Burning puncture needle

Abstract

Provided is a cauterization puncture needle with which it is possible to easily puncture a target narrow site in a membrane tissue such as the atrial septum without causing problems such as damage to peripheral tissues in a living body, and with which it is possible to easily confirm that the tip of the needle has reached the opposite side of the membrane tissue. A cauterization puncture needle (10) is provided with: a metal hollow tube (15) having a hollow section (2) communicating in the longitudinal direction; and a tip electrode part (7) which is integrally disposed at the tip of the hollow tube (15), has an insertion tip shape such as a semiellipsoid shape, is supplied with a high-frequency current, and has a hole (9) formed in the side surface thereof, said hole communicating with the hollow part (2).

Description

[0001] This invention application is a divisional application of the invention application with an international application date of July 11, 2019, an international application number of PCT / JP2019 / 027533, a national application number of 201980058888.5 entering the Chinese national phase, and an invention name of “Cauterization Puncture Needle”. Technical Field

[0002] The present invention relates to a medical cautery puncture needle for cauterizing and puncturing a treatment area using high frequency (radio waves). Background Art

[0003] As a medical treatment instrument for puncturing a treatment part as a target in a living body, a catheter (puncture needle) having a sharp needle disposed at its top end is used. In addition, in recent years, a cautery puncture needle having an electrode for generating a high-frequency current disposed at its top end has been proposed (see Patent Document 1). In the case of using a puncture needle having a needle disposed at its top end, a mechanical pressing force is applied to a treatment part such as a membranous part as a target to make a hole. On the other hand, in the case of using a cautery puncture needle, a treatment part such as a membranous part as a target is brought into contact with the electrode, and a high-frequency current is flowed into the electrode. Thus, Joule heat can be generated in the living body, and a hole can be made in the membranous part by cauterization.

[0004] When puncturing the membranous part using a puncture needle equipped with a mechanical needle, it is difficult to increase or decrease the applied force, so it is necessary to fully consider not to cause damage to unexpected parts. In contrast, when puncturing the membranous part using a cautery puncture needle, after the part pressed by the electrode at the top is slightly moved in the pressing direction, a high-frequency current is passed through the electrode. As a result, a hole is opened in the pressed part of the membranous part, the electrode at the top reaches the opposite side of the membranous part, and the part that is pressed and slightly moved returns to the initial position. Therefore, even in surgeries that require very delicate operations, such as puncturing the atrial septum that separates the right atrium and the left atrium, the use of a cautery puncture needle can reduce the possibility of problems such as damage to unexpected parts.

[0005] When puncturing a tiny membrane tissue such as the atrial septum, it is necessary to confirm that the tip has reached the opposite side of the membrane tissue. For example, a puncture needle for cauterization is proposed in which a jet hole for jetting a contrast medium is formed in a portion covered by an insulating layer closer to the base end than the tip electrode (see Patent Document 2).

[0006] Prior art literature

[0007] Patent Literature

[0008] Patent Document 1: Japanese Patent Application Publication No. 2008-237620

[0009] Patent Document 2: Japanese Patent Application No. 2015-518752 Summary of the invention

[0010] Problems to be solved by the invention

[0011] In order to confirm that the tip electrode of the puncture needle proposed in Patent Document 2 has reached the opposite side of the membrane tissue, it is necessary to reliably make the injection hole enter the opposite side of the membrane tissue. However, if the injection hole is made to enter the opposite side of the membrane tissue, the tip electrode will also enter the opposite side of the membrane tissue too much, so the possibility of causing damage to unexpected parts and the like will also increase. In addition, if the tip electrode is made to enter the opposite side of the membrane tissue too much, the burden on the living body will also increase.

[0012] The present invention has been proposed in view of such a situation, and its object is to provide a cautery puncture needle that can easily puncture a narrow target site in a membrane tissue such as the atrial septum without causing problems such as damaging surrounding tissues in a living body, and that can easily confirm that the tip of the needle has reached the opposite side of the membrane tissue.

