Bulge anchor for urinary catheter

Abstract

The embodiments disclosed herein are directed to a urinary catheter having a bulge anchor configured to transition from an insertion mode, in which the catheter can be advanced through the urethra, to an anchor mode, in which the catheter is prevented from being retracted proximally. Often, a clinician needs to estimate when the anchor is in the bladder to prevent premature deployment of the anchor that would cause trauma to the patient. The embodiments include an indicator aperture configured to provide a first fluid flow to indicate when the anchor is correctly positioned. The clinician can actuate a locking handle to deploy the anchor and place the drain aperture in fluid communication with the bladder to provide a second fluid flow that is greater than the first fluid flow.

Description

[Technical field]

[0001] The present invention relates to a bulge anchor for a urinary catheter. [Background technology]

[0002] Briefly summarized, the embodiments disclosed herein relate to a bulge anchor for a urinary catheter. Balloon-anchored urinary catheters, such as Foley catheters, rely on expanding a distal portion of the catheter within the bladder to anchor the distal tip therein. The clinician must estimate the length of the urethra to determine when the balloon anchor is within the bladder before expanding to a fixed position. If the balloon anchor is deployed prematurely, the balloon may expand within the bladder neck or urethra, causing trauma to the patient. Similarly, over-insertion of the catheter may cause the tip of the catheter to impinge on the bladder wall, causing pain or discomfort. In addition, the balloon catheter includes a drainage eyelet located distal to the fixation balloon. Thus, when the catheter is fixed within the bladder, a portion of the fluid may collect between the drainage eyelet and the bladder neck, causing fluid stagnation in the bladder. The embodiments disclosed herein are directed to the above. Summary of the Invention

[0003] Disclosed herein is an indwelling urinary catheter comprising: a catheter body defining a lumen; and an anchor disposed at a distal end of the catheter body, transitional between an insertion mode and an anchored mode, the anchor comprising first and second slit valves, each extending longitudinally and defining a first and second arm; and an indicator opening disposed proximal to one or both of the first and second slit valves, configured to provide a first fluid flow to the lumen in both the insertion mode and the anchored mode, wherein the first and second slit valves each define a drain opening to allow a second fluid flow to the lumen in the anchored mode and are configured to prevent a second fluid flow to the lumen in the insertion mode.

[0004] In some embodiments, the first fluid flow is smaller than the second fluid flow. In some embodiments, the indicator aperture communicates with one of the first slit valve or the second slit valve.

[0005] In some embodiments, one or both of the indicator opening and the exhaust opening extend through a sidewall of the catheter body to communicate with the lumen. In some embodiments, the first arm and the second arm define a first outer diameter in the insertion mode and a second outer diameter in the anchoring mode, the first diameter being smaller than the second diameter.

[0006] In some embodiments, the indwelling urinary catheter further includes a locking handle coupled to a proximal end of the catheter body and a string extending through the lumen, wherein a proximal end of the string is coupled to a female part of the locking handle and a distal end of the string is coupled to a distal tip of the catheter body, and a proximal end of the catheter body is coupled to a male part of the locking handle, the female part being slidably engaged with the male part to transition the anchor between the insertion mode and the anchor mode.

[0007] In some embodiments, the female part is configured to slide proximally relative to the male part to transition the anchor into the anchor mode. In some embodiments, the female component includes a channel having a distal lateral channel in communication with a longitudinal channel in communication with a proximal lateral channel, and the male component includes a post extending from its outer surface, the post slidably engages with the distal lateral channel in the insertion mode, the post slidably engages with the proximal lateral channel in the anchoring mode, and the post slidably engages with the longitudinal channel when transitioning between them.

[0008] Also disclosed is a urethral catheter including an outer catheter including a distal opening and a first handle coupled to its proximal end, and an inner catheter coaxially disposed with and slidably engaged to the outer catheter, the inner catheter including a distally disposed anchor transitionable between an insertion mode and an anchored mode, an indicator opening disposed at a distal tip of the inner catheter, a drainage opening disposed proximal to the anchor, and a second handle coupled to its proximal end.

[0009] In some embodiments, the anchor is configured to be advanced distally of the distal opening to transition to the anchoring mode and retracted proximally of the distal opening to transition to the insertion mode.

[0010] In some embodiments, the first handle is coaxially disposed with the second handle along the longitudinal axis and is slidably engaged with the second handle along the longitudinal axis between the first and second configurations to transition the anchor between the insertion mode and the anchor mode.

[0011] In some embodiments, the first handle includes a post extending from an outer surface thereof and the second handle includes a channel having a distal lateral channel in communication with a longitudinal channel in communication with a proximal lateral channel, the post slidably engages with the proximal lateral channel in the insertion mode, slidably engages with the distal lateral channel in the anchoring mode, and slidably engages with the longitudinal channel when transitioning between the insertion mode and the anchoring mode.

[0012] In some embodiments, the anchor is biased toward one of a J-shape or a pigtail shape in the anchor mode and is elastically deformed to a linear shape in the insertion mode where the anchor is retracted proximally into the distal portion of the outer catheter.

[0013] In some embodiments, the anchor is biased toward a linear shape and further includes a tether extending between the distal tip of the inner catheter and the distal tip of the outer catheter, the tether configured to elastically deform the anchor into a non-linear configuration when the anchor is advanced distal to the distal opening.

[0014] In some embodiments, the anchor further includes a first magnetic element biased toward a linear shape and disposed at a distal tip of the inner catheter and a second magnetic element disposed in a wall of the inner catheter proximal to the anchor, the first magnetic element configured to be attracted to the second magnetic element when the second magnetic element is advanced distal to the distal opening to elastically deform the anchor to a nonlinear configuration.

