JPH07507696A - Interstitial treatment device and method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Interstitial treatment device and method Related applications This application is filed in U.S. Patent Application No. 07/625, filed December 10, 1990. This is a continuation in part of No. 332.

field of invention The invention particularly provides for inserting an elongated shaft into a body cavity adjacent to the organ to be treated; In addition, the cannula can be extended to perform treatment or diagnosis at a predetermined location within the organ. The present invention relates to an organ interstitial treatment or diagnostic device and method thereof. More specifically, Cannula can be reversed into position after positioning and during treatment It is provided with interstitial locking means for locking to.

Background of the invention Advances in medical technology have led to the emergence of many new therapeutic and diagnostic techniques. for example, U.S. Patent No. 4.950.267 to Inohara et al. A mirror laser beam treatment device is disclosed. This endoscope has a laser probe from which the laser probe is directed to the part of the organ to be treated. push forward. However, this disclosure does not address how to insert a laser probe into an organ. Less specific is also U.S. Patent No. 5 to Rydel. No. 047.026 discloses an electrosurgical implant that cuts into tissue. There is. This instrument emits an arc discharge when an RF voltage is applied, thereby , with two separate end portions at its distal ends that allow the instrument to cut into tissue. It is growing. However, the distal end can be removed with minimal damage to the healthy tissue surrounding the treatment area. There is no way to move it to a specific treatment area.

Ike's treatment technology is for radiotherapy or drug therapy that interstitially targets cells. , some implant radioactive nodes. In addition, using an endoscope or ultrasound There are many different forms of diagnostic techniques, such as visualization. However, these techniques There are no suitable devices and methods in the art to apply the technique.

As such, many advanced and novel technologies are being developed for medical and diagnostic purposes. Nevertheless, there is a lack of knowledge in the art that excessively and unnecessarily destroys tissue surrounding the treatment area. Suitable for treating and diagnosing selected areas interstitially without causing any damage. Devices and methods for this remain a challenge.

An object of the present invention is to provide a method and apparatus for interstitially performing this.

Yet another object of the invention is to allow the operator to To enable easy and accurate manipulation to treat or diagnose a desired interstitial location. , to provide equipment.

Another object of the invention is that the position of the cannula does not have to be constantly monitored, but can be The cannula is interstitially anchored within the organ so that local treatment or diagnosis is possible. It is to provide the means.

The above and other objects, according to the present invention, provide interstitial treatment or diagnosis of an organ. an elongated, at least partially flexible cannula device for treatment; means for positioning the cannula within the body cavity adjacent the organ; and means for positioning the cannula within the body cavity; guide means provided on the positioning means to guide the patient during treatment or diagnosis; and means for locking the needle in place. The equipment The position comprises a proximal portion supporting a positioning means for operation, the proximal portion supporting a positioning means for operation. Rotate the positioning means to position the guide means and place the cannula in place. This allows for introduction into the organ.

A preferred embodiment of the invention includes a distally extending shaft surrounding the positioning means. The support structure further includes a support structure having a top portion. In an embodiment of this device, the movable an assembly mounted within the support structure and cooperating with the positioning means; and for causing the guide means to rotate in response to its own rotation. Also, The proximal end of the cannula is secured to this movable assembly so that this movable assembly The axial translation causes the cannula to be translated with respect to the positioning means, thereby This allows the cannula to be inserted into the organ.

According to yet another embodiment of the invention, the cannula includes an outer member and a cannula disposed within the outer member. and a received inner member. The locking means is located on the inner side adjacent to the distal end thereof. A locking member fixed to the member and located approximately midway between the inner member and the outer member. ing. The locking member locks from a first unlocked position between the inner and outer members. movably positioned to extend into the tissue surrounding the nure to a second locking position; It is. Such movement occurs in response to relative motion between the inner and outer members. be exposed. The movable assembly includes a main body member secured to the outer cannula member and an inner cannula member. It is equipped with a support member fixed to the Yure member, so that the main body member and the support member are The locking member moves from the first position to the second position as the material moves relative to the material.

To enable the operator to operate the device with one hand, the device is equipped with a support structure. further comprising a handle member disposed on the body and cooperating with the body member of the movable assembly. so that when this handle member is squeezed, the movable assembly will move relative to the support structure. Advance the cannula into the organ for 11 tL. The device is mounted on a support structure and further comprising a trigger member cooperating with the support structure such that the trigger member When pulled, the support member moves and separates from the body member, removing the locking member from its first position. Move to second position. Furthermore, the main body member has a wheel like a thumb operation wheel. Means are provided to facilitate rotation of the body member and position the guide means. That's how you get it.

In a preferred embodiment of the invention, the locking cannula has a radial radius adjacent to its distal end. and an inner member having a hollow, flexible needle defining a directional opening. the inner part The kio includes an energy supply means located inside the needle. needle and energy The relative movement between the locking member and the supply means causes the locking member to move from its first unlocked position to its circumference. The locking member is configured to provide energy to move the locking member to a second locking position extending into the surrounding tissue. It is fixed to the supply means.

