Title of Invention: ELECTRODE NEEDLE OF RADIO FREQUENCY ABLATION DEVICE

Technical Field

[1] The present invention relates to an electrode needle of a radio frequency ablation

(RFA) device (including a high frequency thermotherapy device and a micro ablation device) and, more particularly, to an electrode needle of an RFA device, which is inserted into a human body to cauterize a lesion portion by using RF (including high frequency and microwave) heat, capable of easily checking the position or depth of the electrode needle for a medical operation within the human body. Background Art

[2] A general RFA device is used to heat a lesion portion such as cancerous tissue, or the like, with RF to cauterize it to death.

[3] When cancerous tissue, or the like, is generated in organs such as the liver or the thyroid gland, it is treated with a surgical operation method and a non-surgical operation method.

[4] Recently, the non-surgical operation method has been commonly used. Transarterial chemoembolization (TACE), Percutaneous Ethanol Injection (PEIT), Systemic chemotherapy, partial heat treatment (local thermotherapy), and the like, are known as common non-surgical operation methods, and among them, partial heat treatment is reported to be the most effective.

[5] Partial heat treatment includes RFA (including microwave ablation), laser ablation, and the like, and among them, thermal treatment using RF (including high frequency and microwave) is favored by doctors or patients because it is considered to be the most effective treatment.

[6] The electrode device for RFA is configured such that an electrode needle radiating

RF is assembled to have a grip body (i.e., a body to be gripped), a cooling line for cir- culatively supplying cooling water into the interior of the grip body and the electrode needle, and an insulating portion is formed on an outer circumferential surface of the electrode needle. Accordingly, the electrode needle passes through the skin of a human body so as to be inserted into the lesion portion.

[7] Then, as power is applied to the electrode needle from an external source, the electrode needle inserted into the lesion portion is heated to radiate RF, and the lesion portion, such as the cancerous tissue or the like, is cauterized and coagulated to death by the RF radiated from the electrode needle and heat.

[8] However, when the related art electrode needle for RFA is inserted into the lesion portion while being observed by imaging equipment, for example, an ultrasound imaging device or X-ray, an operator (i.e., a person who provides a medical treatment or performs a medical operation) cannot accurately recognize how deep the electrode needle has been inserted, being exposed to the possibility that he or she will insert the electrode needle either too deeply or too shallowly, as well as the possibility that he or she will even insert the electrode needle into the lesion portion several times, depending on his or her experience or know-how. That is, the operation is not smoothly performed.

[9] Thus, a method for accurately recognizing the position of a medical (or surgical) operation by using imaging equipment, for example, an ultrasound imaging device, or by irradiating X-rays allowing for the ascertaining of degree of insertion of the electrode needle when the electrode needle is inserted for a medical operation, and an improved electrode needle having a marker attached to facilitate indicating the position of a guide tube capable of variably adjusting the length of an energized portion (exposed part) of an electrode pin at an electrode having the guide tube.

[10]

Disclosure of Invention Technical Problem

[11] An aspect of the present invention provides an electrode needle of a radio frequency ablation (RFA) device capable of allowing the position of a medical operation of an electrode pin with markers formed thereon and a guide tube to be easily recognized according to a radiation non-transmissive operation and diffused-reflection operation of ultrasonic waves when X-rays are applied or ultrasonic waves are radiated by using ultrasound imaging equipment from the exterior of a human body.

[12] Another aspect of the present invention is to form a marker by bending a thin plate in a band- like shape or winding a wire to thus increase the utilization of the marker according to its usage conditions.