[0015] Also disclosed is an indwelling urethral catheter including: a catheter body defining a lumen; an anchor structure including a tether disposed at a distal end of the catheter body and integrally formed with the catheter body, the tether extending from a distal tip of the catheter body to a proximal end of the anchor structure; an opening extending through a wall of the catheter body and in communication with the lumen, the opening disposed proximal to the anchor structure; and a push rod extending through the lumen and configured to be biased distally to elastically deform the anchor structure from an insertion mode defining a first diameter to an anchor mode defining a second diameter larger than the first diameter.

[0016] In some embodiments, the opening in the insertion mode defines a first opening diameter to provide a first fluid flow, and the opening in the anchor mode defines a second opening diameter larger than the first opening diameter to provide a second fluid flow larger than the first fluid flow.

[0017] Also disclosed is a method of draining fluid from a patient's bladder, the method including: advancing a distal tip of a catheter through the urethra and into the bladder, the catheter including an anchor, an indicator opening, and a drainage opening; advancing the indicator opening into the bladder to provide a first fluid flow indicating that the anchor is correctly positioned to transition from the insertion mode to the anchor mode; transitioning a locking handle between a first configuration and a second configuration; transitioning the anchor from the insertion mode to the anchor mode; and providing fluid communication between the drainage opening and the bladder to provide a second fluid flow different from the first fluid flow.

[0018] In some embodiments, the exhaust opening includes a slit valve disposed proximal to the indicator opening and transitions from a closed position in the insertion mode that prevents the second fluid flow to an open position in the anchor mode that provides the second fluid flow.

[0019] In some embodiments, the catheter includes an outer catheter body and an inner catheter body slidably engaged therewith and coaxially aligned therewith, and transitioning the anchor to the anchor mode includes advancing the anchor and the exhaust opening distal to a distal tip of the outer catheter body.

[0020] In some embodiments, the method further includes a tether extending between the distal tip of the inner catheter body and the distal tip of the outer catheter body, elastically deforming a distal portion of the inner catheter body into a non-linear configuration.

[0021] In some embodiments, the method further includes a first magnetic element disposed at the tip of the inner catheter body and a second magnetic element disposed in a wall of the inner catheter body proximal to the anchor, and transitioning the anchor to the anchor mode includes advancing the first magnetic element and the second magnetic element distal to a distal tip of the outer catheter body to enable the first magnetic element to couple with the second magnetic element and elastically deform a distal portion of the inner catheter body to a nonlinear configuration.

[0022] In some embodiments, transitioning the anchor into the anchor mode further includes advancing a push rod distally through a lumen of the catheter to elastically deform the anchor, the anchor including a tether integrally formed with the anchor and extending from a distal tip of the catheter to a proximal end of the anchor.

[0023] Also disclosed is an indwelling urinary catheter including a catheter body defining a lumen, a locking handle coupled to a proximal end of the catheter body, and an anchor disposed at a distal end of the catheter body and transitionable between an insertion mode and an anchored mode, the anchor including an indicator opening disposed at a first longitudinal position, a drainage opening disposed at a second longitudinal position proximal to the first longitudinal position, and a string extending from a distal tip of the catheter body, on an outer surface of the anchor, through the indicator opening, and through the lumen of the catheter body, the proximal end of the string coupled to the handle.

[0024] A more detailed description of the present disclosure will now be given with reference to certain embodiments illustrated in the accompanying drawings. It will be understood that these drawings represent only typical embodiments of the present invention and therefore should not be considered limiting of its scope. Exemplary embodiments of the present invention will be described and explained with additional features and details using the following accompanying drawings. [Brief description of the drawings]

[0025] [Figure 1] 1 illustrates an exemplary urinary catheter including a bulge anchor and a locking handle, according to embodiments disclosed herein. [Figure 2A] 1 illustrates a lock handle in a first configuration according to an embodiment disclosed herein. [Figure 2B] 1 illustrates a lock handle in a second configuration according to an embodiment disclosed herein. [Figure 2C] 1 illustrates an exploded view of a lock handle according to an embodiment disclosed herein. [Figure 2D] 2D shows an enlarged detail view of the lock handle of FIG. 2C according to an embodiment disclosed herein. [Figure 2E] 2D shows an enlarged detail view of the lock handle of FIG. 2C according to an embodiment disclosed herein. [Diagram 3]2 shows the distal end of the catheter of FIG. 1 positioned within the bladder in an anchored mode, according to an embodiment disclosed herein. [Figure 4A] 2 illustrates the distal end of the catheter of FIG. 1 in an insertion mode, according to an embodiment disclosed herein. [Figure 4B] 2 shows the distal end of the catheter of FIG. 1 in an anchored mode, according to an embodiment disclosed herein. [Figure 5A] 1 shows a perspective view of a catheter including a loop anchor according to an embodiment disclosed herein. [Figure 5B] 5B shows a schematic diagram of the catheter of FIG. 5A according to an embodiment disclosed herein. [Figure 5C] 5B illustrates the distal end of the catheter of FIG. 5A in an insertion mode, according to an embodiment disclosed herein. [Figure 5D] 5B shows the distal end of the catheter of FIG. 5A in an anchored mode, according to an embodiment disclosed herein. [Figure 5E] 5B shows the distal end of the catheter of FIG. 5A positioned within the bladder in an anchored mode, according to an embodiment disclosed herein. [Figure 6A] 1 shows a perspective view of a catheter including a locking handle and a J-anchor according to an embodiment disclosed herein. [Figure 6B] 6B shows a schematic diagram of the catheter of FIG. 6A according to an embodiment disclosed herein. [Figure 6C] 6B shows the distal end of the catheter of FIG. 6A in an insertion mode, according to an embodiment disclosed herein. [Figure 6D] 6B shows the distal end of the catheter of FIG. 6A in an anchored mode, according to an embodiment disclosed herein. [Figure 6E] 6B shows an exploded view of the lock handle of FIG. 6A according to an embodiment disclosed herein. [Figure 6F] 6F shows an enlarged detail view of the lock handle of FIG. 6E according to an embodiment disclosed herein. [Figure 7A]FIG. 1 shows a perspective view of a catheter including a tethered J-anchor according to an embodiment disclosed herein. [Figure 7B] 7B shows a schematic diagram of the catheter of FIG. 7A according to an embodiment disclosed herein. [Figure 8] 1 shows a schematic diagram of a catheter including a magnetic J-anchor according to an embodiment disclosed herein. [Figure 9A] 1 shows a perspective view of a catheter including a push rod anchor according to an embodiment disclosed herein. [Figure 9B] 9B shows a schematic diagram of the catheter of FIG. 9A according to an embodiment disclosed herein. [Figure 9C] 9B shows the distal end of the catheter of FIG. 9A in an insertion mode, according to an embodiment disclosed herein. [Figure 9D] 9B shows the distal end of the catheter of FIG. 9A in an anchored mode, according to an embodiment disclosed herein. [Figure 9E] 9B shows the distal end of the catheter of FIG. 9A positioned within the bladder in an anchored mode, according to embodiments disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Before some specific embodiments are disclosed in more detail, it should be understood that the specific embodiments disclosed herein do not limit the scope of the concepts provided herein. It should also be understood that the specific embodiments disclosed herein may have features that can be easily separated from the specific embodiment and can be combined or substituted in any way with any of the other several embodiments disclosed herein.

