阅读说明：本技术 烧灼穿刺针 (Cauterizing puncture needle ) 是由 酒井康一 吉田弘毅 于 2019-07-11 设计创作，主要内容包括：本发明提供一种烧灼穿刺针,该烧灼穿刺针能够容易地向心房中隔等膜组织中的作为目标的狭小部位穿刺而不易发生损伤生物体内的周边组织等的问题,并且,能够容易地确认其顶端已到达膜组织的相反侧的情况。烧灼穿刺针(10)包括：金属制的中空管(15),其具有在长度方向上连通的中空部(2)；以及前端电极部(7),其一体地配设在中空管(15)的顶端,且其插入顶端形状为半椭圆球状等,并被通入高频电流,在前端电极部(7)的侧面形成有与中空部(2)连通的孔(9)。(The invention provides a cauterization puncture needle which can easily puncture a target narrow part in a membranous tissue such as a septum of a heart chamber, is not easy to damage peripheral tissues in a living body, and can easily confirm that the tip of the cauterization puncture needle reaches the opposite side of the membranous tissue. A cautery puncture needle (10) comprises: a hollow tube (15) made of metal, which has a hollow portion (2) communicating in the longitudinal direction; and a tip electrode part (7) which is integrally arranged at the tip of the hollow tube (15), has a shape of a semi-ellipsoid or the like at the insertion tip, and is supplied with a high-frequency current, wherein a hole (9) communicating with the hollow part (2) is formed in the side surface of the tip electrode part (7).)

1. A cautery needle, comprising:

a hollow tube made of metal and having a hollow portion communicating in a longitudinal direction; and

a tip electrode section which is integrally disposed at the tip end of the hollow tube and to which a high-frequency current is supplied,

a hole communicating with the hollow portion is formed in a side surface of the front end electrode portion.

2. The cautery needle of claim 1,

the inserting top end of the front end electrode part is shaped like a semi-ellipsoid sphere.

3. The cautery needle of claim 2,

the outer diameter of the front-end electrode part is 0.4-0.9 mm.

4. The cautery puncture needle according to any one of claims 1 to 3,

the opening shape of the hole is an oblong shape or an elliptical shape extending in the length direction.

Technical Field

The present invention relates to a medical cauterizing needle for cauterizing and puncturing a treatment site at a high frequency (radio wave).

Background

As a medical treatment instrument for puncturing a target treatment portion in a living body, a catheter (puncture needle) having a sharp needle disposed at a distal end thereof is used. In recent years, a cauterizing puncture needle having an electrode for generating a high-frequency current disposed at the tip thereof has been proposed (see patent document 1). In the case of using a puncture needle having a needle disposed at the distal end thereof, a mechanical pressing force is applied to a treatment portion such as a targeted membrane portion to open a hole. On the other hand, when a cauterization puncture needle is used, a treatment portion such as a target membrane portion is brought into contact with an electrode, and a high-frequency current is caused to flow into the electrode. Thus, joule heat is generated in the living body, and the membrane-like portion can be perforated by cauterization.

In the case of puncturing the membrane-like portion using a puncture needle in which a mechanical needle is arranged, it is sometimes difficult to increase or decrease the force applied, and therefore, it is necessary to sufficiently consider that the unintended portion is not damaged. On the other hand, when the cauterization puncture needle is used to puncture the membrane portion, a portion pushed by the distal electrode is slightly moved in the pushing direction, and then a high-frequency current is applied to the electrode. Thus, the pressed portion of the membrane portion is perforated, the electrode at the tip reaches the opposite side of the membrane portion, and the pressed and slightly moved portion returns to the initial position. Therefore, even in an operation requiring a very delicate operation such as puncturing the interatrial septum which separates the right atrium and the left atrium, for example, the use of the cauterization needle can reduce the possibility of causing a problem such as damage to an unintended site.

