SK94194A3 - Apparatus for interstitial treatment - Google Patents

Abstract

An apparatus and method for interstitial treatment and diagnosis in organs utilizing a flexible cannula (12) having an interstitial locking means (16) thereon. The apparatus includes a shaft for insertion into a body passage adjacent to the organ to be treated and adapted to guide cannula into the organ. The shaft is also adapted to receive an endoscope (28) to visualize insertion of the cannula. The cannula locking means includes a locking member which extends from the distal end of the cannula in response to relative motion between parts of the cannula.

Description

Technical field

The present invention relates to an apparatus and method for interstitial treatment or diagnosis of organs, more particularly by inserting an elongated handle of the device through an opening of the body near the organ to be treated and by extending the cannula into the organ to introduce treatment or diagnosis at a selected location. More specifically, the cannula comprises an interstitial locking device for reversibly blocking the cannula at the set point and during its operation.

BACKGROUND OF THE INVENTION

Advances in medical technology have enabled many new treatments and diagnostic techniques. For example, U.S. Pat. No. 4,950,267 to Ishara et al. discloses a laser beam treatment device for an endoscope.

The endoscope transports the laser probe to a certain position in the body,

from which to operate. laser probe is imprinted However, the disclosure probe is inserted into that part of the organ where it has not too specified how to organ. Also, U.S. Pat.

No. 5,047,026 to Rydel discloses an electrosurgical tissue section implant. The apparatus comprises two separate distal outlets.

which allow arc discharge after RF voltage is applied, allowing the devices to cut tissue. However, it does not include data on how the distal end is delivered to a specific site with minimal damage to healthy tissue, eg.

surrounding the treatment site.

Other therapeutic techniques include implantation of radioactive seeds for radiotherapy, or interstitial cell-targeted drug therapy. In addition, many different types of diagnostic techniques, such as endoscopy or ultrasound observation, are known. However, suitable devices and methods for interstitial application of these tech2 are lacking in the art

Despite considerable advances and new techniques for treatment and diagnosis, there remains a need in the art for a suitable device and method for interstitially introducing said treatment, or for diagnosis at selected sites within an organ, without significant and unnecessary tissue damage around the site to be treated.

This application is in part a continuation of U.S. patent application Ser. 07 / 625,322, filed Dec. 10, 1990.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a method and apparatus for interstitially delivering various therapeutic effects or diagnosing at selected locations in an organ.

Another object of the invention is to provide such a device that the operator can control easily and accurately for direct action or diagnosis in the desired interstitial position with minimal damage to the surrounding tissue.

Another purpose of the present invention is to provide a device for securing the cannula interstitially within an organ that would guarantee that the effect or diagnosis occurs at a selected location without the need for continuous monitoring of the cannula position.

These and other objects are accomplished according to the invention by an interstitial or organ diagnosis device comprising an elongated and at least partially flexible cannula, a device for positioning the cannula in the opening of the body near the organ to be treated, a guide device mounted on the a positioning aid for insertion of the cannula into the organ and a device for blocking the cannula at the desired location during treatment or diagnosis. The device further comprises a proximal portion that supports the positioning aid in handling and allows the positioning aid to rotate so that the guiding aid reaches the position to direct the cannula into the organ at a predetermined location.

A preferred embodiment of the invention further comprises a support structure with a distally extended portion of the shaft that surrounds the positioning aid. In this embodiment of the device, the movable assembly is fitted to the support structure to support each other with the positioning aid, and rotate the positioning aid and the guide aid in response to its own rotation. The proximal end of the cannula is also secured to the movable assembly so that the axial movement of the movable assembly causes the cannula to be displaced relative to the positioning aid and thus allows the cannula to be inserted into the organ.

In another embodiment of the invention, the cannula consists of an outer member and an inner member that is in the outer member. The locking device comprises a locking member secured to the inner member near the distal end and positioned substantially between the inner and outer members. The locking element is configured to be able to move from a first unlocked position between an inner and an outer element, to a second locked position, extending into the tissue surrounding the cannula. Said movement is a response to the relative movement between the inner and outer elements. The movable assembly comprises an element body secured to the outer cannula element and a support element secured to the inner cannula element such that relative movement between the element body and the support element causes the locking element to move from the first to the second position.

To allow the operator to operate the device with one hand, the device further comprises a handle mounted on the support structure interacting with the body of the movable assembly element, wherein pressing the handle causes the movable assembly to move relative to the support structure so as to insert the cannula into the organ. The device further comprises a trigger which is also mounted on the support structure and which co-operates with the support element such that pressing the trigger separately moves the support element away from the body of the element, causing the locking element to move from the first position to the second position. In addition, there is a circular element on the body, which is controlled by the thumb, which makes it easy to rotate the body of the element for positioning the guide element.