[0027] With respect to the terms used herein, it should also be understood that the terms are intended to describe certain particular embodiments, and that the terms do not limit the scope of the concepts provided herein. Ordinal numbers (e.g., first, second, third, etc.) are generally used to distinguish or identify different features or steps within a group of features or steps, and do not provide sequentiality or numerical limitations. For example, the "first," "second," and "third" features or steps need not appear in that order, nor need a particular embodiment that includes such features or steps be limited to those three features or steps. Designations such as "left," "right," "top," "bottom," "front," "rear," and similar terms are used for convenience and are not intended to imply, for example, a particular fixed position, orientation, direction, etc. Rather, such designations are used to reflect, for example, a relative position, orientation, direction, etc. The singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise.

[0028] In the following description, the terms "or" and "and / or" as used herein should be interpreted as being inclusive or meaning any one or any combination. As an example, "A, B or C" or "A, B and / or C" means "any of A, B, C, A and B, A and C, B and C, A and B and C." Exceptions to this definition occur only when combinations of elements, components, features, steps or acts are in some way inherently mutually exclusive.

[0029] For example, references to the "proximal," "proximal portion," or "base end" of a catheter disclosed herein include the portion of the catheter that is intended to be located near the clinician when the catheter is used on a patient. Similarly, for example, the "proximal length" of a catheter includes the length of the catheter that is intended to be located near the clinician when the catheter is used on a patient. For example, the "proximal end" of a catheter includes the end of the catheter that is intended to be located near the clinician when the catheter is used on a patient. The proximal, proximal, or proximal length of a catheter may include the proximal end of the catheter. However, the proximal, proximal, or proximal length of a catheter need not include the proximal end of the catheter. That is, unless the context suggests otherwise, the proximal, proximal, or proximal length of a catheter is not the distal, or distal, length of the catheter.

[0030] For example, references to the "distal," "distal portion," or "tip" of a catheter disclosed herein include the portion of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. Similarly, for example, the "distal length" of a catheter includes the length of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. For example, the "distal end" of a catheter includes the end of the catheter that is intended to be located near or within the patient when the catheter is used on a patient. The distal portion, tip, or distal length of a catheter may include the distal end of the catheter. However, the distal portion, tip, or distal length of a catheter need not include the distal end of the catheter. That is, unless the context suggests otherwise, the distal portion, tip, or distal length of a catheter is not the terminal portion or end length of the catheter.

[0031] To aid in illustrating the embodiments disclosed herein, as shown in Figure 2C, a longitudinal axis extends substantially parallel to the axial length of the catheter, a lateral axis extends perpendicular to the longitudinal axis, and a transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0032] Unless defined otherwise, all technical or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0033] FIG. 1 illustrates an exemplary bulge anchor urinary catheter ("catheter") 100, which generally includes a catheter body 110, a locking handle ("handle") 120, and an anchor 150. The catheter body 110 may include a substantially tubular structure defining one or more lumens 116 and extending longitudinally between a distal tip 112 and a proximal end 114. The catheter body 110 may be formed of a flexible material, such as a plastic, polymer, elastomer, rubber, silicone rubber, or the like. The locking handle 120 may be coupled to a proximal end of the catheter body 110 and may be configured to transition the anchor 150 between an insertion mode and an anchor mode. Additionally, the handle 120 may maintain the anchor in one of the insertion mode and the anchor mode until repositioned. In one embodiment, the handle 120 may include an indicator, such as one or more colored portions, symbols, alphanumeric symbols, or the like, to indicate whether the handle is in one of the first configuration or the second configuration. For example, a portion of the male part 122 may include an indicator, which is covered in the first configuration.

[0034] In one embodiment, the anchor 150 can transition between an insertion mode (e.g., FIG. 4A) and an anchor mode (e.g., FIG. 4B). In the insertion mode, the anchor 150 can define a first outermost diameter (d1). In the anchor mode, the anchor 150 can define a second outermost diameter (d2) that is greater than the first diameter (d1). The first diameter (d1) can be equal to or less than the inner diameter of the urethra. The second diameter (d2) can be greater than the inner diameter of the urethra. In the insertion mode, the anchor 150 can be configured to pass through the urethra and into the bladder 90. In the anchor mode, the anchor 150 can prevent the distal tip 112 from being retracted proximally from the bladder 90.

