Catheter cleaning system and method

Abstract

Disclosed herein is a catheter lumen cleaning system including a catheter (110) and a lumen cleaning system (140). The catheter includes a catheter tube (112) defining a lumen (114). The lumen cleaning system includes a shaft (142) extending longitudinally through the catheter lumen, a handle (146) disposed at a proximal end of the shaft, and a head (144) disposed at a distal end of the shaft. An outer surface of the head is configured to engage an inner surface of the catheter lumen as the head is pushed proximally through the catheter lumen. This engagement allows the head to effectively clean deposits from the catheter lumen, thereby ensuring unobstructed flow and optimal performance of the catheter.

Description

[0001] priority

[0002] This application claims the priority benefit of U.S. Patent Application No. 18 / 618,839, filed March 27, 2024, the entire contents of which are incorporated herein by reference. Background Technology

[0003] Previous methods for clearing deposits from catheters have involved a variety of approaches and devices. One common method involves using mechanical cleaning devices, such as brushes or wires, inserted into the catheter lumen and manually manipulated to remove the deposits. While these mechanical devices can be effective in some cases, they typically require considerable force and dexterity to operate, which can be challenging for healthcare professionals and may cause patient discomfort or injury. Furthermore, they are often introduced distally, posing a risk of deposit displacement toward the body cavity.

[0004] Another approach involves using chemical reagents or solutions to dissolve or break down deposits within the catheter lumen. These methods typically involve introducing a liquid or gel into the catheter and allowing it to stand for a period of time to promote the dissolution of the deposits. While these cleaning methods may be effective for certain types of deposits, they may not be suitable for all types of catheters or deposits, and there is a risk of damaging the catheter or surrounding tissue if the active ingredient is not properly selected or used.

[0005] In addition, some previous methods utilized a combination of mechanical and chemical cleaning methods. These systems typically involved combining mechanical cleaning equipment with chemical reagents to enhance the cleaning process. While these combined methods can provide improved cleaning capabilities, they can still be time-consuming and may require multiple steps or components to achieve the desired results.

[0006] This article discloses a catheter cleaning system and related methods designed to address the aforementioned problems. Summary of the Invention

[0007] In some aspects, the technology described herein relates to a catheter cleaning system comprising: a catheter having a catheter fitting defining a catheter lumen; and a lumen cleaning system comprising: a shaft extending longitudinally through the catheter lumen; a handle disposed at a proximal end of the shaft; and a head disposed at a distal end of the shaft, the outer surface of the head being configured to engage an inner surface of the catheter lumen to clean deposits when the head is pushed proximally through the catheter lumen.

[0008] In some respects, the technology described herein relates to a catheter clearance system in which the catheter is one of an intermittent catheter, a Foley catheter, a balloon catheter, an indwelling catheter, a peritoneal catheter, or a pleural drainage catheter.

[0009] In some respects, the technology described herein relates to a catheter clearance system in which a catheter is configured to drain urine from a patient's bladder.

[0010] In some aspects, the technology described herein relates to a catheter cleaning system in which the catheter further includes a funnel disposed at the proximal end of the catheter fitting and in fluid communication with the catheter lumen.

[0011] In some aspects, the technology described herein relates to a catheter cleaning system, wherein the catheter further includes one or more orifices disposed in the sidewall of the catheter fitting and providing fluid communication with the catheter lumen.

[0012] In some aspects, the technology described herein relates to a catheter cleaning system, which also includes a connector configured to secure one or both of the handle and the proximal portion of the shaft to the outer surface of the catheter near the proximal end.

[0013] In some aspects, the technology described herein relates to a catheter cleaning system in which the connector includes tape having tear lines and is configured to adhere a proximal portion of the shaft to the outer surface of the catheter.

[0014] In some aspects, the technology described herein relates to a catheter cleaning system in which the connector includes a clip molded into the outer surface of the catheter and configured to releasably secure the proximal portion of the shaft using an interference fit engagement or a snap-fit ​​engagement.

[0015] In some aspects, the technology described herein relates to a catheter cleaning system, which also includes a gripper that slidably engages with the outer surface of the catheter fitting.