In the case of puncturing a minute membranous tissue such as a septum of a atrium, it is necessary to confirm that the tip has reached the opposite side of the membranous tissue. For example, a puncture needle for cauterization has been proposed in which an injection hole for injecting a contrast medium is formed in a portion covered with an insulating layer on the proximal side of the distal electrode (see patent document 2).

Documents of the prior art

Patent document

Patent document 1: japanese laid-open patent publication No. 2008-237620

Patent document 2: japanese laid-open patent publication No. 2015-518752

Disclosure of Invention

Problems to be solved by the invention

In order to confirm that the tip electrode of the puncture needle proposed in patent document 2 has reached the opposite side of the membranous tissue, it is necessary to reliably make the injection hole enter the opposite side of the membranous tissue. However, if the ejection holes are made to penetrate the opposite side of the membranous tissue, the tip electrode also penetrates the opposite side of the membranous tissue too much, and therefore, there is a high possibility that unexpected sites are damaged or the like. Further, if the tip electrode is excessively advanced to the opposite side of the membranous tissue, the burden on the living body is also increased.

The present invention has been made in view of the above circumstances, and an object thereof is to provide a cauterizing needle which can easily puncture a target narrow portion of a membranous tissue such as a septum of a atrium and the like to prevent a problem of damaging peripheral tissues and the like in a living body, and which can easily confirm that a tip thereof has reached the opposite side of the membranous tissue.

Means for solving the problems

The invention according to claim 1 is a cauterizing puncture needle comprising: a hollow tube made of metal and having a hollow portion communicating in a longitudinal direction; and a tip electrode portion that is integrally disposed at the tip end of the hollow tube and to which a high-frequency current is supplied, and a hole that communicates with the hollow portion being formed in a side surface of the tip electrode portion.

In the cautery puncture needle according to claim 2 of the present invention, in addition to the above-mentioned aspect 1, the insertion tip of the tip electrode portion has a semi-ellipsoidal shape.

The cauterizing puncture needle according to claim 3 of the present invention is the cauterizing puncture needle according to claim 2, wherein the outer diameter of the distal electrode portion is 0.4 to 0.9 mm.

The cauterizing puncture needle according to claim 4 of the present invention is the cauterizing puncture needle according to any one of claims 1 to 3, wherein the opening of the hole has an oblong or elliptical shape extending in the longitudinal direction.

Effects of the invention

According to the aspect of the present invention, it is possible to provide a cautery puncture needle which can easily puncture a target narrow portion of a membranous tissue such as a septum of an atrium and the like, and which is less likely to cause a problem of damaging peripheral tissues and the like in a living body, and which can easily confirm that a distal end thereof has reached the opposite side of the membranous tissue.

Drawings

FIG. 1 is a partial cross-sectional view schematically showing one embodiment of the cautery puncture needle of the present invention.

FIG. 2 is a partial perspective view schematically showing an embodiment of the cautery puncture needle of the present invention.

FIG. 3 is a partial perspective view schematically showing another embodiment of the cautery puncture needle of the present invention.

FIG. 4 is a partial side view schematically showing one embodiment of the cautery puncture needle of the present invention.

FIG. 5 is an overall perspective view schematically showing an embodiment of the cauterizing needle of the present invention.

Fig. 6 is a partial cross-sectional view showing an example of a state in which liquid is ejected from the hole.

Fig. 7 is a partial cross-sectional view showing another example of the state of ejection of liquid from the hole.

Fig. 8A is a partial cross-sectional view illustrating a manufacturing process of the front electrode portion.

Fig. 8B is a partial cross-sectional view illustrating a manufacturing process of the front electrode portion.

Fig. 8C is a partial cross-sectional view illustrating a manufacturing process of the front electrode portion.

Fig. 8D is a partial cross-sectional view illustrating a manufacturing process of the front electrode portion.