[0035] 2A-2E show further details of the lock handle 120, including a male part, or first handle 122, slidably engaging with a female part, or second handle 124. FIG. 2A shows the lock handle 120 in a first configuration, e.g., an insertion mode. FIG. 2B shows the lock handle 120 in a second configuration, e.g., an anchor mode. However, it will be understood that in one embodiment, the first configuration can be an anchor mode and the second configuration can be an insertion mode. As shown, the male part 122 is disposed distal to the female part 124, however, it will be understood that other configurations of the lock handle 120 are contemplated, including the female part 124 being disposed distal to the male part 122. These and other configurations of the lock handle 120 are contemplated to be within the scope of the present invention.

[0036] FIG. 2C shows an exploded view of the handle 120. FIG. 2D shows an enlarged detail view of the female part 124, and FIG. 2E shows an enlarged detail view of the male part 122. The male part 122 can define a male part lumen 126, and the female part 124 can define a female part lumen 128. The distal end of the male part 122 can be coupled to the proximal end 114 of the catheter body 110, and the male part lumen 126 can be in fluid communication with the lumen 116 of the catheter body 110. In one embodiment, the outer diameter of the catheter body 110 can be equal to the inner diameter of the distal end of the male part lumen 126. The catheter body 110 can be engaged with the male part 122 in an interference fit engagement, a press fit engagement, or a snap fit engagement. In one embodiment, the catheter body 110 can be coupled to the male part 122 using adhesives, bonding, welding, ultrasonic welding, or similar suitable means. In one embodiment, the outer diameter of the male part 122 can be equal to the inner diameter of the distal end of the female part lumen 128. Thus, the male part lumen 126 and the catheter body lumen 116 can be in fluid communication with the female part lumen 128.

[0037] In one embodiment, the male part 122 can slidably engage the female part lumen 128 along the longitudinal axis and can provide a fluid-tight seal therebetween. In one embodiment, the handle 120 can further include an O-ring 130 formed of an elastomer, rubber, silicone rubber, or similar suitable material. The O-ring 130 can be bonded to a proximal end of the male part 122 to ensure a fluid-tight seal between the male part lumen 126 and the female part lumen 128 while still allowing the male part 122 and the female part 124 to slide relative to one another.

[0038] The male part 122 may further include a post 132 extending from an outer surface of the male part 122 along an axis extending perpendicular to the central longitudinal axis 70. In one embodiment, the handle 120 may include more than one post 132, for example, the handle 120 may include a first post 132 extending from a first side and a second post (not shown) extending from a second side opposite the first post 132. However, it will be understood that other numbers and configurations of posts 132 are contemplated.

[0039] The post 132 can be slidably engaged with a channel 134 disposed on an inner surface of the female part lumen 128. The channel 134 can substantially define a U-shape having a distal lateral channel 134A, a longitudinal channel 134B, and a proximal lateral channel 134C. When the post 132 is located in one of the distal lateral channel 134A or the proximal lateral channel 134C, the post 132 can prevent longitudinal movement of the male part 122 relative to the female part 124. When the post 132 is located in the longitudinal channel 134B, the post 132 can slide longitudinally, allowing the male part 122 to slide longitudinally relative to the female part 124.

[0040] In one embodiment, the catheter 100 can further include a string 136 or push rod 138 extending longitudinally through the catheter lumen 116. The proximal end of the string 136 or push rod 138 can be coupled to the female part 124, for example at a cross bar 140. It should be noted that while one of the strings 136, push rod 138, or cross bar 140 may extend into one or more of the catheter lumen 116, the male part lumen 126, and the female part lumen 128, these structures have no, or only a minimal, effect on fluid flow therethrough.

[0041] In use, with the handle 120 in the first configuration (FIG. 2A), the post 132 can be located in the proximal lateral channel 134C and can prevent the male part 122 from sliding relative to the female part 124. To transition the handle 120 from the first position (FIG. 2A) to the second position (FIG. 2B), the clinician can rotate the male part 122 relative to the female part 124 about the central longitudinal axis 70 until the post 132 enters the longitudinal channel 134B. The male part 122 can then slide longitudinally relative to the female part 124 until the handle 120 is transitioned to the second configuration. The clinician can rotate the male part 122 relative to the female part 124 in the opposite direction about the central longitudinal axis 70 until the post 132 enters the distal lateral channel 134A to lock the handle 120 in the second configuration (FIG. 2B). Advantageously, the location of distal lateral channel 134A and proximal lateral channel 134C can ensure that anchor 150 is correctly expanded into the anchor mode and correctly retracted into the insertion mode before removal. This can prevent over- or under-expansion of anchor 150 to ensure correct placement and ensure that anchor 150 is fully retracted into the insertion mode before removing anchor 150 from bladder 90. In one embodiment, handle 120 can be biased towards one of the first configuration or the second configuration. In one embodiment, handle 120 can be bi-stable in both the first and second configurations.

[0042] With continued reference to FIG. 1, the catheter can include a Malecot-type bulge anchor ("Malecot anchor") 150. Further details of the Malecot anchor 150 are shown in FIGS. 3-4B. FIG. 4A shows the Malecot anchor 150 in an insertion mode. FIG. 4B shows the Malecot anchor 150 in an anchor mode. The Malecot anchor 150 can include one or more longitudinally extending slit valves, "slits" 152. A distal end of the slit 152 can extend to a point proximal to the distal tip 112 of the catheter body 110. A proximal end of the slit 152 can extend to a point distal to an indicator opening 154. In one embodiment, the slit 152 can communicate with an indicator opening 154 located at its proximal end.

