WO1993015664A1 - Appareil et methode de traitement interstitiel - Google Patents

Appareil et methode de traitement interstitiel Download PDF

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Publication number
WO1993015664A1
WO1993015664A1 PCT/US1993/001077 US9301077W WO9315664A1 WO 1993015664 A1 WO1993015664 A1 WO 1993015664A1 US 9301077 W US9301077 W US 9301077W WO 9315664 A1 WO9315664 A1 WO 9315664A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
locking
organ
distal end
treatment
Prior art date
Application number
PCT/US1993/001077
Other languages
English (en)
Inventor
Joshua Makower
John H. Burton
Michael Collison
Thomas A. Mcnicholas
Russell J. Redmond
Claude Tihon
Claude A. Vidal
Original Assignee
American Medical Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by American Medical Systems, Inc. filed Critical American Medical Systems, Inc.
Priority to KR1019940702707A priority Critical patent/KR950700032A/ko
Priority to BR9305845A priority patent/BR9305845A/pt
Priority to SK941-94A priority patent/SK94194A3/sk
Priority to EP93904953A priority patent/EP0652729A1/fr
Priority to JP5514216A priority patent/JPH07507696A/ja
Publication of WO1993015664A1 publication Critical patent/WO1993015664A1/fr
Priority to FI943653A priority patent/FI943653A/fi
Priority to NO942911A priority patent/NO942911L/no

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00274—Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22072—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other
    • A61B2017/22074—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
    • A61B2017/22077—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel with a part piercing the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547—Prostate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2238—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with means for selectively laterally deflecting the tip of the fibre

