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WO1993004727A1 - Catheter a ballonnet - Google Patents

Catheter a ballonnet Download PDF

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Publication number
WO1993004727A1
WO1993004727A1 PCT/GB1992/001552 GB9201552W WO9304727A1 WO 1993004727 A1 WO1993004727 A1 WO 1993004727A1 GB 9201552 W GB9201552 W GB 9201552W WO 9304727 A1 WO9304727 A1 WO 9304727A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
catheter
fibre
probe
tissue
Prior art date
Application number
PCT/GB1992/001552
Other languages
English (en)
Inventor
Thomas A. Mcnicholas
Joshua Makower
Original Assignee
American Medical Systems
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 filed Critical American Medical Systems
Priority to BR9206440A priority Critical patent/BR9206440A/pt
Priority to JP5505017A priority patent/JPH06510450A/ja
Priority to EP92918434A priority patent/EP0601025A1/fr
Publication of WO1993004727A1 publication Critical patent/WO1993004727A1/fr
Priority to NO940662A priority patent/NO940662L/no
Priority to FI940916A priority patent/FI940916A7/fi

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/067—Radiation therapy using light using laser light
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00017—Electrical control of surgical instruments
    • A61B2017/00022—Sensing or detecting at the treatment site
    • A61B2017/00084—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods 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
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22054—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation with two balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • 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
    • A61B2018/00005—Cooling or heating of the probe or tissue immediately surrounding the probe
    • A61B2018/00011—Cooling or heating of the probe or tissue immediately surrounding the probe with fluids
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925—Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A61B2090/3929—Active markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3962—Markers, e.g. radio-opaque or breast lesions markers palpable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • A61M2025/09183—Guide wires having specific characteristics at the distal tip having tools at the distal tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/107—Balloon catheters with special features or adapted for special applications having a longitudinal slit in the balloon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/32—General characteristics of the apparatus with radio-opaque indicia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082—Catheter tip comprising a tool
    • A61M25/0084—Catheter tip comprising a tool being one or more injection needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N2005/002—Cooling systems
    • A61N2005/007—Cooling systems for cooling the patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0601—Apparatus for use inside the body
    • A61N5/0603—Apparatus for use inside the body for treatment of body cavities
    • A61N2005/061—Bladder and/or urethra
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/02—Radiation therapy using microwaves
    • A61N5/04—Radiators for near-field treatment
    • A61N5/045—Radiators for near-field treatment specially adapted for treatment inside the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/062—Photodynamic therapy, i.e. excitation of an agent

