Coated urethral balloon catheter with placement aid

Abstract

The present invention relates to a balloon catheter for transurethral use, having a proximal region (2) including a catheter shaft (4) with at least one lumen having an inflatable lumen and an inflatable balloon (5) connected in a fluid-permeable manner to the distal end of the inflatable lumen, and a distal region (3) including a distal shaft (7) and a distal tip (9), wherein the balloon (5) is coated with a drug, and a placement aid (10) is provided at least in the proximal region (2), and the placement aid (10) is provided in a tubular manner at least in the region of the balloon (5), with respect to its length, the tubular portion being at least the length of the balloon (5). The balloon catheter according to the present invention enables conservative treatment of benign prostatic hyperplasia without the use of additional imaging methods.

Description

Technical Field

[0001] The present invention relates to a balloon catheter, particularly a balloon catheter for the treatment of benign prostatic hyperplasia, which is arranged through the urethra using an arrangement aid, and the balloon is suitable for administering drugs.

Background Art

[0002] Benign prostatic hyperplasia is understood to be a harmless enlargement of the prostate. In the initial stage, it can be treated very well without drugs.

[0003] In the later stage, when the enlarged prostate significantly obstructs the normal excretion of urine or shows complications that can no longer be dealt with by conservative treatment, surgery is generally required.

[0004] Today, various surgical options are available. However, the standard examination is transurethral resection of the prostate, in which part of the prostate is removed by shaving or peeling.

[0005] Even if this surgical method brings good results over a long period, intraoperative complications such as bleeding, and postoperative complications such as urinary incontinence and ejaculatory disorders are often related to the limitation of the quality of life for patients, so they need to be taken very seriously.

[0006] It is desirable to provide an alternative to the known invasive methods of prostatectomy that functions without using drugs and brings good treatment results, especially a reduction in prostate size, particularly in the later stage of benign prostatic hyperplasia.

[0007] Furthermore, it is desirable to readily arrange an alternative device in the urethra for use in the treatment of benign prostatic hyperplasia without using expensive imaging methods such as X-ray or ultrasonic devices.

Summary of the Invention

Problems to be Solved by the Invention

[0008] Therefore, an object of the present invention is to provide a device that does not have the aforementioned drawbacks and is particularly suitable for use in the non-invasive treatment of benign prostatic hyperplasia. [Means for solving the problem]

[0009] This objective is solved by the present invention having the features of claim 1. Each dependent claim relates to an advantageous embodiment. Note that the features listed individually in the claims can be combined with each other in any technically convenient manner, and thus further embodiments of the present invention are disclosed.

[0010] The urethral balloon catheter according to the present invention (hereinafter also referred to as a balloon catheter for brevity) is intended for transurethral use and comprises at least one lumen with an inflatable lumen and an inflatable balloon, the balloon being connected to the distal end of the inflatable lumen in a fluid-permeable manner.

[0011] The urethral balloon catheter comprises at least a double-lumen catheter shaft having an inflation lumen and a discharge lumen.

[0012] The portion of the urethral balloon catheter that includes the catheter shaft and balloon will also be referred to as the proximal catheter region below.

[0013] The urethral balloon catheter according to the present invention further comprises a flexible distal shaft and a distal tip positioned distal to the balloon.

[0014] The distal shaft optionally includes a thickened portion located proximal to the tip.

[0015] In embodiments having at least a double-lumen shaft with a discharge lumen, the distal end of the discharge lumen is preferably open radially outward at the tip to discharge urine when the tip of the flexible shaft enters a full bladder. In this way, the treating physician can determine that the distal tip has reached the bladder based on the outflow of urine.

[0016] The portion of the urethral balloon catheter that includes a distal shaft with an optionally thickened section and distal tip will hereafter be referred to as the distal catheter region.

[0017] The urethral balloon catheter according to the present invention further comprises a placement aid, which is provided at least in the proximal region and has a tubular portion within the region of the balloon, the tubular portion having a length that is at least the length of the balloon.

[0018] The urethral balloon catheter is positioned correspondingly within the distal tubular portion of the placement aid, at least partially, and especially at least together with the balloon.

