Intermittent catheter assembly
By designing an intermittent catheter assembly that includes a catheter housing and a retractable sheath, the problem of dirt and grime before and after use of existing intermittent catheters is solved, lubrication and cleaning are simplified, urine leakage is prevented, and a convenient user experience is provided.
Patent Information
- Application Number
- CN202180058499.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2020-08-03
- Filing Date
- 2021-07-30
- Publication Date
- 2026-03-17
- Estimated Expiration
- 2041-07-30
AI Technical Summary
Existing intermittent catheters are prone to getting dirty before and after use, and the leakage of lubricant or water causes inconvenience. There is a need for an intermittent catheter assembly that is easy to clean.
An intermittent catheter assembly has been designed, comprising an intermittent catheter, a catheter housing, a retractable sheath, and a lubricant or lubricating sponge. A two-piece handle is formed by sliding the distal part and the inner part to achieve lubrication and cleaning of the catheter, and to form a seal after use to prevent leakage.
It simplifies the cleaning process before and after use, reduces the leakage of lubricant or water, maintains the sterility of the catheter and prevents urine leakage, and provides a convenient user experience.
Smart Images

Figure CN116056746B_ABST
Abstract
Description
[0001] priority
[0002] This application claims priority to U.S. Provisional Application No. 63 / 060,627, filed August 3, 2020, which is incorporated herein by reference in its entirety. Background Technology
[0003] Users of urinary catheters (such as intermittent catheters) self-insert the catheter four to six times a day. However, catheter insertion using such intermittent catheters can be messy. In fact, existing intermittent catheters typically include water or lubricant in their packaging for lubrication before insertion. Users usually pour most of the water or lubricant out of the packaging before insertion to minimize any mess caused by spillage. There is a need for an intermittent catheter that is easy to use and allows for cleaning before and after use.
[0004] This article discloses an intermittent catheter assembly and method for solving the aforementioned problems. Summary of the Invention
[0005] This document discloses an intermittent catheter assembly, which in some embodiments includes an intermittent catheter and a catheter housing. The intermittent catheter includes a proximal member having a neck, a cap configured to cover a proximal opening of the proximal member, and a catheter fitting fluidly connected to the proximal member. The catheter housing surrounds at least the catheter fitting. The catheter housing includes a distal member and a retractable sheath. The distal member includes a chamber or receiver comprising a lubricant or lubricating sponge for lubricating the catheter fitting proximally as the distal member slides over the catheter fitting. The retractable sheath includes a distal portion coupled to the distal member and a proximal portion coupled to the neck of the proximal member of the intermittent catheter. In a packaged state, the entire catheter fitting is disposed within the catheter housing.
[0006] In some implementations, the cap is configured to seal the proximal part when the intermittent catheter is not actively placed for urination, when urination is not performed, or when the intermittent catheter is not removed after urination.
[0007] In some embodiments, the cap is configured to sit on a flange in the proximal portion of the proximal member. The flange includes a gasket positioned between the cap and the proximal member, forming a fluid-impermeable seal when the cap covers the proximal member.
[0008] In some implementations, the cover is connected to the proximal part via a movable hinge.
[0009] In some embodiments, the proximal portion of the cap includes a receiver configured to receive, in an ouroborosly manner, the ribbed portion of the distal part of the catheter housing inserted therein.
[0010] In some implementations, the distal part of the receiver of the insert cap forms a post-use storage state of the intermittent catheter assembly, which is configured to prevent urine leakage from the intermittent catheter assembly after urination with the intermittent catheter assembly.
[0011] In some embodiments, the catheter fitting includes multiple orifices near the tip of the catheter. The orifices are in fluid communication with a proximal opening of the proximal fitting.
[0012] In some embodiments, the intermittent catheter assembly also includes a removable foil seal located above the distal opening of the distal piece in the packaged state of the intermittent catheter assembly. The foil seal is configured to maintain the sterility of the intermittent catheter prior to use.
[0013] In some implementations, the foil seal is also configured to retain lubricant within the intermittent conduit assembly when it is in its packaged state.
[0014] In some embodiments, the catheter housing also includes an internal component slidably disposed around the catheter fitting. The internal component is coupled to the sheath between the proximal and distal portions of the sheath, thereby providing support for the sheath.
[0015] In some implementations, the proximal portion of the sheath is pleated or corrugated, while the distal portion of the sheath is not pleated or corrugated.
[0016] In some implementations, the distal member and the inner member are configured for placement of the intermittent catheter. At least when the distal member slides proximally over the catheter fitting to the inner member, the distal member and the inner member form a two-piece handle for placement of the intermittent catheter, and this sliding also exposes the distal portion of the catheter fitting for placement of the intermittent catheter.
[0017] This document also discloses a package for an intermittent catheter assembly, in some embodiments of which the package includes a resealable package and a set of intermittent catheter assemblies disposed therein. The package includes a cutout portion, a removable element, and a body. The cutout portion includes a notch configured for tearing the removable element from the package. The body includes a cavity and a ziplock at an end of the body for resealing the package after removal of the removable element. The set of intermittent catheter assemblies is disposed within the cavity of the package. Each of the one or more intermittent catheter assemblies is in its packaged state.
[0018] This document also discloses a carrying case for one or more intermittent catheter assemblies, in some embodiments of which the carrying case includes a body, a top, and a cavity formed between the body and the top. The top of the carrying case is connected to the body of the carrying case via a movable hinge. The cavity formed between the body and the top is configured to contain the one or more intermittent catheter assemblies in one or more states.
[0019] This document also discloses a method for assembling an intermittent catheter assembly, which in some embodiments includes a catheter acquisition step, a capping step, a catheter fitting exposure step, a catheter fitting insertion step, and a urine expulsion step. The catheter acquisition step includes acquiring the intermittent catheter assembly in a packaged state. The intermittent catheter assembly includes a catheter housing including a sheath of a catheter fitting at least surrounding the intermittent catheter. The capping step includes removing a cap that covers the proximal opening of the proximal fitting of the intermittent catheter. The cap is attached to the proximal fitting via a movable hinge. The catheter fitting exposure step includes exposing the insertable portion of the catheter fitting by sliding the distal fitting of the catheter housing proximally over the catheter fitting, which in turn lubricates the catheter fitting in the chamber or receiver of the distal fitting with a lubricant or lubricating sponge. The catheter fitting insertion step includes inserting the catheter fitting into the urethra. The urine expulsion step includes urinating from the bladder while the intermittent catheter is properly positioned in the bladder.
[0020] In some implementations, the intermittent catheter assembly in its packaged state is further packaged within an intermittent catheter assembly package, providing approximately one day's supply of the intermittent catheter assembly.
[0021] In some embodiments, the method further includes a foil removal step. The foil removal step includes removing the foil seal from the distal opening of the distal fitting prior to the conduit fitting exposure step.
