and other end is preferable, as the marker 5, the other end may reach the other end of a rod-shaped main-body part. Moreover, the surface which becomes the inclined surface side of an inclination flat plate part may become a flat surface, and the marker 5 may be formed in the flat surface at the other end part of the rod-shaped main-body part 2. FIG.
In addition, one end (tip) of the marker 5 is preferably located 10 to 280 mm from the tip of the rod-shaped main body 2. The other end (rear end) of the marker 5 is preferably located 45 to 100 mm from the other end of the rod-like main body 2. The axial length of the marker 5 is preferably 30 to 100 mm. The width of the marker 5 is preferably 0.5 to 8.0 mm.

Furthermore, the other end 22 (base end) of the rod-shaped main body 2 does not have a clear edge on the outer surface, and is entirely rounded. For this reason, the living body is prevented from being damaged when the subcutaneous penetration tool 1 is operated. And since the other end 22 of the rod-shaped main-body part 2 does not have a clear edge and the whole is rounded, the other end 22 of the rod-shaped main-body part is made into the 2nd end part for in-vivo insertion. Can be used. Therefore, the subcutaneous penetration device 1 of this embodiment can be inserted from the incision portion formed in the living body from the other end 22 side.
Further, in this embodiment, the other end 22 (base end portion) of the rod-like main body portion 2 is provided with a tapered portion 22a whose diameter decreases toward the other end. For this reason, the catheter guiding subcutaneous penetration device 1 of this embodiment can be easily inserted into the living body from the other end 22 side. It should be noted that the other end of the catheter guiding subcutaneous penetrating device of all the embodiments described later may be configured as described above.

The catheter guiding subcutaneous penetration device 1 of the present invention is a rod-like body that extends almost linearly. The material for forming the catheter guiding subcutaneous penetration device 1 may be any material that has a certain level of strength and does not exhibit toxicity when inserted into a living body. For example, metals and resins can be used. Examples of the metal include stainless steel (specifically, SUS304, SUS316 of JIS G4304), pure titanium (specifically, JISH4670), titanium alloy (specifically, Ti-6Al-4V of JISH4657, ASTM-136). Ti-6Al-4V ELI) is used. The resin is preferably hard or semi-rigid and slightly bent. For example, polycarbonate, acrylic resin (polyacrylate (ex, PMMA: polymethyl methacrylate), polyacrylamide, acrylonitrile-styrene copolymer, acrylonitrile-butadiene-styrene copolymer, etc.), polyester (polyethylene terephthalate, polybutylene terephthalate), Polyolefin (polyethylene, polypropylene, ethylene-propylene copolymer), styrene resin (polystyrene, MS resin (methacrylate-styrene copolymer), MBS resin (methacrylate-butylene-styrene copolymer), polyvinyl chloride (hard vinyl chloride) Polyamide (6 nylon, 66 nylon), polysulfone, polyarylate and the like are used.

Furthermore, the catheter guiding subcutaneous penetration tool is made of a plastically deformable material, and the tilt angle of the tilted flat plate portion 3 with respect to the rod-shaped main body portion 2 may be changed during use. As a material for forming the catheter guiding subcutaneous penetration device 1, it is preferable to use a material that is plastically deformed by pressing with a certain amount of force. As such a material, for example, as a metal, stainless steel (specifically, SUS304, SUS316, etc. of JISG4304), as a resin, polycarbonate, acrylic resin (polyacrylate (ex, PMMA: polymethyl methacrylate), Polyacrylamide, acrylonitrile-styrene copolymer, acrylonitrile-butadiene-styrene copolymer), polyester (polyethylene terephthalate, polybutylene terephthalate), polyolefin (polyethylene, polypropylene, ethylene-propylene copolymer), MS resin (methacrylate-styrene copolymer) Polymer), MBS resin (methacrylate-butylene-styrene copolymer), polyvinyl chloride (hard vinyl chloride), polyamide (6 nylon, 66 nylon) Such as is used. The resin may be softened by heating, can be deformed at the time of softening, and retains the deformed state to some extent after cooling.