Definitions

  • the present invention relates to surgical devices generally, and in particular to surgical devices suitable for use in the thermal or photo-mediated treatment of body tissues, such as the prostate gland.
  • the prostate gland is located at the base of the bladder, where it surrounds a portion of the urethra, the duct by which urine is conveyed from the bladder to the exterior.
  • the function of the prostate is to produce a fluid which becomes a part of the ejaculated semen (also carried through the urethra) .
  • Prostatic disease both benign and malignant, is a common urological problem which accounts for a major part of the health care expenditure in developed countries. As men grow older, the tissue of the prostate often begins to enlarge, a condition called hyperplasia.
  • BPH benign prostatic hypertrophy or hyperplasia
  • the signs of BPH are difficulty in starting urination, dribbling following urination, reduced force of the stream of urine, a tendency to urinate frequently in small amounts, as well as pain and discomfort, and an increase in urinary tract infections.
  • the symptoms are common with 75 to 80% of men over the age
  • the transurethral resection involves inserting a resectoscope through the urethra.
  • a spring wire adapted to carry an electric current, is inserted through the resectoscope for use in removing tissue.
  • the wire carries one current for cutting away the tissue and another current for cauterizing the remaining tissue to minimize bleeding.
  • 30cm 3 about 2 cubic inches
  • Heat treatment has for many years been investigated as a way of destroying diseased tissue.
  • Microwaves and radiofrequency ultrasound have been used to treat enlarged prostate tissue, the applied heat causing the swelling to subside.
  • These techniques generally involve inserting a probe comprising an antenna capable of emitting microwaves into the patient's rectum at a point adjacent to the prostate gland.
  • the emitted microwaves are capable of penetrating the wall of the rectum and are focused into the prostate.
  • the problem with this techniques is largely one of accuracy, that is, directing the energy into the target tissue without heating adjacent normal tissue, and delivering sufficient energy to raise the diseased tissue to the requisite temperature to cause cell death. Because of this, several treatments are normally required before the prostate returns to its normal size, thereby making this process both time-consuming and expensive.
  • Laser surgery utilises laser light transmitted through flexible optic fibres, either illuminating the target in a hollow viscus or inserted percutaneously, through needles, directly into the centre of the target lesion, thereby minimising the effects on surrounding tissues.
  • Interstitial hyperthermia induced by lasers was first described by Bown, S.G., "Phototherapy of Tumours", World T. Surg, Vol.7, pp.700 to 709, 1983 and subsequently by Hashimoto, E. et al. , "In Depth Radiation Therapy by YAG Laser for Malignant Tumours in the Liver Under Ultrasonic Imaging", Gastroenterology, Vol.88, p.1663, 1985; Godlewski, G. et al. , “Deep Localized Neodymium (Nd)-YAG Laser Photocoagulation in Liver Using a New Water Cooled and Echoguided Handpiece", Lasers in Surgery and Medicine.
  • the device described in US Patent No. 4,672,963 uses a computer to continuously adjust the amount of laser radiation transmitted to the prostate during the procedure.
  • the device includes an ultrasonic probe, inserted transurethrally or positioned externally, for imaging the prostate in real time during the procedure so as to provide real time data regarding the destruction of the prostate tissue, thereby enabling the computer to adjust the laser radiation accordingly.
  • Transrectal and external ultrasonic imaging of the prostate are well known as further suggested by Sanders, R.C et al. , "Update on Prostatic Ultrasound", Urologic Radiology, 1967; Fleischer, A.C, "Prostatic Endosonography - A Potential Screening Test", Diagnostic Imaging, April 1987, pp.78 to 82; and Lee, F. , "Prostatic Evaluation By Transrectal Sonography: Criteria for Diagnosis of Early Carcinoma", Radiology, Vol. 158, pp.91 to 95, January 1986.
  • the device for use in dilating the urethra of the prostate gland to relieve the symptoms of prostate enlargement.
  • the device generally comprises a catheter having disposed at the remote end thereof an inflatable balloon for temporarily dilating at least a portion of the prostatic urethra and sized so as to compress the tissue of an average sized prostate gland enlarged by BPH.
  • the catheter also includes means for transmitting a laser beam along an axis transverse to the general direction of the urethra so that the laser beam can be selectively directed into portions of the tissue compressed by the balloon.
  • the balloon is preferably made of a material substantially transparent to the laser beam, the laser being focused by the surgeon through the wall of the balloon into the prostatic tissue.
  • the tissue heated by the laser is denatured producing a general coagulation necrosis of the treated region. As the denatured tissue heals, the treated tissue region contracts so as to effectively dilate the urethral passageway, thereby restoring urine flow.
  • the present invention provides various devices which find general application in the heat treatment of body tissues.
  • the devices of the invention find particular utility in the treatment of benign prostate hypertrophy and prostate cancer.
  • the preferred embodiments of the devices of the invention are described hereinafter for use in prostatic surgery they
  • SUBSTITUTESHEET can also be used to treat tissue(s) in other parts of the body, such as the bladder, lesions within the kidney or adrenal gland, benign or malignant growths within the liver, gut, breast, brain, lung, uterus and skin and vascular abnormalities throughout the body.
  • Thermal treatment of diseased prostatic tissue and in particular laser surgery of the prostate represents an alternative approach to curative therapy without the morbidity of radical surgery or radiotherapy.
  • the term "thermal treatment” as used herein is intended to encompass both mild heating, commonly referred as 'hyperthermia', as well as the more vigorous heating used to denature (or coagulate) the treated tissue.
  • Thermal treatment can be performed by a variety of methods, such as microwave, radiofrequency and whole body heating, but the advantage of laser surgery is that the thermal energy can be delivered deep within the tissues of the body through optic fibres of relatively non-traumatic size.
  • laser surgery generally refers to the delivery of laser radiation into the body to effect the thermal warming of the target tissue, but it is also intended to encompass photodynamic therapy in which the target tissue is pretreated with a photoreactive chemical before exposure to radiation of the appropriate wavelength to initiate the photochemical reaction.
  • a catheter dimensioned for insertion into the body and having thereon a balloon, the catheter further comprising an inlet and outlet to the balloon to allow pressurisation/inflation of said balloon and the circulation of a cooling fluid into and out of said balloon to effect cooling of the outer surface thereof.
  • the cooling fluid is responsible for inflating/pressurising the balloon.
  • the device ordinarily comprises at least two conduits disposed along the catheter and arranged so as to transport cooling fluid to and from the balloon.
  • the balloon-catheter devices of the invention find particular utility in the selective heat treatment of certain body tissues where they are used to provide cooling for those non-target tissues or organs in close proximity to the tissue(s) being treated.
  • the cooling fluid is circulated through the device to cool the cuff of the balloon which is in direct contact with the tissue(s) and/or organs to be protected.
  • a cooling fluid such as saline
  • SUBSTITUTESHEET simultaneous cooling of non-target tissue(s) together with, on inflation of the balloon, therapeutic dilation of the body tissue being treated.
  • the balloon is preferably sized such that, when inflated, it compresses the target tissue, thereby generating a zone of relative ischaemia and increasing the efficiency of the heat treatment.
  • inflation of the balloon may, by distending the passageway, contribute to restoring its original calibre.
  • the balloon-catheter is in the heat-treatment of the prostate, e.g. , to treat BPH or prostatic carcinoma, to provide cooling for the proximal and/or distal urethral sphincter muscles and most importantly for the lining of the urethra during removal of the diseased tissue.
  • the balloon-catheter is preferably dimensioned such that it can be inserted into the body via the urethra, ordinarily through the operating channel of conventional endoscope, such that the balloon lies within the prostatic fossa.
  • the balloon-catheter may, however be inserted via any appropriate transrectal, transperineal (or other transcutaneous route) or transurethral route using any of a conventional endoscope, cystoscope or resectoscope.
  • the balloon is preferably sized such that, when inflated within the prostate fossa, the urethra will expand so as to compress at least a selected portion of the prostatic tissue, thereby generating a zone of relative ischaemia.
  • the balloon is generally designed to accommodate temperatures of up to 10 atmospheres (1.01 x 10 6 Nm “2 ) , although in situ the balloon pressure would not normally exceed about 5 atmospheres (5.05 x 10 5 Nm "2 ) .
  • the balloon-catheter may also comprise one or more conduits disposed along the catheter and arranged so as to allow the site of insertion to be flushed with a local anaesthetic gel or solution.
  • the outer surface of the balloon may be textured so as to retain an anaesthetic gel or solution applied thereon.
  • the balloon-catheter may also comprise one or more conduits disposed along the catheter adapted to receive viewing means, e.g., a viewing fibre optic or rod lens, to allow the surgeon to monitor the insertion manoeuvre and/or the site of insertion.
  • viewing means e.g., a viewing fibre optic or rod lens
  • the balloon-catheter may also include a smaller, secondary balloon located either proximal and/or distal to the main balloon through which the cooling fluid is also circulated to provide cooling for the urethral sphincter muscle apparatus.