[0022] In some embodiments, sliding the distal part proximally over the catheter fitting according to the catheter fitting exposure step includes sliding the distal part to the inner part of the catheter housing to form a two-piece handle for inserting the catheter fitting into the urethra. As the distal part slides to the inner part, the distal portion of the sheath retracts between the distal part and the inner part.
[0023] In some embodiments, the catheter fitting exposure step further includes sliding the inner part of the catheter housing or the two-piece handle proximally over the catheter fitting to the proximal part of the intermittent catheter. As the inner part or the two-piece handle slides to the proximal part, the proximal portion of the sheath contracts between the inner part and the proximal part.
[0024] In some embodiments, the method further includes a catheter fitting removal step, a capping step, and a catheter fitting covering step. The catheter fitting removal step includes removing the catheter fitting from the urethra after a urine excretion step. The capping step includes capping the proximal opening of the proximal fitting with a cap. The catheter fitting covering step includes covering the insertable portion of the catheter fitting by sliding the distal fitting distally over the catheter fitting.
[0025] In some embodiments, the method further includes a binding step. The binding step involves inserting the ribbed portion of the distal member into a receiver in the proximal portion of the cap by bending the proximal and distal ends of the intermittent catheter assembly toward each other. The binding step establishes a post-use storage state for the intermittent catheter assembly, configured to prevent leakage of urine from the intermittent catheter assembly after a urination step.
[0026] In some embodiments, the method further includes a catheter assembly storage step. The catheter assembly storage step includes placing the intermittent catheter assembly in a post-use storage state in a multipurpose hard-shell carrying case for future disposal of the intermittent catheter assembly.
[0027] This document also discloses another intermittent catheter assembly, which in some embodiments includes an intermittent catheter and a catheter housing coupled to the intermittent catheter. The intermittent catheter includes a proximal member and a catheter fitting fluidly connected to the proximal member. The proximal member includes a neck. The catheter housing includes a distal member and a retractable sheath. The distal member is configured to slide proximally over the catheter fitting. The retractable sheath includes a distal portion coupled to the distal member and a proximal portion coupled to the neck of the proximal member of the intermittent catheter. In a packaged state, the entire catheter fitting is disposed within the catheter housing.
[0028] In some embodiments, the distal portion of the distal member includes a flared receiver, and the proximal portion of the proximal member includes a flange. The receiver is configured to receive the flange inserted therein in an ouroboros-like manner.
[0029] In some embodiments, each of the distal and proximal members includes a central portion having a circumferential ridge. The circumferential ridge is configured to grip the distal and proximal members when the flange is inserted into the receiver.
[0030] In some embodiments, the circumferential ridge of the distal member is also configured to grip the distal member when it is slid toward the proximal member on the catheter fitting to expose the catheter fitting. The circumferential ridge of the distal member is also configured to grip the distal member when it is slid away from the proximal member on the catheter fitting to re-cover the catheter fitting.
[0031] In some embodiments, the receiver includes an inner lip, and the flange includes an integrated gasket. The inner lip and gasket are configured to form a fluid-impermeable seal when the flange is inserted into the receiver.
[0032] In some implementations, the flange of the insertion receiver forms the packaged state of the intermittent catheter assembly. The packaged state of the intermittent catheter assembly is configured to retain the hydrophilic coating above the catheter fitting, maintain the moisture content of the hydrophilic coating, and preserve its sterility before use of the intermittent catheter.
[0033] In some implementations, the flange of the receiver inserted after use of the intermittent catheter forms a post-use storage state for the intermittent catheter assembly. This post-use storage state is configured to prevent leakage of any residual urine present in the intermittent catheter from the assembly after urination using the intermittent catheter assembly.
[0034] In some embodiments, the catheter fitting includes a plurality of orifices near the tip of the catheter, the orifices being in fluid communication with a proximal opening of the proximal fitting.
[0035] This document also discloses another method for assembling an intermittent catheter assembly, which in some embodiments includes a catheter acquisition step, a flange removal step, a catheter fitting exposure step, a catheter fitting insertion step, and a urine excretion step. The catheter acquisition step includes acquiring the intermittent catheter assembly in its packaged state. The intermittent catheter assembly includes a catheter housing including a sheath of a catheter fitting at least surrounding the intermittent catheter. The flange removal step includes removing a flange in the proximal portion of the proximal portion of the intermittent catheter from a flared receiver on the distal portion of the distal portion of the catheter housing. The catheter fitting exposure step includes exposing the insertable portion of the catheter fitting, which includes sliding the distal portion proximally toward the proximal portion of the catheter fitting. The sheath contracts between the distal and proximal portions, wherein the distal portion slides on the catheter fitting to expose the catheter fitting. The catheter fitting insertion step includes inserting the catheter fitting into the urethra. The urine excretion step includes expelling urine from the bladder while the intermittent catheter is properly positioned in the bladder.
[0036] In some implementations, the flange is inserted into the receiver in an ouroboros-like manner while the intermittent conduit assembly is in its packaged state.
[0037] In some implementations, sliding the distal part toward the proximal part of the catheter fitting can form a two-piece handle between the distal and proximal parts for use in the catheter fitting insertion step.
[0038] In some embodiments, the method further includes a catheter fitting removal step, a catheter fitting re-covering step, a catheter assembly bending step, and a coupling step. The catheter fitting removal step includes removing the catheter fitting from the urethra after urine has been expelled from the bladder. The catheter fitting re-covering step includes re-covering the catheter fitting by covering the insertable portion of the catheter fitting with a sheath by sliding the distal fitting distally over the catheter fitting. The catheter assembly bending step includes bending the proximal and distal portions of the intermittent catheter assembly toward each other. The coupling step includes inserting the flange of the proximal fitting in an ouroborosiform manner into the receiver of the distal fitting, thereby forming a post-use storage state of the intermittent catheter assembly. The post-use storage state of the intermittent catheter assembly is configured to prevent leakage of urine from the intermittent catheter assembly after urine has been expelled from the bladder.
[0039] In some embodiments, the method further includes a storage step. The storage step includes placing the intermittent catheter assembly in its post-use storage state in a multipurpose hard-shell carrying case for future disposal of the intermittent catheter assembly.
[0040] In some implementations, the intermittent catheter assembly, in its packaged or post-use storage state, is further packaged in a carrying case containing approximately one day's supply of other intermittent catheter assemblies.
[0041] These and other features of the concept provided herein will become more apparent to those skilled in the art in view of the accompanying drawings and the following description, which describe in more detail specific embodiments of such a concept. Attached Figure Description
[0042] Figure 1 A perspective view of an intermittent catheter assembly according to some embodiments is shown.
[0043] Figure 2 The following are shown in their packaged state according to some embodiments. Figure 1 Side view of the intermittent catheter assembly.
[0044] Figure 3 The following are illustrated according to some implementation schemes. Figure 1 Side view of the intermittent catheter assembly when uncapped.
[0045] Figure 4 The diagram illustrates a fully exposed conduit fitting according to some embodiments. Figure 1 Side view of the intermittent catheter assembly.
