Transurethral balloon catheter with different balloons

Abstract

The invention relates to a balloon catheter (1) for transurethral use, comprising an at least two-lumen catheter shaft (2) having a first inflation lumen (3a) and a second inflation lumen (3b) and a first inflatable balloon (6), wherein the first balloon (6) is fluidically connected to the first inflation lumen (3a) via a first opening (4), and a second inflatable balloon (7), wherein the second balloon (7) is fluidically connected to the second inflation lumen (3b) via a second opening (5), wherein the first balloon (6) is made from Pebax or silicone and the second balloon (7) from nylon or latex. A balloon catheter (1) equipped in this way is easy to handle and is advantageous particularly in the treatment of benign prostatic hyperplasia.

Description

[0001] RBBN0103

[0002] December 11, 2025

[0003] XD / KM

[0004] Balloon catheters with different balloons

[0005] The invention relates to a balloon catheter, in particular a balloon catheter for the treatment of benign prostatic hyperplasia, wherein the balloon catheter comprises at least two balloons.

[0006] Benign prostatic hyperplasia (BPH) refers to a non-cancerous enlargement of the prostate gland. In its early stages, it can be treated with medication with considerable success.

[0007] In later stages, when the enlarged prostate significantly obstructs the normal flow of urine or other complications that can no longer be controlled conservatively occur, surgery is usually indicated.

[0008] Nowadays, various surgical options are available. The gold standard is considered to be transurethral resection of the prostate, in which part of the prostate is removed by scraping or peeling.

[0009] Even though this surgical procedure leads to good results in the long term, intraoperative complications, especially bleeding, as well as postoperative complications such as urinary incontinence and loss of ejaculation, are very serious, as they often result in a reduction in the quality of life for those affected.

[0010] It would therefore 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.

[0011] Furthermore, it would be desirable for an alternative device for use in the treatment of benign prostatic hyperplasia to be easily placed inside the urethra, without the need for costly imaging procedures such as X-ray or ultrasound equipment.

[0012] It is therefore an object of the invention to provide a device that does not have the aforementioned disadvantages and is particularly suitable for use in non-invasive treatment, especially of benign prostatic hyperplasia.

[0013] Balloon catheters are used in a wide variety of medical applications. They are fundamentally characterized by the presence of an inflatable balloon, which is typically inflated inside the patient's body by the introduction of a liquid medium.

[0014] The balloon can be used to widen certain sections of the body, for example narrowed blood vessels, but the balloon can also be used for the transmission and delivery of medication.

[0015] Balloon catheters for the treatment of benign prostatic hyperplasia are known in the prior art. EP 3 442 612 A1, for example, describes such a catheter with constrictions in the balloon, the constrictions being considered advantageous for the placement and application of a drug.

[0016] However, the known balloon catheters for treating benign prostatic hyperplasia have several disadvantages. In particular, while the prior art recognizes the problem that the balloon of a balloon catheter should be better fixed during placement and subsequent inflation to prevent dislocation, the only regularly offered solution is to sequentially divide the balloon, for example, by making it stepped or with constrictions. Further modifications to the balloon section of the catheter could, however, be advantageous. Accordingly, the object of the invention is to provide a balloon catheter that offers an improved or at least alternative solution for the placement and fixation of the balloon at the inflation site.

[0017] This problem is solved by an invention with 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 technologically meaningful way, thus revealing further embodiments of the invention.

[0018] The urethral balloon catheter according to the invention, hereinafter also referred to as a balloon catheter for the sake of simplicity, is intended for transurethral use and comprises a catheter shaft with at least two lumens, having a first and a second inflation lumen, and at least a first or proximal and at least a second or distal inflatable balloon, wherein the first inflation lumen is fluid-permeable to the first balloon and the second inflation lumen is fluid-permeable to the second balloon.

[0019] The first and second balloons are arranged sequentially at the distal end of the catheter; therefore, when referring to a first or proximal balloon, this first or proximal balloon is located proximal to the second or distal balloon, but according to the invention, still at the distal end of the catheter.

[0020] The term "proximal" refers to the area along the catheter that points towards the user, and "distal" refers to the area that points away from the user. The catheter tip is positioned distally. A forward movement thus indicates a distal movement, and a backward movement indicates a proximal movement. The positions of the balloons and other spatial relationships are illustrated in the figures.

