SE2150095A1 - A kit and method intended for prostate surgery - Google Patents

A kit and method intended for prostate surgery

Info

Publication number
SE2150095A1
SE2150095A1 SE2150095A SE2150095A SE2150095A1 SE 2150095 A1 SE2150095 A1 SE 2150095A1 SE 2150095 A SE2150095 A SE 2150095A SE 2150095 A SE2150095 A SE 2150095A SE 2150095 A1 SE2150095 A1 SE 2150095A1
Authority
SE
Sweden
Prior art keywords
prostate
adrenaline
catheter
unit
balloon
Prior art date
Application number
SE2150095A
Other versions
SE544983C2 (en
Inventor
Anette Israelsson
Johan Wennerholm
Sonny Schelin
Thomas Falk
Original Assignee
Prostalund Ab
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 Prostalund Ab filed Critical Prostalund Ab
Priority to SE2150095A priority Critical patent/SE544983C2/en
Priority to CN202121598419.3U priority patent/CN215875920U/en
Priority to EP22746350.2A priority patent/EP4284481A1/en
Priority to PCT/SE2022/050080 priority patent/WO2022164369A1/en
Publication of SE2150095A1 publication Critical patent/SE2150095A1/en
Publication of SE544983C2 publication Critical patent/SE544983C2/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • A61M25/10182Injector syringes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/1204Type of occlusion temporary occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/12136Balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00238Type of minimally invasive operation
    • A61B2017/00274Prostate operation, e.g. prostatectomy, turp, bhp treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00547Prostate

Abstract

The present invention describes a method for performing a prostate surgical treatment, said method comprising:- arranging a catheter 1 inside of a urethra of a patient and anchored against the bladder neck of the patient subsequent to the filling of the balloon stopper unit 5 with a fluid when the balloon stopper unit 5 is arranged inside of the bladder of a patient;said method also comprising- injecting at least one anesthetic agent and adrenaline or injecting botulinum toxin (Botox) and/or penicillin to the prostate via the injection tube 9 and the hollow tip 10 at an intended position of the prostate.Moreover, the present invention also refers to a kit comprising a catheter 1 according to the present invention and one or more syringe(s) 1000 containing adrenaline and at least one anesthetic agent and/or at least a syringe 1000 or vial containing botulinum toxin (Botox) and/or penicillin.

Description

A KIT AND METHOD INTENDED FOR PROSTATE SURGERY Field of the invention The present invention relates to a kit and method intended for prostatesurgery or treatment.Technical background There are several known catheters suitable for prostate surgery andtreatments. For instance, in WOO1/49195 there is disclosed a device fortreatment of the prostate, comprising a catheter for treatment which isinserted through the urethra, wherein the catheter is provided with a frontportion that comprises an expandable container for positioning of the catheterwith said front portion in the urinary bladder, wherein at least one hollow tip isprovided to be extended from the catheter into the prostate tissue surroundingcatheter and wherein the tip is connected with a syringe for supply of anastringent and analgesic medicine.
The present invention provides an improved kit intended for prostatesurgery and prostate treatment. Furthermore, the present invention is alsodirected to providing a novel and improved method in which said kit is used.Both these and several additional embodiments are disclosed and furtherexplained below.
Summary of the invention The present invention refers to a kit comprising- a catheter comprising - an introduction unit with a top, said introduction unit also comprising adrainage lumen hole for drainage of a urinary bladder; - a balloon stopper unit in connection with and thus possible to fill via aballoon inflation connection and balloon filling tube arranged inside of theintroduction unit, wherein filling of the balloon stopper unit with a fluid isintended when the balloon stopper unit is arranged inside of the bladder of apatient to provide for a stopper function of the balloon stopper unit against thebladder neck of the patient;said catheter also comprising 2- an injection connection connected to an injection tube arranged inside of the introduction unit, which injection tube extends in a hollow tip arranged to be provided to extend from the introduction unit; - a drainage outlet;said kit also comprising- at least one or more syringe(s) connectable to the injection connection of thecatheter and containing adrenaline and at least one anesthetic agent,and/or- at least a syringe or vial containing botulinum toxin (Botox) and/or penicillin.