[0046] Figure 5 The following are illustrated according to some implementation schemes. Figure 1 Side view of the intermittent catheter assembly when capped.
[0047] Figure 6A The following are illustrations of a lubricant-filled chamber according to some embodiments. Figure 1 The longitudinal section of the distal portion of the intermittent catheter assembly.
[0048] Figure 6B The following are shown, according to some embodiments, a lubricating sponge-filled chamber. Figure 1 The longitudinal section of the distal portion of the intermittent catheter assembly.
[0049] Figure 6C A lubricating sponge-filled receiver is shown according to some embodiments. Figure 1 The longitudinal section of the distal portion of the intermittent catheter assembly.
[0050] Figure 7 The following are illustrated according to some implementation schemes. Figure 1 A perspective view of the proximal portion of the intermittent catheter assembly at capping.
[0051] Figure 8 The following are illustrated according to some implementation schemes. Figure 1 A perspective view of the proximal portion of the intermittent catheter assembly when uncapped.
[0052] Figure 9 The following are examples of implementation schemes. Figure 1 Detailed view of the distal part of the catheter housing of the intermittent catheter assembly being attached to the cap of the intermittent catheter of the intermittent catheter assembly.
[0053] Figure 10 A perspective view is shown of a distal member inserted into the cap of an intermittent catheter according to some embodiments, forming... Figure 1 The storage state of the intermittent catheter assembly after use.
[0054] Figure 11 The packaging of intermittent catheter assemblies according to some embodiments is shown, for example Figure 1 Intermittent catheter assembly.
[0055] Figure 12 A carrying case for one or more intermittent catheter assemblies is shown according to some embodiments, such as Figure 1 Intermittent catheter assembly.
[0056] Figure 13 A side view of another intermittent catheter assembly according to some embodiments is shown.
[0057] Figure 14 The following are illustrated according to some implementation schemes. Figure 13 A perspective view of the distal portion of the intermittent catheter assembly.
[0058] Figure 15 The following are illustrated according to some implementation schemes. Figure 13 A perspective view of the proximal portion of the intermittent catheter assembly.
[0059] Figure 16 A perspective view of the distal portion of the catheter housing, inserted into the proximal portion of an intermittent catheter according to some embodiments, is shown, forming... Figure 13 The packaging condition or post-use storage condition of the intermittent catheter assembly.
[0060] Figure 17 Detailed views of the distal member inserted into the proximal member of an intermittent catheter according to some embodiments are shown, forming Figure 13 The packaging condition or post-use storage condition of the intermittent catheter assembly.
[0061] Figure 18A carrying case for one or more intermittent catheter assemblies is shown according to some embodiments, such as Figure 13 Intermittent catheter assembly.
[0062] Figure 19 The following are examples of implementation schemes. Figure 18 Carrying case removal Figure 13 The intermittent catheter assembly may be placed in a carrying case. Detailed Implementation
[0063] 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 allow them to be readily separable from the specific embodiments and optionally combined with or substituted for features of any of the many other embodiments disclosed herein.
[0064] Regarding the terminology used herein, it should also be understood that these terms are for descriptive purposes and do not limit the scope of the concepts presented 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 any order or numerical limitation. For example, the features or steps “first,” “second,” and “third” do not necessarily have to appear in that order, and the features including such features or steps do not necessarily have to be limited to 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 suggest, 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 indicates otherwise.
[0065] The terms "proximal," "proximal portion," or "proximal section" for catheters, such as those disclosed herein, include the portion of the catheter intended to be close to the clinician when used with a patient. Similarly, the term "proximal length" for a catheter includes the length of the catheter intended to be close to the clinician when used with a patient. For example, the term "proximal end" for a catheter includes the tip of the catheter intended to be close to the clinician when used with a patient. A proximal portion, proximal section, or proximal length of a catheter may include the proximal end of the catheter; however, a proximal portion, proximal section, or proximal length of a catheter does not necessarily include the proximal end of the catheter. That is, unless the context otherwise suggests, a proximal portion, proximal section, or proximal length of a catheter is not the distal portion or distal length of the catheter.
[0066] The terms "distal," "distal portion," or "distal part" of a catheter, as disclosed herein, include the portion of the catheter intended to be close to or within the patient when used in a patient. Similarly, the term "distal length" of a catheter, for example, includes the length of the catheter intended to be close to or within the patient when used in a patient. For instance, the term "distal end" of a catheter includes the tip of the catheter intended to be close to or within the patient when used in a patient. A distal portion, distal part, or distal length of a catheter may include the distal end of the catheter; however, a distal portion, distal part, or distal length of a catheter does not necessarily include the distal end of the catheter. That is, unless the context otherwise suggests, a distal portion, distal part, or distal length of a catheter is not the distal portion or distal length of the catheter.
[0067] 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.
[0068] As mentioned above, catheter insertion using intermittent catheters can be messy. In fact, existing intermittent catheters typically include water or lubricant in their packaging for lubrication before insertion. Users usually pour most of the water or lubricant out of the packaging before insertion to minimize any mess caused by spillage. There is a need for an intermittent catheter that is easy to use and allows for cleaning before and after use.
[0069] This article discloses an intermittent catheter assembly and method for solving the aforementioned problems.
[0070] Intermittent catheter assembly
[0071] Figures 1 to 5 Various views of the intermittent catheter assembly 100 in various states according to some embodiments are shown. For example: Figure 1 and Figure 2 The intermittent catheter assembly 100 is in its packaged state, as described below. Figure 3 The intermittent catheter assembly 100 is in its pre-insertion state, for example, before the catheter fitting exposure step of the method described below. Figure 4 The intermittent catheter assembly 100 is in its pre-insertion state, such as after the catheter fitting exposure step of the method described below, in its inserted state, such as during the urine excretion step of the method described below, or in its post-insertion state, such as after the catheter fitting removal step of the method described below. Figure 5 The intermittent catheter assembly 100 is in its pre-bonded state, for example, prior to the bonding step of the method described below. Continue to refer to Figures 6A to 6C , Figure 7 and Figure 8 , Figures 6A to 6C The image shows a longitudinal section of the distal portion of an intermittent catheter assembly 100 according to some embodiments, while Figure 7 and Figure 8 A perspective view of the proximal portion of an intermittent catheter assembly 100 according to some embodiments is shown.
[0072] As shown in the figure, in some embodiments, the intermittent catheter assembly 100 includes an intermittent catheter 102 (e.g., a positive intermittent catheter) and a catheter housing 104. Each major component of the intermittent catheter assembly 100 (i.e., the intermittent catheter 102 and the catheter housing 104) is described below in sequence. The following description of the major components of the intermittent catheter assembly 100 is a description of additional features for the intermittent catheter assembly 100.
[0073] The intermittent catheter 102 includes a proximal member 106 having a neck 108, a cap 110 configured to cover a proximal opening 112 of the proximal member 106, and a catheter fitting 114 fluidly connected to the proximal member 106.