[0021] Optionally, the urethral balloon catheter includes a catheter shaft with at least three lumens, comprising a first and a second inflation lumen and an additional third lumen, which is intended, for example, as a drainage lumen for draining urine or other fluids, as a guidewire lumen for receiving a guidewire, or as an application lumen for applying a fluid, such as a drug or lubricant.

[0022] The urethral balloon catheter according to the invention further comprises a flexible distal shaft arranged distal to the distal balloon and a distal tip.

[0023] Optionally, the distal shaft includes a thickened section located proximally at the tip.

[0024] In embodiments with a third lumen, the distal end of the third lumen terminates openly at the distal tip, preferably laterally outwards. If the third lumen is, for example, designed as a drainage lumen, the attending physician can determine that the distal tip has reached the bladder by observing the outflow of urine from the proximal end of the drainage lumen.

[0025] If the third lumen is intended as an application lumen, the arrangement of the distal opening of this lumen in the distal tip facing laterally outwards is also preferred here.

[0026] If the third lumen is intended as a guide wire lumen, the arrangement of the distal opening centrally located in the distal tip is preferred.

[0027] A tubular placement aid may optionally be provided at least in the area of ​​the balloons, wherein the tubular section has a length at least equal to that of the first, proximal balloon, i.e., extends at least from the distal end of the proximal balloon to the proximal end of the proximal balloon.

[0028] The part of the urethral balloon catheter comprising the catheter shaft and the proximal balloon will hereinafter also be referred to as the proximal catheter area.

[0029] The part of the urethral balloon catheter comprising the distal shaft with an optionally thickened section as well as a distal tip and the distal balloon shall hereinafter also be referred to as the distal catheter section.

[0030] It can be useful to equip at least some sections of the balloons or balloon catheter with radiopaque markers for visualization in imaging procedures, particularly angiography. The markers are preferably placed on the catheter shaft to identify the respective structure located in that area, such as a balloon. A marker between the balloons can also be helpful for optimal catheter placement.

[0031] It is particularly advantageous to include at least one such marker in the distal balloon, especially when the balloon catheter is intended for use as a urethral catheter for the treatment of benign prostatic hyperplasia. This allows the treating physician to see on the X-ray when the distal balloon segment is located within the patient's bladder.

[0032] It remains advantageous to include at least one such marker in the proximal balloon, especially when the balloon catheter is intended as a urethral catheter for the treatment of benign prostatic hyperplasia. This allows the treating physician to see on the X-ray when the proximal balloon segment is within the patient's prostate. For this purpose, two markers can be provided, specifically to indicate the beginning and end of the coating.

[0033] Additional markers may be provided to better determine the position of the balloon catheter; in particular, another marker may be provided between the distal and the proximal balloon.

[0034] The inflation lumens extend from the proximal end of the urethral balloon catheter to the inflatable balloons. The optional third lumen extends from the proximal end of the urethral balloon catheter to the tip of the distal shaft.

[0035] To secure the distal shaft to the rest of the balloon catheter, a process made of polyamide or a similarly robust and rigid material, such as that used for the balloon, is preferably provided on the distal portion of the balloon catheter. The distal shaft can be secured to this process. Accordingly, the process itself and the proximal portion of the distal shaft overlap in the area of ​​the process.

[0036] The extension continues the third lumen of the catheter shaft, and the distal shaft also includes a corresponding third lumen which, when fixed to the extension, continues the third lumen of the catheter shaft.

[0037] The balloons are designed to be inflated and can be reversibly transformed from a compressed state to an expanded state through inflation. Deflation transforms the balloons back into a compressed state.

[0038] According to the invention, the materials and other properties of the two balloons differ.

[0039] According to the invention, the distal balloon serves to fix or anchor the catheter in the patient's bladder. Accordingly, this balloon does not need to be in close contact with the bladder wall and does not need to be inflated with high pressure.

[0040] The distal balloon is preferably made of a polyamide such as Pebax or nylon (polyhexamethylene adipamide); a block copolymer of polyamides, polyethers, and polyesters; polyesters, polyurethanes, and / or polyolefins; or latex. Nylon and latex are preferred because balloons made of these materials can be inflated at low pressure, which is advantageous in terms of handling.

[0041] The distal balloon has dimensions that allow for easy anchoring in the bladder; in particular, its diameter is larger than that of the urethra following the bladder. The distal balloon preferably has an approximately spherical shape with a diameter of 1 to 6 cm, preferably 1.5 to 4 cm, and particularly with a diameter of 2 cm.

