JPH06233779A - Medical ablation catheter - Google Patents

Abstract

PURPOSE: To provide a catheter for directly heating a diseased part and directly and efficiently eliminating the fused tissue of the diseased part. CONSTITUTION: A medical-use fusion-eliminator catheter 3501 has a slender member 3510 having the end part 3506, the base part 3505 and the middle part between them (i.e., the end and base parts have sizes and shapes being adaptable for the organs of the diseased part of patient), fixing means 3702 or 3703 to which at least either one of the end part and base part adapts suitably for the patient's organs (i.e., fixing the middle part to the patient's organ), and a heat generating element 3502 provided in the middle part.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION The present invention relates to a catheter for ablating malignant tissue by heating it.

[0002]

2. Description of the Related Art Currently, surgery, radiation therapy, chemotherapy, immunotherapy and the like are performed to treat malignant tumors. Despite the current advances in medical technology, the treatment of malignant tumors such as cancer is extremely difficult. It is currently known that malignant tumors such as cancer are vulnerable to anoxia, nutrient deficiency, low PH and high temperature. The mechanism by which cancer cells are killed by heating them is not completely clear. As such a heat treatment method, heat treatment is performed by using a microwave, radio frequency induction and ultrasonic treatment. Most of these heat treatment methods are performed outside the patient's body. Therefore, the heating energy cannot penetrate the skin and be directly applied to the affected area. Therefore, there is a drawback that the affected area cannot be locally heated and the temperature distribution is uniform so that normal tissue is also heated.

[0003]

SUMMARY OF THE INVENTION An object of the present invention is to provide a catheter for directly and efficiently ablating the tissue of the affected area by directly heating the affected area.

[0004]

In order to solve the above-mentioned problems, a medical ablation catheter 3501 of the present invention has an elongated member 3510 (a tip end portion 3506) having a tip portion 3506, a root portion 3505 and an intermediate portion 3507 therebetween. And the root has a size and shape adapted to the affected organ of the patient) and at least one of the tip and the root adapted to the organ of the patient. Fixing means 3702 or 3703 (by this means) Fixing the intermediate portion to the affected organ of the patient) and a heating element 3502 arranged in the intermediate portion.

Another embodiment of the medical ablation catheter 3701 of the present invention is a first ablation catheter that is axially movable relative to each other.
An elongated coaxial member 3538 and a second elongated coaxial member 3539 (the first and second members respectively have a first fixing means 3540 and a second fixing means 3596 for fixing an organ of a first patient); One of the elongated coaxial members has a heating element 3590 disposed between the first and second fixing means.

[0006]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Referring to FIGS. 1 and 2, a partial axial cross-sectional view of a urethral ablation catheter 3501 is shown. The urethral ablation catheter 3501 has a heat-conducting heating element 3502 embedded in the vicinity of the distal end, and generates a predetermined heat distribution in the prostate tissue between the internal sphincter and the external sphincter. This heat distribution ablates the urethra near the prostate and the tissue around it. As a result, the diameter of the lumen penetrating the prostate tissue and the urethra is increased, which can increase the flow of fluid therethrough.

The urethral ablation catheter 3501 has a tip fixed cooling balloon 3503 and a root fixed cooling balloon 3504, which are inflatable to be fixed around the internal and external sphincter muscles, respectively. This tip portion fixed cooling balloon 3503, the root portion fixed cooling balloon 350
When the 4 are inflated, they are passed through the urethral ablation catheter 35.
01 and the axial position of the heat transfer heat generating element 3502 are fixed to the internal sphincter and the external sphincter, respectively. This reduces exposure of the sphincter to ablation heat generated by the heat transfer heating element 3502. This sphincter is protected from ablation temperature by circulating a coolant that penetrates through the distal and root balloons during abdominal urethral ablation surgery.

This urethral ablation catheter 3501 is
It is connected to a control device that controls the energy supplied to the heating element and the coolant supplied to the inside of the balloon. The controller controls the energy of the coolant delivered to the catheter and balloon in response to the temperature measured by the sensor located on the catheter. By controlling energy and coolant, the catheter creates and maintains a predetermined heat distribution within the prostate tissue, ablating the surrounding tissue without damaging the sphincter.

The urethral ablation catheter 3501 has an elongated member tube 3510.
Reference numeral 10 has a root portion 3505, a tip portion 3506, and an intermediate portion 3507 extending therebetween. The shape and size of this intermediate portion 3507 is such that it contacts the line of the urethra near the prostate. This intermediate portion 3507 is a heat transfer heat generating element 3502.
The heat-conducting heat generating element 3502 is embedded in the side wall 3694. The tip 3506 is the tip fixing structure 3
702, the tip fixation structure 3702 includes a tip fixation cooling balloon 3503, which is inserted through the internal sphincter into the patient's body. This tip fixing structure 3702
Also has an annular ring 3508, the annular ring 3
508 is disposed around the fixed tip cooling balloon 3503 to provide an annular recess into which it expands and places the patient's internal sphincter therein. When the internal sphincter is placed within the annular recess of the balloon, the root and tip of the catheter in the urethra near the prostate are separated.
The expansion of the tip-fixed cooling balloon 3503 creates an outer diameter that extends into the bladder and withdraws the catheter from the root to bring the external sphincter to the melting temperature. This root part 3505 is a root fixing structure 3
703, the root fixation structure 3703 has a root fixation cooling balloon 3504 extending through the patient's external sphincter. The root fixing structure 3703 has an annular ring 3509, which is arranged around the root fixing cooling balloon 3504 to form an annular recess in the root fixing cooling balloon 3504 when inflated, The patient's external sphincter is placed therein. The root-fixing cooling balloon 3504 is inflated to have a double trapezoidal shape and is fixedly arranged around the external sphincter muscle, whereby the distal end portion and the root portion of the urethral ablation catheter 3501 are separated, and Prevents the sphincter, or external sphincter, from being exposed to melting temperatures. Tip-fixed cooling balloon 3503 and root-fixed cooling balloon 3504
Either one or both of them are fixedly placed in the urethra near the patient's prostate.