[0074] The proximal member 106 is configured to provide a handle for retaining the intermittent catheter assembly 100 during urination through the proximal opening 112 of the proximal member 106. The proximal member 106 includes a flange 116, in which a gasket 118 (e.g., an O-ring) is located on the proximal portion of the proximal member 106. The gasket 118 is configured to be located between the flange 116 and the cap 110, and to form a fluid-impermeable seal when the cap 110 closes the proximal member 106.
[0075] A cap 110 (e.g., a flip-top cap) is configured to seal the proximal member 106 when the intermittent catheter 102 is not actively inserted for urination, when urination is not performed, or when the intermittent catheter 102 is not removed after urination. The cap 110 is connected to the proximal member 106 via a movable hinge 120. The cap 110 is configured to lie above the flange 116 of the proximal member 106 such that a gasket 118 is located between the cap 110 and the flange 116, thereby forming a fluid-impermeable seal when the cap 110 seals the proximal member 106.
[0076] The cover 110 is also configured to achieve a post-use storage state for the intermittent catheter assembly 100, as described below. Specifically, the cover 110 includes a receiver 122 for the ribbed portion 136 of the distal part 130 of the catheter housing 104, as described below, to achieve the post-use storage state of the intermittent catheter assembly 100. This post-use storage state prevents urine leakage from the intermittent catheter assembly 100 after urination using it. For example, see... Figure 9 and Figure 10 。 )
[0077] The catheter fitting 114 is configured for insertion into the urethra to drain urine from the bladder. In one embodiment, the catheter fitting 114 includes a plurality of orifices 124 near the catheter tip 126. The orifices 124 are in fluid communication with a proximal opening 112 of the proximal member 106 via a catheter fitting lumen 128 extending along the length of the catheter fitting 114. Although two orifices 124 are shown, any number or shape of openings is possible and within the scope of the invention, such as one large opening, more than two openings, etc. Moreover, the one or more openings may be spaced apart around the circumference of the catheter fitting 114.
[0078] The catheter housing 104 includes a distal member 130, an inner member 132, and a sheath 134. In the packaged state of the intermittent catheter assembly 100, the entire catheter fitting 114 is arranged within the catheter housing 104, as... Figure 1 and Figure 2 As shown. However, in any state of the intermittent catheter assembly 100, the catheter housing 104 surrounds at least a portion of the catheter fitting 114. (See, for example, see...) Figure 1 and Figure 2 , Figure 4 and Figure 10 。 )
[0079] The distal member 130 is configured to form a two-piece handle 144 with the inner member 132, as described below, for placing the intermittent catheter 102. The distal member 130 is thus slidably arranged around the catheter fitting 114 so that the distal member 130 slides to the inner member 132.
[0080] The distal member 130 is also configured to achieve a post-use storage state for the intermittent catheter assembly 100, as described below. Specifically, the distal member 130 includes a ribbed portion 136 in its distal portion for achieving the post-use storage state of the intermittent catheter assembly 100. Similarly, the post-use storage state of the intermittent catheter assembly 100 prevents leakage of urine from the intermittent catheter assembly 100 after urination using the intermittent catheter assembly 100. (See, for example, [link to relevant documentation]). Figure 9 and Figure 10 。 )
[0081] The distal part 130 is also configured to mitigate the migration of liquids (e.g., water, lubricant, or combinations thereof) into the orifice 124 of the catheter fitting 114, through the lumen 128 of the catheter fitting 114, and out of the proximal opening 112 of the proximal part 106 when opened, or out of the distal opening 138 of the distal part 130 when the foil seal 150 is removed. Each of these mitigations reduces any mess that may occur when the user begins using the intermittent catheter assembly 100. In practice, the distal part 130 includes a chamber 140 or receiver 142 for mitigating liquid migration, as described below.
[0082] The inner component 132 is configured to form a two-piece handle 144 with the distal component 130 for at least placement of the intermittent catheter 102. Therefore, the inner component 132 is slidably arranged around the catheter fitting 114 to allow the inner component 132 to slide independently or together with the distal component 130. In effect, the distal component 130 and the inner component 132 form a two-piece handle 144 for placement of the intermittent catheter 102 when at least the distal component 130 slides proximally across the catheter fitting 114 to the inner component 132, which incidentally also exposes the distal portion of the catheter fitting 114 for placement of the intermittent catheter 102, or allows the inner component 132 to slide distally across the catheter fitting 114 to the distal component 130. Figure 4 The former is shown, wherein the two-piece handle 144 is positioned proximal to the intermittent catheter assembly 100 for its pre-insertion state, such as after the catheter fitting exposure step of the method described below, its insertion state, such as during the urination step of the method described below, or its post-insertion state, such as after the catheter fitting removal step of the method described below. Figure 10 The latter is shown, in which the two-piece handle 144 is in a distal position of the intermittent catheter assembly 100 for its post-use storage state.
[0083] The inner component 132 is also configured to provide internal structural support for the sheath 134. In fact, the inner component 132 is connected to the sheath 134 between the distal portion 146 and the proximal portion 148 of the sheath 134, as described below, thereby providing structural support for the sheath 134.
[0084] The sheath 134 is configured to maintain the sterility of the catheter fitting 114 at least in the packaged state of the intermittent catheter assembly 100, and to retain urine in the stored state after use of the intermittent catheter assembly 100.
[0085] The sheath 134 is retractable for switching between different states of the intermittent catheter assembly 100. The sheath 134 includes a distal portion 146 coupled to the distal member 130, a proximal portion 148 coupled to the neck 108 of the proximal member 106, and a portion coupled to the inner member 132 between the distal portion 146 and the proximal portion 148 (e.g., the middle portion of the sheath 134). The proximal portion 148 of the sheath 134 is pleated or corrugated to extend over the catheter fitting 114 in a post-use storage state of the intermittent catheter assembly 100. (See...) Figure 10 However, the distal portion 146 of the sheath 134 does not need to be pleated or corrugated as shown in the illustrated embodiment.
[0086] The intermittent catheter assembly 100 also includes a removable foil seal 150 on the distal opening 138 of the distal part 130 of the catheter housing 104 in the packaged state. (See...) Figure 1 and Figure 2 The foil seal 150 is configured to maintain the sterility of the intermittent catheter 102 prior to its use.
[0087] The intermittent conduit assembly 100 may also include a liquid (e.g., lubricant 152, water 153, or a combination thereof) disposed within the intermittent conduit assembly 100, in a sheath cavity 154 between the conduit fitting 114 and the sheath 134, for lubricating the conduit fitting 114. The foil seal 150 is further configured to retain the liquid within the intermittent conduit assembly 100 when it is in its packaged state. Figures 6A to 6C Additional or alternative lubrication devices for lubricating conduit fitting 114 are shown, each lubrication device also including a liquid holding device for holding liquid (e.g., lubricant 152, water 153 or a combination thereof) in intermittent conduit assembly 100.