In a preferred embodiment of the invention, the cannula comprises an outer element which consists of a hollow flexible needle determining the size of the radial opening near its distal end. The inner member comprises a power supply device disposed in the needle. A locking element secured to the power transmission device such that relative movement between the needle and the energy transmitting device causes the locking element to move from the first unlocked position to the second, locked position by penetrating into the surrounding tissue.

In a further preferred embodiment, the inner cannula blocking element consists of a hollow inner shell with a locking element disposed thereon. The outer element also consists of a hollow sheath that determines the size of the radial opening near its distal end. The locking element and the aperture are spaced such that relative movement between the inner outer casing causes the locking element to move through the aperture, from the first, unlocked position to the second, locked position. According to further details of the invention, the inner shell may consist of a spiral wound construction and may have a separate distal tip portion that determines a recess in which the locking element is in its first position. The distal tip in the energy transfer embodiment of the present invention is preferably of a heat resistant and non-conductive material.

The present invention also includes a kit for interstitial action or diagnostics in an organ that essentially comprises a cannula blocking as described above, and a device, generally described above, and further, an endoscope, configured and dimensioned to be inserted into the device and thereby allow visual monitoring of intrusion of the cannula into the organ. The kit of the invention may also include a obturator adapted to be inserted into the device to allow positioning of the device in the body opening. The kit may also include a stylet adapted to be inserted through the cannula and distally extending beyond the cannula into the organ. Another part of the kit is an energy source having a transfer means constructed and sized to be inserted through the cannula and extending beyond the distal end of the cannula to deliver energy to the organ. The power sources included in the kit include microwave energy, ultrasonic energy, laser energy, radio frequency energy and thermal energy. In order to carry out the energy transfer of these different types of energy, the power transmission kit includes an antenna, optical fibers, conductors, a dipole device or a piezoelectric element.

The invention also includes a method for interstitial action or diagnosis in an organ. According to this method, a tubular element is inserted in the opening of the body close to the organ to be treated. The tubular element leads the cannula into the organ, the cannula piercing the organ tissue. The cannula is placed in the organ with the distal end into the zone of action. The cannula is blocked in the organ and is operated or diagnosed in the zone.

The method of the invention comprises a multi-step mode of action in which the cannula is guided and inserted into the organ along with the stylet. After the cannula is introduced at the desired site in the treatment zone, the stylet is withdrawn and the cell-targeted compound sensitive to the respective type of energy is interstitially applied by cannula. The appropriate type of energy is then transferred through the cannula to the target cells.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a mid-sectional view of the male pelvis illustrating the use of one embodiment of the device of the present invention for treating prostate;

Figures 2 to 5 are a sequence of enlarged sections of the prostate, illustrating the progressive application of the method of the invention, using the device shown in Figure 1;

Figure 6 is a schematic partial cross-sectional view of the device shown in Figure 1 illustrating a cannula positioning, shifting and locking mechanism according to one embodiment of the present invention;

Figure 7 is an end view of the guide wheel shown in the apparatus of Figures 1 and 6;

Figure 8 is an enlarged partial cross-sectional view of the device shown in Figure 1; 6;

Figure 9 is an enlarged portion of the distal end of the cannula blocking shown in Figure 1, with the barb blocking device of the present invention in the retracted position;

Figure 10 is a partial view of the barbed locking device shown in Figure 9 in the extended and locked position;

Figure 11 is a side view of the distal end of an alternative embodiment of a device according to the invention, similar to the device shown in Figure 1, with an extended shaft;

Figure 12 shows another alternative embodiment of the device according to the invention;

Figures 13 and 14 show a obturator and a stylet for use in the apparatus shown in Figs. 12;

Figure 15 is a fragmentary view of the distal end of the blocking cannula of the device of Figure 12 with the locking in the prone retracted position and the probe needle in place;

Figure 16 is a fragmentary view of the barbed locking device shown in Figure 15 in the extended and locked position, with the power supply device inserted;

Figure 17 is a fragmentary view of the distal end of an alternative blocking cannula;

Figure 18 is a fragmentary view of the distal end of the alternative blocking cannula shown in Figure 17 with the power supply device inserted; and

Figure 19 is a partial cross-sectional view of another alternative embodiment of the locking cannula of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

In order to achieve a broad understanding of the invention, the method of the invention will be discussed in relation to the laser ablation effect on benign prostate hypertrophy (BPH). It will be apparent to those of ordinary skill in the art that the general method and device as described herein are equally applicable to the action of another organ achievable through the orifice in the body, similar to the reachability of the urethra of the prostate. For example, the prostate can be achieved rectally or peritoneally by a laparoscopic technique, like other organs. Numerous other organ treatments, such as laser ablation, are also possible according to the invention.