In yet another preferred embodiment of the invention, the inner member of the locking cannula further comprises: It has a hollow inner sheath in which a locking member is disposed. In addition, the outer member a hollow sheath defining a radial opening adjacent the distal end of the tube. Locking part The material and the opening are such that relative movement between the sheaths allows the locking member to pass through the opening. It is arranged to move from one unlocked position to a second locked position. Further details of the invention According to the details, the inner north has a spirally wound structure and is engaged in a first position. It has a separate distal tip portion forming a recess for receiving the member. Energy of the present invention In the embodiment of the electrical feed, this distal tip is made of a heat resistant and non-conductive material. It is preferable that the

The present invention also provides a kit for treating or diagnosing interstitial space in an organ, which includes the above-mentioned kit. a locking cannula substantially the same as that of, and a device generally identical to that described above; It is possible to visualize the state of inserting the cannula into the organ by inserting it into the device. an endoscope formed in a shape and size such that it can be Ru. This kit, according to the invention, can be inserted into a device to position the device within a body cavity. It is possible to provide a sealed body that is easy to eat. In addition, this kit adapted to be received within the cannula and extending distally beyond the cannula. , can also be equipped with a stylet to facilitate insertion of the cannula into the organ. .

Further components of the kit are shaped and dimensioned to be received within the cannula. It is said to be an energy organ that extends beyond the end of the cannula and supplies energy to the organ. energy supply means. This energy source included in the kit is Microwave energy, ultrasonic energy, laser energy, radiation energy and thermal engineering Contains unlucky sources. In order to supply these various types of energy, this kit uses an antenna. energy supply means such as optical fibers, electrical wires, bipolar devices or piezoelectric elements. I'm here The invention also relates to a method for interstitial treatment or diagnosis within an organ. This person According to the method, a tubular member is placed within the body cavity adjacent to the organ to be treated. Kanyu The cannula is guided into the organ by a tubular member, and the cannula punctures the tissue of the organ. do. The cannula is positioned such that its distal end is within the treatment area within the organ. The cannula is placed inside the organ and treatment or diagnosis is performed in this area. .

The method according to the invention includes a multi-step method, wherein the cannula is The islet is guided into the organ by placing it within the cannula, and the cannula and stylet together into the organ by advancing them into the organ. Kanyu After placing the stylet on the treatment area and locking it in place, pull out the stylet, Compounds that target cells that can sense energy types are delivered through the cannula to organs. It is given interstitially within the body. Then, through the cannula, that particular type of energy is released. It is given to targeted cells.

FIG. 1 shows a state in which an embodiment of the device according to the invention is used to treat the prostate gland. , Figures 2 to 5 are views of the central lateral portion of the male pelvis. a series of enlarged cross-sectional views of the prostate gland illustrating the stages of one embodiment of the present invention used; FIG. 6 shows a mechanism for positioning, advancing, and locking a cannula according to one embodiment of the present invention. FIG. 7 is a schematic partial cross-sectional view of the apparatus shown in FIG. End view of the guide wheel shown with the device, FIG. 8 is an enlarged section of the device shown in FIG. A cutaway view, FIG. 9, shows FIG. 1 when the lace-like locking means according to the invention is in the retracted position. An enlarged cross-sectional view of the distal portion of the locking cannula shown in FIG. a sectional view when the locking means is extended and in the locking position; FIG. 11 shows the invention similar to the device shown in FIG. 1 with an elongated shaft. FIG. 12 shows a side view of the distal portion of another embodiment of the device according to the invention. Figures 13 and 14 show further embodiments for use with the apparatus shown in Figure 12. diagrams of the closure and stylet, respectively; Figure 15 shows the lace locking means in the retracted position and the stylet in place. A cross-sectional view of the distal end of the locking cannula of the device of FIG. 12, FIG. the cord-like locking means is extended and in the locking position, and the energy supply means is in the predetermined position. FIG. 17 is a cross-sectional view of the distal end of another locking cannula; FIG. The end of the alternative locking cannula shown in FIG. 17 when the energy supply means is in place. sectional view of the end, FIG. 19 is a cross-sectional view of yet another embodiment of a locking cannula according to the present invention.

Detailed description of the preferred embodiment In order to understand the present invention as a whole, the method of the present invention will be described in detail below. (BPII) laser ablation treatment method will be explained. However, those skilled in the art will understand that the specification The overall method and apparatus described herein makes the prostate gland accessible by the urethra. as well as any other organ that is accessible through a body cavity. It should be understood that applicable. For example, as in other organs , the prostate gland can also be accessed laparoscopically rectally or through the peritoneum. It is. Also, according to the present invention, numerous treatment methods other than laser ablation are possible. .

First, referring to FIG. 1, the interstitial treatment device 10 according to the present invention has its distal end connected to the prostate gland. It is positioned within the urethra A of the prostate, adjacent to B. Locking cannula 1 The interstitial locking means 16 is extended by squeezing the trigger lever 14 with two forces. Expand by subtracting. The sharp tip 20 of the laser fiber 22 allows the laser to energy is delivered or is being delivered to the treatment area. Nd; YAG or Diode lasers provide a suitable source of laser energy. Also, specific application examples Depending on the requirements, it is also possible to use a tunable dye laser. A person skilled in the art would understand that It is possible to identify other laser sources and select the appropriate optical fiber to use with them. Probably. Its functions and their interrelationships are illustrated in Figure 1, which is explained in more detail below. Other components of device 10 include fluid ports 24, 26, endoscope 28, and cannula. The kite 30, guide wheel 32, hand piece 34 and shaft 36 are Ru.