[0088] Figures 6A to 6C A longitudinal section of the distal portion of an intermittent conduit assembly 100 according to some embodiments is shown, including a lubricant-filled chamber 140 in the distal member 130, a lubricating sponge-filled chamber 140 in the distal member 130, and a lubricating sponge-filled receiver 142 in the distal member 130.
[0089] Figures 6A to 6C The lubrication device shown is configured to lubricate the conduit fitting 114 as it passes through the chamber 140 or the receiver 142 (e.g., when the distal fitting 130 slides proximally on the conduit fitting 114). An associated fluid retention device is configured to mitigate fluid (e.g., lubricant 152, water 153, or a combination thereof) migration into the orifice 124 of the conduit fitting 114, through the lumen 128 of the conduit fitting 114, and out of the proximal opening 112 of the proximal fitting 106 when the foil seal 150 is removed, or to mitigate fluid migration from the distal opening 138 of the distal fitting 130. Reducing fluid migration from the proximal opening 112 of the proximal member 106 or the distal opening 138 of the distal member 130 mitigates any mess that may occur when the user begins using the intermittent catheter assembly 100 (e.g., opening the cap 110 to seal the proximal opening 112 of the proximal member 106 of the intermittent catheter 102, removing the foil seal 150 from the distal opening 138 of the distal member 130, etc.).
[0090] As shown in the figure Figure 6A and Figure 6B The distal component 130 of each intermittent catheter assembly 100 in each figure includes a chamber 140, wherein, Figure 6AThe illustrated chamber 140 includes a liquid (e.g., lubricant 152, water 153, or a combination thereof) for lubricating the catheter fitting 114 as needed, and wherein, Figure 6B The illustrated chamber 140 includes a lubricating sponge 156 (e.g., a liquid-impregnated sponge) for lubricating the catheter fitting 114 as needed. Due to the narrow cylindrical gap 158 between the chamber 140 and the sheath lumen 154 proximal to the distal fitting 130, any fluid ingress from the sheath lumen 154 into the chamber 140 is minimal, if not nonexistent, especially if the fluid is relatively viscous (e.g., a lubricating gel). This limits the amount of fluid that can migrate into the orifice 124 of the catheter fitting 114 and exit from the proximal opening 112 of the proximal fitting 106 when open. Similarly, the narrow cylindrical gap 160 between the chamber 140 and the distal opening 138 of the distal fitting 130 restricts any fluid outflow from the chamber 140, thereby limiting the amount of fluid that can migrate out of the distal opening 138 of the distal fitting 130 when the foil seal 150 is removed. Regarding the lubricating sponge 156, the lubricating sponge 156 further reduces any liquid entering or leaving the chamber 140 due to its rate-limiting wicking mechanism. Furthermore, when the lubricating sponge body is saturated, the lubricating sponge body 156 will not wick any liquid from the inner cavity 154 of the sheath into the chamber 140.
[0091] Although Figure 6C The distal part 130 of the intermittent catheter assembly 100 includes a receiver 142 instead of Figure 6A or Figure 6B The intermittent catheter assembly 100 shown has a chamber 140, but the receiver 142 still restricts the flow of any liquid (e.g., lubricant 152, water 153, or a combination thereof) out of the receiver 142 through a narrow cylindrical gap 160 between the receiver 142 and the distal opening 138 of the distal member 130, similar to the chamber 140 described above. Additionally, the lubricating sponge 162, having a distal portion of the liquid disposed within the sheath cavity 154, further reduces any liquid entry or exit from the receiver 142 due to its rate-limiting wicking mechanism, and when the lubricating sponge is saturated, it cannot wick any liquid from the sheath cavity 154 into the receiver 142.
[0092] Figure 9 A detailed view is shown of the distal part 130 of the catheter housing 104 being attached to the cap 110 of the intermittent catheter 102 according to some embodiments. Figure 10 A perspective view of the distal part 130 of the catheter housing 104 inserted into the cap 110 of the intermittent catheter 102, according to some embodiments, is shown, forming the intermittent catheter assembly 100 in a post-use storage state.
[0093] As implied above, both the cap 110 and the distal member 130 are configured to achieve a post-use storage state for the intermittent catheter assembly 100. Specifically, the cap 110 includes a receiver 122, and the distal member 130 includes a ribbed portion 136, which is configured to receive the ribbed portion 136 inserted therein when the intermittent catheter assembly 100 is bent end-to-end, a configuration resembling that of a dragon or snake devouring its own tail (e.g., the Orobaro serpent in ancient Egyptian iconography). The distal member 130 is further configured to achieve a post-use storage state for the intermittent catheter assembly 100 together with the inner part 132 of the catheter housing 104 within a two-piece handle 144. Specifically, when the two-piece handle 144 is in the distal position of the intermittent catheter assembly 100, it is in a position similar to... Figure 10 In the post-use storage state shown, the two-piece handle 144 provides structural support to counteract circumferential stress at that location when the intermittent catheter assembly 100 is in its post-use storage state. Similarly, the post-use storage state of the intermittent catheter assembly 100 prevents leakage of urine from the intermittent catheter assembly 100 after urination using the intermittent catheter assembly 100.
[0094] Figures 13 to 17 Various views of the intermittent catheter assembly 200 in various states according to some embodiments are shown. For example: Figure 13 The intermittent catheter assembly 200 is in its pre-insertion state, for example, before the catheter fitting exposure step of the method described below. Or, Figure 13 The intermittent catheter assembly 200 is in its pre-binding state, for example, before the binding step of the method described below. Figure 16 The intermittent catheter assembly 200 is in its packaged state as described below. Alternatively, Figure 16 The intermittent catheter assembly 200 is in its post-use storage state as described below.
[0095] As shown in the figure, in some embodiments, the intermittent catheter assembly 200 includes an intermittent catheter 202 (e.g., a positive intermittent catheter) and a catheter housing 204 coupled to the intermittent catheter 202. Each major component of the intermittent catheter assembly 200 (i.e., the intermittent catheter 202 and the catheter housing 204) will be described below in turn.
[0096] The intermittent catheter 202 includes a proximal member 206 having a neck 208 and a catheter fitting 214 fluidly connected to the proximal member 206.
[0097] The proximal member 206 is configured to provide a handle, or part of a two-piece handle as described below, for holding the intermittent catheter assembly 200 while urine is drained through the proximal opening 212 of the proximal member 206. Specifically, the proximal member 206 includes a central portion having a circumferential ridge 209 configured to grip the proximal member 206 while urine is drained through the proximal opening 212. The proximal member 206 includes a flange 216, with an integrated gasket 218 (e.g., an integrated O-ring) on top of the proximal portion of the proximal member 206. The gasket 218 is configured to form a fluid-impermeable seal when the flange 216 is inserted into the receiver 222 as described below. Notably, the circumferential ridge 209 is also configured to grip the proximal member 206 when the flange 216 is inserted into the receiver 222.