[0043] As shown, the malecot anchor 150 may include four slits 152 spaced equidistantly around the circumference of the catheter body 110. The slits 152 may thus define four longitudinally extending arms 156. However, it will be understood that other numbers and configurations of the slits 152 and arms 156 are also contemplated. In one embodiment, the malecot anchor 150 may include a single indicator aperture 154 in communication with one of the slits 152. In one embodiment, the malecot anchor may include one or more indicator apertures 154, each indicator aperture 154 in communication with one of the one or more slits 152. However, it will be understood that other numbers and configurations of the slits 152 and indicator apertures 154 are also contemplated.

[0044] The malecot anchor 150 can transition between an insertion mode (FIG. 4A) and an anchor mode (FIG. 4B). In the insertion mode, the malecot anchor 150 can define a first outermost diameter (d1). The slit 152 is in a closed position in which a first sidewall of the first arm 156A contacts a second sidewall of the second arm 156B to form a fluid-tight seal therebetween. Thus, the slit 152 in the closed position prevents any fluid flow therethrough. In the anchor mode (FIG. 4B), the distal end of the string 136 coupled to the distal tip 112 of the catheter body 110 is retracted proximally, elastically deforming one or more arms 156 radially outward to define a second outermost diameter (d2). As the arms 156 elastically deform outward, the slit 152 transitions to an open position to provide one or more discharge openings 158 in fluid communication with the catheter lumen 116. It should be noted that the indicator opening 154 can provide fluid communication with the catheter lumen 116 in both the insertion mode and the anchored mode, while the exhaust opening 158 can provide fluid communication with the catheter lumen 116 only in the anchored mode.

[0045] In use, with the malecot anchor 150 in the insertion mode, the clinician can advance the malecot anchor 150 through the patient's urethra 92 and into the bladder 90. Once the indicator opening 154 enters the bladder 90, a first fluid flow can immediately enter the catheter lumen 116 and flow proximally to the proximal end of the handle 120. The fluid can then be collected in a suitable container (urine bag, container, toilet, etc.). Optionally, a fluid collection bag can be coupled to the handle 120 and in fluid communication with the catheter lumen 116. Advantageously, the first fluid flow can be sufficient to indicate to the clinician that the anchor 150 is correctly positioned in the bladder 90, while being a small enough flow that the clinician can stop the flow of the fluid 94 if desired. Optionally, the clinician can retract the catheter 100 proximally until the indicator opening 154 re-enters the neck 96 of the bladder 90, stopping all fluid flow if desired.

[0046] When the anchor 150 is within the bladder 90, as indicated by the first fluid flow, the clinician can transition the handle 120 from the first configuration to the second configuration to transition the malecot anchor 150 to the anchor mode. In the anchor mode, the arms 156 are elastically deformed to define a second diameter (d2) and the slits 152 are opened to provide a second fluid flow through the one or more drainage openings 158. The second fluid flow can be greater than the first fluid flow and can drain the fluid 94 from the bladder 90.

[0047] The clinician can retract the malecot anchor 150 proximally until the arm 156 engages the neck 96 of the bladder 90 and prevents further proximal movement. As shown in FIG. 3, in such a position, the drainage opening 158 can be positioned at the neck 96 of the bladder 90 and can drain all of the fluid 94 from the bladder 90, preventing any fluid from stagnating. To remove the catheter 100 from the bladder 90, the process can be reversed. In one embodiment, the arm 156 can bias the catheter 100 towards the insertion mode. Advantageously, the indicator opening 154 can confirm to the clinician when the anchor 150 is within the bladder 90 and can prevent the anchor 150 from transitioning to the anchor mode prematurely and causing trauma to the urethra 92 or the neck 96 of the bladder 90. Similarly, the indicator opening 154 can prevent over-insertion of the catheter 100 into the bladder 90, where the distal tip 112 strikes the wall of the bladder 90 and causes pain or discomfort to the patient. Advantageously, transitioning the anchor 150 between the insertion mode and the anchor mode does not require adding additional volume to the bladder 90, which can cause trauma, pain, discomfort, or bladder spasms to the patient.

[0048] Figures 5A-5E show details of catheter 100 including loop anchor 250. Figure 5A shows a perspective view of catheter 100 including handle 120 and loop anchor 250. Figure 5B shows a schematic view of catheter 100 including handle 120 and loop anchor 250. Figure 5C shows loop anchor 250 in insertion mode. Figure 5D shows loop anchor 250 in anchor mode. Figure 5E shows loop anchor 250 positioned within bladder 90 in anchor mode.

[0049] The loop anchor 250 can include an indicator opening 254 disposed at a first longitudinal position and a drain opening 258 disposed at a second longitudinal position proximal to the first longitudinal position. The indicator opening 254 can define a relatively small opening diameter and therefore can provide a first fluid flow. The drain opening 258 can define a relatively large opening diameter and therefore can provide a second fluid flow that is greater than the first fluid flow. The loop anchor 250 can further include a string 136 that extends through the catheter lumen 116 to the indicator opening 254 and can extend through the indicator opening 254 onto an outer surface of the loop anchor 250. A distal tip of the string 136 can be coupled to an outer surface of the distal tip 112 of the catheter body 110.

[0050] In use, the loop anchor 250 in the insertion mode can be pushed through the urethra 92 until the loop anchor 250 enters the bladder 90. Once the indicator opening 254 enters the bladder 90, a first fluid flow can flow through the catheter body lumen 116 to indicate that the loop anchor 250 is entirely within the bladder 90. The clinician can then actuate the handle 120 to retract the string 136 and transition the loop anchor 250 to the anchor mode, as described herein. In the anchor mode, the distal tip 112 can be bent toward the indicator opening 254 to form a loop having a second outermost diameter (d2). The loop anchor 250 in the anchor mode can prevent the distal tip 112 from being retracted proximally from the bladder 90.

