WO2013122412A1

WO2013122412A1 - Electrical electrode assembly for surgery operation and surgery operation device comprising same

Info

Publication number: WO2013122412A1
Application number: PCT/KR2013/001186
Authority: WO
Inventors: 김병국; 배석일; 김상운
Original assignee: (주)인투케어
Priority date: 2012-02-15
Filing date: 2013-02-15
Publication date: 2013-08-22
Also published as: CN104114119A; KR101139940B1; CN104114119B

Abstract

The present invention relates to an electrical electrode assembly for a surgery operation and a surgery operation device comprising same, and more specifically, to an electrode assembly and a surgery operation device comprising same, which can control direction for locally or selectively removing a specific area in the body by using RF heat energy while enabling easy adjustment even with a small force.

Description

Electrosurgical electrode body and surgical instrument comprising the same

The present invention relates to an electrosurgical electrode body and a surgical surgical device including the same, and more particularly, to an electrode body capable of directional control to locally or selectively remove specific parts of the body using RF thermal energy and the same. It relates to a surgical surgical instrument.

The term 'disk', which we often misunderstand as a disease name, refers to a structure that connects the vertebral bodies. The exact name of the disease is 'vertebral disc herniation' or 'nucleus herniation'.

The most common cause of lumbar discs is the degenerative changes in the lumbar intervertebral discs, which begin in the late teens to early 20s. The incidence of intervertebral disc proliferation begins to increase in the twenties and develops into active 40s.

The degenerative changes of the intervertebral discs change both the nucleus pulposus, which is a component of the intervertebral disc, and fibrin, the rigid fibrous membrane surrounding it. First, as the water content in the nucleus decreases and the fibrous component called collagen increases, the nucleus nucleus nucleus becomes crumbly, so that it cannot effectively absorb the force on the intervertebral discs, and the fiber lubrication also decreases the moisture and shows cracks. . At this time, if excessive force, in particular bending and rotational force exerted at the same time, the fiber ruptures while the inner nucleus pulsating the fiber yun to protrude to the outside. But sometimes the escape of the nucleus can occur without any excessive force. In other words, if there is a degenerative change in the intervertebral disc for a long time and some excessive force is exerted, the fiber lubrication can no longer hold up or be pushed or burst. The protruding intervertebral disc portion is not circularly reconstructed to maintain a continuously protruding shape, which causes pressure on the nerves near the spine and causes back pain.

Treatment methods for disc herniation can be divided into conservative treatment and surgical treatment. The treatment method is determined by the duration of symptoms, intensity, occupation, age, recurrence, and responsiveness to conservative treatment. Most are restored to bed rest, drug therapy, and physical therapy alone.

Inevitable cases have to resort to surgical treatment. However, surgical surgery can provide as much as 30% of surgical patients. In addition, 5-10% of surgical patients suffer from Failed Back Surgery Syndrome (F.B.S.S), because surgical procedures involve the removal of spinal nerves.

Another approach to the treatment of intervertebral disc herniation is to remove the nucleus constituents inside the intervertebral disc to reduce the pressure inside the intervertebral disc, thereby restoring the protruding portion of the intervertebral disc to spontaneously revert to the intervertebral disc. As a non-surgical operation, a radiofrequency electrode is inserted into the intervertebral disc, and then a radiofrequency is applied to the tissue around the electrode using a radiofrequency to generate electrons and positive charges. There is a method of removing in a gaseous state separated by ions. The method of removing the tissue in the body by using the radiofrequency electrode can reduce the hospital stay in hospital, significantly reduce the cost of surgery and reduce the risk of side effects after surgery compared to the surgical procedure

In order to perform such a procedure, the electrode should be approached to the desired human body part. When using a straight electrode, the accessible part within the human body is extremely limited and thus becomes ineffective.

Accordingly, various technologies have been developed to bend an electrode in a human body to reach a desired human part.