The elongated member tube 3510 is formed of nylon, polytetrafluoroethylene, or other polymeric material and preferably withstands a melting temperature of 70-100 ° C. The outer diameter of the transurethral ablation catheter 3501 is approximately 18 French (6 mm or 0.236 inches). The size of the elongate tube 3510 is such that it is in direct contact with the patient's urethra and can vary in size, ranging from 8-21 French, depending on the size of the individual patient. The transurethral ablation catheter 3501 further includes an axial passage 3684 having a diameter of 0.036 inches with a 0.034 inch diameter wire guide 3511 extending therethrough. The wire guide 3511 is positioned to position the elongated member tube 3510 within the patient's urethra. Radiopaque ring 35
12 is arranged around the tip of the elongated member tube 3510 and is embedded in the surface thereof. The radiopaque ring 3512 is visible under fluoroscopy. The tip of the transurethral ablation catheter 3501 can be placed in the urethra or bladder.

The root portion 3505 and the root portion of the transurethral ablation catheter 3501 are shown in FIG.
1 extends from there. The three-pronged connector 3515 abuts the root 3505 and is secured thereto by a commercially available heat shrink tube 3516. The three-pronged connector 3515 includes a side arm 3517 and includes a fixed tip cooling balloon 350.
3. A single lumen tube 35 communicating with the passageway of the catheter communicating with the inside of the root fixed cooling balloon 3504
Store 18-3521. The single lumen tube 3518-3521 has a known female luer lock connector secured to its root. This three-pronged connector 3
515 has a side arm 3522, and accommodates a temperature sensor lead wire and a heating element lead wire. This heating element lead wire has one common wire and three single wires, each of which has a urethral penetration ablation catheter 35.
01 for three temperature sensors. Electrical ring connectors 3523-3528 are used to connect internal lead wires to other devices in the ablation system via cables (not shown).

The known bifurcated connector 3529 abuts the main arm 3685 of the trifurcated connector 3515 and is secured thereto by a heat shrink tube 3686. The bifurcated connector 3529 has a known internal seal that houses the main arm 3530 and the wire guide 3511. The bifurcated connector 3529 has a side arm 3531 and is connected to a drain tube 3532 to discharge urine from the bladder into a waste container (not shown).

In FIG. 3, the axial passageway 3684 is shown extending the length of the transurethral ablation catheter 3501 from which the wire guide has been removed. The axially extending balloons 3680 and 3681 have a supply means which is a tip fixed cooling balloon 3.
In communication with the interior of 503, the balloon is inflated through which the coolant circulates. Balloons 3682 and 368
3 also has a supply means, which communicates with the interior of the root-fixed cooling balloon 3504 to inflate the balloon and circulate the coolant. This balloon 3680-
The 3683 has a diameter of at least 1 French (0.3 mm). The axial passage 3533 is approximately 1 French (0.0
14 inches in diameter, and accommodates a pair of insulation heating element lead wires 3534 having a diameter of about 0.006 inches and four temperature sensor lead wires 3535. Alternatively, the lead wire does not necessarily have to be insulated and can be placed either on the wall of the catheter or in a separate furnace surface. Balloons 3680 and 3681 are balloons 3
They can be placed in diametrically opposite positions, such as 682 and 3683. Also, the balloons 3680-3683 and the axial passages 3533 can be equally placed around the wall of the elongate member. Two balloon passages are shown, and a method of continuously circulating the coolant through the balloons is shown, but only one balloon passage is required to inflate the balloon and suction and discharge of the coolant. It is also possible to do separately. A passage can be used to circulate the coolant through the interior of the balloon, and the suction and discharge of the coolant can be done at the same time or one way.

In FIG. 4, the tip end fixed cooling balloon 3 is shown.
Urethral penetration ablation catheter 350 with 503 inflated
One tip 3506 and middle 3507 are shown. The distal fixed cooling balloon 3503 has a trapezoidal shape and is fixedly arranged in the bladder neck 3563, and the internal sphincter 356.
It penetrates from 1. An annular recess 3541 is formed in the distal fixed cooling balloon 3503 by an annular ring 3508 and has an internal sphincter 3561 disposed therein. The tip fixed cooling balloon 3503 has a length of about 20 mm and a diameter of 25 mm when expanded, and is fixed to the urethral ablation catheter 3501 with a medical adhesive. This tip fixed cooling balloon 3503 is, for example, about 80 mm.
90mm x 18mm polyester sheet
× 8 mm Similarly, another sheet made of polyester material is bonded with a commercially available medical adhesive to form a trapezoidal trapezoid. Annular ring 3508 is a soft C-FLEX
^{The TM} strong polymeric material ring has a rectangular cross section that minimizes the cross sectional area of the transurethral ablation catheter 3501 when the balloon is deflated. This annular ring 3508 is fixed around the deflated balloon with a commercially available medical adhesive. Alternatively, the annular ring 3508 is friction bonded and formed of a bond thread and O-ring, or a cannula made of polymeric material, or a radiopaque material such as stainless steel or tantalum. The tip-end fixed cooling balloon 3503 is pressed against the annular ring 3508 by the expansion of the balloon or the force of the cooling agent. An inner diameter of the elongated member tube 3510 and a deflated distal fixed cooling balloon 3503 disposed around it form fluid communication with either side of the annular ring 3508 inside the distal fixed cooling balloon 3503. Alternatively, except for the annular ring 3508 of the tip fixed cooling balloon 3503,
The pressure exerted by the internal sphincter 3561 may also cause the fixed tip cooling balloon 3503 to have any suitable shape, such as trapezoidal or double toroidal.

