WO2006121508A2

WO2006121508A2 - Two-piece lubricant housing for urinary catheter packages

Info

Publication number: WO2006121508A2
Application number: PCT/US2006/010754
Authority: WO
Inventors: Thorsten Rodtmann; Terence King
Original assignee: Hollister Incorporated
Priority date: 2005-05-06
Filing date: 2006-03-24
Publication date: 2006-11-16
Also published as: WO2006121508A3

Abstract

A lubricant housing for a urinary catheter is provided with a body portion that may be squeezed inwardly for temporarily holding a catheter against sliding movement. The housing has a proximal end with an opening and an inwardly extending shoulder spaced axially from the opening. The shoulder is received in an outwardly-facing channel of a grommet, the grommet in turn having a catheter-receiving passage in which an annular wiper membrane is provided for sealingly engaging the outer surface of a catheter to prevent lubricant from leaking from the housing.

Description

_<

TWO-PIECE LUBRICANT HOUSING FOR URINARY CATHETHER PACKAGES

Background and Summary of the Invention

[0001] Co-owned Kavanagh et al. U.S. Patent No. 6,578,709 discloses a urinary catheter package having a housing containing a lubricant gel which lubricates the outer surfaces of a catheter as it is advanced through the housing during a catheterization procedure. The housing is shown to be formed in one piece (although multiple-piece constructions are disclosed) from a soft, deformable and shape-recoverable material. The proximal end of the housing has a frusto-conical wall 50 with an aperture 51 through which the urinary catheter 20 extends.

[0002] A characteristic feature of the housing as described in the 709 patent is that its conically-shaped end wall 50, in addition to performing the known function of preventing the escape of lubricant in a proximal direction from the housing, also serves as gripping means for restraining longitudinal movement of the catheter unless a threshold level of axial force is applied to the catheter. The gripping action by the housing as so disclosed is intended to prevent retraction of a catheter during the step of a catheterization procedure in which an outer pouch is being returned to an unfolded condition in preparation for the further step of incrementally advancing the catheter.

[0003] In practice, the construction as disclosed in the patent was modified because it was found that the conically-shaped end wall would not function in the manner described, partially because of the softness of the elastic material of the housing (silicone rubber) and partially because lubricant within the chamber essentially precluded a forceful gripping action, making a catheter even easier to retract than to advance. To prevent catheter retraction, users have therefore turned to the earlier practice of squeezing the body of the housing until its walls engage opposite sides of the catheter and thereby immobilized the catheter while the outer pouch was being returned to unfolded condition (see, for example, Kubalak et al. U.S. Patent No. 5,454,798). [0004] The lubricant housing of the 709 patent was also found difficult to mold, and the increases in production costs occasioned by such difficulties were compounded by the use of silicone rubber, a relatively expensive elastomeric material. Accordingly, a main aspect of this invention lies in providing a two-piece lubricant housing that is molded from a thermoplastic (i.e. non-silicone) elastomer and, because of its construction, presents lower production costs, superior performance and greater adaptability in providing lubricant housings suitable for use with catheters of different outside diameters.

Drawings

[0005] Figure 1 is a perspective view of a two-piece lubricant housing embodying the invention, the pieces of the housing being shown in separated condition for clarity of illustration.

[0006] Figure 2 is an end elevational view of the housing.

[0007] Figures 3A and 3B are longitudinal sectional views of the housing and its grommet shown in separated condition and taken along line 3B-3B of Figure 2.

[0008] Figures 4A and 4B are longitudinal sectional views taken along line 4B-4B of Figure 2.

[0009] Figure 5 is an enlarged longitudinal sectional view of the housing and grommet in assembled condition.

Detailed Description of Preferred Embodiments

[0010] Referring to the drawings, the numeral 10 generally designates a lubricating device for a urinary catheter package comprising a guide housing 11 and a grommet 12. Each component is molded from a thermoplastic elastomer. While the elastomer may be different for each of the components, it is considered preferable to use the same elastomer for both. Any of a variety of known thermoplastic elastomers may be utilized, but particularly effective results may be achieved with styrene-type thermoplastic elastomers such as styrene/butadiene block copolymers, styrene/isoprene block copolymers, styrene/ethylene/butylene block copolymers, styrene/ethylene/propylene block polymers, styrene/butadiene rubber, and styrene/butadiene/methyl methacrylate copolymers.

[0011] The guide housing 11 has proximal and distal end portions 11a and 11b and a body portion 11c that, as shown in Figure 5, may be squeezed or pressed inwardly in the directions of arrows 13 to engage and restrain movement of a catheter 14 extending through the housing. The housing is preferably oval in cross-section so that it may be positioned in a flattened condition in a pouch 15. Such a pouch is shown only in phantom in Figures 3B and 4B, but may be similar to the pouch 11 shown in U.S. Patent No. 6,578,709, the disclosure of which is incorporated herein by reference. The distal end portion 11B of the housing extends through an opening in the pouch, and an introducer sleeve 16 with a rounded and slitted end portion 16a extends through the opening. As brought out in the 709 patent, the length of the introducer sleeve is such that upon insertion into the urethra, the sleeve shields the catheter 14 against contact with and contamination by a short stretch of the urethra adjacent the labia. The walls of the pouch 15 are heat sealed or otherwise sealingly secured to the distal neck portion of the housing adjacent the introducer sleeve.

