CATHETER ASSEMBLY

A catheter assembly may include a catheter member having a proximal portion and an outer surface; an introducer having a lumen configured to receive the proximal portion of the catheter member; and a sleeve having a compressed portion housed in the lumen of the introducer, the sleeve being configured to evert over the outer surface as the catheter member is inserted through the lumen of the introducer. The proximal portion of the catheter member may be configured to push a distal portion of the sleeve proximally, and the compressed portion of the sleeve may form a soft proximal tip of the catheter assembly as the catheter member exits a proximal opening of the introducer.

TECHNICAL FIELD

The present disclosure relates generally to catheters, and more particularly to two-part catheter assemblies configured to reduce friction of a catheter member when introduced into a bodily lumen.

BACKGROUND

Urinary catheters are often used to void urine from a patient's bladder by being inserted through a urethra and into the bladder. Friction between the catheter and the urethra can cause discomfort during insertion and/or removal. The present invention solves one or more problems involving the catheters of the prior art.

SUMMARY

One aspect of the present invention is directed to a catheter assembly including a catheter member, an introducer, and a sleeve. The catheter member may have a proximal portion and an outer surface. The introducer may have a lumen configured to receive the proximal portion of the catheter member, and the sleeve may have a compressed portion housed in the lumen of the introducer, the sleeve being configured to evert over the outer surface as the catheter member is inserted through the lumen of the introducer.

In some embodiments, the proximal portion of the catheter member is configured to push a distal portion of the sleeve proximally, and the compressed portion of the sleeve forms a soft proximal tip of the catheter assembly as the catheter member exits a proximal opening of the introducer. In some embodiments, the sleeve is not secured 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 sleeve when contained 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 flaps. In some embodiments, the retaining member forms a projection extending proximally from the enlarged proximal surface. In some embodiments, the introducer includes a handle member having a surface configured to be gripped 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 sleeve is secured 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 sleeve is releasably engaged by an internal shoulder of the introducer. In some embodiments, the handle member includes a plurality of elongated guide members extending from a 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 a distal portion. In some embodiments, the catheter assembly is non-lubricated.

Another aspect of the present invention is directed to a method of inserting the catheter assembly into a bodily lumen. The method may include inserting the catheter member into the lumen of the introducer containing the compressed portion of the sleeve, and everting the sleeve over the catheter member as the catheter member is inserted into the bodily lumen.

In some embodiments, the method may further include pushing a distal portion of the sleeve proximally, and forming a soft proximal tip of the catheter assembly with the compressed portion of the sleeve as the catheter member is inserted into the bodily lumen. In some embodiments, the method may further include inserting a dome member of the introducer into the bodily lumen. In some embodiments, the method may further include retaining the sleeve in the introducer with a retaining member, and deflecting the retaining member as the sleeve is advanced proximally from the introducer.

DETAILED DESCRIPTION

The present invention is generally directed to catheter assemblies and methods of use including a compact unit or introducer housing a thin pliable membrane or sleeve compressed in a bunched, bellowed, and/or folded configuration. The present invention incorporates a friction free concept into a compact introducer that may be used with any device (e.g., any type of elongated member including open or closed tip tubular members) without being integrated into the device. The present invention also allows for a two-piece concept for intermittent catheters, including a disposable sleeve and a reusable pusher and/or catheter member. The catheter member may be inserted into a bodily lumen (e.g., a urethra) through the disposable sleeve minimizing the friction during insertion, as the introducer translates relatively along an outer surface of the catheter member. The sleeve and the catheter member may be removed together or separately. For example, the catheter member may be first removed through the sleeve, and then the sleeve may be removed reducing any discomfort caused during removal. In some embodiments, the introducer may additionally or alternatively include clamping members that clamp the catheter member for a one step removal. The catheter assembly may be non-lubricated to prevent spilling and staining of clothing of the user or administer. The present invention may be used in any number of applications, including urology applications (e.g., intermittent catheters, Foley catheters, endo devices, delivery systems), vascular applications (e.g., sheaths), and other surgical applications. The terms “proximal” and “distal” as used herein are defined by the relative proximity to the person, animal, object, or other recipient into which the catheter assembly is being inserted. The catheter assembly may be self-administered such that the terms “proximal” and “distal” may refer to the proximity to the administer and the recipient.

FIG. 1illustrates a side view of a catheter assembly10according to embodiments of the present invention, andFIG. 2illustrates an exploded view of the catheter assembly10. As illustrated, the catheter assembly10may include an introducer100and a catheter member200. The catheter member200may be configured to be inserted into a lumen of the introducer100prior to insertion into a bodily lumen. As further illustrated inFIG. 2, the introducer100may include a handle member120, a cap member140, and a sleeve160. The cap member140may be on a proximal end portion of the handle member120, and the sleeve160may be housed by the handle member120and/or the cap member140. The catheter member200may include a tubular member210extending proximally from a handle member220. The handle member120, the cap member140, and/or the sleeve160may collectively define the lumen of the introducer100that receives the tubular member210as the tubular member210is introduced into the bodily lumen.