[0016] In some aspects, the technology described herein relates to a catheter clearance system in which a proximal surface of the head defines an annular concave surface extending about a central longitudinal axis of the head to define an acute angle relative to the radial outer edge of the head.

[0017] In some aspects, the technology described herein relates to a catheter cleaning system, which further includes a retaining ring disposed on the inner surface of the catheter lumen and extending circumferentially, the retaining ring being configured as part of an abutment portion to releasably secure the head at the distal end of the catheter lumen.

[0018] In some aspects, the technology described herein relates to a catheter cleaning system in which the head also includes one or more cutting portions extending longitudinally along the outer surface of the head.

[0019] In some aspects, the technology described herein relates to a catheter cleaning system, which also includes a loading clamp configured to push the head and the distal portion of the shaft through the catheter lumen and position the head at the most distal point of the catheter lumen.

[0020] In some aspects, the technology described herein relates to a method for cleaning a catheter lumen, comprising: grasping a handle of a lumen cleaning system, the handle being coupled to a proximal end of a shaft, the shaft including a head disposed at a distal end; pushing the handle proximally to push the head proximally, the outer surface of the head engaging an inner surface of the catheter lumen and removing deposits therefrom; and pushing the head to the proximal end of the catheter lumen to remove deposits and restore patency of the catheter lumen.

[0021] In some aspects, the technology described herein relates to a method in which a catheter includes a catheter fitting defining a catheter lumen and a funnel disposed at the proximal end of the catheter fitting and in fluid communication with the catheter lumen.

[0022] In some aspects, the techniques described herein relate to a method that also includes draining fluid into the lumen of a catheter through orifices arranged in the sidewall of the catheter fitting.

[0023] In some respects, the techniques described herein relate to a method in which the catheter is one of an intermittent catheter, a Foley catheter, a balloon catheter, an indwelling catheter, a peritoneal catheter, or a pleural drainage catheter.

[0024] In some respects, the techniques described herein involve a method that also includes draining urine from a patient's bladder.

[0025] In some aspects, the technology described herein relates to a method that further includes detaching one or both of the handle and the proximal portion of the shaft from a connector before pushing the handle proximally, the connector releasably securing one or both of the handle and the proximal portion of the shaft to the outer surface of the catheter.

[0026] In some aspects, the techniques described herein relate to a method in which the connector is a tape, and removing one or both of the handle and the proximal portion of the shaft from the connector also includes breaking a tear line extending through the tape.

[0027] In some aspects, the techniques described herein relate to a method in which a proximal surface of a head defines an annular concave surface extending about a central longitudinal axis of the head to define an acute angle relative to a radially outer edge.

[0028] In some aspects, the technology described herein relates to a method in which pushing the head proximally further includes disengaging the head from a retaining ring disposed at the distal end of the catheter lumen, the retaining ring abutting the connector to releasably retain the head at the distal end of the catheter lumen. Attached Figure Description

[0029] A more specific description of the disclosed text will be presented by reference to specific embodiments of the disclosed text illustrated in the accompanying drawings. It should be understood that these drawings depict only typical embodiments of the invention and are therefore not intended to limit the scope of the invention. Exemplary embodiments of the invention will be described and explained with additional specificity and detail using the accompanying drawings, in which:

[0030] Figure 1 A perspective view of a catheter system according to an embodiment disclosed herein is shown. The catheter system typically includes a catheter, a catheter cleaning system, and a loading clamp.

[0031] Figure 2 The embodiments disclosed herein are shown. Figure 1 A perspective view of the duct cleaning system.

[0032] Figure 3 The embodiments disclosed herein are shown. Figure 1 Close-up details of the proximal end of the catheter system.

[0033] Figure 4 The embodiments disclosed herein are shown. Figure 1 Longitudinal cross-sectional view of the distal end of the catheter system.

[0034] Figure 5 The embodiments disclosed herein are shown. Figure 1 A perspective view of the distal end of the catheter system, in which the catheter is shown in a wireframe for ease of illustration.