  • the balloon-catheter is preferably configured so as to facilitate the delivery and temporary implantation of and/or the secure retention of an optic fibre or other heat generating probe (referred to hereinafter simply as the "probe") into a given tissue or organ of the body for the express purpose of delivering laser/thermal energy thereto.
  • the probe may be inserted into the target tissue independently of the balloon-catheter, the simple act of inflating the balloon stabilising the probe by pressing it against and/or compressing the tissue in which it is inserted.
  • the outer surface of the balloon may be advantageously textured so as to increase the purchase of the balloon for the probe.
  • the probe may be slidably manipulated through the catheter into the target tissue.
  • the balloon-catheter may include means to facilitate the implantation of the probe into the target tissue.
  • the implantation means may take the form of a needle-tipped canula which is slidably manipulated through the catheter into the target tissue, the probe in turn being manipulated through the canula.
  • the balloon-catheter may also include means to deflect the probe and/or the canula away from the catheter into the target tissue and/or means to displace the probe predictably forwards into the target tissue or the canula predictably backwards to expose the probe.
  • the balloon-catheter or a component part thereof may be treated so as to render it more echogenic to ultrasound imaging and/or provided with readable depth markings so as to allow the surgeon to monitor the depth of insertion into the body.
  • an applicator device for inserting an optic fibre or other heat generating probe into the body, the device comprising: a housing adapted to be held by the surgeon; an elongate delivery tube adapted to be inserted into the body, one end of which is mounted in said housing; said optic fibre or other heat generating probe being disposed within the delivery tube, and means to protrude the optic fibre or probe from the delivery tube or means to retract the delivery tube over the static optic fibre or probe so as to expose the fibre/probe.
  • the optic fibre or probe is ordinarily shrouded by a needle-tipped canula likewise disposed within the delivery tube and which can be protruded or retracted so as to expose the probe/fibre.
  • At least one of the delivery tube, canula and optic fibre or probe is separable from the remainder of the device which can be withdrawn from the body leaving the separable component in place within the body.
  • the applicator device may also comprise one or more of the following optional features:
  • SUBSTITUTE SHEET canula may be treated so as to render it more echogenic to ultrasound location.
  • At least a portion of the delivery tube and/or canula may be provided with readable markings to allow the surgeon to determine the depth of insertion into the body.
  • the delivery tube and/or the canula may be provided with anchoring means to facilitate their temporary anchorage within the body.
  • the applicator device may be provided with a inflatable balloon on the delivery tube, the tube further comprising an inlet and outlet to the balloon to allow the pressuri ⁇ ation/inflation of the balloon and/or the circulation of a cooling fluid into and out of the balloon.
  • a method of heat or photo-treating a given tissue or organ of the body in which an optic fibre or other heat generating probe is inserted, either percutaneously or through an appropriate body cavity, into the target tissue or organ using an applicator device of the invention for the purpose of delivering laser/thermal energy thereto.
  • the present invention also relates to the combination of a balloon-catheter and an applicator device of the invention.
  • an optic fibre for use in the heat and /or photo-treatment of a given tissue or organ within the body, the fibre comprising a core having thereon a cladding and comprising one or more of the following:
  • the positioning means (a) may comprise, for example: treating at least a portion of the fibre so as to render it more echogenic to ultrasound location; providing at least a portion of the fibre with an ultrasound emitter to aid its ultrasound location; providing at least a portion of the fibre with a plurality of readable markings to allow the depth of insertion to be determined, and providing a self-tightening or lockable bead which is slidably disposed along the fibre so as to abut a suitable anatomical landmark.
  • the steering means (b) may comprise, for example: one or more steering wires affixed to the remote end of the fibre and disposed along the length thereof and arranged such that by appropriate manipulation of said wire(s) the direction of travel of the fibre can be controlled.
  • the anchoring means (c) may comprise, for example: an inflatable balloon arranged such that, when the fibre is inserted into said tissue or organ, the balloon can be inflated to secure the fibre in position for the duration of the treatment, and one or more protrudable anchoring members disposed on the fibre and arranged such that, when the fibre is inserted into said tissue or organ, the anchoring member(s) can be protruded into the target tissue to secure the fibre in position for the duration of the treatment.
  • the anchoring member may take the form of a wing, cage, spike or hook.
  • the optical fibre may also comprise a collar enshrouding at least a portion of the fibre, the collar bearing the above described features (a) to (d) .
  • a method of heat or photo-treating a given tissue or organ of the body in which an optic fibre of the invention is inserted into the body, either percutaneously or through an appropriate body cavity, for the purpose of delivering laser radiation to said target tissue or organ.
  • a cooling jacket for an ultrasound probe adapted to be inserted into the body of a patient, the jacket comprising an outer sleeve defining a central space and having an opening at one end to allow the remote end of the ultrasound probe to be inserted into the central space, the opening being dimensioned such that the sleeve has a sealing fit about the ultrasound probe, the jacket further comprising an inlet and an outlet to allow pressurisation/inflation of the jacket and the circulation of a cooling fluid through the jacket to effect cooling of the outer sleeve.
  • the cooling fluid is responsible for pressurising/inflating the jacket.
  • the cooling jacket ordinarily comprises at least two conduits arranged for transporting cooling fluid to and from the jacket.
  • the cooling jacket may optionally be provided with an inner sleeve having a complementary fit about the remote end of the ultrasound probe.
  • the cooling jacket is preferably formed of a compliant material, such as latex, to allow for independent movement of the probe when inserted into the body.
  • the invention also relates to the combination of an ultrasound probe and the aforesaid cooling jacket.
  • Ultrasound probes provided with such a cooling jacket find particular utility in the selective heat treatment of certain body tissues where they can be used to provide cooling for those non-target tissues or organs in
  • the cooling fluid typically water, saline or any other physiologically compatible fluid, is circulated through the jacket to cool the outer sleeve which is in direct contact with the tissues and/or organs to be protected.
  • a method of heat treating the body in which thermal energy is delivered to a target body tissue or organ wherein an ultrasound probe fitted with a cooling jacket of the invention is inserted into the body and cooling fluid is circulated through the jacket to effect cooling of non-target tissues or organs in close proximity thereto.
  • One preferred application of the cooling jacket is in the heat-treatment of the prostate to provide cooling for the lining of the rectum.
  • the ultrasound probe is preferably dimensioned such that it can be inserted into the rectum of the patient via the anus with the cooling jacket sized such that, when inflated, the outer sleeve of the jacket contacts the walls of the rectum to protect the lining of the rectal wall from heat damage.
  • the cooling jacket is preferably configured so as to facilitate the delivery and temporary implantation of and/or the secure retention of an optic fibre or other heat generating probe into the target tissue or organ.
  • the cooling jacket may comprise one or more conduits extending through the jacket to a port(s) provided in the outer sleeve to allow the optic fibre or probe to be manipulated through the jacket into the target tissue or organ. Movement of the optic fibre or probe can adventageously be directed via real-time feedback from visual ultrasound images generated by the ultrasound probe of the thermal- tissue effect.
  • Figure 1 is a simplified anatomical illustration of the human (male) uro-genital system
  • Figure 2 is a longitudinal section through one embodiment of a balloon-catheter in accordance with the invention
  • Figure 3 is a transverse section along the line A-A of the balloon-catheter of Figure 2;
  • Figure 4 is a perspective view of the remote end of an alternative embodiment of balloon-catheter in accordance with the invention
  • Figures 5 and 6 represent simplified anatomical illustrations of the human (male) uro-genital system having disposed within the urethra a balloon-catheter in accordance with the invention
  • FIG. 7 to 9 are simplified representations of applicator devices in accordance with the invention.
  • FIGS 10a and 10b are sectional views of the remote end of the delivery tube of an applicator device in accordance with the invention.
  • Figure 12 illustrates another embodiment of applicator device in accordance with the invention
  • Figure 13 illustrates a further embodiment of applicator device in combination with a balloon-catheter of the invention
  • Figure 14 is an anatomical illustration of the uro- genital system of a patient undergoing laser surgery of the prostate and having disposed within the prostatic fossa a balloon-catheter of the invention;
  • Figure 15 illustrates another embodiment of pplicator device in combination with a balloon-catheter of the invention
  • Figure 15a illustrates a perspective view of the remote end of the delivery tube of a modified version of the applicator device of Figure 15;
  • Figure 16 illustrates a further embodiment of applicator device in combination with a balloon-catheter of the invention
  • Figure 16a is a sectional view along the line B-B of the applicator device/balloon-catheter combination of Figure 16;
  • Figures 17a and 17b are perspective views of the remote end of a canula having a self-anchoring mechanism for use with an applicator device in accordance with the invention