1 is a diagram of a conventional electrode body described in Korean Patent Publication No. 10-1104851, wherein the electrode body 12 is manufactured in a state of being bent in a predetermined direction in advance and inserted into the outer tube 11 in a straight line or an outer tube ( Protruding from 11 is bent in a predetermined direction. In the prior art, since the electrode body 12 can only be bent to a predetermined degree, there is a problem that a part that can be reached in the human body is still limited.

2 is a perspective view and a partially exploded view of a conventional electrode body published in Japanese Patent Laid-Open No. 10-2009-0127835. The conventional electrode body in FIG. 2 inserts the direction control ring 10 and connects the two

wires

11 and 12 to the rear end of the direction control ring 10 to have a phase difference of 180 degrees to connect the

wires

11 and 12. The direction of the electrode body was adjusted by pulling.

However, in this method, when one of the two wires 11 is pulled to bend one side 13 of the direction control ring in the A direction, there is a ring of metallic material on the side 14 with the undrawn wire. Due to the poor bending, the operator had to apply excessive force.

The present invention has been invented to solve the above-described problems, the present invention can be easily operated with a relatively small force, while reaching the electrode accurately to the desired human body parts by using RF thermal energy to local or selective It is an object of the present invention to provide an electrode body that can be removed with a surgical instrument comprising the same.

Electrode for electrosurgical operation according to the present invention

A first electrode part including a cap, a connecting body having an inclined surface connected to a rear end of the cap, a cylindrical body connected to a rear end of the connecting body, and a first electrode line connected to the cylindrical body;

An insulation part surrounding the connecting body and the cylindrical body;

A second electrode part including a ring surrounding the cylindrical body with the insulating part interposed therebetween, and a second electrode line connected to the ring;

Insertion tube extending to the rear end of the insulating portion; And

Direction control including a direction switch line having a phase difference of 180 degrees inside the insertion tube and installed at positions different from each other at a distance from the cap, and a direction control plate connected to a direction change plate installed near the cap among the direction change plates. It is characterized by including a wealth.

Surgical instrument according to the present invention is a surgical instrument comprising an electrode body, an induction tube for accommodating the electrode body therein, and a regulator connected to one end of the electrode body and the induction tube to adjust the electrode body and the induction tube; as,

The electrode body includes the electrode body as described above,

The regulator is connected to the induction pipe is characterized in that the induction pipe control button is installed to slide the induction pipe in the front and rear direction.

Since the inside of the human body is filled with various substances including fluids, it is necessary to change the direction of the electrode body inside the human body, which requires a considerable force, which may cause the operator to make a mistake, but the surgical procedure according to the present invention Since the first turning plate connected to the direction control line and the second turning plate not connected to the direction control line do not face each other, the direction of the first turning plate is changed when the direction is changed by pulling the first turning plate. Unobstructed by this second turning plate, the turning can be performed with a relatively small force.

In addition, since the turning plate is inserted into the electrode body in a pre-bent state, there is an advantage that the turning is easier.

1 is a diagram of a conventional electrode body described in Korean Patent Publication No. 10-1104851;

2 is a perspective view and a partially exploded view of a conventional electrode body published in Japanese Patent Laid-Open No. 10-2009-0127835,

3 is a front view of an electrode body according to the present invention;

4 is a cross-sectional view of the XX 'portion of FIG.

5 is a cross-sectional view of each component constituting the electrode body according to the present invention,

6 is a cross-sectional view of the state without protrusions in FIG.

7 is a cross-sectional view taken along the line YY 'in FIG. 3;

8 is a view showing a coupling method of the soft portion and the hard portion,

9 is a schematic view of a surgical procedure apparatus according to the present invention.

Advantages and features of the present invention, and methods for achieving them will be apparent with reference to the embodiments described below in detail in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below, but may be implemented in various different forms.

In this specification, the embodiments are provided so that the disclosure of the present invention may be completed and the scope of the present invention may be completely provided to those skilled in the art. And the present invention is only defined by the scope of the claims. Thus, in some embodiments, well known components, well known operations and well known techniques are not described in detail in order to avoid obscuring the present invention.