Next, the catheter guiding subcutaneous penetration tool 10 of the embodiment shown in FIGS. 5 to 8 will be described.
The catheter guide subcutaneous penetration tool 10 of this embodiment is a catheter guide subcutaneous penetration tool used to dispose the catheter 15 under the skin. The subcutaneous penetration tool 10 includes a rod-shaped main body portion 2, an inclined flat plate portion 30 provided at one end 21 of the rod-shaped main body portion 2 and formed obliquely with respect to the rod-shaped main body portion 2, and the rod-shaped main body portion 2. The marker 5 is provided at the other end and can be confirmed by a tactile sensation provided on a surface on the inclined direction side of the inclined flat plate portion 30. Further, the inclined flat plate portion 30 is provided so as to pass through the inclined surface of the inclined flat plate portion 30, and the catheter insertion holding portion 4 for holding the inserted catheter and holding the inserted catheter is rounded as a whole. And a living body insertion end 6.

The catheter-guided subcutaneous penetration device 10 of the present invention is a rod-like body that extends substantially linearly. As the material for forming the catheter guiding subcutaneous penetrating device 10, those described above can be suitably used. Moreover, the inclination angle with respect to the rod-shaped main-body part 2 of the inclination flat plate part 30 may be changeable at the time of use.
The catheter-guided subcutaneous penetrating device 10 includes a rod-like main body portion 2 extending a predetermined length and an inclined flat plate portion 30 provided at one end 21 of the rod-like main body portion 2.
In the subcutaneous penetration tool 10 of this embodiment, the rod-shaped main body 2 is substantially cylindrical. The rod-shaped main body 2 may be a narrow flat plate whose upper surface and lower surface are flat surfaces, or a kamaboko shape whose only upper surface is a flat surface. The length of the rod-shaped main body 2 is preferably 100 to 350 mm, and particularly preferably 150 to 250 mm. The width of the rod-like main body 2 is preferably 3.0 to 8.0 mm, and particularly preferably 4.0 to 6.0 mm.

The inclined flat plate portion 30 is provided at one end 21 (tip) of the rod-shaped main body portion 2. The inclined flat plate portion 30 is formed obliquely at a predetermined angle with respect to the rod-shaped main body portion 2. The inclination angle of the inclined flat plate portion 30 with respect to the rod-like main body portion 2 is preferably 1 to 30 degrees, and particularly preferably 5 to 20 degrees. The length of the inclined flat plate portion 30 is preferably 15 to 100 mm, and particularly preferably 20 to 50 mm. The width of the inclined flat plate portion 30 is preferably 3.0 to 10.0 mm, and particularly preferably 4.0 to 6.0 mm. The thickness of the inclined flat plate portion 30 is preferably 1.5 to 6.5 mm, particularly preferably 2.0 to 4.0 mm.

As described above, since the inclined flat plate portion is inclined with respect to the rod-shaped main body portion, the inclined flat plate portion is easy to visually recognize, and the operation of pressing the flat plate portion, and further, the pressed flat plate portion is moved back and forth. Easy to move to. Furthermore, as shown in FIG. 11, in the state where the end portion of the catheter is mounted, the bottom surface of the catheter and the bottom surface of the rod-like main body portion can be substantially linear, and the catheter can be easily pulled.

Furthermore, the inclined flat plate portion 30 has a living body insertion end portion 6. The living body insertion end 6 does not have a clear edge on the outer surface, and is rounded as a whole. For this reason, the living body is prevented from being damaged when the subcutaneous penetration tool 10 is inserted into the living body. In particular, in the subcutaneous penetration device 10 of this embodiment, the in vivo insertion end 6 of the inclined flat plate portion 30 has a semicircular shape with the center portion protruding most. Moreover, when the rod-shaped main-body part 2 has a flat surface, it is preferable that the inclination flat plate part 30 is formed so that it may continue with the flat surface. Moreover, in the subcutaneous penetration tool 10 of this Example, the inclination flat plate part 30 is a thing wider than the rod-shaped main-body part 2, as shown in FIG. For this reason, the inclined flat plate portion is a bulging portion. The width of the inclined flat plate portion 30 is preferably 0 to 2.0 mm larger than the width of the rod-shaped main body portion 2. By using the inclined flat plate portion as such a bulging portion, the flat plate portion has a certain area, and an operation of pressing the flat plate portion and an operation of moving the pressed flat plate portion back and forth are facilitated.

