Patent Application
20230338705
The present invention relates to a kit and method intended for prostate surgery or treatment.
There are several known catheters suitable for prostate surgery and treatments. For instance, in WO01/49195 there is disclosed a device for treatment of the prostate, comprising a catheter for treatment which is inserted through the urethra, wherein the catheter is provided with a front portion that comprises an expandable container for positioning of the catheter with said front portion in the urinary bladder, wherein at least one hollow tip is provided to be extended from the catheter into the prostate tissue surrounding catheter and wherein the tip is connected with a syringe for supply of an astringent and analgesic medicine.
The present invention provides an improved method and kit intended for prostate surgery and prostate treatment. Both these and several additional embodiments are disclosed and further explained below.
The present invention refers to a method for performing a prostate surgical or medical treatment, said method comprising:
The present invention differs in relation to the device disclosed in WO01/49195 in relation to improvements of the catheter linked to the needle used, and further also to both the method presented and the kit provided according to the present invention. A key aspect of the present invention relates to the fact that the has at least one outflow opening being provided in a radial direction from the needle, preferably at least two opposite outflow openings being provided in a radial direction from the needle.
There are several advantages with a needle according to the present invention. First of all, a perforated needle according to the present invention is not cutting into the tissue. The sharp needle is penetrating, and the tissue is only displaced and not cut, and that part of the tissue is folded back when the needle is taken out from the tissue again. Secondly, and as a consequence, by using a needle according to the present invention, bleeding in the tissue is minimized or avoided. Moreover, a needle according to the present invention minimizes the risk for intravascular injection as compared with a standard cutting needle.
Further advantages of the needle and method according to the present invention are mentioned and discussed below.
Furthermore, also embodiments of the method according to the present invention are further disclosed below and differ from the suggested handling of the catheter according to WO01/49195 in several ways. As an example, the method according to the present invention provides an improved method for suppressing both blood flow to the prostate, which is of interest to eliminate or at least diminish cooling down of the prostate during e.g. a heat treatment thereof, and also blood supply to the prostate, which in turn is of interest to minimize the blood coming out at the surface of the prostate during a trimming action in a transurethral resection of the prostate (TURP) surgery.
Such differences and further embodiments according to the present invention will become clear from reviewing the full description below.
Below several embodiments of the present invention are provided and explained further.
According to one embodiment of the present invention, the needle has at least two outflow openings being provided in radial directions from the needle. Double side holes provides an increased diffusion volume around the needle without the need for displacement of the needle in depth. This is a benefit when injecting the prostate with an anesthetic agent and e.g. adrenaline.
In relation to different agents, it should be noted that not only the agents above may be used according to the present invention. In line with the above, according to one embodiment, the method involves injecting at least one anesthetic agent and at least one antibiotic agent, preferably also adrenaline. Furthermore, according to yet another embodiment, the method involves injecting at least one anesthetic agent and adrenaline, preferably also at least one of an antibiotic agent, botulinum toxin, at least one corticosteroid or at least one anti-inflammatory agent, or a combination thereof.
Furthermore, when using drugs, such as potentially toxic drugs, e.g. anesthetic agent(s) or botulinum toxin, then to ensure where this is administered is of great relevance. As this also may be linked to the efficiency of a treatment method according to the present invention, to ensure a correct positioning of the hollow tip of the injection tube into the prostate is of great relevance.
Moreover, as said the method according to the present invention may also be used in combination with the injection of botulinum toxin and/or antibiotic agents, such as penicillin. Therefore, according to one embodiment of the present invention, the method involves injecting botulinum toxin and/or an antibiotic agent to the prostate, preferably injecting botulinum toxin and/or an antibiotic agent to a lower part of the prostate. According to one embodiment, injecting botulinum toxin and/or antibiotic agent to the prostate is performed as a treatment of prostatitis. Botulinum toxin may then be used according to the present invention to kill nerves in the prostate, and as a treatment of prostatitis. Antibiotic agents, such as penicillin may also be used as a treatment or prevention of prostatitis.