Detailed Description

Hereinafter, embodiments of the present invention will be described, but the present invention is not limited to the embodiments below. FIG. 1 is a partial cross-sectional view schematically showing one embodiment of the cautery puncture needle of the present invention. Further, FIG. 2 is a partial perspective view schematically showing an embodiment of the cautery puncture needle of the present invention. As shown in fig. 1 and 2, the cautery puncture needle 10 of the present embodiment includes a tip electrode portion 7 and a metal hollow tube 15 having a hollow portion 2 communicating with each other in a longitudinal direction. The distal electrode portion 7 is integrally disposed at the distal end of the hollow tube 15, and generates joule heat in the living body when a high-frequency current is applied thereto. Further, a hole 9 communicating with the hollow portion 2 in the hollow tube 15 is formed in the side surface of the tip electrode portion 7. The hollow portion 2 communicating with the hole 9 communicates with the operation proximal side of the cauterizing needle 10 in the longitudinal direction of the hollow tube 15. FIG. 5 is an overall perspective view schematically showing an embodiment of the cauterizing needle of the present invention. As shown in fig. 5, for example, a relay cable 42 and a luer connector 46 having a syringe connection part 44 are disposed on the operation proximal end side of the cauterizing needle 10. Relay cable 42 is a mechanism for electrically connecting a generation source of high-frequency (radio wave (RF)) current to hollow tube 15 and tip electrode portion 7. The syringe connecting portion 44 is a luer taper fitting portion to be connected to a syringe. When a syringe filled with a contrast medium is connected to the syringe connection portion 44 and the contrast medium is injected into the hollow portion, the chemical liquid can be injected to the outside from the hole 9 (fig. 1) formed in the side surface of the distal electrode portion 7. That is, the hole formed in the side surface of the distal electrode portion functions as an injection hole for injecting a chemical liquid such as a contrast medium to the outside.

The cauterizing needle 10 of the present embodiment has a hole 9 (fig. 1 and 2) functioning as an injection hole for injecting a contrast medium formed in a side surface of the distal electrode portion 7 closer to the insertion tip 12. That is, according to the cauterization puncture needle 10 of the present embodiment, since the contrast medium can be ejected from the hole 9 provided at a position closer to the insertion tip 12 in the living body, it can be easily confirmed that the distal electrode portion 7 has reached the opposite side of the membranous tissue such as the atrial septum.

The opening shape of the hole 9 formed in the side surface of the tip electrode portion 7 of the cauterizing needle 10 shown in FIGS. 1 and 2 is an oval shape extending in the longitudinal direction of the hollow tube 15. FIG. 3 is a partial perspective view schematically showing another embodiment of the cautery puncture needle of the present invention. The cauterizing needle 20 shown in fig. 3 includes a hollow tube 25 made of metal and a tip electrode portion 17. A hole 19 having a circular opening communicating with the hollow portion in hollow tube 25 is formed in the side surface of tip electrode portion 17. As shown in fig. 1 and 2, the opening of hole 9 is preferably in the shape of an oblong circle or an oval extending in the longitudinal direction of hollow tube 15.

Fig. 6 is a partial cross-sectional view showing an example of a state in which liquid is ejected from the hole. Fig. 7 is a partial cross-sectional view showing another example of the state of liquid discharge from the hole. The opening shape of the hole 9 of the cauterizing needle 10 shown in fig. 6 is an oblong shape extending in the longitudinal direction of the hollow tube (fig. 1 and 2). On the other hand, the opening shape of the hole 19 of the cauterizing needle 20 shown in FIG. 7 is a perfect circle (FIG. 3). As shown in fig. 6 and 7, the cautery needle 10 (fig. 6) having the hole 9 with an oblong or elliptical opening shape can eject the contrast medium 14 as a liquid more forward in the insertion direction than the cautery needle 20 (fig. 7) having the hole 19 with a perfect circle shape. That is, if the opening shape of the hole is an oblong shape or an elliptical shape, the contrast medium can be injected further forward. Therefore, even if the injection amount of the contrast medium is made smaller, imaging can be performed clearly by fluoroscopy. This makes it possible to further easily confirm that the insertion tip has reached the opposite side of the membranous tissue. In addition, since the ejection amount of the contrast medium can be reduced, the burden on the living body can be further reduced.

