JPH1024049A - Device for electric surgical operation - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a device for electric surgical operation for treating myoma, or more concretely, a multi-electrode device for necrotizing a mass quantity of leiomyoma of the uterus by use for one time. SOLUTION: A bipolar type electric myoma breaking device 10 for a surgical operation is provided with a thin and long shaft 14 of such a size as to be engaged in a cannula for a peritoneoscope operation to a myoma of the uterus which is also known as fibroma. The myoma breaking device 10 is designed to break a mass quantity of tissue by use for one time. A terminal end 16 of the shaft 14 has at least three electrodes 17 of such a design as to get in contact with the tissue. In a substitutional mode of execution of the myoma breaking device 10, four, six, or eight electrodes are provided. A power generator for a surgical operation is connected to the myoma breaking device 10 to provide a high frequency current to the electrodes 17. At least one electrode is connected to a first bipolar type output terminal of the power generator, and at least one of the other electrodes is connected to a second bipolar type output terminal.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to an electrosurgical device for treating fibroids, and more particularly, to a multi-electrode device for necrosis of leiomyomas of the uterus.

[0002]

BACKGROUND OF THE INVENTION Fibroids are tumors composed of muscle tissue.
The tumor that arises in the uterus is a leiomyoma. This type of tumor is also called fibroid.

[0003] Leiomyomas of the uterus are benign tumors that usually occur in the muscle layer of the uterus. Such tumors are found in 20% to 30% of women of childbearing age. The highest incidence of leiomyomas is in women in their 50s. Of the hysterectomy performed in the United States, more than 25% have developed fibroids.

[0004] Depending on size and location, fibroids may be completely asymptomatic or cause back pain, dyspareunia, pressure, dysuria, recurrent menorrhagia. Uterine leiomyomas are rarely malignant;
%.

[0005]

There are currently four basic treatments for uterine fibroids. Hormone therapy, the first of which is effective in reducing the volume of fibroids,
It may regrow after treatment has ceased. Furthermore, hormones are expensive and can cause undesirable side effects.

The second method, hysterectomy, involves complete removal of the uterus. This is the only permanent method of removing fibroids, but makes pregnancy impossible and requires long hospital stays. Hysterectomy methods can also cause serious complications such as ureteral, bladder and intestinal damage.

[0007] The third method is a method for removing fibroids. This is a complicated method depending on the size and location of the fibroids. Removal of fibroids retains the possibility of pregnancy in some patients, but is technically more difficult and has higher mortality than hysterectomy. This method is not appropriate in cases where it is difficult to close the uterine wall after removing fibroids.

A fourth method for treating leiomyomas of the uterus is
This is a method for disrupting fibroids. This treatment is less complicated than removal of fibroids, since fibroids do not need to be removed surgically. Instead, fibroid fibers are destroyed by laser or electrosurgical methods through desiccation of the cells. For this reason, fibroids contract sufficiently to be asymptomatic. Also, the fibroids may contract because the vasculature that supplies blood to the entire fibroids is disrupted. At least some of the dead tissue is ultimately removed from the patient's body by natural processes. Destruction of fibroids has the advantage of preserving the uterus and minimizing hospital stay.

[0009] Destruction of fibroids can be performed by an endoscopic method such as a laparoscopic method or a transvaginal method. Laparoscopic techniques use a cannula and an instrument for fibroid disintegration can be introduced through the cannula. Transvaginal techniques can be performed through the cervix or the vaginal disc. The fibroid disintegration device and method disclosed herein can be used in any of these methods.

[0010] Dr. Herbert Goldfarb, February 1994.
, "Method of removing uterine fibroids by laparoscopic method (Removing Uterine Fibro)
ids Laparoscopically)
The use of laser and electrosurgical techniques to coagulate uterine leiomyomas laparoscopically has been described. The electrosurgical procedure described in this article introduces a bipolar instrument with two steel needles. This device is 1
In a single use, only a small amount of tissue can be desiccated. Thus, the physician must repeatedly pierce the needle with different parts of the fibroid to completely necrotize the tissue. The Journal of Gynecological Laparoscopy Association, February 1995 (The Journal of the Gynecological Society)
e American Association of
Gynecological Laparoscopis
ts), another paper published by Herbert Goldfarb, "Bipolar Laparoscopic Needed for Coagulation of Fibroids.
les for Myoma Coagulatio
n) ", an average of 30 bipolar needles
Reports that they have to pierce ~ 50 times.