Referring first to Figure 1, the device 10 according to the invention is placed in a suitable position for introducing the ureter A with the distal end of the device near the prostate B. The locking cannula 12 is released by pressing the handle 14 and the interstitial locking device 16 is extended by pressing the trigger. 18. The laser energy is fed to the treatment area C by the focused tip 20 of the laser fiber 22. The Nd: YAG or diode laser is a suitable laser source. A tunable color laser can also be used, depending on the nature of the application. Those of ordinary skill in the art may know other sources of laser radiation and may select appropriate optical fibers for this application. Other parts of the device 10 shown in Figure 1, whose functions and relationships will be explained below, are the fluid inlets 24 and 26, the endoscope 28, the cannula guide 30, the guide wheel 32, the holder 34 and the shaft 36.

After insertion of the endoscope 28 into the holder 34, the extension 36 is inserted into the prostate ureter A with visualization of the verumontane as indicated by the arrow 37 in Figure 2. The dilatation fluid may be fed internally through one of the apertures 24 or 26 which are connected to the distal aperture 38 facilitating insertion of the shaft. The dilatation fluid may be removed by another aperture 24 or 26, or may be temporarily accumulated in bladder D. By rotating the guide wheel 32, the cannula guide is directed against the urethral wall corresponding to the action zone E. The focused tip permits penetration of the urethra wall and pushing the cannula through the prostate. However, a sharp Laser Fiber is not required. For example, as explained below, a probing needle may be used to introduce the cannula into the organ, and then the stylet will replace the laser fiber, or other, energy-transmitting device, with any desired spike to act.

The depth of insertion into prostate B can be determined by observing the contrast markers 42 on the outside of the cannula 12. Such contrast markers may be on the outer surface of the cannula, for example as impregnated plastic rings, or localized on the inner surface, visualized through the outer surface of the cannula. Other markers are possible, but the primary requirement is the ability to be well visualized on the outer surface of the cannula.

When the distal end of the blocking cannula reaches the treatment zone E, ultrasound is used to fine adjust the treatment tip. The ultrasound can be applied, for example, by a transrectal ultrasound probe or after removal of the endoscope 28 and insertion of a transurethral ultrasound probe through the handpiece 36. Preferably, the cannula 12 is constructed with an echogenic design or a contrast enhancement surface allowing ultrasound visualization.

When the tip 20 is in the desired operating position, the locking element is released as shown in Figure 5 to confidently locate the cannula during treatment. The locking device 16 is extended by depressing the trigger 18, causing a coaxial movement which is transmitted to the toothing or other devices. Various alternative configurations of blocking devices are described in more detail below.

Referring again to Figure 1, it is shown how the energy of the laser is applied through the focused spike 20 to act on the prostate. The area of application when the focused tip is generally spherical, approximately the center of the ball at the tip.

During the application of the laser energy, it is necessary to monitor the temperature of the surrounding tissue to prevent unwanted tissue damage. For this purpose, temperature sensing devices 46, such as thermocouples, or miniaturized thermistors, are placed in a suitable position along the handpiece 36, as well as on the cannula 12, as explained below. People ordinarily skilled in the art should have sufficient knowledge to make the necessary connections to the monitoring devices and the exact location of the sensing devices.

In high temperature energy transmission systems, cooling of body parts is required to protect against overheating. For example, the coolant can be supplied through the orifices. 24 or 26 to cool the shaft 36 in the area of the outer sphincter F. Damage to the external sphincter could cause incontinence. It may also be required that the shaft 36 distally elongates, as shown in Figure 11, to achieve direct cooling of the bladder neck region G. The coolant may be circulated to and from the recesses 24 and 26, or may exit through the aperture 38 and temporarily collect in the bladder. bladder. Collecting in the bladder also causes some cooling of the bladder neck without having to guide the device shaft.

Upon termination, the locking device is retracted and the cannula removed. Alternatively, the position of the cannula may be changed and the locking device ejected again for further action.

In Figures 6 and 19, the same numerals refer to like parts and may be used to describe the invention in more detail in several alternative embodiments. Figure 6 schematically illustrates the operating mechanism of the apparatus 10 shown in Figure 1. The apparatus 10 generally comprises a movable assembly 48 and a cylindrical portion 50 contained in a support structure 52. The support structure 52 comprises a shaft portion 36 and a handle 34. The movable assembly 48 is mounted so as to allow both rotation and axial movement, the cylindrical portion 50 being secured against axial movement but rotating with the movable assembly 48. In addition to supporting the movable assembly and the cylindrical portion, the support structure has a passageway for fluid flow between the recesses 24 and 26; The arrangement of such a passage is a matter of ordinary skill in the art and may therefore be omitted from the drawings for reasons of clarity.

The handle 34 is constructed of a suitable rigid material such as stainless steel or plastic to support the movable assembly 48 and to facilitate the handling of the hands.