FIG. 3illustrates an isometric view of the introducer100, andFIGS. 4-9illustrate one or more components of the introducer100. As illustrated inFIGS. 3-5, the cap member140may have a retaining member configured to cover and/or retain the sleeve160in the introducer100during storage. The retaining member may open when a sufficient proximal pushing force is applied by the catheter member200. The retaining member may include a plurality of flaps142separated by preformed radial slots144and substantially close a proximal opening147(as illustrated inFIG. 11B). The flaps142may be resilient to sufficiently cover and/or retain the sleeve160within the introducer100and/or prevent pathogens from entering the introducer100through the proximal opening147. The flaps142may separate or resiliently deflect when pressed proximally as the catheter member200exits proximally through the proximal opening147. The slots144may extend distally to a solid tubular wall segment145. The cap member140may form a projection146in the form of a narrow portion extending proximally from the cap member140. The projection146may be inserted into an opening of the bodily lumen to align and initially retain the introducer100with respect to the bodily lumen. The projection146may be a hollow dome structure formed by the flaps142and/or the solid tubular wall segment145. The cap member140may further include a flange148distal of the projection146. The flange148may have an enlarged, substantially flat proximal surface150configured to engage tissue around an opening of the bodily lumen to prevent further insertion of the introducer into the bodily lumen. The flat proximal surface150may have angled and/or convex side surfaces151to conform to anatomy. The flange148may also have an angled and/or concave distal surface152to prevent user contact with the projection146and resultant introduction of pathogens into the bodily lumen.

As further illustrated inFIG. 5, the cap member140may have a lumen154extended therethrough for receiving the handle member120, the sleeve160, and the catheter member200. The lumen154may include a distal opening156having tapered walls that facilitates insertion and retention of a proximal end portion of the handle member120. The lumen154may also have a widened region158configured to receive the proximal end portion of the handle member120. The widened region158may be wider than the distal opening156to provide an interference and/or snap-fit to retain the handle member120and prevent detachment.

FIG. 6illustrates a cross-sectional view of the sleeve160. The sleeve160may have a proximal end portion162and a distal end portion164, and the entirety of the sleeve160may be housed in the introducer100prior to insertion of the catheter member200. The proximal end portion162may be secured to the introducer100, and the distal end portion164may be configured to be pushed by the catheter member200proximally from the introducer100through the bodily lumen. Thus, the proximal end portion162may have a folded portion166secured to the introducer100by being sandwiched between the handle member120and the cap member140. The distal end portion164may have a compressed portion168releasably housed in the introducer100prior to insertion of the catheter member200. The sleeve160may be housed such that the proximal end portion of the catheter member200engages and pushes the distal end portion164of the sleeve160. The compressed portion168may unfold and evert over the catheter member200as the catheter member200exits the proximal opening147and passes through the bodily lumen. The compressed portion168may form a soft proximal tip on the proximal end portion of the catheter member200as the catheter member200is advanced through the bodily lumen. The compressed portion168may be compressed and/or folded in a uniform configuration maintaining a lumen170therethrough, thus allowing passage of fluids without the sleeve160being completely unfolded. This may allow the compressed portion168to form the soft proximal tip on the catheter member200through the entire length of the bodily lumen.

FIG. 7illustrates a side view of the handle member120,FIG. 8illustrates a cross-sectional view of the introducer100, andFIG. 9illustrates a cross-sectional view of the catheter assembly10. The handle member120may have a concave and/or textured surface configured to be gripped by the user, for example, formed by a concave surface122and/or one or more circumferential ridges123. The handle member120may further include a proximal end portion124received in the lumen154of the cap member140in a mating configuration. The proximal end portion124may include a male member125having a barb127configured to be inserted through the distal opening156and be retained in the widened region158of the lumen154. Thus, the folded portion166of the sleeve160may be positioned over the male member125of the handle member120, and the proximal end portion162may be secured between the barb127of the male member125and the cap member140. The handle member120may also have a retaining member formed by an internal shoulder126configured to releasably engage the distal end portion164when the sleeve160is housed in the introducer100prior to insertion of the catheter member200. The handle member120may have a distal end portion including a plurality of longitudinal guide members128separated by slots129. A finger grip or pad130may be disposed on at least one of the guide members128to facilitate manipulation of the introducer100.

FIG. 10further illustrates the tubular member210of the catheter member200. In some embodiments, the catheter assembly10has the handle member220on a distal end portion of the catheter member200(as illustrated inFIGS. 1-2). The handle member220may have an internal funnel and/or a bag attached to collect a fluid (e.g., urine) flowing through the catheter member200. In some embodiments, the proximal end portion of the catheter member200is open, and the catheter member200has a lumen therethrough. The catheter member200may be used in urology applications (e.g., intermittent catheters, Foley catheters, endo devices, delivery systems), vascular applications (e.g., sheaths), and other surgical applications. The catheter assembly10may be non-lubricated enabled by the non-frictional insertion provided by the everting sleeve160. The non-lubricated feature prevents spilling and staining of clothing of the user or administer.