The present invention differs in relation to device disclosed inWOO1/49195 in relation to improvements of the catheter as such and the kitprovided according to the present invention. Furthermore, the methodaccording to the present invention is further disclosed below and differs fromthe suggested handling of the catheter according to WOO1/49195 in severalways. As an example, the method according to the present invention providesan improved method for suppressing both blood flow to the prostate, which isof interest to eliminate or at least diminish cooling down of the prostate duringe.g. a heat treatment thereof, and also blood supply to the prostate, which inturn is of interest to minimize the blood coming out at the surface of theprostate during a trimming action in a transurethral resection of the prostate(TURP) surgery.
Such differences and further embodiments according to the presentinvention will become clear from reviewing the full description below.
Specific embodiments Below several embodiments of the present invention are provided andexplained further.
According to one embodiment of the present invention, a multi-connection unit is arranged at an end of the catheter, said end being oppositeto the top of the introduction unit, said multi-connection unit being arranged tohold the balloon inflation connection, the injection connection and at least afirst portion of the drainage outlet. One embodiment of such a multi-connection unit is shown in the attached figures. Furthermore, a multi-connection as provided according to the present invention has the advantage 3of providing a simple and user-friendly arrangement which may hold all units of the catheter in place. This also simplifies when connecting a syringeaccording to the present invention to the catheter. l\/loreover, according to yet another embodiment of the presentinvention, one or more of the balloon inflation connection, the injectionconnection and the drainage outlet are arranged with one or more valve(s).One such alternative is shown for the balloon inflation connection in fig. 2.
Furthermore, according to yet another embodiment of the presentinvention, the hollow tip arranged to be provided to extend from theintroduction unit has a length in the range of 30 - 60 mm, preferably 40 - 50mm, extending from the introduction unit. This length is suitable whenintroducing the hollow tip into the prostate. ln relation to the above it should be mentioned that the injection tubeand hollow tip may be provided as one single unit, thus the hollow tip is thefinal part of the injection tube which is possible to extend from the introductionunit and thus possible to introduce into the prostate. Furthermore, accordingto one embodiment of the present invention the hollow tip arranged to beprovided to extend from the introduction unit is arranged to extend from theintroduction unit with an angle in the range of 20 - 40°from the introductionunit. This angle is suitable angle for introducing the hollow tip into theprostate. l\/loreover, according to yet another embodiment of the presentinvention, the injection tube and hollow tip are made of PEEK (polyether etherketone). Again, suitably the injection tube and hollow tip are provided as onesingle unit, and where the hollow tip is only the final part of that single unit.Furthermore, in relation to material choices, another aspect of the presentinvention may be discussed further. To be able to locate the position of thehollow tip may be important when performing a prostate surgery method,such as a method according to the present invention described below. As thecatheter is arranged inside of the urethra when the hollow tip is about to beintroduced into the prostate, to enable this is not an obvious task. A materialpossible to see when using assisting technologies, such as ultrasound, CTetc., during surgery may be of interest according to the present invention. At 4the same time, the material of the hollow tip and injection tube may be suitable for introducing into the prostate. PEEK is one such suitable material.Furthermore, the injection tube may be reinforced, such as by use of a steelmaterial. l\/loreover, the locating of the hollow tip may be enabled by othermeans, such as e.g. by the use of nanoparticles.