Depending on the particular application and other circumstances determined by the operator, the shaft portion 36 may have different shapes. For example, it may be rigid, flexible, ductile, articulated, or extensible. The flexible embodiment may be constructed by a similarly known catheter. By making controllable joints, the articulated design can be very suitable for handling in the peritonium. The extensible embodiments permit longitudinal extension by means of a telescopic shaft and also a radial enlargement, for example by means of a balloon structure on the shaft. U.S. Patent Application Ser. No. 07 / 622,332, filed Dec. 10, 1990, which is incorporated herein by reference, discloses several balloon stick configurations suitable for use in a portion of the stick of the present invention. Balloon expandable shafts are blockable in addition to the described blockable cannulas, and thus have increased reliability in accuracy of application. Hatching balloons can also be inflated using a cooling or heat transfer medium to cool the body opening and surrounding tissue during energy delivery.

The movable assembly 48 is rotated by a rotating guide wheel 54. This also causes the cylindrical portion 50 to adjust the position of the cannula guide 30 as described above. Any suitable device can be used as a guide for the cannula 30 to guide the cannula. A preferred embodiment comprises an element defining an arc passage through which the cannula slides. The movable assembly is moved by depressing the hand lever 14. When moved in the direction of the arrow 56, the hand lever rotates about the tip 58 mounted on the support structure 52 and moves the cam forward. The cam 60 pushes the lever ring 62, causing axial movement of the movable assembly. The lever ring is secured to the movable assembly 48. The groove 64 in the cam 60 allows the lever ring to rotate as the guide wheel is rotated while simultaneously and continuously pressing the ring 62 to achieve axial alignment. The guide wheel 54 (Figure 7) has an inner tongue 66 that fits into the slot 68 in the movable assembly 48 thereby allowing rotational engagement and free axial movement of the guide wheel relative to the movable assembly.

The trigger 18 is slidably mounted on the support portion. 52. The trigger arm 70 includes a groove 72 that engages the trigger ring 76 in the same manner as the groove 64 and the lever ring 62. However, the trigger ring 76 is not attached to the movable assembly 48. The trigger ring 76 moves with the movable assembly until the trigger 18 is depressed. When the trigger is depressed, the trigger ring moves to the left as shown in Figure 6, independent of the movable assembly. 48th

As shown in Figure 8, the cannula 12 is comprised of an inner shell 80 and an outer shell 82. An energy delivery device, in this case a laser fiber conductor 22 is housed in the inner shell 80. The cannula and the laser fiber waveguide are not shown. The cannula is generally flexible to allow it to be guided by the cannula guide 30 and to easily enter the organ. The flexible cannula 12 is also very suitable for use as a guided fiber as disclosed in dependent application no. 07/625 332 to achieve a cannula that can be operated in the organ. In certain applications, the cannula may be required to be provided with a rigid tip portion to allow penetration or increase of the insulating characteristic as discussed below, or the rigid proximal portion of the shaft improves cannula control. As will be appreciated by those skilled in the art, such rigid portions need not reduce the general flexibility of the cannula.

Also shown in Figure 8 is an endoscope channel 81 and a rotary joint bar 83. The rotary joint bar ensures that the cylindrical portion 50 rotates with the movable assembly 48, but is inserted in the cavity to facilitate movement of the movable assembly without moving the cylindrical portion.

The trigger ring 76 has a front extension, the inner casing of the support element 84. The support element is hollow and thereby determines the entrance for the laser fiber waveguide. It is secured to the inner casing 80 by a joint 86 ,. The inner casing support element 84 is slidably received in the outer casing support element 88. The outer casing support element protrudes from the body 90 of the movable assembly and is connected to the outer casing 82 by a connection 92. Therefore, when the lever ring 62 is displaced as explained above, then the outer sheath is advanced and, unless the trigger is depressed, the inner sheath and the laser waveguide are moved together, and the cannula 12 is inserted into the prostate or other organ to be treated.

When the cannula has been brought into action, the locking device 16 is extended. This is accomplished by depressing the trigger 18 which engages the elements as explained above, causing the inner housing 80 to move back or proximally. In Figure 8, the trigger ring 76 is shown in a partially depressed position.

The extension of the locking element 16 according to the embodiment shown in Figure 1 can be explained in more detail with reference to Figures 9 and 10. Figure 1 shows the use of multiple locking devices, but in Figures 9 and 10 only a simple locking device is shown for clarity.

Figure 9 illustrates the distal end of the cannula as extended into the organ. The focused tip 20 of the laser fiber waveguide forms the sharp tip of the cannula. As discussed below, other constructions such as a separate stylet or hollow needle may serve for this purpose. Preferably, they have a tapered distal end of the inner and outer skins to form a sliding profile.