Definitions

  • the present invention relates to an apparatus and method for interstitial treatment or diagnosis in organs, in particular, by insertion of an elongated shaft of the apparatus into a body passage adjacent the organ to be treated and extension of a cannula into the organ for delivery of treatment or diagnosis at a selected site within the organ.
  • the cannula includes an interstitial locking means for reversibly locking the cannula in place after positioning and during treatment.
  • U.S. Patent No. 4,950,267 to Ishihara et al. discloses a laser beam treatment device for an endoscope.
  • the endoscope delivers a laser probe to a position in a body, from which the laser probe is thrust into the part of the organ to be treated.
  • the disclosure is not too specific as how the laser probe is inserted into the organ.
  • U.S. Patent No. 5,047,026 to Rydel discloses an electrosurgical implant for cutting through tissue.
  • the instrument includes two separate terminals at the distal end that provide an arc discharge when a RF voltage is applied, thereby allowing the device to cut tissue.
  • Another object of the present invention is to provide means for securing a cannula interstitially within an organ to ensure that treatment delivery or diagnosis occurs at the selected site without the necessity of constantly monitoring the position the cannula.
  • an apparatus for interstitial treatment or diagnosis in an organ which includes an elongated, and at least partially flexible cannula, means for positioning the cannula in a body passage adjacent to the organ to be treated, a guide means mounted on the positioning means to guide the cannula into the organ, and means for locking the cannula in place during treatment or diagnosis.
  • the apparatus further includes a proximal portion that supports the positioning means for manipulation and allows the positioning means to be rotated in order to position the guide means for directing the cannula into the organ at a predetermined location.
  • a preferred embodiment of the invention further includes a support structure with a distally extending shaft portion that surrounds the positioning means.
  • a moveable assembly is mounted into the support structure to cooperate with the positioning means and rotate the positioning means and guide means in response to its own rotation.
  • the proximal end of the cannula is also secured to the moveable assembly such that axial translation of the moveable assembly causes the cannula to translate with respect to the positioning means, thus, allowing the cannula to be inserted into the organ.
  • the cannula comprises an outer member and an inner member received within the outer member.
  • the locking means includes a locking member secured to the inner member adjacent to the distal end and disposed substantially between the inner and outer members.
  • the locking member is arranged such that it is capable of movement from a first non-locking position between the inner and outer members to a second locking position extending into the tissue surrounding the cannula. Such movement is in response to relative movement between the inner and outer members.
  • the moveable assembly includes a body member secured to the outer cannula member and a support member secured to the inner cannula member such that relative movement between the body member and support member effects the movement of the locking member from the first to second positions.
  • the apparatus further includes a handle member mounted on the support structure cooperating with the body member of the moveable assembly, whereby squeezing the handle member causes translation of the moveable assembly with respect to the support structure in order to advance the cannula into the organ.
  • the apparatus further includes a trigger member also mounted on the support structure and cooperating with the support member such that depressing the trigger member moves the support member separately from the body member to move the locking member from the first position to the second position.
  • a wheel means such as a thumb wheel is provided on the body member to allow ease of rotation of the body member for positioning the guide means.
  • the locking cannula includes an outer member that comprises a hollow flexible needle defining a radial opening adjacent to its distal end.
  • the inner member comprises an energy delivery means disposed within the needle. The locking member secured to the energy delivery means such that relative motion between the needle and energy delivery means causes the locking member to move from the first non-locking position to the second locking position extending into surrounding tissue.
  • the inner member of the locking cannula comprises a hollow inner sheath with the locking member disposed thereon.
  • the outer member also comprises a hollow sheath which defines a radial opening adjacent to its distal end.
  • the locking member and the opening are arranged such that relative movement between the sheaths moves the locking member through the opening from the first non ⁇ locking position to the second locked position.
  • the inner sheath may comprise a helically wound construction and have a separate distal tip portion which defines a recess that receives the locking member in the first position.
  • the distal tip is preferably a heat resistent and non-conductive material.
  • the present invention also includes a kit for interstitial treatment or diagnosis in an organ including a locking cannula substantially as described above and an apparatus generally as described above, and, further, an endoscope configured and dimensioned to be inserted into the apparatus to allow for visualizing the insertion of the cannula into the organ.
  • the kit may also include an obturator adapted to be inserted into the apparatus to facilitate positioning of the apparatus in the body passage.
  • the kit may also include a stylet adapted to be received in the cannula and extend distally beyond the cannula in order to facilitate insertion of the cannula into the organ.