Also, like reference numerals refer to like elements throughout. In addition, the terms used (discussed) herein are for the purpose of describing the embodiments are not intended to limit the invention. In this specification, the singular also includes the plural unless specifically stated otherwise in the phrase. In addition, components and operations referred to as 'includes (or includes)' do not exclude the presence or addition of one or more other components and operations.

Unless otherwise defined, all terms (including technical and scientific terms) used in the present specification may be used in a sense that can be commonly understood by those skilled in the art. In addition, the terms defined in the commonly used dictionary are not ideally or excessively interpreted unless they are defined.

Hereinafter, technical features of the present invention will be described in detail with reference to the accompanying drawings.

3 is a front view of an electrode body according to the present invention, FIG. 4 is a cross-sectional view of part XX 'of FIG. 3, and FIG. 5 is a cross-sectional view of each component constituting the electrode body according to the present invention.

3 to 5, the electrode body according to the present invention includes the first electrode part 110, the second electrode part 130, the insulation part 120, the insertion tube 140, and the direction control part 150. ).

The first electrode unit 110 includes a cap 111, a connector 112, a cylindrical body 113, and a first electrode line 114.

The cap 111 corresponds to the foremost portion of the electrode body 100, which substantially serves as the first electrode. The shape of the cap 111 is not particularly limited, but in order to minimize resistance when inserting the body, it is preferable to manufacture the round shape.

The connecting body 112 is connected to the rear end of the cap 111 and has an inclined surface. Due to the inclined surface, the insulating part surrounding the connecting body 112 is prevented from being separated from the first electrode part 110, thereby making it possible to reliably maintain the insulating state between the first electrode part 110 and the second electrode part 130. do.

The cylindrical body 113 is a cylindrical shape connected to the rear end of the connecting body 112, the diameter of the cylindrical body 113 is smaller than the maximum diameter of the connecting body 112, the outside of the cylindrical body 113 is the insulating portion 120 ) Is wrapped.

The first electrode line 114 is connected to the cylindrical body 113, which is finally connected to the regulator 300.

The first electrode 110 is not particularly limited as long as the radiation frequency current can flow. Preferably, the first electrode 110 is made of any one of stainless steel, general alloy steel, titanium steel, and shape memory alloy.

On the other hand, the rear end of the cylindrical body 113 may be further attached to the rod-shaped protrusions 115 protruding rearward. The protrusion 115 will be described in detail in the method of manufacturing the electrode body, which will be described later, which is a part for improving the bonding strength between the first electrode part 110 and the insertion tube 140. There is no particular limitation on the cross-sectional shape of the projections, but it is preferable to make it rectangular in terms of preventing rotation. For reference, FIG. 4 is a state where protrusions are attached, and FIG. 6 is a cross-sectional view of a state without protrusions.

The second electrode unit 130 includes a ring 131 and a second electrode line 132. The ring 131 surrounds the outside of the insulating portion 120 surrounding the cylindrical body 113 and substantially serves as a second electrode. The second electrode line 132 is connected to the inside of the ring 131, which is finally connected to the regulator 300.

Like the first electrode 110, the second electrode 130 is not particularly limited as long as the radiation frequency current can flow, but is preferably a metal, more preferably stainless steel, general alloy steel, or titanium. It is made of one of steel and shape memory alloy.

In addition, the first electrode unit 110 and the second electrode unit 130 may be an anode or a cathode, and the first electrode unit 110 and the second electrode unit 130 must have different polarities.