[0035] Figure 6A A close-up detail of the distal end of the catheter clearance system according to the embodiment disclosed herein is shown.

[0036] Figure 6B A longitudinal cross-sectional view of the distal end of a catheter cleaning system according to an embodiment disclosed herein is shown.

[0037] Figure 7 A lateral cross-sectional view of the distal end of a catheter and catheter clearance system according to an embodiment disclosed herein is shown. Detailed Implementation

[0038] Before disclosing some specific embodiments 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 embodiments, and these features may optionally be combined with or replace features of any of the many other embodiments disclosed herein. It should be understood that the accompanying drawings are schematic and illustrative representations of exemplary embodiments of the invention and are neither limiting nor necessarily drawn to scale.

[0039] Regarding the terminology used herein, it should be understood that these terms are for the purpose of describing certain specific embodiments and 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 in a set of features or steps and do not provide for a sequence or numerical limitation. For example, features or steps “first,” “second,” and “third” do not necessarily appear in that order, and a particular embodiment including such features or steps is not necessarily limited to these three features or steps. For convenience, labels such as “left,” “right,” “top,” “bottom,” “front,” “back,” etc., are used, and these labels are not intended to imply, for example, any particular fixed position, orientation, or direction. Rather, such labels are used to reflect, for example, relative position, orientation, or direction. The singular forms “a,” “an,” and “the” include plural references unless the context clearly specifies otherwise. Furthermore, the words “comprising,” “having,” and “containing” as used herein (including the claims) shall have the same meaning as the word “comprising.”

[0040] In the following description, the terms “or” and “and / or” as used herein shall be interpreted as inclusive or referring to either or any combination thereof. For example, “A, B, or C” or “A, B, and / or C” means “any one of the following: A; B; C; A and B; A and C; B and C; A, B, and C”. Exceptions to this definition will only occur if a combination of elements, components, functions, steps, or actions is inherently mutually exclusive in some way.

[0041] In contrast to "proximal," for example, the "proximal portion" or "proximal portion" of a catheter or system disclosed herein includes the portion of the catheter or system intended to be placed near or relatively closer to the clinician when used in a patient. Similarly, for example, the "proximal length" of a catheter or system includes the length of the catheter or system intended to be placed near or relatively closer to the clinician when used in a patient. For example, the "proximal end" of a catheter or system includes the end of the catheter or system intended to be placed near or relatively closer to the clinician when used in a patient. The proximal portion, proximal portion, or proximal length of a catheter or system may include the proximal end of the catheter or system; however, the proximal portion, proximal portion, or proximal length of a catheter or system need not include the proximal end of the catheter or system. That is, unless the context otherwise indicates, the proximal portion, proximal portion, or proximal length of a catheter or system is not necessarily the distal portion or distal length of the catheter or system.

[0042] In contrast to "distal," for example, the "distal portion" or "distal part" of a catheter or system disclosed herein includes the portion of the catheter or system intended to be placed near or relatively closer to the patient when used in a patient. Similarly, the "distal length" of a catheter or system includes the length of the catheter or system intended to be placed near or relatively closer to the patient when used in a patient. The "distal end" of a catheter or system includes the end of the catheter or system intended to be placed near or relatively closer to the patient when used in a patient. The distal portion, distal part, or distal length of a catheter or system may include the distal end of the catheter or system; however, the distal portion, distal part, or distal length of a catheter or system need not include the distal end of the catheter or system. That is, unless the context otherwise indicates, the distal portion, distal part, or distal length of a catheter or system is not necessarily the distal portion or distal length of the catheter or system.

[0043] To help describe the implementation scheme described in this article, such as Figure 1 As shown, the longitudinal axis extends substantially parallel to the axial length of the conduit. The lateral axis extends perpendicular to the longitudinal axis, and the transverse axis extends perpendicular to both the longitudinal and lateral axes.

[0044] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art.

