JPH079317U - External catheter and applicator combination for men - Google Patents

Abstract

(57) [Summary] [Purpose] To provide a combination of an external catheter for men and an applicator, which facilitates the correct attachment of an external catheter for a drainage device for males to a patient. The purpose is to do. The catheter is preferably of the well-known external type, and the applicator comprises a tube open at its relatively rigid end and a substantially slidable surface relative to the surface of the tube. And a flexible tubular sleeve formed of a non-stretchable material. The sleeve includes a first portion disposed within the applicator tube and surrounding the neck portion of the catheter, and a second portion sandwiched between the outer surface of the tube and the cylindrical body of the catheter. When applying the catheter to the patient, the user touches the penis on the inner surface of the catheter sheath at one end of the applicator tube, while pulling out the catheter exit portion so that the catheter is pulled out from the opposite end of the applicator tube. Grab and pull.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to a male external catheter and applicator combination.

[0002]

[Prior art]

 The use of external catheters for male urine drainage devices is well known as disclosed in U.S. Pat.Nos. 4,378,018, 4,187,851, 3,863,638 and 3,835,857. There is. In essence, such a device comprises an elastic sheath or pod adapted to be fitted over the user's penis, the sheath or pod being guided at its distal end to a suitable collection container. Has an outlet connected to. The sheath has a cylindrical portion that fits over the penile shaft, a tapered neck portion that acts as a wobble or surge chamber near the distal end of the sheath, and a reduced extension that extends beyond the neck portion. And a drainage pipe part. In the preferred arrangement, the sheath also includes an inner sleeve portion for sealingly (but not adhesively) engaging the head or glans of the penis.

[0003] Outer catheters also quite generally have an annular layer of pressure sensitive adhesive on the inner surface of the tubular section to hold the sheath in place. Whether coated with an adhesive or not, such catheters are commonly marketed in rolled form, with instructions to unfold the sheath in use in essentially the same manner as a prophylactic condom. Has been issued.

Experience has shown that such a procedure is not as easy as it seems. Orienting and unfolding the sheath relative to the flaccid (probably contracting) penis is difficult even for patients who possess manual dexterity and can apply such products themselves. Obviously, it is more difficult for a nurse or other attendant lacking tactile feedback, which would assist the patient in performing such procedures on their own. Nurses performing such procedures typically wear surgical gloves, and if the gloves happen to come into contact with the catheter adhesive while the catheter is being unrolled, the gloves and catheter will be stiffened together. The problem is compounded by the fact that it can stick. The nurse holds the penis in one hand and directs the penis into the wound catheter opening held in the other hand, then covered with a sheath immediately after beginning the spreading action. Experience has shown that the problem of applying such a catheter tends to be reduced if the penis is stretched or lengthened while grasping the glans and continuing the spreading motion. However, nurses are sometimes believed to be unable to perform such procedures completely or with sufficient patience and caution because they care about the patient's considerable discomfort or rudeness. Or because they are in a hurry to perform other health care or healthcare missions, or simply because the nurse can thus directly and long-distance the incontinence penis of a patient with incontinence. This is because they feel uncomfortable with being in contact with each other. As a result, such outer catheters are often improperly or improperly applied resulting in discomfort and urine leakage during use of the drainage device.

[0005]

[Outline of the device]

 The present invention broadly relates to a combination of a male external catheter and a tubular applicator (or applier), the tubular applicator being a material for facilitating catheter application to the penis. A portion of the non-extensible low friction sleeve. Finger contact with the penis may be made early in the application procedure to ensure that the penis and applicator are properly oriented with respect to each other, but even such limited contact is rarely necessary. It is not done. Later, during the actual application of the elastic sheath to the penis, both hands are in contact with the applicator (and possibly with the portion of the sheath carried by the applicator) rather than the penis, and one hand is , Used to grab and pull the exit portion of the catheter that partially protrudes through the open rear end of the applicator tube, the other hand directs the applicator tube and positions the applicator tube inlet opening close to the penis. And is used to propel the cylindrical portion of the sheath toward its inlet opening, if desired.

The present invention is particularly effective when used with an outer catheter having an inner sleeve for sealingly engaging the head or glans of the penis. It is also desirable for the catheter sheath to be of the adhesive coated type, because the combination of the present invention presents a risk that the pressure sensitive adhesive coating of the sheath may be contacted by the user's finger. It permits the application of such catheters to patients with little or no.