Balloons 3680 and 3681 extend axially within sidewall 3694 of elongate member tube 3510 to communicate with the interior of distal fixed cooling balloon 3503. Balloon 3681 has multiple wash ports 3536 to return fluid from inside the balloon located on either side of the annular link. Cleaning port 3553-3 for balloon 3680
556 has different cross-sectional areas, they increase from the axial direction with a slope of 8.6%. By gradually increasing the cross-sectional area in this manner, the flow velocity of the coolant from the axial passage is configured to be lower at the root portion than at the tip portion of the port. This 8.6% tilt allows for ports located about 4 mm apart.
Annular coolant 3542 is sterile water, saline, or a fluid that is safe for injection into the patient. The annular coolant 3542 includes an internal sphincter muscle 3561 and a distal end fixed cooling balloon 3503.
Cools the tissue around it to prevent thermal damage to the tissue.

The radiopaque rings 3543 and 3513 are arranged around the elongated member tube 3510 and embedded in the surface of the elongated member tube 3510 so that the annular recess 3541 and the tip of the heat-conducting heat generating element 3502 are exposed under the fluoroscopy method. Make it visible A temperature sensor 3544 is located on the surface of the catheter of the fixed tip cooling balloon 3503 and is used to measure the temperature of the coolant therein. Temperature sensor 35
44 is connected to the controller via a signal lead wire and a common lead wire and sends temperature information to it. This controller utilizes the temperature information to control the temperature and flow rate of the coolant. Circulating coolant keeps the internal sphincter 3561 at a temperature of up to 40 ° C. The temperature sensor 3544 comprises a commercially available thermistor material, or optical fiber, and may be a thermocouple or other commercially available temperature sensor. The catheter's axial passageway 3684 injects fluid into and out of the bladder and places it over the word wire as the catheter is placed in the urethra.

The heat transfer heating element 3502 is formed by spirally winding a wire having a diameter of 0.006 inches such as nichrome, nickel chrome alloy, or other high resistance material. Alternatively, the coil is formed to have a square cross section. The coil is also made of a biocompatible metal or a non-biocompatible metal coated with a biocompatible substance. This heat transfer heating element 3502 is embedded in the wall of the elongated member tube 3510 when it is pulled out. The heat transfer heating element 3502 has a length of about 3-4 cm, and can be changed in a range of 2-6 cm depending on the body shape of an individual patient. The heat transfer heating element 3502 is welded to the lead wire pair, and the lead wire pair is connected to the ring connector pair at the root of the catheter as shown in FIG. The temperature sensor 3545 is embedded in the catheter and arranged in the central portion along the length direction of the heat conductive heating element 3502 to measure the temperature in the vicinity of the heat conductive heating element 3502. The temperature sensor 3545 is connected to the controller via the second signal lead wire and the common lead wire and provides temperature information regarding the heat transfer heating element 3502. The controller uses this temperature information to control the amount of energy supplied to the heat-conducting heat generating element 3502, thereby generating a predetermined heat distribution.

In FIG. 5, the urethral penetration ablation catheter 3
501 has a root portion 3505 and an intermediate portion 3507,
The root fixed cooling balloon 3546 is in an expanded state. This root fixed cooling balloon 3546 is made of a polyester material and has a length of about 10 mm, and when expanded, it is 10 mm.
Has a diameter of. This root fixed cooling balloon 3546
Is fixed to the elongated member tube 3510 with a commercially available medical adhesive. The annular ring 3509 of the root fixed cooling balloon 3546 is a tip fixed cooling balloon 3503.
Of the C-FLEX ^™ strong polymer material having a rectangular square cross section. The annular ring is attached to the deflated balloon material with a commercially available medical adhesive. When the root fixation cooling balloon 3546 expands, the root fixation cooling balloon 3546 is formed by the annular ring 3509 to place the external sphincter muscle 3562 therein. The difference between the inner diameter of the annular ring 3509 and the outer diameter of the side wall 3694 is such that the deflated balloon material is placed around it and is in communication with fluid on either side of the annular ring inside the fixed root cooling balloon 3546. . Alternatively, the annular ring of root fixed cooling balloon 3546 is removed and the pressure from the external sphincter 3562 causes the root fixed cooling balloon 354.
6 may be trapezoidal.

