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WO2010079480A1 - Anastomosis device for joining a severed bladder neck to the severed end of a urethral stump - Google Patents

Anastomosis device for joining a severed bladder neck to the severed end of a urethral stump Download PDF

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Publication number
WO2010079480A1
WO2010079480A1 PCT/IL2010/000006 IL2010000006W WO2010079480A1 WO 2010079480 A1 WO2010079480 A1 WO 2010079480A1 IL 2010000006 W IL2010000006 W IL 2010000006W WO 2010079480 A1 WO2010079480 A1 WO 2010079480A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
catheter
severed
bladder
balloon
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/IL2010/000006
Other languages
French (fr)
Inventor
Eran Hirszowicz
Ami Sidi
Shmuel Beck
Hamid Sharim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MEDIFLOW MEDICAL SOLUTIONS Ltd
Original Assignee
MEDIFLOW MEDICAL SOLUTIONS Ltd
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 MEDIFLOW MEDICAL SOLUTIONS Ltd filed Critical MEDIFLOW MEDICAL SOLUTIONS Ltd
Publication of WO2010079480A1 publication Critical patent/WO2010079480A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136—Balloons
    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • 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
    • A61M25/1011—Multiple balloon catheters
    • 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
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • 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
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00278—Transorgan operations, e.g. transgastric
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00982—General structural features
    • A61B2017/00991—Telescopic means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B2017/1103—Approximator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/12127—Double occlusion, e.g. for creating blood-free anastomosis site
    • 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
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • 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
    • 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
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • 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
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A61M2025/0006—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system which can be secured against axial movement, e.g. by using a locking cuff
    • 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
    • A61M2025/0008—Catheters; Hollow probes having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
    • 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
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/16—Male reproductive, genital organs
    • A61M2210/166—Prostate
    • 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
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections

Definitions

  • the present invention is in the field of surgical apparatus and methods and is more specifically directed to apparatus and methods for effecting a radical prostatectomy which avoids the shortcomings of the prior known procedures for such operations.
  • the invention is also intended for general use in tubular anastomosis.
  • the presently employed surgical procedures involved in the anastomosis of the distal urethra and the bladder neck results in trauma and injury to the nerves adjacent to the apex of the prostate and the urethra.
  • post-operative leakage results from the fact that the anastomosis is frequently not liquid-tight so that urine leaks outside the anastomosis, resulting in scarring and distortion of the bladder neck with possible encasement of the nerves.
  • RP radical prostatectomy
  • a major impediment of radical prostatectomy remains its postoperative sequel related to the urethro-vesical anastomosis, which if not properly performed can lead to both urinary incontinence and outflow obstruction secondary to stricture at the anastomosis site.
  • An aspect of the invention provides an anastomosis catheter for joining together first and second severed tubular body elements.
  • the aforementioned said catheter comprises a semi-rigid shaft having a distal end and a proximal end, wherein at least a portion of the semi-rigid shaft has a length that is adjustable ; a distal balloon positioned at the distal end of the shaft and configured for being inserted and at least partially inflated within a first severed body element ; a proximal balloon positioned at the proximal end of the aforementioned shaft and configured for being inserted and at least partially inflated within a second severed body element such that when the shaft is introduced between the body elements and the balloons are inflated within the body elements and the adjustable length portion is adjusted accordingly, the severed ends are maintained and held in contact with one another so that healing between the severed ends is promoted over a period of time .
  • a further aspect of the invention provides the aforementioned anastomosis catheter for joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient.
  • the aforementioned catheter comprises; a flexible and adjustable semi rigid shaft for inserting into the bladder of a patient via the urethra, so as to provide a connection between the bladder and urethra, the aforementioned shaft having a distal end and a proximal end; a first balloon positioned at the distal end of the shaft, for introducing and at least partially inflating within the bladder, so as to effectively anchor said bladder, a second balloon positioned at the proximal end of the shaft, for introducing and at least partially inflating in the urethral stump so as to effectively anchor the urethral stump; such that when the shaft is introduced between the severed ends, and the balloons are introduced and at least partially inflated within the severed ends, and the shaft is
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the semi-rigid shaft includes an inner catheter shaft and an outer catheter shaft, the inner catheter shaft coupled to the first balloon for facilitating anchoring of the first balloon within the bladder an outer catheter shaft coupled to the second balloon for facilitating anchoring of the second balloon proximal to the urinary sphincter, wherein the inner catheter shaft is at least partially housed within the outer catheter shaft and is extendable and withdrawable from the outer catheter shaft;
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising a graduated locking mechanism connecting the inner catheter shaft to the outer catheter shaft for incrementally adjusting the extension of the inner catheter shaft from the outer catheter shaft.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the aforementioned catheeter further comprises a flexible and adjustable stretchable tube mechanically connecting the first balloon to the second balloon so as to provide tension between the connected balloons whilst the inner catheter shaft is extended from the outer catheter shaft .
  • a further aspect of the invention provides the aforementioned anastomosis catheter whereinthe balloons and shafts are enclosed within a lumen.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein each of the balloons and shafts is provided with a separate lumen.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the lumens are arranged coaxially.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is adapted to incrementally shorten the distance between the balloons when the balloons are in anchoring positions during a surgical procedure, thereby bringing the bladder neck and the urethral stump into contact with one another.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft comprises at least two telescopic parts adapted so that the shaft can be lengthened or shortened by adjustment of the telescopic parts.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft comprises at least two portions, at least one of the portions is screwable into the other, such that the length of the shaft can be adjusted.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is semi-collapsible and/or concertina -like, such that the length of said shaft can be adjusted.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein wherein the shaft is hollow along at least a portion of the length thereof.
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising a pullable lanyard attached to the distal end of the shaft, the lanyard running the length of the shaft, and the lanyard adapted to collapse, telescope or otherwise shorten the shaft in a predetermined manner when pulled by the surgeon.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the lanyard is provided with stoppers or notches for facilitating incremental shortening or lengthening of the shaft.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is provided with visualisation means.