Briefly, the conjugate takes the form of an applicator tube supporting an external male urinary catheter, including the distal end portion of the catheter (including the catheter neck portion and the catheter outlet portion). Are partially disposed within the tube and partially extend out of the tube, while the cylindrical portion of the catheter is turned over and extends around the outside of the tube. A flexible, tubular, longitudinally inextensible, low friction sleeve is sandwiched between the inner and outer surfaces of the tube and catheter to reduce static and sliding friction. The pulling force exerted on the exit portion of the catheter causes the portion of the catheter external to the rigid applicator tube to be pulled into and out of the tube, and at the same time the cylindrical portion of the catheter, Try to take its final flipped position around the penis shaft.

Adhesive-coated catheters are not supported on the applicator tube in a rolled state, at least in the sense that the inner and outer surfaces of the sheath are in direct concentric contact with each other. The outer surface of the mold does not require a release coating of the type disclosed in earlier U.S. patents such as Re. 33,206 and 4,581,026. Typically, a silicone release coating is applied to the exterior surface of conventional catheters, but the release agent remains in solution and the solvent or solvent commonly used in the past poses environmental concerns. Can be raised. These concerns are eliminated by the conjugates of the present invention, because such release coatings are not required.

Other features, advantages and objects of the present invention will be apparent from the following description and drawings.

[0010]

【Example】

 With reference to the figures, numeral 10 generally indicates the coupling of an outer catheter 11 for men and an applicator 12. The catheter may be an application of a conventional external catheter, for example of the type disclosed in US Pat. Nos. 4,378,018 (FIG. 7) and 4,187,851 (FIG. 3), but co-owned patent 4,581,026. It is believed that a catheter having the features disclosed in U.S.A. is particularly desirable because of its internal sleeve structure and the presence of an internal band or region of pressure sensitive adhesive.

The catheter 11 is formed from a flexible and highly elastic natural or synthetic rubber. Natural latex is preferred, although other elastomers with similar properties such as silicone rubber can be used. The catheter includes a sheath or sheath having an elongated cylindrical portion 11a, a reduced outlet portion 11b, and a tapered neck portion 11c disposed therebetween. The wall thickness of the cylindrical portion 11a is substantially smaller than the wall thickness of the neck and outlet portion. For example, a cylindrical section has a wall thickness in the general range of 0.01524 cm (0.006 in) to 0.0254 cm (0.010 in) and is usually too thin to hold the cylindrical shape without support. It is flexible. In contrast, the wall thickness of the outlet and neck is greater than or equal to 0.127 cm (0.050 inch), which is such that the outlet and neck retain the shape shown in the strain-free state, and It is generally large enough to return to the shape shown when the strain force is removed.

At its forward or distal end, the neck portion 11c is provided with a rounded taper leading to the reduced opening 13. The outlet portion 11b, which turns into a tapered neck portion 11c, is provided with a plurality of convolutions or annular enlargements 14. Two such convolutions of progressively varying dimensions are shown, the purpose of these convolutions is to allow for large elongation, bending and twisting of the outlet section during use of the device, which Minimize the chance of kinking or obstruction of the cavity. Also, because the interior of the outlet section is enlarged in such a convolution section, the convolution section increases the fluid-carrying capacity of the outlet section, and, together with the neck section, prevents fluid agitation or flooding when the catheter is in use. Provides a reservoir for adjustment.

The inner sleeve portion 15 has a proximal end portion 15a that smoothly absorbs and merges with the distal end of the cylindrical body portion 11a of the sheath or sheath and an extended portion disposed within the neck portion 11c of the sheath. And a distal end portion 15b. The distal end portion 15b tapers anteriorly and inwardly, and terminates in a reduced distal aperture 16 appropriately spaced behind the aperture 13 (ie, proximal to the aperture 13). This setback or setback also provides an annular and axially extended expansion space 17 between the outer surface of the sleeve distal end portion 15b and the inner surface of the neck portion 11c. It will also be provided. The wall thickness of the sleeve may vary, but to ensure conformability, good sealing properties, and comfort for the wearer, such wall thickness is close to that of the relatively thin cylindrical body portion 11a. Should do. Thus, both the cylindrical body portion 11a and the inner sleeve 15 should appear as a thin, flexible, highly extensible membrane, as opposed to the outlet and neck portions 11b and 11c having shape-retaining properties. is there.

In the preferred embodiment disclosed herein, the catheter or sheath 11 is also provided with an internal (when the catheter is flipped over) adhesive (sticky) coating or band 18. To be The adhesive area is located in the cylindrical portion 11a of the sheath behind the inner sleeve 15. The adhesive coating may extend the entire length of the cylindrical portion 11a, as can be imagined, but with the adhesive region of a narrow but continuous band positioned within the distal portion of the cylindrical portion 11a of the sheath. We believe that it is preferable to put it in the form. The adhesive coating may be comprised of any suitable medical grade pressure sensitive adhesive of the type well known in the art, with hypoallergenic acrylic adhesives believed to be particularly effective. .