  • Figures 18 and 19 are sectional views of the remote end of the canula of an applicator device of the invention having means to limit the extent of maximum travel of an optic fibre disposed therein;
  • Figure 20 is a sectional view of a body cavity having disposed therein an ultrasound probe fitted with a cooling jacket in accordance with the invention
  • Figures 21 and 22 are simplified anatomical illustrations of the prostate of a patient undergoing prostatic surgery having disposed therein the probe/jacket combination of Figure 18;
  • Figure 23 is a sectional view of the anal passage of a patient undergoing prostatic surgery having disposed therein an ultrasound probe fitted with an alternative embodiment of cooling jacket in accordance with the invention
  • Figure 24 is a perspective view of the proximal end of the probe/jacket combination of Figure 23;
  • Figures 25 and 27 are simplified anatomical illustrations of the prostate of a patient undergoing prostatic surgery having disposed therein the probe/jacket combination of Figure 23;
  • Figure 26 is a transverse sectional view along the line C-C of the anatomical illustration of Figure 25;
  • Figure 28 is a transverse sectional view through a probe fitted with a further embodiment of cooling jacket in accordance with the invention.
  • FIGS 29 to 41 illustrate various embodiments of optic fibres modified in accordance with the invention.
  • SUBSTITUTESHEET Figure 1 is a simplified anatomical illustration of the human (male) uro-genital system.
  • the prostate (2) is a gland found in male mammals surrounding the urethra (4) in the region where it leaves the bladder (6) . It releases a fluid containing various substances, including enzymes and an anti-coagulating factor, that contribute to the production of semen which is released through the penis (8) via the urethra (4) at sexual orgasm.
  • the size and secretory function of the prostate (2) are under hormonal control.
  • the position of the seminal vesicles (14) and the pubic symphysis (16) is also shown.
  • Benign prostatic hypertrophy is generally caused by the transitional (or central) zone (18) of the prostate (2) enlarging, usually with age, thereby compressing and restricting the outflow of urine from the bladder (6) .
  • Malignant prostate cancer now the second commonest cause of death from malignant disease in the UK and the commonest cause of death from malignant disease in US males, is normally associated with the peripheral zone (20) of the prostate (2), sometimes referred to as the "true prostate".
  • the prostate or other target tissue or organ
  • TRUS transrectal ultrasound
  • the target areas may be marked in the scanner's memory as a series of three-dimensional co-ordinates which allow for the precise insertion of the optic fibre or other heat generating probe (and/or any other appropriate surgical instrument/device) into the area(s) of interest.
  • One surgical device of the invention comprises a catheter dimensioned for insertion into the body and having thereon a balloon, the catheter further comprising an inlet and an outlet to allow pressurisation/inflation of the balloon and circulation of a cooling fluid into and out of the balloon.
  • the balloon-catheter is primarily intended to be used in the selective thermal treatment of diseased body tissue to cool those non-target tissues in close proximity to the tissue being treated.
  • the balloon-cather is normally hand held and inserted into the body via the transrectal, transperineal (or other transcutaneous route) or transurethral route using a resectoscope, endoscope or cystoscope.
  • the balloon-catheter is preferably sized so as to allow for its insertion through the operating channel of a conventional endoscope if it is to be inserted via a body cavity, such as the urethra.
  • the balloon-catheter may be sufficiently rigid so as to allow for its insertion through the skin, e.g., the skin of the perineum. Insertion through the skin would ordinarily be guided by the use of biopsy guides and channels.
  • Each device (22) generally comprises an elongate catheter (24) dimensioned so as to be capable of insertion into the body cavities of the patient and having thereon a balloon (26) . Both ends of the balloon (26) are secured to the catheter (24) to form a hermetic seal between the balloon (26) and the outer wall of the catheter (24) .
  • the balloon is preferably sized such that when it is inflated within the prostatic urethra, the urethra of an average sized hypertrophied prostate gland will expand so as to compress the prostatic tissue, preferably without exceeding its elastic limit.
  • An inflated balloon having a diameter of about 12 to 25 mm is normally adequate for the average sized hypertrophied prostate gland to achieve the desired compression of the prostatic tissue, although this dimension may vary with smaller and larger prostate glands with the balloon being sized accordingly.
  • the balloon may be made of various known materials already used in other medical procedures, such as those described in US Patent No. 4490421. .
  • the balloon is generally designed to accommodate up to about 10 atmospheres (1.01 x 10 6 Nm “2 ) and preferably no more than about 6 atmospheres (6.06 x 10 5 Nm "2 ) of water pressure and should be capable of holding that pressure for at least 5 minutes.
  • the balloon material is designed to rupture should the pressure exceed the aforesaid limits in order to ensure that ruptures at even greater pressures would not occur causing potential harm to the patient.
  • the material used for the balloon for other procedures in other body passageways, e.g., the rectum may be of a type which is more compliant, such as a latex material, so as to more readily conform to the shape of the passageway, and may operate at other pressures depending on the balloon size and application.
  • the balloon-catheter (22) generally comprises at least two conduits (28 and 30) for transporting a cooling fluid (32) to and from the balloon (26) .
  • the two conduits (28 and 30) may be connected at their distal ends, thereby forming a closed loop for the cooling fluid (32) or, more preferably, both conduits (28 and 30) may open at their distal end into the balloon (26) as shown in Figure 2.
  • the cooling fluid (32) is responsible for pressurising and inflating the balloon (26) , although if desired separate pressurising/inflation means may be provided.
  • the pressure differential required to inflate the balloon may be provided by a suitable valve mechanism positioned at the proximal end of the conduit draining fluid from the balloon or, alternatively and as shown, the conduit(s) (30) draining the cooling fluid (32) may simply have a smaller bore than the supply conduit (28) or a constriction to provide the requisite pressure differential.
  • the proximal end (34) of the catheter (24) is adapted to be connected to a suitable fluid supply and pump mechanism (not shown) to allow the balloon (26) to be inflated/pressurised and the cooling fluid circulated therethrough.
  • the device may also be connected to a suitable control unit (not shown - but see Figures 7 to 19) comprising a pistol or scissor grip to facilitate its in situ manipulation.
  • the cooling fluid is circulated through the device to cool the outer surface (or cuff) of the balloon which is in direct contact with the tissu (s) to be protected.
  • This is in marked contrast to known catheters incorporating cooling means where an opening is provided at the remote end to simply flood the site of insertion. It will be appreciated that it is not possible to cool those tissues, e.g., the lining of the urethra, in direct contact with the catheter using such devices.
  • the balloon-catheter (22) may advantageously include a smaller secondary balloon (shown in dotted outline (36) in Figure (4)) situated just below the main balloon (26) through which the cooling fluid (32) is also circulated.
  • the secondary balloon (36) overlies the sphincter active area at the apex of the prostate (2) leading to the urethra (4) , to protect the distal sphincter muscle (12) .
  • the second balloon (36) can also be used as an aid to positioning the device (22) by providing a palpable marker which can be felt transrectally by the surgeon, thereby confirming that the main balloon (26) has been advanced into the prostatic urethra.
  • the balloon-catheter (22) may include another secondary balloon (shown in dotted outline (38) in Figure 6) situated above the main balloon (26) which lies in the neck of the bladder (5) and when inflated, anchors the device (22) in position.
  • Cooling fluid (32) may be circulated through the balloon (38) to provide cooling for the proximal sphincter muscle (10) .
  • the balloon-catheter (22) When treating a patient suffering from BPH, the balloon-catheter (22) is typically inserted into the urethra (4) , as shown in Figures 5 and 6, such that the balloon (26) lies within the prostatic region of the urethra (4) .
  • the patient is appropriately anaesthetized, for example, with a topical anaesthetic applied liberally within the urethra (4) or by injection of local anaesthetic agents about the target tissue or by regional, spinal or
  • the balloon-catheter may advantageously include a conduit (not shown) extending through or along the catheter to allow the prostatic urethra to be flushed at periodic intervals with an anaesthetic gel or solution. Subsequent expansion of the balloon presses the anaesthetic gel into contact with the tissue of the prostatic fossa.
  • the outer surface of the balloon (26) may be advantageously textured so as to retain an anaesthetic gel or paste applied thereon.
  • the penis (8) is then appropriately prepared and draped and the tip (42) of the catheter (24), with the balloo (s) (26, 36 and 38) deflated, inserted through the urethra (4) as shown in Figures 5 and 6.
  • the manoeuvre can be observed, either endoscopically, ultrasonically or fluoroscopically using any of the appropriate apparatus known in the art, to ensure precise positioning of the balloon.
  • the balloon- catheter may advantageously include a channel or conduit (not shown) extending through or along the catheter for a flexible viewing fibre optic or rigid rod lens to allow the surgeon to endoscopically monitor the passage of the device along the urethra.
  • the balloon is properly positioned, it is inflated, normally to a pressure of from 2 to 5 atmospheres (2.02 x 10 5 to 5.05 x 10 5 Nm "2 ) .