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising bladder drainage means.
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising drug delivery means.
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising bladder sound introduction means .
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising electrical cauterizing means .
  • a further aspect of the invention provides the aforementioned anastomosis catheter further comprising distance measuring means .
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is provided with means for bending in a predetermined manner.
  • a further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is provided with additional means for maintaining the patency of the join between the severed bladder neck and the severed urethral stump.
  • a further aspect of the invention discloses a method of joining together a first and second severed tubular body element, wherein the method comprises steps of; a. obtaining an anastomosis catheter, the aforementioned catheter comprising; i. a semi-rigid shaft having a distal end and a proximal end, wherein at least a portion of the semi-rigid shaft has a length that is adjustable; ii. a distal balloon positioned at the distal end of the shaft and configured for being inserted and at least partially inflated within a first severed body element iii.
  • a proximal balloon positioned at said proximal end of said shaft and configured for being inserted and at least partially inflated within a second severed body element ; b. introducing the shaft between the body elements c. inflating the balloons within the body elements and d. adjusting length of the shaft adjustable length portion thereby maintaining and holding the severed ends in contact with one another so that healing between the severed ends is promoted over a period of time .
  • a further aspect of the invention discloses a method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the method comprises steps of obtaining an anastomosis catheter, the catheter comprising; a flexible and adjustable semi rigid shaft for inserting into the bladder of a patient via the urethra, so as to provide a connection between said bladder and urethra, the aforementioned shaft having a distal end and a proximal end; a first balloon positioned at the distal end of the shaft, for introducing and at least partially inflating within the bladder, so as to effectively anchor the bladder, a second balloon positioned at the proximal end of the shaft, for introducing and at least partially inflating in the urethral stump so as to effectively anchor the urethral stump introducing the shaft is between the severed ends; introducing the balloons within the severed ends partially inflating balloons within the severed ends and adjusting length of the shaft thereby pressing
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the semi-rigid shaft includes an inner catheter shaft and an outer catheter shaft, the inner catheter shaft coupled to the first balloon for facilitating anchoring of the first balloon within the bladder and an outer catheter shaft coupled to the second balloon for facilitating anchoring of the second balloon proximal to the urinary sphincter, wherein the inner catheter shaft is at least partially housed within the outer catheter shaft and is extendable and withdrawable from the outer catheter shaft
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises a graduated locking mechanism connecting the inner catheter shaft to the outer catheter shaft for incrementally adjusting the extension of the inner catheter shaft from the outer catheter shaft.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises a flexible and adjustable stretchable tube mechanically connecting the first balloon to the second balloon so as to provide tension between the connected balloons whilst the inner catheter shaft is extended from the outer catheter shaft .
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises the balloons and shafts enclosed within a lumen.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises the balloons and shafts provided with a separate lumen.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the lumens are arranged coaxially.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is adapted to incrementally shorten the distance between the balloons when the balloons are in anchoring positions during a surgical procedure, thereby bringing the bladder neck and the urethral stump into contact with one another.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft comprises at least two telescopic parts adapted so that the shaft can be lengthened or shortened by adjustment of the telescopic parts.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft comprises at least two portions, at least one portion is screwable into the other, such that the length of the shaft can be adjusted.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is semi-collapsible and/or concertina -like, such that the length of the shaft can be adjusted.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is hollow along at least a portion of the length thereof.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft further comprises a pullable lanyard attached to the distal end of the shaft, the aforementioned lanyard running the length of the shaft, and the lanyard adapted to collapse, telescope or otherwise shorten the shaft in a predetermined manner when pulled by the surgeon.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the lanyard is provided with stoppers or notches for facilitating incremental shortening or lengthening of said shaft.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is provided with visualisation means.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises bladder drainage means.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises drug delivery means.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises bladder sound introduction means.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises electrical cauterizing means .
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises distance measuring means .
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein said shaft is provided with means for bending in a predetermined manner.
  • a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is provided with additional means for maintaining the patency of the join between the severed bladder neck and the severed urethral stump.
  • FIG. 1 is a schematic illustration of an embodiment of the invention.
  • FIG. 2 is a schematic illustration of an embodiment of the invention.
  • FIG. 3 is a schematic illustration of an embodiment of the invention.
  • FIG. 4 is a schematic illustration of an embodiment of the invention.
  • the following disclosure describes means and methods of joining the severed bladder neck to the urethral stump after a radical prostectomy in a manner convenient for the surgeon, so as to improve the outcomes of radical prostatectomy. It will be apparent from the following description that variations of the means and methods disclosed will be useful for connecting other generally tubular structures in humans and animals.
  • the core of the invention is the disclosure of a means for bringing and holding together, the bladder neck and the urethral stump after a radical prostetectomy, so that the bladder neck and the urethral stump form a join, without the necessity of suturing them together.
  • the embodiments of the invention are designed to hold together these elements for at least two weeks under appropriate and adjustable tension whilst the healing and urethral stump to bladder neck joining process takes place.
  • a flexible and adjustable catheter having a proximal portion and a distal portion is characterised by a distal balloon 120 and a proximal balloon 180 with an adjustable element of the catheter between them.
  • the catheter is made up of two catheter shafts, and an inner catheter shaft 100 and an outer catheter shaft 170, the inner catheter shaft being partially extendable from the outer catheter shaft to a predetermined fixable length.
  • the inner catheter shaft 100 is provided with a distal balloon portion 120 which, after introduction through the severed bladder neck, acts as the bladder anchoring balloon from within the bladder.
  • the aforementioned distal balloon 120 is inflatable and deflatable by a lumen, controlled by a proximally located one way valve 150.