[0098] The catheter fitting 214 is configured for insertion into the urethra to allow urination from the bladder. Regarding insertion into the urethra, the catheter fitting 214 includes an activating or wetting hydrophilic coating on top of the catheter fitting 214. Regarding urination from the bladder, in one embodiment, the catheter fitting 214 includes a plurality of orifices near the tip of the catheter. (See, for example, [link to relevant documentation]). Figure 4 (The orifice 124 and the conduit tip 126 of the conduit fitting 114.) The orifice is in fluid communication with the proximal opening 212 of the proximal fitting 206 through a conduit fitting lumen extending along the length of the conduit fitting 214. (See, for example, see...) Figures 6A to 6C (The inner lumen 128 of the conduit fitting 114.)
[0099] The catheter housing 204 includes a distal member 230 and a sheath 234. For example... Figure 16 and Figure 19 As shown, in the packaged state of the intermittent catheter assembly 200, the entire catheter fitting 214 is arranged within the catheter housing 204. However, in any state of the intermittent catheter assembly 200, the catheter housing 204 surrounds at least a portion of the catheter fitting 214.
[0100] The distal member 230 is slidably disposed around the catheter fitting 214 for sliding proximally on the catheter fitting 214 to the proximal member 206 to expose the catheter fitting 214 for catheter insertion. The distal member 230 is also slidably disposed around the catheter fitting 214 for sliding distally on the catheter fitting 214 away from the proximal member 206 to re-conceal the catheter fitting 214 after catheter insertion. Similar to the proximal member 206, the distal member 230 includes a central portion having a circumferential ridge 231 configured to grip the distal member 230 when sliding proximally or distally on the catheter fitting 214. Additionally, the distal member 230 is configured to form a two-piece handle with the proximal member 206 when sliding proximally on the catheter fitting 214 to the proximal member 206. (See, for example, [link to relevant documentation]). Figure 4 The intermittent catheter assembly 200 comprises a proximal member 106 and a distal member 130. A two-piece handle is configured to hold the intermittent catheter assembly 200 while urinating through the proximal opening 212 of the proximal member 206, via circumferential ridges 209 and 231 of the proximal member 206. Notably, the circumferential ridge 231 is also configured to grip the distal member 230 when the flange 216 is inserted into the receiver 222, which is described below.
[0101] The distal part 230 is also configured to achieve both a packaged state and a post-use storage state for the intermittent catheter assembly 200. Specifically, the distal part 230 includes a flared receiver 222 having an inner lip 223 in the distal portion of the distal part 230 for forming a fluid-impermeable seal when the flange 216 is inserted into the receiver 222. Insertion of the flange 216 into the receiver 222 achieves both the initial packaged state and the post-use storage state of the intermittent catheter assembly 200. The post-use storage state of the intermittent catheter assembly 200 is configured to prevent leakage of any residual urine present in the intermittent catheter 202 from the intermittent catheter assembly 200 after urination using the intermittent catheter assembly 200. (See, for example, see...) Figure 16 and Figure 19 。 )
[0102] The sheath 234 is configured to retain the hydrophilic coating above the catheter fitting 214 in the packaged state of the intermittent catheter assembly 200, maintain the moisture content of the hydrophilic coating in the packaged state of the intermittent catheter assembly 200, and maintain the sterility of the intermittent catheter 202 in the packaged state before its use. The sheath 234 is also configured to prevent urine leakage from the intermittent catheter assembly 200 in the post-use storage state. However, other features of the intermittent catheter assembly 200 used to achieve the aforementioned states also contribute to the foregoing.
[0103] The sheath 234 is retractable for switching between different states of the intermittent catheter assembly 200. The sheath 234 includes a distal portion connected to the distal member 230 and a proximal portion connected to the neck 208 of the proximal member 206. The sheath 234 is pleated or corrugated to facilitate switching between different states of the intermittent catheter assembly 200, including a packaged state and a post-use storage state.
[0104] As described above, both the distal member 230 and the proximal member 206 are configured to achieve a packaged state and a post-use storage state for the intermittent catheter assembly 200. Specifically, the distal member 230 includes a receiver 222, and the proximal member 206 includes a flange 216. The receiver 222 is configured to receive the flange 216 inserted therein when the intermittent catheter assembly 200 is bent end-to-end, a configuration resembling that of a dragon or snake eating its own tail (e.g., the Orobaro serpent in ancient Egyptian iconography). In the packaged state, the hydrophilic coating above the catheter fitting 214 is retained, maintaining its moisture content and preserving the sterility of the intermittent catheter 202 before use. In the post-use storage state, leakage of urine from the intermittent catheter assembly 200 is prevented.
[0105] Packaged intermittent catheter assembly
[0106] Figure 11 The packaging of an intermittent catheter assembly 1000 according to some embodiments is shown.
[0107] As shown in the figure, in some embodiments, the intermittent catheter assembly 1000 is packaged as a resealable package 1102 and a set of intermittent catheter assemblies 1104 disposed therein.
[0108] The package 1102 includes a cutout portion 1106, a removable part 1108, and a main body 1110.
[0109] The cut portion 1106 of the packaging 1102 includes a cut 1112 configured to tear the removable part 1108 from the packaging 1000 or its packaging 1102.
[0110] The body 1110 includes a cavity and a self-locking ziplock 1114 at the end of the body 1110 for resealing the package 1000 or its package 1102 after the removable part 1108 is removed.
[0111] This set of intermittent catheter assemblies 1104 (e.g., approximately a one-day supply) is arranged within the lumen of package 1102. Each intermittent catheter assembly 100 of this set of intermittent catheter assemblies 1104 is arranged in its extended form within package 1102 to minimize its curvature, which could complicate insertion. Additionally, each intermittent catheter assembly 100 is arranged in its packaged state as described above.
[0112] Case
[0113] Figure 12 A carrying case 1200 for one or more intermittent catheter assemblies (e.g., intermittent catheter assembly 100) is shown according to some embodiments.
[0114] As shown in the figure, the carrying case 1200 is a multi-purpose rigid-shell carrying case. In some embodiments, the carrying case includes a top 1202, a body 1204, and a cavity 1206 formed between the top 1202 and the body 1204. The carrying case 1200, including the top 1202 and the body 1204, can be rigid to prevent damage to any intermittent catheter assemblies disposed therein and to facilitate long-term use of the carrying case.
[0115] The top 1202 of the carrying case 1200 is configured such that the open end of the body 1204 of the carrying case 1200 is located above the flange 1208, which facilitates keeping the carrying case 1200 closed by an interference fit between the top 1202 and the flange 1208. The top 1202 of the carrying case 1200 is connected to the body 1204 of the carrying case 1200 by a movable hinge 1210, which facilitates fitting the top 1202 above the flange 1208 of the body 1204 and eliminates misalignment of the top 1202.
[0116] When the top 1202 is assembled above the open end of the body 1204, the cavity 1206 formed between the body 1204 of the carrying case 1200 and the top 1202 of the carrying case 1200 is configured to contain the one or more intermittent catheter assemblies in one or more of their states.
[0117] Figure 18 A carrying case 1800 for one or more intermittent catheter assemblies (e.g., intermittent catheter assembly 200) is shown according to some embodiments.