[0051] Once the loop anchor 250 is secured in the anchor mode, the clinician can adjust the catheter body 110 proximally or distally until the drainage opening 258 is positioned at the neck 96 of the bladder 90 to provide a second fluid flow that is greater than the first fluid flow and drain all of the fluid 94 from the bladder 90. In one embodiment, the loop anchor 250 can be advanced into the bladder 90 and transitioned to the anchor mode. The catheter 100 can then be retracted proximally until the distal tip 112 strikes the wall of the bladder 90. The longitudinal position of the drainage opening 258 can be such that when the distal tip 112 strikes the wall of the bladder 90, the drainage opening 258 is aligned with the neck 96 of the bladder to drain all of the fluid from the bladder 90.

[0052] It should be noted that the distal portion of the catheter body 110 may be biased toward the insertion mode and may be elastically deformed into the anchor mode. Thus, to transition the loop anchor 250 from the anchor mode to the insertion mode, the clinician may transition the handle 120 from the second configuration to the first configuration to allow the distal portion of the catheter 110 to regain the linear configuration.

[0053] 6A-6F show an embodiment of a catheter 300 including a locking handle 120 and a J-anchor 350. The catheter 300 can include an outer catheter body 310 and an inner catheter body 302, each extending coaxially along a central longitudinal axis 70. The outer catheter body 310 can define a lumen 316 and extend longitudinally between a proximal end 314 and a distal tip 312. The proximal end 314 of the outer catheter 310 can be coupled to the male part 122 of the handle 120 as described herein. The distal tip 312 of the outer catheter 310 can define a distal opening 318. The inner catheter body 302 can also extend longitudinally between a proximal end 306 and a distal tip 304. The proximal end 306 of the inner catheter body 302 can be coupled to the female part 124. The inner catheter body 306 may define an inner catheter body lumen 308 in fluid communication with the female part lumen 128 .

[0054] The outer diameter of the inner catheter body 310 can be equal to or slightly smaller than the inner diameter of the outer catheter body lumen 316. Thus, the inner catheter body 302 can slidably engage the outer catheter body 310 along the longitudinal axis 70 while maintaining a substantially fluid-tight seal therebetween. In one embodiment, as shown in Figures 6E-6F, any fluid that enters the outer catheter body lumen 316 along the outer surface of the inner catheter body 302 is drained proximally into the male part lumen 126, the female part lumen 128, and may be collected in a suitable container as described herein.

[0055] In one embodiment, the distal end of the inner catheter body 302 can include a J-anchor 350. The J-anchor 350 can include a portion of the inner catheter body 302 that defines a non-linear, curved, or “pigtail” shape. In one embodiment, the non-linear shape of the J-anchor 350 can be maintained by varying a wall thickness between a first side and a second side of the distal portion of the inner catheter body 302. The J-anchor 350 can be elastically deformed from the non-linear shape to a different non-linear or linear shape. Additionally, the J-anchor 350 can include an indicator aperture 354 and an exhaust aperture 358, each extending through the wall of the inner catheter 302 and in communication with the inner catheter lumen 308. The indicator aperture 354 can define a first aperture diameter and the exhaust aperture 358 can define a second aperture diameter. The first aperture diameter can be smaller than the second aperture diameter. The indicator aperture 354 can be located at the distal tip 304 of the inner catheter body 302. A drainage opening 358 can be located at the proximal end of the J anchor 350 .

[0056] In use, as shown in Figures 6C-6D, in an insertion mode, the J-anchor 350 can be retracted proximally into the outer catheter 310. The inner catheter body 302 can be formed of a more flexible material relative to the outer catheter body 310. Thus, the J-anchor 350 can be resiliently deformed to a substantially linear configuration within the outer catheter body 310. The distal tip 304 of the inner catheter body 302, including the indicator aperture 354, can be positioned adjacent or proximal to the distal opening 318 of the outer catheter body 310.

[0057] The catheter 300 can be advanced through the urethra 92 until the indicator opening 354 enters the bladder 90. A first fluid flow can flow proximally through the inner catheter lumen 308 to the female part lumen 128. The first fluid flow can indicate to the clinician that the distal tip 112 of the outer catheter body 310 is within the bladder 90 and the J-anchor 350 can be safely deployed. The clinician can then transition the handle 120 from the second configuration (FIG. 2B) to the first configuration (FIG. 2A) to extend the J-anchor 350 distal to the distal end opening 318 of the outer catheter body 310. Thus, the J-anchor 350 can resume the nonlinear resting position of the anchor mode (FIG. 6D). In the anchor mode, the drain opening 358 can extend distal to the distal opening 318 and provide a second fluid flow that is greater than the first fluid flow. Additionally, the drainage opening 358 may be positioned adjacent the neck 96 of the bladder 90 to ensure that all fluid drains from the bladder 90 .

[0058] In one embodiment, as shown in Figures 7A-7D, the catheter 300 can include a tethered J-anchor 450. The catheter 300 can include an inner catheter body 302 coaxially aligned and slidably engaged with an outer catheter 310. As described herein, the proximal end 314 of the outer catheter body 310 can be coupled to the male part 122 and the proximal end 306 of the inner catheter body 302 can be coupled to the female part 124 of the handle 120. The tethered J-anchor 450 can define a substantially linear configuration and can be elastically deformed to a non-linear shape in the anchor mode. The tethered J-anchor 450 can further include a tether 452 extending from the distal tip 312 of the outer catheter body 310 and the distal tip 304 of the inner catheter body 302.

[0059] In use, the catheter 300 can be advanced through the urethra 92 until the indicator opening 354 enters the bladder 90 and provides a first fluid flow, as described herein. The clinician can transition the handle 120 from the second configuration (FIG. 2B) to the first configuration (FIG. 2A). The inner catheter body 302 can be biased distally relative to the outer catheter body 310. The tether 452 prevents the distal tip 304 of the inner catheter body 302 from advancing in a linear direction, instead elastically deforming the tethered J-anchor 450 into a non-linear, curved, or "pigtail" shape, as shown in FIGS. 7A, 7B. With the handle 120 in the first configuration, the drain opening 358 can be advanced distal to the distal opening 318 to provide a second fluid flow that is greater than the first fluid flow. The tethered J-anchor 450 can prevent the distal tip 312 of the outer catheter body 310 from being retracted proximally from the bladder 90 in the anchored mode.

