WO2021192284A1

WO2021192284A1 - Drug solution injection needle system

Info

Publication number: WO2021192284A1
Application number: PCT/JP2020/014252
Authority: WO
Inventors: 智春小磯; 綾季星田; 毅町野; 佐藤　明; 伸行村越
Original assignee: 日本ライフライン株式会社
Priority date: 2020-03-27
Filing date: 2020-03-27
Publication date: 2021-09-30
Also published as: JP7373055B2; JPWO2021192284A1

Abstract

The present invention aims to provide a drug solution injection needle system capable of reliably injecting a drug solution into a cardiac muscle layer. This system comprises: a catheter (60) having a tip electrode (63); and a hollow drug solution injection needle (100) that is inserted into the lumen of a catheter shaft, causes a tip section to extend from an opening in the tip electrode, and punctures the cardiac muscle layer of a patient. The drug solution injection needle comprises a metal tip member (10), an insulating connecting tube (20), a metal tube (30), and an insulating layer (40) that covers the outer circumferential surface of a base end section (32) of the metal tube. A side hole (25) that passes through a cavity in the needle and opens to the outer circumferential surface of the connecting tube is formed in the connecting tube. An electrode comprises a tip section (31) of the metal tube that is not covered by the insulating layer. The system comprises a notification means (80) that notifies an operator that drug solution can be injected into the cardiac muscle layer when a first potential measured by the tip electrode in the catheter is at least a first threshold value and a second potential measured the electrode in the drug solution injection needle is at least a second threshold value.

Description

Chemical injection needle system

The present invention relates to a drug solution injection needle system including a drug solution injection needle for puncturing the myocardium of a patient and injecting the drug solution.

In recent years, a treatment method for regenerating cardiomyocytes has been performed by directly administering a drug solution such as a myocardial regenerating cell preparation to cardiomyocytes that are losing their functions due to myocardial infarction or the like.
In addition, in order to identify a target site requiring medication treatment prior to treatment and to confirm the treatment result, the electrical activity of the heart is measured and mapped by a mapping catheter.

In order to directly administer to cardiomyocytes, a hollow needle (medicine solution injection needle) that punctures the patient's myocardium and injects the drug solution is used (see Patent Document 1 below).

This drug solution injection needle is introduced into the living body cavity (heart chamber) while being inserted into the sheath or guiding catheter, and when the tip of the sheath or guiding catheter reaches the vicinity of the target site, the drug solution is opened through the tip opening. The needle tip of the injection needle is projected and punctured at the target site (myocardium) to administer the drug solution to cardiomyocytes.

International Publication No. 99/49926

Therefore, in the case of medication treatment using a drug solution injection needle, it is important to reliably administer the drug solution to the patient's cardiomyocytes. It is necessary that the opening is located in the myocardium.

However, it is not easy to confirm whether or not the opening of the drug solution injection needle is located in the myocardium.
For example, like the drug solution injection needle described in Patent Document 1, even if a radiation opaque band or the like is placed on the needle tip and the position of the needle tip is to be confirmed by a cine image, the shape of the heart wall is determined by the cine image. Since it cannot be grasped, it is difficult to distinguish whether the needle tip is located inside the heart wall (myocardium) or outside the heart wall (heart chamber).

Further, even if the needle tip (the opening) of the drug solution injection needle is positioned in the myocardium, the needle tip may come off from the myocardium due to the beating of the heart or the like.

The present invention has been made based on the above circumstances.
An object of the present invention is that the opening for injecting a drug solution is located inside the heart wall (myocardium), and it can be easily recognized that the needle tip including the opening is difficult to come out of the myocardium, and the myocardium. It is an object of the present invention to provide a drug solution injection needle system capable of reliably injecting a drug solution.

(1) The drug solution injection needle of the present invention includes an electrode catheter having a shaft on which at least one lumen is formed, and a tip electrode attached to the tip of the shaft and having a through hole communicating with the lumen.
A drug solution is punctured into the myocardium of a patient by being inserted into the lumen of the shaft constituting the electrode catheter and the through hole of the tip electrode and extending the tip portion from the tip opening of the through hole. A drug solution injection needle system with a hollow drug solution injection needle for injecting.
The chemical injection needle has a sharp metal tip member and
An electrically insulating connecting pipe connected to the base end side of the tip member,
A metal pipe connected to the base end side of the connecting pipe and
An insulating layer that covers the outer peripheral surface of the base end portion of the metal tube is provided.
The connecting tube and / or the tip member is formed with at least one hole that communicates with the lumen of the needle and opens to the outer surface of the connecting tube or the tip member.
The tip portion of the metal tube not coated with the insulating layer constitutes an electrode for potential measurement;
When the first potential measured by the tip electrode of the electrode catheter is equal to or higher than the first threshold value and the second potential measured by the electrode of the chemical solution injection needle is equal to or higher than the second threshold value, the chemical solution is used. It is characterized by providing a notification means for notifying the operator that injection into the myocardial layer is possible.

According to the drug solution injection needle system having such a configuration, when an electrode composed of the tip portion of the metal tube constituting the drug solution injection needle is introduced into the inside of the heart wall (myocardium), it is measured by the electrode. The potential (second potential) rises sharply and becomes equal to or higher than a certain value (second threshold). Further, since this electrode (the tip portion of the metal tube) is on the proximal end side of the hole formed in the connecting tube and / or the tip member, when the electrode is introduced into the heart wall, the hole is formed. The opening (the opening for injecting the drug solution) is always located inside the heart wall.