[0118] Similar to carrying case 1200, carrying case 1800 is a multi-purpose rigid-shell carrying case. In some embodiments, the carrying case includes a top 1802, a body 1804, and a cavity 1806 formed between the top 1802 and the body 1804. The carrying case 1800, including the top 1802 and the body 1804, can be rigid to prevent damage to any intermittent catheter assemblies disposed therein and to facilitate long-term use of the carrying case 1800.
[0119] The peripheral edge 1803 extending from the top 1802 of the carrying case 1800 is configured such that the open end of the body 1804 of the carrying case 1800 is located on the inner lip 1808. This facilitates the keeping of the carrying case 1800 closed by an interference fit between the peripheral edge 1803 and the peripheral edge 1805 extending from the body 1804 beyond the inner lip 1808. The top 1802 of the carrying case 1800 is connected to the body 1804 of the carrying case 1800 by a movable hinge 1810, which facilitates the fitting of the top 1802 above the body 1804 and eliminates any misalignment of the top 1802.
[0120] When the top 1802 is fitted over the open end of the body 1804, the cavity 1806 formed between the body 1804 of the carrying case 1800 and the top 1802 of the carrying case 1800 is configured to contain the one or more intermittent catheter assemblies in one or more of their states.
[0121] method
[0122] Figure 1 The method of the intermittent catheter assembly 100 includes the method of using the intermittent catheter assembly 100. For example, in some embodiments, the method of the intermittent catheter assembly 100 includes a catheter acquisition step, a capping step, a catheter fitting exposure step, a catheter fitting insertion step, and a urine excretion step.
[0123] The catheter acquisition step includes obtaining the intermittent catheter assembly 100 in its packaged state. The intermittent catheter assembly 100 in its packaged state may be further packaged in a package of intermittent catheter assembly 1100 to provide a supply of approximately one day. As described above, the intermittent catheter assembly 100 includes a catheter housing 104, which includes a sheath 134 at least surrounding a catheter fitting 114 of the intermittent catheter 102.
[0124] The cap removal step involves removing the cap 110 to seal the proximal opening 112 of the proximal part 106 of the intermittent conduit 102. As described above, the cap 110 is connected to the proximal part 106 via a movable hinge 120.
[0125] The method also includes a foil removal step. The foil removal step includes removing the foil seal 150 from the distal opening 138 of the distal part 130 of the conduit housing 104 prior to the conduit fitting exposure step.
[0126] The catheter fitting exposure step includes exposing the insertable portion of the catheter fitting 114, which is achieved by sliding the distal part 130 of the catheter housing 104 proximally over the catheter fitting 114. Sliding the distal part 130 of the catheter housing 104 proximally over the catheter fitting 114 according to the catheter fitting exposure step includes sliding the distal part 130 to the inner part 132 of the catheter housing 104 to form a two-piece handle 144 for inserting the catheter fitting 114 into the urethra. As the distal part 130 slides to the inner part 132, the distal portion 146 of the sheath 134 retracts between the distal part 130 and the inner part 132. The catheter fitting exposure step also includes sliding the inner part 132 or the two-piece handle 144 of the catheter housing 104 proximally over the catheter fitting 114 to the proximal part 106 of the intermittent catheter 102. As the inner part 132 or the two-piece handle 144 slides to the proximal part 106, the proximal portion 148 of the sheath 134 retracts between the inner part 132 and the proximal part 106.
[0127] The catheter fitting insertion procedure includes inserting the catheter fitting 114 into the urethra.
[0128] The urine excretion procedure includes expelling urine from the bladder while the intermittent catheter 102 is properly placed in the bladder.
[0129] The method also includes a catheter / fitting removal step, a capping step, and a catheter / fitting covering step.
[0130] The catheter fitting removal step includes removing the catheter fitting 114 from the urethra after the urine excretion step.
[0131] The capping step includes capping the proximal opening 112 of the proximal part 106 with cap 110 after the catheter fitting removal step.
[0132] The catheter fitting covering step includes covering the insertable portion of the catheter fitting 114 by sliding the distal part 130 of the catheter housing 104 distally on the catheter fitting 114.
[0133] The method may also include a binding step. The binding step involves inserting the ribbed portion 136 of the distal part 130 of the catheter housing 104 into the receiver 122 in the proximal portion of the cap 110 by bending the proximal and distal ends of the intermittent catheter assembly 100 toward each other. The binding step establishes a post-use storage state of the intermittent catheter assembly 100, configured to prevent leakage of urine from the intermittent catheter assembly 100 after a urination step.
[0134] The method may also include a catheter assembly storage step. The catheter assembly storage step includes placing the intermittent catheter assembly 100 in its post-use storage state in a carrying case 1200 or another container for future disposal of the intermittent catheter assembly 100.
[0135] Figures 13 to 17 and Figure 19 Methods involving the intermittent catheter assembly 200 include methods of using the intermittent catheter assembly 200. For example, in some embodiments, the methods of the intermittent catheter assembly 200 include a catheter acquisition step, a flange removal step, a catheter fitting exposure step, a catheter fitting insertion step, and a urine excretion step.
[0136] The catheter acquisition step includes obtaining the intermittent catheter assembly 200 in its packaged state. As described above, the intermittent catheter assembly 200 includes a catheter housing 204, which includes a sheath 234 at least surrounding the catheter fitting 214 of the intermittent catheter, wherein the flange 216 is inserted into the receiver 222 in an ouroboros-like manner in the packaged state of the intermittent catheter assembly 200. It is worth noting that the intermittent catheter assembly 200 in its packaged state can be further packaged in a carrying case with approximately one day's supply of other intermittent catheter assemblies.
[0137] The flange removal step includes removing the flange 216 in the proximal portion of the proximal portion of the intermittent catheter 202 from the flared receiver 222 of the distal portion of the distal portion 230 of the catheter housing 204.
[0138] The catheter fitting exposure step includes exposing the insertable portion of catheter fitting 214, which involves sliding the distal fitting 230 proximally toward the proximal fitting 206 on catheter fitting 214. A sheath 234 retracts between the distal fitting 230 and the proximal fitting 206, wherein the distal fitting 230 slides on catheter fitting 214 to expose catheter fitting 214. Notably, sliding the distal fitting 230 proximally toward the proximal fitting 206 on catheter fitting 214 forms a two-piece handle between the proximal fitting 206 and the distal fitting 230 for use in the catheter fitting insertion step.
[0139] The catheter fitting insertion step includes inserting catheter fitting 214 into the urethra.
[0140] The urine excretion procedure includes excreting urine from the bladder while the intermittent catheter 202 is properly placed in the bladder.
[0141] The method also includes a catheter fitting removal step, a catheter fitting re-covering step, a catheter assembly bending step, and a storage state formation step.
[0142] The catheter fitting removal procedure includes removing the catheter fitting 214 from the urethra after urine has been excreted from the bladder.
