Coated urethra balloon catheter with positioning aid

Abstract

The invention relates to a balloon catheter for a transurethral application, having a proximal region (2), which comprises an at least single-lumen catheter shaft (4) with an inflation lumen and an inflatable balloon (5) that is connected to the distal end of the inflation lumen in a fluid-permeable manner, and a distal region (3), which comprises a distal shaft (7) and a distal tip (9). The balloon (5) is coated with a medicament, and a positioning aid (10) is provided at least in the proximal region (2). The positioning aid (10) is provided at least in the region of the balloon (5) in a tubular manner, and the length of the tubular section equals at least that of the balloon (5). The balloon catheter according to the invention allows a conservative treatment of benign prostate hyperplasia without the use of additional imaging methods.

Description

[0001] Coated urethral balloon catheter with placement aid

[0002] The invention relates to a balloon catheter, in particular for the treatment of benign prostatic hyperplasia, wherein the balloon catheter is placed through the urethra with a placement aid and wherein the balloon is suitable for delivering a medication.

[0003] Benign prostatic hyperplasia is a non-cancerous enlargement of the prostate. In its early stages, this can be treated with medication with relatively good success.

[0004] In later stages, when the enlarged prostate already significantly obstructs the normal flow of urine or other complications arise that can no longer be controlled conservatively, surgery is usually indicated.

[0005] Today, various surgical options are available. However, the gold standard is still transurethral resection of the prostate, in which a portion of the prostate is removed by scraping or peeling.

[0006] Even though this surgical procedure leads to good long-term results, intraoperative complications, especially bleeding, and postoperative complications such as urinary incontinence and loss of ejaculation must be taken very seriously, as they often impair the quality of life for those affected. It would be desirable to offer an alternative to the known invasive methods of prostate resection that works with medication and leads to a good treatment outcome, namely a reduction in prostate size, especially in later stages of benign prostatic hyperplasia.

[0007] Furthermore, it would be desirable for an alternative device for use in the treatment of benign prostatic hyperplasia to be easily placed within the urethra without the need for costly imaging techniques such as X-ray or ultrasound equipment.

[0008] It is therefore an object of the invention to provide a device which does not have the aforementioned disadvantages and is particularly suitable for use in a non-invasive treatment, in particular of benign prostatic hyperplasia.

[0009] This object is achieved by an invention having the features of claim 1. Advantageous embodiments are the subject of the dependent claims. It should be noted that the features listed individually in the claims can also be combined with one another in any desired and technologically expedient manner, thus revealing further embodiments of the invention.

[0010] The urethral balloon catheter according to the invention, hereinafter also referred to as balloon catheter for simplification, is intended for transurethral use and comprises an at least single-lumen catheter shaft with an inflation lumen and an inflatable balloon, wherein the balloon is connected to the distal end of the inflation lumen in a fluid-permeable manner.

[0011] Optionally, the urethral balloon catheter comprises at least a double-lumen catheter shaft with an inflation lumen and a drainage lumen.

[0012] The part of the urethral balloon catheter comprising the catheter shaft and the balloon will hereinafter also be referred to as the proximal catheter region. The urethral balloon catheter according to the invention further comprises a flexible distal shaft arranged distal to the balloon and a distal tip.

[0013] Optionally, the distal shaft includes a thickened section located proximal to the tip.

[0014] In designs with at least a double-lumen shaft with a drainage lumen, the distal end of the drainage lumen for draining urine ends open at the tip, preferably radially outward, when the tip of the flexible shaft enters the filled bladder. This allows the attending physician to determine that the distal tip has reached the bladder based on the discharge of urine.

[0015] The part of the urethral balloon catheter comprising the distal shaft with an optionally thickened section and a distal tip will hereinafter also be referred to as the distal catheter region.

[0016] The urethral balloon catheter according to the invention further comprises a placement aid which is provided at least in the proximal region and has a tubular section in the region of the balloon, wherein the tubular section has at least the length of the balloon with regard to its length.

[0017] The urethral balloon catheter is accordingly arranged at least partially, namely at least with the balloon, within the distal tubular section of the placement aid.