The inner sheath 80 comprises a shaft portion 96 that is constructed of a spiral wound wire, similar to the known guide wires, in order to achieve a suitable combination of sufficient axial stiffness and extrusion strength with flexibility. At the distal end of the inner shell 80 is a tip 98.

provided for supporting the locking bar 100 in the groove 102. The bar 100 may be made of any biocompatible material having sufficient strength, hardness and elasticity for a large number of flawless ejections and insertions from the surrounding tissue. Such materials may include stainless carbonized or anodized steel, nitinol and various hard plastics. The end of the locking bar 100 is flush with the aperture 104 in the outer shell 82. When the inner shell is moved back as described above, the locking bar 100 is extended through the aperture 104 to be grafted into the organ as shown in Figure 10. cannula 12 near the site of action. The operator can then release his or her gripping device 10 so that he can concentrate on his own treatment without having to manually hold the laser fiber waveguide or other medical devices in place.

The locking devices 16 are retracted or returned by moving the trigger ring 76 in the reverse direction before being released to the locked position. This can be achieved automatically or manually. One method (not shown) of automatic retraction is by means of a spring mechanism that can be locked by the operator and, when released, affects the trigger ring 76 to reach the retracted position.

In the case of transfer of energy to a treatment site associated with the formation of a high temperature, such as laser ablation, the tip is preferably made of a thermally non-conductive material to prevent heat transfer to the shaft portion 98. In order to monitor the energy transfer and temperature, sensing devices 46 are placed along the laser waveguide 22 and the cannula 12. In addition to the thermocouples or thermistors as explained above, temperature sensing can be achieved by a fiber optic temperature sensor or infrared measurement along the cannula. Ultrasound can also be used for remote temperature measurement by characterizing the surrounding tissue by processing the ultrasound imaging signal. The proportion of damaged tissue can also be determined by sensing NADPH, a compound resulting from cell death.

Depending on the type of treatment provided, the material and design of the outer shell 82 (as well as the inner shell 80) vary. For high temperature energy transfer systems, materials which are sufficiently resistant to high temperatures must be used. The outer sheath must also be made of insulating and non-conductive material to prevent heat transfer to the shaft. One advantage of the present invention is that when inserting a cannula through a relatively small puncture, the wound heals rapidly with minimal chance of infection after the procedure. If there is sufficient heat transfer to the outer sheath to cauterize the surrounding tissue, longer lasting and heavier healing wounds may occur. Like the inner sheath, the outer sheath must also be axially rigid but flexible, and stiffness can be achieved by a structure similar to the guided wire of the inner sheath. Alternatively, the outer and inner skins may be of two or more portions, with a relatively rigid tapered distal portion and of a highly non-conductive material such as ceramic. Those skilled in the art can identify suitable materials such as teflon, silicone, polyrethane, polymers and copolymers that meet the requirements for this specific use.

To aid in positioning with the aid of ultrasound, the cannula may have an echogenic design. This may be the result of the effect of two different materials selected on the inner and outer sheaths, or may be intentionally formed, for example, by shaping a cannula of two different materials having different acoustic impedance and which unevenly adjust to one another to produce multiple reflection angles.

In certain applications, a sustained wound may be required, for example to drain, or otherwise cauterize surrounding tissue. In such cases, the skins may be constructed from a highly conductive material such that the energy supplied to the tip is guided down along the outer skirt. Alternatively, and especially in applications without power supply, the cannula itself may be required to be equipped with a heat source for cauterization. For example, electrical resistance heating can be used for this purpose.

Figure 11 shows an alternative embodiment of the device 10 having an extended portion of the shaft 106. The shaft has an opening 108 to allow access of the cannula driver 30 and the endoscope opening to the ureter wall. Otherwise, the design and operation of the apparatus is essentially the same as described above. The elongated portion of the shaft 106 is particularly suitable for the use of a spherical balloon as disclosed in U.S. Patent Application Ser. 07/625 332. The elongated shaft can be of sufficient length to be inserted through the neck of the bladder during the application of energy to achieve direct cooling of the source.

Figure 12 shows another alternative embodiment of the invention. Referring to Figure 12, the device 110 is shown to be substantially in a power treatment organ assembly. The insertion assembly 112 comprises a shaft 114 which generally corresponds to the shaft 36 in the device 10. The preferred configuration of the shaft 114 has a cannula of 21-22 French stainless steel, although alternatives are possible as explained above in connection with the device 10. The endoscope 116 is shown as being inserted into the insertion assembly. The distal end of the shaft 114 is provided with an endoscope opening and forms a cannula guide 122. Thus, the insertion direction of the cannula 12 can be controlled by rotating the insertion assembly.

The lockable cannula 12 extends through the insertion assembly 112 through the opening 126 and protrudes from the cannula guide 122. The lock actuator 130 causes coaxial movement between the outer shell 82 and the inner shell 80 (shown in detail in Figures 15 and 16). The power supply device 136 is inserted into the cannula through the opening 138 in the lock actuator 130.