According to one embodiment of the present invention, the injectiontube has a stopper so that the injection tube cannot be pulled out from theintroduction unit entirely, preferably wherein the injection tube has a stopperand wherein there is a distance marking provided outside of the injectiontube. These features simplify the using as well as helps a user to calculatethe position of the injection tube and hollos tip. This simplifies for the user toensure that the hollow tip is introduced into the prostate at the intended place. l\/loreover, according to yet another embodiment, the introduction unitis made of a rubber or plastic material, preferably wherein the introductionunit is provided with a marking in its lower portion. Such a type of material,neither too stiff not too flexible, e.g. made of a silicone material, ensures thatthe user can understand the position of the catheter inside of the urethra andalso eliminates the risk of the catheter being twisted inside of the urethra.Therefore, this marking may be said to show if the catheter is held in placeinside of the urethra and not twisted. l\/loreover, and as mentioned, thedistance marking of the injection tube provides assistance for the user toknow the position of the injection tube and thus hollow tip before introducingthe same into the prostate. ln relation to the above it may be mentioned that a lubricant, such asvaseline, may be used to ensure that the catheter is simple to insert into theurethra and simple to pull back and forth inside of the urethra, both to find theright position and also as part of the method according to the presentinvention, which is further explained below. Also the use of a lubricant may beseen as means to increase the correct locating of the catheter and hollow tipbefore inserting /introducing the hollow tip into the prostate. Based on theabove, according to one embodiment of the present invention, the kit alsocomprises a lubricant, such as vaseline. Furthermore, it should be noted thatat least the introduction unit of the catheter according to the present invention 5may also be produced in or coated by a sliding material so that the catheter is simple to insert into the urethra.
The present invention also refers to a method for performing a prostatesurgical treatment, said method comprising:- arranging a catheter comprising - an introduction unit with a top, said introduction unit also comprising adrainage lumen hole for drainage of a urinary bladder; - a balloon stopper unit in connection with and thus possible to fill via aballoon inflation connection and balloon filling tube arranged inside of theintroduction unit, wherein filling of the balloon stopper unit with a fluid isintended when the balloon stopper unit is arranged inside of the bladder of apatient to provide for a stopper function of the balloon stopper unit against thebladder neck of the patient;said catheter also comprising - an injection connection connected to an injection tubearranged inside of the introduction unit, which injection tube extends in ahollow tip arranged to be provided to extend from the introduction unit; - a drainage outlet;inside of a urethra of a patient and anchored against the bladder neck of thepatient subsequent to the filling of the balloon stopper unit with a fluid whenthe balloon stopper unit is arranged inside of the bladder of a patient;said method also comprising- injecting at least one anesthetic agent and adrenaline or injecting botulinumtoxin (Botox) and/or penicillin to the prostate via the injection tube and thehollow tip at an intended position of the prostate.
According to this first general embodiment of the present invention, thisinvolves arranging the catheter into the urethra and injecting at least oneanesthetic agent and adrenaline or injecting botulinum toxin (Botox) and/orpenicillin to the prostate via the injection tube and the hollow tip at anintended position of the prostate. First of all, the catheter in introduced intothe urethra. The balloon stopper unit is filed with a fluid, suitably sterile water,so that the stopper unit starts working as an anchor holding the catheter inplace. The drainage lumen hole is used for drainage of the urinary bladder. 6Then, a movement back and forth is suggested to ensure that the catheter is securely positioned in the right place in the urethra. As hintedabove, to simplify this, a lubricant, such as vaseline, may be used, or theintroduction unit may have a s|iding / slippery surface.
Finally, when the catheter is held in place, then the hollow tip isinserted into the prostate at the intended position. One important aspectaccording to the present invention is to ensure the correct locating of thehollow tip before inserting the same into the prostate. This is obtained by asuitable handling, and e.g. assisting means, such as a lubricant, and mayalso be accomplished by use of ultrasound or CT, and also by providing thehollow tip in a material simply to see when using such technology or by usenanoparticles inside the hollow tip so that these are visible after insertion intothe prostate.
