Bladder instrument for the relief of urine retention

Abstract

A stent for a bladder is provided. The bladder includes a drainage tube, a shell with flexible leaf-shaped sections ("spring leaves") and a string tether. The shell surrounds the drainage tube and the tether is attached to the drainage tube. In addition, the spring leaves are attached at the top of the drainage tube and the spring leaves are attached at the bottom of the shell by a ring with an opening through which the drainage tube can pass freely.

Description

BLADDER INSTRUMENT FOR THE RELIEF OF URINE RETENTIONCROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application Serial No. 63 / 522,110, filed June 20, 2023, which application is hereby incorporated by reference in its entirety.FIELD OF THE INVENTION

[0002] The present invention relates to catheter devices.BACKGROUND OF THE INVENTION

[0003] This section is intended to introduce the reader to various aspects of art that may be related to various aspects of the present invention, which are described and / or claimed below. This discussion is believed to be helpful in providing the reader with background information to facilitate a better understanding of various aspects of the present invention. Accordingly, it should be understood that these statements are to be read in this light, and not as admissions of prior art.

[0004] Underactive bladder (UAB) is a common lower urinary tract symptom in clinical practice and has received increasing attention from clinicians. Its clinical manifestations are dominated by voiding phase symptoms manifested as a slow stream, intermittency, hesitancy, and feeling of incomplete emptying of the bladder. These may be accompanied by storage phase and post-voiding symptoms. Detrusor underactivity (DU) is a diagnosis based on urodynamics and is defined by the International Continence Society (ICS) as “a contraction of reduced strength and / or duration, resulting in prolonged bladder emptying and / or a failure to achieve complete bladder emptying within a normal time span”. There are numerous causes of DU, including advanced age, neurological disease, low-level spinal cord injury, and bladder outlet obstruction. According to epidemiological statistics, DU is diagnosed in up to 48% of elderly men and 45% of elderly women undergoing urodynamic evaluations.

[0005] Voiding is the coordinated activity of the smooth and transverse muscles of the bladder and outlet (consisting of the bladder neck, urethra, and urethral sphincter) under the control of the nervous system. As the bladder is at the lowest level of innervation, disease or injury anywhere in the voiding reflex (especially the sacral nerve and below) can lead to UAB, which contributes to the pathogenesis of the UAB complex. According to The EuropeanAssociation of Urology (EAU), intermittent catheterization (IC) remains the preferred treatment for UAB / DU. This procedure involves a patient being catheterized 3-5 times a day to induce urine flow and reduce residual urine. However, this technique significantly affects the patient’s typical voiding pattern and quality of life, and may result in complications such as urethral stricture, urethral false channel, hematuria, and bacteriuria. In general, treatment choices for UAB / DU remain inadequate, which considerably hampers the ability of clinicians to treat UAB.SUMMARY OF THE INVENTION

[0006] Certain exemplary aspects of the invention are set forth below. It should be understood that these aspects are presented merely to provide the reader with a brief summary of certain forms the invention might take and that these aspects are not intended to limit the scope of the invention.

[0007] In an embodiment of the invention, a stent for a bladder is provided. The bladder includes a drainage tube, a shell with flexible leaf-shaped sections (“spring leaves”) and a string tether. The shell surrounds the drainage tube and the tether is attached to the drainage tube. In addition, the spring leaves are attached at the top of the drainage tube and the spring leaves are attached at the bottom of the shell by a ring with an opening through which the drainage tube can pass freely.

[0008] In one embodiment, the tether is attached to the base of the drainage tube. In another embodiment, the drainage tube is hollow. In one embodiment, the drainage tube has a diameter in the range of 4 to 5 mm. In another embodiment, the drainage tube has a length in the range of 3 to 5 cm. In one embodiment, the shell has an undeformed diameter equal to the length of the drainage port tube. In another embodiment, the spring leaves are only attached to each other at the top of the drainage tube and the ring. In one embodiment, the tether comprises a bead attached to the tether at the terminal end.

[0009] In another embodiment of the invention, a device intended to facilitate urination in a subject is provided. The device includes a bladder stent as described above, an insertion tool and a removal tool. In one embodiment, the insertion tool comprises a hollow tube capable of containing the bladder stent in a collapsed state. In another embodiment, the removal tool comprises a hollow tube capable of containing the bladder stent in a collapsed state.