In use, the insertion device is first assembled with the obturator 140 shown in Figure 13. In this situation, neither the endoscope nor the cannula can be placed in the insertion assembly. The operator then pushes the insertion assembly 112 with the obturator 140 into the ureter in a manner similar to the insertion of a cytoscope. As with the device 10, the example of ureter and prostate is again used here only in relation to the description of the purpose and not as a limitation of the invention.

When the distal end of the shaft 114 comes into proximity to the prostate or other target organ, the obturator 140 is removed and the endoscope 116 is inserted with appropriate connections to the light source and irrigation. A probe (stylet) is inserted through the opening 138 into the cannula 12. The probing needle is shown in Figures 14 and 15. The cannula is then inserted through the opening 126 into the insertion assembly until it protrudes from the cannula guide and is visible by the endoscope. The insertion assembly is rotated to direct the cannula to the desired zone of action. Then, the cannula 12 is ejected into the prostate by clamping its proximal end and pushing or pressing the actuator 130 to move the stylets 142 into the prostate. Contrast markers can also be observed with the endoscope or through the naked eye through the eye 126. The ultimate adjustment for action is again achieved by ultrasound.

Once the action zone is reached, the inner shell 80 is pulled through the actuator anchor clips 146 and 148. The locking device 16 is pulled out as described above. As shown in Figure 16, once the distal end of the cannula 12 is locked at the desired location, the probe needle 142 is removed and the power supply device 136 is inserted to extend a predetermined distance distal to the cannula. The amount of extrusion can be determined visually by means of markers or mechanically.

Figures 17 and 18 show another alternative embodiment of the invention. In this embodiment, the coaxial movement of the inner shell and the outer shell is reversed as compared to the movement as shown in Figures 15 and 16. When the treatment zone is reached, the inner shell 80 extends forward to the final position. Movement is caused by a barb 150 that projects from the aperture 152 and blocks the distal end of the cannula at the set position. In order for the barb 150 to assume its hook shape, it is preferably made of a material with a good shape memory such as nitinol. After the spike has been extended, the probe needle 142 can be withdrawn and a power supply device 136 can be inserted in its place.

The power supply device 136 need not be just a laser fiber waveguide. Other energy delivery systems may also be used to achieve the desired tissue impact. For example, for ablation, the device 136 may consist of a microwave antenna, an ultrasonic probe (either with remote control wires or a piezoelectric device in a distal position), a radio frequency source such as a dipole located on the tip, or other thermal energy delivery systems such as electrical resistance systems.

The present invention is particularly well suited for multi-stage therapy, since only the power supply device can be removed from the device as a whole without ejecting it. For example, photodynamic therapy may be used using a compound that is specifically targeted to particular cells and sensitive to certain light frequencies. Said target can be achieved by binding the compound to monoclonal antibodies having affinity for the target cells. The compound is injected via cannula 12 and allowed sufficient time to reach the target cells. The optical fiber is then inserted into the cannula and a laser or other light that has the desired effect is applied. The interstitial locking device 16 ensures that the light energy acts at the same site where the compound is applied.

It is also not required to use the power supply system at all. After locating the cannula and blocking it at the desired location with the locking device 16 and removing the probe needle 142., the cannula is an ideal guide for further treatments such as interstitial drug therapy, radiation by implantation of radioactive seeds, or implantation of microwave seeds (essentially small). metal strips) for subsequent application of microwave energy. The cannula 12 can also be used for aspiration or irrigation at the site of action.

In addition, the cannula 12 can be used for diagnostic as well as therapeutic purposes. Thus, for example, an endoscope probe or ultrasonic imager may be directed to a specific organ site. Contrast media can be delivered through the cannula to enhance external radiographic imaging, magnetic resonance imaging, or ultrasound imaging.

* The cannula 12 is not required to have coaxial sheaths. Figure 19 illustrates another embodiment of the invention that uses a flexible needle 154 as an outer member and a power supply device 136 to eject the locking bar 156. The locking bar 156 is secured to the power supply device 136 by the collar 158 and seated in the groove 160 of the needle 154 when inserted. . In use, the needle 154 is pushed into the organ at the site of action in an appropriate manner as described herein. The needle is then slightly retracted, and the device 136 is self-extended to the action position, while the barrel 15 is extended simultaneously through the bore hole 162. The device 136 may have a tapered or sharpened end to facilitate its ejection into the hole formed by the needle. This embodiment is particularly well suited for use with the resilient and control needles and devices disclosed in U.S. Pat. 07/625 332, which was incorporated by reference.