Furthermore, adrenaline is used to provide several actions. First of all,it is used to eliminate or at least diminish cooling down of the prostate duringe.g. a heat treatment thereof. Secondly, adrenaline also ensures to suppressthe blood supply to the prostate, which in turn is of interest to minimize theblood coming out at the surface of the prostate during a trimming action in atransurethral resection of the prostate (TURP) surgery. So, independently onthe intended surgery used, adrenaline has an aided function. Adrenalineensures less perioperative bleeding and total blood loss according to thepresent invention. Fact is that by injecting adrenaline before a TURP surgery,perioperative bleeding may be decreased substantially. The kit and methodaccording to the present invention form the basis of injecting adrenaline at theright position(s) into the prostate before surgery thereof, which is yet a furtherimprovement in relation to procedures used today. l\/loreover, a suitableanesthetic agent to be used together with adrenaline is carbocaine(mepivacaine). This is a preferred combination to be used according to thepresent invention.
Furthermore, the kit according to the present invention may alsocomprise other additives. One example is at least one cytostatic agent.
The catheter according to the present invention ensures the possibilityof injecting at least one anesthetic agent and adrenaline or injecting botulinum 7toxin (Botox) and/or penicillin to the prostate via the injection tube and the hollow tip at an intended position of the prostate. Furthermore, as the injectiontube and hollow tip is made in one piece and of a suitable (stiff but flexible)material, e.g. PEEK, this provides for the ability to remove the hollow tip fromone site of the prostate to insert it at another site of the prostate in asubsequent step. This is described further below. Furthermore, in relation tothe material of the injection tube, this should be stiff enough but still flexible,without deforming when being bended.
As mentioned above, there are different procedures used whentreating prostates today. Both transurethral resection of the prostate (TURP)surgery and thermal treatments are being used frequently. The embodimentsmentioned below are suitable to be used in such procedures. According toone embodiment of the present invention, the method involves injecting atleast one anesthetic agent to the prostate via the hollow tip and injectingadrenaline to the prostate via the hollow tip during at least a first phase of themethod, wherein at least the injecting of adrenaline to the prostate isperformed sequentially. This embodiment implies using multiple injections ofthe adrenaline. This enables to trim part of the prostate into which partadrenaline has been injected, and then trim another part of the prostate afteran additional injection of adrenaline into that part of the prostate. This furtherimplies that the catheter being used is inserted and pulled out from theurethra before the trimming action and then inserted again when injecting asecond dose of adrenaline, and so on. Both the anesthetic agent andadrenaline may be injected at the same time in these multiple injections.
With reference to a thermal treatment, the multiple injections ofadrenaline and anesthetic agent is also of interest. Again, by decreasing theblood supply and cooling effect thereof, the thermal treatment effect isincreased according to the present invention. lt may be mentioned that thissequential mode may be obtained by using yet another catheter intended forthe thermal treatment or may be obtained by including such functions (heatingelements) in a catheter according to the present invention. Possible heatingelements may operate based on different technologies, such as e.g. microwaves. 8The procedure according to the present invention is beneficial as the effect of adrenaline decreases after injection into the prostate. The effect iskept at a high level during at least 10 minutes, and up to 15 minutes, but thendecreases. Therefore, it is beneficial to inject adrenaline into one volume andthen trim this part and then inject adrenaline again at another part and thentrim that part. As such, the bleeding may be suppressed, which is beneficialwhen performing trimming of or heat treatment to the prostate. ln relation to aheat treatment it is beneficial to anesthetize the entire prostate as the heattreatment is performed on a large part of the surface, said heat treatmentbeing evenly distributed extending out from the urethra.
Furthermore, with reference to changing the injection position of theprostate, according to one embodiment of the present invention, the methodinvolves changing the position of the hollow tip in the prostate to enable for atleast injection of adrenaline at different positions in the prostate, preferably forinjection of at least one anesthetic agent, such as carbocaine, and adrenalineat different positions in the prostate. Suitably, adrenaline and carbocaine isadmixed in the syringes being used.
