Catheter assembly

Abstract

A catheter assembly (10) may include a catheter member (200) having a proximal portion and an outer surface; a introducer (100, 300) having a lumen configured to receive the proximal portion of the catheter member; and a cannula (160) having a compression portion (168) received within the lumen of the introducer, the cannula being configured to evert over the outer surface when the catheter member is inserted through the lumen of the introducer. The proximal portion of the catheter member may be configured to push the distal portion (164) of the cannula proximally, and when the catheter member exits the proximal opening of the cannula, the compression portion of the cannula may form a soft proximal tip of the catheter assembly.

Description

[0001] Priority

[0002] This application claims the benefit of priority to U.S. Provisional Patent Application No. 62 / 848,333, filed on May 15, 2019, the entire disclosure of which is incorporated herein by reference in its entirety. Field of the Invention

[0003] The present disclosure generally relates to catheters, and more particularly to a two-piece catheter assembly configured to reduce friction when a catheter member is introduced into a body cavity. Background of the Invention

[0004] Urinary catheters are commonly used to drain urine from a patient's bladder by insertion through the urethra. Friction between the catheter and the urethra can cause discomfort during insertion and / or removal. The present invention addresses one or more problems associated with prior art catheters. Summary of the Invention

[0005] One aspect of the present invention relates to a catheter assembly including a catheter member, a guide, and a sleeve. The catheter member may have a proximal portion and an outer surface. The guide may have a lumen configured to receive the proximal portion of the catheter member, and the sleeve may have a compressed portion received within the lumen of the guide, the sleeve being configured to evert over the outer surface when the catheter member is inserted through the lumen of the guide.

[0006] In some embodiments, the proximal portion of the catheter member is configured to push the distal portion of the cannula proximally, and when the catheter member exits the proximal opening of the introducer, the compressed portion of the cannula forms a soft proximal tip of the catheter assembly. In some embodiments, the cannula is not fixed to the catheter member. In some embodiments, the introducer includes a cap member having an enlarged proximal surface. In some embodiments, the cap member has a retaining member that covers the cannula when received in the introducer and deflects as the catheter member is advanced proximally from the introducer. In some embodiments, the retaining member includes a plurality of fins. In some embodiments, the retaining member forms a protrusion extending proximally from the enlarged proximal surface. In some embodiments, the introducer includes a handle member having a surface configured to be grasped by a user. In some embodiments, the surface of the handle member includes a concave surface and / or one or more ridges. In some embodiments, the proximal portion of the cannula is fixed to the introducer. In some embodiments, the cap member and the handle member are in a mating configuration. In some embodiments, the distal portion of the cannula is releasably engaged with an inner shoulder of the introducer. In some embodiments, the handle member includes a plurality of elongate guide members extending from the distal portion. In some embodiments, the proximal portion of the catheter member is open and the catheter member has a lumen therethrough. In some embodiments, the catheter member includes a funnel member on the distal portion. In some embodiments, the catheter assembly is non-lubricated.

[0007] Another aspect of the present invention relates to a method of inserting a catheter assembly into a body cavity. The method can include inserting a catheter member into the lumen of an introducer that contains a compressed portion of a cannula and everting the cannula over the catheter member when the catheter member is inserted into the body cavity.

[0008] In some embodiments, the method can further include pushing the distal portion of the cannula proximally and forming a soft proximal tip of the catheter assembly with the compressed portion of the cannula as the catheter member is inserted into the body cavity. In some embodiments, the method can further include inserting a dome member of the introducer into the body cavity. In some embodiments, the method can further include holding the cannula in the introducer with a retaining member and deflecting the retaining member as the cannula is advanced proximally from the introducer. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 A side view of a catheter assembly according to a first embodiment of the present invention is shown.