According to yet another embodiment of the present invention, said at least two outflow openings are provided on opposite sides of the needle. This also supports an efficient diffusion volume around the needle. Moreover, it should be noted that also several outflow openings are possible according to the present invention.
Below there is presented a possible handling of a kit, catheter and needle according to the present invention. First of all, the catheter is introduced into the 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 in place. The drainage lumen hole is used for drainage of the urinary bladder.
Then, a movement back and forth is suggested to ensure that the catheter is securely positioned in the right place in the urethra. As hinted above, to simplify this, a lubricant, such as vaseline, may be used, or the introduction unit may have a sliding/slippery surface.
Finally, when the catheter is held in place, then the needle is inserted into the prostate at the intended position. One important aspect according to the present invention is to ensure the correct locating of the needle before inserting the same into the prostate. This is obtained by a suitable handling, and e.g. assisting means, such as a lubricant, and may also be accomplished by use of ultrasound or CT, and also by providing the needle in a material simply to see when using such technology or by use nanoparticles inside the needle so that these are visible after insertion into the prostate.
Furthermore, adrenaline is suitably used to provide several actions. First of all, it is used to eliminate or at least diminish cooling down of the prostate during e.g. a heat treatment thereof. Secondly, adrenaline also ensures to suppress the blood supply to the prostate, which in turn is of interest to minimize the blood coming out at the surface of the prostate during a trimming action in a transurethral resection of the prostate (TURP) surgery. So, independently on the intended surgery used, adrenaline has an aided function. Adrenaline ensures less perioperative bleeding and total blood loss according to the present invention. Fact is that by injecting adrenaline before a TURP surgery, perioperative bleeding may be decreased substantially. The kit and method according to the present invention form the basis of injecting adrenaline at the right position(s) into the prostate before surgery thereof, which is yet a further improvement in relation to procedures used today. Moreover, a suitable anesthetic agent to be used together with adrenaline is carbocaine (mepivacaine). This is a preferred combination to be used according to the present invention. Furthermore, the kit according to the present invention may also comprise other additives. One example is at least one cytostatic agent or botulinum toxin (Botox).
According to one embodiment of the present invention, the method involves injecting at least one anesthetic agent and adrenaline. This is of importance when transurethral resection of the prostate (TURP) surgery is intended. It should be noted that there are other methods which may utilize the kit according to the present invention. The kit and method according to the present invention may be used for several types of minimal invasive treatments. Examples of minimal invasive treatments in this field are for example Rezum, UroLift®, iTind and GreenLight™ Laser Therapy. For minimal invasive treatments for the prostate, then an anesthetic agent is needed. Fact is that the kit and method according to the present invention are of interest when performing any form of sterile anesthesia, especially to a prostate. The kit according to the present invention may also be used for injection of cytotoxins, botulinum toxin (Botox) or any form of slow release compound.
In relation to using the kit according to the present invention for prostate treatment, the needle according to the present invention has several advantages. First of all, the needle ensures an efficient anesthesia throughout the base area of the prostate regardless of prostate size. Secondly, and as mentioned, bleeding is suppressed. Moreover, and as hinted above, anesthesia can be provided by using said at least one anesthetic agent, and also with and without adrenaline.
As mentioned above, there are different procedures used when treating prostates today. Both transurethral resection of the prostate (TURP) surgery and thermal treatments are being used frequently. The embodiments mentioned below are suitable to be used in such procedures. According to one embodiment of the present invention, the method involves injecting at least one anesthetic agent to the prostate via the needle and injecting adrenaline to the prostate via the needle during at least a first phase of the method, wherein at least the injecting of adrenaline to the prostate is performed sequentially. This embodiment implies using multiple injections of the adrenaline. This enables to trim part of the prostate into which part adrenaline has been injected, and then trim another part of the prostate after an additional injection of adrenaline into that part of the prostate. This further implies that the catheter being used is inserted and pulled out from the urethra before the trimming action and then inserted again when injecting a second dose of adrenaline, and so on. Both the anesthetic agent and adrenaline may be injected at the same time in these multiple injections.