Further, when the tip electrode constituting the electrode catheter is in contact with the heart wall, the potential (first potential) measured by the tip electrode is measured when the tip electrode is separated from the heart wall. It shows a clearly higher value (above the first threshold) than the first potential. On the other hand, when the tip electrode is in contact with the heart wall, the tip opening edge of the through hole of the tip electrode is pressing the heart wall, and in such a state, from the tip opening of the through hole. The tip portion (needle tip) of the drug solution injection needle that extends and is punctured in the myocardium does not easily come off from the myocardium even by pulsation or the like.

Therefore, the notification from the notification means made when the first potential measured by the tip electrode of the electrode catheter becomes equal to or higher than the first threshold value and the second potential measured by the electrode of the drug solution injection needle becomes equal to or higher than the second threshold value. By waiting for the injection operation of the drug solution, the drug solution can be reliably injected into the myocardial layer of the patient.

Further, since the chemical injection needle includes a metal tube and an insulating layer that covers the outer peripheral surface of the base end portion thereof, the tip portion of the metal tube can be used as an electrode of the chemical solution injection needle. The base end portion of the metal tube can be used as the lead of the electrode.
As a result, it is not necessary to separately provide a ring-shaped electrode on the outer surface of the needle or to provide an electrode lead wire inside or outside the metal tube, so that the diameter of the needle can be reduced and the inside of the needle can be reduced. Sufficient cavity space can be secured.

Further, since the metal tip member constituting the chemical injection needle and the metal tube are electrically insulated from each other by the connecting tube and the tip member does not form an electrode, the tip member and the connecting tube are inside the heart wall. Even if it is introduced into, the second potential does not rise at the stage where the tip portion (electrode) of the metal tube is not introduced.

(2) In the chemical injection needle system of the present invention, the tip of the tip member of the chemical injection needle is blocked.
The tube wall of the connecting pipe of the chemical injection needle is formed with a plurality of side holes that communicate with the lumen of the needle (the lumen of the connecting pipe) and open on the outer peripheral surface of the connecting pipe. Is preferable.

According to the drug solution injection needle system having such a configuration, the length of the tip portion, which is inferior in flexibility, is shortened in the drug solution injection needle constituting the drug solution injection needle as compared with the drug solution injection needle having a hole formed in the tip member. can do.

(3) In the chemical injection needle system of the present invention, it is preferable that the first threshold value is set in the range of 0.03 to 10 mV and the second threshold value is set in the range of 0.03 to 20 mV.

(4) In the drug solution injection needle system of the present invention, it is preferable that the electrode catheter includes a mapping electrode for measuring the electrical activity of the heart.

According to the drug solution injection needle system having such a configuration, the electrode catheter constituting the system is used as a guiding catheter for guiding the tip portion of the drug solution injection needle to the target site at the time of medication treatment, and the treatment is performed. It can be used as a mapping catheter for pre- and post-diagnosis (identification of the target site to be treated and confirmation of treatment results).

(5) In the drug solution injection needle system of the present invention, it is preferable that the drug solution is a myocardial regenerating cell preparation.

According to the drug solution injection needle system of the present invention, the opening of the hole for injecting the drug solution formed in the connecting tube and / or the tip member of the drug solution injection needle is located inside the heart wall (myocardium), and the opening is located inside the heart wall (myocardium). It can be easily recognized by the notification from the notification means that the needle tip including the needle tip is difficult to come out from the myocardium, and by waiting for the notification and performing the injection operation of the drug solution, the drug solution is injected into the myocardium. It can be reliably injected.

It is explanatory drawing which shows the schematic structure of the chemical solution injection needle system of this invention. It is a front view which shows the guiding catheter (electrode catheter), the drug solution injection needle and the gripping part thereof which constitute the drug solution injection needle system which concerns on one Embodiment of this invention. FIG. 2 is a cross-sectional view taken along the line III-III of FIG. It is a front view which shows the chemical liquid injection needle which comprises the chemical liquid injection needle system which concerns on one Embodiment of this invention. FIG. 6 is a partially enlarged front view (detailed view of the V portion) showing the tip portion of the chemical solution injection needle shown in FIG. It is a partially enlarged cross-sectional view which shows the tip part of the chemical solution injection needle shown in FIG. It is explanatory drawing which shows the state which a part of the tip member and a part of the connecting tube which make up the chemical solution injection needle shown in FIG. 4 are introduced into the inside of the heart wall. It is explanatory drawing which shows the state which the tip part (electrode) of the metal tube which constitutes the chemical solution injection needle shown in FIG. 4 is introduced into the inside of a heart wall. It is a flowchart which shows the process by the notification means which comprises the chemical solution injection needle system which concerns on one Embodiment of this invention. It is explanatory drawing which shows the use mode of the chemical solution injection needle system of this invention. It is a perspective view which shows the tip part in the modified example of a chemical solution injection needle. It is a partially enlarged cross-sectional view which shows the tip part in the modification of the chemical solution injection needle.