After inserting the endoscope 28 into the handpiece 34, as shown by arrow 37 in FIG. While viewing the image of the veruminum, the shaft 36 is advanced into the urethra A of the prostate gland. distal opening Expansion fluid is introduced through one of ports 24 or 26 communicating with section 38 to This makes it easier to introduce software. This expansion fluid is supplied to ports 24 or 26. It can be removed through the other side, or it can be allowed to accumulate temporarily in the bladder. come. By rotating the guide wheel 32, the cannula guide 30 moves into the treatment area. It is directed towards the wall of the urethra, which corresponds to area E. Arrow 39 indicates movement of cannula guide 30. The positioning of the shaft 36 and cannula guide 30 is performed using the endoscope 28 and the cannula guide 30. and through the endoscope port 40.

3 and 4, when the handle lever 14 is squeezed, the sharp fiber tip A locking cannula 12 with 20 is exposed through the urethral wall and into the treatment area E. Directed. The sharp tip facilitates puncture of the urethral wall and also cannulate the prostate. Make it easier to push into the However, sharp laser fibers are not required. for example, Use the stylet to insert the cannula into the organ, as described below. and then insert a laser fiber (or other energy source) with any desired tip. It is also possible to perform treatment by using a lugi supply means) in place of the stylet.

The insertion depth into the prostate B is determined by observing the control mark 42 on the outside of the cannula 12. This can be determined based on the following. Such control labels can be used, for example, on impregnated plastics. As a ring, placed on the outside of the cannula or visible through the outside of the cannula. It is also possible to arrange it on its inner surface, as can be seen in . Other signs can also be adopted, the main condition being that it can be easily seen visually on the outer surface of the cannula. is possible.

When the distal end of the locking cannula approaches the treatment area E, the tip 2 is 0 accurately for treatment. For example, ultrasound can be or by removing the endoscope 28 and transmitting transrectal ultrasound through the shaft 36. Ultrasonic waves can be applied by inserting a probe. canyule 1 2, to increase contrast and facilitate ultrasound imaging, It is desirable to provide a structure for use or to perform surface treatment.

Once the tip 20 has reached the desired position for treatment, it is engaged, as illustrated in FIG. The stop means 16 is deployed to securely lock the cannula in place during treatment.

The stop means 16 is deployed by pulling the trigger 18, thereby causing the whiskers to Or a coaxial movement is made to extend the means of the pond. Different types of locking means This will be explained in more detail below.

Referring again to FIG. 1, laser energy is applied through a sharp tip 20. , the condition of treating the prostate gland is indicated. The sharp tip allows the treatment area to be As a result, it becomes spherical, and the tip is placed approximately at the center of the sphere.

During the application of laser energy, keep the surrounding area clean to prevent unintended tissue damage. It is necessary to monitor tissue temperature. For this purpose, as described below A temperature sensing device 46, such as a thermocouple or a tiny thermistor, is placed along the shaft 36. It can also be placed at any suitable location on the cannula 12. skilled in the art The person shall make the necessary connections to the monitoring equipment and provide the precise location of the detection equipment. will have sufficient knowledge to

To prevent damage from overheating in high-temperature energy supply devices, avoid touching body parts. Cooling is desirable. For example, directing cooling fluid through ports 24 or 26. cooling of the shaft 36 in the area of the external sphincter F. external sphincter Damage to the muscles can cause incontinence. In addition, as shown in FIG. Then, the shaft 36 is extended distally to directly cool the constriction G of the bladder. Both are desirable. This cooling fluid is circulated in and out of ports 24 or 26. or exit through the opening 38 and temporarily accumulate in the bladder. You may. If it accumulates in the bladder, the shaft will not extend between It is possible to cool the waist part to some extent.

After treatment, the locking means are retracted and the cannula is removed. Apart from this, Kanyu It is also possible to reposition the device and deploy the locking means again for further treatment. It is Noh.

Next, referring to FIGS. 6 to 19, where similar components are designated by like reference numerals, , details of various alternative embodiments of the present invention will be described in further detail. Figure 6 shows the A schematic diagram of the working mechanism of the device 10 is shown. The device 10 as a whole and includes a movable assembly 48 and a barrel 50 held within a support structure 52. . Support structure 52 includes a shaft portion 36 and a handpiece 34 .

Movable assembly 48 is mounted for both rotational and axial movement. While the outer cylinder 50 is restrained from moving axially, the movable assembly 48 In addition to supporting the movable assembly and barrel in motion together, the support structure 52 Provides a passageway for body flow between ports 24,26 and opening 38.

The specific arrangement of such passageways is within the knowledge of those skilled in the art and, as such, they , not shown in the drawings for simplicity.

Hunt piece 34 is made of a suitable rigid material such as stainless steel or plastic. It supports the movable assembly 48 and is operable by hand.

Depending on the specific application and other factors set by the operator, the shaft portion 36 can take various forms. For example, this includes rigidity, flexibility, may be ductile or articulable or expandable; A highly flexible embodiment can be formed in a manner similar to known catheters. come. By providing a controllable joint, articulatable embodiments allow intraperiosteal It is fully suitable for operation. Inflatable embodiment is telescopic/yaft more longitudinally inflated, and with a balloon structure on the shaft, e.g. It can expand in any direction. 1990, incorporated herein by reference. U.S. Patent No. 07/625.332, filed February 10, describes the invention. A number of shaft balloon configurations suitable for use on shaft portions are disclosed. . The balloon-inflatable shaft may be used in addition to the locking cannula described herein. provides a locking function and thus provides greater confidence in the accuracy of the treatment area. It becomes possible to have it. Additionally, shaft balloons do not use cooling or heat transfer media. cooling the body cavity and surrounding tissue while inflating and delivering energy. I can do that.