For instance, according to one embodiment of the present invention, the method involves changing the position of the needle in the prostate to enable for injection of at least one anesthetic agent and adrenaline at different positions in the prostate.
With reference to a thermal treatment, the multiple injections of adrenaline and anesthetic agent is also of interest. Again, by decreasing the blood supply and cooling effect thereof, the thermal treatment effect is increased according to the present invention. It may be mentioned that this sequential mode may be obtained by using yet another catheter intended for the thermal treatment or may be obtained by including such functions (heating elements) in a catheter according to the present invention. Possible heating elements may operate based on different technologies, such as e.g. microwaves.
The procedure according to the present invention is beneficial as the effect of adrenaline decreases after injection into the prostate. The effect is kept at a high level during at least 10 minutes, and up to 15 minutes, but then decreases. Therefore, it is beneficial to inject adrenaline into one volume and then trim this part and then inject adrenaline again at another part and then trim that part. As such, the bleeding may be suppressed, which is beneficial when performing trimming of or heat treatment to the prostate. In relation to a heat treatment it is beneficial to anesthetize the entire prostate as the heat treatment is performed on a large part of the surface, said heat treatment being evenly distributed extending out from the urethra.
Furthermore, with reference to changing the injection position of the prostate, according to one embodiment of the present invention, the method involves changing the position of the needle in the prostate to enable for at least injection of adrenaline at different positions in the prostate, preferably for injection of at least one anesthetic agent, such as carbocaine, and adrenaline at different positions in the prostate. Suitably, adrenaline and carbocaine is admixed in the syringes being used.
According to yet another embodiment of the present invention, linked to a TURP treatment, the method involves injecting both at least one anesthetic agent and adrenaline to one first half of the prostate, then removing the catheter from the patient and performing trimming of that first half of the prostate in a transurethral resection of the prostate surgical treatment, then inserting the catheter again into the patient and injecting both at least one anesthetic agent and adrenaline to the second half of the prostate, then removing the catheter from the patient again and performing trimming of that second half of the prostate.
As an example, first a left side of the prostate in injected with a mixture of adrenaline and carbocaine. Then the catheter is removed from the urethra and trimming is performed on the left side of the prostate. The blood supply is diminished by use of the adrenaline and carbocaine so that the TURP trimming is possible to perform with strong visibility and in a safe way. Then the catheter is inserted again, and injection is performed on the right side of the prostate. The catheter is removed again, and trimming is performed on the right side of the prostate.
In relation to performing a thermal treatment of a prostate, according to one embodiment of the present invention, the method involves injecting both at least one anesthetic agent and adrenaline to one part of the prostate, then supplying heat to the surface of the prostate at a corresponding position to that part of the prostate, then injecting both at least one anesthetic agent and adrenaline to another part of the prostate and then supplying heat to the surface of the prostate at a corresponding position to that other part of the prostate, optionally by removing the catheter from the patient after the injecting of at least one anesthetic agent and adrenaline and inserting another catheter for enabling the supplying of heat via one or more heating elements. According to this embodiment, another catheter is used for enabling the supplying of heat via one or more heating elements. According to the present invention, the catheter according to the present invention may include such functionality, i.e. also having heating elements intended for supplying heat to a prostate surface.
As mentioned above, the time frames used are relevant with reference to the effect of adrenaline. As a consequence, according to one embodiment of the present invention, the method involves a sequence of injecting both at least one anesthetic agent and adrenaline to a volume of the prostate and then performing trimming in a transurethral resection of the prostate (TURP) surgical treatment or a heat treatment of a corresponding surface of the prostate within a time frame of maximum 25 minutes, preferably maximum 20 minutes, more preferably maximum 15 minutes, and then performing yet another similar sequence to another volume of the prostate.
Moreover, as hinted above, the prostate may be divided into different sections to ensure an efficient and safe treatment. Therefore, according to one embodiment of the present invention, the method involves injecting at least adrenaline, preferably both at least one anesthetic agent, such as carbocaine, and adrenaline, sequentially to different parts of the prostate, preferably to at least two different positions of the prostate, more preferably to four different squares of the prostate.