[0010] Figure 2 Shown is Figure 1 an exploded view of the catheter assembly of

[0011] Figure 3 shows Figures 1-2 a perspective view of a guide of a catheter assembly of

[0012] Figure 4 shows Figures 1-3 a side view of a cap member of a catheter assembly of

[0013] Figure 5 illustrates Figure 4 a cross - sectional view of a cap member of a catheter assembly of

[0014] Figure 6 shows Figures 1-5 a cross - sectional view of a cannula of a catheter assembly of

[0015] Figure 7 shows Figures 1-6 a side view of a handle member of a catheter assembly of

[0016] Figure 8 shows Figures 1-7 a cross - sectional view of a guide of a catheter assembly of

[0017] Figure 9 shows Figures 1-8 a cross - sectional view of a catheter assembly of

[0018] Figure 10 shows Figures 1-9 a side view of a catheter member of a catheter assembly of

[0019] Figure 11A -D shows Figures 1-10 a method of using a catheter assembly of

[0020] Figure 12A -C shows a view of a guide of a catheter assembly according to a second embodiment of the present invention. Detailed Description

[0021] The present invention generally relates to catheter assemblies and methods of use, including a compact unit or introducer that houses a flexible membrane or cannula compressed in a bundled, bellows, and / or folded configuration. The present invention incorporates the concept of frictionless into a compact introducer that can be used with any device (e.g., any type of elongate member, including open or closed end tubular members) without being integrated into the device. The present invention also allows for a two-piece concept for intermittent catheters, which includes a disposable cannula and a reusable pusher and / or catheter member. As the introducer is translated relative to the outer surface of the catheter member, the catheter member can be inserted into a body cavity (e.g., the urethra) through the disposable cannula, thereby minimizing friction during insertion. The cannula and the catheter member can be removed together or separately. For example, the catheter member can first be removed through the cannula, and then the cannula can be removed to reduce any discomfort caused during removal. In some embodiments, the introducer can additionally or alternatively include a clamping member for clamping the catheter member in a one-step removal. The catheter assembly can be non-lubricated to prevent spillage and soiling of the user's or the administrator's clothing. The present invention can be used in any number of applications, including urological applications (e.g., intermittent catheters, Foley catheters, intra-device, delivery systems), vascular applications (e.g., sheaths), and other surgical applications. As used herein, the terms "proximal" and "distal" are defined in terms of relative proximity to a human, animal, object, or other recipient into which the catheter assembly is inserted. The catheter assembly can be self-administered, such that the terms "proximal" and "distal" can refer to proximity to the administrator and the recipient.

[0022] Figure 1 A side view of a catheter assembly 10 according to an embodiment of the present invention is shown, and Figure 2 An exploded view of the catheter assembly 10 is shown. As shown, the catheter assembly 10 can include an introducer 100 and a catheter member 200. The catheter member 200 can be configured to be inserted into the lumen of the introducer 100 before being inserted into a body cavity. As Figure 2 Further shown, the introducer 100 can include a handle member 120, a cap member 140, and a cannula 160. The cap member 140 can be at the proximal portion of the handle member 120, and the cannula 160 can be received by the handle member 120 and / or the cap member 140. The catheter member 200 can include a tubular member 210 extending proximally from a handle member 220. The handle member 120, the cap member 140, and / or the cannula 160 can jointly define the lumen of the introducer 100 that receives the tubular member 210 when the tubular member 210 is introduced into the body cavity.

[0023] Figure 3 An axonometric view of the introducer 100 is shown, and Figures 4-9 One or more members of the introducer 100 are shown. As Figures 3-5As shown, the cap member 140 may have a retaining member configured to cover the cannula 160 and / or retain the cannula 160 within the introducer 100 during storage. The retaining member may open when sufficient proximal thrust is applied by the catheter member 200. The retaining member may include a plurality of flaps 142 separated by preformed radial slots 144 and substantially closing the proximal opening 147 (as Figure 11B shown). The flaps 142 may be resilient to sufficiently cover and / or retain the cannula 160 within the introducer 100 and / or prevent pathogens from entering the introducer 100 through the proximal opening 147. The flaps 142 may separate or deflect resiliently when pressed proximally as the catheter member 200 exits the proximal end through the proximal opening 147. The slots 144 may extend distally to a solid wall section 145. The cap member 140 may be formed with a protrusion 146 in the form of a narrow portion extending proximally from the cap member 140. The protrusion 146 may be inserted into the opening of the body cavity to align and initially retain the introducer 100 relative to the body cavity. The protrusion 146 may be a hollow dome structure formed by the flaps 142 and / or the solid tubular wall section 145. The cap member 140 may further include a flange 148 located distally of the protrusion 146. The flange 148 may have an enlarged, substantially flat proximal surface 150 configured to engage tissue around the body cavity opening to prevent further insertion of the introducer into the body cavity. The flat proximal surface 150 may have inclined and / or convex side surfaces 151 to conform to the anatomical structure. The flange 148 may further have an inclined and / or recessed distal surface 152 to prevent the user from contacting the protrusion 146 and prevent pathogens from entering the body cavity therefrom.