[0060] 8, the catheter 300 may include a magnetic J-anchor 550. The magnetic J-anchor 550 may include a first magnetic element 552 disposed in a wall of the inner catheter body 302 adjacent the distal tip 304. The magnetic J-anchor 550 may include a second magnetic element 554 disposed in a wall of the inner catheter body 302 adjacent the drainage opening 358. As used in this embodiment, the magnetic element may include a permanent magnet, an electromagnet, a magnetized ferrous material, or a ferrous material.

[0061] In use, the catheter 300 in the insertion mode can include a magnetic J-anchor 550 in a linear configuration disposed within a distal portion of the outer catheter 310. When the indicator opening 354 enters the bladder 90, a first fluid flow can indicate that the distal tip 312 of the outer catheter 310 has entered the bladder 90. The clinician can then transition the handle 120 from the second configuration (FIG. 2B) to the first configuration (FIG. 2A) to advance the magnetic J-anchor 550, including the second magnetic element 554, distal to the distal opening 318. Thus, the first magnetic element 552 can be attracted to the second magnetic element 554, elastically deforming the magnetic J-anchor 550 into the anchor mode and preventing the catheter 300 from being retracted proximally. In the anchor mode, as described herein, the drain opening 358 can be positioned distal to the distal opening 318 to provide a second fluid flow through the inner catheter lumen 308 to drain fluid from the bladder 90.

[0062] To retract the catheter 300 from the bladder 90, the clinician can transition the handle 120 from a first configuration (FIG. 2A) to a second configuration (FIG. 2B). The handle 120 can retract the inner catheter 302 into the outer catheter 310, urging the wall of the outer catheter 310 between the first magnetic element 552 and the second magnetic element 554. Separating the first magnetic element 552 and the second magnetic element 554 allows the magnetic J-anchor 550 to return to the linear configuration of the insertion mode and be retracted into the outer catheter lumen 316.

[0063] 9A-9E show a catheter 100 including a push rod anchor 650 disposed at its distal end. The catheter 100 can include a lumen 116 extending from a closed distal tip 112 to a handle 120 as described herein. The push rod anchor 650 can include an indicator opening 154 disposed at a proximal end of the push rod anchor 650 and can include a tether 652 extending from the distal tip 112 of the catheter body 110 to the proximal end of the push rod anchor 650. In one embodiment, the tether 652 can be integrally formed with the catheter body 110 and extend over an exterior surface of the catheter body 110.

[0064] In other words, the distal portion of the catheter body 110 that defines the push rod anchor 650 can include a tether opening 654 that extends between a first side of the catheter body 110 and a second side of the catheter body 110 opposite the first side. The tether opening 654 can thus define a tether 652. In one embodiment, the tether 652 can be formed as a solid structure and can be formed of the same material as the catheter body 110. In one embodiment, the tether 652 can be formed as a hollow structure and is in fluid communication with the catheter lumen 116. In one embodiment, the tether 652 can be formed as a structure separate from the structure of the catheter body 110 and can be coupled to the catheter body 110 using adhesives, bonding, welding, or similar suitable means. The tether 652 can be formed of the same material or a different material than the material of the catheter body 110.

[0065] In one embodiment, the catheter 100 can include a push rod 138 extending through the catheter lumen 116. The proximal end of the push rod 138 can be coupled to the female part 124 of the handle 120, such as the crossbar 140. The distal tip of the push rod 138 can extend through the catheter lumen 116 to the distal tip 112 of the catheter body 110. In one embodiment, the distal end of the push rod 138 can include an atraumatic tip, ball tip, or similar slug coupled to the distal tip of the push rod 138 and configured to prevent trauma to the catheter body 110. In one embodiment, the push rod 138 can be formed from a plastic, polymer, metal, alloy, composite, or similar suitable material. In one embodiment, the push rod anchor 650 can transition between an insertion mode (FIG. 9C) and an anchor mode (FIG. 9D). The push rod anchor 650 can be biased toward the insertion mode and can be elastically deformed into the anchor mode.

[0066] In use, with the push rod anchor 650 in the insertion mode, the clinician can advance the distal tip 112 of the catheter 110 through the urethra 92 and into the bladder 90. The indicator aperture 154 located at the proximal end of the push rod anchor 650 can enter the bladder 90 and provide one of a first fluid flow or a second fluid flow indicating that the push rod 650 is fully disposed within the bladder 90. The clinician can then transition the handle 120 from the second configuration (FIG. 2B) to the first configuration (FIG. 2A) to advance the push rod 138 distally relative to the catheter body 110. Thus, the distal tip of the push rod 138 can impact the distal tip 112 of the catheter 110 and elastically deform the push rod anchor 650 into the anchor mode, preventing the distal tip 112 from being retracted proximally from the bladder 90. In one embodiment, the indicator opening 154 in the insertion mode can define a first opening diameter and can provide a first fluid flow. The push rod anchor 650 in the anchor mode can elastically deform the indicator opening 154 from the first opening diameter to a second opening diameter and can provide a second fluid flow that is greater than the first fluid flow.