  • a further component of the kit is an energy source having a means for delivering energy configured and dimensioned to be received within the cannula and extend beyond the distal end of the cannula for delivery of energy to the organ.
  • Energy sources included with the kit include sources of microwave energy, ultrasound energy, laser energy, radiofrequency energy and thermal energy.
  • the kit includes energy delivery means such as an antenna, optical fiber, wire, bipole device or piezoelectric element.
  • the present invention also includes a method for interstitial treatment or diagnosis within an organ.
  • a tubular member is placed within the body passage adjacent to the organ to be treated.
  • a cannula is guided into the organ by the tubular member with the cannula puncturing the tissue of the organ.
  • the cannula is located with its distal end at a treatment zone within the organ. The cannula is locked in the organ and treatment or diagnosis is performed at the zone.
  • the method according to the invention includes a multi-step treatment method wherein the cannula is guided and inserted into the organ by placing a stylet within the cannula and advancing both the cannula and the stylet together into the organ. After the cannula is located at the treatment zone and locked in place, the stylet is withdrawn and a cell targeted compound sensitive to an energy type is interstitially applied to the organ through the cannula. The particular type of energy is then applied through the cannula to the targeted cells.
  • FIG. 1 is a view of the median sagittal section of the male pelvis illustrating the use of one embodiment of the apparatus according to the present invention for treating the prostate;
  • FIGS. 2-5 are a sequence of enlarged cross- sectional views of the prostate, illustrating the steps of one embodiment the method of the present invention, utilizing the apparatus shown in FIG. 1;
  • FIG. 6 is a schematic, partial section view of the apparatus shown in FIG. 1, illustrating a mechanism for positioning, advancing and locking the cannula according to one embodiment of the invention
  • FIG. 7 is an end view of the guide wheel shown with the apparatus in FIGS. 1 and 6;
  • FIG. 8 is an enlarged, partial section view of the apparatus shown in FIG. 6;
  • FIG. 9 is an enlarged section view of the distal end of the locking cannula shown in FIG. 1, with a barb locking means according to the present invention in the retracted position;
  • FIG. 10 is a section view of the barb locking means shown in FIG. 9 in the extended and locked position
  • FIG. 11 is a side view of the distal end of an alternative embodiment of the apparatus of the invention, similar to the apparatus shown in FIG. 1 with an extended shaft;
  • FIG. 12 illustrates a further alternative embodiment of the apparatus according to the invention.
  • FIGS. 13 and 14 illustrate an obturator and stylet, respectively, for use with the apparatus shown in FIG. 12;
  • FIG. 15 is a section view of the distal end of the locking cannula of the apparatus of FIG. 12, with a barb locking in the retracted position and the stylet in place;
  • FIG. 16 is a section view of the barb locking means shown in FIG. 15 in the extended and locked position, with an energy delivery means in place;
  • FIG. 17 is a section view of the distal end of an alternative locking cannula
  • FIG. 18 is a section view of the distal end of the alternative locking cannula shown in FIG. 17, with an energy delivery means in place;
  • FIG. 19 is a section view of a further alternative embodiment of the locking cannula according to the present invention. Detailed Description of the Preferred Embodiments
  • the method of the invention will be discussed with reference to laser ablation treatment of benign prostatic hypertrophy (BPH) .
  • BPH benign prostatic hypertrophy
  • the general method and apparatus as described herein are equally applicable treatment of any organ which is accessible through a body passage similar to the accessibility of the prostate by the urethra.
  • the prostate could be approached rectally or peritoneally by laparoscopic techniques, as could other organs.
  • numerous treatments other than laser ablation are possible with the present invention.
  • an interstitial treatment delivery apparatus 10 is positioned in the prostatic urethra A with its distal end adjacent to the prostate B.
  • Locking cannula 12 has been extended by squeezing hand lever 14 and the interstitial locking means 16 deployed by depressing trigger 18.
  • Laser energy has been or is being delivered to treatment area C by sharpened tip 20 of laser fiber 22.
  • An Nd:YAG or diode laser provides a suitable laser energy source.
  • a tuneable dye laser also may be used depending on the particular application. Persons of ordinary skill in the art could identify other laser sources and select suitable optical fibers for use therewith.
  • Other components of apparatus 10 shown in FIG. 1, whose function and interrelationship will be explained in detail below, are fluid ports 24 and 26, endoscope 28, cannula guide 30, guide wheel 32, hand piece 34 and shaft 36.
  • shaft 36 After insertion of endoscope 28 into hand piece 34, shaft 36 is advanced into the prostatic urethra A while visualizing the veru ontanum, as indicated by arrow 37 in FIG. 2.
  • a dilation fluid may be introduced through one of ports 24 or 26 which communicate with distal openings 38 to facilitate introduction of the shaft.
  • the dilation fluid can be removed through the other of ports 24 or 26, or be allowed temporarily to accumulate in the bladder D.
  • cannula guide 30 By rotating guide wheel 32, cannula guide 30 is directed toward the wall of the urethra corresponding to the treatment zone E. Arrow 39 indicates the movement of cannula guide 30. Positioning of shaft 36 and cannula guide 30 is viewed through endoscope 28 and endoscope port 40.
  • a sharpened laser fiber is not required.
  • a stylet may be used for insertion of the cannula into the organ and subsequently a laser fiber (or other energy delivery means) with any desired tip may replace the stylet for treatment.