[0024] As Figure 5 further shown, the cap member 140 may have a lumen 154 extending therethrough for receiving the handle member 120, the cannula 160, and the catheter member 200. The lumen 154 may include a distal opening 156 having a tapered wall that facilitates insertion and retention of the proximal portion of the handle member 120. The lumen 154 may further have a widened area 158 configured to receive the proximal portion of the handle member 120. The widened area 158 may be wider than the distal opening 156 to provide an interference and / or snap fit to retain the handle member 120 and prevent separation.

[0025] Figure 6A cross-sectional view of the cannula 160 is shown. The cannula 160 may have a proximal portion 162 and a distal portion 164, and the entire cannula 160 may be received within the introducer 100 prior to insertion of the catheter member 200. The proximal portion 162 may be fixed to the introducer 100, and the distal portion 164 may be configured to be pushed proximally from the introducer 100 through the body cavity by the catheter member 200. Thus, the proximal portion 162 may have a folded portion 166 that is fixed to the introducer 100 by being clamped between the handle member 120 and the cap member 140. Prior to insertion of the catheter member 200, the distal portion 164 may have a compressed portion 168 that is releasably received within the introducer 100. The cannula 160 may be received such that the proximal portion of the catheter member 200 engages and pushes the distal portion 164 of the cannula 160. When the catheter member 200 exits the proximal opening 147 and passes through the body cavity, the compressed portion 168 may unfold and evert over the catheter member 200. As the catheter member 200 is advanced through the body cavity, the compressed portion 168 may form a soft proximal tip on the proximal portion of the catheter member 200. The compressed portion 168 may be compressed and / or folded into a uniform configuration such that the lumen 170 passes therethrough, thereby allowing fluid passage while the cannula 160 is not fully deployed. This may allow the compressed portion 168 to form a soft proximal tip on the catheter member 200 as it passes through the entire length of the body cavity.

[0026] Figure 7 A side view of the handle member 120 is shown, Figure 8 A cross-sectional view of the introducer 100 is shown, Figure 9 A cross-sectional view of the catheter assembly 10 is shown. The handle member 120 may have a concave and / or textured surface configured to be grasped by a user, e.g., formed by the concave surface 122 and / or one or more circumferential ridges 123. The handle member 120 may further include a proximal portion 124 received in a mating configuration within the lumen 154 of the cap member 140. The proximal portion 124 may include a convex member 125 having barbs 127 configured to insert through the distal opening 156 and be retained within the widened region 158 of the lumen 154. Thus, the folded portion 166 of the cannula 160 may be positioned over the convex member 125 of the handle member 120, and the proximal portion 162 may be fixed between the barbs 127 of the convex member 125 and the cap member 140. The handle member 120 may also have a retaining member formed by an inner shoulder 126 configured to releasably engage the distal portion 164 when the cannula 160 is received within the introducer 100 prior to insertion of the catheter member 200. The handle member 120 may have a distal portion including a plurality of longitudinal guide members 128 separated by slots 129. A finger grip or pad 130 may be provided on at least one of the guide members 128 to facilitate manipulation of the introducer 100.

[0027] Figure 10 Further shown is the tubular member 210 of the catheter member 200. In some embodiments, the catheter assembly 10 has a handle member 220 on the distal portion of the catheter member 200 (as Figures 1-2 shown). The handle member 220 may have an attached internal funnel and / or bag to collect fluid (e.g., urine) flowing through the catheter member 200. In some embodiments, the proximal portion of the catheter member 200 is open and the catheter member 200 has a lumen therethrough. The catheter member 200 can be used for urological applications (e.g., intermittent catheter, Foley catheter, internal device, delivery system), vascular applications (e.g., sheath), and other surgical applications. Due to the non-frictional insertion provided by the everted cannula 160, the catheter assembly 10 can be non-lubricated. The non-lubricated feature prevents spillage and soiling of the user's or caregiver's clothing.