The movable assembly 48 can be rotated by turning the guide wheel 54.

This also causes the barrel 50 to rotate, thereby causing the cannula leg to rotate as described above. Position the id 30. Any suitable means of orienting the cannula It functions as a Yure guide 30. A preferred embodiment is a curved area on which the cannula slides. It includes a member that forms a passage. This movable assembly grips the handle lever 14. Proceed by doing this. When moved in the direction of arrow 56, the handle lever 58 (attached to support structure 52) to move the cam member 60 forward. Lend. Cam member 60 engages lever ring 62 and moves the movable assembly axially. vinegar.

Lever ring 62 is fixed to movable assembly 48 . Notch in cam member 60 64 allows the lever ring 62 to rotate when the guide wheel is rotated. At the same time, it continuously engages ring 62 to effect axial adjustment. guide The wheels 5, 4 (FIG. 7) cooperate with the slots 68 of the movable member 48 and The eel rotatably engages and permits free axial movement with respect to the movable assembly. It is equipped with an internal key 66.

Trigger 18 is slidably attached to support structure 52 . The trigger arm 70 is a notch that cooperates with the trigger ring 76 in a similar manner to the notch 64 and the lever ring 62; It is equipped with 72. However, the trigger ring 76 is fixed to the movable assembly 48. There is no one. Trigger ring 76 remains with the movable assembly unless trigger 18 is released. Move. When the trigger is pulled, the trigger ring 76 engages the movable assembly 48 as shown in FIG. Move independently to the left.

As shown in FIG. 8, the cannula 12 has an inner sheath 80 and an outer sheath 82. We are prepared. The energy supply means, in this case the laser fiber 22, is connected to the inner sheath 8. It is kept within 0. The cannula and laser fiber are shown in the cross-sectional view. do not have. The cannula is flexible as a whole and guided by the cannula guide 30. It can also be easily inserted into organs.

Also, since the cannula 12 is flexible, the cannula 12 is As disclosed in No. 32, it is suitable for use with steering fibers. , providing a cannula that is steerable within the organ. In certain embodiments stiffness for ease of insertion and, as explained below, for increased insulation properties. The stiffness of the shaft can be used to provide a flexible tip or to facilitate manipulation of the cannula. It may be desirable to provide a flexible proximal portion. As understood by those skilled in the art , such a rigid section can be provided without compromising the overall flexibility of the cannula. It's something you get.

Also shown in FIG. 8 is an endoscope passageway 81 and a rotatable integral rod 83. . The rotatable integral rod allows the barrel 50 to rotate with the movable assembly 48, but with no hole. the movable assembly is received within and allows the movable assembly to translate without translating the outer barrel. make it possible.

Trigger ring 76 includes a forwardly extending inner sheath support member 84 .

The support member 84 is hollow to form a passage for the laser fiber and is It is secured to the inner sheath 80 at a portion 86. The inner sheath support member 84 is It is slidably received within the side north support member 88 . Support part of the outer sheath The material extends from the body 90 of the movable assembly and connects to the outer sheath 82 at a connection 92. has been done. Therefore, as described above, when the lever ring 62 is advanced, the outer side The sheath 82 moves forward, causing the inner sheath and laser fiber to move forward unless the trigger 18 is pulled. The levers move together to insert the cannula 12 into the prostate or other organ to be treated. Stretch it.

Once the cannula is positioned for treatment, the locking means 16 is deployed.

This is done by pulling the trigger 18, resulting in an interaction with the elements described below. The cooperation moves inner sheath 80 posteriorly, ie, proximally. trigger ring 7 6 is shown in a partially pulled position in FIG.

9 and 10 regarding the deployment of the locking means 16 according to the embodiment shown in FIG. This will be explained in more detail below. Figure 1 shows the usage of a number of locking members. However, for simplicity, it is not shown as one locking member in FIGS. 9 and 10. . Figure 9 shows the distal end of the cannula when extended into the organ. sharp rays The fiber tip 20 forms the puncture tip of the cannula. I will explain below However, the structure of the pond, such as a separate stylet or hollow needle, also serves this purpose. It can be achieved. The inner and outer sources are tapered at the ends. It has a profile that facilitates insertion.

The inner sheath 80 is made of a spirally wound wire similar to the known wire. It is equipped with a shaft portion 96 made of IjI and has sufficient axial rigidity and Achieved by combining tuckability with flexibility. At the distal end of the inner sheath 80, a locking string is attached. A tip 98 is provided that retains the shaped portion 100 within the recess 102. The string-like part 1 00 can be inserted into and pulled from surrounding tissue many times without rupture. formed of any biocompatible material with sufficient strength, stiffness, and elasticity to can be achieved. Such materials include stainless steel, carbon steel, anodized steel, Includes tinol and various hard plastics. End of locking string-like portion 100 is aligned with opening 104 in outer/- space 82. As mentioned above, the inner sheath 8 0 is moved rearward, the locking string-like portion 100 comes out from the opening 104, and as shown in FIG. 10, implanted within the organ. When the locking string-like part is extended, the cover The distal end of the nure 12 is secured adjacent the treatment site. Next, the laser fiber or the operator can operate the device 10 without having to manually maintain the pond treatment means in place. By releasing or holding it, it becomes possible to concentrate on the treatment area.