  • the depth of insertion into the prostate B can be determined by viewing contrasting markings 42 on the outside of cannula 12.
  • Such contrasting markings can be on the outer surface of the cannula, for example as impregnate plastic rings, or located on an inner surface, visualizable through the cannula outer surface. Other markings are possible, the primary requirement being the ability to be readily visualized on the cannula outer surface.
  • ultrasound is used to finely position tip 20 for treatment.
  • the ultrasound may be applied, for example, with a transrectal ultrasound probe or by removing endoscope 28 and inserting a transurethral ultrasound probe through shaft 36.
  • cannula 12 is provided with an echogenic construction or surface treatment to improve contrast and facilitate ultrasound visualization.
  • locking means 16 are deployed as shown in FIG. 5, to positively lock the cannula in place during treatment.
  • Locking means 16 are deployed by depressing trigger 18, which causes a coaxial movement that extends barbs or other means.
  • depressing trigger 18 causes a coaxial movement that extends barbs or other means.
  • laser energy is shown applied through sharpened tip 20 to treat the prostate.
  • the area of treatment is generally spherical, with the tip located approximately at the center of the sphere.
  • temperature sensing devices 46 such as thermocouples or miniaturized thermistors, are placed in appropriate locations along shaft 36, and also on cannula 12 as explained below.
  • thermocouples or miniaturized thermistors are placed in appropriate locations along shaft 36, and also on cannula 12 as explained below.
  • cooling fluid may be introduced through ports 24 or 26 to cool shaft 36 in the region of the external sphincter F. Damage to the external sphincter could cause incontinence. It also may be desirable to extend shaft 36 distally, as shown in FIG. 11, in order to provide direct cooling to the bladder neck area G.
  • the cooling fluid may be circulated in and out of ports 24 and 26, or it may exit openings 38 and temporarily accumulate in the bladder. Accumulation in the bladder would also allow a degree of cooling of the bladder neck without a shaft extending therebetween.
  • the locking means is retracted and the cannula removed.
  • the cannula may be repositioned and the locking means redeployed for further treatment.
  • FIG. 6 schematically illustrates the operating mechanism of apparatus 10, shown in FIG. 1.
  • Apparatus 10 generally comprises a moveable assembly 48 and barrel 50 contained within support structure 52.
  • Support structure 52 includes shaft portion 36 and hand piece 34.
  • Moveable assembly 48 is mounted for both rotation and axial movement, whereas barrel 50 is constrained against axial movement but does rotate with moveable assembly 48.
  • support structure 52 provides passages for flow of fluids between ports 24 and 26, and openings 38. The specific arrangement of such passages is within the skill of an ordinary skilled worker in the art and therefore they have been omitted from the drawing for reasons of clarity.
  • Hand piece 34 is constructed of a suitable rigid material such as stainless steel or plastic in order to support moveable assembly 48 and allow for manipulation by hand.
  • shaft portion 36 can take a variety of forms.
  • it may be rigid, flexible, malleable, articulatable or expandable.
  • Flexible embodiments may be constructed similar to known catheters. By providing controllable joints, articulatable embodiments would be well suited for manipulation within the peritoneum.
  • Expandable embodiments include longitudinal expansion by telescoping shafts and radial expansion, for example, by balloon structures on the shaft.
  • Balloon expandable shafts provide a locking feature in addition to the locking cannula described herein and, thus, provide increased confidence in the accuracy of treatment application.
  • Shaft balloons can also be inflated using a cooling or heat transfer medium in order to cool the body passage and surrounding tissue during energy delivery.
  • Moveable assembly 48 is rotated by rotating guide wheel 54. This also causes barrel 50 to rotate, which positions cannula guide 30 as described above. Any suitable means for directing the cannula may serve as cannula guide 30.
  • a preferred embodiment includes a member defining a curved passage through which the cannula slides.
  • the moveable assembly is advanced by squeezing handle lever 14. When moved in the direction of arrow 56, the handle lever pivots at point 58 (mounted on support structure 52) and moves cam member 60 forward. Cam member 60 engages lever ring 62 to cause axial movement of the moveable assembly. Lever ring 62 is fixed to moveable assembly 48.
  • Notch 64 in cam member 60 allows lever ring 62 to rotate when the guide wheel is rotated, while at the same time constantly engaging ring 62 for axial adjustment.
  • Guide wheel 54 (FIG. 7) has an internal key 66 that cooperates with slot 68 in moveable assembly 48 to allow rotational engagement and free axial movement of the guide wheel with respect to the moveable assembly.
  • Trigger 18 is slideably mounted on support structure 52.
  • Trigger arm 70 includes notch 72 that cooperates with trigger ring 76 in the same manner as notch 64 and lever ring 62. However, trigger ring 76 is not fixed to moveable assembly 48. Trigger ring 76 moves with the moveable assembly so long as trigger 18 is not depressed. When the trigger is depressed, trigger ring 76 moves to the left as shown in FIG. 6, independent of moveable assembly 48.
  • cannula 12 comprises inner sheath 80 and outer sheath 82.
  • An energy delivery means in this case laser fiber 22, is contained within inner sheath 80.
  • the cannula and laser fiber are not shown in section.
  • the cannula is generally flexible to allow it to be guided by cannula guide 30 and for ease of insertion into the organ.
  • cannula 12 is well suited for use of a steering fiber as disclosed in co-pending application No. 07/625,332 in order to provide a cannula that is steerable within the organ.