As illustrated inFIG. 10, the proximal end portion of the tubular member210may include slots or holes230extending through a side wall that render the proximal end portion relatively more flexible than the rest of the tubular member210. The slots230may extend at least partially around the perimeter of the tubular member210. For example, as illustrated inFIG. 10, the slots230may extend circumferentially in a pairwise manner, and vary along the proximal end portion of the tubular member210. Thus, the slots230may alternate circumferentially in a pairwise manner along the length of the proximal end portion of the tubular member210. The density of the slots230may, additionally or alternatively, increase proximally along the proximal end portion of the tubular member210, such that a first length232of the tubular member210has a greater density of slots230than a second length234distal of the first length232. The second length234may also have a greater density of the slots230than a third length236of the tubular member210distal of the second length234. The proximally increasing density of the slots230may provide more flexibility at the proximal tip of the tubular member210to allow for easier insertion through the urethra, especially in cases where the path of travel is curved or tortuous. In use, the slots230would be covered by the sleeve160such that the slots230do not affect the passage of fluid. The tubular member210may further include a tapered and/or rounded proximal tip240to engage the sleeve160. In some embodiments, the sleeve160is not secured to (e.g., only releasably engaging) the catheter member200, such that the sleeve160and the catheter member200may be inserted and/or removed from the lumen separately.

FIGS. 11A-Dillustrate a method of inserting the catheter assembly10in a bodily lumen, such as a urethra (U). As illustrated inFIG. 11A, the introducer100may act as an introducer aid and facilitate handing of the catheter member200and locating/engaging of tissue around the bodily lumen, such as the urethra meatus (UM). The introducer100housing the entirety of the sleeve160may be place against the urethra meatus (UM). The sleeve160may be retained in the introducer100between the internal shoulder126of the handle member120and the closed flaps142of the cap member140. The projection146may be initially inserted into the urethra meatus (UM) to align the lumen of the introducer100with the urethra (U). The proximal surface150and/or side surfaces151of the cap member140may engage the urethra meatus (UM) preventing further insertion.

As illustrated inFIG. 11B, a proximal end portion of the tubular member210may be inserted into the distal opening of the introducer100. The longitudinal guide members128may guide the tubular member210through the lumen of the introducer100. The proximal end portion of the tubular member210may engage the distal end portion of the sleeve160, as further illustrated inFIG. 9. The proximal end portion of the tubular member210may lift the distal end portion164of the sleeve160off the internal shoulder126of the introducer100. The tubular member210and the sleeve160may exit the proximal opening147of the cap member140through the flaps142. As the tubular member210translates proximally, the compressed portion168gradually unfolds from the proximal to the distal direction and everts over the tubular member210. The everting of the sleeve160prevents transmission of pathogens from the initial location of the urethra meatus (UM) proximally up through the urethra (U) and prevents frictional irritation of the inner epithelial layer. The distal end portion the compressed portion168may maintain a compressed configuration on the proximal tip of the tubular member210(shown in a cross-section cutaway) producing a soft proximal tip of the catheter assembly10to further reduce injury to the sensitive inner epithelial lining of the urethra (U). Even in the compressed configuration, the compressed portion168may maintain the lumen170such that the compressed portion168does not have to be unfolded to allow passage of fluid.

As illustrated inFIG. 11C, the proximal end portion of the catheter member200and sleeve160may reach the bladder (B). Urine may pass through the lumen of the catheter member200through the funnel of the handle member220into a toilet or into an optional bag attached to the distal end portion of the catheter member200. After urine is voided, the catheter member200may be removed prior to the sleeve160. The sleeve160may then be removed after the catheter member200with reduced comfort due to the pliability of the sleeve160. However, in some embodiments, the sleeve160may be removed with the catheter member200in a one-step removal process.

FIGS. 12A-Cillustrate views of an introducer300of a catheter assembly according to a second embodiment. The introducer300includes a handle member320and a cap member340similar to the introducer100. The introducer300may retain a sleeve in a similar manner (not shown) as discussed above with regard to introducer100. The above discussion of the handle member120,320, the cap member140,340, and the sleeve160is incorporated herein by reference for sake of brevity. However, the introducer300may be configured for one-step removal of the catheter assembly. For example, the handle member320may include clamping members380on opposing sides of the handle member320. The clamping members380may be configured to be pressed and/or deflected into a lumen of the introducer300to clamp the tubular member210of the catheter member200when inserted into the bodily lumen. Thus, for the catheter member200may be removed with the introducer300in a one-step process. The clamping members380may be attached to the handle member320in a cantilever configuration defining a U-shaped slot382. The clamping members380may each include a protrusion384to facilitate pressing by the user. The introducer300may also include a finger grip or pad330on an outer surface of the handle member320circumferentially transverse to the clamping members380. The finger grip or pad330may allow undisturbed insertion of the introducer300into the opening of the bodily lumen.