The locking means 16 causes the trigger ring 76 to move in the opposite direction when the locking means is deployed. Retracted or reversed by retracting or reversing. This is done by hand Or it can be done automatically. One means (not shown) of automatically retreating is , to provide a spring mechanism that can be locked by an operator, and this spring I +! The mechanism, when released, biases the trigger ring 76 to the retracted position.

For energy treatment procedures that involve high temperatures, such as laser ablation, the tip 98 Preferably, it is formed of a non-thermal conductive material to prevent heat transfer to portion 98. Yes. Laser fiber 22 and cannula are used to monitor energy supply and temperature. A temperature detection device 46 is arranged along the rail 12. Thermocouple or thermistor as mentioned above In addition, a fiber optic temperature sensor or infrared measuring device is installed along the cannula. By doing so, it becomes possible to perform temperature detection. In addition, ultrasonic waves are used to Temperature can be monitored remotely by imaging the tissue by processing the sound wave image signal. It is also possible to view the In addition, N is a compound generated by cell destruction. , A　D　PH　H, it is possible to measure the degree of tissue damage. It is Noh.

Depending on the type of treatment being performed, the structure and structure of outer sheath 82 (and inner sheath 80) may vary. It is possible to change the material and material. In the case of high temperature energy supply equipment, Durable materials must be used. Also, the outer sheath must be made of an insulating or non-conductive material to prevent heat transfer. No. One advantage of the present invention is that the cannula is advanced through a relatively small bore. This will ensure that the hole heals quickly and minimizes the risk of post-treatment infection. In some cases, the heat transfer to the outer sheath is sufficient to cauterize the surrounding tissue. , the holes formed will be more permanent and difficult to recover. Also, similar to the inner sheath In addition, the outer sheath must be axially rigid and bendable; That stiffness can be provided by a guidewire-like structure in the inner sheath.

Alternatively, these inner and outer sheaths may be in two or more parts. The tapered end portion is made of a relatively rigid and extremely It can be made completely non-conductive. Those skilled in the art will be able to determine the conditions for a particular application. f4, Teflon, Soricon, Polyurethane, Polymer and Copolymer etc. It is possible to identify suitable materials.

The cannula is equipped with an echo image to assist in ultrasound positioning. It can be formed in any possible structure. This is selected for the inner and outer sheath e.g. the acoustic impedance is the result of one factor of different materials having different The cannula is formed from two different materials that are non-uniformly connected to each other and This can be done intentionally by forming a number of reflection angles.

In some applications, for example, for drainage or to burn the surrounding tissue. It may be desirable to create a more permanent hole through cauterization. In such case , North, where energy transfer at the tip occurs downward along the outer sheath. As such, it can be made of a highly conductive material. Aside from this , especially in applications that do not supply energy, the cannula itself is It may be desirable to provide a heat source for For example, for this purpose, electrical resistance It is also possible to use heat.

Referring now to FIG. 11, another version of the device 10 having an elongated shaft portion 106 is shown. The example is illustrative. The cannula guide 30 and endoscope port 40 are attached to the urethral wall. An opening 108 is formed in the shaft to permit access. There is. In other tables, the structure and operation of the equipment is substantially the same as that described above. Ru. Elongated shaft portion 106 is disclosed in co-owned U.S. patent application Ser. No. 07/625.33. Particularly well suited for use with tipped balloons, as disclosed in No. 2 . This elongated shaft is inserted into the waist of the bladder G while delivering energy. and can be of sufficient length to provide a direct source of cooling to this area. .

FIG. 12 shows yet another embodiment of the invention. In FIG. 12, the device 11 0 should be treated by supplying energy to the organ (approximately in place) This is an indication. Introducer assembly 112 generally corresponds to shaft 36 of device 10 A shaft 114 is provided. The preferred form of shaft 114 is 21-22. A stainless steel cannula of French dimensions, but as described above with respect to device 10. Other forms such as the above are also possible. The endoscope 116 includes an introducer assembly It is shown inserted inside. Also, cleaning and light source connections 118 and 120 Each is provided. The distal end of shaft 114 provides an endoscopic port and also , forming a cannula guide 122. Therefore, the insertion direction of the cannula 12 is , can be controlled by rotating the introducer assembly.

Locking cannula 12 enters introducer assembly 112 through port 126 and locks the cannula. It extends outward from the Yure guide 122. The locking actuator 130 is allows coaxial movement between the sheath 82 and the inner sheath 80 (FIGS. 15 and 16). (illustrated in more detail). The energy supply means 136 is connected to the locking actuator 130 . It is inserted into the cannula through port 138.

In use, the introducer is first fitted with the seal 140 shown in FIG. 13. this At this time, neither the endoscope nor the cannula may be placed within the introducer assembly. do not have. The operator then inserts the seal 140 in a similar manner to inserting a cystoscope. Introducer assembly 112 is then inserted into the urethra. In this case, similarly to device 1o, , urethra and prostate are described for illustrative purposes only and do not limit the invention. It's not a thing.

