Gutartige Prostatavergrößerung behandeln - Visite - NDR
Effective date : Prostate cancer is the most common male tumor. Currently, about 64, new cases are diagnosed each year in Germany. Due to better diagnostics, prostate cancer is increasingly diagnosed at the localized stage, so that the possibility of curation is given. In the past, localized prostate cancer therapy was almost exclusively radical prostatectomyectomy.
In recent years, various competing therapies have been developed that have led to altered patient preference. In particular, those therapeutic measures prevailed in which it succeeds with the help of technologically sophisticated measures to destroy carcinoma tissue precisely and accurately. Based on evidence-based data, especially radiological treatment methods were able to establish themselves.
They have been shown to provide satisfactory control of the tumor. The interdisciplinary moderate Vergrößerung der Prostata for early detection in particular of quality S3diagnosis and therapy of the various stages of prostate cancer therefore also recommend radiological therapy as the primary treatment of localized prostate cancer.
In America, this therapy method has been established for years. Every year, about 80, out of aboutnewly infected patients are treated with a localized prostate carcinoma.
The main dysfunctions affect bladder function. These disorders are characterized moderate Vergrößerung der Prostata irritative and obstructive symptoms of the prostate and bladder. In particular, the moderate Vergrößerung der Prostata and bladder mucosa are affected. Irradiation leads to irritation of the prostate and bladder mucosa and increased urinary frequency moderate Vergrößerung der Prostata irritative symptoms.
As a result, there is a disturbance of the bladder storage phase, which causes a considerable urge symptoms. In addition, edema of the irradiated prostate can cause obstruction. Irritative and obstructive components lead to symptoms moderate Vergrößerung der Prostata include pollakiuria, nocturia, dysuria and residual urine formation up to urinary retention. Consequently, very high doses of the administered substances are often required, but this can lead to undesirable systemic side effects.
Furthermore, not only prostate cancer, but also the enlargement of the prostate as a disease is in the foreground in men over the age of 50 years. At this age, the first signs of benign enlargement occur, called benign prostatic hyperplasia BPH.
This benign prostatic hyperplasia may be referred to as "common disease" in older men. The Prevalence of benign prostatic hyperplasia BPH increases significantly with age.
Enlargement of the prostate compresses the urethra, moderate Vergrößerung der Prostata to clinically relevant consequences or dysfunctions. The resulting clinical symptoms can be broken down into irritative and obstructive symptoms. Among the irritative symptoms are the pollakisuria frequent micturition during the daythe urge symptoms and nocturia nocturnal micturition.
The obstructive symptoms are manifested by a weakened stream of urine, prolonged voiding, "teething troubles", urine drip, and "residual urine". If left untreated, these symptoms may include urinary retention, "overflow bladder", bladder stone formation, detrusor depletion muscle failurehydronephrosis kidney congestionor postrenal renal insufficiency serious or even life-threatening consequences.
For the treatment of benign prostatic hyperplasia BPHvarious treatment options are available, namely simple monitoring in patients with "mild" symptoms, drug therapies and surgical therapies T.
The indication for initiating treatment depends on the severity of the symptoms and any complications that may occur. The transurethral resection of the prostate TUR-P is performed in the Federal Republic of Germany with approximately 60, patients per year and in Europe with approximatelypatients per year.
The complications include significant hyponatraemia, TUR syndrome, hemorrhage requiring treatment, blood transfusions, urinary tract infections, epididymitis, incontinence, bladder neck sclerosis, urethral strictures, retrograde ejaculation, and impotence A. Leyh, R. Höfner, CG Stief, U.
Both in transurethral resection of the prostate TUR-P and in vaporization, a large wound area is created in the surgical site. In a differentiated view, this wound surface leads to pronounced irritative symptoms, temporary incontinence as well as bladder spasms and dysuria, especially during long-term observation at least 30 days. If one evaluates the therapeutic success of a transurethral resection or vaporization with the help of a symptom score, then it must also be stated that the symptom relief has reached its optimum only after six months.
The quality of life of the transurethrally resuscitated patients is thus significantly limited, in particular due to the irritative symptoms. However, in this document, only a physical treatment of the prostate by compression or pressure and heat is provided, since no drug delivery can take place from the catheter. The medicament is already introduced into the space between the prostate balloon and the porous membrane during the production of the catheter, so that expensive sterilization measures are required and the catheter has only a limited shelf life, since the filling must take moderate Vergrößerung der Prostata before instillation of the catheter.
In addition, larger amounts of drug may leak through the porous membrane prior to use of the catheter. In addition, a subsequent addition of the drug in the inserted state of the catheter is no longer possible. It is mainly based on the treatment of the bladder after radiation therapy of a prostate carcinoma. In principle, however, the drug treatment of the prostate is provided, for which three equal approaches are disclosed, namely an outside coating of the prostate balloon with a drug, at least outside incorporation of a drug for the treatment of the prostate in the wall of the prostate balloon or a permeable or Semipermeable training of the wall of the prostatic balloon for drug delivery, with no specific information can be found in this regard.