FIG. 4 is a partial side view schematically showing one embodiment of the cautery puncture needle of the present invention. When the opening of the hole 9 has an oblong or elliptical shape, the ratio of the major axis L to the minor axis S (L/S ratio) of the hole 9 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 medium 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, but is preferably 1 to 4, and more preferably 2 or 3. By setting the number of holes formed in the tip electrode portion to 2 or 3, the tip electrode portion can be maintained at a more appropriate strength.

As shown in fig. 1 and 2, the insertion tip of the distal electrode portion 7 of the cauterizing needle 10 is preferably shaped like a semi-ellipsoid (a shell, a half-rugby). If the insertion tip has a semi-ellipsoidal shape in which the outer diameter gradually decreases as the insertion tip 12 goes, the insertion tip 12 can be more reliably brought into contact with a narrow portion of membranous tissue such as an atrial septum, and the contact area of the narrow portion in contact can be made smaller. When puncturing the atrial septum, the insertion tip 12 is likely to be displaced because the heart is in a pulsating state, but if the insertion tip is shaped like a semi-elliptical sphere, the insertion tip 12 can be pressed against the atrial septum more strongly. This can effectively suppress the positional deviation of the insertion tip 12, and concentrate joule heat at a desired narrow portion in the membranous tissue, thereby enabling more reliable perforation.

The distal electrode portion is formed of metal so as to be supplied with a high-frequency current. The metal forming the distal electrode portion is not particularly limited as long as a high-frequency current can be applied thereto, and a metal that can be imaged with high contrast by fluoroscopy is preferably used so that the position of the metal at the surgical site can be easily confirmed. Specifically, platinum (Pt), iridium (Ir), an alloy of both (Pt — Ir alloy), and an alloy of the above metals and stainless steel (Pt — Ir — SUS alloy) can be mentioned.

The hollow tube 15 can be composed of a tip tube 3 provided with a tip electrode portion 7, and a base tube 5 connected to the base end side of the tip tube 3 and having a diameter slightly larger than the tip tube (fig. 1). By forming the insertion tip side of the hollow tube 15 with the tip tube 3 having a smaller diameter, the minimum necessary number of small holes can be formed. Further, the operation proximal end side of the hollow tube 15 is constituted by the larger diameter proximal end tube 5, so that the operation on the operation side can be more accurately transmitted to the distal end.

The hollow tube (tip tube, base tube) is made of a metal having good flexibility. Examples of the metal include stainless steel such as SUS302, SUS304V, and SUS316L, and various alloys such as nitinol and CoCr. Stainless steel such as SUS304V is particularly preferable.

A coating layer 16 is formed on the surface of the hollow tube 15 (fig. 1 and 2). By forming the coating layer 16, the sliding resistance of the cautery puncture needle 10 in the living body can be reduced while preventing accidental high-frequency (radio wave) cauterization of blood vessels, organs, etc., and the operability can be improved. The material forming the coating layer 16 is preferably a water-repellent resin material. In particular, it is preferable to form the coating layer of a fluorine-based resin such as PTFE, ETFE, PFA or the like so as to more effectively reduce the sliding resistance of the cauterizing needle.

The dimensions of each part of the tip electrode portion 7 are preferably as follows (fig. 4). That is, the entire length A of the tip electrode portion 7 (the length from the insertion tip 12 to the coating layer 16) is preferably 1.16 to 2.50 mm. Preferably, the length B from the insertion tip 12 to the open front end of the hole 9 is 0.50 to 1.10 mm. The length C from the base end of the opening of the hole 9 to the coating layer 16 is preferably 0.30 to 0.80 mm.