[0042] Naturally, the distal balloon can also have any other shape, provided it guarantees secure anchoring of the catheter in the bladder. The balloon can therefore also be elongated, with the aforementioned sizes for the preferred diameters and a corresponding length of 1 to 6 cm, preferably 1.5 to 4 cm, and particularly 2 cm, with combinations of all the aforementioned diameters and lengths being conceivable.

[0043] The distal balloon is designed for inflation pressures between 1 and 10 bar, preferably between 2 and 8 bar, and particularly between 4 and 6 bar. A pressure of 4 bar is preferred as standard.

[0044] The distal balloon is preferably designed to be compliant, but can also be manufactured as a semi-compliant balloon.

[0045] According to the invention, the proximal balloon serves to apply a drug to the vessel wall, particularly in the urethra in the region of the prostate. Accordingly, this balloon must be inflated with a relatively higher pressure than the distal balloon.

[0046] The proximal balloon is preferably made of a polyamide such as Pebax, nylon (polyhexamethylene adipamide); a block copolymer of polyamides, polyethers, and polyesters; polyesters, polyurethanes, and / or polyolefins. Particularly robust materials, such as Pebax or silicone, are preferred. This material selection is advantageous because it allows for the production of tear-resistant balloons that can be inflated to an increased pressure of 2 to 20 bar, preferably 4 to 14 bar, and particularly 6 to 12 bar. A pressure of 8 bar is preferred as standard.

[0047] The proximal balloon has a substantially tubular shape, as is known and common in endovascular balloon catheters. The length of the proximal balloon is 2 to 10 cm, preferably 3 to 8 cm, and particularly 4 to 6 cm. The diameter of the proximal balloon is 6 to 40 mm, preferably 8 to 30 mm, and particularly 12 to 25 mm. All combinations of the aforementioned diameters and lengths are conceivable.

[0048] The proximal balloon is preferably semi-compliant or non-compliant. The proximal balloon can be coated, at least partially, with one or more drugs, the drug preferably being a cytostatic or antiproliferative agent, such as paclitaxel or sirolimus. Preferably, the drug is paclitaxel. However, the applications are not limited to the drugs mentioned above, but include all drugs that can be administered via a balloon catheter, such as anti-inflammatory, antimicrobial, or antifungal drugs.

[0049] By expanding the coated proximal balloon, the drug, in particular paclitaxel, is applied to the urethra and diffuses to the prostate, inhibiting the cell proliferation of the corresponding prostate cells and thereby treating the hyperplasia.

[0050] The distal shaft includes a relatively soft distal tip, which is made of silicone, for example, and may be coated with polytetrafluoroethylene, hydrogel, or a silicone elastomer for lubrication.

[0051] The tip may have a larger diameter at a thickening than the other areas of the balloon catheter.

[0052] The distal section, the distal catheter shaft, is preferably 2 to 7 cm and particularly 3 to 5 cm long, with the tip comprising 1 to 4 cm and preferably 2 to 3 cm of this length. The outer diameter of the distal shaft, and particularly of the distal tip, can be 6 to 8 French (2 to 2.667 mm); the catheter shaft can have an outer diameter of 3 to 6 French and particularly 4 to 5 French.

[0053] The distal shaft or distal tip is preferably made of silicone, the catheter shaft preferably of polyamide.

[0054] At the distal tip, there is optionally at least one opening through which the optional third lumen, which is intended, for example, as a drainage lumen, a guide wire lumen, or an application lumen, opens to the outside.

[0055] The optional opening is preferably located laterally in the distal region of the tip, i.e., in a radial direction. This ensures that urine flow through the drainage lumen is only detected once it reaches the bladder. However, the opening can also be located at the end, i.e., in an axial direction, which is advantageous, for example, when the device functions as a guide wire lumen.

[0056] For treatment, the attending physician can advance the urethral balloon catheter according to the invention into the urethra until at least the distal balloon, i.e., the usually uncoated pilot balloon, is located in the bladder. For further placement of the balloon, the distal balloon can then be inflated by applying pressure as required and subsequently withdrawn to the bladder neck.

[0057] The proximal balloon is now located in the area of ​​the prostate and can also be inflated after any placement aid that may be present has been removed or withdrawn.