[0018] The placement aid is designed to be retractable or movable along the balloon catheter, particularly proximally, to initially cover the entire balloon of the balloon catheter in various positions, partially retracted to cover only a proximal portion of the balloon, and further retracted to no longer cover the balloon. If the placement aid is retracted so far proximally that the balloon is no longer positioned within the placement aid or the placement aid no longer impedes balloon inflation, this corresponds to complete retraction of the placement aid.

[0019] If the placement aid covers the entire balloon of the balloon catheter, the balloon cannot be inflated with standard pressure. If the placement aid covers only a proximal portion of the balloon, only the distal portion of the balloon can be inflated with standard pressure. If the placement aid does not cover the balloon, the balloon can be inflated over its entire length with standard pressure.

[0020] Accordingly, the distal portion of the balloon can expand if the placement aid is retracted just a little proximally from the balloon. This allows the balloon catheter to be secured when the entire urethral balloon catheter is retracted, because the expanded portion of the balloon does not pass the prostate, thus securing it distal to the prostate. Once the balloon is correctly positioned, the placement aid can be completely removed from the balloon, the balloon can be fully expanded, and the medication can be administered.

[0021] Accordingly, at least the tubular section of the placement aid that covers the balloon of the balloon catheter is designed to be dimensionally stable (non-compliant) so that it can withstand application-specific pressurization and prevents inflation of the balloon in this area.

[0022] Distally, the placement aid preferably extends beyond the balloon of the balloon catheter, but not beyond the thickened portion of the shaft or even to the distal tip. The placement aid preferably ends distally before the proximal end of the distal shaft.

[0023] Proximally, the placement aid extends so far that the proximal end of the placement aid is still outside the urethra even when the urethral balloon catheter has been inserted or placed into the urethra as intended, and thus the proximal end of the placement aid can be grasped by the user in order to be able to gradually withdraw the placement aid proximally from the balloon of the urethral catheter.

[0024] "Proximal" refers to the area along the catheter that points toward the user, and "distal" refers to the area along the catheter that points away from the user. The position of the catheter tip is correspondingly distal. A "forward" movement thus indicates a distal movement, and a backward movement a proximal movement. Further positional relationships are evident from the figures.

[0025] A handle element can optionally be provided at the proximal end of the placement aid to allow easy gripping and retraction of the placement aid.

[0026] Likewise, a marker element may be provided at the proximal end of the urethral balloon catheter and / or at the proximal end of the placement aid to indicate to the user the exact distal position of the placement aid.

[0027] This marking element can, for example, comprise a number of individual markers at the proximal end of the urethral balloon catheter and / or at the proximal end of the placement aid, wherein, for example, the first marker indicates the position of the placement aid in which the balloon is completely within the placement aid, the second marker indicates the position of the placement aid in which only the distal portion of the balloon is outside the placement aid, and the third marker indicates the position of the placement aid in which the balloon is completely outside the placement aid. Additional markers can be used to represent additional positions of the placement aid.

[0028] Preferably, the placement aid is formed entirely from its distal to its proximal end by a tubular, preferably flexible element. However, embodiments of the placement aid are also conceivable in which only certain sections of the placement aid are tubular, while other sections are formed, for example, by connecting elements such as threads, bands, or similar elements.

[0029] For example, it is conceivable for the placement aid to comprise only a tubular section distally, in which the balloon of the balloon catheter is arranged. Connecting elements can be provided proximally, by means of which the distal tubular section can be gradually retracted. Embodiments in which tubular sections and connecting elements alternate along the length of the placement aid are also conceivable.

[0030] Preferably, the placement aid is made of a low-friction material, particularly polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE). This low-friction material simplifies both the advancement of the urethral balloon catheter according to the invention through the urethra and the gradual retraction of the placement aid during placement and treatment.

[0031] The inflation lumen extends from the proximal end of the urethral balloon catheter to the inflatable balloon. The optional drainage lumen extends from the proximal end of the urethral balloon catheter to the tip of the distal shaft.

[0032] To secure the distal shaft to the rest of the balloon catheter, a projection made of polyamide or a similarly robust and rigid material, such as can also be used for the balloon, is provided on the part of the balloon catheter distal to the balloon. The distal shaft can be secured to this projection. Accordingly, in the area of ​​the projection, the projection itself and the proximal region of the distal shaft overlap. The projection continues the drainage lumen of the catheter shaft, and the distal shaft also includes a corresponding drainage lumen, which, when secured to the projection, continues the drainage lumen of the catheter shaft.