Currently, two bipolar electrosurgical devices are available for uterine fibroid disintegration. One such device is J. J., 14 Herzog Place, Hicksville, New York, 11801. E. FIG. M. D. It is a bipolar needle available from Medical. The other device is the Resnick Surgical Instruments (R.K.
eznic Surgical Instrument
s) is manufactured. Currently, both designs available are bipolar with two needles. Such a device can only desiccate a small amount of tissue in a single use. Both of these designs have the disadvantage that the fibroid has to be punctured many times. This increases the time required for surgery and increases the risk of accidentally damaging adjacent tissue.

[0012] Other devices for treating tumors are also known. For example, U.S. Pat. No. 4,763,671 discloses a method of treating a tumor by selectively applying heat and radiation. The method includes inserting a plurality of flexible catheters, each holding an external electrode, into a tumor. Next, an electrosurgical current is passed between the electrodes to selectively heat the tumor. In addition, a radioactive material is inserted into one of the catheters to necrosis the tumor.

US Pat. No. 4,776,334 discloses a catheter for use in treating tumors. The device has a plurality of conductors, each of which is individually connected to a high frequency current source. In addition, means are provided for separately detecting the temperature at each of the conductors so as to provide a continuous and uniform temperature throughout the tumor.

[0014] Other bipolar needle devices are known, but are not effective in the destruction of fibroids. For example, U.S. Patent No. 5,470,309 discloses a medical probe having a stylet port that allows a flexible stylet to extend perpendicular to the probe. This device cannot cause significant trauma to fibroid tissue in a single use due to the relatively limited RF field.
Also, this flexible stylet does not have the rigidity necessary to penetrate fibroids.

[0015]

SUMMARY OF THE INVENTION An electrosurgical myomalysis device can be dimensioned to pass through a cannula for laparoscopic surgery on the uterus. The end of the fibroid disintegration device has a plurality of electrodes designed to contact tissue. An electrosurgical generator is connected to the fibroid disruption device to provide high frequency current to the electrodes.

The fibroid disintegration device may be monopolar in one embodiment or bipolar in another embodiment. In a bipolar embodiment, the fibroid disintegration device works without the need for a separate return electrode to the patient. Also, this bipolar embodiment comprises at least one electrode connected to the first output of the generator and at least one other electrode connected to the second output of the generator. I have. In the monopolar embodiment, all electrodes are connected to the same generator output. In this monopolar embodiment, a return electrode to the patient is used separately,
It is electrically connected to the second output of the generator.

One advantage of the present invention is that each time the needle electrode is applied to a fibroid, a large amount of tissue can be necrotic.
This is due to the quality and spacing of the electrodes provided at the end of the device. Currently available bipolar needles have only two electrodes. That is, one electrode is connected to the first pole and the other electrode is connected to the second pole. An electrosurgical current flows between the two electrodes, necrosing the tissue between them. In the case of the present invention, it has been found that by providing three or more electrodes at the end of the device, a large amount of necrotic tissue can be generated. Currently, there are only two output poles, and typically each of the electrodes is connected to one or the other of the output poles. However, by providing more than two electrodes, the electrosurgical current can be widely distributed through the tissue. The importance of causing large trauma in fibroids is that the total time required to dry-destroy the fibroids is less than currently available devices. This is beneficial to the patient by reducing the overall time required for surgery.

Another advantage is that the device is used less frequently to necrosis fibroids. Less trauma to the uterus because the electrode is less often pierced into the fibroid. This can also result in damage to surrounding tissue,
Alternatively, the risk of adhesion is reduced.

Another advantage of the present invention is that the needle electrode can be retracted with respect to the sheath surrounding the needle electrode. This makes it possible to protect the physician from accidentally piercing the patient's tissue and the surgical staff. This also allows the physician to easily extract the needle electrode from the desiccated tissue without pulling on the surrounding structures. For example, fibroids can stick to a needle when pulled out. However, the shaft of the device can be used to hold the fibroid in place while the needle is withdrawn.