  • the inner catheter shaft also comprises a lumen for urine flow from the bladder (distal opening of the lumen) 130 to the proximal drainage opening 140.
  • the inner catheter shaft is further characterized by a proximal portion and a distal portion fluidly connected by a flexible and adjustable and stretchable tube (see fig 3, 311). This tube 311 maintains the distance between the distal and proximal balloons under predetermined tensions.
  • the outer catheter shaft 117 partially encloses the inner catheter shaft 100.
  • the outer catheter shaft comprises an inflation / deflation lumen and a runway valve 110 for inflating and deflating the proximal balloon 180 which acts as the urethral retaining balloon. Both shafts are mechanically connected by a graduated locking mechanism 190, which in this example, includes (see fig 4) an inner catheter stopper 460 which is part of the inner catheter shaft 410 and 100, snugly enclosed by the stopper housing 490 which is part of the outer catheter shaft 470, 117. It can be seen that the inner catheter shaft can be incrementally withdrawn or inserted into the outer catheter shaft by mechanical adjustment such that the required length of notches 460 are exposed on the proximal side of the inner catheter shaft .
  • FIG. 2 schematically illustrating a preferred embodiment of the invention wherein the balloons are in a deflated state.
  • the inner catheter balloon 212 is deflated on the inner catheter shaft 210 towards its distal end.
  • the urinary inlet 230 is located at the distal end of the inner catheter shaft and the drainage funnel 240 is at the proximal end of the inner catheter shaft.
  • the urethral retaining balloon 280 is deflated on the outer catheter shaft 270.
  • the inflation and deflation of the balloon is controlled by the runway valve 280.
  • the cutaway diagram shows a portion of the catheter where a portion of the inner catheter shaft 310 is moveably housed within a portion of the outer catheter shaft 370.
  • the urethral retaining balloon 380 arises from the outer catheter shaft.
  • the flexible and adjustable and stretchable tube 311 connects the proximal portion of the inner catheter shaft with the distal portion of the inner catheter shaft.
  • Some embodiments of the invention comprise the following: A catheter comprising two inflatable balloons are assembled on a central shaft. The shaft is adapted to have a degree of elasticity that is adjustable during the coaptation or anastomosis procedure.
  • the first balloon is proximally located and the second balloon is distally located.
  • the distal balloon is introduced via the bladder neck in a deflated state into the bladder, whereupon it is inflated in the interior in the bladder neck to serve as an anchor.
  • the second inflatable balloon is placed proximal to the urinary sphincter also providing anchoring.
  • the at least two (2) balloons are assembled on a center shaft, and at least a part of the shaft has an elastic element with a degree of elasticity that can be regulated during the anastomosis procedure.
  • the inflatable balloons and shaft may be enclosed within a lumen.
  • lumens are provided for each balloon, and the shaft.
  • each balloon is provided with a seperate lumen.
  • the shaft has a separate lumen.
  • the lumens are arranged coaxially.
  • the lumens are arranged in a variety of geometries found to be useful.
  • the shaft comprises at least two parts which can be telescoped, and the shaft can be lengthened or shortened by adjusting the extent of the telescope.
  • the shaft is divided into at least two portions and at least two shaft parts can be screwed into each other, partially or completely.
  • the central shaft is semi-collapsible and/or concertina -like, and can be collapsed or expanded the distance required to bring together the bladder neck and the urethral stump.
  • the shaft is hollow, collapsible and semi rigid and provided with a lanyard attached to the bladder anchoring end of a portion of the hollow shaft.
  • the lanyard can be pulled through the hollow bore of the shaft, thereby collapsing or semi collapsing the shaft, thereby urging the bladder neck forward to meet the urethral stump.
  • the lanyard can be tugged and tied off.
  • the lanyard is provided with stoppers or notches which are used to incrementally bring the bladder -neck into contact with the urethral stump and maintain contact therewith until sufficient healing has taken place to effect a permanent anastomosis of the bladder neck with the urethral stump.
  • 'balloon or " balloon - like” herein refers to any inflatable member.
  • the balloons herein function as anchoring members, and it is of course envisaged that some embodiments of the invention will have, instead of a distal balloon(s), a distal anchoring member (s) which can take up at least two configurations, a first non extended or collapsed configuration for ease of introduction into the bladder neck and a second extended configuration for anchoring of the bladder neck from the interior of the bladder.
  • a proximal urinary sphincter anchoring member which can take up at least two configurations, a first non extended or collapsed configuration for ease of introduction through the urethra proximal to the urinary sphincter and a second extended configuration for anchoring the urethra from the urinary sphincter.
  • the aforementioned distal anchoring members will be umbrella-like.
  • patency of the join between said severed bladder neck and said severed urethral stump during the healing process is maintained by means of a stent or any other element known to a person skilled in the art.

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Abstract

An anastomosis catheter for joining a first and second severed tubular body element, comprising;(a)semi-rigid shaft characterized by an adjustable length having a distal end and a proximal end with; (b)a distal balloon positioned at said distal end of said shaft and configured for being inserted and at least partially inflated within a first severed body element; (c)a proximal balloon positioned at said proximal end of said shaft and configured for being inserted and inflated within a second severed body element; such that when said shaft is introduced between said body elements and said balloons are inflated within said body elements and said adjustable length portion is adjusted accordingly, said severed ends are maintained and held in contact with one another so that healing between said severed ends is promoted.

Description

ANASTOMOSIS DEVICE FOR JOINING A SEVERED BLADDER NECK TO THE SEVERED END OF A URETHRAL STUMP
FIELD OF THE INVENTION
The present invention is in the field of surgical apparatus and methods and is more specifically directed to apparatus and methods for effecting a radical prostatectomy which avoids the shortcomings of the prior known procedures for such operations. The invention is also intended for general use in tubular anastomosis.