[0033] The balloon is coated with one or more drugs, preferably a cytostatic or antiproliferative drug, such as paclitaxel or sirolimus. The drug is preferably paclitaxel.

[0034] The balloon is designed to be inflatable and can be reversibly converted from a compressed state to an expanded or dilated state by inflation. Deflation converts the balloon to the compressed or contracted state. The balloon is preferably made of a polyamide such as nylon (polyhexamethylene adipamide); a block copolymer of polyamides, polyethers, and polyesters; polyesters, polyurethanes, and / or polyolefins.

[0035] By expanding the balloon, the drug, especially paclitaxel, is applied to the urethra and diffuses to the prostate, which inhibits the cell proliferation of the corresponding cells of the prostate and thereby treats the hyperplasia.

[0036] The distal shaft comprises a relatively soft distal tip, which is made of silicone, for example, and can be coated with polytetrafluoroethylene, hydrogel, or a silicone elastomer for lubrication.

[0037] The tip may have a larger diameter at a thickening than the other areas of the balloon catheter.

[0038] The distal portion is preferably 4 to 8, and in particular 5 to 6 cm long, with the tip thereof 1 to 5, and preferably 2 to 3 cm long. The outer diameter of the distal shaft, and in particular of the distal tip, may be 6 to 8 French (2 to 2.667 mm); the catheter shaft may have an outer diameter of 3 to 6, and in particular 4 to 5 French.

[0039] The distal shaft or distal tip is preferably made of silicone, the catheter shaft is preferably made of polyamide.

[0040] At the distal tip, there is optionally at least one opening through which the optional drainage lumen opens to the outside. The optional at least one opening is preferably located laterally in the distal region of the tip, i.e., in the radial direction. This ensures that urine flow through the drainage lumen can only be detected once it reaches the bladder. However, the at least one opening can also be arranged at the end, i.e., in the axial direction.

[0041] For treatment, the attending physician can advance the inventive urethral balloon catheter into the urethra until the distal end of the balloon is distal to the prostate, but proximal to the bladder. For final placement of the balloon in the prostate region, the placement aid can now be retracted proximally from the balloon until a distal portion of the balloon lies outside the placement aid and can thus be inflated by applying pressure as required.

[0042] With a preferred embodiment of the urethral balloon catheter, which includes an opening in the tip and a drainage lumen ending there, the attending physician can advance the urethral balloon catheter into the urethra until the bladder is reached and the distal tip of the catheter penetrates the bladder. This is noticeable by the discharge of urine, which flows through an opening in the distal tip through the drainage lumen to the proximal end of the catheter.

[0043] This indicates to the physician that at least the distal portion of the coated balloon is located between the bladder and the prostate, namely proximal to the bladder and distal to the prostate. To finally position the balloon in the prostate region, the physician can then withdraw the placement aid proximally from the balloon until a distal section of the balloon lies outside the placement aid and can thus be inflated by applying appropriate pressure. The optional opening in the distal portion of the tip can also be used for lubrication during catheter advancement by introducing a suitable fluid from proximally through the drainage lumen.

[0044] The invention also includes a method for treating benign prostatic hyperplasia using a urethral balloon catheter according to the invention, comprising the following steps:

[0045] (A) providing a urethral balloon catheter according to the invention;

[0046] (B) Insertion of the urethral catheter into the urethra of a patient requiring treatment for benign prostatic hyperplasia;

[0047] (C) Advance the urethral catheter into the urethra and, if necessary, lubricate the catheter tip by introducing a suitable fluid through the optional drainage lumen;

[0048] (D) Place the urethral catheter by advancing the catheter into the urethra to a point where the distal end of the balloon lies between the bladder and the prostate;

[0049] (E) Partially retract the placement aid so that a distal portion of the balloon lies outside the placement aid;

[0050] (F) Inflating the exposed distal portion of the balloon;

[0051] (G) Withdraw the urethral catheter with the partially inflated balloon until the inflated portion of the balloon rests against the prostate and is fixed in the proximal direction; (H) Completely withdraw the placement aid so that the balloon is completely outside the placement aid;

[0052] (I) Complete inflation of the balloon;

[0053] (J)Deflating the balloon;

[0054] (K) If necessary, repeating steps (I) and (J) once or several times until sufficient drug release is achieved;

[0055] (L) Removal of the urethral catheter with deflated balloon by completely withdrawing the urethral catheter from the urethra.