[0045] Figure 1A perspective view of a catheter system 100 is shown, which typically includes a catheter 110 and an end-cavity clearing system 140. The catheter system 100 can be configured to enter and drain fluid from a patient's body cavity. For example, the distal end of the catheter can be placed into the patient's bladder to drain urine. However, these examples are not intended to be limiting, and it should be understood that other catheters, body cavities, and drainage fluids falling within the scope of this invention are also contemplated. Exemplary catheters include intermittent catheters, Foley catheters, balloon catheters, indwelling catheters, peritoneal catheters, pleural drainage catheters, etc.

[0046] The catheter 110 or a portion thereof may be formed of a flexible material, such as plastic, polymer, rubber, elastomer, silicone rubber, etc. The catheter 110 may be flexible enough to extend through tortuous paths and into body cavities. Furthermore, the catheter 110 may exhibit sufficient columnar strength to allow axial forces to propel the catheter 110 through tortuous paths and into body cavities without kinking or collapsing.

[0047] In one embodiment, the catheter 110 includes a catheter fitting 112 extending along a longitudinal axis and defining a catheter lumen 114. The distal end of the catheter fitting 112 includes one or more orifices 116 extending through the sidewall of the catheter fitting 112 and providing fluid communication with the catheter lumen 114. It should be understood that various numbers, configurations, and locations of orifices falling within the scope of the invention are also contemplated. The proximal end of the catheter fitting 112 includes a funnel 118. Optionally, the proximal end of the funnel 118 includes a connector that allows connection to a fluid collection container, collection bag, drainage tube, or a combination thereof to collect fluid from the catheter lumen 114.

[0048] In one embodiment, the catheter further includes a gripper 120. The gripper 120 includes a gripper body 122 defining a gripper lumen 124. A portion of the catheter 110 extends through and slidably engages with the gripper lumen 124. A first or proximal end of the gripper lumen 124 defines a funnel or flared shape. Furthermore, a second or distal end of the gripper lumen 124 also defines a funnel or flared shape. Advantageously, the gripper 120 facilitates holding and manipulating the catheter 110 during placement without direct contact with the catheter fitting 112, thereby reducing the risk of infection.

[0049] In one embodiment, the catheter system 100 further includes an end-lumen clearing system 140 configured to facilitate the clearing of biofilms, mucus, or similar deposits disposed within the catheter lumen 114 that may affect the patency or flow rate of drainage fluid from the catheter lumen, or may completely obstruct the catheter lumen 114. Advantageously, the end-lumen clearing system 140 facilitates mechanical clearing of the catheter lumen 114 without requiring additional medication to break down and remove deposits therein. This reduces the overuse of catheter clearing medications and any associated side effects or contraindications, such as damage to the medical device or surrounding tissues. Advantageously, the catheter system 100 facilitates mechanical clearing of the catheter lumen 114 prior to or simultaneously with the use of catheter clearing medications to increase the efficacy of these medications and / or require lower doses of catheter clearing medications, thereby reducing any associated side effects, contraindications, or damage to surrounding medical devices or tissues.

[0050] like Figure 2 As shown, the lumen cleaning system 140 typically includes a shaft 142 extending longitudinally between a head 144 disposed distally and a handle 146 disposed proximally. The head 144 may be disposed distally at the end of the catheter lumen 114, from which the shaft 142 extends proximally through the catheter lumen 114 to the proximal end of the funnel 118. Figure 1 As shown, the proximal portion of shaft 142 (including handle 146) can fold back onto itself to extend along the outer surface of conduit 110. Note that, as Figure 2 The illustrated configuration of the lumen cleaning system 140 includes a proximal portion folded back onto itself, such that the handle 146 is positioned distally, as if the lumen cleaning system 140 were positioned within the catheter 110. For ease of illustration, details are not shown. Figure 2 The catheter 110 is shown in the image.

[0051] The lumen cleaning system 140 or a portion thereof may be formed of plastic, polymer, polypropylene, nylon polyamide, metal, alloy, composite material, etc. In one embodiment, the shaft 142 may be formed of a single strand of material or of multiple strands woven or twisted together, for example, to form a band, filament, or rope. In one embodiment, the lumen cleaning system 140 may be formed of the same material or may include two or more different materials. For example, the shaft 142 may be formed of two or more different materials twisted together to form a band. In one embodiment, the shaft 142 may be flexible, elastically deformable, or stretchable to fit within the catheter 110 and allow the catheter 110 to maintain sufficient flexibility to extend through tortuous paths to enter the patient's body cavity.