  • a rigid tip portion to facilitate insertion or increase insulative characteristics as discussed below, or to provide a rigid proximal shaft portion to enhance manipulation of the cannula.
  • rigid portions can be provided without compromising the general flexibility of the cannula.
  • Trigger ring 76 has a forward extending, inner sheath support member 84.
  • the support member is hollow to define a passage for the laser fiber and is secured to inner sheath 80 at joint 86.
  • Inner sheath support member 84 is slideably received in outer sheath support member 88.
  • the outer sheath support member extends from body 90 of the moveable assembly and is connected to outer sheath 82 at joint 92. Therefore, when lever ring 62 is advanced as explained above, outer sheath 82 moves forward and, as long as trigger 18 is not depressed, the inner sheath and laser fiber move with it to extend cannula 12 into the prostate or other organ to be treated.
  • Trigger ring 76 is shown in a partially depressed position in FIG. 8.
  • FIG. 1 shows the use of multiple locking members, however, a single locking member is shown in FIGS. 9 and 10 for clarity.
  • FIG. 9 illustrates the distal end of the cannula as it is extended into the organ. Sharpened laser fiber tip 20 forms the piercing tip of the cannula. As discussed below, other structures such as a separate stylet or hollow needle may serve this purpose.
  • the inner and outer sheaths are tapered at the distal end to form a profile that facilitates insertion.
  • Inner sheath 80 includes a shaft portion 96 that is constructed from helically wound wire, similar to known guide wires, in order to combine sufficient axial stiffness and pushability with bendability.
  • a tip 98 is provided that carries locking barb 100 in recess 102.
  • Barb 100 can be made of any biocompatible material having sufficient strength, hardness and elasticity to be inserted and withdrawn from the surrounding tissue a number of times without failure. Such materials include stainless, carbonized or anodized steel, nitinol and various hard plastics.
  • the end of locking barb 100 is aligned with opening 104 in outer sheath 82.
  • locking barb 100 exits opening 104 to become implanted in the organ as shown in FIG. 10. With the locking barb extended, the distal end of cannula 12 is secured adjacent to the treatment site. The operator may then release his or her grip on apparatus 10 in order to concentrate on the treatment, without the need to manually maintain the laser fiber or other treatment means in place.
  • Locking means 16 is retracted or reversed by moving trigger ring 76 in the opposite direction from that used to deploy the locking means. This can be accomplished manually or automatically.
  • One means (not shown) for automatic retraction is to provide a spring mechanism which can be locked by the operator and, when released, biases trigger ring 76 to the retracted position.
  • tip 98 be made of a non-heat conductive material in order to prevent heat transfer to shaft portion 98.
  • temperature sensing devices 46 are located along laser fiber 22 and cannula 12.
  • temperature sensing can be accomplished by fiber optic temperature sensors or infrared measuring along the cannula.
  • ultrasound may be used to measure temperature remotely by tissue characterization through signal processing of the ultrasound image. The amount of tissue damage can also be determined by sensing NADPH, a compound produced by cell death.
  • outer sheath 82 also inner sheath 80
  • materials capable of withstanding the high temperatures must be used.
  • the outer sheath also must be made of an insulating or nonconductive material to prevent heat transfer down its shaft.
  • One advantage of the present invention is that by delivering the cannula through a relatively small puncture wound, the hole heals quickly and with minimal chance for infection after treatment. If heat transfer down the outer sheath is sufficient to cauterize the surrounding tissue, a more permanent and difficult to heal hole can be created.
  • the outer sheath must be axially stiff but bendable, although the stiffness may be provided by a guide wire-like construction of the inner sheath.
  • the outer and inner sheaths can be two or more parts, with the tapered distal portion being a relatively stiff and highly nonconductive material such as ceramic.
  • suitable materials such as teflon, silicon, polyurethane, polymers and copolymers, which will meet the requirements for the particular application.
  • the cannula can be provided with an echogenic construction. This may result as a function of the different materials chosen for the inner and outer sheaths, or can be intentionally created, for example, by forming the cannula with two different materials having different acoustical impedances and interfacing non-uniformly to create multiple angles of reflectance.
  • the sheaths may be constructed of highly conductive material such that energy delivery at the tip is transferred down along the outer sheaths.
  • FIG. 11 there is shown an alternative embodiment of apparatus 10 having an extended shaft portion 106.
  • An opening 108 is provided in the shaft to allow cannula guide 30 and endoscope port 40 to access the urethral wall. Otherwise the construction and operation of the apparatus is substantially the same as described above.
  • Extended shaft portion 106 is especially well suited for use of a tip balloon as disclosed in co- pending U.S. application No. 07/625,332.
  • the extended shaft can also be of sufficient length to be disposed within the bladder neck G during energy delivery in order to provide a direct cooling source thereto.
  • FIG. 12 illustrates a further alternative embodiment of the present invention.
  • apparatus 110 is shown substantially as it would appear in place for energy delivery treatment to an organ.
  • An introducer assembly 112 includes shaft 114, which generally corresponds to shaft 36 in apparatus 10.