[0056] Furthermore, the invention also encompasses the use of the catheter according to the invention for the transurethral treatment of benign prostatic hyperplasia, such as in the method described above.

[0057] The urethral balloon catheter according to the invention avoids the disadvantages of conventional surgical procedures in which parts of the prostate are mechanically removed or destroyed, and in particular their intra- and postoperative side effects.

[0058] Another advantage over conventional surgical procedures is that the treatment can be performed on an outpatient basis, for example, using lidocaine as a local anesthetic, without the need for a complex, X-ray-equipped catheter laboratory. Unlike other radiological interventions, no X-ray monitoring of catheter placement is necessary, as correct placement is achieved by partial balloon expansion and the resulting fixation of the balloon catheter. Furthermore, if a drainage lumen is present, the urine can be diverted when the distal tip penetrates the bladder to indicate that the bladder has been reached. If necessary, additional ultrasound guidance ensures further safety during the procedure.

[0059] In particular, the urethral balloon catheter according to the invention makes it possible, thanks to the placement aid, to place the balloon very precisely in the area of ​​the prostate even without imaging techniques and thus achieve optimal drug transfer to the target area.

[0060] The invention and the technical environment are explained in more detail below using the figures as examples. It should be noted that the figures show a particularly preferred embodiment of the invention. However, the invention is not limited to the embodiment shown. In particular, the invention encompasses, to the extent technically feasible, any combination of the technical features listed in the claims or described in the description as relevant to the invention.

[0061] They show:

[0062] Fig. 1 the urethra according to the invention

[0063] Balloon catheter with attached placement aid.

[0064] Fig. 2 the urethra according to the invention

[0065] Balloon catheter with partially retracted placement aid.

[0066] Fig. 3 the urethra according to the invention

[0067] Balloon catheter with partially retracted placement aid and partially inflated balloon.

[0068] Fig. 4 the urethra according to the invention

[0069] Balloon catheter with fully retracted placement aid and fully inflated balloon. Figure 1 shows a preferred embodiment of the urethral balloon catheter 1 with a proximal region 2 and a distal region 3. The proximal region 2 comprises the at least single-lumen catheter shaft 4 (shown here in abbreviated form) with the inflation lumen and the optional drainage lumen (not shown), with a drug-coated balloon (DCB) 5, and a distal extension 6 of the catheter shaft or DCB for securing the distal shaft 7. The distal region 3 comprises the distal shaft 7 with a distal thickening 8 and a distal tip 9 with preferably lateral openings (not shown).

[0070] In the proximal region 2 of the urethral balloon catheter 1, the placement aid 10 according to the invention is provided, which is preferably tubular and made of a low-friction material and extends distally beyond the balloon 5.

[0071] The inflation lumen and optional drainage lumen begin at the proximal end of the catheter shaft 4. Distally, the inflation lumen extends to the balloon 5 and is fluid-permeable to it for inflation and deflation. The drainage lumen ends distally with one or more openings, preferably on the side, in the area of ​​the distal tip 9.

[0072] Proximal to the distal tip 9, the distal shaft 7 preferably has a thickening 8 with a larger diameter than the rest of the shaft 7. The thickening 8 preferably has a larger diameter than the rest of the catheter 1 when the balloon 5 is compressed.

[0073] Figure 2 shows the urethral balloon catheter 1 according to the invention shown in Figure 1 with the proximal region 2 and the distal region 3. The proximal region 2 comprises the at least single-lumen catheter shaft 4 (shown here in abbreviated form), with a drug-coated balloon (DCB) 5 and a distal extension 6 of the catheter shaft or DCB for securing the distal shaft 7. The distal region 3 comprises the distal shaft 7 with an optional distal thickening 8 and a distal tip 9. The placement aid 10 provided in the proximal region 2 of the urethral balloon catheter 1 is pulled proximally a short distance, exposing a distal section 5a of the balloon 5. The remaining balloon 5 is located within the placement aid 10.