[0058] The placement aid is optional and serves, for example, to protect the coating of the proximal balloon.

[0059] If the optional radiopaque markers are attached to the catheter, the positioning of the balloons can also be optionally checked in the X-ray image.

[0060] After sufficient time for medication delivery, the proximal balloon can preferably be deflated first, followed by the distal balloon, and removed from the urethra and bladder. Alternatively, it is also possible to deflate the distal balloon first, followed by the proximal balloon, or both balloons simultaneously.

[0061] The invention further comprises a method for treating benign prostatic hyperplasia using a urethral balloon catheter according to the invention with an optional placement aid, wherein the proximal balloon is coated with a drug, comprising the following steps: A. Providing a urethral balloon catheter according to the invention;

[0062] B. Optional numbing of the urethra by introducing a local anesthetic into the urethra;

[0063] C. Insertion of the urethral catheter into the urethra of a patient requiring treatment for benign prostatic hyperplasia;

[0064] D. Advancement of the urethral catheter into the urethra and, if necessary, further lubrication of the catheter tip by introducing a suitable fluid through an optional third lumen;

[0065] E. Placing the urethral catheter by advancing the catheter into the urethra until the distal balloon lies inside the bladder;

[0066] F. Optional control of the catheter position using X-ray imaging, provided a radiopaque marker is provided in the distal balloon;

[0067] G. Inflating the distal balloon with a pressure of 1 to 10 bar, preferably 4 to 6 atm and particularly with 4 bar;

[0068] H. Withdraw the entire catheter so that the distal balloon becomes lodged in the bladder outlet and blocks it;

[0069] I. Optionally, withdraw the optional placement aid so that the proximal balloon is exposed and no longer covered by the placement aid;

[0070] J. Optional verification of the catheter's position using X-ray imaging, provided that at least one radiopaque marker is provided in the coated proximal balloon; K. Inflating the proximal balloon with a pressure of 2 to 20 atm, preferably 4 to 14 atm and particularly with 6 to 12 atm;

[0071] L. Remaining the catheter in the inflated state until sufficient drug delivery is achieved, which may take 1 to 15 minutes, 4 to 12 minutes and especially 8 to 10 minutes;

[0072] M. Simultaneous or sequential deflation of the balloons;

[0073] N. If necessary, repeat steps (K) to (M) once or several times until sufficient drug delivery is achieved;

[0074] O. Removal of the urethral catheter with deflated balloons by completely withdrawing the urethral catheter from the urethra.

[0075] Furthermore, the invention also includes the use of a catheter according to the invention for the transurethral treatment of benign prostatic hyperplasia, as for example in the methods described above.

[0076] The urethral balloon catheter according to the invention overcomes the disadvantages of conventional balloon catheters for the treatment of benign prostatic hyperplasia.

[0077] The specific selection of materials for the two separate balloons, along with the other described properties of the distal and proximal balloons—such as the ability to inflate them to different pressures and their varying compliance characteristics—surprisingly leads to significantly improved balloon placement and fixation during the intervention, as precise positioning is guaranteed. This can be ensured even without imaging procedures. Furthermore, the bladder neck is protected.

[0078] Additionally, if a drainage lumen is present, the outflow of urine upon penetration of the distal tip into the bladder can indicate that the bladder has been reached. If necessary, additional ultrasound monitoring ensures further safety during the procedure. The invention and its technical context are explained in more detail below with reference to the figures. 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, insofar as it is technically feasible, any combination of the technical features listed in the claims or described as relevant to the invention in the description.

[0079] They show:

[0080] Fig. 1 shows a preferred embodiment of the urethral balloon catheter according to the invention with three lumens.

[0081] Figure 1 shows a preferred embodiment of the urethral balloon catheter 1 according to the invention. For clarity, the balloon catheter 1 is shown in its inflated state. The balloon catheter 1 comprises a catheter tube 2 with preferably three lumens 3a, b, c. The first lumen 3a comprises a first opening 4 and the second lumen 3b comprises a second opening 5.

[0082] The balloon catheter 1 further comprises a first proximal balloon 6 and a second distal balloon 7, wherein the first opening 4 of the first inflation lumen 3a is fluid-permeable to the proximal balloon 6 and the second opening 5 of the second inflation lumen 3b is fluid-permeable to the distal balloon 7. To improve the visibility of the balloon catheter 1, and in particular the positions of the balloons 6 and 7, in radiographic images, the balloon catheter 1 preferably includes various markers. A first marker 8 is provided in the region of the proximal balloon 6, a second marker 9 in the region of the distal balloon 7, and an optional third marker 10 in the region between the proximal balloon 6 and the distal balloon 7.