[0028] As Figure 10 shown, the proximal portion of the tubular member 210 may include slots or holes 230 extending through the sidewall, which makes the proximal portion relatively more flexible than the rest of the tubular member 210. The slots 230 can extend at least partially around the perimeter of the tubular member 210. For example, as Figure 10 shown, the slots 230 can extend circumferentially in a paired manner and vary along the proximal portion of the tubular member 210. Thus, the slots 230 can circumferentially alternate in a paired manner along the length of the proximal portion of the tubular member 210. The density of the slots 230 can additionally or alternatively increase proximally along the proximal portion of the tubular member 210 such that a first length 232 of the tubular member 210 has a greater density of slots 230 than a second length 234 distal to the first length 232. The second length 234 can also have a greater density of slots 230 than a third length 236 distal to the second length 234 of the tubular member 210. The proximally increasing density of the slots 230 can provide greater flexibility at the proximal end of the tubular member 210 to allow for easier insertion through the urethra, especially in cases where the travel path is curved or tortuous. In use, the slots 230 will be covered by the cannula 160 such that the slots 230 do not affect the passage of fluid. The tubular member 210 may also include a tapered and / or rounded proximal tip 240 to engage the cannula 160. In some embodiments, the cannula 160 is not fixed to (e.g., only releasably engages) the catheter member 200 such that the cannula 160 and the catheter member 200 can be inserted into and / or removed from the lumen separately.

[0029] Figure 11A -D shows a method of inserting the catheter assembly 10 into a body cavity such as the urethra (U). As Figure 11AAs shown, the introducer 100 can act as an introducer assist device and facilitate the manipulation of the catheter member 200 and the positioning / engagement of tissue around the body cavity such as the urethral meatus (UM). The introducer 100 that houses the entire cannula 160 can be placed against the urethral meatus (UM). The cannula 160 can be held between the inner shoulder 126 of the handle member 120 in the introducer 100 and the closing flap 142 of the cap member 140. The protrusion 146 can be initially inserted into the urethral meatus (UM) to align the lumen of the introducer 100 with the urethra (U). The proximal surface 150 and / or the side surface 151 of the cap member 140 can engage the urethral meatus (UM) to prevent further insertion.

[0030] As Figure 11B shown, the proximal portion of the tubular member 210 can be inserted into the distal opening of the introducer 100. The longitudinal guide member 128 can guide the tubular member 210 through the lumen of the introducer 100. The proximal portion of the tubular member 210 can engage the distal portion of the cannula 160, as Figure 9 further shown. The proximal portion of the tubular member 210 can lift the distal portion 164 of the cannula 160 from the inner shoulder 126 of the introducer 100. The tubular member 210 and the cannula 160 can exit the proximal opening 147 of the cap member 140 through the flap 142. As the tubular member 210 translates proximally, the compression portion 168 gradually unfolds from proximal to distal and everts over the tubular member 210. The eversion of the cannula 160 prevents pathogens from spreading upward through the urethra (U) from the initial position of the urethral meatus (UM) and prevents frictional irritation of the inner epithelial layer. The distal portion of the compression portion 168 can remain in a compressed configuration (shown in cross-sectional view) on the proximal tip of the tubular member 210, thereby creating a soft proximal tip of the catheter assembly 10 to further reduce damage to the sensitive inner epithelial inner wall of the urethra (U). Even in the compressed configuration, the compression portion 168 can maintain the lumen 170 such that the compression portion 168 does not have to unfold to allow fluid passage.

[0031] As Figure 11C shown, the proximal portion of the catheter member 200 and the cannula 160 can reach the bladder (B). Urine can pass through the lumen of the catheter member 200, through the funnel of the handle member 220 into the toilet or into an optional bag attached to the distal portion of the catheter member 200. After urination, the catheter member 200 can be removed before the cannula 160. Due to the flexibility of the cannula 160, the cannula 160 can then be removed with reduced comfort after the catheter member 200. However, in some embodiments, the cannula 160 can be removed together with the catheter member 200 in a one-step removal process.