[0013] Means for solving problems

[0014] The first embodiment of the present invention is a cautery puncture needle, comprising: a metal hollow tube having a hollow portion connected in the length direction; and a front end electrode portion, which is integrally arranged at the top end of the hollow tube and is passed with a high-frequency current, and a hole connected to the hollow portion is formed on the side of the front end electrode portion.

[0015] The cautery puncture needle according to a second aspect of the present invention is the one according to the first aspect, wherein the insertion tip of the distal electrode portion is in a semi-ellipsoidal spherical shape.

[0016] The cautery puncture needle according to a third aspect of the present invention is the one according to the second aspect, wherein the outer diameter of the distal electrode portion is 0.4 to 0.9 mm.

[0017] The cautery puncture needle according to a fourth aspect of the present invention is according to the first to third aspects, wherein the opening shape of the hole is an oblong shape or an elliptical shape extending in the longitudinal direction.

[0018] Effects of the Invention

[0019] According to the above aspect of the present invention, a cautery puncture needle can be provided which can easily puncture a narrow target site in a membrane tissue such as the atrial septum without causing problems such as damaging surrounding tissues in a living body, and can easily confirm that its tip has reached the opposite side of the membrane tissue. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1This is a partial cross-sectional view schematically showing one embodiment of the cautery puncture needle of the present invention.

[0021] Figure 2 This is a partial perspective view schematically showing one embodiment of the cautery puncture needle of the present invention.

[0022] Figure 3 This is a partial perspective view schematically showing another embodiment of the cautery puncture needle of the present invention.

[0023] Figure 4 This is a partial side view schematically showing one embodiment of the cautery puncture needle of the present invention.

[0024] Figure 5 This is an overall perspective view schematically showing one embodiment of the cautery puncture needle of the present invention.

[0025] Figure 6 This is a partial cross-sectional view showing an example of a state in which liquid is ejected from a hole.

[0026] Figure 7 This is a partial cross-sectional view showing another example of the state of liquid being ejected from the hole.

[0027] Fig. 8A It is a partial cross-sectional view illustrating the steps of manufacturing the front end electrode portion.

[0028] Figure 8B It is a partial cross-sectional view illustrating the steps of manufacturing the front end electrode portion.

[0029] Figure 8C It is a partial cross-sectional view illustrating the steps of manufacturing the front end electrode portion.

[0030] Fig.8D It is a partial cross-sectional view illustrating the steps of manufacturing the front end electrode portion. DETAILED DESCRIPTION

[0031] Hereinafter, embodiments of the present invention will be described, but the present invention is not limited to the following embodiments. Figure 1 : is a partial cross-sectional view schematically showing one embodiment of the cautery puncture needle of the present invention. Figure 2 FIG. 2 is a partial perspective view schematically showing an embodiment of the cautery puncture needle of the present invention. Figure 1 and Figure 2As shown in FIG. 1 , the cautery puncture needle 10 of the present embodiment includes a front electrode portion 7 and a metal hollow tube 15 having a hollow portion 2 connected in the length direction. The front electrode portion 7 is integrally arranged at the top end of the hollow tube 15, and is configured to generate Joule heat in the body by passing a high-frequency current. In addition, a hole 9 connected to the hollow portion 2 in the hollow tube 15 is formed on the side of the front electrode portion 7. The hollow portion 2 connected to the hole 9 is connected to the operation base end side of the cautery puncture needle 10 in the length direction of the hollow tube 15. Figure 5 FIG. 2 is a schematic overall perspective view showing an embodiment of the cautery puncture needle of the present invention. Figure 5 As shown, a relay cable 42 and a Luer connector 46 having a syringe connection portion 44 are provided on the operation base end side of the cautery puncture needle 10. The relay cable 42 is a mechanism for electrically connecting the high-frequency (radio wave (RF)) current generating source to the hollow tube 15 and the front end electrode portion 7. In addition, the syringe connection portion 44 is a Luer tapered fitting portion connected to the syringe. If a syringe filled with contrast agent is connected to the syringe connection portion 44 and the contrast agent is injected into the hollow portion, the liquid medicine can be discharged from the hole 9 ( Figure 1 That is, the hole formed on the side surface of the front end electrode portion functions as an injection hole for injecting a liquid medicine such as a contrast agent to the outside.