BACKGROUND
Impotence frequently results from radical prostatectomy operations as a consequence of injury to the branches of the pelvic plexus that are necessary for sexual function. Additionally, incontinence is also a frequent occurrence resulting from prior known radical prostatectomy procedures. The occurrence of most cases of impotence and incontinence arises as a consequence of three factors inherent in present procedures. Firstly, the presently employed surgical procedures involved in the anastomosis of the distal urethra and the bladder neck results in trauma and injury to the nerves adjacent to the apex of the prostate and the urethra.Secondly, post-operative leakage results from the fact that the anastomosis is frequently not liquid-tight so that urine leaks outside the anastomosis, resulting in scarring and distortion of the bladder neck with possible encasement of the nerves. Thirdly, there are often obstructions from intra- lumenal bladder neck contracture.
The prior art procedures for effecting anastomosis require the surgeon to suture the urethra in a "blind" area beneath the symphysis pubis in which it is not possible to see the area being sutured. Consequently, imperfect anastomosis and nerve damage frequently result. Moreover, the prior known surgical procedures employed in the anastomosis suffer from the further shortcoming of being extremely time consuming and tedious, factors which decrease the surgeon's skill and the patent's stamina. The prostate remains the second most common cause of cancer death. Because the incidence of prostate cancer increases more rapidly with age than does any other cancer and because the life expectancy is increasing, the number of men with prostate cancer and the number of deaths from the disease are expected to rise. Most prostate cancers detected nowadays are clinically localized and likely to be cured. A major treatment alternative for these patients includes radical prostatectomy (RP), which is the complete surgical removal of the prostate gland along with its fascial coverings, requiring disconnection of the prostate from the urethra at the urogenital diaphragm and the urinary bladder at the bladder neck. To restore continuity of the urinary tract where the prostate has been removed, a new connection (anastomosis) of the bladder neck to the urethral stump must be accomplished. While the urethra-vesical anastamosis is generally technically challenging when surgeons use an open technique (open RP), it becomes even more difficult when applying the laparoscopic technique (laparoscopic radical prostatectomy LRP) with or without assistance of a robotic system (robotic assisted LRP) It is the attachment of the urethral stump to the bladder neck which is particularly difficult. This difficulty arises from several aspects, including the tendency of the urethral stump to retract proximally, as well as its delicate structure mandating placement of thin and accurate sutures to ascertain that sufficient urethral tissue is incorporated into the anastomosis without damaging the sphincteric mechanism. Further complicating this procedure is the fact that the urethral stump is located beneath the pubic bone thus requiring that the surgeon work at a difficult angle and in positions that are uncomfortable and limiting compared to open RP, laparoscopic surgeons face a 2 -dimensional screen further hindering their ability to place the urethral structures accurately.
A major impediment of radical prostatectomy remains its postoperative sequel related to the urethro-vesical anastomosis, which if not properly performed can lead to both urinary incontinence and outflow obstruction secondary to stricture at the anastomosis site.
Thus there remains a long felt need for the present invention relating to the reconnection of the urethra and bladder after a radical retropubic prostatectomy, specifically a method and device for performing an urethro-vesicle anastomosis. US patent 4,873,977 to Avant et al offers a stapling method and apparatus for attaching the bladder neck to the urethral stump after radical prostatectomy. The method includes a locking means to hold the bladder/urethra in in place whilst conventional suturing is carried out. US Patent application US2007/0219584 Al of Copa et al. proposes a sutureless method of contacting the opposite sides of a bladder wall and a perineal floor one balloon in the bladder and the other below the perineal floor at a spacing that maintains contact between the severed bladder neck tissue and the urethral stump. This method has disadvantages since the perineal floor is not very moveable, distant form the bladder, making it difficult for the surgeon to match the severed end of the urethral stump accurately to the severed bladder neck. There therefore remains a long felt and unmet need for means and methods of joining the severed bladder neck to the urethral stump in a manner convenient to the surgeon. Moreover, there remains a general long felt and unmet need for suture free means and methods of joining the severed ends of two tubular biological structures.
SUMMARY OF THE INVENTION
An aspect of the invention provides an anastomosis catheter for joining together first and second severed tubular body elements. The aforementioned said catheter comprises a semi-rigid shaft having a distal end and a proximal end, wherein at least a portion of the semi-rigid shaft has a length that is adjustable ;a distal balloon positioned at the distal end of the shaft and configured for being inserted and at least partially inflated within a first severed body element ;a proximal balloon positioned at the proximal end of the aforementioned shaft and configured for being inserted and at least partially inflated within a second severed body element such that when the shaft is introduced between the body elements and the balloons are inflated within the body elements and the adjustable length portion is adjusted accordingly, the severed ends are maintained and held in contact with one another so that healing between the severed ends is promoted over a period of time .
A further aspect of the invention provides the aforementioned anastomosis catheter for joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient. The aforementioned catheter comprises; a flexible and adjustable semi rigid shaft for inserting into the bladder of a patient via the urethra, so as to provide a connection between the bladder and urethra, the aforementioned shaft having a distal end and a proximal end; a first balloon positioned at the distal end of the shaft, for introducing and at least partially inflating within the bladder, so as to effectively anchor said bladder, a second balloon positioned at the proximal end of the shaft, for introducing and at least partially inflating in the urethral stump so as to effectively anchor the urethral stump; such that when the shaft is introduced between the severed ends, and the balloons are introduced and at least partially inflated within the severed ends, and the shaft is
3 «51 IRSTITUTE SHEET (RULE 26) adjusted accordingly in length, the severed ends are thereby pressed, held and maintained in contact with one another for a sufficient period such that healing takes place.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the semi-rigid shaft includes an inner catheter shaft and an outer catheter shaft, the inner catheter shaft coupled to the first balloon for facilitating anchoring of the first balloon within the bladder an outer catheter shaft coupled to the second balloon for facilitating anchoring of the second balloon proximal to the urinary sphincter, wherein the inner catheter shaft is at least partially housed within the outer catheter shaft and is extendable and withdrawable from the outer catheter shaft;
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising a graduated locking mechanism connecting the inner catheter shaft to the outer catheter shaft for incrementally adjusting the extension of the inner catheter shaft from the outer catheter shaft.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the aforementioned catheeter further comprises a flexible and adjustable stretchable tube mechanically connecting the first balloon to the second balloon so as to provide tension between the connected balloons whilst the inner catheter shaft is extended from the outer catheter shaft .