[13] Another aspect of the present invention is to attach a marker to a guide tube to facilitate the indication of the position of the guide tube, which is configured such that the length of an energized portion of an electrode pin can be variably adjusted, thus allowing for the easy recognition of an operational depth of the electrode needle and the range of energization. Solution to Problem

[14] According to an aspect of the present invention, there is provided an electrode needle of an RFA device, which is inserted into a lesion portion to cauterize the lesion portion by using RF radiated from the RFA device, wherein an electrode pin having a tip end is coupled to one end of an electrode main body that can be held or grasped by a user's hand, one or more markers coated or plated with a radiation non-transmissive material thereon are inserted into or wound around an outer circumferential surface of the electrode pin and then fixedly bonded by using a polymer adhesive, regions, excluding an end portion, of the electrode pin are wrapped (or covered), along with the markers, with an insulating tube, and heat is then applied thereto to allow the insulating tube to be contracted to fixedly compress the markers, whereby the position of the electrode pin can be easily recognized according to a non-transmissive operation when X-rays are irradiated to the marker or according to a diffused-reflection operation of ultrasonic waves when the marker is observed by using ultrasound imaging equipment in a state in which the electrode needle is inserted for a medical operation.

Advantageous Effects of Invention

[15] As described above, the position of a medical operation of an electrode pin and a guide tube with markers formed thereon can be easily recognized according to a radiation non-transmissive operation and diffused-reflection operation of ultrasonic waves when X-rays are applied or ultrasonic waves are radiated by using ultrasound imaging equipment from the exterior of a human body.

[16] Because the marker is formed by bending a thin plate in a band- like shape or winding a wire, utilization of the marker can be increased according to its usage conditions.

[17] Also, because the marker is attached to a guide tube to facilitate the indication of the position of the guide tube, which is configured such that the length of an energized portion of an electrode pin can be variably adjusted, an operational depth of the electrode needle and the range of energization can be easily recognized. Brief Description of Drawings

[18] FIG. 1 is an overall perspective view of an electrode needle connected to a radio frequency ablation (RFA) device according to an exemplary embodiment of the present invention;

[19] FIG. 2 is an overall front view of the electrode needle with a guide tube connected to the RFA device according to an exemplary embodiment of the present invention;

[20] FIG. 3 is an enlarged perspective view of the electrode needle of FIG. 1 ;

[21] FIG. 4a is a view showing the process of bonding a marker in a band- like shape to an electrode pin of the electrode needle of FIG. 1 ;

[22] FIG. 4b is a sectional view taken along line A-A in FIG. 4a;

[23] FIG. 5a is a view showing the process of fixing the marker in the coil-like shape to the electrode pin of the electrode needle of FIG. 1 by using an insulating tube;

[24] FIG. 5b is a sectional view taken along line B-B in FIG. 5a;

[25] FIG. 6 is a partially enlarged front view of the guide tube of FIG. 2;

[26] FIG. 7a is a view showing the process of fixing the marker in the band-like shape to the guide tube by using a polymer adhesive;

[27] FIG. 7b is a sectional view taken along line C-C in FIG. 7a;

[28] FIG. 8a is a view showing the process of fixing the marker in a coil-like shape to the guide tube by using a polymer adhesive;

[29] FIG. 8b is a sectional view taken along line D-D in FIG. 8a;

[30] FIG. 9a is a view showing the process of fixing the marker in the band-like shape to the guide tube by using an insulating tube;

[31] FIG. 9b is a sectional view taken along line E-E in FIG. 9a;

[32] Fig. 10a is a view showing the process of fixing the marker in the coil-like shape to the guide tube by using an insulating tube;

[33] FIG. 10b is a sectional view taken along line F-F in FIG. 10a;

[34] FIG. 11 is a view showing how the electrode needle of FIG. 1 is used for a medical operation; and

[35] FIG. 12 is a view showing how the electrode needle of FIG. 2 is used by using a guide tube for a medical operation. Best Mode for Carrying out the Invention

[36] Hereinafter, an exemplary embodiment of the present invention will now be described with reference to the accompanying drawings.

[37] As shown in FIGS. 1 and 3, an electrode needle 100 of a radio frequency ablation

(RFA) device according to an exemplary embodiment of the present invention, which is to be inserted into a lesion portion to cauterize the lesion portion by using RF radiated from the RFA device, includes an electrode main body 11, an electrode pin 12, markers 20 fixedly inserted to or wound around an outer circumferential surface of the electrode pin 12, and an insulating tube 13 coupled to wrap the outer circumferential surface of the electrode pin 12 and the markers 20 therein.