[0052] In one embodiment, shaft 142 may exhibit increased tensile strength to allow shaft 142 to be as thin as possible while still allowing head 144 to be pulled through catheter lumen 114 without shaft 142 breaking. In one embodiment, shaft 142 may exhibit increased columnar strength to allow head 144 to be pushed distally through catheter lumen 114 to its distal end without buckling or collapsing.

[0053] like Figure 2 As shown, the handle 146 includes a plug integrally formed with the proximal end of the shaft 142 and configured to facilitate gripping of the proximal end of the shaft 142. However, it should be understood that the handle 146 may also include other shapes or structures, including a T-shaped handle, a finger ring, or similar structures configured to facilitate gripping of the proximal end of the shaft 142. The handle 146 may be formed of the same material as the shaft 142 or a different material.

[0054] like Figure 3 As shown, in one embodiment, one or both of the handle 146 and the proximal portion of the shaft 142 extend along the outer surface of the conduit 110 and can be releasably coupled thereto. Figure 3 As shown, one or both of the handle 146 and the proximal portion of the shaft 142 are releasably coupled in place using a connector 130 (such as tape). However, it should be understood that the connector 130 may also include adhesives, latches, clips, snap clips, interference fits, press fits, snap fits, combinations thereof, etc. In one embodiment, the connector may be integrally formed with the exterior of the catheter 110, such as a snap fit clip configured to releasably retain the proximal portion of the shaft 142. In one embodiment, the connector may be formed as a separate structure and coupled to the catheter 110.

[0055] In one embodiment, the connector 130 includes tape disposed on one or both of the handle 146 and the proximal portion of the shaft 142, securing the handle 146 and / or a portion of the shaft 142 to the outer surface of the funnel 118. In one embodiment, the connector 130 also includes a tear line 132, such as a perforation, laser-cut line, or a similar weak line extending through it and aligned with the portion of the handle 146 and / or shaft 142 disposed below it. Advantageously, the tear line 132 facilitates the release of the tape along the tear line, thereby releasing the portion of the handle 146 and / or shaft 142 disposed below it when the user grasps the handle 146 and pushes the handle 146 away from the outer surface of the conduit 110.

[0056] Figures 4 to 7 Further details of the distal end of the cavity cleaning system 140 are shown. Figure 4 A longitudinal cross-sectional view of the head 144 disposed at the distal end of the catheter lumen 114 is shown. Figure 5A perspective view of the head 144 disposed at the distal end of the lumen 114 of the catheter is shown, wherein the catheter is shown in a wireframe for ease of illustration. Figure 6A A perspective view of head 144 is shown. Figure 6B A longitudinal cross-sectional view of head 144 is shown. Figure 7 A lateral cross-sectional view of the head 144 disposed at the distal end of the lumen 114 of the catheter is shown.

[0057] The head 144 is defined as having a generally cylindrical or slightly conical shape with a circular lateral cross-section to match the circular lateral cross-section of the catheter lumen 114. The outer diameter of the head 144 is equal to or slightly larger than the inner diameter of the catheter lumen 114. Therefore, the head 144 fits snugly within and slidably engages with the catheter lumen 114. In one embodiment, the radially outer surface of the head 144 contacts at least a portion of the circumference of the head 144 against the inner wall of the catheter lumen 114. In one embodiment, the outer surface of the head 144 contacts the entire circumference of the head 144 against the catheter lumen 114.