[0143] The catheter fitting re-covering step includes re-covering the catheter fitting 214 by sliding the distal member 230 distally on the catheter fitting 214 and covering the insertable portion of the catheter fitting 214 with a sheath 234.
[0144] The catheter assembly bending step includes bending the proximal and distal portions of the intermittent catheter assembly 200 toward each other.
[0145] The storage state formation step includes inserting the flange 216 of the proximal member 206 into the receiver 222 of the distal member 230 in an ouroborosiform manner, thereby forming a post-use storage state of the intermittent catheter assembly 200. The post-use storage state of the intermittent catheter assembly 200 is configured to prevent leakage of urine from the intermittent catheter assembly 200 after urine has been excreted from the bladder.
[0146] The method may also include a storage step. The storage step involves placing the intermittent catheter assembly 200 in its post-use storage state in a multi-purpose hard-shell carrying case for future disposal. The intermittent catheter assembly 200 in its post-use storage state may be stored or packaged in the carrying case with a daily supply of other intermittent catheter assemblies.
[0147] 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 be apparent to those skilled in the art, and these adaptations and / or modifications are also covered 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. An intermittent urinary catheter assembly comprising: an intermittent urinary catheter comprising: a proximal piece comprising a neck; a cap configured to seal a proximal opening of the proximal piece fluid-tight after urination; a catheter tube fluidly connected to the proximal piece; and a catheter housing coupled to the intermittent urinary catheter, the catheter housing comprising: a distal piece comprising a chamber or receptacle comprising a lubricant or lubricating sponge for lubricating the catheter tube when the distal piece is slid proximally over the catheter tube; and a retractable sheath comprising a distal portion coupled to the distal piece and a proximal portion coupled to the neck of the proximal piece of the intermittent urinary catheter, the entire catheter tube being disposed in the catheter housing in a packaged state of the intermittent urinary catheter assembly, wherein a proximal portion of the cap comprises a receptacle configured to accept a ribbed portion of the distal piece of the catheter housing in a tail-of-a-snake-like manner when inserted therein to complete a post-use storage state of the intermittent urinary catheter assembly that prevents leakage of urine from the intermittent urinary catheter assembly after urination using the intermittent urinary catheter assembly.
2. The intermittent urinary catheter assembly of claim 1, wherein the cap is configured to seal the proximal piece when the intermittent urinary catheter is not actively placed for urination, no urination is taking place, or the intermittent urinary catheter is not removed after urination.
3. The intermittent urinary catheter assembly of claim 1 or 2, wherein the cap is configured to sit over a flange in a proximal portion of the proximal piece, the flange comprising a gasket thereover, the gasket configured to sit between the cap and the proximal piece and form the fluid-tight seal when the cap seals the proximal piece.
4. The intermittent urinary catheter assembly of claim 1, wherein the cap is coupled to the proximal piece by a living hinge.
5. The intermittent urinary catheter assembly of claim 1, wherein the catheter tube comprises a plurality of eyelets proximate a catheter tip, the eyelets being in fluid communication with a proximal opening of the proximal piece.
6. The intermittent catheter assembly of claim 1, further comprising: a removable foil seal over a distal opening of the distal piece in the packaged state of the intermittent urinary catheter assembly, the foil seal configured to maintain sterility of the intermittent urinary catheter prior to use of the intermittent urinary catheter.
7. The intermittent urinary catheter assembly of claim 6, wherein the foil seal is further configured to maintain the lubricant in the intermittent urinary catheter assembly while the intermittent urinary catheter assembly is in its packaged state.
8. The intermittent urinary catheter assembly of claim 1, the catheter housing further comprising an inner piece slidably disposed about the catheter tube, the inner piece coupled to the sheath between the proximal portion of the sheath and the distal portion of the sheath to provide support to the sheath.
9. The intermittent urinary catheter assembly of claim 8, wherein the proximal portion of the sheath is pleated or corrugated, and wherein the distal portion of the sheath is not pleated or corrugated.
10. The intermittent catheter assembly of claim 8 or 9, wherein the distal piece and the inner piece are configured for placement of the intermittent catheter, the distal piece and the inner piece forming a two-piece handle for placement of the intermittent catheter at least when the distal piece is slid proximally over the catheter tube to the inner piece to expose a distal portion of the catheter tube for placement of the intermittent catheter.
11. A package of intermittent catheter assemblies, comprising: a resealable package, the resealable package comprising: a cutout portion; a removable piece, the cutout portion including a cutout configured for tearing the removable piece from the package; and a main body including a cavity and a self-lock in an end of the main body for resealing the package after removal of the removable piece; and a set of intermittent catheter assemblies disposed in the cavity, each intermittent catheter assembly of the one or more intermittent catheter assemblies in its packaged state, and each intermittent catheter assembly of the one or more intermittent catheter assemblies comprising: an intermittent catheter, the intermittent catheter comprising: a proximal piece including a neck portion; a cap configured to seal a proximal opening of the proximal piece in a fluid-tight seal after urination; and a catheter tube fluidly connected to the proximal piece; and a catheter housing coupled to the intermittent catheter, the catheter housing comprising: a distal piece including a chamber or receptacle, the chamber or receptacle including a lubricant or lubricating sponge for lubricating the catheter tube when the distal piece is slid proximally over the catheter tube; and a collapsible sheath including a distal portion coupled to the distal piece and a proximal portion coupled to the neck portion of the proximal piece of the intermittent catheter, in the packaged state of the intermittent catheter assembly, the entire catheter tube is disposed in the catheter housing, wherein a proximal portion of the cap includes a receptacle configured to accept a ribbed portion of the distal piece of the catheter housing in a tail-chasing manner when inserted therein to complete a post-use storage state of the intermittent catheter assembly, the post-use storage state preventing leakage of urine from the intermittent catheter assembly after urination using the intermittent catheter assembly.
12. The package of intermittent catheter assemblies of claim 11, wherein the cap includes a proximal portion including a receptacle configured to accept a ribbed portion of the distal piece of the catheter housing in a tail-chasing manner when inserted therein to complete a post-use storage state of the intermittent catheter assembly, the post-use storage state preventing leakage of urine from the intermittent catheter assembly after urination using the intermittent catheter assembly.
13. The package of intermittent catheter assemblies of claim 11 or 12, wherein the cap includes a proximal portion including a receptacle configured to accept a ribbed portion of the distal piece of the catheter housing in a tail-chasing manner when inserted therein to complete a post-use storage state of the intermittent catheter assembly, the post-use storage state preventing leakage of urine from the intermittent catheter assembly after urination using the intermittent catheter assembly.
14. The package of intermittent catheter assemblies of claim 11, wherein the cap includes a proximal portion including a receptacle configured to accept a ribbed portion of the distal piece of the catheter housing in a tail-chasing manner when inserted therein to complete a post-use storage state of the intermittent catheter assembly, the post-use storage state preventing leakage of urine from the intermittent catheter assembly after urination using the intermittent catheter assembly.
Citation Information
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