The present invention is therefore an object of the invention to provide a catheter for the treatment of dysfunction or diseases of the prostate and optionally the bladder and a kit containing this catheter kit-of-parts or set, the previously described, with the state The technology associated disadvantages are at least largely avoided or at least mitigated.
In particular, unwanted drug-related side effects, as they occur in a systemic administration of drugs, at least largely avoided. It is a further object of the present invention to provide a catheter, in particular an indwelling catheter, and a kit ready for use kit of parts containing this catheter, wherein preferably a suitability for the treatment of functional disorders or diseases of the prostate and optionally Bladder associated with or following transurethral moderate Vergrößerung der Prostata or vaporization of the prostate, associated with benign prostatic hyperplasia, or associated with or following radiation therapy moderate Vergrößerung der Prostata a prostate carcinoma.
To solve the problem described above, the present invention thus proposes a catheter, in particular indwelling catheter, according to claim 1. Further, advantageous properties of the catheter according to the invention are the subject of the relevant subclaims.
A further subject of the present invention is a kit ie a kit-of-parts or setin moderate Vergrößerung der Prostata a catheter system comprising on the one hand the catheter according to the invention and on the other hand at least one application device containing at least one drug for administration of the medicament, as described in the corresponding US Pat. It goes without saying that particular embodiments and embodiments, which are described only in connection with an aspect of the invention, also apply correspondingly in relation to the other aspects of the invention, without this being expressly described.
Incidentally, the person skilled in the art may deviate from moderate Vergrößerung der Prostata number, value or range given below for the purposes of the application or the individual case without departing from the scope of the present invention. The catheter according to the invention is a special indwelling catheter with which not only dysfunctions of the prostate and optionally the bladder, but also diseases such as prostate carcinomas, benign enlargements of the prostate, bladder carcinomas or moderate Vergrößerung der Prostata like, are treated both by physical and by medicinal measures can.
In particular, the catheter according to the invention is suitable for treating the prostate and optionally the bladder in connection with or after a transurethral resection or moderate Vergrößerung der Prostata of the prostate or in conjunction with or after an irradiation therapy of a carcinoma of the prostate.
In this case, the catheter according to the invention, in particular indwelling catheter should have a residence time of a maximum of 60 hours, in particular a maximum of 48 hours, although shorter or longer residence times are not excluded. The prostate balloon provided according to the invention serves on the one hand the compression and thus the local physical treatment of the prostate.
Due to the permeable moderate Vergrößerung der Prostata formed by pores can also be introduced into the Prostate balloon drug targeted and locally limited in the prostate area to be treated, so that both an efficient drug treatment can take place, with the topical or moderate Vergrößerung der Prostata delivery of the drug high local Concentration of active ingredient compared to a systemic administration can be achieved, although due to the local application, the absolute amount of active ingredient can be significantly reduced.
Usually, the delivery of the drug through the permeable wall of the prostate balloon is at least substantially via diffusion processes, i. Finally, the filled prostate balloon dilates the urethra in the area of moderate Vergrößerung der Prostata prostate and medically influences or treats it. The catheter according to the invention enables on the one hand a physical treatment, in particular by means of compression, and on the other hand an efficient pharmacological treatment by targeted drug delivery.
In order to enable efficient drug delivery, the permeable wall of the prostate balloon generally has a plurality of pores.
The number of pores can vary within wide limits. In general, the wall of the prostate balloon has a pore number of 1 to 1, pores, moderate Vergrößerung der Prostata particular 1 to pores, preferably 2 to pores, preferably 2 to 50 pores, more preferably 2 to 20 pores, most preferably 3 to 10 pores, especially preferred 4 to 6 pores, up.
In this moderate Vergrößerung der Prostata, an optimal drug concentration is achieved at the treatment site in the prostate area. Particularly good results are obtained according to the invention when the permeable wall of the prostate balloon in the expanded state pores having a pore size, in particular with a diameter in the range of 1 to In this way it is ensured in particular that the drug to be dispensed at least substantially via diffusion-controlled processes is released and an overly rapid delivery of the medicament to be released is prevented, ie in this way the transport of medicaments is controlled by physical processes.
Particularly good results according to the invention are obtained when the pores of moderate Vergrößerung der Prostata permeable wall of the prostate balloon are produced by laser perforation, in particular by means of an ultrashort pulse laser. In this way, a defined and predetermined pore size can be tailored so to speak, without affecting the remaining material of the prostate balloon.