The distal end of shaft 114 is positioned near the prostate or other targeted organ. After that, the seal 140 is removed, the endoscope 116 is inserted, and the light source and cleaning solution are applied. Connect properly. Stylet 142 is inserted into cannula 12 through port 138. The inserting stylet 142 is shown in FIGS. 14 and 15. Next, crab The cannula extends from the Yureguide 122 until it is visible through the endoscope. 12 is inserted into the introducer assembly through port 126. Rotate the introducer assembly. Rotate to position the cannula toward the treatment area. Next, Kanyu Grasp the base end of the lever 12 and push it in, or press it onto the actuator 130. , by forcing the stylet 142 into the prostate, the cannula 12 is moved forward. Stretch it out while standing. The control mark 42 on the cannula 12 is visible through the endoscope. It can be seen with the naked eye at Poe [26].

Once the treatment area is reached, finger grip portion 146 . of anchor actuator 130 . 148 is used to retract the inner source 80. As mentioned above, this results in The locking means 16 can be deployed. As shown in FIG. 16, cannula 12 Once the distal end of the is locked in place, the stylet 142 is removed and the energy delivery The feeding means 136 is inserted and extended distally a predetermined distance out of the cannula. Make it longer. This degree of elongation can be checked with the naked eye by a sign or mechanical stopper. I can judge.

17 and 18 show yet another embodiment of the present invention. In this example 15 and 16, the coaxial movement of the inner sheath 80 and outer north 82 is shown in FIGS. This is the opposite of what is shown in . Once the treatment area is approached, move the inner sheath 80 to the final position. Extend it forward until it reaches the desired position. This action causes the string-like portion 150 to move through the opening 152. and lock the distal end of the cannula in place. The string-like portion 150 is , in order to form that hook-like shape, a material with sufficient elastic restoring force, such as Nitinol, is required. Preferably, it is made of a material. After stretching this string-like part, the stylet 142 and insert the energy supply means 136 into its position.

This energy supply means 136 need not be a laser fiber. to the organization Other energy delivery systems can also be used to achieve the desired effect. example For example, for ablation, the means 136 may include a microwave antenna, an ultrasound probe (a remote (can be either a line leading to the source of the gap or a piezoelectric device at the terminal position), the tip radio frequency sources such as dipoles placed in the It is also possible to have a Lugi system.

The invention is particularly advantageous since the energy supply means can be removed without removing the entire device. It is particularly suitable for multi-stage treatment directions. For example, targeting and selecting specific cells. Photodynamic therapy can be performed using compounds that sense selected light frequencies The setting of such a target would be based on antibodies that have similar properties to the target cells. This can be achieved by combining the following compounds. This compound canyure 1 2 to allow sufficient time to reach the target cells. Next, the optical fiber The fiber is inserted into cannula 12 and a laser or other suitable device is used for treatment. Give light. The interstitial locking means 16 is such that light energy is applied to the same location as the compound. ensure that

It is also possible not to use all of the energy supply means.The cannula 12 After being locked in place by the locking means 16 and removing the stylet 142, the crab is Yule uses interstitial targeted drug therapy and the implantation of radioactive "seeds." or by implanting a microwave “nd” (essentially a small piece of metal) and then , to deliver other treatments such as radiation therapy that delivers microwave energy. Provide a logical conduit. In addition, the cannula 12 directly suctions the treatment area. It can be used for washing or washing.

Furthermore, the cannula 12 can be used not only for treatment but also for diagnosis. It is. For example, directing an endoscope or ultrasound probe to a specific location within an organ. I can do it. To enhance external radiographic, magnetic resonance, or ultrasound imaging , it is also possible to supply a control agent.

Cannula 12 need not have a coaxial north. In Figure 19, the locking string As an outer member and energy supply means 136 for deploying the shaped portion 156, a flexible Yet another embodiment of the present invention is shown using a needle 154 of. Locking string-like part 1 56 is fixed to the supply means 136 by a collar 158, and when retracted , is received within the recess 160 of the needle 154. In use, the needle 154 is Insert into the organ to the treatment site by any suitable means as described. Next, tighten this needle slightly The upper means 136 is separately advanced to the treatment position while the curved guide The lace portion 156 is deployed through the hole 162. Means 136 is formed by a needle. have a tapered or sharp end to facilitate advancement into the passageway I can do it. This example is based on the U.S. patent application incorporated herein by reference. Flexible steerable needle and device disclosed in No. 07/625.332 It is particularly suitable for application with

International search report 11r7/ll (+II/1III’l17 front page continuation) tree (72) Inventor Collison, Michael Lynnfield Brae, Goleta, California 93117, United States S 484 H (72) Inventor: Mac Nicholas, Thomas A. Hertfordshire, UK Nissey 4.9 Edabriu, Hitchin, London Road (no street address) ), Little Lotz (72) Inventor Redmond, Russell J. America 7 North Fairview Avenue, Goleta, California 93117 2) Inventor: Taihon, Cloud 55347, Minnesota, United States. Eden Braley, Blue Stem Rain 2) Inventor Vidal, Cloud A For California, USA 5426 San Patricio Drive, Santa Barbara 93111°

Claims (40)