[0012] Referring to Figures 3B and 4B, the proximal end portion 11a of the housing has an end surface or face 17 that surrounds an opening 18. An inwardly facing annular shoulder 19 is located within the housing and is spaced a distance inwardly from the opening.

[0013] When the parts are in assembled condition, grommet 12 is located within the proximal end portion 11a of the housing. The grommet has a tubular wall 20 which is open at its opposite ends and defines a catheter- receiving passage 21 therethrough. An outwardly facing annular channel 22 is formed in the outer wall of the grommet for receiving and interlocking with the shoulder 19 about the inner surface of the housing. As depicted in the drawings, the longitudinal cross-sectional shape of the channel 22 matches the cross-sectional contour of the shoulder.

[0014] As shown most clearly in Figure 5, an annular wiper membrane 23 is formed integrally with the grommet and is located within the passage 21. The inner edges of the membrane define an opening that matches, or may be slightly smaller than, the outside dimensions of a catheter 14 extending through the grommet. The rounded edges of the membrane slidably engage the catheter's outer surface to prevent or at least restrain the leakage of lubricant in a proximal direction from the housing 11. In Figure 5, a body of lubricant 24 is depicted in phantom.

[0015] The wiper membrane is spaced from both of the opposite ends of the grommet with such location helping to ensure that flexing action of a membrane (shown in broken lines in Figure 5) will not disturb the frictional fit between the grommet and the proximal end portion of the housing. As shown, the thin wiper membrane is highly flexible and may readily flex in either direction (either proximally or distally) depending on the direction of catheter movement. Because of its thinness and flexibility, and because it extends perpendicular or normal to the longitudinal axis of the catheter extending through it and freely flexes in either direction, it imposes no functional restraint against catheter movement. Should a user desire to immobilize the catheter against sliding movement with respect to the housing, the user must necessarily squeeze the housing's walls together to engage the sides of the catheter as indicated by arrows 13.

[0016] At its proximal end, the grommet is provided with a flange 25 that abuts end surface 17 of the body and has outside dimensions matching those of the housing. The flange, along with the interfit between shoulder 19 and channel 22, prevent the grommet from being pushed into the proximal end portion of the housing further than shown in Figure 5. The parts are therefore held tightly together against axial displacement despite the fact that no adhesive is used to join the them together.

[0017] In the operation of the lubricating device, catheter 14 is advanced through the grommet passage 21 and the chamber of the housing 11 , becoming lubricated by lubricant 24 within the housing. The membrane 23 retains the lubricant within the housing although some lubricant coating the surface of the catheter is expected to escape in a proximal direction when the catheter is retracted. In other words, while wiper membrane 23 operates effectively to retain lubricant in the chamber, it does not engage the outer surface of the catheter firmly enough to wipe all of the lubricant from the catheter's surface upon catheter retraction. Such retraction is undertaken as standard procedure following catheterization when, for example, urine is collected in the pouch, at which time the user simply pulls the catheter back into the pouch and then discards the pouch and its contents.

[0018] A particularly advantageous aspect of the construction shown and described herein is that a plurality of grommets 12 may be provided for use with catheters of different outside dimensions. Such grommets would have identical outer contours and dimensions with the only differences being the hole diameters through the wiper membranes 23 of the different grommets. Grommets for use with catheters of different outside diameters may therefore be used with identical housings. Alternatively, the housings might differ in the diameters of the introducer sleeve 16 or otherwise be identical to each other.

[0019] While in the foregoing, embodiments of the invention have been disclosed in considerable detail for purposes of illustration, it will be understood by those skilled in the art that many of these details may be varied without departing from the spirit and scope of the invention.

Claims

g Claims:

1. A lubricating device for a urinary catheter comprising a guide housing formed of a thermoplastic elastomer; said housing having proximal and distal end portions and a body portion that may be squeezed inwardly to engage and temporarily hold a catheter against sliding movement within said housing; said proximal end portion having an end face defining an opening and an inwardly-extending annular shoulder spaced axially from said opening; and a grommet formed of a thermoplastic elastomer located within said proximal end portion of said housing; said grommet having a tubular wall open at its opposite ends and defining a catheter-receiving passage therethrough; said wall of said grommet having an outwardly-facing annular channel for receiving and interlocking with said shoulder of said housing; and an annular wiper membrane formed integrally with said grommet and located within said passage spaced from both of said opposite ends thereof to sealingly engage the outer surface of a catheter extending through said passage for preventing the leakage of lubricant from said housing.

2. The device of claim 1 in which said grommet is frictionally retained in said proximal end portion of said housing.

3. The device of claims 1 or 2 in which said grommet has an annular flange in contact with said end face of said housing.

4. The device of claims 1 or 2 in which said proximal end and said body portions of said housing have outer and inner surfaces, and said grommet has an outer surface, of oval shape.

5. The device of claims 1 or 2 in which said lubricating device is located within a pouch of thermoplastic film and said distal end portion of said housing extends through an opening in the wall of said pouch.

6. The device of claim 5 in which a body of lubricant is located within said housing.

7. The device of claim 6 in which said lubricant is a lubricating gel.

8. The device of claim 6 in which a urinary catheter is located within said pouch and extends into said housing through the passage of said grommet.

9. The device of claims 1 or 2 in which said annular wiper membrane has an opening therethrough defined by edges of said membrane rounded in axial directions.

10. The device of claims 1 or 2 in which said grommet is one of a plurality of grommets having identical outer contours but having membrane openings of different size to accommodate catheters having different outside diameters.