Moreover, as the injection tube and needle is made in one piece and of a suitable (stiff but flexible) material, e.g. PEEK, this provides for the ability to remove the needle from one site of the prostate to insert it at another site of the prostate in a subsequent step. This is described further below. Furthermore, in relation to the material of the injection tube, this should be stiff enough but still flexible, without deforming when being bended.
Furthermore, also locating the needle to ensure an intended position for the injection into the prostate is of relevance according to the present invention. Therefore, according to one embodiment of the present invention, the method involves means for locating a tip of the needle. According to one specific embodiment, said means for locating is an external means, preferably an ultrasound device or a CT (computed tomography) device, or internal means to be injected through the needle, preferably nanoparticles. As an example, robotic CT technology may be used, such as together with a robotic arm.
Moreover, as mentioned above, also a lubricant, such as vaseline, may be used to ensure that the catheter is simple to pull back and forth inside of the urethra, both to find the right position and also to simplify for removal and insertion of a catheter according to the present invention. Therefore, also the use of a lubricant may be seen as means to increase the correct locating of the catheter and needle before inserting/introducing the needle into the prostate.
Furthermore, the method according to the present invention may also involve using complementing additives. In line with this, according to one embodiment of the present invention, the method also involves injecting adrenaline and/or one or more cytostatic agents to the prostate. Cytostatic agents may as such be used as an aid for the treatment of prostate cancer.
The present invention also provides a kit comprising
As mentioned above, according to one embodiment of the present invention, the needle has at least two outflow openings being provided in radial directions from the needle. Furthermore, according to yet another embodiment, said at least two outflow openings are provided on opposite sides of the needle.
In relation to a kit according to the present invention, it may be mentioned that this kit may include several flasks or vials containing different agents which may be used in one or more connectable syringes. In line with this, according to one embodiment, the kit according to the present invention comprises also one or more vials or flasks containing at least one of the following: an anesthetic agent, adrenaline, an antibiotic agent, botulinum toxin, a corticosteroid, an anti-inflammatory agent, or a combination thereof, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter, preferably several vials or flasks of which there is contained a combination of an anesthetic agent, adrenaline, an antibiotic agent, botulinum toxin, a corticosteroid, an anti-inflammatory agent, or a combination thereof. It should be noted that all combinations of the agents mentioned above are possible according to the present invention. Suitably, these agents are provided in different vials or flasks which content may then be filled into the syringe. Therefore, according to one embodiment of the present invention, the kit comprises at least individual flasks or vials for at least one anesthetic agent, adrenaline, and at least one antibiotic agent, which are intended to be contained in said at least one or more syringe(s) connectable to the injection connection of the catheter.
As should be clear from above, according to one embodiment, said at least one or more syringe(s) connectable to the injection connection of the catheter also contains adrenaline. Also in this case the adrenaline may be provided in an individual flask or vial in the kit according to the present invention.
Furthermore, according to one embodiment of the present invention, a multi-connection unit is arranged at an end of the catheter, said end being opposite to the top of the introduction unit, said multi-connection unit being arranged to hold the balloon inflation connection, the injection connection and at least a first 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 of providing a simple and user-friendly arrangement which may hold all units of the catheter in place. This also simplifies when connecting a syringe according to the present invention to the catheter.
Furthermore, and as may be seen in
Moreover, according to yet another embodiment of the present invention, one or more of the balloon inflation connection, the injection connection and the drainage outlet are arranged with one or more valve(s). One such alternative is shown for the balloon inflation connection in
Furthermore, according to yet another embodiment of the present invention, the needle arranged to be provided to extend from the introduction unit has a length in the range of 30-60 mm, preferably 40-50 mm, extending from the introduction unit. This length is suitable when introducing the needle into the prostate.
In relation to the above it should be mentioned that the injection tube and needle may be provided as one single unit, thus the needle is the final part of the injection tube which is possible to extend from the introduction unit and thus possible to introduce into the prostate. Furthermore, according to one embodiment of the present invention the needle arranged to be provided to extend from the introduction unit is arranged to extend from the introduction unit with an angle in the range of 20-40° from the introduction unit. This angle is suitable angle for introducing the needle into the prostate.