Claims (40)

PATENT CLAIMS 1. Equipment for interstitial treatment or diagnosis in an organ, characterized in that it consists of: an elongated and at least a portion of a flexible cannula having a distal end for insertion into the organ and a proximal end; a device for positioning the cannula in the body opening adjacent the organ, said positioning device having a proximal and distal end; a device for introducing the cannula into the organ mounted on said device; and devices to block the movement of the cannula in place during treatment or diagnosis. Device according to claim 1, characterized in that the cannula blocking device is positioned near the distal end. The device of claim 1, wherein the positioning aid provides a passage for inserting the endoscope and the opening of the endoscope allows observation of insertion of the cannula into the organ. 4. The device of claim 3, further comprising contrast markers visible on the outer surface of the cannula through which the depth of penetration of the cannula into the organ can be assessed by an endoscope. The apparatus of claim 3, further comprising a proximal portion supporting said positioning aid at its proximal end and a device suitable for actuating said positioning aid, and wherein the positioning aid can rotate to adjust the position of the guide aid. to guide the cannula into the organ at a predetermined location. 6. The apparatus of claim 5, further comprising at least one fluid inlet on the proximal portion, and at least one fluid passageway in said apparatus coupled to a fluid inlet for coolant circulation so that the tissue can be cool around said positioning aid at a predetermined location. 7. The device of claim 5, wherein the guide means comprises an element mounted on the distal end of said positioning aid, said element defining an arc passage having a configuration and suitable dimensions for insertion of the cannula and for its axial sliding movement. Device according to claim 5, characterized in that the cannula comprises an outer element and an inner element inserted in the outer element so that the elements can move axially therebetween, the cannula is removable from, and axially retractable into said positioning aid, and the proximal end; the locking device comprises a locking element secured to the inner element and capable of moving between a first, non-locked position substantially between the inner element and the outer element, and a second, locked, position protruding into the tissue surrounding the cannula in response to the relative movement between the inner and outer elements; and the device comprises a device at the proximal end of the cannula for operating the locking device, comprising a first element secured to the outer element and a second element secured to the inner element of the cannula, moving the first element relative to said second element to move the locking element from the first position to its second position. . The apparatus of claim 5, wherein the proximal portion comprises a support structure having a distal elongated shaft portion surrounding the positioning aid. 10. The apparatus of claim 9, further comprising a movable assembly mounted rotatably and movably to the support structure, wherein said movable assembly engages a positioning aid for rotating the positioning aid and guide device in response to the rotation of the movable device. an assembly in which the proximal end of the cannula is secured to the movable assembly so that the axial movement of the movable assembly moves the cannula with respect to the positioning aid so that the cannula can be inserted into the organ. Device according to claim 10, characterized in that the cannula consists of an outer element and an inner element disposed in the outer element so that they can move axially with respect to each other; the locking device has a locking element secured to the inner element near the distal end, capable of moving between a first, unlocked, position substantially between the inner element and the outer element, and between the second, locked, position, and projecting into the tissue surrounding the cannula in response for relative movement between the inner and outer elements; and the movable assembly comprises a body to which the outer element is secured and a support device for the inner cannula element, at least partially inserted into the body and secured to the inner element, said inner element and the support element being capable of moving either separately from the body; For with the body. The apparatus of claim 11, further comprising a handle mounted on the support structure and engaging the body by which movement of said handle causes movement of the movable assembly relative to the support structure; a trigger mounted on the support structure and engaging the inner member and the support member, thereby moving said trigger causing the inner member to move away from the body to move the locking member from the first position to the second position; and * a wheel element rotatably mounted in the body of the device, the rotation of the wheel adjusting the position of the guide device. 13. The apparatus of claim 12, wherein the handle, the trigger, and the wheel are configured to be operable with one hand by the operator. 14. The device of claim 1, wherein the cannula locking device is mounted on the cannula and comprises a locking element capable of moving between a first, unlocked, position and a second, locked, position protruding into the tissue surrounding the cannula. 15. The device of claim 14, wherein the cannula is comprised of a hollow and flexible needle defining a radial bore near the distal end; said device further comprising a device for supplying energy to the organ which is contained within the needle; and the locking element is secured to the power supply means so that it is substantially disposed between the needle and the supply means in the first position, and the relative movement between the needle and the supply means moves the locking element through said opening to the second position. 16. The device of claim 14, wherein the cannula consists of: an inner housing with a cannula blocking element mounted thereon; and an outer shell defining a radial opening; of the locking element and the aperture positioned such that the locking element is substantially disposed between the skins in the first position, and the relative movement between the skins moves the locking element through said aperture to the second position. 17. The apparatus of claim 16, further comprising: a device for supplying energy to the organ contained within the cannula; and power supply temperature sensing means comprising a sensing means disposed on the cannula. 