[0010] In another embodiment of the invention, a method of facilitating urination in a subject in need thereof is provided. The method involves inserting the stent described above into the subject’s bladder via the subject’s urethra and allowing the shell of the stent to expandto an undeformed state, where the tether of the stent remains in the urethra. Then activating the stent for urination by pulling the tether to move the drainage tube into the urethra past the subject’s urethral sphincter a sufficient distance for urine to empty from the bladder through the drainage tube. Finally, the tether is released, allowing the drainage tube to retract back into the bladder. In one embodiment, the tether is pulled into the urethra by a distance in the range of 3-4 cm. In another embodiment, the stent remains in the bladder for a period of time from 2 days to 29 days.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The objects and advantages of the disclosed invention will be further appreciated in light of the following detailed descriptions and drawings in which:

[0012] FIG. 1A is an image of a catheter according to the present invention where the catheter is in a resting state.

[0013] FIG. IB is an image of a catheter according to the present invention where the catheter is at full deflection.

[0014] FIG. 2A is an image of a CC Stent according to the present invention within a bladder and urethra showing the stent resting in the bladder.

[0015] FIG. 2B is an image of a CC Stent according to the present invention within a bladder and urethra showing tension applied to the tether.

[0016] FIG. 2C is an image of a CC Stent according to the present invention within a bladder and urethra showing a fully deployed drain tube.

[0017] FIG. 3 is an image of an insertion tool according to the present invention.

[0018] FIG. 4A is an image of a removal tool according to the present invention.

[0019] FIG. 4B is an image of a device according to the present invention.

[0020] FIG. 5A is an image of a top view of a stent according to the present invention.

[0021] FIG. 5B is an image of a bottom view of a stent according to the present invention.

[0022] FIG. 5C is an image of a perspective view of a stent according to the present invention.

[0023] FIG. 5D is an image of a perspective view of a stent according to the present invention.

[0024] FIG. 6A is an image of a stent according to the present invention in a deployed state.

[0025] FIG. 6B is an image of a stent according to the present invention in an undeployed state.

[0026] FIG. 7A is an image of a stent according to the present invention in a compressed state.

[0027] FIG. 7B is an image of a stent according to the present invention in a nearly fully restored state.

[0028] FIG. 7C is an image of a stent according to the present invention in a rebounded state.

[0029] FIG. 7D is an image of a stent according to the present invention in a restored state.

[0030] FIG. 8 is an image of a stent according to the present invention in an undeployed state in a bladder model.DEFINITIONS

[0031] The present disclosure may be understood more readily by reference to the following detailed description of the embodiments taken in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this application is not limited to the specific devices, methods, conditions or parameters described and / or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting. Also, in some embodiments, as used in the specification and including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and / or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.

[0032] As used herein, the term “spring leaves” means leaf-shaped structures that can recoil into their original position after an applied force is released. Alternative shapes may also function as spring leaves, including rectangular bars and spiral configurations.DETAILED DESCRIPTION OF THE INVENTION

[0033] One or more specific embodiments of the present invention will be described below. In an effort to provide a concise description of these embodiments, all features of an actual implementation may not be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project,numerous implementation-specific decisions must be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0034] In one embodiment, the present invention involves a mechanical prosthetic device intended to facilitate urination in patients with an underactive bladder detrusor muscle disorder. The present invention provides a novel design, referred to herein as the “Comfort Catheter” or “CC ” This device overcomes many of the problems associated with conventional indwelling and intermittent catheters.

[0035] The CC device is inserted externally through the urethra into the bladder. In one embodiment, the CC is made of biocompatible material. The CC can remain in the human bladder for prolonged time periods. In one embodiment, the CC is capable of remaining in the human bladder for up to 29 days. However, unlike a conventional indwelling catheter, the CC does not leave a drainage port tube in the urethra full time. Only a thin tether remains in the urethra. This tether is attached to the drainage port tube. The CC drainage port tube remains retracted into the bladder until pulled into the urethra to facilitate urination. To activate, the patient gently pulls the tether to move the drainage port into the urethra past the urethral sphincter (valve) a sufficient distance for urine to empty from the bladder through the port. In one embodiment, tether is pulled approximately 3-4cm.