  • the balloon is preferably sized such that when inflated it compresses at least a selected portion of the prostate to generate a region of relative ischaemia, the compressed tissue having less blood to absorb the laser radiation and/or to remove the heat generated by tissue warming, thereby producing a greater heating effect per Joule of energy administered.
  • the cooling fluid circulating through the balloon cools the walls of the prostatic urethra allowing the surgeon to increase the amount of energy applied to the prostate to effect the destruction of the target tissue, while preserving the lining of the urethra.
  • the balloon-catheter is preferably constructed of ultrasonic-visible material to facilitate its positioning via ultrasound imaging.
  • the balloon-catheter or a portion thereof, e.g., the catheter tip may also be treated using one or more conventional techniques known in the art, such as, etching, sand blasting etc. , for rendering it device more echogenic to ultrasound, as explained hereinafter with reference to the optic fibres shown in Figures 29 to 31.
  • the balloon- catheter is arranged so as to facilitate the delivery and the implantation of an optic fibre for administering laser radiation to the target tissue, although any other fine calibre, heat generating probe could be employed, e.g., a microwave antenna or a heated wire element.
  • the fibre (44) can, in the' simplest embodiment, be slidably manipulated through the lumen (46) of the catheter (24) and out of a suitable aperture (48) provided in the remote end thereof into the target tissue.
  • the simple act of inflating the balloon(s) can be used to stabilise the fibre by pressing it against the wall of the prostatic urethra and/or compressing the tissue in which it is inserted.
  • the outer surface of the balloon may advantageously be textured so as to increase the purchase of the balloon on the fibre.
  • the balloon-catheter preferably includes means to facilitate the implantation of the fibre into the tissue.
  • the applicator means may comprise a needle-tipped canula (not shown) extending through the lumen of the catheter which can be used as a guide to facilitate the accurate delivery of the optic fibre, the fibre being manipulated through the needle- tipped canula into the target tissue.
  • a needle-tipped canula (not shown) extending through the lumen of the catheter which can be used as a guide to facilitate the accurate delivery of the optic fibre, the fibre being manipulated through the needle- tipped canula into the target tissue.
  • the canula Once guided into position, either by ultrasonic and/or endoscopic or other guidance, then either the canula would be retracted while maintaining the fibre optic at the desired position or, the fibre would be protracted from the canula.
  • the balloon is inflated once the fibre has been correctly positioned and includes a groove or slot into which the fibre and/or implantation device sits enveloped in the balloon.
  • Preferred applicator devices are described hereinafter with reference to Figures 7 to 19.
  • the balloon-catheter may allow for the insertion of a canula at each of the predetermined target points, after which a fibre is passed down the individual canulae.
  • each fibre is protruded (or the canula retracted) by a predetermined distance to allow it to stand clear of the canula.
  • the device is desirably provided with means to deflect the fibre (and/or the canula) away from the balloon and into the target tissue.
  • the fibre (44) is threaded through the lumen of the catheter (24) into a channel (50) provided in the balloon (26) which is configured so as to deflect the emerging fibre (44) , in this particular embodiment, in a direction approximately perpendicular to the direction of travel of the prostatic urethra.
  • the thermal energy must be directed to the main mass of the lateral lobe of the transitional zone but sufficiently far away from the sphincter areas , the pelvic plexus nerves controlling sexual potency and the lining of the urethra to avoid damage to those structures.
  • the balloon-catheter is ordinarily provided with one or more temperature sensors, to allow the surgeon to monitor the temperature of the tissues being protected.
  • the device (22) is provided with at least one thermocouple (52) at a position approximately equivalent to the middle point of the prostatic urethra so as to monitor the temperature of the urethral lining and preferably a second thermocouple (54) at a position approximately equivalent to the level of the distal sphincter muscle.
  • the leads extending from the therocouples (52 and 54) have been omitted in the interests of clarity.
  • the laser delivery system preferably includes a laser capable of providing a deeply penetrating continuous or pulsed wave beam.
  • a laser capable of providing a deeply penetrating continuous or pulsed wave beam.
  • a preferred example is a neodymlum- YAG laser because its radiation is not absorbed so strongly by body tissue as some other lasers.
  • the neodymium-YAG laser also provides a more pronounced scattering, with a larger volume tissue effect occurring.
  • Examples of such laser delivery systems include the PEGASUS Laser System, commercially available from Pfizer Laser System Inc. and the MEDILASE 2 Laser System commercially available from MBB Incorporated.
  • the balloon-catheter may include means (not shown) for ultrasonically viewing at least a portion of the prostatic tissue so that the portions of the prostate to be irradiated can be selected by the user, and the selected tissue exposed to the laser radiation can be observed and monitored by the user in real time during the course of the treatment.
  • This observation is particularly facilitated by the fact that the treated tissue becomes strongly echogenic, that is, visible by ultrasound imaging during the course of the treatment, allowing modification of the position of the fibre and/or the duration of heating if necessary.
  • the position of the fibre may be changed to encompass a larger volume of tissue, usually by gradually withdrawing the fibre.
  • the device may, for example, include a u/s emitter/receiver which receives the reflected u/s waves from the target region and converts them into an electric signal which correlates with the temperature of that region.
  • the temperature data so produced can be projected onto a colour monitor as coloured areas or bands representing zones of warmer or cooler tissue which can be used as a visual guide to the operator in the positioning, movement and repositioning of the optic fibre (or other heat generating probe) and/or the increase/decrease of the laser energy being delivered.
  • the change in the blood flow rate within the target region can be analysed from the change in u/s signal reflection using the "doppler shift" principle, to give a velocity value which is projected onto the image of the blood vessel on a screen as a blue colour for relatively slow moving fluid and red colour for faster moving fluid.
  • the blood vessels at the periphery of the heated area initially dilate, thereby increasing the rate of the blood flow (seen as becoming more red) , but as the heated area eventually reaches those vessels, the rate of blood flow slows (becoming more blue) , presumably as they become thrombosed, eventually ceasing to flow at tissue death.
  • the laser is energized so as to deliver an amount of radiation sufficient to cause the tissue to coagulate.
  • the ultrasonic transducers may be used to view the tissue ultrasonically during and after the treatment to determine the area and extent of coagulation. The typical result of such treatment is indicated by the crosshatched region (56) shown in Figure 6.
  • the balloon-catheter may be withdrawn and loaded with a small temporary indwelling stent which can then be placed in position and dilated to its full diameter over the balloon when it is seen, either endoscopically or ultrasonically, to be lying in an appropriate position within the prostatic urethra, thereby overcoming any consequent oedema that might cause temporarily increased obstructive symptoms.
  • a small temporary indwelling stent which can then be placed in position and dilated to its full diameter over the balloon when it is seen, either endoscopically or ultrasonically, to be lying in an appropriate position within the prostatic urethra, thereby overcoming any consequent oedema that might cause temporarily increased obstructive symptoms.
  • the damaged tissue will shrink, thereby reopening the urethra and restoring the calibre to something like its normal diameter.
  • the balloon-catheter may also be provided with readable depth markings, e.g., as explained hereinafter with reference to the optic fibre shown in Figure 29, such that the surgeon can determine the depth of insertion into the body.
  • radio-opaque markers may be provided at opposite ends of the balloon which can be seen fluoroscopically to ensure that the balloon is safely advanced into the prostatic urethra before inflation so as to minimise the risk of damage to either sphincter muscle when the balloon is inflated.
  • the balloon-catheters of the invention are believed to provide several advantages in the treatment of symptoms of BPH and prostatic carcinoma, in particular, preservation of the urethral lining with necrosis of underlying obstructive/malignant tissue, as well as reducing the chances of tissue and muscle damage associated with impotence and incontinence. Furthermore, by inflating the balloon sufficiently to squeeze the tissue so as to compress the tissue without necessarily exceeding its elastic limit, the tissue will not be unnecessarily damaged due to tearing.
  • FIGS 7 and 8 illustrate the general principles of an applicator device (100) in accordance with the present invention.
  • the device generally comprises an
  • SUBSTITUTESHEET elongate, ordinarily rigid but in a preferred embodiment articulated, delivery tube (102) dimensioned for insertion into the body of the patient, and a housing (104) which separates as shown in Figure 7, on operation of the scissor grip (106) .
  • the device When treating the prostate, the device may be inserted through the urethra or the rectum or via the skin by direct puncture, preferably guided by ultrasound and usually inserted via the biopsy channel of an ultrasound probe.
  • a surgical instrument (108) which may be a needle or optic fibre for delivering laser radiation, is anchored in one section (110) of the housing (104) such that operation of the scissor grip (106) causes the instrument (108) to be protruded from and retracted into the delivery tube (102) .