Another advantage of the present invention is that the needle electrode can be rubbed against the sheath to remove eschar deposits. The importance of rubbing the needle is that the electrosurgical current can be more uniformly applied from a clean needle due to the low contact impedance. A sheath for guiding and separating the electrodes can be incorporated into the spacing element at the distal end of the shaft.

Certain embodiments of the present invention have the advantage that an operating passage is available through the device. This allows the physician to use the fibroid disintegration device in a laparoscopic manner and to utilize the operating passageway for graspers, scopes or other devices. This gives the physician more freedom to use different instruments without having to insert another trocar into the patient.
One use is to provide a fibroid screw in the operating passage to hold the fibroid in place while introducing the needle electrode into the fibroid. This is especially important when the fibroids are composed of very dense or calcified tissue.

Another embodiment of the present invention has the advantage that it can be used transvaginally. Such an embodiment reduces or eliminates the need for a trocar. This makes it possible to use the invention in an operating procedure performed in the examination room.

[0023]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The fibroid disruption apparatus 10 shown in FIG.
Can be used to desiccate, coagulate and necrotize tissue in the uterus. The fibroid disintegration device 10
Is the first bipolar output terminal 12 as shown in FIG.
And an electrosurgical generator 11 having a second bipolar output terminal 13. The electrosurgical generator 11 has an output terminal 1.
RF transmitted to fibroid disintegration device 10 through 2 and 13
Generate an electrical waveform.

In a preferred embodiment, the fibroid disintegration device 10 has an elongated shaft 14 sized to fit within a cannula for laparoscopic surgery. In one embodiment, the shaft 14 is dimensioned to fit within a 10 mm cannula. In another embodiment, the shaft 14 is dimensioned to fit within a 5 mm cannula.

The shaft 14 has a proximal end 15 and a distal end 16. The proximal end 15 is designed to be used and controlled by a physician. The distal end 16 is designed to contact the patient's tissue. During operation of the fibroid disruption device 10, at least three electrodes 17 extend beyond the distal end 16 and come into contact with the patient's tissue.

The shaft 14 is very rigid and the electrodes 17
Can support enough force to push the fibroma into the fibroid. Certain fibroids have been identified to consist of dense tissue. This stiffness of the shaft 14 allows a physician to apply force without bending the fibroid disruption device 10.

Also, certain embodiments of the fibroid disintegration device 10 can be used endoscopically by reaching the fibroids vaginally. These embodiments are:
It has a curved shaft 14 to allow the doctor to more easily access the uterus. The electrode 17 in these embodiments extends at an angle with respect to the end of the shaft 14.

These electrodes 17 have a needle-like shape in a preferred embodiment. Those skilled in the art will understand that needle-like shapes include curved needles, needles of various cross-sections, and needles with sharp edges. The function of the electrode 17 is
To penetrate fibroids and transmit electrosurgical current. The term acicular shape is intended to mean a shape that can penetrate a fibroid. The needle electrode 17 is sufficiently rigid,
Therefore, these needle electrodes do not bend when pushed into the fibroid.

The fibroid disintegration device 10 can be monopolar in one embodiment, or bipolar in another embodiment. In a bipolar embodiment, the fibroid disintegration device 10 works without the need for a separate return electrode to the patient. One bipolar embodiment is illustrated in FIG. 3, where at least one electrode 17 is connected to the first output 12 of the generator 11 while at least one other electrode 17 is connected.
Is connected to the second output 13 of the generator 11. Each electrode in the preferred embodiment is electrically connected to one or the other of the outputs 12 or 13 of an electrosurgical generator 11. The monopolar embodiment connects all the electrodes to the same side of the generator output 12 or 13. A separate return electrode to the patient (not shown) is used in a monopolar embodiment, which is electrically connected to the second output of the generator.

The shaft 14 has an internal space 18 in which the electrodes 17 are stored in a manner that protects doctors and patients from accidental sticks. For example, the interior space 18 allows the sheath to slide over the distal end 16 and the electrode 17
Can be formed. The sheath can be slid along a portion of the shaft 14 to surround or expose the electrode 17. Alternatively, the interior of the shaft 14 can be partially hollow, creating an internal space 18 near the distal end 16 (a space where the electrode 17 can be safely pulled in, as shown in FIG. 6).