The chemical injection needle system 200 of the present embodiment shown in FIGS. 1 to 6 includes a shaft 61 in which a central lumen 611 and sublumens 612 to 617 are formed, a control handle 62 connected to a base end of the shaft 61, and a shaft. To deflect the tip electrode 63 mounted on the tip of the 61 and having a through hole communicating with the central lumen 611, the 13 ring-shaped electrodes 64 mounted on the tip of the shaft 61, and the tip of the shaft 61. A guiding catheter (electrode catheter) 60 having the operating

wires

651 and 652 of the
The patient's myocardium is inserted through the central lumen 611 of the shaft 61 constituting the guiding catheter 60 and the through hole of the tip electrode 63, and the tip portion (needle tip) is extended from the tip opening of the through hole. A hollow drug solution injection needle 100 for puncturing the layer and injecting the drug solution,
It is provided with a grip portion 50 of the chemical injection needle attached to the proximal end side of the metal tube 30 constituting the chemical injection needle 100.

The chemical injection needle 100 constituting the chemical injection needle system 200 includes a sharp metal tip member 10 whose tip is closed, and an electrically insulating connecting tube 20 connected to the proximal end side of the tip member 10. A metal pipe 30 connected to the base end side of the connecting pipe 20 and an insulating layer 40 covering the outer peripheral surface of the base end portion 32 of the metal pipe 30 are provided. Ten side holes 25 (251 to 259, 25X) that communicate with the cavity and open on the outer peripheral surface of the connecting pipe 20 are formed, and the potential is formed by the tip portion 31 of the metal pipe 30 that is not covered with the insulating layer 40. An electrode for measurement is configured.

This chemical injection needle system 200 further
A heart to which a potential (first potential) measured by the tip electrode 63 of the guiding catheter 60 and a potential (second potential) measured by the electrode of the drug solution injection needle 100 (tip 31 of the metal tube 30) are input. Potential meter 70 and
An indifferent electrode 72 connected to the electrometer 70 and placed in the body (vena cava) of patient P,
When the first potential input to the electrocardiograph 70 is equal to or higher than the set first threshold value and the second potential input to the electrocardiograph 70 is equal to or higher than the second threshold value, the myocardium is reached. It is provided with a notification means 80 for notifying the operator OP that the chemical solution can be injected (injecting operation is permitted).

The drug solution injection needle system 200 of the present embodiment includes a guiding catheter 60, a drug solution injection needle 100, a grip portion 50 of the drug solution injection needle, an electrometer 70, an indifferent electrode 72, and a notification means 80. ing.

The guiding catheter 60 constituting the drug solution injection needle system 200 is an electrode catheter that guides the tip portion of the drug solution injection needle 100 to the heart chamber H of the patient P, and precedes the tip portion so as to be located in the vicinity of the target site. Will be inserted.

As shown in FIG. 2, the guiding catheter 60 includes a shaft 61, a control handle 62, a tip electrode 63, and 13 ring-shaped electrodes 64.
The tip portion of the shaft 61 constituting the guiding catheter 60 has flexibility, and the tip portion can be bent (bent) by a tip deflection operation.

As shown in FIG. 3, the shaft 61 is formed with a central lumen 611 and sublumens 612 to 617.
A chemical injection needle 100 is inserted through the central lumen 611 of the shaft 61, and operating

wires

651 and 652 for performing a tip deflection operation are inserted through the

sub-lumens

612 and 615, respectively.
Conductors (not shown) of the tip electrode 63 or the ring-shaped electrode 64 are inserted through the

sublumens

613, 614, 616 and 617 of the shaft 61.

The outer diameter of the shaft 61 is usually 1 to 5 mm, and a suitable example is 2.4 mm.
The effective length of the shaft 61 (L61 shown in FIG. 2) is usually 600 to 2300 mm, and a suitable example is 1100 mm.

The control handle 62 connected to the base end of the shaft 61 includes a handle body 621 and a rotation operation unit 622.

The handle body 621 is provided with an injection needle insertion port 66 for inserting the chemical injection needle 100 into the central lumen 611 of the shaft 61, and the lead wires of the tip electrode 63 and the ring-shaped electrode 64 are connected to each other. A connector 69 having a terminal is attached.
In FIG. 2, 67 is a hemostatic valve, and 68 is a side injection tube connected to the hemostatic valve 67 to flush the central lumen 611 of the shaft 61.

As shown in FIGS. 1 and 2, the drug solution injection needle 100 is inserted into the injection needle insertion port 66 provided in the handle body 621 via the hemostatic valve 67.
Further, the connector 69 attached to the handle body 621 is connected to the catheter connection connector 75 of the electrometer 70.

As shown in FIG. 3, the base ends of the

operation wires

651 and 652 for performing the tip deflection operation are fixed to the rotation operation unit 622.
The tips of the operating

wires

651 and 652 are fixed to the inner wall of the tip of the shaft 61, for example, with the central shaft of the shaft 61 interposed therebetween.

By rotating the rotation operation unit 622 in the direction shown by the arrow A1 in FIG. 2, the operation wire 651 is pulled, and the tip portion of the shaft 61 can be bent in the direction shown by the arrow A in the figure.
By rotating the rotation operation unit 622 in the direction shown by the arrow B1 in FIG. 2, the operation wire 652 is pulled, and the tip portion of the shaft 61 can be bent in the direction shown by the arrow B in the figure.