The applicator (or wearer) 12 includes two components. The applicator tube 20 is relatively rigid, and the flexible tubular low-friction sleeve 21. Tube 20 is generally tubular in shape and is open at both its proximal and distal ends 20a and 20b, respectively. The edge of the tube at the proximal end 20a is rounded (when viewed in longitudinal section), and the edge at the opposite end can be similarly formed if desired. The tube 20 can be comprised of any of a wide variety of generally rigid materials, with relatively rigid polyolefins such as polypropylene or high density polyethylene being particularly effective. Other polymeric materials with similar properties may also be used.

The length of the applicator tube 20 is substantially shorter than the length of the elastic sheath 11. The outer diameter of the applicator tube should be slightly larger than the maximum inner diameter of the unstretched sheath, in particular the cylindrical portion 11a of the sheath. The length of the applicator tube is preferably greater than the length of the cylindrical portion 11a of the sheath, so that when the cylindrical portion is supported externally on the smooth outer surface of the applicator tube 20, The annular portion 20c of the outer surface of the tube adjacent the distal end 20b is exposed and can be grasped between the fingers during use of the device as shown in FIGS. The length of the outlet portion 11b should also be sufficient to extend a sufficient distance outwardly from the distal end 20b so that a person can easily grasp the outlet portion and apply the catheter.

The tubular sleeve 21 has an inner diameter (when supported in a cylindrical shape) that is slightly larger than the outer diameter of the rigid applicator tube 20, and along the cylindrical portion of the catheter. It has a sufficient length to extend and at least partially surround the neck portion 11c. In the embodiment shown, the sleeve comprises an open mesh of flexible, interconnected polymer fibers or filaments. Two sets 22 and 23 of such fibers intersect to provide a number of mesh openings 24, each set of parallel fibers being preferably not perpendicular to the longitudinal axis of the applicator tube and the sleeve. Extend in directions other than parallel. As a result, the sleeve can slide smoothly at the entrance or proximal end 20a of tube 20 over the rounded edge without ratcheting movements that would otherwise occur. Such ratcheting behavior would occur if either set of fibers were extending in a plane perpendicular to the tube axis. The smooth fibers of the draw sleeve or the drawsleeve do not substantially stretch in response to the amount of force that would be expected during use of the product and the applicator tube Can be formed from any material that has a relatively low coefficient of friction to Nylon (polyamide) meshes are believed to be suitable, and particularly effective results have been obtained with meshes formed from polyolefins such as polypropylene or polyethylene. In particular, the frictional resistance between the sleeve 21 and the smooth surface of the applicator tube 20 should be substantially less than the frictional resistance between the sleeve and the material of the catheter sheath 11.

FIG. 1 illustrates a preferred catheter / applicator combination in the form that would be made available to the user. Catheter sheath 11 has a neck and outlet portion extending axially within applicator tube 20. The neck portion 11c extends outwardly through the inlet opening at the first or proximal end 20a of the tube and is turned over so that the cylindrical portion 11a is arranged around the outside of the tube. However, the sheath is not in direct contact with the tube. Instead, the sleeve 21 has a first portion 21a disposed within the tube 20 between the sheath neck and outlet portion and the inner surface of the tube 20. The turned over second portion 21b extends through an opening at the proximal end 20a of the tube and is sandwiched between the smooth outer surface of the tube 20 and the cylindrical portion of the elastic sheath 11. As shown, the second portion 21b is substantially shorter than the applicator tube 20. If there is a band or band of pressure sensitive adhesive 18 on the second portion of the sheath, the adhesive will be made of siliconized paper or other material, represented by phantom line 26 in FIG. It is preferably covered by a release strip. The release strip will be stripped by the user to expose the pressure sensitive adhesive band prior to beginning the act of applying the sheath to the patient.

If the catheter sleeve 11 is provided with the inner sleeve 15 described and shown, the proximal end portion 15a of the sleeve is also flipped out to provide an opening at the proximal end 20a (FIG. 1) of the tube. It has been found to be advantageous to mount a sheath on the tube 20 (with a sleeve 21 between them) so that it is placed around the outside of the tube 20 adjacent to the tube. The effect is to lengthen or widen the proximal end of the sleeve and reduce the length of the portion of the sleeve that is placed within tube 20. This positions the distal end portion 15b at the inlet of the support tube 20, so that the distal end portion is exposed in a manner that facilitates attachment of the catheter to a patient, as will be described below.