  • Figure 9 illustrates an alternative arrangement of applicator device (112) in which protraction/retraction of the instrument (108) is effected by drawing together the two sections of the housing (104) as indicated.
  • a resiliently-flexible member (114) biases the two sections of the housing (104) apart so that the instrument is ordinarily retracted within the delivery tube (102) .
  • a latch mechanism (not shown) may be provided to allow the two sections of the housing (104) to be locked together, thereby fixing the instrument (108) in the protracted position and allowing the surgeon the use of both hands.
  • the delivery tube may be retracted over the static instrument to leave it standing clear of the device.
  • the delivery tube is preferably provided with a suitable deflection mechanism to steer the emerging instrument away from the device and into the tissue of the body, e.g., the lateral lobes of the prostate.
  • the remote end of the delivery tube (102) may have sufficient flexibility to allow for the use of a control wire (116) embedded in or affixed to the end of the delivery tube (102) to control the angle of deflection of an optic fibre (118) as shown.
  • FIGS 11 to 19 illustrate more sophisticated applicator devices.
  • the delivery tube (102) encloses a needle-tipped canula (122) having disposed therein an optic fibre (118) for administering laser radiation to body tissue(s) .
  • the delivery tube (102) is provided with an adjustable deflector (124) to steer the emerging cannula (122)/fibre (118) at a range of angles away from the device
  • SUBSTITUTESHEET protrude from the delivery tube (102) .
  • the fibre (118) is in turn protruded from the canula (122) by the surgeon pushing on the finger grip (130) of a collar (132) secured to the proximal end of the fibre (118) , as shown in Figure lie.
  • the collar (132) may be adjustable to allow the surgeon to define the maximum allowable protrusion of the fibre (118) .
  • the scissor grip (106) will typically allow for between 3 to 5 cm movement of the canula (122) and full displacement of the fibre, that is, until the collar (132) abuts the housing (128) of the device, a further 0.5 to 2 cm thereover.
  • a latch mechanism (134) may be provided to allow the surgeon to lock the collar (132) to the housing (128) to stabilise the protruded fibre (118) in position.
  • the needle-tipped canula or, alternatively, the relevant instrument (fibre) or delivery tube may be disengaged from the remainder of the housing. In this manner, the surgeon can load and implant a succession of canulae into the target region, an optic fibre being manipulated through each canula, to allow for the simultaneous treatment of two or more regions of the target tissue.
  • a viewing fibre-optic or rod lens (136) may be mounted atop the housing (128) to allow visual inspection of the chosen site of insertion and to confirm that the emerging canula (122) and/or fibre (118) is entering the tissue well away from the sphincter regions.
  • the eyecup (138) of the rod lens (136) may be connected to a suitable video monitor.
  • Figure 12 illustrates an alternative embodiment of applicator device (140) in which a rod lens (136) , together with one or more light conducting elements, the needle- tipped canula (122) and enclosed optic fibre (118) are contained within the delivery tube (102) .
  • Inlet and outlet ports (142 and 144) are provided to allow an irrigant, such as water, saline or any other physiologically compatible fluid to be flushed through the delivery tube (102) in order to improve visibility, free obstructions etc. It will be appreciated that the applicator and balloon-catheter devices of the invention are closely related.
  • Figure 13 illustrates an alternative embodiment of applicator device (146) in combination with a balloon- catheter (22) .
  • the applicator device (146) is inserted through an orifice (148) provided in the proximal end of the balloon-catheter (22) which acts, in this embodiment, as a sheath for the applicator device (146) .
  • a window (149) is provided in the remote end of the balloon-catheter (22) through which the surgeon can visualize the target tissue using a rod lens (136) or other similar viewing instrument and though which the optic fibre (118) can pass to the target tissue.
  • the applicator device (146) may be withdrawn, as shown in Figure 14, or left in position as desired.
  • the balloon (26) is then inflated by circulating cooling fluid therethrough and heating commenced. The whole operation, including the heating stage, would normally be monitored by
  • FIG. 15 illustrates another embodiment of applicator device (150) adapted to deliver a balloon- catheter (22) to the prostatic urethra.
  • the balloon-catheter (22) is inserted through the delivery tube (102) of the applicator device (150) .
  • the balloon- catheter (22) may lie in a slot (152) provided in the remote end of the delivery tube (102) .
  • Figures 16 and 16a illustrate a further embodiment of applicator device (154) in which the delivering tube (102) is formed with a A U-shaped' cross-section in which the balloon-catheter (22) rests.
  • a conduit (156) extending therethrough is provided for the optic fibre (118) or other instrument.
  • the two devices may be combined in a single integral unit.
  • the cooling balloon may be provided on the delivery tube of the applicator device, with the conduits supplying cooling fluid to and from the balloon passing through or along the delivery tube.
  • the applicator device or a portion thereof may optionally be provided with readable depth markings and/or treated to render it more echogenic to ultrasound imaging as described hereinafter with reference to the optic fibres shown in Figures 29 to 32.
  • the delivery tube and/or the canula may also be provided with anchoring means as described hereinafter with reference to the optic fibres shown in Figures 34 to 39.
  • the needle- tipped canula (122) which may be disengagable from the remainder of the applicator device (not shown) , may be provided with an anchoring member to allow for the temporary anchoring of the canula (122) into the target tissue during treatment.
  • the canula (122) is provided with two wire 'wings' (158) which can be manipulated by the surgeon pushing/ ulling on a control wire (160) from a 'collapsed' state, as shown in Figure 17a, in which it lies substantially flush with the surface of the canula (122) in slot (162) , to an anchoring position, as shown in Figure 17b, in which the wings (158) project into the target tissue, thereby securing the canula (122) in position.
  • the remote end of the needle-tipped canula (122) may, in a preferred embodiment, be provided with a stop (164) which, as the optic fibre (118) is protruded from the canula (122) into the target tissue, abuts the cladding (166) of the fibre (118) preventing its further movement. In this manner, the length of the fibre core (168) exposed, represented by 'x', will determine the extent of fibre protrusion into the target tissue.
  • the optic fibre (118) may be provided with a collar (170) secured about the fibre (118) a predetermined distance r y' from the fibre tip which, as the fibre (118) is protruded from the canula (122) , abuts stop (164) .
  • the collar (170) may be adjustable to allow the surgeon to control the length of fibre (118) protruded from the canula (122) . It will be appreciated that the stop and collar need not be positioned at the remote end of the canula/fibre but may be located at any point along the length thereof.
  • FIG 20 illustrates a sectional view of the body cavity (200) of a patient having disposed therein an ultrasound probe (202) of conventional type provided with a cooling jacket (204) in accordance with the invention.
  • the cooling jacket (204) is ordinarily formed of a compliant material, such as latex, and comprises an outer sleeve (206) defining a central space (208) .
  • An opening is provided in one end (210) of the cooling jacket (204) to allow the remote end of the probe (202) to be inserted into the central space (208) , as shown, the jacket (204) having a sealing fit thereabout.
  • the cooling jacket (204) is provided in said one end (210) with an inlet (212) which allows for the introduction of a cooling fluid (214) , typically water, saline or any other physiologically compatible fluid, into the central space (208) , thereby inflating/pressurising the jacket (204) .
  • a cooling fluid typically water, saline or any other physiologically compatible fluid
  • the inlet (212) is connect to a suitable reservoir of cooling fluid (not shown) and pump mechanism (also not shown) to allow the cooling fluid (214) to be circulated through the central space (208) and out of the cooling jacket (204) via outlet (216) to effect the cooling of the body tissues in contact with the outer sleeve (206) , in this case, the walls (218) of the body cavity (200) .
  • separate inflation and cooling means may be provided.
  • the pressure differential required to inflate the cooling jacket (204) may be provided by a suitable valve mechanism (not shown) at the outlet or, alternatively, the outlet (216) may simply have a smaller diameter
  • the probe (202) is inserted into the rectum (220) of the patient through the anus (222) , with the cooling jacket (204) deflated and positioned such that it lies adjacent the prostate (2) .
  • the probe (202) allows the surgeon to visualise the prostate region to facilitate the location of, for example, an optic fibre (224) (or other heat generating probe) inserted either transcutaneously through the skin of the perineum (226) (see Figure 21) or transrectally through the biopsy channel (228) of the probe (202) and/or to monitor the progress of the treatment in real-time, while simultaneously providing cooling for the walls (230) of the rectum (220) .
  • an optic fibre 224
  • SUBSTITUTESH (204) is provided with a port (232) , explained hereafter with reference to figures 23 to 27, through which the optic fibre (224) passes out of the jacket (204) into the rectal passageway.
  • the cooling fluid circulating through the jacket (204) causes it to swell and fill the rectal passageway, thereby anchoring the probe (202) in position.
  • Figures 23 to 27 illustrate an alternative embodiment of cooling jacket (204) in which the end wall (210) of the jacket (204) is provided with an inner sleeve (234) having a complementary fit about the remote end of the probe (202) , the cooling fluid circulating through the closed space (208) defined between the outer and inner (206 and 234) sleeves.