According to yet another embodiment of the present invention, linkedto a TURP treatment, the method involves injecting both at least oneanesthetic agent and adrenaline to one first half of the prostate, thenremoving the catheter from the patient and performing trimming of that firsthalf of the prostate in a transurethral resection of the prostate surgicaltreatment, then inserting the catheter again into the patient and injecting bothat least one anesthetic agent and adrenaline to the second half of theprostate, then removing the catheter from the patient again and performingtrimming of that second half of the prostate.
As an example, first a left side of the prostate in injected with a mixtureof adrenaline and carbocaine. Then the catheter is removed from the urethraand trimming is performed on the left side of the prostate. The blood supply isdiminished by use of the adrenaline and carbocaine so that the TURPtrimming is possible to perform with strong visibility and in a safe way. Thenthe catheter is inserted again, and injection is performed on the right side of 9the prostate. The catheter is removed again, and trimming is performed on the right side of the prostate. ln relation to performing a therma| treatment of a prostate, according toone embodiment of the present invention, the method involves injecting bothat least one anesthetic agent and adrenaline to one part of the prostate, thensupplying heat to the surface of the prostate at a corresponding position tothat part of the prostate, then injecting both at least one anesthetic agent andadrenaline to another part of the prostate and then supplying heat to thesurface of the prostate at a corresponding position to that other part of theprostate, optionally by removing the catheter from the patient after theinjecting of at least one anesthetic agent and adrenaline and inserting anothercatheter for enabling the supplying of heat via one or more heating elements.According to this embodiment, another catheter is used for enabling thesupplying of heat via one or more heating elements. According to the presentinvention, the catheter according to the present invention may include suchfunctionality, i.e. also having heating elements intended for supplying heat toa prostate surface.
As mentioned above, the time frames used are relevant with referenceto the effect of adrenaline. As a consequence, according to one embodimentof the present invention, the method involves a sequence of injecting both atleast one anesthetic agent and adrenaline to a volume of the prostate andthen performing trimming in a transurethral resection of the prostate (TURP)surgical treatment or a heat treatment of a corresponding surface of theprostate within a time frame of maximum 25 minutes, preferably maximum 20minutes, more preferably maximum 15 minutes, and then performing yetanother similar sequence to another volume of the prostate. l\/loreover, as hinted above, the prostate may be divided into differentsections to ensure an efficient and safe treatment. Therefore, according toone embodiment of the present invention, the method involves injecting atleast adrenaline, preferably both at least one anesthetic agent, such ascarbocaine, and adrenaline, sequentially to different parts of the prostate,preferably to at least two different positions of the prostate, more preferably tofour different squares of the prostate.
Furthermore, also locating the hollow tip to ensure an intended position for the injection into the prostate is of relevance according to the presentinvention. Therefore, according to one embodiment of the present invention,the method involves means for locating the hollow tip. According to onespecific embodiment, said means for locating is an external means, preferablyan ultrasound device or a CT (computed tomography) device, or internalmeans to be injected through the hollow tip, preferably nanoparticles. As anexample, robotic CT technology may be used, such as together with a roboticarm. l\/loreover, as mentioned above, also a lubricant, such as vaseline, maybe used to ensure that the catheter is simple to pull back and forth inside ofthe urethra, both to find the right position and also to simplify for removal andinsertion of a catheter according to the present invention. Therefore, also theuse of a lubricant may be seen as means to increase the correct locating ofthe catheter and hollow tip before inserting /introducing the hollow tip into theprostate.
Furthermore, the method according to the present invention may alsoinvolve using complementing additives. ln line with this, according to oneembodiment of the present invention, the method also involves injecting oneor more cytostatic agents to the prostate. Cytostatic agents may as such beused as an aid for the treatment of prostate cancer. l\/loreover, the method according to the present invention may also beused in combination with the injection of botulinum toxin (Botox) and/orpenicillin. Therefore, according to one embodiment of the present invention,the method involves injecting botulinum toxin (Botox) and/or penicillin to theprostate, preferably injecting botulinum toxin (Botox) and/or penicillin to alower part of the prostate. According to one embodiment, injecting botulinumtoxin (Botox) and/or penicillin to the prostate is performed as a treatment ofprostatitis. Botox is then used according to the present invention to kill nervesin the prostate, and as a treatment of prostatitis. Penicillin may also be usedas a treatment or prevention of prostatitis. 11lt should also be noted that the kit according to the present invention may include a separate syringe containing botulinum toxin (Botox) and/orpenicillin.