[0019] The placement aid is positioned to be retractable or displaceable along the balloon catheter, particularly in the proximal direction, thereby covering the entire balloon of the balloon catheter at various positions, covering only the proximal portion of the balloon after partial retraction, and no longer covering the balloon after further retraction. Full retraction of the placement aid is considered to have occurred when the placement aid is retracted proximal to the extent that the balloon is no longer positioned within the placement aid or the placement aid no longer hinders the inflation of the balloon.

[0020] If the placement aid covers the entire balloon of the balloon catheter, the balloon cannot be inflated with the appropriate pressure for the intended use. If the placement aid covers only the proximal portion of the balloon, only the distal portion of the balloon can be inflated with the appropriate pressure for the intended use. If the placement aid does not cover the entire balloon, the balloon can be inflated along its entire length with the appropriate pressure for the intended use.

[0021] Therefore, the distal portion of the balloon can be expanded when the placement aid is slightly pulled back proximal to the balloon, and as a result, the entire urethral balloon catheter is pulled back, thereby achieving fixation of the balloon catheter, because the expanded portion of the balloon does not pass through the prostate, and thus this portion fixes the prostate distally. After the balloon is properly positioned, the placement aid is completely removed from the balloon, the balloon is fully expanded, and the medication can be administered.

[0022] Therefore, at least the tubular portion of the placement aid covering the balloon of the balloon catheter is provided in a dimensionally stable (non-compliant) manner, withstands the pressure application according to the application, and prevents the balloon from inflating in this area.

[0023] At the distal end, the placement aid preferably extends over the balloon of the balloon catheter, but does not extend to the thickened portion of the shaft or the distal end. Preferably, the placement aid terminates distally in front of the proximal end of the distal shaft.

[0024] Proximal, even in the case of a urethral balloon catheter inserted or positioned within the urethra depending on the application, the positioning aid extends so that its proximal end remains outside the urethra, and thus the user can grasp the proximal end of the positioning aid and pull it back in a stepwise manner proximal to the balloon of the urethral catheter.

[0025] "Proximal" is understood to refer to the region along the catheter that faces the user, and "distal" is understood to refer to the region along the catheter that moves away from the user. Therefore, the tip of the catheter is located distally. Consequently, movement "forward" means movement in the distal direction, and movement "backward" means movement in the proximal direction. Further positional relationships are evident from the diagram.

[0026] At the proximal end of the placement aid, optionally, a grip element can be provided for easily grasping and retracting the placement aid.

[0027] Similarly, a marking element can be provided at the proximal end of the urethral balloon catheter and / or at the proximal end of the placement aid, and this marking element indicates to the user the exact distal position of the placement aid.

[0028] This marking element can include, for example, a plurality of individual markers at the proximal end of the urethral balloon catheter and / or at the proximal end of the placement aid. For example, the first marker indicates the position of the placement aid where the balloon is completely located within the placement aid, the second marker indicates the position of the placement aid where only the distal portion of the balloon is located outside the placement aid, and the third marker indicates the position of the placement aid where the balloon is completely located outside the placement assisting means. Additional markers can be used to indicate further positions of the placement assisting means.

[0029] Preferably, the placement aid is formed entirely from a tubular, preferably flexible, element from its distal end to its proximal end.

[0030] However, embodiments of the placement aid are also conceivable where only specific portions of the placement aid are provided tubular, while other portions are formed by connecting elements such as screws, straps, or similar elements.

[0031] Thus, for example, it is conceivable that the placement aid includes a tubular portion only distally, and the balloon of the balloon catheter is arranged therein. Proximally, a connecting element can be provided, by which the distal tubular portion can be retracted step by step. Similarly, embodiments where the tubular portion and the connecting element are arranged alternately over the length of the placement aid are also conceivable.

[0032] Preferably, the placement aid is provided from a low-friction material, particularly polytetrafluoroethylene (PTFE) or ePTFE. The low-friction material facilitates both advancing the urethral balloon catheter according to the present invention through the urethra and gradually withdrawing the placement aid during placement and treatment.

[0033] The inflation lumen extends from the proximal end of the urethral balloon catheter to the inflatable balloon. Therefore, an optional discharge lumen advances from the proximal end of the urethral balloon catheter to the tip of the distal shaft.

[0034] To secure the distal shaft to the rest of the balloon catheter, an extension made of polyamide or a similar tough and rigid material, which can also be used for the balloon, is preferably provided in the portion of the balloon catheter distal to and adjacent to the balloon. The distal shaft can be fixed to this extension. Correspondingly, the extension itself and the proximal region of the distal shaft overlap in the region of the extension.