  • the cooling jacket (204) is advantageously provided with one or more conduits (236) which extend through the closed space (208) to a port (232) provided in the outer sleeve (206) .
  • Each conduit (236) is dimensioned so as to allow the surgeon to manipulate surgical instruments, such as biopsy knives, viewing fibre optics etc. , through the device into whatever body cavity the probe has been inserted.
  • the conduits (236) may be integrally formed of the same material as the remainder of the cooling jacket (204) , but are more preferably formed from or lined with a rigid or semi-rigid material to allow for the insertion of edged instruments.
  • Each conduit (236) is, due to the compliant nature of the outer sleeve (206) , afforded a degree of relative mobility, thereby allowing the probe (202) to move freely and to scan various areas as desired.
  • Each port (232) may be provided with a rupturable membrane (not shown) , which may be self-sealing or, it may simply be left open.
  • Cooling jacket (204) may also be provided with one or more integrally formed channels (238) extending through the outer sleeve (206) , into which finer instruments, such as temperature sensors may be inserted to allow the surgeon to monitor the temperature of the relevant body cavity.
  • the device may be used to facilitate the insertion of a optic fibre (224) into the prostate (2) .
  • the optic fibre (224) ordinarily enclosed in a needle-tipped cannula (not shown) , is manipulated through the device via conduit (236a) , through the wall (230) of the rectum (220) and into the target prostatic tissue.
  • the cooling fluid (214) is then circulated through the jacket (204) such that it swells and fills the rectal passageway, as shown in Figures 27, thereby anchoring the probe (202) and fibre (224) in position.
  • Figure 28 represents a section through an alternative embodiment of cooling jacket (204) , in which the inner sleeve (234) is formed as an extension of the outer sleeve (206) .
  • Anchoring filaments (240) may be provided between the conduits (236) and inner sleeve (234) , as shown.
  • the pressure produced by the inflated sheath on the internal conduit may serve to secure any instruments extending therethrough in position.
  • Each fibre generally comprises a core and outer cladding.
  • the outer cladding (300) is ordinarily stripped from the remote end of the fibre to expose the core tip (302) , typically the distal 0.5cm thereof, which is then blunted and polished.
  • Figure 29 illustrates one embodiment of optic fibre (304) in which the outer cladding (300) is provided with a plurality of readable depth markings (305) at regular intervals, typically every 0.5cm, to facilitate the accurate positioning of the fibre (304) within the target tissue when using endoscopic or other visual means of guidance.
  • the core tip (302) has also been treated using techniques, such as etching, sand blasting etc., to render it more echogenic (visible) to ultrasound imaging. Moreover, by roughening-the core tip (302) in this manner, it is possible to increase the light-emitting surface area of the fibre (304) .
  • the fibre may be modified to increase visibility by that imaging modality.
  • Figure 30 illustrates another embodiment of optic fibre (306) in which the outer cladding (300) is provided with an ultrasound emitter (308), e.g., a piezo-ceramic compound, to increase the visibility of the remote end of the fibre (306) to ultrasound imaging.
  • the piezo-ceramic compound is excited by an electric current passed along the fibre to improve or allow for u/s location.
  • Other devices known in the art will emit when stimulated by the presence of an u/s field.
  • the ultrasound emitter may be provided at regular intervals along the outer cladding of the fibre in a similar manner to the optic fibre (304) shown in Figure 29.
  • Figure 31 illustrates an alternative embodiment of optic fibre (310) in which the core tip (302) is provided with the ultrasound emitter (308) .
  • the core tip (302) is normally provided with a silicone subbing layer (312) onto which the ultrasound emitter (308) is coated to avoid affecting the light propagating properties of the fibre (310) .
  • Figure 32 illustrates another embodiment of optic fibre (313) in which the remote end (314) of the outer cladding (300), typically the last 0.5 cm, has been treated to render it more echogenic to ultrasound imaging as described earlier with reference to Figure 29.
  • the fibre (312) is also provided with a temperature sensor, e.g., a thermocouple (316) , to allow the surgeon to monitor the temperature of the target tissue.
  • the lead (318) from the thermocouple (316) may be embedded in or simply affixed to the outer cladding (300) of the fibre (313) .
  • the fibre may be provided with a plurality of temperature sensors spaced at periodic intervals along its length to allow the surgeon to simultaneously monitor the temperature of the target and adjacent tissues.
  • Figure 33 illustrates a sectional view through another embodiment of optic fibre (320) in which a collar (322) shrouding one or more temperature sensors (316) surrounds the fibre (320) .
  • the collar (322) may be slidably manipulated by the surgeon from a retracted position (as shown) to a protracted position indicated in dotted outline (324) to allow the surgeon to measure the temperature of the body tissue at any point along the length of the fibre (320) .
  • the collar may optionally be provided with readable-depth markings as described earlier with reference to Figure 29 and/or treated to render it more echogenic to ultrasound imaging, for example, the collar may be formed of a plastics material having embedded therein metal particles.
  • Figures 34 to 39 illustrate a series of fibres incorporating anchoring means to facilitate the secure retention of the fibres at the target site (whether it be in the prostate, bladder, kidney, breast, brain, lung, uterus, adrenal gland, skin, liver, pancreas, gut etc.
  • Such means allow for the temporary anchoring of the fibre (or the cannula or delivering tube of the aforesaid applicator devices - see Figures to 7 to 19 if the anchoring means are applied to them) during treatment, after which, the anchoring means may be released or stowed or otherwise rendered inactive to allow the fibre to be removed or repositioned with further activation of the anchoring means when the next suitable position of the fibre has been achieved.
  • the optic fibre (326) is provided with an inflatable balloon (328) , typically of about 1 to 5 cm 3 volume, which is inflated once the fibre (326) is located at the target site to anchor the fibre (326) in position.
  • the balloon (328) is provided on the outer cladding (300) of the fibre (326) , although a separate collar of the type described
  • the balloon (328) is inflated by passing a fluid, ordinarily water, saline or similar physiologically compatible fluid, through a delivery tube (330) into the balloon (328) .
  • a fluid ordinarily water, saline or similar physiologically compatible fluid
  • the proximal end of the delivery tube (330) is normally connected to a syringe (not shown) to allow the surgeon to inflate/deflate the balloon (.328) as desired.
  • Figures 35 to 38 illustrate a series of closely related optic fibres (332 to 338) in which an anchoring member, either affixed to or embedded in the outer cladding of the fibre (or alternatively provided on a collar described earlier with reference to Figure (33)), can be manipulated by the surgeon from a 'collapsed' state, in which it lies substantially flush with the fibre, to an anchoring position, in which the anchoring member projects into the body tissue, thereby securing the fibre in position.
  • the anchoring member may take a wide range of forms including the 'cage' (340) of Figures 35 and 35a, the 'wing' (342) of Figure 36, the 'spike' (344) of Figure 37 and the 'hook' (346) of Figure 38.
  • the anchoring members (340 to 344) may be made of metal, e.g., a memory alloy, or plastic, and are typically erected/collapsed by the surgeon pushing or pulling on a control wire (348) extending along the fibre (332 to 338) .
  • Figure 39 illustrates a further embodiment of optic fibre (350) having a 'lockable/tightening' bead (352) that can be freely pushed along the fibre (350) until it abuts a suitable anatomical landmark, such as the rectal mucosa, whereupon it can be locked/tightened onto the fibre (350) , thereby aiding the maintenance of the fibre (350) at the target position.
  • the bead (352) may be palpable to further indicate to the surgeon that the fibre (350) is correctly positioned.
  • the bead (352) may be treated to render it more echogenic as described earlier with reference to Figures 30 and 31.
  • Figure 40 illustrates the implantation of a optic fibre (354) incorporating an anchoring member (342) in the form of a 'wing'.
  • the fibre (354) is loaded in an applicator device (356) of the type described previously with reference to Figure 9. Once the applicator device (356) has been correctly positioned, the fibre (354) is protruded from the delivering tube (358) by drawing the body portions (360 and 362) of the housing together as indicated.
  • the anchoring member (342) may be spring-biased to the anchoring position (as shown) or, alternatively, the surgeon may operate a control wire as described previously with reference to Figures 28 to 32.
  • the surgeon relaxes his or her grip on the device (356) allowing the fibre (354) to partially retract, until the anchoring member (342) abuts the delivery tube (358) as shown, preventing further retraction.
  • the fibre (354) is stowed by, in the case of a spring-biased member, forcibly retracting the fibre (354) into the delivery tube (358) or, in the case of a wire- controlled anchoring member by appropriate manipulation of the control wire.
  • SUBSTITUTESHEET Figure 41 illustrates a further embodiment of optic fibre (364) in which a steering wire (366) is attached to or embedded in the outer cladding (300) at the remote end of the fibre (364) .
  • the proximal end of the steering wire (366) is attached to a suitable control unit (not shown) operable by the surgeon to control the extent of deflection into the target tissue.
  • each of the aforesaid devices may be cumulative with any of the other devices of the present invention.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Radiology & Medical Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Hematology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Surgical Instruments (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)
  • Laser Surgery Devices (AREA)
  • Materials For Medical Uses (AREA)