[0074] Figure 3 shows the urethral balloon catheter 1 according to the invention as shown in Figure 2 with the proximal region 2 and the distal region 3. The proximal region 2 comprises the at least single-lumen catheter shaft 4 (shown here in abbreviated form), with a drug-coated balloon (DCB) 5 and a distal extension 6 of the catheter shaft or the DCB for securing the distal shaft 7. The distal region 3 comprises a distal shaft 7 with an optional distal thickening 8 and a distal tip 9.

[0075] The placement aid 10 provided in the proximal region 2 of the urethral balloon catheter 1 has been pulled proximally slightly, exposing a distal portion 5a of the balloon 5. The distal portion 5a of the balloon 5 is inflated. The remaining balloon 5 is still located within the placement aid 10 and cannot be expanded by the applied inflation pressure.

[0076] Figure 4 shows the urethral balloon catheter 1 according to the invention as shown in Figure 3 with the proximal region 2 and the distal region 3. The proximal region 2 comprises the at least single-lumen catheter shaft 4 (shown here in abbreviated form), with a drug-coated balloon (DCB) 5 and a distal extension 6 of the catheter shaft or the DCB for securing the distal shaft 7. The distal region 3 comprises a distal shaft 7 with an optional distal thickening 8 and a distal tip 9.

[0077] The placement aid 10 provided in the proximal region 2 of the urethral balloon catheter 1 is pulled further proximally and now completely releases the balloon 5. The balloon 5 is fully inflated. List of reference symbols

[0078] 1 urethral balloon catheter

[0079] 2 proximal area of ​​the urethral balloon catheter

[0080] 3 Distal area of ​​the urethral balloon catheter 4 Double lumen catheter shaft

[0081] 5 Drug-Coated Balloon (DCB)

[0082] 6 distal process

[0083] 7 distal shaft

[0084] 8 distal thickening 9 distal tip

[0085] 10 Placement aid p proximal d distal

Claims

Patent claims 1. A balloon catheter for transurethral use, comprising a proximal region (2) comprising an at least single-lumen catheter shaft (4) with an inflation lumen and an inflatable balloon (5) connected to the distal end of the inflation lumen in a fluid-permeable manner, and a distal region (3) comprising a distal shaft (7) with a distal tip (9). The balloon (5) is coated with a medicament and a placement aid (10) is provided at least in the proximal region (2). The placement aid (10) is tubular at least in the region of the balloon (5), and the tubular section has a length at least equal to the length of the balloon (5).Balloon catheter according to claim 1, characterized in that the catheter shaft (4) is provided with at least two lumens with an inflation lumen and a drainage lumen, the distal end of the drainage lumen ending open at the distal tip (9) for drainage of the urine when the tip (9) enters the filled urinary bladder.

3. Balloon catheter according to claim 2, characterized in that the distal end of the drainage lumen ends open to the outside at the distal tip (9).

4. Balloon catheter according to one of the preceding claims, characterized in that the distal region (3) comprises a thickening (8) proximal to the distal tip (9).

5. Balloon catheter according to one of the preceding claims, characterized in that the placement aid (10) is made of a low-friction material, in particular of PTFE or ePTFE.

6. Balloon catheter according to one of the preceding claims, characterized in that the medicament is a cytostatic or antiproliferative medicament, in particular paclitaxel or sirolimus and preferably paclitaxel.

7. Balloon catheter according to one of the preceding claims, characterized in that an extension (6) is provided distally on the balloon (5) for fixing the distal shaft (7) to the proximal region (2), wherein the extension (6) is preferably made of polyamide.

8. Balloon catheter according to one of the preceding claims, characterized in that the distal region (3) is 4 to 8 and in particular 5 to 6 cm long, of which the distal tip (9) occupies 1 to 5 and preferably 2 to 3 cm.

9. Balloon catheter according to one of the preceding claims, characterized in that the outer diameter of the distal tip (9) is 6 to 8 French (2 to 2.667 mm).

10. Balloon catheter according to one of the preceding claims, characterized in that the catheter shaft (4) has an outer diameter of 3 to 6 French (1 to 2 mm) and especially 4 to 5 French (1,333 to 1,667 mm).

11. Balloon catheter according to one of the preceding claims, characterized in that the balloon is made of a material selected from the group comprising polyamides; block copolymers of polyamides, polyethers and polyesters; polyesters, polyurethanes and / or polyolefins.

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