[0067] Although some specific embodiments are disclosed herein, and the specific embodiments are disclosed in some detail, the specific embodiments are not intended to limit the scope of the concepts provided herein. Additional improvements and / or modifications may be apparent to those skilled in the art, and the broader aspects encompass these improvements and / or modifications as well. Thus, one may depart from the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. 1. An indwelling urethral catheter, comprising: a catheter body defining a lumen; an anchor disposed at a distal end of the catheter body and capable of transitioning between an insertion mode and an anchor mode; The anchor is a first slit valve and a second slit valve each extending longitudinally and defining a first arm and a second arm; an indicator aperture disposed proximal to one or both of the first slit valve and the second slit valve and configured to provide a first fluid flow to the lumen in both the insertion mode and the anchor mode; The first slit valve and the second slit valve are each configured to define a drainage opening to allow a second fluid flow into the lumen in the anchor mode and to prevent the second fluid flow into the lumen in the insertion mode.

2. The indwelling urinary catheter of claim 1 , wherein the first fluid flow is less than the second fluid flow.

3. The indwelling urinary catheter of claim 1 or 2, wherein the indicator opening communicates with one of the first slit valve or the second slit valve.

4. 4. The indwelling urinary catheter of claim 1, wherein one or both of the indicator opening and the drain opening extend through a side wall of the catheter body to communicate with the lumen.

5. 5. The indwelling urinary catheter of claim 1, wherein the first arm and the second arm define a first outer diameter in the insertion mode and a second outer diameter in the anchoring mode, the first diameter being smaller than the second diameter.

6. a locking handle coupled to a proximal end of the catheter body; a string extending through the lumen, a proximal end of the string is coupled to a female component of the lock handle; a distal end of the string is coupled to a distal tip of the catheter body; a proximal end of the catheter body coupled to a male component of the locking handle; 6. The indwelling urinary catheter of claim 1, wherein the female part is slidably engaged with the male part to transition the anchor between the insertion mode and the anchor mode.

7. The indwelling urinary catheter of claim 6 , wherein the female part is configured to slide proximally relative to the male part to transition the anchor to the anchored mode.

8. the female part includes a channel having a distal lateral channel in communication with a longitudinal channel in communication with a proximal lateral channel; the male component includes a post extending from an outer surface thereof; 8. The indwelling urinary catheter of claim 6 or 7, wherein the post slidably engages with the distal lateral channel in the insertion mode, slidably engages with the proximal lateral channel in the anchoring mode, and slidably engages with the longitudinal channel when transitioning therebetween.

9. 1. A urinary catheter comprising: an outer catheter including a distal opening and a first handle coupled to a proximal end thereof; an inner catheter disposed coaxially with the outer catheter and slidably engaged with the outer catheter; The inner catheter comprises: a distally disposed anchor capable of transitioning between an insertion mode and an anchor mode; an indicator aperture disposed at a distal tip of the inner catheter; a drainage opening disposed proximally of the anchor; and a second handle coupled to the proximal end thereof.

10. 10. The urinary catheter of claim 9, wherein the anchor is configured to be advanced distally of the distal opening to transition to the anchor mode and retracted proximally of the distal opening to transition to the insertion mode.

11. 11. The urinary catheter of claim 9 or 10, wherein the first handle is coaxially disposed with the second handle along a longitudinal axis and is slidably engaged with the second handle along the longitudinal axis between a first configuration and a second configuration to transition the anchor between the insertion mode and the anchor mode.

12. the first handle includes a post extending from an outer surface thereof; the second handle includes a channel having a distal lateral channel in communication with a longitudinal channel in communication with a proximal lateral channel; 12. The urinary catheter of claim 11, wherein the post slidably engages with the proximal lateral channel in the insertion mode, slidably engages with the distal lateral channel in the anchoring mode, and slidably engages with the longitudinal channel when transitioning between the insertion mode and the anchoring mode.

13. 13. The urinary catheter of claim 9, wherein the anchor is biased toward one of a J-shape or a pigtail shape in the anchor mode and is elastically deformed to a linear shape in the insertion mode in which the anchor is retracted proximally into a distal portion of the outer catheter.

14. the anchor further comprises a tether biased toward a linear configuration and extending between a distal tip of the inner catheter and a distal tip of the outer catheter; 13. The urinary catheter of claim 9, wherein the tether is configured to elastically deform the anchor into a non-linear configuration when the anchor is advanced distal to the distal opening.

15. the anchor further comprises a first magnetic element biased toward a linear shape and disposed at a distal tip of the inner catheter and a second magnetic element disposed in a wall of the inner catheter proximal to the anchor; 13. The urinary catheter of claim 9, wherein the first magnetic element is configured to be attracted to the second magnetic element when the second magnetic element is advanced distal to the distal opening to elastically deform the anchor into a non-linear configuration.

16. 1. An indwelling urethral catheter, comprising: a catheter body defining a lumen; an anchor structure disposed at a distal end of the catheter body, the anchor structure including a tether integrally formed with the catheter body and extending from a distal tip of the catheter body to a proximal end of the anchor structure; an opening extending through a wall of the catheter body and in communication with the lumen, the opening being disposed proximal to the anchor structure; a push rod extending through the lumen and configured to be distally biased to elastically deform the anchor structure from an insertion mode defining a first diameter to an anchor mode defining a second diameter larger than the first diameter.

17. the opening in the insertion mode defines a first opening diameter to provide a first fluid flow; 17. The indwelling urinary catheter of claim 16, wherein the opening in the anchored mode defines a second opening diameter greater than the first opening diameter to provide a second fluid flow greater than the first fluid flow.

18. 1. An indwelling urethral catheter, comprising: a catheter body defining a lumen; a locking handle coupled to a proximal end of the catheter body; an anchor disposed at a distal end of the catheter body and capable of transitioning between an insertion mode and an anchor mode; The anchor is an indicator aperture disposed at a first longitudinal position; a discharge opening disposed at a second longitudinal location proximal to the first longitudinal location; a string extending from a distal tip of the catheter body, over an outer surface of the anchor, through the indicator opening, and through the lumen of the catheter body, the proximal end of the string being coupled to the handle.

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