A further aspect of the invention provides the aforementioned anastomosis catheter whereinthe balloons and shafts are enclosed within a lumen.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein each of the balloons and shafts is provided with a separate lumen.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the lumens are arranged coaxially.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is adapted to incrementally shorten the distance between the balloons when the balloons are in anchoring positions during a surgical procedure, thereby bringing the bladder neck and the urethral stump into contact with one another.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft comprises at least two telescopic parts adapted so that the shaft can be lengthened or shortened by adjustment of the telescopic parts. A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft comprises at least two portions, at least one of the portions is screwable into the other, such that the length of the shaft can be adjusted.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is semi-collapsible and/or concertina -like, such that the length of said shaft can be adjusted.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein wherein the shaft is hollow along at least a portion of the length thereof.
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising a pullable lanyard attached to the distal end of the shaft, the lanyard running the length of the shaft, and the lanyard adapted to collapse, telescope or otherwise shorten the shaft in a predetermined manner when pulled by the surgeon.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the lanyard is provided with stoppers or notches for facilitating incremental shortening or lengthening of the shaft.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is provided with visualisation means.
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising bladder drainage means.
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising drug delivery means.
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising bladder sound introduction means .
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising electrical cauterizing means .
A further aspect of the invention provides the aforementioned anastomosis catheter further comprising distance measuring means .
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is provided with means for bending in a predetermined manner.
A further aspect of the invention provides the aforementioned anastomosis catheter wherein the shaft is provided with additional means for maintaining the patency of the join between the severed bladder neck and the severed urethral stump.
A further aspect of the invention discloses a method of joining together a first and second severed tubular body element, wherein the method comprises steps of; a. obtaining an anastomosis catheter, the aforementioned catheter comprising; i. a semi-rigid shaft having a distal end and a proximal end, wherein at least a portion of the semi-rigid shaft has a length that is adjustable; ii. a distal balloon positioned at the distal end of the shaft and configured for being inserted and at least partially inflated within a first severed body element iii. a proximal balloon positioned at said proximal end of said shaft and configured for being inserted and at least partially inflated within a second severed body element ; b. introducing the shaft between the body elements c. inflating the balloons within the body elements and d. adjusting length of the shaft adjustable length portion thereby maintaining and holding the severed ends in contact with one another so that healing between the severed ends is promoted over a period of time .
A further aspect of the invention discloses a method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the method comprises steps of obtaining an anastomosis catheter, the catheter comprising; a flexible and adjustable semi rigid shaft for inserting into the bladder of a patient via the urethra, so as to provide a connection between said bladder and urethra, the aforementioned shaft having a distal end and a proximal end; a first balloon positioned at the distal end of the shaft, for introducing and at least partially inflating within the bladder, so as to effectively anchor the bladder, a second balloon positioned at the proximal end of the shaft, for introducing and at least partially inflating in the urethral stump so as to effectively anchor the urethral stump introducing the shaft is between the severed ends; introducing the balloons within the severed ends partially inflating balloons within the severed ends and adjusting length of the shaft thereby pressing holding and maintaining the severed ends in contact with one another for a sufficient period such that healing takes place. A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the semi-rigid shaft includes an inner catheter shaft and an outer catheter shaft, the inner catheter shaft coupled to the first balloon for facilitating anchoring of the first balloon within the bladder and an outer catheter shaft coupled to the second balloon for facilitating anchoring of the second balloon proximal to the urinary sphincter, wherein the inner catheter shaft is at least partially housed within the outer catheter shaft and is extendable and withdrawable from the outer catheter shaft
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises a graduated locking mechanism connecting the inner catheter shaft to the outer catheter shaft for incrementally adjusting the extension of the inner catheter shaft from the outer catheter shaft.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises a flexible and adjustable stretchable tube mechanically connecting the first balloon to the second balloon so as to provide tension between the connected balloons whilst the inner catheter shaft is extended from the outer catheter shaft .
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises the balloons and shafts enclosed within a lumen.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises the balloons and shafts provided with a separate lumen.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the lumens are arranged coaxially.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is adapted to incrementally shorten the distance between the balloons when the balloons are in anchoring positions during a surgical procedure, thereby bringing the bladder neck and the urethral stump into contact with one another.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft comprises at least two telescopic parts adapted so that the shaft can be lengthened or shortened by adjustment of the telescopic parts. A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft comprises at least two portions, at least one portion is screwable into the other, such that the length of the shaft can be adjusted.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is semi-collapsible and/or concertina -like, such that the length of the shaft can be adjusted.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is hollow along at least a portion of the length thereof.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft further comprises a pullable lanyard attached to the distal end of the shaft, the aforementioned lanyard running the length of the shaft, and the lanyard adapted to collapse, telescope or otherwise shorten the shaft in a predetermined manner when pulled by the surgeon.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the lanyard is provided with stoppers or notches for facilitating incremental shortening or lengthening of said shaft.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is provided with visualisation means.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises bladder drainage means.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises drug delivery means.
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises bladder sound introduction means. A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises electrical cauterizing means .
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the catheter further comprises distance measuring means .
A further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein said shaft is provided with means for bending in a predetermined manner.