A tip electrode 63 is attached to the tip of the shaft 61. The tip electrode 63 is formed with a through hole communicating with the central lumen 611 of the shaft 61 along the axial direction.
The tip electrode 63 measures a first potential that serves as a basis for determining whether or not the tip electrode 63 is in contact with the heart wall.
Here, the first potential measured by the tip electrode 63 in contact with the heart wall is clearly compared with the first potential measured by the tip electrode 63 in a state of being separated from the heart wall. Shows a high value.

Thirteen ring-shaped electrodes 64 are attached to the tip of the shaft 61.
These ring-shaped electrodes 64 serve as mapping electrodes for measuring the electrical activity of the heart in order to identify the target site to be treated and confirm the treatment result before and after the medication treatment by the drug solution injection needle system 200 of the present embodiment. used.
The tip electrode 63 may be used as a mapping electrode before and after the medication treatment.

<Chemical solution injection needle 100>
The chemical injection needle 100 constituting the chemical injection needle system 200 of the present embodiment includes a metal tip member 10, an electrically insulating connecting pipe 20, a metal pipe 30, and an insulating layer 40.

As shown in FIG. 4, a grip portion 50 is attached to the proximal end side of the metal tube 30 constituting the chemical injection needle 100.

The effective length of the chemical injection needle 100 (L100 shown in FIG. 4) protruding from the tip of the grip portion 50 is usually 800 to 2500 mm, and a suitable example is 1300 mm.
The outer diameter of the chemical injection needle 100 is usually 0.3 to 1.5 mm, and a suitable example is 0.8 mm.
The inner diameter of the chemical injection needle 100 is usually 0.1 to 1.3 mm, and a suitable example is 0.6 mm.

The drug solution injection needle 100 is a hollow needle for puncturing the myocardium of a patient and injecting the drug solution into cardiomyocytes.
Here, examples of the "drug solution" include cell preparations such as myocardial regenerative cell preparations and gene transfer agents.

As shown in FIG. 6, the tip member 10 constituting the chemical injection needle 100 is a metal member composed of a solid sharp portion 11 and a tubular portion 12 having an internal space, and is a metal member of the tip member 10. The tip is obstructed.

The length of the tip member 10 (L10 shown in FIG. 5) is usually 0.5 to 5 mm, and a suitable example is 2.5 mm.
If the length of the tip member 10 is too short, the puncture performance may be impaired or the joint strength with the connecting pipe 20 may be lowered.
On the other hand, if the length of the tip member 10 is too long, the blood vessel followability of the drug solution injection needle 100 is impaired, or the tip portion 31 (electrode) of the connecting tube 20 and the metal tube 30 connected to the proximal end side thereof is impaired. It may be difficult to introduce into the myocardium.

As the metal constituting the tip member 10, any metal conventionally known as a metal constituting the chemical injection needle can be used, and examples thereof include stainless steel, NiTi, β-titanium, and platinum iridium.

Further, a part or all of the tip member 10 may be made of a radiation opaque metal, whereby the position of the tip member 10 up to the target portion can be confirmed by a cine image. Examples of the radiation opaque metal include platinum and its alloys, gold, tungsten, tantalum and the like.

The connecting pipe 20 constituting the chemical injection needle 100 is made of an electrically insulating material, and is a member that connects the tip member 10 and the metal pipe 30 while ensuring the electrical insulating properties of both.

The mode of connecting the tip member 10 and the metal pipe 30 via the connecting pipe 20 is not particularly limited, but in the present embodiment, as shown in FIG. 6, the tip-side small diameter portion of the connecting pipe 20 21 is inserted into the internal space of the tip member 10 (tubular portion 12), and the proximal end side small diameter portion 22 of the connecting tube 20 is inserted into the tip opening of the metal tube 30 to form the tip member 10 and the metal tube 30. Are connected.
As shown in FIG. 6, the lumen of the connecting tube 20 and the lumen of the metal tube 30 communicate with each other to form the lumen of the drug solution injection needle 100.

The length of the connecting pipe 20 (L20 shown in FIG. 5) is usually 0.1 to 25 mm, and a suitable example is 14 mm.

If the length of the connecting pipe 20 is too short, the tip member 10 and the metal pipe 30 may not be sufficiently insulated.
On the other hand, if the length of the connecting pipe 20 is too long, the blood vessel followability at the tip portion of the drug solution injection needle 100 may be impaired.

The electrically insulating material constituting the connecting pipe 20 is not particularly limited, but a resin material and a ceramic material are preferable, and the resin material is selected because it has good electrical insulation and heat insulating properties and is easy to mold. It is particularly preferable to use it.

The resin constituting the connecting pipe 20 may be a thermoplastic resin or a thermosetting resin. In addition, the resin includes ebonite. Specifically, cyclic olefin resin, polyphenylene sulfide, polyetheretherketone (PEEK), polybutylene terephthalate, polycarbonate, polyamide, polyacetal, modified polyphenylene ether, polyester resin, polytetrafluoroethylene, fluorine resin, sulfone type. Resin, polyetherimide, polyethersulfone, polyetherketone, polyetherlactone, liquid crystal polyester, polyamideimide, polyimide, polyethernitrile, polypropylene, polyethylene; epoxy resin, unsaturated polyester resin, phenol resin, urea resin, melamine resin , Polyetherketone and the like. Of these, polyetheretherketone, polycarbonate, polyphenylsulfone, polyamide, polyacetal and the like are preferable.