[0032] The cautery puncture needle 10 of this embodiment has a hole 9 ( Figure 1 and Figure 2 That is, according to the cautery puncture needle 10 of this embodiment, since the contrast medium can be injected from the hole 9 provided at a position closer to the insertion tip 12 into the living body, it is easy to confirm that the distal electrode portion 7 has reached the opposite side of the membrane tissue such as the atrial septum.

[0033] exist Figure 1 and Figure 2 The opening shape of the hole 9 formed on the side surface of the distal electrode portion 7 of the cautery puncture needle 10 shown in FIG. 1 is an oval shape extending in the longitudinal direction of the hollow tube 15 . Figure 3 This is a partial perspective view schematically showing another embodiment of the cautery puncture needle of the present invention. Figure 3 The cautery puncture needle 20 shown in FIG. 1 includes a metal hollow tube 25 and a front electrode portion 17. A hole 19 is formed on the side of the front electrode portion 17, which is connected to the hollow portion in the hollow tube 25 and has an opening shape of a perfect circle. Figure 1 and Figure 2 As shown, the opening shape of the hole 9 is preferably an elongated circular shape or an elliptical shape extending along the length direction of the hollow tube 15 .

[0034] Figure 61 is a partial cross-sectional view showing an example of a state in which liquid is ejected from a hole. Figure 7 This is a partial cross-sectional view showing another example of the state of liquid being ejected from the hole. Figure 6 The opening shape of the hole 9 of the cautery puncture needle 10 shown in FIG. 1 is an oblong shape extending along the length direction of the hollow tube ( Figure 1 and Figure 2 ).on the other hand, Figure 7 The opening shape of the hole 19 of the cautery puncture needle 20 shown in FIG. 1 is a perfect circle ( Figure 3 ).like Figure 6 and Figure 7 As shown, the opening shape of the hole 9 is an oblong or elliptical cautery puncture needle 10 ( Figure 6 ) and the shape of the hole 19 is a perfect circle cautery puncture needle 20 ( Figure 7 ), the contrast medium 14 as a liquid can be ejected further forward in the insertion direction. That is, if the opening shape of the hole is set to an oblong shape or an elliptical shape, the contrast medium can be ejected further forward. Therefore, even if the injection amount of the contrast medium is made smaller, it can be clearly photographed by X-ray fluoroscopy. Thus, it is possible to further easily confirm that the insertion top has reached the opposite side of the membrane tissue. In addition, since the injection amount of the contrast medium can be reduced, the burden on the organism can also be further reduced.

[0035] Figure 4 It is a partial side view schematically showing an embodiment of the cautery puncture needle of the present invention. When the opening shape of the hole 9 is an oblong shape or an elliptical shape, the ratio of the major diameter L to the minor diameter S of the hole 9 (L / S ratio) is preferably 1.06 to 6.00, and more preferably 1.19 to 3.67. By setting the L / S ratio to the above range, the contrast agent can be ejected from the hole 9 further forward in the insertion direction. The number of holes formed in the front end electrode portion is not particularly limited, and is preferably 1 to 4, and more preferably 2 or 3. By setting the number of holes formed in the front end electrode portion to 2 or 3, the front end electrode portion can be maintained at a more appropriate strength.

[0036] like Figure 1 and Figure 2As shown, the insertion tip of the front electrode portion 7 of the cautery puncture needle 10 is preferably in the shape of a semi-ellipsoid (cannonball shape, semi-rugby ball shape). If the insertion tip is in the shape of a semi-ellipsoid whose outer diameter gradually decreases as it approaches the insertion tip 12, the insertion tip 12 can be more reliably brought into contact with a narrow portion of the membrane tissue such as the atrial septum, and the contact area of ​​the narrow portion in contact can be made smaller. Assuming the case of puncturing the atrial septum, the insertion tip 12 is prone to positional displacement due to the beating heart, but if the insertion tip is in the shape of a semi-ellipsoid, the pressure of the insertion tip 12 on the atrial septum can be increased. As a result, the positional displacement of the insertion tip 12 can be effectively suppressed, the Joule heat can be concentrated on the desired narrow portion in the membrane tissue, and the hole can be opened more reliably.