18. The apparatus of claim 17, wherein the temperature sensing aid is disposed on the positioning aid and the device comprises a tissue cooling aid surrounding said positioning aid. 19. The device of claim 17, wherein the energy delivery device includes a focused distal tip, locally extending beyond the cannula to facilitate intrusion into the organ. 20. The device of claim 14, further comprising a device for ejecting the cannula into the organ and a device for operating the locking device, wherein the ejection and control units are operable with one hand of the operator. 21. The apparatus of claim 14, further comprising at least one inflatable balloon in the vicinity of said positioning aid and a balloon filling aid to position the positioning aid within the body. A kit for interstitial treatment or diagnosis in an organ, comprising: a cannula having a distal end for intrusion into the organ, a proximal end and a device for blocking the cannula in the organ; a device having a device for positioning the cannula in the body opening near the organ and having a device for introducing the cannula into the organ; and endoscope, with a configuration and dimensions such that it can be inserted into a positioning aid for observing insertion of the cannula into the organ. 23. The kit of claim 22, wherein the cannula locking device comprises a locking element capable of moving between a first, unlocked position and a second, locked position projecting into the tissue surrounding the cannula. 24. The kit of claim 23, further comprising a device for advancing the cannula into the organ and a device for actuating the locking element, wherein the advancing and locking devices are operable with one hand of the operator. 25. The kit of claim 24, further comprising a obturator adapted to be inserted into said positioning aid to facilitate positioning by said positioning aid in the body opening. 26. The kit of claim 24, further comprising a removable stylet adapted to be received within the cannula and protruding distal from the cannula to facilitate penetration of the cannula into the organ. 27. The kit of claim 24, further comprising an energy source with an energy delivery device, having a suitable configuration and dimensions for receiving said device in a cannula, for supplying energy to an organ at a distal end of the cannula. 28. The kit of claim 27, wherein the power source provides microwave, ultrasonic, laser, radio frequency, or thermal energy. Kit according to claim 28, characterized in that the power supply means is an antenna, an optical fiber, a wire, a dipole device or a piezoelectric element. 30. A blockable cannula for interstitial delivery of medical treatment or diagnosis in an organ, comprising: an elongated outer member; an elongated inner member inserted into the outer member with possible axial movement therebetween, each of said members having a distal end for insertion into the organ and a proximal end for actuation; and a locking member secured to the inner member near the distal end, which is capable of moving between a first, unlocked, position substantially between the inner member and the outer member, and between the second, locked, position and projecting into the tissue surrounding the cannula in response for relative movement between the inner and outer elements. 31. The cannula of claim 30, wherein the outer member comprises a hollow flexible needle defining a radial opening adjacent the distal end; the inner member, comprising a power supply means housed in the needle; and the locking element is secured to the power supply means so that it is substantially disposed between the needle and said power supply means in the first position, wherein relative movement between the needle and said power supply means moves the locking element through said opening to a second position. 32. The cannula of claim 31, wherein the inner member comprises a hollow inner housing with a locking member mounted thereon; the outer element forming a hollow outer shell defining a radial opening adjacent the distal end; and the locking element and the aperture are arranged such that relative movement between the skins moves the locking element through the aperture from the first position to the second position. 33. The cannula of claim 32, wherein the inner shell comprises a shank portion including a spiral wound wire structure and a distal tip portion defining a recess for receiving the locking element in the first position. 34. The cannula of claim 33, wherein the tip distal portion is of a heat resistant and non-conductive material. 35. A method of interstitial action or diagnosis in an organ, comprising inserting a tubular portion into a body opening adjacent the organ to be treated; introducing a cannula through said tubular portion and from introducing a cannula into an organ by puncture into its tissue, said cannula having a distal end and comprising a device at the distal end for tissue puncture; placing the distal end of the cannula within the zone of action or diagnosis; blocking the cannula in the organ; and performing the inherent effect or diagnosis in the zone. 36. The method of claim 35, further comprising: unblocking the cannula; at least partially withdrawing the cannula; re-inserting the cannula into the second zone of action or diagnosis; cannula blocking; and performing another action or diagnosis. The method of claim 35, wherein the insertion and positioning steps comprise: inserting the endoscope into the tubular portion; observing the direction of entry by the endoscope; determining the penetration depth by observing contrast markers placed on the cannula at predetermined distances apart; and extending the ultrasonic imaging cannula to its final position. 38. The method of claim 35, wherein the blocking step comprises moving the blocking element disposed near the distal end of the cannula from the first, unlocked, position to the second, locked position, and penetrating it into the tissue surrounding the cannula. 39. The method of claim 35, wherein the step of introducing and penetrating the cannula comprises placing the stylet into a cannula with a pointed tip projecting beyond the distal end, advancing the cannula and the stylet together into the organ; and the step of performing comprises withdrawing the stylet, interstitially delivering the cell-targeted compound through the cannula, wherein the compound is sensitive to some kind of energy, and delivering said type of energy via a cannula to the cells targeted by said compound. 40. The method of claim 35, wherein the step of performing comprises one or successively multiple energy supplies to the treatment zone, aspirations or irrigation of the treatment zone, drug delivery to the treatment zone, radiation material to the treatment zone, contrast material supplies to the treatment zone. the exposure zone, or the location of the display device in the exposure zone.