The balloon passages 3682 and 3683 communicate with the interior of the root fixed cooling balloon 3546 to inflate the balloon and circulate the annular coolant 3542 within the balloon. The balloon passage 3682 is a cleaning port 354.
7-3550. Similar to wash ports 3535-3556 of balloon 3503 of FIG. 4, wash port 3547.
The −3550 cross-sectional area is increased by 8.6% at the root to balance the flow rate of coolant from the balloon passage 3682 to the interior of the balloon. A plurality of isotherms 3573 are formed by the heating element 3502. Fluid is flowed from inside the balloon on either side of the annular ring. A temperature sensor 3552 is located on the catheter surface of the root fixed cooling balloon 3504 to measure the temperature of the coolant. This temperature information is provided to the controller via the third signal lead wire and the common lead wire, which is the tip fixed cooling balloon 3503 of FIG.
The same as in the case of the temperature sensor 3545 of FIG.

Radiopaque rings 3543 and 3551
Is disposed around the catheter tube and embedded in the surface thereof, and the heat-conducting heat-generating element 350 is formed by fluoroscopy.
Allow the root of 2 and the balloon 3546 to be seen. Alternatively, the radiopaque ring 3512-
3514, 3543, 3551 may be completely embedded within the tube material. Radiopaque ring 3512-35
14, 3543, 3551 are made of a radiopaque material such as tantalum. These rings can be replaced by strips of radiopaque material. In addition, the outer surface of the catheter tube can be textured to improve ultrasound visualization of the catheter.

Prior to using the transurethral ablation catheter 3501, the surgeon may view the affected area of the patient using autopsy means. This surgeon detects the positions of the internal and external sphincter and measures the length of the urethra near the prostate. The urethral penetration ablation catheter 3501 of the present invention includes a tip fixed cooling balloon 3503 and a root fixed cooling balloon 3504.
And the insulated heating element lead wire 3534 and the elongated member tube 3510 to contact the line of the urethra near the prostate. A wire guide is inserted into the patient's urethra,
A small catheter and dilation sheath are introduced over it into the urethra. Once the urethra is fully expanded, a treatment catheter is inserted along the wire guide and properly placed within the urethra as shown in FIG. This urethral penetration ablation catheter 3
501 is introduced into the urethra near the prostate through a known introduction sheath. A surgeon injects a contrast medium along the axial passageway of the catheter to improve viewing. The fixed tip cooling balloon 3503 and the fixed fixation cooling balloon 3504 are inflated to secure the catheter to the patient's internal sphincter 3561 and external sphincter 3562. The energy source connected to the insulated heating element lead wire 3534 is switched on to generate a predetermined heat distribution in the patient's tissue. This heat distribution is at ablation temperature, preferably 70-1
Within the range of 00 ° C. Insulation heating element lead wire 35
When 34 produces this predetermined temperature distribution in the patient's body,
The tissue is ablated and the blood vessels are hemostasis. Hemostasis at temperatures above 70 ° C. A temperature of 45-70 ° C. kills the cells, exfoliates the tissue and expands the diameter of the urethra. In an experiment using dogs, when the ablation temperature of 97 ° C was applied to the urethra near the prostate, the blood was stopped in about one hour, and then the tissue was ablated to make the lumen penetrating the prostate large enough. Expand. In the first experiment with dogs, satisfactory results were not obtained under the condition of 80 ° C. for one hour.

When the ablation temperature is generated in the urethra near the prostate, the coolant penetrates through the distal fixed cooling balloon 3503 and the fixed root cooling balloon 3504 to melt the internal sphincter 3561 and the external sphincter 3562. Protect it from becoming. When the operation is completed, the tip-side fixed cooling balloon 3503 and the root-side fixed cooling balloon 3504 are deflated, and the surgical catheter is removed from the urethra.

In FIG. 8, ablation system 3676 is used to remove tissue from the urethra near the prostate using the transurethral ablation catheter 3501 of the present invention. This ablation system 3
Reference numeral 676 denotes a urethral ablation catheter 3501 and a controller 3.
678, energy source 3679, coolant circulation pump 36
Has 87. Urethral Penetration Ablation Catheter 350 of the Invention
1 is placed in the urethra near the patient's prostate, and has a tip fixed cooling balloon 3503 and a root fixed cooling balloon 350.
4 or both, when fixed in the urethra, the internal sphincter 3561, the external sphincter 3562 of the urethra.
Through them, they each extend. Once they are in place, the catheter is energized to create a predetermined heat distribution within the prostate tissue, ablating the tissue and enlarging the urethra. A commercially available energy source 3679 applies energy to the heating element, which is embedded within the middle section 3507 of the transurethral ablation catheter 3501.
This energy source is connected to the heating element by a cable, ring connector, line 3697, and the middle portion 3507.
A predetermined temperature of, for example, 97 ° C. is generated on the surface of.

A temperature sensor 3545 is located in the middle section 3507 of the catheter near the heating element and sends temperature information to controller 3678 via line 3697. The system controller 3678 responds to this temperature information by
A predetermined temperature distribution is formed on the surface of the catheter to generate a predetermined temperature distribution in the prostate tissue. Known controller 3678
Is a commercially available microprocessor (for example, MC68040 manufactured by Motorola), and the controller 3678 controls the energy source 3679 to control the energy by the control line 370.
Send through 0.