Abstract

On décrit un cathéter (22) utilisé dans le traitement thermique ou par la photothérapie des tissus du corps humain, tels que celui de la prostate, ayant des dimensions adaptées pour être inséré dans le corps humain et possédant un ballonnet (26). Ce cathéter (22) comprend également, dans le ballonnet (26), une entrée (28) et une sortie (30) permettant la mise sous pression/le gonflage (32) dudit ballonnet et la circulation du liquide de refroidissement (32) dans ledit ballonnet (26) afin d'effectuer le refroidissement de la surface externe de celui-ci.
PCT/GB1992/001552 1991-08-30 1992-08-24 Catheter a ballonnet WO1993004727A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
BR9206440A BR9206440A (pt) 1991-08-30 1992-08-24 Dispositivos cirúrgicos e usos para os mesmos
JP5505017A JPH06510450A (ja) 1991-08-30 1992-08-24 外科用装置及びその使用方法
EP92918434A EP0601025A1 (fr) 1991-08-30 1992-08-24 Catheter a ballonnet
NO940662A NO940662L (no) 1991-08-30 1994-02-25 Ballongkateter
FI940916A FI940916A7 (fi) 1991-08-30 1994-02-25 Pallo-tyyppinen katetri

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB9118670.0 1991-08-30
GB919118670A GB9118670D0 (en) 1991-08-30 1991-08-30 Surgical devices and uses thereof

Publications (1)

Publication Number Publication Date
WO1993004727A1 true WO1993004727A1 (fr) 1993-03-18

Family

ID=10700729

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB1992/001552 WO1993004727A1 (fr) 1991-08-30 1992-08-24 Catheter a ballonnet

Country Status (10)

Country Link
EP (1) EP0601025A1 (fr)
JP (1) JPH06510450A (fr)
AU (1) AU2469392A (fr)
BR (1) BR9206440A (fr)
CA (1) CA2116534A1 (fr)
FI (1) FI940916A7 (fr)
GB (1) GB9118670D0 (fr)
MX (1) MX9205010A (fr)
NO (1) NO940662L (fr)
WO (1) WO1993004727A1 (fr)

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EP0601025A1 (fr) 1994-06-15
FI940916A0 (fi) 1994-02-25
BR9206440A (pt) 1994-08-02
GB9118670D0 (en) 1991-10-16
NO940662D0 (no) 1994-02-25
NO940662L (no) 1994-04-18
AU2469392A (en) 1993-04-05
FI940916A7 (fi) 1994-04-07
CA2116534A1 (fr) 1993-03-18
MX9205010A (es) 1993-05-01
JPH06510450A (ja) 1994-11-24

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