[0032] Figure 12A-Figure C shows a view of the introducer 300 of the catheter assembly according to the second embodiment. The introducer 300 includes a handle member 320 and a cap member 340 similar to the introducer 100. The introducer 300 can hold the cannula in a similar manner (not shown) as discussed above with respect to the introducer 100. For the sake of brevity, the above discussions of the handle members 120, 320, the cap members 140, 340, and the cannula 160 are incorporated herein by reference. However, the introducer 300 can be configured for one-step removal of the catheter assembly. For example, the handle member 320 can include a clamping member 380 on opposite sides of the handle member 320. The clamping member 380 can be configured to be pressed into and / or deflected into the lumen of the introducer 300 to clamp the tubular member 210 of the catheter member 200 when the catheter member 200 is inserted into the body cavity. Thus, the catheter member 200 can be removed together with the introducer 300 in a one-step process. The clamping member 380 can be attached to the handle member 320 in a cantilever configuration defined as a U-shaped slot 382. The clamping members 380 can each include a protrusion 384 to facilitate pressing by the user. The introducer 300 can also include a finger grip or pad 330 on the outer surface of the handle member 320, which is circumferentially transverse to the clamping member 380. The finger grip or pad 330 can allow the introducer 300 to be inserted into the opening of the body cavity without interference.

[0033] Many features and advantages of the invention are apparent from the detailed description, and thus, the appended claims are intended to cover all such features and advantages of the invention that fall within the true spirit and scope of the invention. Moreover, since numerous modifications and variations will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents fall within the scope of the invention.

Claims

1. A catheter assembly, comprising: A catheter member having a proximal portion and an outer surface; A introducer having a cap member, a handle member, and a lumen configured to receive the proximal portion of the catheter member, the cap member and the handle member being configured to be detachably connected; And A sleeve having a compression portion received in the lumen of the introducer, the sleeve being configured to evert onto the outer surface when the catheter member is inserted through the lumen of the introducer, the proximal portion of the catheter member and the sleeve being configured to reach the bladder; Wherein, the proximal portion of the sleeve is fixed to the introducer between the handle member and the cap member.

2. The catheter assembly according to claim 1, wherein, The proximal portion of the catheter member is configured to push the distal portion of the sleeve proximally, and when the catheter member exits the proximal opening of the introducer, the compression portion of the sleeve forms a soft proximal tip of the catheter assembly.

3. The catheter assembly according to claim 1, wherein, The sleeve is not fixed to the catheter member.

4. The catheter assembly according to claim 1, wherein, The cap member has an enlarged proximal surface.

5. The catheter assembly according to claim 4, wherein, The cap member has a retaining member that covers the sleeve when received in the introducer and deflects as the catheter member is advanced proximally from the introducer.

6. The catheter assembly according to claim 5, wherein, The retaining member includes a plurality of fins.

7. The catheter assembly according to claim 5, wherein, The retaining member forms a protrusion extending proximally from the enlarged proximal surface.

8. The catheter assembly according to any one of claims 1-7, wherein, The handle member has a surface configured to be grasped by a user.

9. The catheter assembly according to claim 8, wherein, The surface of the handle member includes a concave surface and / or one or more ridges.

10. The catheter assembly according to claim 8, wherein, The proximal portion of the sleeve includes a folded portion that is fixed to the introducer by being clamped between the handle member and the cap member.

11. The catheter assembly according to claim 8, wherein the cap member and the handle member are in a mating configuration.

12. The catheter assembly according to any one of claims 2-7, wherein, The distal portion of the sleeve is releasably engaged with the inner shoulder of the introducer.

13. The catheter assembly according to claim 8, wherein, The handle member includes a plurality of elongated guiding members extending from the distal portion.

14. The catheter assembly according to any one of claims 1-7, wherein, The proximal portion of the catheter member is open, and the catheter member has a lumen therethrough.

15. The catheter assembly according to any one of claims 1-7, wherein, The catheter member includes a funnel member on the distal portion.

16. The catheter assembly according to any one of claims 1-7, wherein the catheter assembly is non-lubricated.

17. A method of using the catheter assembly according to any one of claims 1-16, the method comprising: Inserting the catheter member into the lumen of the introducer, the introducer containing the compression portion of the sleeve; And Everting the sleeve onto the catheter member.

18. The method according to claim 17, further comprising: Pushing the distal portion of the sleeve proximally; And Forming a soft proximal tip of the catheter assembly with the compression portion of the sleeve.

19. The method according to claim 17, further comprising: Holding the sleeve in the introducer with a retaining member; And Deflecting the retaining member as the sleeve is advanced proximally from the introducer.

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