Description of the drawings ln fig. 1 there is disclosed a kit according to one embodiment of thepresent invention. The kit comprises a catheter 1 comprising an introductionunit 2 with a top 3, said introduction unit 2 also comprising a drainage lumenhole 4 for drainage of a urinary bladder. l\/loreover, the catheter 1 alsocomprises a balloon stopper unit 5 in connection with and thus possible to fillvia a balloon inflation connection 6 and balloon filling tube arranged inside ofthe introduction unit 2. The filling of the balloon stopper unit 5 with a fluid isintended when the balloon stopper unit 5 is arranged inside of the bladder ofa patient to provide for a stopper function of the balloon stopper unit 5 againstthe bladder neck of the patient. The catheter 1 also comprises an injectionconnection 8 connected to an injection tube 9 arranged inside of theintroduction unit 2, which injection tube 9 extends in a hollow tip 10 arrangedto be provided to extend from the introduction unit 2 and into the prostate of apatient. The catheter 1 also comprises a drainage outlet 11. l\/loreover,according to this embodiment, the catheter1 has a multi-connection unit 12which holds the balloon inflation connection 6, the injection connection 8 andat least a first portion of the drainage outlet 11.Furthermore, the kit also comprises at least one or more syringe(s)1000 connectable to the injection connection 8 of the catheter 1 andcontaining adrenaline and at least one anesthetic agent, and/or at least asyringe 1000 or vial containing botulinum toxin (Botox) and/or penicillin.ln fig. 2 there is disclosed a part shown of the catheter 1 according to the embodiment of a kit according to the embodiment shown in fig. 1.

Claims (21)

Claims
1. A kit comprising- a catheter (1) comprising - an introduction unit (2) with a top (3), said introduction unit (2) alsocomprising a drainage lumen hole (4) for drainage of a urinary bladder; - a balloon stopper unit (5) in connection with and thus possible to fillvia a balloon inflation connection (6) and balloon filling tube arranged inside ofthe introduction unit (2), wherein filling of the balloon stopper unit (5) with afluid is intended when the balloon stopper unit (5) is arranged inside of thebladder of a patient to provide for a stopper function of the balloon stopperunit (5) against the bladder neck of the patient;said catheter (1) also comprising - an injection connection (8) connected to an injection tube (9)arranged inside of the introduction unit (2), which injection tube (9) extends ina hollow tip (10) arranged to be provided to extend from the introduction unit(2): - a drainage outlet (11);said kit also comprising- at least one or more syringe(s) (1000) connectable to the injectionconnection (8) of the catheter (1) and containing adrenaline and at least oneanesthetic agent,and/or- at least a syringe (1000) or vial containing botulinum toxin (Botox) and/or penicillin.
2. The kit according to claim 1, wherein a multi-connection unit (12) isarranged at an end of the catheter (1 ), said end being opposite to the top (3)of the introduction unit (2), said multi-connection unit (12) being arranged tohold the balloon inflation connection (6), the injection connection (8) and atleast a first portion of the drainage outlet (11).
3. 133. The kit according to claim 1 or 2, wherein one or more of the balloon inflation connection (6), the injection connection (8) and the drainage outlet(11) are arranged with one or more valve(s).
4. The kit according to any of claims 1-3, wherein the ho||ow tip (10) arrangedto be provided to extend from the introduction unit (2) has a length in therange of 30 - 60 mm, preferably 40 - 50 mm, extending from the introductionunit (2).