In a preferred embodiment, electrode 17 is
It is movably mounted to extend beyond the distal end 16 or to be retracted into the interior space 18. In another embodiment, the electrode 17 is fixedly secured to the end of the shaft 14 and extends beyond the distal end 16. In one embodiment, these electrodes 17
It extends at least 1 cm beyond the distal end 16 of the shaft 14.

In a preferred embodiment, electrode 17 is
They are located at substantially equal intervals from each other. In one embodiment where four electrodes 17 are used, the electrodes 17 are spaced apart to form each square corner, as shown in FIG. In one embodiment where six electrodes 17 are used, the electrodes 17 are spaced apart so as to form each vertex of a regular hexagon.

The preferred embodiment also has a pointed tip at the distal end 16, as shown in FIG. This sharp tip serves to secure and stabilize the fibroid disintegration device 10 against the fibroid when the electrode 17 is retracted into the interior space 18. This serves to help the physician prevent the fibroid disintegration device 10 from sliding along the surface of the fibroid when the electrode 17 is deployed from the interior space 18. In one alternative embodiment, the end 16 can be provided with a fibroid thread. The fibroid screw can penetrate into the fibroid to secure device 10, after which the needle electrode can be pushed into the fibroid.

In a preferred embodiment, each electrode 17
Is electrically connected to only one of the bipolar output terminals 12 and 13. In a bipolar embodiment,
At least one electrode is a first bipolar output terminal 1
2, while at least one other electrode is electrically connected to the second bipolar terminal 13. In a monopolar embodiment, each electrode is:
The same output terminal 12 is electrically connected, and a separate return electrode is connected to the other output terminal 13. Those skilled in the art will recognize that in high frequency AC circuits, these terminals are interchangeable, but their output terminals are known as "working terminals" and "return terminals."
In operation, RF current flows from one terminal, eg, terminal 12, through one or more electrodes 17, patient tissue, one or more other electrodes 17, and back to the other terminal 13.

In one embodiment, four electrodes 1
7 are provided, the two electrodes 17 of which are connected to the first output bipolar terminal 12, while the other two electrodes 17 are connected to the second output bipolar terminal 13. Electrodes 17 connected to the same output bipolar terminal
Can be provided adjacent to each other or, in another embodiment, diagonally opposite.

In another embodiment, six electrodes 17
Are provided, three of the electrodes 17 are connected to the first output bipolar terminal 12, and the other three electrodes 1
7 is connected to the second bipolar output terminal 13. In yet another embodiment, eight electrodes 17 are provided, the four electrodes 17 being bipolar output terminals 12,
13 are connected to each other. In one design, a particular electrode 17 is located adjacent to the same pole electrode 17. In other designs, each of the electrodes 17 is adjacent to at least one other electrode 17 of the opposite polarity.

In the preferred embodiment, the actuator 19 is mounted near the proximal end 15 of the shaft 14, as shown in FIG. In one embodiment, the actuator has a thumb-actuated ring 20 arranged to move parallel to the axis of the shaft 14. This actuator 19 is shown in the retracted position in FIG. Another embodiment has an actuator 19 shaped like a scissor handle, while the scissor-like movement of the actuator 19 causes the electrode 17 to
Move axially along 4. This actuator 19
Is designed to be easily manipulable by a physician, extending the electrode 17 beyond the distal end 16 and connecting the electrode 17 to the internal space 1.
It is mechanically coupled to the electrode 17 so as to be retracted into 8. In certain embodiments, a mechanical ratchet mechanism is incorporated within actuator 19. This ratchet device allows the physician to extend the electrode 17 beyond the distal tip 16 to the desired length. In another embodiment of the device, the actuator 19 is provided with a scale or indicator to indicate the extent to which the electrode 17 has extended beyond the distal end 16.

In one embodiment, FIGS. 4 and 5
The screen or mesh 21 shown in FIG. 2 is placed at the distal tip of the shaft 14 and when the electrodes are extended or retracted,
The electrodes 17 rub against the screen or mesh. In this manner, the physician can wipe the burned pieces from the electrode 17 by extending or retracting the electrode 17 through the mesh 21. Also, the mesh 21 can be used to guide the electrodes 17 and keep the electrodes 17 separated from each other.