[0083] The urethral balloon catheter 1 according to the invention further comprises a flexible distal shaft 11 arranged distal to the distal balloon 7, with an atraumatically shaped tip. The third lumen 3c can be provided as a drainage lumen or alternatively as a guide wire lumen or as an application lumen for the application of a fluid, for example a drug or a lubricating gel to improve the lubrication of the catheter.

[0084] The third lumen 3c terminates distally, open outwards at its distal tip. If the third lumen 3c is intended as a drainage lumen, the treating physician can determine that the distal tip has reached the bladder by observing the outflow of urine from the proximal end of the drainage lumen. In this case, the opening of the third lumen 3c is preferably oriented laterally outwards.

[0085] If the third lumen 3c is intended as an application lumen, the arrangement of the distal opening of this lumen at the distal tip, laterally outwards, is also preferred here.

[0086] If the third lumen 3c is intended as a guide wire lumen, the distal opening is preferably located centrally in the distal tip.

[0087] Optionally, the distal shaft 11 comprises a thickened section 12 arranged proximal to the tip, the diameter of which is preferably larger than the diameter of the rest of the balloon catheter 1.

[0088] Not shown is an optional protective element that is slidably arranged over the proximal 6 and / or distal balloon 7 and is specifically designed to prevent premature detachment of the coating of the balloons 6, 7 and, in particular, premature detachment of the coating and / or the drug of the proximal balloon 6.

[0089] List of symbols

[0090] 1 Urethral balloon catheter

[0091] 2 Catheter shaft 3 Catheter lumen (3a: first inflation lumen; 3b: second inflation lumen; 3c:

[0092] (Drain lumen)

[0093] 4 first opening (of the first inflation lumen)

[0094] 5 second opening (of the second inflation lumen)

[0095] 6 first or proximal balloon 7 second or distal balloon

[0096] 8 first marker

[0097] 9 second marker

[0098] 10 third marker

[0099] 11 distal shaft 12 distal thickening p proximal d distal

Claims

1. Patent claims 1. Balloon catheter for transurethral use comprising a catheter shaft (2) with at least two lumens, comprising a first inflation lumen (3a) and a second inflation lumen (3b); and a first or proximal inflatable balloon (6), wherein the proximal balloon (6) is connected to the first inflation lumen (3a) via a first opening (4) in a fluid-permeable manner; and a second or distal inflatable balloon (7), wherein the distal balloon (7) is connected to the second inflation lumen (3b) via a second opening (5) in a fluid-permeable manner; characterized in that the proximal balloon (6) is made of Pebax or silicone; and that the distal balloon (7) is made of nylon or latex.

2. Balloon catheter according to claim 1, characterized in that the proximal balloon (6) is coated with a drug.

3. Balloon catheter according to claim 1 or 2, characterized in that the distal balloon (6) is compliant or semi-compliant.

4. Balloon catheter according to one of the preceding claims, characterized in that the proximal balloon (7) is semi-compliant or non-compliant is planned.

5. Balloon catheter according to one of the preceding claims, characterized in that the distal balloon (6) can be inflated with a pressure of 1 to 10 bar, preferably 2 to 8 bar and particularly 4 to 6 bar.

6. Balloon catheter according to one of the preceding claims, characterized in that the proximal balloon (7) can be inflated with a pressure of 2 to 20 bar, preferably from 4 to 14 bar and particularly from 6 to 12 bar.

7. Balloon catheter according to one of the preceding claims, characterized in that the balloon catheter (1) comprises radiopaque markers (8, 9, 10) in the region of the first proximal balloon (6) and / or the second distal balloon (7) and / or between the balloons (6, 7).

8. Balloon catheter according to claim 2, characterized in that the drug is paclitaxel.

9. Balloon catheter according to claim 2, characterized in that two radiopaque markers (8) are provided in the area of ​​the first proximal balloon (6), wherein the markers (8) mark the start and end point of the coating.

10. Use of the balloon catheter (1) according to any of the preceding claims in the transurethral treatment of benign prostatic hyperplasia.

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