The insulating part 120 surrounds the connecting body 112 and the cylindrical body 113 of the first electrode part 110, which electrically insulates the first electrode part 110 and the second electrode part 130. Do it. Heat is applied while the cylindrical insulation portion is inserted into the connecting body 112 and the cylindrical body 113 to form an insulation portion 120 having a shape as shown in FIGS. 3 to 5. For this purpose, the insulation must be electrically non-conductive and heat resistant. The material of the insulating part 120 is preferably at least one member selected from the group consisting of ceramic, silicon, fluorine resin, and heat shrinkable polymer. Examples of the ceramics include Al2O3 and the like. Examples of the silicon include SiO 2 and the like. Examples of the heat shrink polymer include polytetrafluoroethylene (PTFE), tetrafluoroethylene-hexafluoropropylene (FEP), tetrafluoroethylene-perfluoroalkyl vinyl ether (PFA), ethylene-tetrafluoroethylene ( ETFE), polyester (PET), polyesteramide (PEA), polyether ether ketone (PEEK), and the like.

Insertion tube 140 is a tube portion extending to the rear end of the insulating portion 120, the first electrode line 114, the second electrode line 132 and the direction control unit 150 therein and serves to protect them Do it. In addition, when the electrode body 100 is bent in a desired direction, it corresponds to a portion that is substantially bent.

Meanwhile, the insertion tube 140 may be made entirely of one material, but preferably, the insertion tube 140 may be divided into a hard part 141 made of a relatively high strength material and a soft part 142 made of a relatively low strength material. have.

The hard part 141 is a part connected to the rear end of the insulator 120, and this part prevents the insertion tube 140 from being damaged by unwanted RF energy generated at the rear end of the ring 131. The soft part 142 is connected to the rear end of the hard part 141 and is connected to the regulator 300, and accommodates the first electrode line 114, the second electrode line 132, and the direction control line therein. It is a part bent by direction adjustment.

The hard part 141 is preferably made of polyimide or ceramic material,

The soft part 142 is preferably made of polytetrafluoroethylene (PTFE) or ethylene tetrafluoroethylene (ETFE) material.

Since the hard part 141 from the cap 111 is made of a metal or a material of high hardness, this part is substantially not bent by the direction adjusting part, and corresponds to a part where the soft part of the rear end is substantially bent.

The direction controller 150 includes a direction switching plate 151 and a direction control line 154.

The turning plate 151 includes a first turning plate 152 to which the direction control line 154 is connected and a second turning plate 153 to which the direction control line 154 is not connected. The two turning plates 151 are installed to have a phase difference of 180 degrees inside the insertion tube, and the two turning plates 151 are installed at different distances from the cap 111. The first direction switching plate 152 is installed at a close distance from the cap 111, preferably in the hard portion 141.

Since the first direction switching plate 152 and the second direction switching plate 153 are installed at different distances from the cap 111, the cross section of the insertion tube 140 of the portion where the first direction switching plate 152 is located. As shown in FIG. 7, the second direction switching plate 153 is not substantially provided at the portion where the first direction switching plate 152 is connected to the direction control line 154. For reference, FIG. 7 is a cross-sectional view of the portion YY 'in FIG.

Thus, when the first direction switching plate 152 is pulled by using the direction control line 154, the opposite side B of the first direction switching plate 152 is not the second direction switching plate 153 of a hard metal material. Since the electrode 100 is filled with a component having a lower hardness than the metal constituting the insertion tube, the electrode body 100 can be easily bent in a desired direction in the human body with only a relatively small force.

On the other hand, the second direction switching plate 153 is not connected to the direction control line 154, it simply maintains the state inserted into the insertion tube 140, which is the electrode body in the direction of the first direction switching plate 152 By preventing the bend too easily, as a whole it serves to adjust the electrode body to bend as much as desired.

The first turning plate 152 and the second turning plate 153 are preferably made of any one or more of metal, stainless steel, or polymer material having a hardness of more than 60 Crowell hardness (HRc). It can be manufactured in various forms that can be prevented, for example, a square or a rod shape.

In addition, the first turning plate 152 and the second turning plate 153 should be located at different distances from the cap 110. Based on the distance from the cap 110, the second turning plate 153 is preferably installed so as not to overlap at least 1/2 of the length of the first turning plate 152 and the first turning plate 152. Also, even when the first direction switching plate 152 and the second direction switching plate 153 are spaced apart, it is preferable that the distance between them does not exceed 10 mm. This is because if the overlap is more than 1/2, a large amount of force is actually required during the change of direction, and if it exceeds 10 mm, the middle part may be bent.