The connecting pipe 20 has 10 side holes 25 (251) that communicate with the lumen of the connecting pipe 20 (chemical injection needle 100) and open on the outer peripheral surface of the connecting pipe 20 as an outflow path for the chemical solution to be injected. ~ 259,25X) is formed.

As shown in FIGS. 5 and 6, the first side hole group by the side holes 251, 252 and 253, the second side hole group by the side holes 254 and 255, and the third side hole group by the side holes 256, 257 and 258. The side hole group and the fourth side hole group formed by the side holes 259 and 25X are arranged at equal angles (90 °) along the circumferential direction of the connecting pipe 20.
As a result, the drug solution can be injected evenly in the axial direction of the connecting tube 20 (the wall thickness direction of the myocardium) and the circumferential direction of the connecting tube 20.

As for the diameter of each side hole in the first side hole group, the side hole 251 located on the tip side has the largest diameter, the side hole 252 located in the middle next has a large diameter, and the side hole 253 located on the base end side has a large diameter. It is the minimum.
The diameter of each side hole in the second side hole group is larger than that of the side hole 254 located on the distal end side and the side hole 255 located on the proximal end side.
As for the diameter of each side hole in the third side hole group, the side hole 256 located on the tip side is the largest, the side hole 257 located in the middle is the next largest, and the side hole 258 located on the base end side is large. It is the minimum.
The diameter of each side hole in the fourth side hole group is larger than the side hole 25X in which the side hole 259 located on the distal end side is located on the proximal end side.
In this way, by making the diameter of the side hole located on the distal end side larger than the diameter of the side hole located on the proximal end side, the amount of the chemical solution discharged is equalized among the side holes in the same side hole group. It is possible to inject the drug solution more evenly in the axial direction of the connecting tube 20 (the wall thickness direction of the myocardium).

To give an example of the diameter of the side hole 25 (251 to 259, 25X), the side hole 251 and the side hole 256 are 0.27 mm, the side hole 252 and the side hole 257 are 0.23 mm, and the side hole 253 and the side hole 258 are. It is 0.20 mm, the side hole 254 and the side hole 259 are 0.30 mm, and the side hole 255 and the side hole 25X are 0.25 mm.

The metal tube 30 constituting the chemical injection needle 100 is made of a tubular member having a lumen communicating with the lumen of the connecting tube 20.
The length of the metal tube 30 (L100-L10-L20) is usually 800 to 2500 mm, and a suitable example is 1300 mm.
The metal tube 30 is required to have the rigidity (particularly flexural rigidity) and elasticity (particularly bending elasticity) required for a normal chemical injection needle.
Examples of the metal constituting the metal tube 30 include the same metal as the tip member 10. Further, a part or all of the tip portion 31 of the metal tube 30 may be made of a radiation-impermeable metal, whereby the position of the electrode up to the target portion can be confirmed by a cine image.

As shown in FIG. 4, a spiral slit 33 is formed in the tip region of the proximal end portion 32 of the metal tube 30. As a result, the rigidity of the metal tube 30 in the tip region is weakened to some extent to impart flexibility (flexibility), and the chemical injection needle 100 has excellent blood vessel followability and can easily form a blood vessel shape to reach the target site. Can be made to follow.
The slit 33 is a through slit extending from the outer peripheral surface to the inner peripheral surface of the metal tube, but the slit may be formed so as not to reach the inner peripheral surface.

The length of the slit 33 (L33 shown in FIG. 4) formed in the tip region of the base end portion 32 is usually 30 to 400 mm, and a suitable example is 100 mm.

The pitch of the slit 33 is formed so as to be continuously narrowed toward the tip end. As a result, the rigidity of the tip region of the proximal end portion 32 can be continuously (smoothly) lowered toward the tip end direction, thereby improving the operability when introducing the chemical solution injection needle 100 to the target site. be able to. However, all the slits formed in the tip region of the proximal end portion may be formed at the same pitch.

The insulating layer 40 constituting the chemical injection needle 100 is a layer made of an electrically insulating material that covers the outer peripheral surface of the base end portion 32 of the metal tube 30.
By covering the outer peripheral surface of the base end portion 32 of the metal tube 30 with the insulating layer 40, the tip portion 31 of the metal tube 30 not covered with the insulating layer 40 functions as an electrode for potential measurement, and the metal tube 30 is used. The base end portion 32 of 30 functions as a lead of the electrode.
As a result, it is not necessary to separately provide a ring-shaped electrode on the outer surface of the needle or to provide an electrode lead wire inside or outside the metal tube, so that the diameter of the chemical injection needle 100 can be reduced. Sufficient lumen space can be secured.

Further, since the insulating layer 40 can close the slit 33 formed in the tip region of the proximal end portion 32 of the metal tube 30, the liquidtightness of the chemical injection needle 100 can be ensured.

Here, the length of the tip portion 31 of the metal tube 30 that functions as an electrode (L31 shown in FIG. 5) is usually 0.1 to 4 mm (about 0.007 to 0.3% of the total length of the metal tube 30). A suitable example is 0.5 mm, which is extremely short with respect to the length of the base end portion 32 of the metal tube 30.