Lastly, a further aspect of the invention discloses the above mentioned method of joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, wherein the shaft is provided with additional means for maintaining the patency of the join between the severed bladder neck and the severed urethral stump.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic illustration of an embodiment of the invention. FIG. 2 is a schematic illustration of an embodiment of the invention. FIG. 3 is a schematic illustration of an embodiment of the invention. FIG. 4 is a schematic illustration of an embodiment of the invention.
DETAILED DESCRIPTION OF THE DRAWINGS
The most common technique employed for wound closure during surgical operations is that of stitching using either nylon or other plastic thread or stainless steel wire where greater strength is required. Stitching is often complicated by the need to tie knots which must be reliable and not slip, and this frequently prolongs the time taken to complete an operation, thereby adding to the stress and trauma imparted upon the patient. Furthermore, it is sometimes necessary to apply a certain tension between body parts being connected together, which is difficult to achieve when conventional stitching methods are relied upon, whereby substantial skill is required on the part of the surgeon.
The following disclosure describes means and methods of joining the severed bladder neck to the urethral stump after a radical prostectomy in a manner convenient for the surgeon, so as to improve the outcomes of radical prostatectomy. It will be apparent from the following description that variations of the means and methods disclosed will be useful for connecting other generally tubular structures in humans and animals.
Embodiments of the invention are described herein. The core of the invention is the disclosure of a means for bringing and holding together, the bladder neck and the urethral stump after a radical prostetectomy, so that the bladder neck and the urethral stump form a join, without the necessity of suturing them together. The embodiments of the invention are designed to hold together these elements for at least two weeks under appropriate and adjustable tension whilst the healing and urethral stump to bladder neck joining process takes place.
Reference is now made to fig. 1 which schematically illustrates a preferred embodiment of the invention as described herein: A flexible and adjustable catheter having a proximal portion and a distal portion is characterised by a distal balloon 120 and a proximal balloon 180 with an adjustable element of the catheter between them. The catheter is made up of two catheter shafts, and an inner catheter shaft 100 and an outer catheter shaft 170, the inner catheter shaft being partially extendable from the outer catheter shaft to a predetermined fixable length. The inner catheter shaft 100 is provided with a distal balloon portion 120 which, after introduction through the severed bladder neck, acts as the bladder anchoring balloon from within the bladder. The aforementioned distal balloon 120 is inflatable and deflatable by a lumen, controlled by a proximally located one way valve 150. The inner catheter shaft also comprises a lumen for urine flow from the bladder (distal opening of the lumen) 130 to the proximal drainage opening 140. The inner catheter shaft is further characterized by a proximal portion and a distal portion fluidly connected by a flexible and adjustable and stretchable tube (see fig 3, 311). This tube 311 maintains the distance between the distal and proximal balloons under predetermined tensions. The outer catheter shaft 117 partially encloses the inner catheter shaft 100. The outer catheter shaft comprises an inflation / deflation lumen and a runway valve 110 for inflating and deflating the proximal balloon 180 which acts as the urethral retaining balloon. Both shafts are mechanically connected by a graduated locking mechanism 190, which in this example, includes (see fig 4) an inner catheter stopper 460 which is part of the inner catheter shaft 410 and 100, snugly enclosed by the stopper housing 490 which is part of the outer catheter shaft 470, 117. It can be seen that the inner catheter shaft can be incrementally withdrawn or inserted into the outer catheter shaft by mechanical adjustment such that the required length of notches 460 are exposed on the proximal side of the inner catheter shaft .
Reference is now made to fig. 2 schematically illustrating a preferred embodiment of the invention wherein the balloons are in a deflated state. The inner catheter balloon 212 is deflated on the inner catheter shaft 210 towards its distal end.The urinary inlet 230 is located at the distal end of the inner catheter shaft and the drainage funnel 240 is at the proximal end of the inner catheter shaft. The urethral retaining balloon 280 is deflated on the outer catheter shaft 270. The inflation and deflation of the balloon is controlled by the runway valve 280.
Reference is now made to fig. 3 schematically illustrating a preferred embodiment of the invention. The cutaway diagram shows a portion of the catheter where a portion of the inner catheter shaft 310 is moveably housed within a portion of the outer catheter shaft 370. The urethral retaining balloon 380 arises from the outer catheter shaft. The flexible and adjustable and stretchable tube 311 connects the proximal portion of the inner catheter shaft with the distal portion of the inner catheter shaft. When the inner catheter shaft is extended from the outer catheter shaft, the individual stops of the inner catheter stopper are drawn through the snugly fitting yet elastically resilient proximal opening. When the bladder anchoring balloon and the urethral retaining balloon are both inflated, the proximal part of the catheter is anchored to the proximal side of the urethral sphincter and the distal part of the catheter is anchored from within the bladder, the flexible and adjustable and stretchable tube is under tension. In this manner the severed bladder neck and the severed urethral stump can be brought together and fixed in place during the healing process, such that a succesful anastomosis can ensue without the use of sutures. Some embodiments of the invention comprise the following: A catheter comprising two inflatable balloons are assembled on a central shaft. The shaft is adapted to have a degree of elasticity that is adjustable during the coaptation or anastomosis procedure.
The first balloon is proximally located and the second balloon is distally located. The distal balloon is introduced via the bladder neck in a deflated state into the bladder, whereupon it is inflated in the interior in the bladder neck to serve as an anchor. The second inflatable balloon is placed proximal to the urinary sphincter also providing anchoring.
11 SUBSTITUTE SHEET (RULE 26\ The at least two (2) balloons are assembled on a center shaft, and at least a part of the shaft has an elastic element with a degree of elasticity that can be regulated during the anastomosis procedure. The inflatable balloons and shaft may be enclosed within a lumen. In some embodiments of the invention lumens are provided for each balloon, and the shaft. In other embodiments of the invention each balloon is provided with a seperate lumen. In other embodiments of the invention the shaft has a separate lumen. In some embodiments of the invention the lumens are arranged coaxially. In other embodiments of the invention the lumens are arranged in a variety of geometries found to be useful.