[Claims] 1. a distal end for insertion into an organ as a device for interstitial treatment or diagnosis within an organ; and an elongate and at least partially flexible cannula having a proximal end; positioning the cannula, having a proximal end and a distal end, in a body cavity adjacent to an organ; means and means for guiding the cannula into the organ mounted on the positioning means; and treatment. or means for locking the cannula in place during diagnosis. A device that does this. 2. 2. The device of claim 1, wherein the cannula locking means comprises: A device characterized in that it is disposed on the cannula adjacent the distal end. 3. The apparatus according to claim 1, wherein the positioning means receives an endoscope. the cannula, and the cannula is positioned so that insertion of the cannula into the organ can be observed. 1. An apparatus for forming an endoscopic port in which the endoscope is placed. 4. 4. The device of claim 3, wherein the device is provided on the outer surface of the cannula. further comprising a visually visible control mark, thereby indicating that the cannula is A special feature is that the state inserted into the office can be seen through the endoscope. A device used as a sign. 5. The apparatus according to claim 3, wherein the positioning means is supported at a proximal end thereof. a proximal portion holding the positioning means, and providing a means for manipulating the positioning means; a guide hand for rotating the stage to guide the cannula into the organ in position; A device characterized in that the stage can be fixed in place. 6. The device according to claim 5, wherein at least one another fluid port communicating with the fluid port and circulating the fluid to the position. said device is formed to allow the tissue surrounding the determining means to be cooled in place. and at least one fluid passageway. 7. The apparatus according to claim 5, wherein the guide means a member attached to the distal end of the cannula, the member sliding axially through the cannula. forming a curved passageway shaped and dimensioned to be acceptable; device to do. 8. 6. The apparatus of claim 5, wherein the cannula comprises an outer member and a an inner member received within the outer member for axial movement therebetween; , the cannula is removable from the positioning means and the proximal portion; axially insertable within the positioning means and the proximal portion; The locking means is a locking member fixed to the inner member, and the locking means is a locking member fixed to the inner member, and In response to relative movement with the outer member, the inner member and the outer member a first unlocked position between the cannula and a second unlocked position extending into the tissue surrounding the cannula. a locking member movable between a locking position, the device being adapted to actuate the locking means; means at the proximal end of the cannula, the means disposed on the outer cannula portion; a first member affixed to the inner cannula member and a second member affixed to the inner cannula member. comprising, whereby the first member moves relative to the second member, It is characterized in that the locking means is movable from the first position to the second position. A device used as a sign. 9. 6. The device according to claim 5, wherein the proximal portion is connected to the positioning means. a support structure having a distally extending shaft portion surrounding the support structure; A device featuring: 10. A device according to claim 9, which is rotatable and axially translatable. further comprising a movable assembly mounted within the pair of support structures, the movable assembly is cooperating with said positioning means and said positioning means in response to rotation of said movable assembly. Rotate the stage and the guide means until the proximal end of the cannula is secured to the movable assembly. when the cannula is attached and the movable assembly is translated axially. means for inserting said cannula into said organ. A device characterized by the fact that 11. 11. The device of claim 10, wherein the cannula is connected to an outer member. , an inner member received within the outer member for axial movement therebetween; , wherein the locking means is a locking member fixed to the inner member adjacent to the distal end. and in response to relative movement between the inner member and the outer member, the inner portion a first unlocked position approximately between the outer member and the outer member; a locking member movable between a second locking position extending into the fabric; The body includes a body member having a second member secured thereto and at least a portion received within the body member. a support member inserted into the inner member and secured to the inner member; retaining members are movable together with and separable from the body member; A device characterized by: 12. 12. The apparatus of claim 11, wherein the apparatus is mounted on the support structure. and a handle member cooperating with the body member, whereby the handle portion movement of the material allows the movable assembly to move relative to the support rod structure; mounted on and cooperating with the support structure of the inner member; The movement of the trigger member causes the support member of the inner member to engage the body member. and separately moving the locking member from the first position to the second position. sea urchin, wheel means rotatably engaged with said body member, whereby said wheel means is rotatably engaged with said body member; The guide means is positioned by rotation of the guide means. A device that does this. 13. 13. The apparatus of claim 12, wherein the handle member, the trigger The member and said wheel means are operable with one hand of the operator. Featured device. 14. 2. The device of claim 1, wherein the cannula locking means is the locking means is arranged on the cannula and the locking means is arranged between the first unlocked position and the cannula. a locking member movable between a second locking position and a second locking position extending into the tissue surrounding the hole; A device characterized by: 15. 15. The device of claim 14, wherein the cannula is located at the distal end. comprising a hollow, flexible needle forming an adjacent radial opening; The device further comprises organ energy supply means disposed within the needle; The locking means is affixed to the energy supply means and is in contact with the needle in the first position. The needle is arranged approximately between the energy supply means and the relative movement between the needle and the energy supply means. such that said locking means can be moved through said opening to said second position. A device characterized by: 16. 15. The apparatus of claim 14, wherein the cannula has a cap thereon. an inner sheath in which the locking member of the neurule is located and an outer sheath forming a radial opening; a sheath, and the locking member is disposed approximately between the sheath at a first position. and the relative movement between the sheaths causes the locking member to pass through the opening. The locking member and the opening are arranged to move to the second position. A device featuring: 17. 17. The device of claim 16, wherein the device is disposed within the cannula. , comprising means for supplying energy to the organ and detection means disposed on said cannula. and means for detecting the temperature of the supplied energy. 