The tip-fixed cooling balloon 3503 and the root-fixed cooling balloon 3504 cool the internal sphincter 3561 and the external sphincter 3562, and protect them from reaching the melting temperature. The coolant is a cooling balloon 35 fixed at the tip.
03, circulates through the root fixed cooling balloon 3504 to cool the tip fixed cooling balloon 3503 and the root fixed cooling balloon 3504, and further, the internal sphincter 3
561, cooling the external sphincter 3562. The balloon, sphincter muscle and surrounding tissue are cooled so that the temperature does not exceed 40 ° C. The coolant circulation pump 3687 is controlled by the controller 3678 via the control line 3696 to transfer the coolant through the tip fixed cooling balloon 3503, the root fixed cooling balloon 3504, and the single lumen tube and each line 3677. , 3688, 36
Circulating through 90, 3695 inhales or injects coolant. The controller monitors and controls the coolant flow rate and temperature to maintain a constant temperature distribution in the tissue surrounding the catheter. Coolant circulation pump 36
87 is a commercially available centrifugal, diaphragm, or roller pump, for example, MASTE manufactured by Cole-Parmer.
RFLEX ^™ roller pump. Temperature sensor 3544
And 3552 are arranged on the surfaces of the catheters of the tip fixed cooling balloon 3503 and the root fixed cooling balloon 3504, respectively, and send the temperature information of the coolant in each balloon to the controller 3678 via the lines 3698 and 3699. . Each line 3698, 3699 represents a lead wire, ring connector and cable. By controlling the pump based on this information, the control device suppresses the temperature of the sphincter muscle to the maximum temperature or less, and obtains a predetermined temperature distribution of the sphincter muscle tissue.

In FIG. 6, the urethral penetration ablation catheter 3
501 has a heat-conducting heating element 3502 located within the patient's urethra 3557, prostate 3558, and produces a predetermined temperature distribution 3571 when not cooled. The intermediate portion 3507 has a heat-conducting heating element 3502, is arranged along the line of the prostatic urethra 3560, and is held therein by inflating the tip-fixed cooling balloon 3503 at a predetermined axial position therein. Local fixation cooling balloon 3503 extends into bladder 3559 through internal sphincter 3561 and bladder neck 3563, and root fixation cooling balloon 3504 extends through external sphincter 3562.

The temperature distribution 3571 indicates the urethra 35 near the prostate.
60, produced in the prostate 3558, 3689, having isotherms 3564-3570. This isotherm 3564-
3570 represents a static condition in the same tissue after the heating element reaches a predetermined steady state. Isotherm 3564 represents 37 ° C., which is body temperature. The temperature of the tissue gradually increases between the isotherms. For example, the temperature of the tissue between isotherms 3564 and 3565 increases to 40 ° C (the temperature represented by isotherm 3565). Isotherms 3566, 3567, 35
68, 3569 and 3570 are 42 ° C and 47 ° C,
It represents 70 ° C, 92 ° C and 97 ° C. Isotherm 3570 represents the surface temperature of the middle section of the catheter. These isotherms represent the predetermined temperature distribution in the surrounding tissue produced by the catheter. However, the tip fixed cooling balloon 3503,
The coolant in the root fixed cooling balloon 3504 is not circulating. If the coolant is not circulated, the internal sphincter muscle 3561 and the external sphincter muscle 3562 are in the range of 40-47 ° C., which is an unfavorable temperature range. Exposing the sphincter to temperatures in the range of 40-42 ° C. for more than one hour damages the sphincter's nerves and muscles. 42-47
The tissue is killed and ablated by being exposed at, for example, one hour or more. A temperature in the range of 47-70 ° C,
Alternatively, exposure to higher temperatures causes the cells to die rapidly and the blood vessels to cease.

FIG. 7 is a partial cross-sectional view of the transurethral ablation catheter 3501 of FIG.
560, temperature distribution 357 within prostate 3558, 3689
Represents 2. The temperature distribution 3572 is generated by circulating a coolant in the tip-side fixed cooling balloon 3503 and the root-side fixed cooling balloon 3504. Temperature distribution 357
2 has isotherms 3570 and 3573-3578. The isotherm 3573 represents 37 ° C. (body temperature). The temperature of the tissue increases as it approaches the catheter, and isotherms 3574, 357
5, 3576, 3577, 3578, 3570,
40 ℃, 42 ℃, 47 ℃, 70 ℃, 92 ℃, 9
Indicates 7 ° C. Isotherm 3570 represents the surface temperature of the middle section of the catheter. Coolant balloon 350 with fixed coolant
3. By circulating to the root fixed cooling balloon 3504, the internal sphincter 3561 and external sphincter 3562 are prevented from reaching the ablation temperature generated by the catheter. This isotherm of heat distribution indicates that temperatures above body temperature do not thermally transfer heat to the sphincter muscle or tissues near the sphincter muscle.
A few mm of the sphincter and the surrounding tissue is outside the isotherm 3573 (body temperature) and circulates the coolant during ablation surgery.

FIG. 9 shows another embodiment of the present invention, in which the urethral ablation catheter 3624 includes a urethra 3557 and a prostate gland 3.
It is located within 558. As in the urethral penetration ablation catheter 3501 of FIG. 6, the intermediate portion 3626 has a heat transfer heating element 3625 and is fixed within the prostatic urethra 3560 by a tip fixed cooling balloon 3627, a root fixed cooling balloon 3628, They extend through internal sphincter 3561 and external sphincter 3562, respectively. The heat-conducting heating element 3625 of this example extends partially around the catheter and heats a portion of the prostate, and the prostatic prostate discharge duct 3629 empties the seminal vesicle 3630.
To prevent the seminal vesicles 3630 from reaching ablation temperature, the prostate-opposite discharge duct 3629 minimizes the risk of disability or infertility. This heating element is formed by spirally winding a metal wire. This spirally wound heating element is embedded in the wall of the catheter as shown in FIG. The radiopaque rings 3631, 3632 are embedded in the surface of the catheter and placed at each end of the heating element to allow visibility of the circumference and axial direction of the heating element, and these near the prostate. It gives a certain heat distribution to the urethra and the surrounding tissue.