The use of a laser to create the pores gives particularly sharply defined edges. In particular, the plastic material of the prostate balloon is perforated in such a way that the edges of the pores are as it were welded during their production and can not tear. As the Applicant has surprisingly found, alternative methods of creating the pores, particularly by mechanical drilling, incorporation of debris and subsequent stretching or chemical removal moderate Vergrößerung der Prostata the debris or other constituents by means of etching, dissolution or the like, do not lead to the desired results.
Very particularly good results are obtained when the pores of the wall of the prostate balloon are produced by laser perforation by means of a so-called ultrashort pulse laser.
In this way, the plastic material of the prostate balloon to be perforated is exposed to laser treatment only for a very short time, which is particularly gentle on the material. In general, ultrashort pulse lasers are laser beam sources which emit pulsed laser light with pulse durations in the range of picoseconds, femtoseconds and attoseconds; they are generally mode-locked lasers. By the exact selection of the number and size of the pores in the wall of the prostate balloon, the physical transport processes, in moderate Vergrößerung der Prostata the diffusion, of the drug to be administered can be specifically adjusted, in particular depending on the drug to be administered.
As a result, the prostate balloon of the catheter according to the invention fulfills a number of functions. Firstly, as described above, the filling of the prostate balloon moderate Vergrößerung der Prostata compression of the prostate and dilation of the urethra in the area of the prostate. On the other hand, in addition to this physical treatment by the drug delivery on the permeable wall moderate Vergrößerung der Prostata the prostate balloon, the advantages described above.
The prostate balloon filled with a drug to be administered thus makes available a depot or a reservoir which controls or controls a defined amount of a drug directly at the therapeutic site over a longer, defined period of time, preferably via physical processes, in particular via diffusion processes.
Targeted release of medication via the permeable wall of the prostate balloon over a defined period of time makes local drug administration possible. The drugs are administered directly at the treatment site and not distributed - as opposed to a systemic therapy - over the entire body. By focusing moderate Vergrößerung der Prostata delivery of drug relative to the target organ, small amounts of drug can be used, thus saving medication costs and avoiding unwanted systemic side effects.
The term "kit" as used according to the invention refers in particular to a unit of spatially separated but functionally coherent, coordinated moderate Vergrößerung der Prostata prefabricated components, namely the catheter on the one hand and the application device on the other hand. An advantage of the kit according to the invention can be seen in particular in the fact that the two matched components catheter on the one hand and application device on the other hand are ready for use and can be readily combined or combined with one another by the end user, in particular by a doctor or medical staff.
In this way, an efficient as rapid deployment is possible, without the risk of misuse, in particular dosing errors or administration of false drugs. In this context, special combinations of active ingredients for the treatment of the prostate and possibly moderate Vergrößerung der Prostata bladder have proven particularly useful, as will be explained below.
Other features, advantages and applications of the present invention will become apparent from the following description of exemplary embodiments with reference to the drawings drawings and the drawings figure representations itself. In the figure representations according to 1. The catheter tube 4 again has a distal end 5 and a proximal end 7 on, with the catheter connection 5 ' at the distal end 5 located. Furthermore, one is from the catheter port 5 ' up to at least one drain opening 10 in the area of the proximal moderate Vergrößerung der Prostata 7 of the catheter tube 4 reaching first channel 8th intended.
The prostate balloon 16 is located at the proximal end 7 of the catheter tube 4There is also a catheter connection 5 ' up to the prostate balloon 16 in the area of the proximal end 7 of the catheter tube 4 reaching second channel 15 intended. The prostate balloon 16 has one by means of pores 25 permeable wall 17 on, wherein the size, in particular the diameter, of the pores 25 is adjusted such that in the inserted moderate Vergrößerung der Prostata of the catheter 1 a targeted delivery of a drug 14 through the wall 17 can be done through.
By permeable wall by means of pores optimal and targeted delivery of the drug is achieved directly at the therapy site. Thus, through the pores of the prostate balloon, the at least one drug in the body of the patient at the site of treatment, i. The invention thus enables a treatment of the prostate and optionally the bladder over a defined period of time by the continuous delivery of at least one drug through the pores of the prostate balloon directly at the therapy site, via the permeability of the wall of the prostate balloon the delivery amount of the drug per unit time are precisely controlled can.
Like the figure representations according to 1. It goes without saying that it offers itself, ultimately not just a single pore 25 for drug delivery in the region of the prostate at the proximal end of the catheter tube 4 but in the region concerned a large number of pores 25 to realize, so that the number of pores 25 can moderate Vergrößerung der Prostata widely.
In general, the wall faces 17 of the prostate balloon 16 the pores 25 in a number of 1 to 1, pores, in particular 1 to pores, preferably 2 to pores, preferably 2 moderate Vergrößerung der Prostata 50 pores, more preferably 2 to 20 pores, most preferably 3 to 10 pores, especially preferably 4 to 6 pores .