[0035] The extension continues the discharge lumen of the catheter shaft, and similarly, the distal shaft includes a corresponding discharge lumen that, when fixed to the extension, continues the discharge lumen of the catheter shaft.

[0036] The balloon is coated with one or more drugs, the drugs being preferably drugs having cell proliferation inhibitory or antiproliferative effects, such as paclitaxel or sirolimus. Preferably, the drug is paclitaxel.

[0037] The balloon is designed to be inflatable and can reversibly transition from a compressed state to an inflated or expanded state by inflation. By deflation, the balloon transitions to a compressed or contracted state. The balloon is preferably made from a polyamide such as nylon (polyhexamethylene adipamide); a block copolymer of polyamides, polyethers, and polyesters; or polyesters, polyurethanes, and / or polyolefins.

[0038] By inflating the balloon, the drug, particularly paclitaxel, is applied to the urethra and diffused into the prostate, which suppresses the cell proliferation of the corresponding cells in the prostate, thereby treating the hyperplasia.

[0039] The distal shaft includes a relatively soft distal tip, which is manufactured from, for example, silicone and may be coated with polytetrafluoroethylene, hydrogel, or silicone elastomer for lubrication.

[0040] The tip may have a larger diameter in the thickened portion than the rest of the balloon catheter.

[0041] The distal region is preferably 4-8 cm long, particularly 5-6 cm long, with the tip occupying 1-5 cm, preferably 2-3 cm. The outer diameter of the distal shaft, especially the distal tip, can be 6-8 French (2-2.667 mm); the catheter shaft can have an outer diameter of 3-6 French, particularly 4-5 French.

[0042] The distal shaft or distal tip is preferably formed from silicone, and the catheter shaft is preferably formed from polyamide.

[0043] At the distal tip, at least one optional opening is provided, through which an optional discharge lumen leads to the outside. Preferably, the at least one optional opening is located laterally, i.e., radially, in the distal region of the tip. This allows the urine flow to be identified only when it passes through the discharge lumen and reaches the bladder. However, the at least one opening may also be located at the terminal, i.e., axially.

[0044] For treatment, the treating physician can advance the urethral balloon catheter according to the present invention into the urethra until the distal end of the balloon is located distal to the prostate but proximal to the bladder. To finally position the balloon within the region of the prostate, the placement aid can be pulled back proximal to the extent that the distal portion of the balloon is outside the placement aid and therefore can be inflated by applying pressure as appropriate for the application.

[0045] According to a preferred embodiment of a urethral balloon catheter having an opening at its tip and a discharge lumen terminating therein, the treating physician can advance the urethral balloon catheter into the urethra until it reaches the bladder and the distal tip of the catheter enters the bladder. This is confirmed by the outflow of urine that passes through the opening at the distal tip, through the discharge lumen, and to the proximal end of the catheter.

[0046] This allows the physician to recognize that at least the distal region of the coated balloon is located between the bladder and the prostate, specifically proximal to the bladder and distal to the prostate.

[0047] Subsequently, to finally position the balloon in the prostate region, the physician can pull the placement aid back proximal to the extent that the distal portion of the balloon is outside the placement aid and therefore can be inflated by applying pressure as appropriate for the application. An optional opening in the distal region of the tip can also be used for lubrication during catheter advancement, and an appropriate fluid is introduced through the discharge lumen from the proximal end.

[0048] The present invention also includes a method for treating benign prostatic hyperplasia using a urethral balloon catheter according to the present invention, the method comprising the following steps: (A) A step of providing a urethral balloon catheter according to the present invention; (B) The process of inserting a urethral catheter into the urethra of a patient who requires treatment for benign prostatic hyperplasia; (C) A step of advancing a urethral catheter into the urethra, wherein the tip of the catheter is lubricated by optionally introducing an appropriate fluid through an optionally selected drainage lumen; (D) The step of positioning a urethral catheter by advancing the catheter into the urethra until the distal end of the balloon is located between the bladder and the prostate; (E) A step of partially pulling back the placement aid so that the distal portion of the balloon is located outside the placement aid; (F) The process of inflating the free distal portion of the balloon; (G) The step of withdrawing a urethral catheter with a partially inflated balloon until the inflated portion of the balloon is positioned over the prostate and fixed in a proximal direction; (H) The step of fully retracting the placement aid so that the balloon is completely outside the placement aid; (I) The process of fully inflating the balloon; (J) The process of deflating the balloon; (K) A step in which steps (I) and (J) are optionally repeated once or multiple times until sufficient drug delivery is achieved; (L) The process of removing the urinary catheter with the deflated balloon by completely withdrawing the urinary catheter from the urethra.

