ADAPTER, PROCESS AND USE FOR INSTILLATION OF AGENTS INTO THE BLADDER THROUGH THE URETHRA WITHOUT CATHETER

Abstract

An adapter suitable for direct introduction of an active agent, or a contrast agent, into the bladder of a male or female patient without the use of a catheter has an elongated body that defines an internal through passageway and a toroidal sealing collar that surrounds the elongated body at a distal end portion of the elongated body. The distal end portion terminates in a rounded off tip-part sized for insertion into the urethra of the patient. The proximal end portion of the elongated body is adapted for connection to a dosing device.

Claims

1. An adapter suitable for introduction of an active and/or contrast agent directly into a bladder of a male or female patient through an external urethral orifice and comprising an elongated body defining an internal through passageway and having a distal end portion which terminates in a rounded off tip-part sized for insertion into the urethra through said external urethral orifice and a proximal end portion adapted for connection to a dosing device; and a toroidal sealing collar on the distal end portion, spaced from the rounded off tip-part, and having a front face adapted for sealing contact with said external urethral orifice.

2. The adapter in accordance with claim 1 wherein the toroidal sealing collar has a flat front face.

3. The adapter in accordance with claim 1 wherein the toroidal sealing collar has a knurled external periphery.

4. The adapter in accordance with claim 1 wherein said front face is spaced from the rounded off tip-part at a distance in the range of about 8 millimeters to about 12 millimeters.

5. The adapter in accordance with claim 1 wherein the front face is spaced from the rounded off tip-part at a distance of about 10 millimeters.

6. The adapter in accordance with claim 1 wherein the toroidal sealing collar has an outside diameter in the range of about 12 millimeters to about 20 millimeters and a thickness in the range of about 2 millimeters to about 5 millimeters, and wherein the rounded off tip-part has a diameter of about 6 millimeters.

7. The adapter in accordance with claim 1 wherein the toroidal sealing collar has an outside diameter of about 15 millimeters and a thickness of about 3 millimeters, and wherein the rounded off tip-part has a diameter of about 6 millimeters.

8. The adapter in accordance with claim 1 wherein edges of the toroidal sealing collar are chamfered to about 45 degrees.

9. The adapter in accordance with claim 1 wherein the internal through passageway in the distal end portion has a constant internal diameter less than the internal diameter in said proximal end portion.

10. The adapter in accordance with claim 1 wherein the proximal end portion is adapted to receive a Luer Slip tip of a syringe.

11. The adapter in accordance with claim 1 wherein the proximal end portion is adapted to receive a Luer Lock tip of a syringe.

12. The adapter in accordance with claim 1 made of a human therapy suitable flexible material.

13. The adapter in accordance with claim 1 made of a human therapy suitable thermoplastic elastomer.

14. The adapter in accordance with claim 1 made of a human therapy suitable silicone.

15. The adapter in accordance with claim 1 made of a human therapy suitable polystyrene.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0028] FIG. 1A shows a top view of the adapter of the invention.

[0029] FIG. 1B shows one side view of the adapter of the invention,

[0030] FIG. 1C shows another side view of the adapter of the invention,

[0031] FIG. 1D shows a bottom view of the adapter of the invention.

[0032] FIG. 2 shows use of the adapter in a Luer Slip fitting,

[0033] FIG. 3 shows use of the adapter in a Luer Lock fitting.

DETAILED DESCRIPTION OF THE INVENTION

[0034] According to the definitions and notations of the FIGS. 1A to 3, the adapter according to the invention can be described as follows.

[0035] In FIG. 1 enclosed to the specification, the 6 adapter according to the invention is presented in three views, namely top-view (FIG. 1A), side-view (FIGS. 1B and 1C) and bottom view (FIG. 1D).

[0036] The side view is presented in two versions: in a basic segment version (FIG. 1B) and in a half view-half segment version (Fig. C).

[0037] The 6 adapter according to the invention has three parts as clearly shown in the side view of FIG. 1B and FIG. 1C: the 1 tip-part fitting directly to the urethra through the external urethral orifice, the 2 sealing collar preventing leakage of agent, advantageously liquid injected into the urethra, and the 3 cylindrical connecting part, connecting to the 4 appropriate part of the dosing device, advantageously to one of the type of ISO 594 standard Luer Taper tip, either to Luer Slip or to Luer-Lock tip of the syringe by known method, advantageously precisely connected or built on.

[0038] Concerning Luer Slip fitting, the 3 cylindrical connecting part of the adapter is connected by a standard conic tip, concerning Luer Lock fitting, the connection is additionally also fixed by thread or a bayonet lock in case of high pressure injection.