The heat distribution 3633 is generated by the transurethral ablation catheter 3624, which is a coolant with a tip-fixed cooling balloon 3627, a root-fixed cooling balloon 36.
It is in a state of circulating inside 28. This coolant has an axial passageway 3641 with an inner diaphragm 3642 as shown in FIG.
Circulates through and cools the prostate tissue away from the portion of the catheter and the heating element. The predetermined cooled temperature distribution generated by this catheter is the isotherm 363.
4-3640. Isotherm 3634 is 37 ° C
(Body temperature), and isotherms 3635-3639 represent 40 ° C, 42 ° C, 47 ° C, 70 ° C, and 92 ° C, respectively. Isotherm 3640 represents 97 ° C., which is the surface temperature of the catheter. The isotherms shown here mean that temperatures above body temperature are not transmitted to the vicinity of the sphincter or to the tissues surrounding the sphincter. Furthermore, the tissue on the cold side of the catheter, ie the catheter away from the heating element, the prostate opposing discharge duct 3629 and the seminal vesicle 3
The surface facing 630 has a temperature close to body temperature.

FIG. 10 shows the urethral penetration ablation catheter 3 of FIG.
43 is a sectional view taken along line 43-43 of 624. FIG. Axial passageway 3641 has an inner diaphragm 3642 and has a lumen 364.
The coolant is injected at 4, and the coolant is sucked at the lumen 3643. Axial passage 3645 is for draining or injecting fluid from the bladder and for placement of the catheter in the wire guide. The axial passages 3646 and 3647 are for injecting and aspirating the coolant into the distal end fixed cooling balloon 3627 and the root fixed cooling balloon 3628, respectively. The axial passage 3648 has a lead wire of the heat-conducting heat generating element 3625 and has temperature sensors at the tip and the middle.

11 and 12 show a urethral ablation catheter 3
701 is shown, which is an enlarged view of the catheter of the present invention, forming a predetermined temperature distribution within the prostate tissue. The catheter has an inner member 3538 and an outer member 3539, which are in a stretchable relationship with each other. Due to the relative expansion and contraction of the inner member 3538 and the outer member 3539, the tip fixed cooling balloon 3627 and the root fixed cooling balloon 3628 have different spaces 370 therebetween.
4 can be provided to fit the length of the urethra near the prostate of the patient. Inner member 3538 is tube 359
2 and further has a tip portion 3579 and a middle portion 3580, which are in the inflated state, corresponding to the middle and tip portions of the catheter of FIG. Tip 35 of internal member 3538
79 has a distal balloon 3540 that extends through the internal sphincter and into the patient's bladder. Tip balloon 354
0 is fixed to the inner member using a commercially available medical adhesive. Annular ring 3581 is secured around annular recess 3582 to place the internal sphincter therein. Axial balloon passages 3583 and 3584 are provided in the distal balloon 354.
Circulating coolant 3693 is aspirated and infused therethrough in communication with the interior of the 0 to cool the inflated distal fixation cooling balloon 3627, the internal sphincter and surrounding tissue. Axial balloon passage 3583 has a plurality of suction ports 3593. The axial balloon passage 3584 has a plurality of suction ports 3
Have 594. They are similar in size to the injection ports in FIG. A temperature sensor 3585 is located on the surface of the internal member of the tip fixed cooling balloon 3627 to measure the temperature of the coolant around it. The distal end of this internal member has a radiopaque ring 3586-3588 so that the distal end of the member and the catheter are inserted into the urethra by fluoroscopy so that the distal end of the heating element and the position of the internal sphincter can be seen. To The internal member 3538 is further connected to the main shaft passage 3
589, which allows the catheter to be aspirated along the wire guide and infused or drained into the bladder.

Intermediate portion 35 of axial balloon passage 3583
The heating element 80 has a heating element 3590.
0 is embedded in the wall of the member and heats the urethra near the prostate and its tissue, and further has a temperature sensor 3591, which is arranged in the central portion along the length direction of the heating element 3590, Measure the temperature. The outer member 3539 has an elongated member tube 3607 and further has a root portion 3595.
This root portion 3595 corresponds to the root portion of the urethral penetration ablation catheter 3501 of FIG. External member 3539
Has a fixed root cooling balloon 3596 and extends through the patient's external sphincter. Root fixed cooling balloon 3
596 is secured to the outer member 3539 with a commercially available medical adhesive. Annular ring 3597 is secured around inflated root anchor cooling balloon 3628 such that annular recess 3598 is positioned within the balloon to place the external sphincter therein. Axial passages 3599 and 3600 communicate with the interior of root fixed cooling balloon 3596 to circulate circulating coolant 3693 to cool root fixed cooling balloon 3628, the external sphincter and its ambient temperature. The axial passage 3599 has a plurality of 3601. Axial passage 3600 has a plurality of ports 3602, the cross sections of which have similar cross-sectional areas to the injection port of the catheter of FIG. A temperature sensor 3603 is located on the surface of an external member inside the root fixed cooling balloon 3628 to measure the temperature of the coolant. The tip of the outer member has 3604 and 3605, under which the tip of the root-fixed cooling balloon 3628 and the annular recess 3598 are visible and the outer sphincter is placed there. The outer member 3539 has a thinner shaft member 3606 and is arranged to be contractible with the inner member.