[0058] In one implementation scheme, such as Figures 4 to 5 As shown, the inner surface of the catheter lumen 114 includes a retaining ring 128 that extends circumferentially around a central longitudinal axis 70, and is positioned proximal to the head 144 when the head 144 is positioned at the distal end of the catheter lumen 114. In other words, the retaining ring 128 is positioned at a distance (d) from the distal end of the catheter lumen 114. Figure 4 ), where the distance (d) is slightly greater than the length (L) between the distal end of head 144 and the proximal edge 148 of head 144 ( Figure 6B Advantageously, the retaining ring 128 is configured to engage with the outer radial edge 148 of the proximal side in a snap-fit ​​engagement to releasably retain the head 144 at the distal end of the catheter lumen 114 during transport, storage, and / or placement of the catheter 110. When the lumen clearing system 140 is activated, the user can apply an axial force to the shaft 142 to push the head 144 proximally and through the retaining ring 128. Advantageously, the retaining ring 128 holds the head distal to the distal orifice 116 to prevent the head 144 from obstructing the orifice 116 and inhibiting proximal fluid flow through the catheter lumen 114.

[0059] In one embodiment, the distal end of the head 144 defines a hemispherical shape configured to match the hemispherical shape of the inner surface of the distal end of the catheter lumen 114. In one embodiment, the distal end of the catheter 110 includes a distal orifice (not shown) extending therethrough and aligned with the longitudinal axis of the catheter 110.

[0060] In one implementation scheme, such as Figures 6A to 6BAs shown, the proximal surface 152 of the head 144 includes an annular concave shape extending around the central longitudinal axis 70. Therefore, when viewed in a longitudinal section, the radially outer edge 148 of the proximal surface defines an acute angle. Advantageously, the radially outer edge 148 of the proximal surface provides a scraping edge configured to facilitate the removal of deposits from the inner surface of the catheter lumen 114 when the head 144 is pushed proximally.

[0061] In one implementation scheme, such as Figure 6A As shown, the outer surface of the head 144 includes one or more cutting portions, such as a top cutting portion 150A and a bottom cutting portion 150B. When the head 144 is pushed proximally past the retaining ring 128, the cutting portions 150A and 150B allow the radially outer edge 148 to flex radially inward, while still allowing most of the radially outer edge 148 to maintain its circular shape and maintain contact with the inner surface of the catheter lumen without buckling or twisting.

[0062] In one embodiment, the cutting portions 150A and 150B also serve as pressure relief features. When the head 144 is pushed proximally to clear deposits within the catheter lumen 114, the drag force increases significantly as the amount of deposit pushed proximally forward of the head 144 increases. To prevent the drag force from exceeding the tensile strength of the shaft 142, the cutting portions 150A and 150B allow a small amount of deposit to be pushed past the head 144 and allow the head 144 to pass through the catheter lumen 114 without causing the shaft 142 to break or completely block the catheter lumen 114. Similarly, when the lumen clearing system 140 is reset by pushing the head 144 distally through the catheter lumen 114, any deposits trapped between the head 144 and the distal end of the catheter lumen 114 are allowed to pass through the cutting portions 150A and 150B when the head 144 reaches the distal end of the catheter lumen 114 and can be cleared upon subsequent activation of the lumen clearing system 140. This allows the head 144 to be properly positioned on the distal side of the retaining ring 128.

[0063] Figure 7 A lateral cross-sectional view of a head 144 disposed in the distal end of a catheter lumen 114 is shown. In one embodiment, the outer diameter of the head 144 is slightly smaller than the inner diameter of the catheter lumen 114. In one embodiment, the wall of the catheter fitting 112 includes an outer silicone rubber layer 160, an intermediate resin layer 162, and an inner silicone rubber layer 164. The resin layer 162 allows the outer silicone rubber layer 160 to move relative to the inner silicone rubber layer 164 and allows the catheter fitting 112 to flex perpendicular to the longitudinal axis to traverse a tortuous path and enter a body cavity.

[0064] In one embodiment, the wall thickness of the catheter fitting 112 can be reduced, and the inner diameter of the catheter lumen 114 can be increased by 1% to 8% relative to a conventional catheter of similar French size or application. This increased size of the catheter lumen 114 allows the catheter 110 to accommodate the cross-sectional dimensions of the axis 142 within the catheter lumen 114 without reducing patency or flow rate through the catheter lumen 114. In one embodiment, the inner diameter of the catheter lumen 114 can be increased by 4% relative to a conventional catheter of similar French size or application type. Exemplary application types include pediatric, female, male, etc.