The axial distance between the balloons can be adjusted during the procedure, thereby causing the bladder neck to be brought forward to meet the urethral stump in this limb to limb procedure. In some embodiments of the invention, the shaft comprises at least two parts which can be telescoped, and the shaft can be lengthened or shortened by adjusting the extent of the telescope. In some embodiments the shaft is divided into at least two portions and at least two shaft parts can be screwed into each other, partially or completely. In still other embodiments the central shaft is semi-collapsible and/or concertina -like, and can be collapsed or expanded the distance required to bring together the bladder neck and the urethral stump. In other embodiments the shaft is hollow, collapsible and semi rigid and provided with a lanyard attached to the bladder anchoring end of a portion of the hollow shaft. The lanyard can be pulled through the hollow bore of the shaft, thereby collapsing or semi collapsing the shaft, thereby urging the bladder neck forward to meet the urethral stump. When the bladder neck has met the urethral stump, the lanyard can be tugged and tied off. In some embodiments of the invention the lanyard is provided with stoppers or notches which are used to incrementally bring the bladder -neck into contact with the urethral stump and maintain contact therewith until sufficient healing has taken place to effect a permanent anastomosis of the bladder neck with the urethral stump. The term 'balloon" or " balloon - like" herein refers to any inflatable member. The balloons herein function as anchoring members, and it is of course envisaged that some embodiments of the invention will have, instead of a distal balloon(s), a distal anchoring member (s) which can take up at least two configurations, a first non extended or collapsed configuration for ease of introduction into the bladder neck and a second extended configuration for anchoring of the bladder neck from the interior of the bladder. Likewise, it is of course envisaged that some embodiments of the invention will have, instead of a proximal balloon (s), a proximal urinary sphincter anchoring member which can take up at least two configurations, a first non extended or collapsed configuration for ease of introduction through the urethra proximal to the urinary sphincter and a second extended configuration for anchoring the urethra from the urinary sphincter. In some embodiments of the invention, the aforementioned distal anchoring members will be umbrella-like. In some embodiments of the invention, patency of the join between said severed bladder neck and said severed urethral stump during the healing process is maintained by means of a stent or any other element known to a person skilled in the art.
13 SUBSTITUTE SHEET (RULE ?*>

Claims

1. An anastomosis catheter for joining together a first and second severed tubular body element, said catheter comprising;
(a) a semi-rigid shaft having a distal end and a proximal end, wherein at least a portion of said semi-rigid shaft has a length that is adjustable;
(b) a distal balloon positioned at said distal end of said shaft and configured for being inserted and at least partially inflated within a first severed body element;
(c) a proximal balloon positioned at said proximal end of said shaft and configured for being inserted and at least partially inflated within a second severed body element; such that when said shaft is introduced between said body elements and said balloons are inflated within said body elements and said adjustable length portion is adjusted accordingly, said severed ends are maintained and held in contact with one another so that healing between said severed ends is promoted over a period of time.
2. An anastomosis catheter for joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, the catheter comprising; a. a flexible and adjustable semi rigid shaft for inserting into the bladder of a patient via the urethra, so as to provide a connection between said bladder and urethra, said shaft having a distal end and a proximal end; b. a first balloon 120 positioned at said distal end of said shaft, for introducing and at least partially inflating within said bladder, so as to effectively anchor said bladder; c. a second balloon 180 positioned at said proximal end of said shaft, for introducing and at least partially inflating in said urethral stump so as to effectively anchor said urethral stump; such that when said shaft is introduced between said severed ends, and said balloons are introduced and at least partially inflated within said severed ends, and said shaft is adjusted accordingly in length, said severed ends are thereby pressed, held and maintained in contact with one another for a sufficient period such that healing takes place.
14 SUBSTiTUTE SHEET (RULE 26\
3. The catheter according to claim 2, wherein said semi-rigid shaft includes an inner catheter shaft 100 and an outer catheter shaft 170, said inner catheter shaft coupled to said first balloon for facilitating anchoring of said said first balloon within said bladder; a. an outer catheter shaft coupled to said second balloon for facilitating anchoring of said said second balloon proximal to the urinary sphincter, wherein said inner catheter shaft is at least partially housed within said outer catheter shaft and is extendable and withdrawable from said outer catheter shaft;
4. The catheter of claim 3, further comprising a graduated locking mechanism 190 connecting said inner catheter shaft to said outer catheter shaft for incrementally adjusting said extension of said inner catheter shaft from said outer catheter shaft.
5. The catheter of claim 3, further comprising a flexible and adjustable stretchable tube 311 mechanically connecting said first balloon to said second balloon so as to provide tension between said connected balloons whilst said inner catheter shaft is extended from said outer catheter shaft.
6. The catheter of claim 3, wherein said balloons and shafts are enclosed within a lumen.
7. The catheter of claim 3, wherein each of said balloons and shafts is provided with a separate lumen.
8. The catheter of claim 7, wherein said lumens are arranged coaxially.
9. catheter of claim 2, wherein said shaft is adapted to incrementally shorten the distance between said balloons when said balloons are in anchoring positions during a surgical procedure, thereby bringing said bladder neck and said urethral stump into contact with one another.
10. The catheter of claim 2, wherein said shaft comprises at least two telescopic parts adapted so that said shaft can be lengthened or shortened by adjustment of said telescopic parts.
11. The catheter of claim 2, wherein said shaft comprises at least two portions at least one which is portions screwable into the other, such that the length of said shaft can be adjusted.
12. The catheter of claim 2, wherein said shaft is semi-collapsible and/or concertina -like, such that said length of said shaft can be adjusted.
13. The catheter of claim 2, wherein said shaft is hollow along at least a portion of the length thereof.
14. The catheter of claim 2, further comprising a pullable lanyard attached to said distal end of said shaft, said lanyard running the length of said shaft, and said lanyard adapted to collapse ,telescope or otherwise shorten said shaft in a predetermined manner when pulled by the surgeon.