[0039] As in the case low pressure is used, according to the solution of our invention, such a fixation is not needed even concerning Luer Lock fitting, so the 3 cylindrical connecting part can be simply fitted to the Luer Lock tip also by pressing together and held by friction similar to Luer Slip fitting.

[0040] In FIG. 2, Luer Slip fitting and in FIG. 3 Luer Lock fitting are presented, and is also shown and signed in both Figures, that according to the solution of the invention the external circumference of the 2 sealing collar is 7 knurled to facilitate adjusting and removal to the external urethral orifice by hindering the slipping.

[0041] As clearly shown in all three views of FIG. 1, the 6 adapter according to the invention is provided with a 5 central, longitudinal inner through hole through which the agent, advantageously the liquid gets from the dosing device, advantageously from liquid dosing device, advantageously from syringe, further advantageously from infusion device through the 1 tip part and 3 cylindrical connecting part into the external urethral orifice and then into the urethra. The parts of 5 central, inner through hole of 1 tip-part and of 3 cylindrical connecting part of the 6 adapter according to the invention have advantageously different “c” and “f” diameters.

[0042] An important characteristic of the adapter according to the invention and also presented in top and side view of FIG. 1 is, that the 1 tip-part to be inserted into the orifice of the urethra is rounded off specially, its surface, and edges are softened, thus the inner wall of the urethra would be not injured even if a precise coaxial insertion cannot be achieved.

[0043] The characteristic sizes of the different parts of the adapter according to the invention are shown by small letters in the figures.

[0044] According to the side view of FIG. 1B, the “a” length of the 1 tip-part to be inserted into external urethral orifice is advantageously 8 to 12 mm especially advantageously 10 mm to assure safe fitting and its “b” diameter is advantageously 6 mm (18 French) corresponding to an average catheter diameter and can be inserted in the overwhelming majority of cases without difficulty into the urethra.

[0045] As can be seen in the top view of FIG. 1A, the advantageous “c” diameter of the 5 central, longitudinal inner through hole of the 1 tip-part to be inserted into the urethra is advantageously 1.8 mm to 3.5 mm, especially advantageously 2.5 mm so that a thick gel-like solution or suspension can be injected with small resistance into the urethra.

[0046] A further characteristic of the invention is that the edges of the tip of the hole are softened by fine machining.

[0047] The end of the 1 tip-part according to the solution of the invention has a softened shape, so, that no sharp edges causing mucosal lesion should remain. The round-off radius at the 1 tip part's end is no single data, its tolerance is 1 mm downwards (smaller) or 2 mm upwards (larger). The round off and softening are also applied outward and inward to the 5 central, inner through hole.

[0048] According to the top view and bottom view of FIG. 1, FIGS. 1A and 1D, respectively, the 2 sealing collar of the adapter according to the invention is a disk. The “d” diameter of the disk is advantageously 12 mm to 20 mm, specially advantageously 15 mm and the “e” thickness of the disk is advantageously 2 mm to 5 mm especially advantageously 3 mm as illustrated in the side view of FIG. 1B, The disk fits over the roughly round or oval shaped external urethral orifice, and assures perfect sealing without leakage.

[0049] The mucous surfaces close to the external urethral orifice are sensitive even to microscopic lesion, therefore the edges of the disk as a solution by the invention are chamfered to 45 degrees or rounded off in a circle advantageously with 1 mm radius and the remaining edges of the disk should also be softened.

[0050] According to the solution of the invention, as shown in the half-segment-half view version of side view in FIG. 1 C and in FIGS. 2 and 3, presenting the Luer Tapers, the external circumference of the 2 sealing collar is 7 knurled to facilitate adjusting and removal to the external urethral orifice by hindering the slipping.

[0051] According to the bottom view of FIG. 1D and side-view of FIG. 1 B, the 5 central, longitudinal internal hole of 6 adapter is shown as hole of 3 cylindrical connecting part. The “f” inner caliber of the 5 central, inner through hole of 3 cylindrical connecting part is advantageously 3.8 mm to 5.2 mm especially advantageously 4.2 mm and “g” outer diameter is advantageously at least 7 mm, specially advantageously 7 mm which characteristic parameters assure the thickness of wall of cylinder for suitable stability.

[0052] According to the side view of FIG. 1B, the “h” length of the 3 cylindrical connecting part is advantageously at least 20 mm, especially advantageously 20 mm, to assure the required visual control for the person performing, the treatment so even dosing devices advantageously syringes with larger diameter (with e.g. 50 ml capacity) cannot hide the adapter being inserted into the external urethral orifice.