18. The apparatus according to claim 17, wherein the temperature detection means is located at the position disposed on the positioning means, the device cooling tissue surrounding the positioning means; A device characterized in that it comprises means. 19. The apparatus according to claim 17, wherein the energy supply means having a sharp end extending distally beyond the cannula for insertion into said organ; A device characterized by facilitating. 20. 15. The apparatus of claim 14, wherein the cannula is inserted into the organ. further comprising advancing means and means for activating the locking means, the advancing means and A device characterized in that the operating means can be operated with one hand of the operator. 21. 15. The apparatus according to claim 14, further comprising a small at least one inflatable balloon; inflating the balloon; and inflating the balloon; and means for securing the stage within the body cavity. 22. A terminal that is inserted into an organ as a kit for interstitial treatment and diagnosis within an organ. a cannula having a proximal end and means for locking the cannula within an organ; means for positioning said cannula within a body cavity adjacent said organ; and said cannula; and means for guiding a cannula into said organ; A shape and size that can be inserted into the positioning means so that the insertion therein can be visualized. A kit characterized by comprising an endoscope formed by a method. 23. The kit according to claim 22, wherein the cannula locking means is a first unlocked position and a second locked position extending into tissue surrounding said cannula. A kit characterized by comprising a locking member that is movable between the position and the position. 24. A kit according to claim 23, wherein the cannula is inserted into the organ. further comprising: means for advancing the locking means; and means for activating the locking means; and the operating means is operable with one hand of the operator. kit. 25. A kit according to claim 24, which is inserted into the positioning means. , a closed body capable of facilitating positioning of the positioning means within the body cavity; A kit further comprising: 26. A kit according to claim 24 and received within the cannula. and extending distally beyond the cannula into the organ. further comprising a removable stylet to facilitate insertion of the A kit with characteristics. 27. A kit according to claim 24 and received within the cannula. shaped and dimensioned to supply energy to the organ at the distal end of the nuclear force nerve. further comprising an energy source having an energy supply means formed therein. kit. 28. 28. The kit of claim 27, wherein the energy source is a micro A kit characterized by providing wave, ultrasound, laser, radio frequency, or thermal energy. to. 29. 29. The kit according to claim 28, wherein the energy supply means comprises a A key characterized in that it is a antenna, an optical fiber, an electric wire, a bipolar device, or a piezoelectric element. t. 30. an elongated outer member for use as a locking cannula for interstitial treatment or diagnosis within an organ; and, an elongated inner member received within said outer member for axial movement therebetween; members, each of said members having a distal end for insertion into an organ and a proximal end for manipulation. and has affixed to the inner member adjacent the distal end, the inner member being fixed to the inner member relative to the outer member; in response to a first position between said inner member and said outer member; movable between a second locking position extending into tissue surrounding the cannula; A cannula comprising a locking member having a shape. 31. 31. The cannula of claim 30, wherein the outer member is comprising a hollow, flexible needle forming a radial opening adjacent the end; said inner member comprising an energy supply means disposed within said needle; said inner member comprising an energy supply means disposed within said needle; is fixed to the energy supply means, and when the locking member is in the first position, the front disposed approximately between the marking needle and the supply means, and relative movement between the needle and the supply means; so that the locking member can move through the opening to the second position. , a cannula fixed to said energy supply means. 32. 32. The cannula of claim 31, wherein the inner member further comprises: a hollow inner sheath having a locking member disposed therein, the outer member being adjacent to the distal end; a hollow outer sheath forming a radial opening to The relative movement between the sheaths causes the locking member to move from the first position to the open position. the locking member and the opening are arranged to move through the mouth to the second position; A cannula characterized by being placed. 33. 33. The cannula of claim 32, wherein the inner sheath is helical. A shaft portion having a wire structure wound in a shape and receiving the locking member at a first position. a distal tip portion forming a recess into which the cannula is inserted. 34. The cannula according to claim 33, wherein the distal tip portion comprises: A cannula characterized by being made of a heat-resistant and non-conductive material. 35. A method of interstitial treatment or diagnosis within an organ, adjacent to the organ to be treated. placing a tubular member within the body cavity and guiding a cannula with the tubular member; cannulating the organ by puncturing the tissue; a cannula comprising a distal end and a tissue puncture means disposed at the distal end; positioning the distal end of the cannula in a treatment or diagnosis area; positioning the area within the organ; and performing treatment or diagnosis in the area. A method characterized by: 36. The method as set forth in claim 35 allows the cannula to be unlocked. withdrawing at least a portion of said cannula; and withdrawing said cannula. reinserting the cannula into a second treatment or diagnosis area; and locking the cannula. floor and and performing further treatment or diagnosis. 37. The method according to claim 35, the guiding and positioning step but, Inserting an endoscope into the tubular member and visually determining the direction of insertion through the endoscope. and a control placed a predetermined distance apart on said cannula. The step of determining the depth of insertion by observing the markings and the step of determining the depth of insertion by observing the advancing the cannula to its final position. 38. 36. The method of claim 35, wherein the locking step a locking member disposed adjacent the distal end of the cannula from a first unlocked position. to a second locking position extending into the surrounding tissue. How to do it. 39. A method as claimed in claim 35, including guiding and inserting the cannula. The inserting step involves inserting the stylet into the cap with the sharp tip extending beyond the distal end. the cannula and stylet together into the organ. and the implementing step includes a step of withdrawing the stylet and a step of applying energy. A compound that targets type-sensing cells is delivered interstitially through the cannula. and targeting said compound through said cannula. and supplying the cells. 40. 36. The method of claim 35, wherein the administering step is directed to a treatment area. sequentially applying one or more energy supplies to the treatment area; and applying suction to the treatment area; a step of cleaning the treatment area, a step of delivering the drug to the treatment area, and a step of applying radioactive material to the treatment area. supplying a control substance to the treatment area or positioning an imaging device in the treatment area. and positioning the method.