[0065] In an exemplary method of use, a catheter system 100 as described herein is provided. A user places a catheter 110 into a patient's body cavity to drain fluid therefrom. For example, the distal end of a catheter fitting 112 is pushed through the urethra to enter the bladder. An orifice 116 provides fluid communication between the bladder and the catheter lumen 114 to drain urine proximally through the catheter lumen 114 and via a funnel 118. During use, deposits (e.g., biofilms, mucus layers, or similar deposits) may form on the inner surface of the catheter lumen 114. These deposits may reduce patency and fluid flow through the catheter lumen 114, or may completely obstruct fluid flow.

[0066] Advantageously, the user can actuate the lumen cleaning system 140 to remove deposits from the catheter lumen 114 and restore patency of the catheter lumen 114. To activate the lumen cleaning system 140, the user grasps the handle 146 at the proximal end of the catheter system 100 and optionally releases the handle from the connector 130. The user then pushes the handle 146 proximally to push a portion of the shaft 142 and the head 144 through the catheter lumen 114. The user applies sufficient proximal force to push the head 144 proximally past the retaining ring 128. As the head 144 is pushed proximally, the radially outer edge 148 of the proximal surface 152 of the head 144 scrapes any deposits from the inner surface of the catheter lumen 114 and pushes the deposits proximally out of the catheter lumen 114. Once the lumen cleaning system 140 is removed from the catheter lumen 114, patency of the catheter fitting 112 has been restored, and the user can continue to use the catheter 110.

[0067] In one embodiment, once the lumen cleaning system 140 has been removed from the catheter 110, the shaft 142 provides sufficient columnar strength to allow the head 144 to be pushed back into the catheter lumen 114 and reach its distal end, and to allow for the reuse of the lumen cleaning system 140. In one embodiment, the lumen cleaning system 140 is a single-use system; the lumen cleaning system is disposed of once it is removed from the catheter 110, and the catheter can be disposed of once the catheter 110 is removed from the patient. In one embodiment, both the lumen cleaning system 140 and the catheter 110 can be cleaned and sterilized after use, and as... Figure 1 Reassembly as shown. In one implementation, as... Figure 1 As shown, system 100 also includes a loading clamp 170, such as a needle or a pressurized air gun. The loading clamp includes a loading shaft 172 configured to insert distally into the catheter lumen 114 and push a head 144 and a portion of the shaft 142 distally through the catheter lumen 114 to position the head 144 at the distal end of the catheter lumen 114. In one embodiment, the loading clamp 170 is used to load the lumen cleaning system 140 into the catheter 110 after catheter 110 is formed and before it is transported to the end user. In one embodiment, system 100 is provided with the loading clamp 170 to allow the end user to reload the lumen cleaning system 140 back into the catheter after use and after the catheter has been cleaned and sterilized.

[0068] Advantageously, the lumen clearing system 140 allows the user to restore the patency of the catheter 110 without having to remove the catheter and re-insert it into the lumen, thereby reducing medical waste and associated costs, and reducing the additional pain and discomfort associated with re-insertion of the catheter into the body cavity.

[0069] While certain specific embodiments have been disclosed herein, and while these specific embodiments have been disclosed in considerable detail, they are not intended to limit the scope of the concepts provided herein. Other adaptations and / or modifications will arise in those skilled in the art, and are also encompassed in a broader sense. Therefore, changes may be made to the specific embodiments disclosed herein without departing from the scope of the concepts provided herein.

Claims

1. A catheter clearance system, comprising: A catheter, having a catheter fitting that defines the inner lumen of the catheter; and The cavity cleaning system includes: A shaft, which extends longitudinally through the lumen of the catheter; A shank, which is arranged near the end of the shaft; and A head, located at the distal end of the shaft, has an outer surface configured to engage the inner surface of the catheter lumen to clear deposits when the head is pushed proximally through the lumen.