[0036] The port only remains in the urethra while tension is maintained on tether. When the tether is relaxed, the port tube is retracted back into the bladder by spring force. The CC system consists of three components: a bladder stent (depicted in FIGs 1 and 2), an insertion tool (depicted in FIG. 3), and a removal tool (depicted in FIG. 4A).Comfort Catheter Bladder Stent

[0037] In one embodiment, the CC Bladder Stent is a monolithic tube and spring body comprised of an ISO 10993 complaint biocompatible elastomer material. A representative embodiment of the stent of the present invention is depicted in FIGs 1 A and IB. The stent 100 has a hollow drainage port tube 110 of approximately 14 French diameter (4.62 mm), and approximately 4 cm long, surrounded by a shell of spring leaves 120 with an undeformed diameter equal to the length of the drainage port tube. The spring leaves 120 are attached at the top of the drainage port tube 110. The spring leaves 120 are joined at the bottom by a ringwith an opening 130 through which the drainage port tube can pass freely. A string tether 140 is attached to the base of the drain tube. The resting state of the stent 100 is depicted in FIG. 1A, while the activated state of maximum deflection is depicted in FIG. IB. The activated state, with the drain tube 100 is extended past the spring leaves 120, through the base opening 130, by applying a tensile force to the tether 140.

[0038] When the CC stent is inserted into the bladder, the spring leaves rest against the bladder walls 180 (FIG. 2A). In the resting state (no tension on the tether, shown in FIGs 1 A and 2A) the stent maintains a spherical shape with the drainage tube fully retracted into the bladder and out of the urethra (FIG. 2A). The sting tether extends from the drainage tube into the proximal urethra, emerging from the distal urethra. In one embodiment, a bead 150 terminates the free end of the sting tether to prevent the tether from retracting into the distal urethra.

[0039] The primary function of the string tether 140 is to deploy the CC drain tube through the urethra to facilitate urination. When tension is applied to the tether the spring leaves deflect allowing the drain tube to pass into the proximal urethra (FIG. 2B). As tension is maintained on the tether the drain tube is drawn past the urethral sphincter muscle until the tip of the drain tube reaches the distal urethra (FIG. 2C). When the stent reaches the fully deflected state (depicted in FIGs IB and 2C) the drain tube provides an unobstructed channel for urine to drain from the bladder.

[0040] The string tether 140 also serves to maintain the orientation of the stent with the drainage port tube pointing toward the urethra, as well as facilitating removal of the stent from the bladder. The CC stent is capable of remaining in the bladder for an extended period (< 29 days), like a conventional indwelling urinary catheter.Advantages of the CC over conventional catheters

[0041] Unlike an indwelling catheter, the drain tube does not remain inside of the urethra. The drain tube is only intermittently in the urethra when the patient needs to urinate, minimizing discomfort and risk of infection associated with indwelling catheters. Furthermore, the CC does not require a urine collection bag. Unlike conventional intermittent catheters, the CC does not need to be externally inserted into the urethra multiple times per day to urinate.Comfort Catheter Insertion Tool

[0042] A tubular insertion tool (see FIG. 3) is used to place CC in the bladder. The stent is packaged in a collapsed state, within a hollow tube. The tubular insertion tool 300 includesa handle 320 and a tube 330. In one embodiment, the tube 330 has a maximum outer diameter of 24 French (approximately 8 mm) and an inner diameter sufficient to contain the collapsed stent, and a length >50 mm. The inner and outer surfaces of the tube 330 are coated with a biocompatible lubricant. The stent is oriented within the tube 330 such that the tether extends from the base. A hollow plunger (not shown) enters the base of the tube, encircling the tether. This entire assembly is prepackaged in a sterilized state.

[0043] To deploy the stent into the bladder, the insertion tool is inserted into the urethra approximately 40mm. Next, the plunger is pressed toward the urethra to push the stent into the bladder. Once out of the insertion tool, the stent opens to the previously described resting state, where it is retained in the bladder. The insertion tool is backed out of the urethra once the stent has opened to the resting state. The tether remains in the urethra after the insertion tool is removed.Comfort Catheter Removal Tool

[0044] Like the stent insertion tool, the stent removal tool 400 (see FIG. 4) comprises a hollow tube 410 and a removal tool handle 420. In one embodiment, the tube 410 has a diameter of 24 French (approximately 8 mm) and a length > 50mm, terminating in a flange with a diameter > 24 French. The tip of the tube 410 is shaped to ease insertion into the urethra and facilitate retraction of the stent. The removal tube’s inner and outer surfaces are coated in a biocompatible lubricant. The tube has a hook 440 that can pull the tether attached to the device and bring the folded device through the hollow tube 410.