5. The kit according to any of claims 1-4, wherein the ho||ow tip (10) arrangedto be provided to extend from the introduction unit (2) is arranged to extendfrom the introduction unit (2) with an angle in the range of 20 - 40°from theintroduction unit (2).
6. The kit according to any of claims 1-5, wherein the injection tube (9) andho||ow tip (10) are made of PEEK (poiyether ether ketone).
7. The kit according to any of claims 1-6, wherein the injection tube (9) has astopper so that the injection tube (9) cannot be pulled out from theintroduction unit (2) entirely, preferably wherein the injection tube (9) has astopper and wherein there is a distance marking provided outside of the injection tube (9).
8. The kit according to any of claims 1-7, wherein the introduction unit (2) ismade of a rubber or plastic material, preferably wherein the introduction unit (2) is provided with a marking in its lower portion.
9. The kit according to any of claims 1-8, wherein the kit also comprises a lubncant
10. A method for performing a prostate surgical treatment, said methodcomprising: - arranging a catheter (1) comprising 14- an introduction unit (2) with a top (3), said introduction unit (2) also comprising a drainage lumen hole (4) for drainage of a urinary bladder; - a balloon stopper unit (5) in connection with and thus possible to fillvia a balloon inflation connection (6) and balloon filling tube arranged inside ofthe introduction unit (2), wherein filling of the balloon stopper unit (5) with afluid is intended when the balloon stopper unit (5) is arranged inside of thebladder of a patient to provide for a stopper function of the balloon stopperunit (5) against the bladder neck of the patient;said catheter (1) also comprising - an injection connection (8) connected to an injection tube (9)arranged inside of the introduction unit (2), which injection tube (9) extends ina hollow tip (10) arranged to be provided to extend from the introduction unit(2): - a drainage outlet (11);inside of a urethra of a patient and anchored against the bladder neck of thepatient subsequent to the filling of the balloon stopper unit (5) with a fluidwhen the balloon stopper unit (5) is arranged inside of the bladder of apatient;said method also comprising- injecting at least one anesthetic agent and adrenaline or injecting botulinumtoxin (Botox) and/or penicillin to the prostate via the injection tube (9) and the hollow tip (10) at an intended position of the prostate.
11. The method according to claim 10, wherein the method involves injectingat least one anesthetic agent to the prostate via the hollow tip (10) andinjecting adrenaline to the prostate via the hollow tip (10) during at least a firstphase of the method, wherein at least the injecting of adrenaline to the prostate is performed sequentially.
12. The method according to claim 10 or 11, wherein the method involveschanging the position of the hollow tip (10) in the prostate to enable for atleast injection of adrenaline at different positions in the prostate, preferably for injection of at least one anesthetic agent and adrenaline at different positions in the prostate.
13. The method according to any of claims 10-12, wherein the methodinvolves injecting both at least one anesthetic agent and adrenaline to onefirst half of the prostate, then removing the catheter (1) from the patient andperforming trimming of that first half of the prostate in a transurethralresection of the prostate (TURP) surgical treatment, then inserting thecatheter (1) again into the patient and injecting both at least one anestheticagent and adrenaline to the second half of the prostate, then removing thecatheter (1) from the patient again and performing trimming of that secondhalf of the prostate.
14. The method according to any of claims 10-12, wherein the methodinvolves injecting both at least one anesthetic agent and adrenaline to onepart of the prostate, then supplying heat to the surface of the prostate at acorresponding position to that part of the prostate, then injecting both at leastone anesthetic agent and adrenaline to another part of the prostate and thensupplying heat to the surface of the prostate at a corresponding position tothat other part of the prostate, optionally by removing the catheter (1) from thepatient after the injecting of at least one anesthetic agent and adrenaline andinserting another catheter for enabling the supplying of heat via one or moreheating elements.