2. The catheter clearance system according to claim 1, wherein the catheter is one of an intermittent catheter, a Foley catheter, a balloon catheter, an indwelling catheter, a peritoneal catheter, or a pleural drainage catheter.

3. The catheter clearance system of claim 1, wherein the catheter is configured to drain urine from the patient's bladder.

4. The catheter cleaning system according to any one of the preceding claims, wherein the catheter further comprises a funnel in fluid communication with the lumen of the catheter, the funnel being disposed at the proximal end of the catheter fitting.

5. The catheter cleaning system according to any one of the preceding claims, wherein the catheter further comprises one or more orifices disposed in the sidewall of the catheter fitting and providing fluid communication with the inner lumen of the catheter.

6. The catheter cleaning system according to any one of the preceding claims further includes a connector configured to secure one or both of the handle and the proximal portion of the shaft to the outer surface of the catheter near the proximal end.

7. The catheter cleaning system of claim 6, wherein the connector comprises tape having a tear line and configured to adhere the proximal portion of the shaft to the outer surface of the catheter.

8. The catheter cleaning system of claim 6, wherein the connector includes a clip molded into the outer surface of the catheter and the proximal portion of the shaft configured to releasably secure the shaft using an interference fit engagement or a snap-fit ​​engagement.

9. The catheter cleaning system according to any one of the preceding claims further includes a gripper that slidably engages with the outer surface of the catheter fitting.

10. The catheter cleaning system according to any one of the preceding claims, wherein the proximal surface of the head defines an annular concave surface extending about a central longitudinal axis of the head to define an acute angle relative to the radial outer edge of the head.

11. The catheter cleaning system according to any one of the preceding claims further includes an annularly extending retaining ring disposed on the inner surface of the catheter lumen, the retaining ring being configured to abut against a portion of the head to releasably secure the head at a distal end of the catheter lumen.

12. The catheter cleaning system according to any one of the preceding claims, wherein the head further includes one or more cutting portions extending longitudinally along the outer surface of the head.

13. The catheter cleaning system according to any one of the preceding claims further includes a loading clamp configured to push the head and the distal portion of the shaft through the catheter lumen distally, and to position the head at the distal point of the catheter lumen.

14. A method for cleaning the lumen of a catheter, comprising: A handle for gripping the cavity cleaning system, the handle being coupled to a proximal end of a shaft, the shaft including a head disposed at a distal end; Push the handle proximally to push the head proximally, the outer surface of the head engaging the inner surface of the catheter lumen and removing deposits therefrom; as well as The head is pushed to the proximal end of the catheter lumen to remove the deposits and restore the patency of the catheter lumen.

15. The method of claim 14, wherein the catheter includes a catheter fitting defining the lumen of the catheter and a funnel disposed at the proximal end of the catheter fitting in fluid communication with the lumen of the catheter.

16. The method of claim 15, further comprising draining fluid into the lumen of the conduit through an opening disposed in the sidewall of the conduit fitting.

17. The method according to any one of claims 14 to 16, wherein the catheter is one of an intermittent catheter, a Foley catheter, a balloon catheter, an indwelling catheter, a peritoneal catheter, or a pleural drainage catheter.

18. The method according to any one of claims 14 to 16, further comprising draining urine from the patient's bladder.

19. The method according to any one of claims 14 to 18, further comprising: Before pushing the handle proximally, detach one or both of the handle and the proximal portion of the shaft from the connector, which releasably secures one or both of the handle and the proximal portion of the shaft to the outer surface of the catheter.

20. The method of claim 19, wherein the connector is an adhesive tape, and removing one or both of the handle and the proximal portion of the shaft from the connector further comprises breaking a tear line extending through the adhesive tape.

21. The method according to any one of claims 14 to 20, wherein the proximal surface of the head defines an annular concave surface extending about a central longitudinal axis of the head to define an acute angle relative to a radially outer edge.

22. The method of any one of claims 14 to 21, wherein pushing the head proximally further comprises disengaging the head from a retaining ring disposed at the distal end of the catheter lumen, the retaining ring abutting the head to releasably retain the head at the distal end of the catheter lumen.

Images