  • a preferred configuration of shaft 114 is a 21-22 french stainless steel cannula, although alternatives such as those explained above in connection with apparatus 10 are also possible.
  • Endoscope 116 is shown inserted into the introducer assembly. Irrigation and light source connections 118 and 120, respectively, are also provided.
  • the distal end of shaft 114 provides an endoscope port and forms a cannula guide 122. The direction of insertion of cannula 12 thus may be controlled by turning the introducer assembly.
  • Locking cannula 12 enters introducer assembly 112 through port 126 and extends out of cannula guide 122.
  • Locking actuator 130 provides coaxial movement between outer sheath 82 and inner sheath 80 (shown in detail in FIGS. 15 and 16) .
  • An energy delivery means 136 is inserted into the cannula through port 138 in locking actuator 130.
  • the introducer assembly In use, the introducer assembly would first be fitted with obturator 140, shown in FIG. 13. At this point neither the endoscope nor the cannula would be placed in the introducer assembly. The operator would then insert introducer assembly 112, with obturator 140, into the urethra in a similar manner to the insertion of a cystoscope.
  • introducer assembly 112 With obturator 140, into the urethra in a similar manner to the insertion of a cystoscope.
  • the urethra and prostate are used as a reference for descriptive purposes only and not as a limitation of the invention.
  • obturator 140 is removed and endoscope 116 is inserted with appropriate connections to the light source and irrigation.
  • Stylet 142 is inserted into cannula 12, through port 138.
  • Stylet 142 is shown in FIGS. 14 and 15.
  • Cannula 12 is then inserted into the introducer assembly through port 126 until it extends from cannula guide 122 and is visible through the endoscope.
  • the introducer assembly is rotated to position the cannula in the direction of the treatment zone.
  • Cannula 12 is then extended into the prostate by gripping its proximal end and pushing or by pushing on actuator 130 to force stylet 142 into the prostate. Contrasting markings 42 on cannula 12 can be viewed through the endoscope and also with the naked eye at port 126. Final positioning for treatment is again accomplished by ultrasound.
  • inner sheath 80 is retracted using finger grips 146 and 148 of anchor actuator 130. Locking means 16 is thereby deployed as previously described. As shown in FIG. 16, once the distal end of cannula 12 is locked in place, stylet 142 is removed and energy delivery means 136 is inserted to extend a predetermined distance distally out of the cannula. The amount of extension can be determined visually by markings or by a mechanical stop.
  • FIGS. 17 and 18 illustrate another alternative embodiment of the present invention.
  • the coaxial movement of inner sheath 80 and outer sheath 82 is reversed from that shown in FIGS. 15 and 16.
  • inner sheath 80 is extended forward to the final position.
  • This action causes barb 150 to extend out of opening 152 and lock the distal end of the cannula in place.
  • barb 150 be made of a material with a good elastic memory, such as nitinol.
  • stylet 142 may be withdrawn and energy delivery means 136 inserted in its place.
  • Energy delivery means 136 need not be a laser fiber. Other energy delivery systems which will produce the desired effect on the tissue may be used.
  • means 136 could comprise a microwave antenna, an ultrasound probe (either a wire leading to a remote source or a piezoelectric apparatus at the distal location) , a radio frequency source such as a bipole located at the tip, or other thermal energy systems such as electrical resistance. Due to the capability of removing the energy delivery means without removing the apparatus as whole, the present invention is particularly well suited for multiple step therapies. For example, a photodynamic therapy may be applied using a compound which is specifically targeted to particular cells and sensitive to selected light frequencies. Such targeting can be achieved by linking the compound to monoclonal antibodies having an affinity for the target cells.
  • the compound would be applied through cannula 12 and allowed sufficient time to reach the target cells.
  • An optical fiber would then be inserted into cannula 12 to apply laser or other appropriate light for treatment.
  • the interstitial locking means 16 ensures that the light energy is applied at the same location as was the compound.
  • cannula 12 After cannula 12 is locked in place by locking means 16, and stylet 142 is removed, the cannula provides an ideal conduit for other treatments such as interstitially targeted drug therapy, radiation treatment by implantation of radioactive "seeds", or implantation of microwave "seeds" (essentially small metal strips) for subsequent application of microwave energy. Cannula 12 also may be used for aspiration or irrigation directly at a treatment site.
  • cannula 12 can be used for diagnostic purposes as well as therapeutic.
  • the probe of an endoscope or ultrasound imager may be directed to a specific location in an organ. Contrast agents could be delivered to improve external radiographic, magnetic resonance or ultrasound imaging.
  • FIG. 19 shows a further embodiment of the invention utilizing flexible needle 154 as an outer member and energy delivery means 136 to deploy locking barb 156.
  • Locking barb 156 is secured to delivery means 136 by collar 158 and received in recess 160 in needle 154 when retracted.
  • needle 154 is inserted into the organ, to the treatment location, by suitable means as described herein.
  • the needle is then slightly backed off and means 136 separately advanced into the treatment position, simultaneously deploying barb 156 through curved guide hole 162.
  • Means 136 may have a tapered or sharpened end to facilitate its advancement into the passage created by the needle. This embodiment is particularly well suited for application with the flexible and steerable needles and apparatus disclosed in U.S. application No. 07/625,332, which has been incorporated by reference.