Moreover, according to yet another embodiment of the present invention, the injection tube and needle are made of PEEK (polyether ether ketone). Again, suitably the injection tube and needle are provided as one single unit, and where the needle is only the final part of that single unit. Furthermore, in relation to material choices, another aspect of the present invention may be discussed further. To be able to locate the position of the needle may be important when performing a prostate surgery method, such as a method according to the present invention described below. As the catheter is arranged inside of the urethra when the needle is about to be introduced into the prostate, to enable this is not an obvious task. A material possible to see when using assisting technologies, such as ultrasound, CT etc., during surgery may be of interest according to the present invention. At the same time, the material of the needle 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 steel material.
According to one embodiment, then the injection tube, suitably made of a PEEK material, is complemented with a metal wire or a reflector on at least on a top of the injection tube. Furthermore, according to another embodiment of the present invention the injection tube is alloyed. To complement with a metal material and/or a reflector on a top of the injection tube, such as part of the needle, implies that this part and its position may clearly been seen/located when using x-ray or transrectal ultra-sound or the like. This is of relevance to ensure that the injection tube is inserted into the prostate at the right and intended place. Based on the above, according to yet another embodiment, at least part of the injection tube, preferably the needle, is alloyed and/or is complemented with a metal wire.
Furthermore, when using drugs, such as potentially toxic drugs, e.g. anesthetic agent(s) or e.g. botulinum toxin (Botox), then to ensure where this is administered is of even greater relevance. As this also may be linked to the efficiency of a treatment method according to the present invention, to ensure a correct positioning of the needle of the injection tube into the prostate is of great relevance.
Moreover, the locating of the needle may be enabled by other means, such as e.g. by the use of nanoparticles.
According to one embodiment of the present invention, the injection tube has a stopper so that the injection tube cannot be pulled out from the introduction unit entirely, preferably wherein the injection tube has a stopper and wherein there is a distance marking provided outside of the injection tube. These features simplify the using as well as helps a user to calculate the position of the injection tube and hollos tip. This simplifies for the user to ensure that the needle is introduced into the prostate at the intended place.
Moreover, according to yet another embodiment, the introduction unit is made of a rubber or plastic material, preferably wherein the introduction unit 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 that the user can understand the position of the catheter inside of the urethra and also 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 place inside of the urethra and not twisted. Moreover, and as mentioned, the distance marking of the injection tube provides assistance for the user to know the position of the injection tube and thus needle before introducing the same into the prostate.
In relation to the above it may be mentioned that a lubricant, such as Vaseline or local anesthetic gel, may be used to ensure that the catheter is simple to insert into the urethra and simple to pull back and forth inside of the urethra, both to find the right position and also as part of the method according to the present invention, which is further explained below. Also the use of a lubricant may be seen as means to increase the correct locating of the catheter and needle before inserting/introducing the needle into the prostate. Based on the above, according to one embodiment of the present invention, the kit also comprises a lubricant, such as vaseline. Furthermore, it should be noted that at least the introduction unit of the catheter according to the present invention may also be produced in or coated by a sliding material so that the catheter is simple to insert into the urethra.
In
The catheter 1 also comprises a drainage outlet 11. Moreover, according to this embodiment, the catheter 1 has a multi-connection unit 12 which holds the balloon inflation connection 6, the injection connection 8 and at 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 and, in this case, containing adrenaline and at least one anesthetic agent, which could be a local anesthetic agent.
In
This application is a continuation-in-part of co-pending U.S. application Ser. No. 17/988,368 filed Nov. 16, 2022, which is a continuation-in-part of co-pending U.S. patent application Ser. No. 17/160,728 filed Jan. 28, 2021, both of which are incorporated herein by reference in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17988368 | Nov 2022 | US |
| Child | 18205693 | US | |
| Parent | 17160728 | Jan 2021 | US |
| Child | 17988368 | US |