Furthermore, in the subcutaneous penetrating device 10 of this embodiment, the outer surface of the base end portion of the inclined flat plate portion 30 does not have a clear edge, and the whole is rounded. By doing so, it is possible to prevent the living body from being damaged when the subcutaneous penetration tool is inserted into the living body (particularly, when it is pulled to the proximal end side).
The inclined flat plate portion 30 includes the catheter insertion holding portion 4 provided so as to penetrate the inclined surface of the inclined flat plate portion 30. In this embodiment, the catheter insertion holding part 4 has a long hole shape extending in the axial direction of the inclined flat plate part 30. And it can insert in this catheter insertion holding part 4 in the state which crushed the edge part of the catheter.

In the subcutaneous penetration device 10 of this embodiment, the catheter insertion holding portion 4 is a catheter holding hole as shown in FIG. The catheter holding hole is a through-hole penetrating with substantially the same width. Further, the catheter holding hole of this embodiment has an oval shape extending in the axial direction of the inclined flat plate portion. The catheter holding hole may have a rectangular shape or a polygonal shape, but preferably has a long hole shape extending in the axial direction of the inclined flat plate portion 30 as described above.

Further, the catheter inserted through the catheter insertion holding portion (holding hole) 4 is held by the inner surface of the catheter holding hole 4 and the inner edge of the opening. In particular, in this embodiment, the inner edge of the upper surface opening of the catheter holding hole 4 has an edge and constitutes a catheter retaining portion 7. The inner edge of the lower surface opening of the catheter holding hole 4 may also have an edge. Further, as shown in FIG. 7, the catheter holding hole 4 is preferably formed so as to be substantially orthogonal to the inclined surface. By doing so, it is possible to reliably prevent the end of the catheter inserted through the catheter holding hole 4 from being detached.

Furthermore, as the catheter insertion holding portion (holding hole), the upper surface of the inclined flat plate portion 30a is similar to the catheter holding hole 4a provided in the inclined flat plate portion 30a of the catheter guiding subcutaneous penetration device 10a of the embodiment shown in FIG. The width may narrow toward the side. By setting it as such, it can prevent reliably the detachment | leave of the edge part of the catheter inserted in the catheter holding hole. Also in the holding hole 4a of this embodiment, it is preferable that the opening inner edge of the catheter holding hole 4a, particularly the opening inner edge 7a on the upper surface side of the inclined flat plate portion 30a having a narrow width, has an edge. Note that the catheter holding hole may have a width that becomes narrower toward the lower surface side of the inclined flat plate portion 30a, contrary to that shown in FIG.

Further, as the catheter insertion holding portion (holding hole), like the catheter holding hole 4b provided in the inclined flat plate portion 30b of the catheter guiding subcutaneous penetration device 10b of the embodiment shown in FIG. The protrusion part 8 may be provided on the inner surface of the part. In particular, the catheter holding hole 4b of this embodiment is gradually narrower toward the protruding portion 8 than the upper and lower surfaces of the inclined flat plate portion 30b. By setting it as such, the detachment | leave of the edge part of the catheter inserted in the catheter holding hole 4b can be prevented reliably. In the holding hole 4b of this embodiment, it is preferable that the protruding portion 8 has an edge. Moreover, it is preferable that the opening inner edge of the catheter holding hole 4b also has an edge.

Furthermore, in all the embodiments described above, as the catheter insertion holding portion (holding hole), the catheter holding hole 4c included in the inclined flat plate portion 30 of the catheter guiding subcutaneous penetration device 10f of the embodiment shown in FIG. The thing of such a shape may be sufficient. As described above, the holding hole 4c includes a circular catheter insertion base end portion and a catheter holding portion that protrudes in the distal direction from the base end portion and narrows toward the distal end. It has become. In this embodiment, the tip end of the holding hole 4c is a vertex portion that abruptly approaches.

In all the embodiments described above, the catheter insertion holding portion (holding hole) is like the catheter holding hole 4d provided in the inclined flat plate portion 30 of the catheter guiding subcutaneous penetration device 10g of the embodiment shown in FIG. It may be of any shape. Similarly to the holding hole 4c described above, the holding hole 4d protrudes in the distal direction from the base end portion for inserting the catheter formed in a circular shape, and has a width based on the base end portion. The catheter holding part is smaller than the inner diameter of the end part. And the catheter holding | maintenance part becomes a thing a little narrow toward the front-end | tip direction. In this embodiment, the tip of the holding hole 4d is a flat portion.