On the other hand, any one or more of the first turning plate 152 and the second turning plate 153 may be processed in a slightly curved state in advance so that it can be easily bent in the human body. In this case, since the electrode body 100 may be slightly bent in a direction in which the electrode body 100 is bent in advance at the moment of protruding from the induction pipe 200 to be described later, the operator may be more convenient to operate.

In addition to the turning plate 151, the portion from the cap 111 to the hard part 141 may be processed in a slightly curved state in advance. This can be processed in a curved state as desired by adding a binder such as lactite and curing in a slightly curved state in the process of making the electrode body.

Direction control line 154 is connected to the rear end of the first direction switching plate 152, which should be finally connected to the regulator 300. The direction control line 154 is preferably made of any one or more of stainless steel, alloy wire, or elastic polymer material.

The present invention allows the electrode body to be bent substantially only toward the side where the first turning plate 152 is installed by using the fact that the electrode wire is bent in only one direction in the human body, thereby allowing the electrode body to be bent. The part can be easily accessed, and furthermore, when the direction control line for pulling the first direction switching plate 152 is released, it can be removed from the human body by using the property of returning to its original position by elasticity.

Next, the assembly method of the electrode body by this invention is demonstrated.

Heat is applied in a state where the circular insulating part 120 is covered on the outside of the first electrode part 110 so that the insulating part 120 is in close contact with the outside of the first electrode part 110.

The second electrode part 130 is inserted into the outside of the insulating part 120 to be in close contact with the cap 111.

After connecting the hard part 141 to the rear end of the insulator 120, the first turning plate 151 is inserted into the hard part 141, and an adhesive such as lactite is inserted into the electrode body. .

Next, the soft part having three passages through which three lines of the first electrode line 114, the second electrode line 132, and the direction control line 154 pass may be coupled to the rear end of the hard part. In this case, when the second turning plate 153 is not inserted into the hard part 141, a separate groove (not shown) for inserting the second turning plate 153 into the soft part should be formed. .

On the other hand, various methods may be used to improve the strength of the bond when the soft portion and the hard portion are bonded.

8 illustrates a method of joining the soft portion and the hard portion. As shown in FIG. 8 (a), the protrusion 115 protruding from the cylindrical portion 113 of the first electrode portion extends to the end of the hard portion 141, and the protrusion 115 is formed on the soft portion. You can also use adhesive to bond to the groove,

Furthermore, as shown in FIG. 8 (b), a protrusion may be made at the end of the hard part 141, and a recess may be formed at the end of the soft part 142 to accommodate it, and then, the adhesive may be bonded between them. have.

Of course, the protruding portion and the recessed portion may be formed opposite to each other in the hard portion 141 and the soft portion 142 as shown in FIG.

Next, a surgical procedure apparatus including the electrode body 100 described above will be described.

9 is a schematic view of a surgical procedure apparatus according to the present invention. As shown in FIG. 9, the surgical procedure device according to the present invention includes an electrode body 100, an induction pipe 200, and a regulator 300.

Since the electrode body 100 has been described in detail above, further description thereof will be omitted.

The induction pipe 200 is a tube that accommodates the electrode body 100 therein, which invades the human body through a needle (not shown) in a state in which the electrode body 100 is accommodated therein.

Since the adjuster 300 is a part that the operator grips and manipulates by hand, the adjuster 300 should be manufactured in a form that is easy to handle and easy to manipulate by hand. The controller 300 has an operation switch (not shown) for generating RF, an operation knob 310 for pulling and releasing a direction change line, and an induction pipe control button 320 for controlling the movement in the front and rear directions of the induction pipe 200. ) Must be installed. Since the operation switch is not much different from the prior art, the description of this part is omitted.