15. The catheter of claim 14, wherein said lanyard is provided with stoppers or notches for facilitating incremental shortening or lengthening of said shaft.
16. The catheter of claim 2, wherein said shaft is provided with visualisation means.
17. The catheter of claim 2, further comprising bladder drainage means.
18. The catheter of claim 2, further comprising drug delivery means.
19. The catheter of claim 2, further comprising bladder sound introduction means.
20. The catheter of claim 2, further comprising electrical cauterizing means.
21. The catheter of claim 2, further comprising distance measuring means.
22. The catheter of claim 2, wherein said shaft is provided with means for bending in a predetermined manner.
23. The catheter of claim 2, wherein said shaft is provided with additional means for maintaining the patency of the join between said severed bladder neck and said severed urethral stump.
24. A method of joining together a first and second tubular body element, wherein said method comprises steps of; a. obtaining an anastomosis catheter said catheter comprising; i. a semi-rigid shaft having a distal end and a proximal end, wherein at least a portion of said semi-rigid shaft has a length that is adjustable; ii. a distal balloon positioned at said distal end of said shaft and configured for being inserted and at least partially inflated within a first severed body element; iii. a proximal balloon positioned at said proximal end of said shaft and configured for being inserted and at least partially inflated within a second severed body element; b. introducing said shaft between said body elements; c. inflating said balloons within said body elements and; d. adjusting length length of said shaft adjustable length portion thereby maintaining and holding said severed ends in contact with one another so that healing between said severed ends is promoted over a period of time.
25. A method for joining the severed end of a bladder-neck of a patient to the severed end of the urethral stump of a patient, said method comprising steps of; a. obtaining an anastomosis catheter, said catheter comprising; i. a flexible and adjustable semi rigid shaft for inserting into the bladder of a patient via the urethra, so as to provide a connection between said bladder and urethra, said shaft having a distal end and a proximal end; ii. a first balloon 120 positioned at said distal end of said shaft, for introducing and at least partially inflating within said bladder, so as to effectively anchor said bladder; iii. a second balloon 180 positioned at said proximal end of said shaft, for introducing and at least partially inflating in said urethral stump so as to effectively anchor said urethral stump; b. introducing said shaft is between said severed ends; c. introducing said balloons within said severed ends; d. partially inflating balloons within said severed ends and; e. adjusting length of said shaft thereby pressing holding and maintaining said severed ends in contact with one another for a sufficient period such that healing takes place.
26. The method according to claim 25, wherein said semi-rigid shaft includes an inner catheter shaft 100 and an outer catheter shaft 170, said inner catheter shaft coupled to said first balloon for facilitating anchoring of said said first balloon within said bladder and an outer catheter shaft coupled to said second balloon for facilitating anchoring of said said second balloon proximal to the
17 SuSSTiTUTE SHEET (RULE 26 * urinary sphincter, wherein said inner catheter shaft is at least partially housed within said outer catheter shaft and is extendable and withdrawable from said outer catheter shaft.
27. The method according to claim 25 wherein said catheter further comprises a graduated locking mechanism 190 connecting said inner catheter shaft to said outer catheter shaft for incrementally adjusting said extension of said inner catheter shaft from said outer catheter shaft.
28. The method according to claim 25 wherein said catheter further comprises a flexible and adjustable stretchable tube 311 mechanically connecting said first balloon to said second balloon so as to provide tension between said connected balloons whilst said inner catheter shaft is extended from said outer catheter shaft.
29. The method according to claim 25 wherein said catheter further comprises said balloons and shafts enclosed within a lumen.
30. The method according to claim 25 wherein said catheter further comprises said balloons and shafts provided with a separate lumen.
31. The method according to claim 25 wherein said said lumens are arranged coaxially.
32. The method according to claim 25 wherein said shaft is adapted to incrementally shorten the distance between said balloons when said balloons are in anchoring positions during a surgical procedure, thereby bringing said bladder neck and said urethral stump into contact with one another.
33. The method according to claim 25 wherein said shaft comprises at least two telescopic parts adapted so that said shaft can be lengthened or shortened by adjustment of said telescopic parts.
34. The method according to claim 25 wherein said shaft comprises at least two portions at least one which is portions screwable into the other, such that the length of said shaft can be adjusted.
35. The method according to claim 25 wherein said shaft is semi-collapsible and/or concertina -like, such that said length of said shaft can be adjusted.
36. The method according to claim 25 wherein said shaft is hollow along at least a portion of the length thereof.
37. The method according to claim 25 wherein said shaft, further comprises a pullable lanyard attached to said distal end of said shaft, said lanyard running
18 SUBSTITUTE SHEET (RULE 26^ the length of said shaft, and said lanyard adapted to collapse ,telescope or otherwise shorten said shaft in a predetermined manner when pulled by the surgeon.
38. The method according to claim 25 wherein said lanyard is provided with stoppers or notches for facilitating incremental shortening or lengthening of said shaft.
39. The method according to claim 25 wherein said shaft is provided with visualisation means.
40. The method according to claim 25 wherein said catheter further comprises bladder drainage means.
41. The method according to claim 25 wherein said catheter, further comprises drug delivery means.
42. The method according to claim 25 wherein said catheter further comprises bladder sound introduction means.
43. The method according to claim 25 wherein said catheter of claim 2, further comprises electrical cauterizing means.
44. The method according to claim 25, further comprising distance measuring means.
45. The method according to claim 25, wherein said shaft is provided with means for bending in a predetermined manner.
46. The method according to claim 25, wherein said shaft is provided with additional means for maintaining the patency of the join between said severed bladder neck and said severed urethral stump.
PCT/IL2010/000006 2009-01-06 2010-01-05 Anastomosis device for joining a severed bladder neck to the severed end of a urethral stump Ceased WO2010079480A1 (en)

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