[38] The electrode main body 11 is configured to allow a user to hold it with his hand and connected to the RFA device (not shown) by using an electrode line 11a through which RF and cooling water are supplied.

[39] Here, one end of the electrode line 1 Ia is connected to the electrode main body 11, and a connector 1 Ib, which is connected to an RF generator, is connected to the other end of the electrode line 11a.

[40] The electrode pin 12, having a tip end (i.e., having such a form that its end is acute), is connected to be coupled to one end of the electrode main body 11 such that it can be provided with RF and cooling water.

[41] The electrode pin 12 has a hollow therein to allow cooling water to circulate therein to reduce heat when RF heat is generated.

[42] One or more markers 20, coated with a non-transmissive (or opaque) material on its surface, are formed to be inserted into or wound around the outer circumferential surface of the electrode pin 12.

[43] As shown in FIGS. 4a and 4b, the markers 20 are configured by bending a thin plate coated or plated with a radiation non-transmissive material thereon in the shape of a band and inserting it into the outer circumferential surface of the electrode pin 12.

[44] As shown in FIGS. 5a and 5b, in another example, the marker 20 may also be configured by winding a wire 21 coated or plated with a radiation non-transmissive material thereon on the outer circumferential surface of the electrode pin 12.

[45] The marker 20 formed on the electrode pin 12 is fixed to the electrode pin 12 by using a polymer adhesive (P) in order to prevent the marker 20 from moving on the electrode pin 12.

[46] An insulating tube 13 wraps the regions, excluding an end portion, of the outer circumferential surface of the electrode pin 12 and the markers 20 to insulate them.

[47] Namely, the insulating tube 13 is configured to prevent human body tissues, other than the lesion portion, from being cauterized when RF is transmitted to the electrode pin 12.

[48] When heat is applied to the insulating tube 13 covering the electrode pin 12 and the markers 20, the insulating tube 13 is contracted, allowing the marker 20 to be fixedly compressed.

[49] As shown in FIGS. 2 and 6, the electrode needle 100 of the RFA device according to an exemplary embodiment of the present invention, which is to be inserted into a lesion portion to cauterize the lesion portion by using RF radiated from the RFA device, includes the electrode main body 11, the electrode pin 12, a guide tube 14 formed as a polymer tube or a metal pipe and inserted into the outer circumferential surface of the electrode pin 12 such that it moves up and down on the outer circumferential surface of the electrode pin 12, and the markers 20 inserted into or wound around the outer circumferential surface of the guide tube 14.

[50] The electrode main body 11 is configured to allow a user to hold it with his hand and connected to the RFA device (not shown) by using an electrode line 11a through which RF and cooling water are supplied.

[51] Here, one end of the electrode line 1 Ia is connected to the electrode main body 11, and a connector 1 Ib, which is connected to an RF generator, is connected to the other end of the electrode line 11a.

[52] The electrode pin 12, having a tip end (i.e., having such a form that its end is acute), is connected to be coupled to one end of the electrode main body 11 such that it can be provided with RF and cooling water.

[53] The electrode pin 12 has a hollow therein to allow cooling water to circulate therein to reduce heat when RF heat is generated. [54] The guide tube 14 wraps the regions, excluding an end portion, of the electrode pin

12 therein and is formed as a polymer tube or a metal pipe. When a switch l ie formed on the electrode main body 11 is operated, the guide tube 14 is drawn out of the electrode main body 11 or inserted into the electrode main body 11 to adjust the length of an energized portion of an electrode pin 12.

[55] Namely, how the markers 20 are fixed varies depending on the material of the guide tube 14.

[56] The markers 20 coated or plated with a radiation non-transmissive material on its surface is formed on the outer circumferential surface of the guide tube 14. One or more markers 20 may be inserted into or wound around the outer circumferential surface of the guide tube 14.