And the other end part of the rod-shaped main-body part 2 is provided with the marker 5 which can be confirmed by the tactile sense provided in the surface used as the inclination direction side of the inclination flat plate part 30. As shown in FIG. In the subcutaneous penetration device 10 of this embodiment, the marker 5 is formed by a recess provided at a position slightly on one end side (front end side) from the other end 22 (rear end) of the rod-shaped main body portion 2. In particular, the marker 5 of this embodiment is a recess having a flat bottom surface. Like the marker 5 in this embodiment, it is easy to pull the subcutaneous penetrating device 10 to the proximal side (the other end side) by having a depression that allows a finger to be put on the other end side of the rod-shaped main body 2. It will be a thing. In addition, since there is a depression on one end side of the marker 5 where a finger can be put, the operation of pushing the subcutaneous penetration tool 10 toward the distal end side (one end side) is also easy.
In addition, although the recessed part which has the above-mentioned one end and other end is preferable, as the marker 5, the other end may reach the other end of a rod-shaped main-body part. Moreover, the surface which becomes the inclined surface side of an inclination flat plate part may become a flat surface, and the marker 5 may be formed in the flat surface at the other end part of the rod-shaped main-body part 2. FIG.

In addition, one end (tip) of the marker 5 is preferably located 10 to 280 mm from the tip of the rod-shaped main body 2. The other end (rear end) of the marker 5 is preferably located 45 to 100 mm from the base end of the rod-like main body 2. The axial length of the marker 5 is preferably 30 to 100 mm. The width of the marker 5 is preferably 0.5 to 8.0 mm.
Furthermore, the other end 22 (base end) of the rod-shaped main body 2 does not have a clear edge on the outer surface, and is entirely rounded. For this reason, the living body is prevented from being damaged when the subcutaneous penetration tool 10 is operated. And since the other end 22 of the rod-shaped main-body part 2 does not have a clear edge and the whole is rounded, the other end 22 of the rod-shaped main-body part is made into the 2nd end part for in-vivo insertion. Can be used. Therefore, the subcutaneous penetration device 10 of this embodiment can be inserted from the incision portion formed in the living body from the other end 22 side.

In the catheter guide subcutaneous penetration type having the through hole as described above, the inclined flat plate portion is provided in the catheter guide subcutaneous penetration tool 10c shown in FIG. 12, FIG. 13 and FIG. There may be.
The inclined flat plate portion 30c provided in the catheter guiding subcutaneous penetrating device 10c of this embodiment is thinner than the subcutaneous penetrating device 10 of the above-described embodiment. The thickness of the inclined flat plate portion 30c is preferably 1.5 to 5.0 mm, particularly preferably 2.0 to 4.0 mm. The thickness of the inclined flat plate portion 30c is preferably 1.5 to 6.5 mm thinner than the thickness (or outer diameter) of the rod-like main body portion. In this way, by making the inclined flat plate portion thin, it becomes easy to insert the inclined flat plate portion portion, in other words, the distal end portion of the catheter guiding subcutaneous penetration device 10c into the living body. Further, in the catheter guiding subcutaneous penetration device 10c of this embodiment, the top surface 21a of the distal end portion of the rod-like main body portion 2 connected to the inclined flat plate portion 30c is inclined. For this reason, the inclined flat plate portion 30c and the rod-like main body portion 2 do not have a step. Therefore, it is easy to insert not only the inclined flat plate portion 30c but also the distal end portion of the rod-shaped main body portion 2 into the living body.

In all of the above-described embodiments, the marker for the catheter guiding subcutaneous penetration device of the present invention may be in the form of the catheter guiding subcutaneous penetration device 10d shown in FIGS.
In the subcutaneous penetration tool 10d of this embodiment, the marker 5a is composed of a plurality of convex portions protruding from the surface of the rod-like main body portion 2 on the inclined flat plate portion side. In particular, the marker 5 a is configured by a plurality of convex portions having a plurality of predetermined widths extending in a direction orthogonal to the axial direction of the rod-shaped main body portion 2. In the illustrated embodiment, a plurality (specifically, four) linear convex portions are provided so as to be substantially parallel.