In one embodiment, the proximal end 15 of the fibroid disintegration device 10 has an electrical switch 22 mounted in a manner that permits easy operation by a physician, as shown in FIG. ing. In one alternative, the switch is a foot switch 23 as shown in FIG.
Therefore, it is not attached to the fibroid disintegration device 10. The switch 22 or 23 is electrically arranged so as to complete the circuit between the first bipolar terminal 12 and the second bipolar terminal 13, while the circuit
It is completed through the electrode 17. When operating the uterus, the physician inserts the electrode 17 into the fibroid and, after that, activates the switch 22 or 23 so that RF current flows between the electrodes 17 and through tissue. Under certain circumstances, the physician can select whether to activate switch 22 or switch 23 while electrode 17 is inserted into the fibroid to facilitate penetration into the fibroid.

When an electrosurgical current is applied, the fibroids are heated and desiccated. If the electrosurgical current is applied too long, the tissue will scorch and adhere to the electrodes 17. In one embodiment of the present invention, a thermocouple 24
Are mounted near the distal end 16. The thermocouple 24 is used to monitor the temperature of the treated tissue and to know when to stop applying current.

Even when the electrosurgical current is accurately applied, some tissue may adhere to the electrode 17. The disadvantage of burnt deposits results in the electrosurgical current not being applied uniformly to the tissue. For this reason,
In one embodiment of the invention, the interior space 18
A rubbing surface is provided therein. This rubbing surface is firmly attached to the shaft 14. As the electrode 17 extends and retracts from the interior space 18, the electrode 17 slides across this rubbing surface to remove any attached debris.

During certain operations, it may be necessary to reach a fibroid that has entered the wall of the uterus. This type of fibroid is sometimes referred to as a complete intrauterine fibroid. In such situations, it is desirable to protect the uterine wall from being dried and destroyed. Thus, in one embodiment, the present invention has a partially insulated electrode 17.
This insulated portion, designated 25 in FIG. 4, protects the uterine wall while the ends of the non-insulated electrode 17 dry out the fibroid. In yet another embodiment, the electrode 18
This insulating portion 25 in can be a slidable sleeve and can be adjusted by a physician.

In still another embodiment of the present invention, the electrodes 17 are not substantially parallel to each other. For example, FIG.
b shows the base of the electrode 17 (the electrode is
9 are closer to each other at the distal end of the electrode 17 than at (the part connected to 9). This embodiment makes it possible to change the electric field in such a way that the inner part of the fibroid can be preferentially dried and destroyed near the distal tip of the electrode 17. In another example shown in FIG. 7a, in a way that the surface of the fibroids is preferentially desiccated due to a stronger electric field at the base of the electrode 17,
The distal tips are spread apart. In these embodiments, electrode 17 is made of a metal that maintains a predetermined shape, such as Nitinol.

In certain situations, the shape of the fibroid may require that the individual electrodes 17 be extended to different lengths. Thus, in one embodiment of the present invention, actuators 19 are mechanically coupled to individual electrodes 17 in a manner that permits selective deployment, as shown in FIG. . This feature allows the physician to protect the surrounding structures from electrosurgical treatment.

Certain embodiments of the fibroid disintegration device 10 have an operating passage 26 extending through the shaft 14, as shown in FIG. Thus, in a laparoscopic procedure, a physician can use the fibroid disintegration device 10 and utilize the operating passage 26 for a grasper, scope, or other device. This is because doctors use different instruments without inserting another trocar into the patient's body,
Enables doctors to have greater freedom. One use is to provide a fibroid screw in the operating passage 26 to hold the fibroid while introducing the needle electrode 17 into the fibroid. Another use of the operating passage 26 is to perform suction and irrigation of a surgical site.

It should be understood that the above-described embodiment is merely an example of an application of the principles of the present invention. Numerous modifications and alternative arrangements can be devised by those skilled in the art without departing from the spirit and scope of the invention. The claims are intended to cover such modifications and arrangements.

[Brief description of the drawings]

FIG. 1 is a perspective view of a first embodiment of a fibroid disintegration device.

FIG. 2 is a perspective view of an actuator of a fibroid disintegration device in a retracted position.

FIG. 3 shows a second embodiment of a fibroid disintegration device with individually deployable electrodes, and also shows an electrosurgical generator and a foot switch.