[0053] The 3 cylindrical connecting part of the 6 adapter according to the invention is connected by known method, advantageously precisely connected, linked, integrated or built to the 4 appropriate part of the dosing device, advantageously to a syringe, especially advantageously to the ISO 594 standard Luer Slip or Luer Lock tip of the syringe, it can be also a part of the dosing device. The advantageous solutions are illustrated in FIGS. 2 and 3.

[0054] The essential of the catheter-free, for both genders, adults and children, advantageously for women, men and children applicable process according to the invention is, that after fitting, connecting or building the adapter according to the invention to the appropriate part of the dosing device, advantageously to the ISO 594 standard Luer Slip or Luer Lock tip of syringe by known method, the active and/or contrast agent is injected leakage-free into the urethra and/or into the bladder through the external urethral orifice and the urethra, using overpressure, advantageously low overpressure, especially advantageously maximum pressure of 60 water cm for men, male patients and maximum pressure of 30 water cm for women, female patients.

[0055] As an advantageous solution of the invention, the active and/or contrast agent is injected, advantageously slowly injected into the urethra and/or bladder through the external urethral orifice painlessly or by reduced pain, avoiding lesions of urethra, further advantageously injected using gravity pressure, especially advantageously using an infusion device, further advantageously pressing out from balloon or tube, using manual pressure by a method as above, so, that the active agent, advantageously active agent with curative effect or drug, further advantageously diagnostic agent comprising contrast agent should remain in appropriate agent concentration of active ingredient or diagnostic agent also in the urethra in its full length.

[0056] The leakage-free, catheter-free process, injection is implemented by a method, so that the adapter according to the invention fitted or connected by known method—defined and advantageously defined as above—to the dosing device or built on the dosing device, advantageously to the syringe as above, is squeezed to the external urethral orifice, and during injection, the leakage flow is inhibited by the help of the 2 sealing collar of the 6 adapter.

[0057] A primary basic condition of the leakage-free, catheter-free injection process is the steady visibility of the adapter as placed in the urethral orifice whereby any leakage or flow can be detected in due time and eliminated by changing the axial direction and/or the force of squeeze. The visibility depends on the “h” size of characteristic length of the 3 cylindrical connection part (FIG. 1, side view), which size should be advantageously at least 20 mm, especially advantageously 20 mm.

[0058] Further condition of the leakage-free, catheter-free process is that the dosing device, advantageously syringe or infusion device, can be used for injection of active and/or contrast agent, advantageously agents defined as above, into the bladder through the urethra for local treatment or diagnosis of bladder and/or urethra and also for ensuring of the appropriate overpressure.

In addition the process according to invention avoids the superficial lesions and bleedings of the urethra or the mucosa covering the surface of urethra and so the process for the patient is non-invasive painless or pain-reduced.

[0059] The prevention, reducing and avoiding the pain of urethra caused by the intervention itself, and reducing the fear of treatment at the same time, results in a better relaxation, which renders the treatment more tolerable for the patient because reduced overpressure is needed for the injection of agent.

[0060] Further advantage of the catheter-free, non-invasive, humane, leakage-free process according to the invention is that the agents listed above, advantageously agents with curative effect or drug, further advantageously agent, which can be injected comprising diagnostic agent, advantageously liquid, advantageously solution evolve their effect in the urethra itself also, increasing the efficiency of the therapeutic process or diagnostic usage.

[0061] Based on the above the subject matter of our invention, furthermore is a non-invasive, humane, catheter-free process for painless or pain-reduced and leakage-free injection of active and/or contrast agent in liquid, fluid-like, gas or colloid disperse form, advantageously in aerosol, emulsion, gel, foam or suspension form into the urethra or into the urethra and the bladder through the external urethral orifice by using overpressure, advantageously by using manual or gravity pressure in the dosing device, without using a catheter.

[0062] During the process according to the invention, the 3 connecting part of the 6 adapter is connected by known method to the 4 appropriate part of a dosing device, advantageously by a syringe, further advantageously to an infusion device containing the active and/or contrast agent, advantageously to the ISO 594 standard Luer Slip or Luer Lock tip of a syringe, then the active and/or contrast agent is injected, advantageously slowly injected, leakage-free into the urethra or into the urethra and the bladder through the 6 adapter, then through the external urethral orifice by inserting the 1 tip-part of the adapter into the external urethral orifice and squeezing the 2 sealing collar of the adapter in a proper way to the external urethral orifice.