FIG. 12 shows the inner member 3538 and the outer member 35.
At the root of 39, a wire guide 3511 extends from the root from the axial lumen of the internal member. The root 3608 of the outer member is a known three-pronged connector 3609, which has a side arm 3610 and is provided with a plurality of root balloons 3.
613 with a single lumen tube and side arm 361
1 has a heating element and a temperature sensor lead wire. Each lead wire has multiple ring connectors 36 inside.
It is fixed to 12. The three-pronged connector 3609 is fixed to an external member by using a heat shrinkable tube 3614.

The root 3615 of the inner member has a known three-pronged arm connector 3616, which has side arms 3617 and 3618, having a plurality of distal balloons 3619, a single lumen tube, and a plurality of temperature sensors. It has a lead wire. Each temperature sensor lead wire is internally secured to a plurality of electrical ring connectors 3620. The temperature information from the temperature sensor arranged in each balloon is sent to the control device via the lead wire and the ring connector. The control device controls the amount of heat to be sent to the heating element so as to generate a predetermined temperature distribution in the prostate tissue. The three-pronged arm connector 3616 has side arms 3621 for injecting or draining from the bladder via a drainage tube 3622, and further has a main arm 3623 through which a wire guide is inserted into the catheter. The three-pronged arm connector 3616 is fixed to the internal member via the main arm 3685 of the three-pronged connector 3609 and the heat shrinkable tube 3691. The coaxial members are slidably disposed with respect to each other via rotatable lock collar hubs 3705. The position of the coaxial member in the axial direction can be changed, and the tip-side fixed cooling balloon 3627 and the root-side fixed cooling balloon 362 can be changed.
8 to provide a different space 3704, which allows it to be adapted to the individual patient's body shape.

[0036]

As described above, the medical ablation catheter of the present invention can heat and ablate only the affected part, and other healthy tissue parts can be cooled by the cooling material injected into the balloon. Local heating is possible. It should be understood that the reference numerals described in the claims are for facilitating the understanding of the invention and do not affect the interpretation of the right.

[Brief description of drawings]

FIG. 1 is a side view of the urethral ablation catheter of the present invention.

FIG. 2 is a side view around a three-pronged connector of the present invention.

FIG. 3 is a cross-sectional view taken along line 37-37 of FIG.

FIG. 4 is a cross-sectional view of the tip of the urethral ablation catheter of the present invention.

FIG. 5 is a cross-sectional view of an intermediate portion of the urethral penetration ablation catheter of the present invention.

FIG. 6 is a diagram showing a state in which the urethral ablation catheter of the present invention is placed in the urethra and the coolant is not circulating.

FIG. 7 is a view showing a state in which the urethral ablation catheter of the present invention is placed in the urethra and a coolant is circulating.

FIG. 8 is a block diagram of an ablation system using the urethral penetration ablation catheter of the present invention.

FIG. 9 is a view showing a state in which the urethral ablation catheter of the present invention is placed in the urethra and a coolant is circulating.

10 is a cross-sectional view taken along the line 43-43 of FIG.

FIG. 11 is a side view of a transurethral ablation catheter of another embodiment of the present invention.

FIG. 12 is a side view of a transurethral ablation catheter.

[Explanation of symbols]

 3501 Transurethral Ablation Catheter 3502 Heat Transfer Heating Element 3503 Tip Fixed Cooling Balloon 3504 Root Fixed Cooling Balloon 3505 Root 3506 Tip 3507 Intermediate Section 3508 Annular Ring 3509 Annular Ring 3510 Elongated Member Tube 3511 Wire Guide 3512 Radiopaque Ring 3513 Radiopaque Ring 3515 Three-pronged Connector 3516 Heat Shrink Tube 3517 Side Arm 3518-3521 Single Lumen Tube 3522 Side Arm 3523-3528 Electrical Ring Connector 3529 Bifurcated Connector 3530 Main Arm 3531 Side Arm 3532 Drain Tube 3533 Axial Passage 3534 Insulation Heating element lead wire 3535 Temperature sensor lead wire 3537 Suction port 35 8 Internal member 3539 External member 3540 Tip balloon 3541 Annular recess 3542 Circulating coolant 3543 Radiopaque ring 3544 Temperature sensor 3545 Temperature sensor 3547-3550 Wash port 3551 Radiopaque ring 3552 Temperature sensor 3535-3556 Wash port 3557 Urethra 3558 Prostate 3559 Bladder 3560 Proximal urethra 3561 Internal sphincter 3562 External sphincter 3562 External sphincter 3563 Bladder neck 3564-3570 Isotherm 3571 Temperature distribution 3571 Temperature distribution 3573-3578 Isotherm 3579 Tip 3580 Middle part 3581 Annular ring 3582 Circular recess 3584, Circular recess 3583 3585 Temperature sensor 3586-3588 Radiopaque ring 3589 Main axis direction passage 3590 Thermal element 3591 Temperature sensor 3593 Suction port 3595 Root part 3596 Root fixed cooling balloon 3597 Annular ring 3598 Annular recess 3607 Elongated member tube 3608 Root part 3609 Three-pronged connector 3610 Side arm 3611 Side arm 3612 Ring connector 3613 Root contraction balloon balloon 3615 Root part 3616 Three-pronged arm connector 3617 Side arm 3618 Side arm 3618 Side arm 3619 Tip balloon 3621 Side arm 3622 Discharge tube 3623 Main arm 3624 Urethra through ablation catheter 3625 Heat transfer element 3626 Intermediate part 3627 Tip fixing cooling balloon 3628 Root fixing Cooling balloon 3629 Opposite prostate discharge duct 3630 Seminal vesicle 3633 Heat distribution 3634-3640 Isotherm 3641 Axial passage 3642 Inner diaphragm 3676 Ablation system 3677, 3688, 3690, 3695 Line 3678 Controller 3679 Energy source 3680, 3681 Balloon passage 3682, 3683 Balloon passage 3688 Axial passage 3685 Main arm ( Port) 3686 Heat shrink tube 3687 Coolant circulation pump 3691 Heat shrink tube 3693 Circulating coolant 3694 Side wall 3696 Control line 3697, 3698, 3699 Line 3700 Control line 3701 Urethral penetration ablation catheter 3702 Tip fixing structure 3703 Root fixing structure 3704 Space 3705 Rotatable Lock Collar Hub