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Abstract

Appareil et méthode de diagnostique et de traitement interstitiel des organes, mettant en ÷uvre une canule souple (12) pourvue d'un dispositif de verrouillage intersticiel (16). L'appareil comprend un tube destiné à être introduit dans le conduit corporel adjacent à l'organe à traiter, ce tube étant conçu pour guider la canule vers l'organe. Ce tube est également adapté pour recevoir un endoscope (28) afin d'observer visuellement l'insertion de la canule. Le dispositif de verrouillage de la canule comprend un élément de verrouillage qui se déploie à l'extrémité distale de la canule sous l'effet du mouvement relatif de plusieurs pièces de celle-ci.
PCT/US1993/001077 1992-02-06 1993-02-05 Appareil et methode de traitement interstitiel WO1993015664A1 (fr)

Priority Applications (7)

Application Number Priority Date Filing Date Title
KR1019940702707A KR950700032A (ko) 1992-02-06 1993-02-05 간질치료 장치 및 방법(apparatus and method for interstitial treatment)
BR9305845A BR9305845A (pt) 1992-02-06 1993-02-05 Aparelho conjunto e processo para tratamento ou diagnose intersticial em um orgao e canula de travamento para ministração intersticial de tratamento ou diagnose intersticial em um orgão e canula de travamento para ministração intersticial de tratamento ou diagnose em um orgão
SK941-94A SK94194A3 (en) 1992-02-06 1993-02-05 Apparatus for interstitial treatment
EP93904953A EP0652729A1 (fr) 1992-02-06 1993-02-05 Appareil et methode de traitement interstitiel
JP5514216A JPH07507696A (ja) 1992-02-06 1993-02-05 間質治療装置及び方法
FI943653A FI943653A (fi) 1992-02-06 1994-08-05 Laite ja menetelmä ruumiin sisätilojen käsittelyä varten
NO942911A NO942911L (no) 1992-02-06 1994-08-05 Innretning og fremgangsmåte for interstitial behandling

Applications Claiming Priority (2)

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US83211592A 1992-02-06 1992-02-06
US832,115 1992-02-06

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WO1993015664A1 true WO1993015664A1 (fr) 1993-08-19

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EP (1) EP0652729A1 (fr)
JP (1) JPH07507696A (fr)
KR (1) KR950700032A (fr)
AU (1) AU3613293A (fr)
BR (1) BR9305845A (fr)
CA (1) CA2129639A1 (fr)
CZ (1) CZ189494A3 (fr)
DE (1) DE9320803U1 (fr)
FI (1) FI943653A (fr)
MX (1) MX9300607A (fr)
NO (1) NO942911L (fr)
SK (1) SK94194A3 (fr)
WO (1) WO1993015664A1 (fr)

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CZ189494A3 (en) 1995-06-14
CA2129639A1 (fr) 1993-08-19
EP0652729A1 (fr) 1995-05-17
JPH07507696A (ja) 1995-08-31
DE9320803U1 (de) 1995-02-02
NO942911L (no) 1994-09-22
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BR9305845A (pt) 1997-02-18
AU3613293A (en) 1993-09-03
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SK94194A3 (en) 1995-07-11
NO942911D0 (fr) 1994-08-05

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