[0063] Using this method, the therapeutic and diagnostic agents defined and advantageously defined as above and as further on for the indications and treatments depending on the injected agents, defined and advantageously defined as above and as further on, can be injected painlessly or pain-reduced into the urethra and/or into the bladder, without using a catheter, any lesion, so that the agent, advantageously liquid or gas, or different agents of colloid disperse systems in appropriate concentration of active agent and/or diagnostic agent, advantageously contrast agent should remain also in the urethra in its full length, to evolve there also their therapeutic and diagnostic effect.

[0064] This causes a gradual increase of the pressure in the urethra and when reaching a certain pressure (retrograde sphincter opening pressure) the sphincter opens and the agent, advantageously the liquid flows into the bladder. This pressure is about 60 cm water column for men, males, and for women, females the average pressure is 30 cm water column lower. These values can be reduced significantly by injection of, advantageously by slow injection of the agent, advantageously liquid, advantageously solution with curative effect or drug solution, and so by avoiding pain in the urethra and reducing the fear of the treatment and by deliberate relaxation. Thus steadily low pressure (30 to 40 cm water column) expands the urethra to a significantly lower extent causing less discomfort and

[0065] The adapter and process according to the invention can be used advantageously for injection of active and/or contrast agents, especially advantageously solution of curative active ingredient or of drug, or of diagnostic agent, advantageously contrast agent into the urethra or into the urethra, and the bladder through the external urethral orifice for local treatment of bladder and/or urethra, further advantageously for bladder filling, bladder rinsing, especially advantageously for intravesical (bladder) instillation or further advantageously for diagnosis.

[0066] Furthermore, the adapter and process according to the invention can be used advantageously for injection active and/or diagnostic agent, advantageously contrast agent in liquid, fluid-like, gas or colloid disperse form, especially advantageously in aerosol, emulsion, gel, foam or suspension form into the urethra and/or bladder through the external urethral orifice for local treatment of bladder and/or urethra, especially advantageously local treatment of interstitial cystitis, bladder pain syndrome, further especially advantageously with analgesic effect, further especially advantageously for local anesthesia, further especially advantageously for local treatment of lower urinary tract symptoms, further especially advantageously for local analgesic after-treatment of patients irradiated for prostate cancer, bladder cancer or pelvic tumor, further especially advantageously for local chemotherapeutical treatment of female patients suffering from bladder cancer.

[0067] Because of the short urethra, the injection of active agents for local chemotherapeutical treatment of bladder can be used only in case of female patients. Because of the larger size of the urethra of male patients and the danger of lesion of the urethra this application cannot be used by men.

[0068] Some advantages of the invention are: [0069] 1. Using the adapter according to the invention by injection of the solution with curative effect or drug solution or diagnostic solution substantially reduces the inconveniences and pain brought about by the treatment. [0070] 2. The catheter-free injection, completely prevents larger and/or smaller mucosal lesions and bleedings of the urethra and serious iatrogenic lesions, as e.g. tardive urethral stricture or chronic bacterial urethritis can be prevented. [0071] 3. In the course of treatment only the sterile agent advantageously solution gets into the urethra and into the bladder, thus the risk of bacterial infection and of developing lower urinary symptoms is reduced. [0072] 4. The process is simple, requires less equipment than bladder filling, bladder instillation with catheter, therefore the treatment without catheter is faster and is less expensive at the same time. [0073] 5. As the drug solution is injected into the bladder through the urethra therefore drug solution with unchanged concentration—here not diluted by urine—remains also in the entire length of the urethra until the following urination (for 2 to 3 hours). Therefore the treatment is more effective, the patients are symptom-free sooner, and the diagnosis of any urethral irregularity or lesion gets easier. [0074] 6. The treatment or diagnosis of urethra solely by the catheter-free process is possible according to the invention. By a process using a catheter, the treatment of urethra is not possible at all. [0075] 7. The cost of production of the adapter and therefore its price is significantly lower than the common price of draining catheter plus of the lubricant gel for the insertion of catheter. Therefore the costs of a process without using a catheter and also the gel for the catheter are significantly lower than the present practice using the process with catheter.

[0076] Thus, using the adapter and process, catheter-free, painless or pain-reduced and leakage-free bladder filling, bladder rinsing, bladder diagnose, advantageously intravesical (bladder) instillation can be implemented without using a catheter. By using the adapter and catheter-free process according to the invention, direct local treatment and diagnosis of the urethra can be implemented, which is impossible by using a catheter.