The insulating layer 40 is the total length (L100-L10-L20-) of the base end portion 32 of the metal tube 30.
It is not necessary to cover the outer peripheral surface extending over L31), and in the present embodiment, the region extending from the tip of the proximal end portion 32 to a certain length is covered with the insulating layer 40.
Here, the length of the region covered by the insulating layer 40 (L40 shown in FIG. 4) is usually 60 to 420 mm, and a suitable example is 120 mm.

The insulating layer 40 can be formed by shrinking the heat-shrinkable resin tube in which the base end portion 32 of the metal tube 30 is inserted inside.
Examples of the heat-shrinkable resin tube for forming the insulating layer 40 include polyethylene terephthalate (PET), a polyether blockamide copolymer resin (PEBAX (registered trademark)), and the like.

The film thickness of the insulating layer 40 is, for example, 10 to 100 μm, and a suitable example is 20 μm.

The drug solution injection needle 100 is introduced into the living body cavity (heart chamber) in a state of being inserted into the central lumen 611 of the guiding catheter 60, and the tip electrode 63 constituting the guiding catheter 60 is a heart wall surface corresponding to a target site. Or when it reaches the vicinity thereof, the needle tip of the drug solution injection needle 100 is projected from the tip opening of the through hole of the tip electrode 63 to puncture the target site (myocardium).

The electrode of the drug solution injection needle 100 composed of the tip portion 31 of the metal tube 30 serves as a basis for determining whether or not at least a part of the electrode is introduced into the inside of the heart wall (myocardium). Two potentials are measured.
Here, the second potential measured by the electrode of the drug solution injection needle 100 introduced inside the heart wall (myocardium) is measured by the electrode in a state where it is not introduced (separated from the heart wall). It shows a clearly higher value than the second potential.

FIG. 7A shows a state in which the drug solution injection needle 100 is punctured into the myocardium and a part (tip portion) of the tip member 10 and the connecting tube 20 is introduced into the heart wall.
At this stage, the rest (base end portion) of the connecting tube 20 including the region where the side hole 25 is formed is located in the heart chamber, so that even if the drug solution is injected at this stage, it leaks into the heart chamber. It comes out and the drug solution cannot be injected into the myocardium.

However, in the state shown in FIG. 7A, since the electrode (tip portion 31 of the metal tube 30) located on the proximal end side of the connecting tube 20 is located in the heart chamber, the potential measured by the electrode (the first). (2 potentials) does not rise sharply.

FIG. 7B shows that the tip member 10 and the connecting tube 20 are completely buried inside the heart wall (myocardium) by further pushing the drug solution injection needle 100, and the tip portion 31 (electrode) of the metal tube 30 on the proximal end side thereof. ) Indicates a state in which it is introduced inside the heart wall (myocardium).
At this stage, the connecting tube 20 in which the side hole 25 is formed is located in the myocardium. Therefore, if the drug solution is injected at this stage, the drug solution can be injected into the myocardium.

Then, in the state shown in FIG. 7B, when the electrode introduced into the myocardium comes into contact with the myocardial tissue, the second potential measured by the electrode rapidly rises to a certain value (second threshold value) or more. It becomes.

<Grip part>
As shown in FIGS. 1, 2 and 4, the grip portion 50 attached to the proximal end side of the chemical injection needle 100 (metal tube 30) is used to supply the chemical solution to the lumen of the chemical solution injection needle 100. Injection port 51
Is provided.
As shown in FIG. 1, an injection port 51 provided in the grip portion 50 is connected to a syringe 55 filled with a chemical solution to be supplied to the lumen of the chemical solution injection needle 100.

As shown in FIGS. 1, 2 and 4, the grip portion 50 is electrically connected to the electrode of the chemical injection needle 100 via a lead wire welded to the base end of the metal tube 30 constituting the chemical injection needle 100. The connector 53 connected to is mounted.
As shown in FIG. 1, the connector 53 connected to the electrode of the chemical injection needle 100 is connected to the injection needle connection connector 76 of the electrocardiograph 70.

<Electrometer>
The electrometer 70 constituting the chemical injection needle system 200 of the present embodiment has a first potential measured by the tip electrode 63 of the guiding catheter 60 and a second potential measured by the electrode of the chemical injection needle 100, respectively. Entered.

As shown in FIG. 1, the electrocardiograph 70 is provided with a catheter connection connector 75, an injection needle connection connector 76, and an indifferent electrode connection connector 77.

An indifferent electrode 72 arranged in the body of the patient P is connected to the indifferent electrode connection connector 77 of the electrocardiograph 70.
The indifferent electrode 72 is provided on an electrode catheter (not shown) different from the guiding catheter 60, and is arranged in the vena cava of the patient P so as not to pick up the electrocardiographic potential of the patient P.

Further, a connector 69 connected to the tip electrode 63 of the guiding catheter 60 is connected to the catheter connection connector 75 of the electrocardiograph 70.
As a result, the first potential, which is the potential between the tip electrode 63 of the guiding catheter 60 and the unrelated electrode 72, is measured, and the measured potential information is measured by the electrocardiograph via the connector 69 and the catheter connection connector 75. It is sequentially input to 70.