The outer diameter D of the front electrode portion 7 is preferably 0.4 to 0.9mm, more preferably 0.5 to 0.8mm (FIG. 4). When a puncture is made into the atrial septum, it is sometimes difficult to eject a contrast medium, although it is sometimes confirmed that the distal electrode portion including the insertion tip of the cauterizing needle has reached the opposite side of the atrial septum (left atrium). In this case, when the outer diameter D of the distal electrode portion 7 is within the above range, it is possible to easily determine whether or not the interatrial septum is punctured by measuring changes in the right atrial pressure and the left atrial pressure. If the outer diameter D of the distal electrode portion 7 is less than 0.4mm, it is difficult to determine the change in the right atrial pressure and the left atrial pressure even if the atrial septum is punctured. On the other hand, when the outer diameter D of the distal electrode portion 7 exceeds 0.9mm, the operability is deteriorated and the burden on the living body tends to increase.

Next, a method of manufacturing the cauterizing needle of the present invention will be described. Fig. 8A to 8D are partial sectional views for explaining the steps of manufacturing the front-end electrode portion. To produce the tip electrode portion, first, as shown in fig. 8A, a tip tube 3 made of 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 tip tube 3. The electrode material 24 is a metal member such as Pt — Ir alloy, for example. Next, the fitted electrode material 24 and the open end of the distal end tube 3 are welded by arc welding such as plasma welding or Tig welding to form a welded end 26 shown in fig. 8B. The welded end 26 is formed of an alloy of the metal constituting the tip pipe 3 and the metal constituting the electrode material 24 (fig. 8A). The welded end 26 formed by the welding is substantially joined to the distal end tube 3 (hollow tube 15) without a seam.

The formed welding end 26 (fig. 8B) is ground, whereby the tip electrode portion 7 having a desired shape such as a semi-ellipsoidal shape shown in fig. 8C can be formed. Next, when the hole 9 communicating with the hollow portion 2 is opened in the side surface of the tip electrode portion 7 by laser processing or the like, the tip electrode portion 7 shown in fig. 8D can be formed. Since the distal electrode portion 7 formed in this manner is formed by joining the hollow tube 15 and the insertion tip 12 substantially seamlessly, problems such as the insertion tip 12 being detached during use are unlikely to occur, and safety is high. Further, if the hollow tube 15 and the insertion tip 12 are formed to be joined seamlessly, the high-frequency current flowing therethrough is not delayed, and the power loss can be reduced.

The base end of the distal end tube having the distal end electrode portion manufactured as described above was inserted into the open end of the base end tube having a slightly larger diameter than the distal end tube, and the two were joined together. Thereby, a hollow tube having a hollow portion communicating from the insertion tip to the operation base end side can be formed. The distal end pipe and the proximal end pipe are joined by, for example, laser welding, adhesion using an adhesive, a combination thereof, or the like. If necessary, it is preferable to perform a concave-convex processing on the outer peripheral surfaces of the distal end pipe and the proximal end pipe in advance so that the coating layers disposed later can be made to adhere to each other and be less likely to shift.

Next, an adhesive is applied to the outer peripheral surface of the hollow tube, and the hollow tube is inserted into a heat-shrinkable tube made of a fluororesin such as PTFE. Then, when the heat-shrinkable tube is appropriately heated to shrink, the coating layer can be formed in close contact with a predetermined portion of the outer peripheral surface of the hollow tube. Thereafter, as shown in fig. 5, a desired portion of the hollow tube 15 is bent to form a bent portion 32, and an operation portion such as a luer connector 46 is connected to the operation proximal end of the hollow tube 15, whereby the cautery puncture needle 10 of the present embodiment can be obtained.

Industrial applicability

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

Description of the reference numerals

2: hollow part

3: front end pipe

5: base end pipe

7. 17: front electrode part

9. 19: hole(s)

10. 20: cauterizing puncture needle

12: insertion tip

14: contrast agents

15. 25: hollow pipe

16: coating layer

24: material for electrode

26: welding the end

32: bending part

42: relay cable

44: syringe connection

46: luer connector