In all the above-described embodiments, the marker for the catheter guiding subcutaneous penetration device of the present invention may be in the form of the catheter guiding subcutaneous penetration device 10e shown in FIG.
In the subcutaneous penetration device 10e of this embodiment, the marker 5b is formed by an etching portion provided on the surface of the rod-shaped main body 2 on the inclined flat plate portion side. As an etching part, a knurled shape or a satin-like shape is preferable.

Next, the operation of the catheter guiding subcutaneous penetration device of the present invention will be described with reference to FIGS. Here, the catheter guiding subcutaneous penetration tool 10 will be described as the catheter guiding subcutaneous penetration tool. The same applies to the case where the catheter guiding subcutaneous penetration device of another embodiment is used.
First, as shown in FIG. 20, the first incision portion 11 is provided in the skin of the patient 20, and one end 15a of the catheter 15 is inserted into a target site (for example, a central vein). Then, the other end portion 15b side of the catheter 15 is exposed from the incision portion 11 to the outside of the body. Subsequently, as shown in FIG. 21, a second incision 12 is formed below the first incision 11 by a predetermined distance. Then, the catheter guide subcutaneous penetrating device 10 of the present invention is inserted from the distal end side of the inclined flat plate portion 30 through the second incision portion and pushed toward the first incision portion 11. Then, as shown in FIG. 22, the inclined flat plate portion 30 of the catheter guiding subcutaneous penetration device 10 is exposed to the outside from the first incision portion.

Subsequently, the other end portion 15 b of the catheter 15 is inserted through the catheter holding hole 4 of the inclined flat plate portion 30 of the subcutaneous penetrating device 10, and the inclined flat plate portion 30 of the subcutaneous penetrating device 10 holds the other end portion 15 b of the catheter 15. State Then, as shown in FIG. 23, while confirming using the marker 5 that the inclined flat plate portion 30 is on the front side of the patient 20, as shown in FIG. Tow toward 12 By continuing this traction, as shown in FIG. 23, the other end portion 15 b of the catheter 15 is exposed to the outside of the body from the second incision portion 12 together with the inclined flat plate portion 30 of the subcutaneous penetration device 10. . Then, the subcutaneous penetration tool 10 is separated from the catheter 15 by cutting the exposed catheter 15 at an appropriate position of the proximal end portion. Then, for example, a chemical solution injection member (not shown) is connected to the cut end of the catheter 15, and then the chemical solution injection member is inserted into the living body through the second incision portion 12. Then, by sewing the

incisions

11 and 12, the catheter and the drug solution injecting member are completed.

The catheter guiding subcutaneous penetration device of the present invention is as follows.
(1) A catheter-guided subcutaneous penetration device used for placing a catheter under the skin, wherein the subcutaneous penetration device is provided at a rod-shaped main body portion and one end of the rod-shaped main body portion, and the rod-shaped main body portion. And a tactile sensation provided on a portion of the rod-like main body portion on the inclined direction side of the inclined flat plate portion and a portion on the other end side of the predetermined distance from the one end. A flat plate portion inclined surface confirmation marker that can be confirmed, and the inclined flat plate portion is provided so as to penetrate the inclined surface of the inclined flat plate portion, and the inserted catheter is capable of being inserted into the catheter. A catheter-guided subcutaneous penetration device having a catheter insertion-holding portion to be held and an in-vivo insertion end portion that is rounded as a whole.

This catheter guiding subcutaneous penetration device can be inserted into the catheter and has a catheter insertion holding portion for holding the inserted catheter, so that the catheter can be easily connected. In addition, since the inclined flat plate portion is inclined with respect to the rod-shaped main body portion, the inclined flat plate portion is easy to visually recognize, and the operation of pressing the flat plate portion, and further, the pressed flat plate portion is moved back and forth. Easy. Furthermore, in the state where the end portion of the catheter is mounted, the bottom surface of the catheter and the bottom surface of the rod-like main body portion can be substantially linear, and the catheter can be easily pulled. Furthermore, since the inclined flat plate portion has a rounded end portion for insertion into the living body, it is less likely to damage the living body when the subcutaneous penetration device is inserted into the living body.