Further, a connector 53 connected to the electrode of the chemical injection needle 100 is connected to the injection needle connection connector 76 of the electrocardiograph 70.
As a result, the second potential, which is the potential between the electrode of the chemical injection needle 100 and the unrelated electrode 72, is measured, and the measured potential information is transmitted to the electrocardiograph 70 via the connector 53 and the injection needle connection connector 76. Is input sequentially to.

<Notification means>
The notification means 80 constituting the drug solution injection needle system 200 of the present embodiment constantly monitors the first potential and the second potential input to the electrometer 70, and the first potential input to the electrometer 70 is used. A state in which the drug solution can be injected into the myocardial layer when it is equal to or higher than the preset first threshold and the second potential input to the electrocardiograph 70 is equal to or higher than the preset second threshold. It is a means for notifying the operator OP that the injection operation is permitted.

Here, the second threshold value, which is the threshold value of the second potential measured by the electrode of the drug solution injection needle 100, is usually a value of 0.03 mV or more as a potential that ensures that the electrode is introduced into the myocardium. It is preferably set to 0.03 to 20 mV, and a suitable example is 2.0 mV.

When the second potential input to the electrocardiograph 70 is equal to or higher than the second threshold value, the electrode of the drug solution injection needle 100 is introduced into the heart wall, and the side hole 25 (251) formed in the connecting tube 20. ~ 259,25X) openings are located inside the heart wall (myocardium).

Further, the first threshold value, which is the threshold value of the first potential measured by the tip electrode 63 of the guiding catheter 60, is usually 0.03 mV or more as the potential that ensures that the tip electrode 63 is in contact with the heart wall. It is preferably set to the value of 0.03 to 10 mV, and a suitable example is 0.2 mV.

When the first potential input to the electrocardiograph 70 is equal to or higher than the first threshold value, the tip electrode 63 of the guiding catheter 60 comes into contact with the heart wall, and the tip opening edge of the through hole of the tip electrode 63 presses against the heart wall. It is in a state of being. In such a state, the tip portion (tip member 10, connecting tube 20, electrode) of the drug solution injection needle 100 extending from the tip opening of the through hole and puncturing the myocardium is myocardial due to pulsation or the like. It does not easily come out of the layer.

FIG. 8 is a flowchart showing processing by the notification means 80.
By turning on the switch of the notification means 80, the processing of the notification means 80 is started (STEP 1).

The notification means 80 determines whether or not the information related to the first potential is input to the electrocardiograph 70, proceeds to STEP3 if it is input, and ends the process if it is not input (if it is not input). STEP2).
The notification means 80 acquires the latest first potential input to the electrocardiograph 70 (STEP3), determines whether or not the acquired first potential is equal to or higher than the first threshold value, and is equal to or higher than the first threshold value. In the case, the process proceeds to STEP5, and if it is less than the first threshold value, the process returns to STEP2 (STEP4).

The notification means 80 determines whether or not the information related to the second potential is input to the electrocardiograph 70, proceeds to STEP 6 if it is input, and ends the process if it is not input (if it is not input). STEP5).
The notification means 80 acquires the latest second potential input to the electrocardiograph 70 (STEP 6), determines whether or not the acquired second potential is equal to or higher than the second threshold value, and is equal to or higher than the second threshold value. In the case, the process proceeds to STEP8, and if it is less than the second threshold value, the process returns to STEP2 (STEP7).

The notification means 80 notifies the operator OP that the drug solution can be injected into the myocardium (STEP 8). Here, the form of notification to the operator OP is not particularly limited, and is not particularly limited, such as displaying a message on a monitor or the like, lighting / blinking a lamp, a buzzer, or a voice message.

The notification means 80 returns to STEP2 to continue the process when the switch turned ON in STEP1 remains ON, and ends the process when the switch is turned OFF (STEP9).

9 (A) to 9 (D) are explanatory views showing a usage mode of the chemical solution injection needle system 200 of the present embodiment. As shown in FIGS. 9A to 9D, the drug solution injection needle 100 constituting the drug solution injection needle system 200 is introduced into the patient's heart chamber while being inserted inside the guiding catheter 60 (central lumen). Has been done.

In the state shown in FIG. 9A, the tip electrode 63 of the guiding catheter 60 is located near the heart wall, but both the tip electrode 63 and the drug solution injection needle 100 are separated from the heart wall. There is.
Therefore, in this state, the first potential measured by the tip electrode 63 does not exceed the first threshold value, and the second potential measured by the electrode of the chemical injection needle 100 does not exceed the second threshold value. ..

By pushing the guiding catheter 60 from the state shown in FIG. 9 (A), the tip electrode 63 is brought into contact with the heart wall as shown in FIG. 9 (B).
In this state, the tip electrode 63 of the guiding catheter 60 is in contact with the heart wall, but the drug solution injection needle 100 is separated from the heart wall.
Therefore, in this state, the first potential measured by the tip electrode 63 is equal to or higher than the first threshold value, but the second potential measured by the electrode of the chemical injection needle 100 does not exceed the second threshold value. The notification by the notification means 80 is not performed.