[0037] The front end electrode portion is formed of metal in order to be passed with a high-frequency current. As the metal forming the front end electrode portion, there is no particular limitation as long as a high-frequency current can be passed, and preferably a metal that can be photographed with high contrast using X-ray fluoroscopy so that its position at the surgical site can be easily confirmed. Specifically, platinum (Pt), iridium (Ir), an alloy of the two (Pt-Ir alloy), and an alloy of the above metals with stainless steel (Pt-Ir-SUS alloy) can be cited.

[0038] The hollow tube 15 can be composed of a front end tube 3 provided with a front end electrode portion 7 and a base end tube 5 connected to the base end side of the front end tube 3 and having a diameter slightly larger than that of the front end tube ( Figure 1 ). By making the insertion front end side of the hollow tube 15 composed of the front end tube 3 with a smaller diameter, a minimum necessary small hole can be opened. In addition, by making the operation base end side of the hollow tube 15 composed of the base end tube 5 with a larger diameter, the action of the operation side can be transmitted to the top end more accurately.

[0039] The hollow tube (front end tube, base end tube) is formed of a metal with good flexibility. As the metal, various alloys such as stainless steel such as SUS302, SUS304V, and SUS316L, and Nitinol and CoCr can be cited. Stainless steel such as SUS304V is particularly preferred.

[0040] A coating layer 16 ( Figure 1 and Figure 2 ). By forming the coating layer 16, it is possible to prevent accidental high-frequency (radio wave) cauterization of blood vessels, organs, etc., while reducing the sliding resistance of the cauterization puncture needle 10 in the living body, thereby improving operability. The material forming the coating layer 16 is preferably a waterproof resin material. In particular, it is preferred to form the coating layer with a fluorine-based resin such as PTFE, ETFE, and PFA, so that the sliding resistance of the cauterization puncture needle can be more effectively reduced.

[0041] The dimensions of the various parts of the front end electrode portion 7 are preferably as follows ( Figure 4 ). That is, the total length A of the front electrode portion 7 (the length from the insertion tip 12 to the coating layer 16) is preferably 1.16 to 2.50 mm. The length B from the insertion tip 12 to the opening tip of the hole 9 is preferably 0.50 to 1.10 mm. In addition, the length C from the opening base of the hole 9 to the coating layer 16 is preferably 0.30 to 0.80 mm.

[0042] The outer diameter D of the distal electrode portion 7 is preferably 0.4 to 0.9 mm, and more preferably 0.5 to 0.8 mm ( Figure 4 ). Assuming the case of puncturing the atrial septum, although it is necessary to confirm that the front end electrode portion of the cautery puncture needle including the insertion tip has reached the opposite side of the atrial septum (left atrium), there are also cases where it is not suitable to inject the contrast agent. In this case, if the outer diameter D of the front end electrode portion 7 is within the above range, it is possible to easily determine whether the atrial septum is punctured by measuring the changes in the right atrial pressure and the left atrial pressure. If the outer diameter D of the front end electrode portion 7 is less than 0.4 mm, even if the atrial septum is punctured, it is difficult to determine because the changes in the right atrial pressure and the left atrial pressure are very small. On the other hand, if the outer diameter D of the front end electrode portion 7 exceeds 0.9 mm, the operability is reduced, and there is a tendency for the burden on the biological body to increase.

[0043] Next, a method for producing the cautery puncture needle of the present invention will be described. Figures 8A to 8D is a partial cross-sectional view illustrating the steps of manufacturing the front end electrode portion. To manufacture the front end electrode portion, first, Fig. 8A As shown in FIG. 1 , a front end tube 3 made of a metal such as stainless steel having a hollow portion 2 and a columnar electrode material 24 are prepared, and the electrode material 24 is inserted and fitted into one open end of the front end tube 3. The electrode material 24 is a metal component such as a Pt-Ir alloy. Next, the fitted electrode material 24 and the open end of the front end tube 3 are welded by arc welding such as plasma welding or Tig welding to form a Figure 8B The weld end 26 is formed by the metal constituting the front end tube 3 and the electrode material 24 ( Fig. 8A ) metal alloy. In addition, the weld end portion 26 formed by the above welding is substantially seamlessly joined to the front end pipe 3 (hollow pipe 15).