Induction pipe control button 320 is to slide the induction pipe 200 forward or backward, which is mechanically connected to the induction pipe 200, while the induction pipe control button 320 is slid back and forth induction pipe 200 Is also sliding together. As the induction pipe 200 slides backward, the electrode body 100 protrudes outward.

The operation knob 310 is used by the operator to adjust the direction of the electrode body 100 by pulling or releasing the direction change line, which may be used conventionally. However, a fixing device for fixing the direction control line 154 may be additionally installed so that the direction control line 154 may be continuously maintained in the pulled state.

Next, the procedure using the surgical instrument according to the present invention will be briefly described.

The electrode body 100 is invaded into the human body in the state accommodated in the induction tube, and by using the induction tube control button 320 to reverse the induction tube to expose a portion of the electrode body 100 into the human body.

In this state, the direction control line 154 is pulled to move the end of the electrode body 100 to a desired body part, and then a desired procedure is performed.

After the procedure, after releasing the direction control line 154 to advance the induction tube while making the electrode body 100 in its original shape, it is removed from the human body.

Claims

A first electrode part including a cap, a connecting body having an inclined surface connected to a rear end of the cap, a cylindrical body connected to a rear end of the connecting body, and a first electrode line connected to the cylindrical body;

An insulation part surrounding the connecting body and the cylindrical body;

A second electrode part including a ring surrounding the cylindrical body with the insulating part interposed therebetween, and a second electrode line connected to the ring;

Insertion tube extending to the rear end of the insulating portion; And

Direction control including two direction changing plate having a phase difference of 180 degrees inside the insertion tube and the distance from the cap is different from each other, and a direction control line connected to the direction changing plate installed near the cap among the direction changing plate. Electrosurgical electrode body comprising a portion.
The electrode body for electrosurgical treatment according to claim 1, wherein the direction changing plate has a square or rod shape.
The electrode assembly of claim 1, wherein the diverter plate is made of at least one of a polymer material having a hardness of 60 or more based on metal, stainless, or Crowell hardness.
The method of claim 1, wherein a point close to the cap of the turning plate located at a distance from the cap among the two turning plates is at least 10 mm at a point not overlapping with the turning plate located at a distance from the cap by at least 1/2 mm. Electrosurgical electrode body, characterized in that located between the non-spaced points.
The electrode assembly for electrosurgical treatment according to claim 1, wherein a protrusion is formed at a rear end of the cylindrical body, and the protrusion is inserted into an insertion tube.
The method of claim 1, wherein the insertion tube is made of a polyimide or ceramic material in contact with the insulating portion and a polytetrafluoroethylene (PTFE) or ethylene tetrafluoroethylene (ETFE) material extending at the rear end of the reinforcing portion. Electrosurgical electrode body comprising a soft portion.
The electrode assembly for electrosurgical treatment according to claim 1, wherein at least one of the two turning plates is bent in one direction.
A surgical procedure apparatus comprising an electrode body, an induction tube accommodating the electrode body therein, and an adjuster connected to one end of the electrode body and the induction tube to adjust the electrode body and the induction tube,

The electrode body is

A first electrode part including a cap having a rounded shape, a connecting body having an inclined surface connected to a rear end of the cap, a cylindrical body connected to a rear end of the connecting body, and a first electrode line connected to the cylindrical body;

An insulation part surrounding the connecting body and the cylindrical body;

A second electrode part including a ring surrounding the cylindrical body with the insulating part interposed therebetween, and a second electrode line connected to the ring;

Insertion tube extending to the rear end of the insulating portion;

Insertion tube extending to the rear end of the insertion tube; And

At least one of the insertion tube and the insertion tube has a phase difference of 180 degrees and the direction control unit including a direction control line connected to the direction change plate and two direction change plates installed at positions different from each other from the cap; Include,

The adjuster is a surgical operation device comprising an electrode assembly for electrosurgical operation, characterized in that the induction pipe control button is connected to the induction pipe to slide the induction pipe in the front and rear direction.