[0049] Furthermore, the present invention also includes, for example, the use of a catheter according to the present invention for transurethral treatment of benign prostatic hyperplasia in the method described above.

[0050] The urethral balloon catheter according to the present invention avoids the drawbacks of conventional surgical interventions, particularly the intraoperative and postoperative side effects, in which a portion of the prostate is mechanically removed or destroyed.

[0051] Another advantage over conventional surgical methods 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 catheterization laboratory equipped with X-ray technology. This is because, unlike other radiotherapeutic interventions, X-ray monitoring of catheter placement is unnecessary, as precise placement is achieved through partial balloon expansion and the resulting fixation of the balloon catheter. Furthermore, if an evacuation lumen is present, the discharge of urine as the distal tip enters the bladder indicates that the bladder has been reached. Optionally, additional ultrasound monitoring can be used to ensure further safety during the procedure.

[0052] In particular, using the urethral balloon catheter according to the present invention, the balloon can be positioned very accurately within the prostate region without the need for imaging methods, using a placement aid, thereby achieving optimal drug delivery within the target region.

[0053] The present invention and the technical field are described more illustratively and in more detail below with reference to the drawings. Note that the drawings illustrate particularly preferred embodiments of the invention. However, the present invention is not limited to the illustrated embodiments. In particular, the present invention encompasses any desired combination of the technical features described in the claims or described in the specification as relating to the invention, insofar as it is technically logical. [Brief explanation of the drawing]

[0054] [Figure 1] A diagram showing a urethral balloon catheter according to the present invention with a placement aid attached. [Figure 2] A diagram showing a urethral balloon catheter according to the present invention with the placement aid partially retracted. [Figure 3] This figure shows a urethral balloon catheter according to the present invention, with the placement aid partially retracted and the balloon partially inflated. [Figure 4] This figure shows the urethral balloon catheter according to the present invention with the placement aid fully retracted and the balloon fully inflated. [Modes for carrying out the invention]

[0055] Figure 1 shows a preferred embodiment of a urethral balloon catheter 1 having a proximal region 2 and a distal region 3. The proximal region 2 includes at least a single-lumen catheter shaft 4 (shown here in abbreviated form), having an inflation lumen and an optional discharge lumen (not shown), 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 includes the distal shaft 7 and has a distal thickened portion 8 and a distal tip portion 9 having a lateral opening (not shown).

[0056] The placement aid 10 according to the present invention is provided in the proximal region 2 of the urethral balloon catheter 1, and the placement aid 10 is preferably provided in a tubular form from a low-friction material and extends distally beyond the balloon 5.

[0057] The inflation lumen and any discharge lumen begin at the proximal end of the catheter shaft 4. Distally, the inflation lumen extends to the balloon 5 and connects to the balloon 5 via fluid permeability for inflation and deflation. The discharge lumen terminates distally and has one or more, preferably lateral, openings within the region of the distal tip 9.

[0058] Proximal to the distal tip 9, the distal shaft 7 preferably includes a thickened portion 8 having a larger diameter than the rest of the shaft 7. The thickened portion 8 preferably has a larger diameter than the rest of the catheter 1 when the balloon 5 is compressed.

[0059] Figure 2 shows a urethral balloon catheter 1 according to the present invention as shown in Figure 1, having a proximal region 2 and a distal region 3. The proximal region 2 includes at least a single-lumen catheter shaft 4 (shown here in abbreviated form), 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 includes the distal shaft 7 and has an optional distal thickening portion 8 and a distal tip portion 9.

[0060] The placement aid 10, located in the proximal region 2 of the urethral balloon catheter 1, is slightly pulled proximal, releasing the distal portion 5a of the balloon 5. The remaining portion of the balloon 5 is positioned within the placement aid 10.