15. The method according to claim 13 or 14, wherein the method involves asequence of injecting both at least one anesthetic agent and adrenaline to avolume of the prostate and then performing trimming in a transurethralresection of the prostate (TURP) surgical treatment or a heat treatment of acorresponding surface of the prostate within a time frame of maximum 25minutes, preferably maximum 20 minutes, more preferably maximum 15minutes, and then performing yet another similar sequence to another volume of the prostate.
16. 16. The method according to any of claims 11-15, wherein the method involves injecting at least adrenaline, preferably both at least one anestheticagent and adrenaline, sequentially to different parts of the prostate, preferablyto at least two different positions of the prostate, more preferably to four different squares of the prostate.
17. The method according to any of claims 10-16, wherein the method involves means for locating the ho||ow tip (10).
18. The method according to c|aim 17, wherein said means for locating is anexternal means, preferably an ultrasound device or a CT (computedtomography) device, or internal means to be injected through the ho||ow tip (10), preferably nanoparticles.
19. The method according to any of claims 10-18, wherein the method also involves injecting one or more cytostatic agents to the prostate.
20. The method according to c|aim 10, 17 or 18, wherein the method involvesinjecting botulinum toxin (Botox) and/or penicillin to the prostate, preferablyinjecting botulinum toxin (Botox) and/or penicillin to a lower part of the prostate.
21. The method according to c|aim 20, wherein injecting botulinum toxin(Botox) and/or penicillin to the prostate is performed as a treatment of prostatitis.
SE2150095A 2021-01-28 2021-01-28 A kit for prostate surgery comprising a catheter, adrenaline and either of botox or penicillin SE544983C2 (en)

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SE2150095A SE544983C2 (en) 2021-01-28 2021-01-28 A kit for prostate surgery comprising a catheter, adrenaline and either of botox or penicillin
CN202121598419.3U CN215875920U (en) 2021-01-28 2021-07-14 Kit intended for prostate surgery
EP22746350.2A EP4284481A1 (en) 2021-01-28 2022-01-27 A kit and method intended for prostate surgery
PCT/SE2022/050080 WO2022164369A1 (en) 2021-01-28 2022-01-27 A kit and method intended for prostate surgery

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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5843016A (en) * 1996-03-18 1998-12-01 Physion S.R.L. Electromotive drug administration for treatment of acute urinary outflow obstruction
WO2001098764A2 (en) * 2000-06-20 2001-12-27 Celsion Corporation System and method for heating the prostate gland using microwaves
US6477426B1 (en) * 2000-06-20 2002-11-05 Celsion Corporation System and method for heating the prostate gland to treat and prevent the growth and spread of prostate tumors
US6524270B1 (en) * 1999-12-23 2003-02-25 Prostalund Operations Ab Method and device for the treatment of prostate tissue
US20050124852A1 (en) * 2003-08-29 2005-06-09 Magnus Bolmsjo Method and device for the treatment of incontinence
US20100198139A1 (en) * 2007-05-01 2010-08-05 Scott Glickman Catheter
US20190076188A1 (en) * 2012-10-29 2019-03-14 Ablative Solutions, Inc. Peri-vascular tissue ablation catheters

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5843016A (en) * 1996-03-18 1998-12-01 Physion S.R.L. Electromotive drug administration for treatment of acute urinary outflow obstruction
US6524270B1 (en) * 1999-12-23 2003-02-25 Prostalund Operations Ab Method and device for the treatment of prostate tissue
WO2001098764A2 (en) * 2000-06-20 2001-12-27 Celsion Corporation System and method for heating the prostate gland using microwaves
US6477426B1 (en) * 2000-06-20 2002-11-05 Celsion Corporation System and method for heating the prostate gland to treat and prevent the growth and spread of prostate tumors
US20050124852A1 (en) * 2003-08-29 2005-06-09 Magnus Bolmsjo Method and device for the treatment of incontinence
US20100198139A1 (en) * 2007-05-01 2010-08-05 Scott Glickman Catheter
US20190076188A1 (en) * 2012-10-29 2019-03-14 Ablative Solutions, Inc. Peri-vascular tissue ablation catheters

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