FIG. 4 is a partially cutaway view showing a terminal portion of a fibroid disintegration device according to a third embodiment.

FIG. 5 is an end view of a distal portion of a fibroid disintegration device.

FIG. 6 is a partially cutaway view showing a terminal portion of a fibroid disintegration device according to a fourth embodiment.

FIG. 7a is a partially cutaway view showing a distal portion of a fifth embodiment of a fibroid disintegration device having non-parallel electrodes. FIG. 7b has non-parallel electrodes,
It is a partially cutaway view showing a terminal portion of a fibroid disintegration device in a sixth embodiment.

FIG. 8 is a cross-sectional side view showing a seventh embodiment of a fibroid destruction device having an operating passage extending through a shaft.

[Explanation of symbols]

Reference Signs List 10 fibroid disintegration device 11 electrosurgical generator 12, 13 output terminal 14 shaft of fibroid disintegration device 15 base end 16 shaft end 17 electrode 18 axis internal space 19 actuator 20 thumb operation ring 21 screen / mesh 22, 23 switch 24 thermocouple 25 insulating part 26 operation passage

 ──────────────────────────────────────────────────続 き Continued on front page (72) Inventor Gregory H. Lambrecht, Varie Road, Kos Cobb, Connecticut, United States 20807 (72) Inventor Michael El Filpot, SA, 61875, Illinois, United States 61875 Le, County Road 1800N 26 (72) Inventor Thomas P. Ryan, Parkview Drive, Fort Collins, 80525, Colorado, USA 970 (72) Inventor Dale F. Schmalz, 80524, Fort, Colorado, United States Collins, Westview Road 2319 (72) Inventor Orlando Cellars Jr., 61821-4462, Illinois, USA, Champaign, Rebecca Dry 2014

Claims (10)

[Claims] An electrosurgical generator (11) having a first output terminal (12) and a second output terminal (13).
An electrosurgical device for use with a proximal end (15), a distal end (16), and an internal space (1).
8), an elongated rigid shaft (14) having an outer diameter of 10 mm or less, and at least three electrodes (17) movably mounted in said interior space (18), at least one of said electrodes being An electrode electrically connected to the first output terminal, at least one other of the electrodes being electrically connected to the second output terminal; and near a proximal end (15) of the shaft (14). And an actuator (19) mechanically coupled to the electrode (17) for extending and retracting the electrode (17) with respect to the distal end (16); An electrical switch (22) connected in a manner to complete an electrical circuit between said output terminal and said second output terminal. 2. The electrosurgical device according to claim 1, further comprising a protective enclosure positioned near said distal end (16) sized sufficiently to surround said electrode. Electrosurgical device characterized by the following. 3. The electrosurgical device according to claim 1, wherein four electrodes are provided. 4. The electrosurgical device according to claim 3, wherein two electrodes are electrically connected to said first output terminal and two other electrodes are electrically connected to said second output terminal. An electrosurgical device characterized by being electrically connected. 5. The electrosurgical device according to claim 1, further comprising means for selectively extending and retracting each of said electrodes (17) with respect to said distal end (16). Surgical equipment. 6. The electrosurgical device according to claim 1, wherein the lumen extends from the proximal end (15) to the distal end (16) through the shaft (14). An electrosurgical device, further comprising the lumen having a diameter dimension sufficient to allow passage of a surgical instrument therethrough. 7. The electrosurgical device according to claim 1, further comprising a threaded tip mounted on said distal end (16). 8. An electrosurgical device according to claim 1, further comprising an electrically insulating coating along a portion of each of said electrodes (17). 9. The electrosurgical device according to claim 1, further comprising a thermocouple (24) mounted near the distal end (16). 10. An electrosurgical generator (1) having a first output terminal (12) and a second output terminal (13).
An electrosurgical device for use in connection with 1) comprising: an elongated rigid shaft (14) having a proximal end (15) and a distal end (16); and at least three needle electrodes, Each have a surface area and extend beyond the distal end (16), each of the electrodes being electrically connected to the first output terminal and a needle electrode having a surface area greater than the surface area of all needle electrodes. An electrosurgical device having a substantially large surface area, said surface area comprising a patient return electrode connected to said second output terminal.