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Joseph F. Erie United States 47906 Indiana West Lafayette Eden Street 618 (72) Inventor Neil E. Fianot United States 47906 Indiana West Lafayette Hamilton 3051

Claims (20)

[Claims] 1. A tip (3506) and a root (350).
5) and an elongated member (3510) having an intermediate portion (3507) therebetween, and the tip and the root have a size and shape adapted to the organ of the affected part of the patient, and at least the tip and the root. One is a fixing means (3702 or 3703) adapted to be arranged in the organ of a patient, and by this means, the intermediate portion is fixed to the affected organ of the patient, and a heating element (3502) arranged in the intermediate portion, A medical ablation catheter (350
1). 2. The fixing means comprises a first inflatable balloon (3) arranged on at least one of a tip portion and a root portion.
503 or 3504). 3. The first inflatable balloon has a first annular recess (3508) which is positioned in the patient's organ when inflated.
Or 3509). 4. The catheter of claim 2, wherein the elongate member has means (3680, 3681) in communication with the first inflatable balloon (3503) for inflating the balloon. 5. The catheter of claim 4, wherein the means is means for circulating a coolant within the first inflatable balloon. 6. The fixing means comprises a second inflatable balloon (35) located on the remainder of the tip and root.
04). 7. The catheter of claim 6, wherein the elongate member includes means (3682, 3683) in communication with the second inflatable balloon (3504) for inflating the balloon. 8. The catheter of claim 7, wherein the means is means for circulating a coolant within the second inflatable balloon. 9. The inflating means includes the first and second
Ports (3) communicating with the interior of the inflatable balloon of
553, 3554).
Catheter. 10. The second inflatable balloon is a second annular recess (3509) positioned in the patient's organ.
The catheter according to claim 6, which further comprises: 11. The catheter of claim 7, further comprising means (3538, 3539) for adjusting the space between the first and second balloons. 12. The catheter according to claim 1, wherein the heating element (3502) comprises a coil formed by spirally winding a conductive wire. 13. The catheter of claim 1, further comprising a temperature sensor (3545) in the middle section. 14. A first elongated coaxial member (3538) and a second elongated coaxial member (35) which are axially movable relative to each other.
39), wherein the first and second members respectively fix a first patient's organ with a first fixing means (3540) and a second fixing means (35).
96) and one of the elongated coaxial members has a heating element (3590) disposed between the first and second fixing means. ). 15. The first and second fixation means comprise first and second annular recesses (35) for fixing an organ of a patient, respectively.
82, 3598).
Catheter. 16. The first and second securing means are provided with first and second inflatable balloons (354) supplied with a coolant to maintain the temperature of a patient's organs below a predetermined maximum value.
0, 3596), respectively. 17. A heat-generating catheter means (3501) inserted into the patient's organ to generate a predetermined temperature distribution in the tissue of the patient's organ, the heat-generating catheter means being a temperature sensor for measuring ambient temperature. Means (3545) for producing a predetermined temperature distribution in the tissue of the patient's organ in response to the temperature measured by said temperature sensor means,
Control means (367) for controlling the amount of energy supplied to the exothermic catheter means from an energy source (3679).
8) A system for ablating tissue of a patient's organ, which comprises: 18. A cooling means (3687) for cooling the heating catheter means (3501), characterized in that the temperature of the tissue of the patient's organ is maintained below a predetermined maximum value. 17 systems. 19. The exothermic catheter means comprises a second temperature sensor (3552 or 3544) for temperature measurement arranged around the cooling means, the control means depending on the temperature of the organ of the patient. 18. System according to claim 17, characterized in that it controls the coolant supplied to the cooling means (3503, 3504). 20. The exothermic catheter means measures the temperature of a first portion of a patient's organ, maintains the temperature below a maximum value, and is disposed at a second location of the patient's organ. 18. The system according to claim 17, further comprising cooling means for maintaining the temperature of the portion below a predetermined maximum value.