And as an embodiment of the catheter penetration subcutaneous penetration device, the following may be sufficient.
(2) The catheter guiding subcutaneous penetration device according to (1), wherein the inclined flat plate portion is thinner than the rod-shaped main body portion.
(3) The catheter guiding subcutaneous penetration device according to (1) or (2), wherein the inclined flat plate portion is wider than the rod-shaped main body portion.
(4) The catheter guide subcutaneous penetrating device according to any one of (1) to (3), wherein an inclination angle of the inclined flat plate portion with respect to the rod-shaped main body portion is 1 to 30 degrees.
(5) The catheter guiding and holding device according to any one of (1) to (4), wherein the catheter insertion holding portion is a catheter holding hole or a catheter holding slit.
(6) The catheter guiding subcutaneous penetration device according to (5), wherein the catheter holding hole and the catheter holding slit are formed so as to be substantially orthogonal to the inclined surface.
(7) The catheter guiding and holding device according to any one of (1) to (6), wherein the catheter insertion holding portion includes a catheter retaining portion.
(8) The catheter guiding subcutaneous penetration tool is formed of a plastically deformable material, and the tilt angle of the tilted flat plate portion with respect to the rod-shaped main body portion can be changed during use. ), A catheter-guided subcutaneous penetration device.
(9) The catheter guiding subcutaneous penetration device according to any one of (1) to (8), wherein the marker is a recess.
(10) The catheter guiding subcutaneous penetration device according to any one of (1) to (9), wherein the marker is a recess, and an outer edge of the recess is chamfered or rounded.
(11) The catheter guiding subcutaneous penetration device according to any one of (1) to (8), wherein the marker is a convex portion or an etched portion.
(12) The catheter guide subcutaneous penetration according to any one of (1) to (11), wherein the other end of the rod-shaped main body portion is a second rounded end portion for insertion into a living body. Tools.
(13) The catheter-guided subcutaneous penetration device according to (12), wherein the second end portion for insertion into a living body is provided with a tapered portion whose diameter is reduced toward the other end.

Claims

A catheter-guided subcutaneous penetration device used for placing a catheter under the skin,
The subcutaneous penetration tool includes a rod-like main body portion, an inclined flat plate portion provided at one end of the rod-like main body portion and formed obliquely with respect to the rod-like main body portion, and the inclined flat plate of the rod-like main body portion. A flat plate portion inclined surface confirmation marker that can be confirmed by a tactile sensation provided on a surface that is on the inclined direction side of the portion and on the other end side of the predetermined distance from the one end, and the inclined flat plate portion, A catheter insertion holding portion that is provided so as to penetrate through the inclined surface of the inclined flat plate portion, holds the inserted catheter, and has a rounded end portion for in vivo insertion; A catheter-guided subcutaneous penetration device.
The catheter penetration subcutaneous penetration device according to claim 1, wherein the inclined flat plate portion is thinner than the rod-shaped main body portion.
The catheter-guided subcutaneous penetration device according to claim 1, wherein the inclined flat plate portion is wider than the rod-shaped main body portion.
The catheter penetration subcutaneous penetration device according to any one of claims 1 to 3, wherein an inclination angle of the inclined flat plate portion with respect to the rod-shaped main body portion is 1 to 30 degrees.
The catheter guiding subcutaneous penetration device according to any one of claims 1 to 4, wherein the catheter insertion holding portion is a catheter holding hole or a catheter holding slit.
The catheter guiding subcutaneous penetration device according to claim 5, wherein the catheter holding hole and the catheter holding slit are formed so as to be substantially orthogonal to the inclined surface.
The catheter guiding and holding device according to any one of claims 1 to 6, wherein the catheter insertion holding portion includes a catheter retaining portion.
The said catheter penetration subcutaneous penetration tool is formed of a plastically deformable material, and can change the inclination angle with respect to the said rod-shaped main-body part of the said inclination flat plate part at the time of use. Subcutaneous penetration tool for catheter guidance.
The catheter guide subcutaneous penetration device according to any one of claims 1 to 8, wherein the marker is a recess.
The catheter guiding subcutaneous penetration device according to any one of claims 1 to 9, wherein the marker is a recess, and an outer edge of the recess is chamfered or rounded.
The catheter guiding subcutaneous penetration device according to any one of claims 1 to 8, wherein the marker is a convex portion or an etched portion.
The catheter-guided subcutaneous penetration device according to any one of claims 1 to 11, wherein the other end of the rod-shaped main body portion is a second rounded end portion for insertion into a living body.
13. The catheter-guided subcutaneous penetration device according to claim 12, wherein the second end portion for insertion into a living body is provided with a tapered portion whose diameter decreases toward the other end.