From the state shown in FIG. 9B, the tip portion of the chemical injection needle 100 was extended from the tip opening of the through hole of the tip electrode 63 while keeping the tip electrode 63 in contact with the heart wall surface, and FIG. 9 (B) As shown in C), the electrode of the drug solution injection needle 100 is introduced into the heart wall.
In this state, the tip electrode 63 of the guiding catheter 60 is in contact with the heart wall, and the electrode of the drug solution injection needle 100 is introduced into the inside of the heart wall (myocardium).
Therefore, in this state, the first potential measured by the tip electrode 63 is equal to or higher than the first threshold value, and the second potential measured by the electrode of the chemical injection needle 100 is equal to or higher than the second threshold value.
As a result, the notification means 80 notifies the operator OP that the drug solution can be injected into the myocardium.

As shown in FIG. 9D, the electrode of the drug solution injection needle 100 is introduced inside the heart wall (myocardium), but the tip electrode 63 of the guiding catheter 60 is separated from the heart wall. In the present state (a state in which the needle tip is easily pulled out from the myocardium due to the beating of the heart or the like), the second potential measured by the electrode of the drug solution injection needle 100 is equal to or higher than the second threshold value, but the tip electrode 63 causes the needle tip to come off. Since the measured first potential does not exceed the first threshold value, the notification means 80 does not notify.

According to the drug solution injection needle system 200 of the present embodiment, the opening of the side hole 25 formed in the connecting tube 20 of the drug solution injection needle 100 is located inside the heart wall (myocardium), and the drug solution injection needle including the opening is located. It can be easily recognized by the notification from the notification means 80 that the tip portion of 100 is in a state where it is difficult to come out of the myocardium, and by waiting for the notification and performing the drug solution injection operation, the patient's myocardium is treated. The drug solution can be reliably injected.

Although the embodiment of the present invention has been described above, the chemical injection needle of the present invention is not limited to this, and various modifications can be made.
For example, the tip member of the drug solution injection needle that constitutes the drug solution injection needle system is formed with a lumen that communicates with the lumen of the connecting pipe and the metal tube, and communicates with the lumen of the tip member to communicate with the outer surface of the tip member. A hole to be opened (the tip surface or the outer peripheral surface) may be formed. In this case, a side hole may or may not be formed on the outer peripheral surface of the connecting pipe.
As such a chemical injection needle, as shown in FIGS. 10A and 10B, a tip member 16 having only a tip surface open, and a connecting pipe 26 connected to the proximal end side of the tip member 16 and having no side hole formed. An example of a drug solution injection needle provided with and.

100 Chemical injection needle 10 Tip member 11 Sharp part of tip member 12 Tubular part of tip member 20 Connecting pipe 21 Tip side small diameter part of connecting pipe 22 Base end side small diameter part of connecting pipe 25 (251 to 259, 25X) side Hole 30 Metal tube 31 Tip part of metal tube 32 Base end part of metal tube 33 Slit 40 Insulation layer 50 Grip 51 Injection port 53 Connector 55 Syringe 200 Chemical injection needle system 60 Guiding catheter 61 Shaft 611 Central lumen 612,613 Sub Lumen 614-617 Sublumen 62 Handle 621 Handle body 622 Rotation operation part 63 Tip electrode 64 Ring-shaped electrode 651,652 Operation wire 66 Injection needle insertion port 67 Blood stop valve 68 Side injection tube 69 Connector 70 Electrocardiograph 72 Indifferent electrode 75 Tube connection connector 76 Injection needle connection connector 77 Indifferent electrode connection connector 80 Notification means

Claims

An electrode catheter having a shaft on which at least one lumen is formed and a tip electrode attached to the tip of the shaft and having a through hole communicating with the lumen.
A drug solution is punctured into the myocardium of a patient by being inserted into the lumen of the shaft constituting the electrode catheter and the through hole of the tip electrode and extending the tip portion from the tip opening of the through hole. A drug solution injection needle system with a hollow drug solution injection needle for injecting.
The chemical injection needle has a sharp metal tip member and
An electrically insulating connecting pipe connected to the base end side of the tip member,
A metal pipe connected to the base end side of the connecting pipe and
An insulating layer that covers the outer peripheral surface of the base end portion of the metal tube is provided.
The connecting tube and / or the tip member is formed with at least one hole that communicates with the lumen of the needle and opens to the outer surface of the connecting tube or the tip member.
The tip portion of the metal tube not coated with the insulating layer constitutes an electrode for potential measurement;
When the first potential measured by the tip electrode of the electrode catheter is equal to or higher than the first threshold value and the second potential measured by the electrode of the chemical solution injection needle is equal to or higher than the second threshold value, the chemical solution is used. A drug solution injection needle system comprising a notification means for notifying an operator that injection into the myocardial layer is possible.
The tip of the tip member of the chemical injection needle is blocked.
The first aspect of the present invention is characterized in that, on the tube wall of the connecting tube of the chemical injection needle, a plurality of side holes communicating with the lumen of the needle and opening on the outer peripheral surface of the connecting tube are formed. Described drug solution injection needle system.
The drug solution injection needle system according to claim 1, wherein the first threshold value is set in the range of 0.03 to 10 mV, and the second threshold value is set in the range of 0.03 to 20 mV.
The drug solution injection needle system according to claim 1 or 2, wherein the electrode catheter includes a mapping electrode for measuring the electrical activity of the heart.
The drug solution injection needle system according to claim 1 or 2, wherein the drug solution is a myocardial regenerative cell preparation.