[0045] To remove the Comfort Catheter stent, the removal tool 400 is placed around the tether and pressed into the urethra from the flange end (FIGs 4A and 4B). Once fully inserted into the urethra, tension is applied on the tether to pull the stent into the removal tool. As the spring leaves deform past normal maximum deflection, the stent inverts (like a sock being pulled back from the toe end through the opening). Once the drain tube is pulled past the base flange of the removal tool, the entire removal tool and collapsed stent are removed from the urethra.

[0046] Referring to FIG 4B, a device 500 is shown in an assembled form for removal of a stent from a subject’s bladder. The device 500 includes the removal tool 400 and the insertion tool 300 and it is attached to the stent 100.

[0047] FIGs 5A-5D are images of the stent of the present invention. FIG. 5A is an image of a top view of the stent. FIG. 5B is an image of a bottom view of the stent. FIG. 5C is animage of a perspective view of the stent. FIG. 5D is an image of another perspective view of the stent.

[0048] FIGs 6A and 6B show the stent in a deployed and undeployed state. FIG. 6A is an image of the stent in a deployed state. FIG. 6B is an image of the stent in an undeployed state.

[0049] FIGs 7A-7D are photos of the stent in various states. FIG. 7A is an image of the stent in a compressed state. FIG. 7B is an image of the stent in a nearly fully restored state. FIG. 7C is an image of the stent in a rebounded state. FIG. 7D is an image of the stent in a restored state.

[0050] FIG. 8 is an image of a stent according to the present invention in an undeployed state in a bladder model.

[0051] Although not described in detail herein, other steps which are readily interpreted from or incorporated along with the disclosed embodiments shall be included as part of the invention. The embodiments that have been described herein provide specific examples to portray inventive elements, but will not necessarily cover all possible embodiments commonly known to those skilled in the art.

Claims

What is claimed is:

1. A stent for a bladder comprising: a. a drainage tube, the tube having a top opening and a base; b. a shell comprising flexible leaf-shaped sections (“spring leaves”), the shell having a top and a bottom, wherein the shell surrounds the drainage tube; and c. a string tether, wherein the tether is attached to the drainage tube; wherein the spring leaves are attached at the top of the drainage tube and the spring leaves are attached at the bottom of the shell by a ring with an opening through which the drainage tube can pass freely.

2. The stent of claim 1 wherein the tether is attached to the base of the drainage tube.

3. The stent of claim 1 wherein the drainage tube is hollow.

4. The stent of claim 1 wherein the drainage tube has a diameter in the range of 4 to 5 mm.

5. The stent of claim 1 wherein the drainage tube has a length in the range of 3 to 5 cm.

6. The stent of claim 1 wherein the shell has an undeformed diameter equal to the length of the drainage port tube.

7. The stent of claim 1 wherein the spring leaves are only attached to each other at the top of the drainage tube and the ring.

8. The stent of claim 1 wherein the tether comprises a bead attached to the tether at the terminal end.

9. A device intended to facilitate urination in a subject comprising: a. a bladder stent according to claim 1; b. an insertion tool; and c. a removal tool.

10. The device of claim 9 wherein the insertion tool comprises a hollow tube capable of containing the bladder stent in a collapsed state.

11. The device of claim 9 wherein the removal tool comprises a hollow tube capable of containing the bladder stent in a collapsed state.

12. A method of facilitating urination in a subject in need thereof, the method comprising: a. inserting the stent of claim 1 into the subject’s bladder via the subject’s urethra;b. allowing the shell of the stent to expand to an undeformed state, wherein the tether of the stent remains in the urethra; c. activating the stent for urination by pulling the tether to move the drainage tube into the urethra past the subject’s urethral sphincter a sufficient distance for urine to empty from the bladder through the drainage tube; and d. releasing the tether, allowing the drainage tube to retract back into the bladder.

13. The method of claim 12 wherein the tether is pulled into the urethra by a distance in the range of 3-4 cm.

14. The method of claim 12 wherein the stent remains in the bladder for a period of time from 2 days to 29 days.

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