[57] As shown in FIGS. 7a and 7b, the markers 20 are configured by bending a thin plate coated or plated with a radiation non-transmissive material thereon in the shape of a band and inserting it into the outer circumferential surface of the guide tube 14.

[58] As shown in FIGS. 8a and 8b, in another example, the marker 20 may also be configured by winding a wire 21 coated or plated with a radiation non-transmissive material thereon on the outer circumferential surface of the guide tube 14.

[59] As shown in FIGS. 7a to 8b, when the guide tube 14 is a polymer tube, the marker 20 may be fixedly bonded to the guide tube 20 with a polymer adhesive (P) which is harmless to the human body, and when the guide tube 14 is manufactured as the polymer tube, it can provide an insulating function, the same function as that of the insulating tube 13.

[60] As shown in FIGS. 9a to 10b, when the guide tube 14 is a metal pipe, the outer side of the marker 20 bonded by the polymer adhesive (P) is wrapped with the insulating tube 13, and heat is applied thereto. Then, the insulating tube 13 is contracted to allow the marker to be fixedly compressed.

[61] The electrode needle 100 is configured to facilitate recognition of the position of the electrode pin 12 or the guide tube 14 according to a non-transmissive operation when X-ray is irradiated to the marker 20 or according to a diffused-reflection operation of ultrasonic waves when the marker 20 is observed by using ultrasound imaging equipment, in a state in which the electrode needle 100 is inserted for a medical operation.

[62] The operation and effect of the electrode needle of an RFA device configured as described above according to an exemplary embodiment of the present invention will now be described.

[63] As shown in FIG. 11, in order to use the electrode needle, first, the connector 1 Ib connected to the electrode line 1 Ia is connected to an RF generator (not shown), a sort of RFA device. [64] Next, cooling water is circulatively supplied into the interior of the electrode pin 12, the position of a lesion portion 200 is checked, and the electrode pin 12 of the electrode needle 100 is inserted into the interior of the human body such that the electrode pin 12 protruded from the end of the insulating tube 13 is inserted into the lesion portion 200 such as a cancerous tissue.

[65] And then, when the RF generator is operated to oscillate RF, the oscillated RF is transferred in the order, starting from the connector 1 Ib the electrode line 11a the electrode main body 11 the electrode pin 12.

[66] In this state, when RF is supplied to the electrode pin 12 of the electrode needle 100 by manipulating the RF generator, RF is energized through the end of the electrode pin 12 not wrapped up by the insulating tube 13 to cauterize the lesion portion 200 with RF heat.

[67] At this time, because the outer surface of the electrode pin 12 positioned within the insulating tube 13 is insulated as it is wrapped up by the insulating tube 13, so that the RF cannot affect other normal human body tissues.

[68] The marker 20 is positioned at the inner side of the human body as the insulating tube 13 is inserted in the process of the medical procedure of the electrode needle 100.

[69] Also, while the electrode needle 100 is being operated, because the marker 20 is coated or plated with the radiation non-transmissive material, the insertion depth or position of the electrode pin 12 or the insulating tube 13 can be simply checked by irradiating X-rays thereupon.

[70] As shown in FIG. 12, in another example, the guide tube 14 of the electrode needle

100 is formed as a polymer tube. The electrode pin 12 is inserted along with the guide tube 14, and in this case, the length of an energized portion of the electrode pin 12 can be adjusted by adjusting the length of an exposed portion of the guide tube 14 by operating the switch l ie according to the area or depth degree of the lesion portion 200, in order to adjust the range of cauterization and, because the position of the marker 20 formed on the guide tube 14 can be accurately recognized, whether or not the insertion is precisely performed for cauterization can be recognized.

[71] While the present invention has been shown and described in connection with the exemplary embodiments, it will be apparent to those skilled in the art that modifications and variations can be made without departing from the spirit and scope of the invention as defined by the appended claims.