[0061] Figure 3 shows a urethral balloon catheter 1 according to the present invention as shown in Figure 2, having a proximal region 2 and a distal region 3. The proximal region 2 includes at least a single-lumen catheter shaft 4 (shown here in abbreviated form), 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 includes the distal shaft 7 and has an optional distal thickening portion 8 and a distal tip portion 9.

[0062] The placement aid 10, located in the proximal region 2 of the urethral balloon catheter 1, is pulled slightly proximal, releasing the distal portion 5a of the balloon 5. The distal portion 5a of the balloon 5 is inflated. The remaining portion of the balloon 5 remains within the placement aid 10 and cannot be expanded by the applied inflation pressure.

[0063] Figure 4 shows a urethral balloon catheter 1 according to the present invention as shown in Figure 3, having a proximal region 2 and a distal region 3. The proximal region 2 includes at least a single-lumen catheter shaft 4 (shown here in abbreviated form), 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 includes the distal shaft 7 and has an optional distal thickening portion 8 and a distal tip portion 9.

[0064] The placement aid 10, located in the proximal region 2 of the urethral balloon catheter 1, is being pulled further proximal, completely releasing the balloon 5. The balloon 5 is fully inflated. [Explanation of symbols]

[0065] 1. Urethral balloon catheter 2. Proximal region of the urethral balloon catheter 3. Distal region of the urethral balloon catheter 4. Dual-lumen catheter shaft 5. Drug-coated balloons (DCB) 6. Distal extension 7. Distal shaft 8. Distal thickened area 9. Distal tip 10 Placement aids p distal d Proximal

Claims

1. A balloon catheter for transurethral use, - A catheter shaft (4) having at least one lumen with an inflatable lumen, and an inflatable balloon (5) connected to the distal end of the inflatable lumen in a fluid-permeable manner, in a proximal region (2), - Distal region (3) including a distal shaft (7) having a distal tip (9) Equipped with, The balloon (5) is coated with a drug, and a placement aid (10) is provided at least within the proximal region (2), and the placement aid (10) is provided in a tubular manner at least within the region of the balloon (5), with respect to its length, the tubular portion being at least the length of the balloon (5). A balloon catheter characterized by the following features.

2. The balloon catheter according to claim 1, wherein the catheter shaft (4) is provided having at least a double lumen having an inflation lumen and an exhaust lumen, the distal end of the exhaust lumen is terminated by being open at the distal tip (9), and when the tip (9) enters a full bladder, urine is discharged.

3. The balloon catheter according to claim 2, characterized in that the distal end of the discharge lumen is terminated by opening outward at the distal tip portion (9).

4. The balloon catheter according to any one of claims 1 to 3, characterized in that the distal region (3) includes a thickened portion (8) proximal to the distal tip portion (9).

5. The balloon catheter according to any one of claims 1 to 4, characterized in that the placement aid (10) is formed from a low-friction material, particularly PTFE or ePTFE.

6. The balloon catheter according to any one of claims 1 to 5, characterized in that the drug is a drug having a cell proliferation inhibitory effect or an antiproliferative effect, particularly paclitaxel or sirolimus, preferably paclitaxel.

7. A balloon catheter according to any one of claims 1 to 6, characterized in that an extension (6) is provided distal to the balloon (5) for fixing the distal shaft (7) to the proximal region (2), and the extension (6) is preferably made of polyamide.

8. The balloon catheter according to any one of claims 1 to 7, characterized in that the distal region (3) is 4 to 8 cm long, particularly 5 to 6 cm long, and the distal tip (9) occupies 1 to 5 cm, preferably 2 to 3 cm, of that region.

9. The balloon catheter according to any one of claims 1 to 8, characterized in that the outer diameter of the distal tip portion (9) is 6 to 8 French (2 to 2.667 mm).

10. The balloon catheter according to any one of claims 1 to 9, characterized in that the catheter shaft (4) has an outer diameter of 3 to 6 Frenchs (1 to 2 mm), particularly 4 to 5 Frenchs (1.333 to 1.667 mm).

11. The balloon catheter according to any one of claims 1 to 10, characterized in that the balloon is manufactured from a material selected from the group consisting of polyamide; block copolymer of polyamide, polyether and polyester; polyester, polyurethane and / or polyolefin.

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