[0044] By forming the welded end 26 ( Figure 8B ) is ground to form Figure 8C Next, if a hole 9 communicating with the hollow portion 2 is opened on the side of the front end electrode portion 7 by laser processing or the like, a desired shape such as a semi-elliptical sphere can be formed. Fig.8DThe front end electrode portion 7 shown in FIG. The front end electrode portion 7 formed in this way makes the hollow tube 15 and the insertion tip 12 substantially seamlessly connected, so that the insertion tip 12 is not likely to fall off during use, and the safety is high. In addition, if the hollow tube 15 and the insertion tip 12 are seamlessly connected, the high-frequency current passed through is not delayed, and the power loss can be reduced.

[0045] The base end of the front end tube having the front end electrode part manufactured in the above manner is inserted into the open end of the base end tube having a diameter slightly larger than that of the front end tube and the two are joined. In this way, a hollow tube having a hollow part connected from the insertion tip to the operation base end side can be formed. The front end tube and the base end tube are joined by, for example, laser welding, bonding using an adhesive, or a combination of these. It should be noted that it is preferred to perform concave-convex processing on the outer peripheral surfaces of the front end tube and the base end tube in advance as needed so that the coating layer to be arranged later can be closely fitted and not easily shifted.

[0046] Next, an adhesive is applied to the outer circumference of the hollow tube, and the hollow tube is inserted into a heat shrink tube made of a fluororesin such as PTFE. Then, if the heat shrink tube is appropriately heated to shrink, a coating layer can be formed in close contact at a predetermined position on the outer circumference of the hollow tube. Figure 5 As shown, by bending a desired portion of the hollow tube 15 to form the bent portion 32 and connecting an operating portion such as a Luer connector 46 to the operating base end of the hollow tube 15 , the cautery puncture needle 10 of the present embodiment can be obtained.

[0047] Industrial Applicability

[0048] The cautery puncture needle of the present invention can be used as a puncture needle for puncturing the atrial septum that separates the right atrium and the left atrium, for example.

[0049] Description of Reference Numerals

[0050] 2: Hollow part

[0051] 3: Front end tube

[0052] 5: Base end tube

[0053] 7, 17: Front electrode part

[0054] 9, 19: Hole

[0055] 10, 20: Cautery needle

[0056] 12: Insert top

[0057] 14: Contrast agents

[0058] 15, 25: Hollow tube

[0059] 16: Coating layer

[0060] 24: Electrode materials

[0061] 26: Welding end

[0062] 32: Bending part

[0063] 42: Relay cable

[0064] 44: Syringe connection

[0065] 46: Luer connector

Claims

1. A cautery puncture needle, characterized in that: include: A metal hollow tube having a hollow portion connected in the length direction; as well as The front electrode part is integrally arranged at the top end of the hollow tube, and a high-frequency current is passed through it. A hole communicating with the hollow portion is formed on the side of the front electrode portion. The insertion tip of the front electrode portion is in the shape of a semi-ellipsoidal sphere. A coating layer is formed on the surface of the hollow tube, The opening shape of the hole is an oblong shape or an elliptical shape extending in the length direction. The oblong or elliptical hole is located between the semi-ellipsoidal portion of the distal electrode portion and the distal electrode portion side of the coating layer and is located on the semi-ellipsoidal portion side.

2. The cautery puncture needle according to claim 1, characterized in that: The outer diameter of the front end electrode portion is 0.4 to 0.9 mm.

3. The cautery puncture needle according to claim 1, characterized in that: The ratio of the major diameter to the minor diameter of the hole is in the range of 1.06 to 6.

00.

4. The cautery puncture needle according to claim 1, characterized in that: The ratio (S / D) of the short diameter (S) of the hole to the outer diameter (D) of the front electrode portion is in the range of 0.25 to 0.

38.

5. The cautery puncture needle according to any one of claims 1 to 4, characterized in that: The hollow tube is seamlessly joined to the front end electrode portion.

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