Referring to FIG. 2, the outlet portion 11b is grasped and pulled by one hand in the direction indicated by arrow 30, and the tube 20 is supported by the other hand in the direction indicated by arrow 31. Can be advanced. As mentioned above, the applicator tube can be indirectly supported and advanced by grasping the assembly as represented by the dotted line 32, in which case the finger is directed toward the proximal end 20a of the tube. The forward movement also contributes to and propels the sliding movement between the tube 20 on the one hand and the sleeve 21 and the catheter 11 on the other hand. In each case, the main force that causes the draw sleeve and the catheter to be flipped back and spread around the penis is the pulling force applied to the outlet portion 11b and exerted in the direction of arrow 30.

FIG. 3 illustrates a further step in the procedure of applying a catheter to a patient, where a sticky or adhesive band 18 is rounded near the tube 20 for contact with the pedicle of the penis P. Wraps around the end edge. In FIG. 4, the catheter application is complete and all that has to be done is to pull the applicator tube 20 and sleeve 21 away from the sheathed penis in the direction indicated by arrow 33.

The applicator tube 20 and sleeve 21 of the present invention may be used with catheters lacking the internal sleeve 15, but particularly effective results are achieved with catheters having such sleeves. The reason is that the extended distal end portion 15b of the sleeve can be brought into direct contact with the end of the penis at the first step of applying the sheath (Fig. 1), then the sheath is flipped over and applied. When applied, the sleeve 15 is pulled and stretched closely over the glans to form a fluid tight, non-sticky seal (FIGS. 3 and 4). The seal is maintained with the inner sleeve 15 in the stretched condition due to the adhesive contact between the band 18 and the penile shaft in the region well posterior to the glans. If the inner sleeve 15 is omitted, it may be necessary or desirable to initiate the turning-back operation without first directly contacting the sheath with the glans, because of the relatively thick taper of the catheter sheath. Such contact with the neck portion 11c may be undesirable in terms of patient comfort and in eliminating space that would otherwise act as a sway or flood chamber. is there.

While the embodiments of the present invention have been disclosed in considerable detail for purposes of illustration, it will be appreciated by those skilled in the art that many of these details may be changed without departing from the spirit and scope of the invention. Will be understood.

[Brief description of drawings]

FIG. 1 is a vertical cross-sectional view showing a combination of a catheter and an applicator which constitutes a preferred embodiment of the present invention.

FIG. 2 is a vertical cross-sectional view showing the first stage in the application of the catheter sheath.

FIG. 3 is a longitudinal section showing an intermediate stage in the application of a catheter sheath.

FIG. 4 is a longitudinal sectional view showing the final stage in the application of a catheter sheath with the sheath fully applied.

[Explanation of symbols]

10 Male outer catheter and applicator combination 11 Catheter 11a Cylindrical part 11b Outlet part 11c Neck part 12 Applicator 15 Inner sleeve part 15a Proximal end part 15b Distal end part 18 Adhesive coating or band 20 Applicator tube 20a Proximal end 20b Distal end 21 Friction-reducing sleeve 21a First part 21b Second part 22,23 Two sets of fibers P Penis

 ─────────────────────────────────────────────────── —————————————————————————————— 72 Inventor Susan Sea Gorski Martin Tribe 19598 Mandelaine, Illinois, USA

Claims (14)

[Scope of utility model registration request] 1. A combination of an outer catheter and an applicator, the catheter having a generally cylindrical portion diverging at one end into a tapered neck portion terminating in a reduced diameter outlet portion. A thin, extensible elastic material sheath is included, the applicator including a relatively rigid tube having inner and outer surfaces and having oppositely facing first and second end openings. The tube has a length substantially less than the length of the sheath and an outer diameter slightly greater than the maximum inner diameter of the sheath in the unstretched state, the applicator also comprising: A flexible, tubular, relatively inextensible, low friction sleeve having a length greater than the tube, the sheath having a neck portion extending axially within the applicator tube. And at least a portion of its outlet portion extends through the second end of the applicator tube, the sheath extends outward through the first end opening, and the cylindrical portion extends through the tube. The sleeve is turned around so that the sleeve is
A first portion disposed within the tube between the neck portion of the sheath and the inner surface of the tube and extending through the first end opening, the outer surface of the tube and the cylinder of the sheath. A second portion sandwiched between the shaped portions, the frictional resistance between the sleeve and the tube being substantially less than the frictional resistance between the sleeve and the sheath, thereby Positioning the first end opening of the tube in the glans of the penis, then pulling the end of the outlet portion of the sheath from the tube to withdraw the sheath from the interior of the tube while simultaneously removing the cylindrical portion of the sheath from the tube. A combination of an external catheter and an applicator adapted to apply the sheath to a patient by reversing and advancing over the penile shaft. 2. The combination of claim 1, wherein the tube is cylindrical. 3. The combination of claim 1, wherein the tube is longer than the cylindrical portion of the sheath. 4. The cylindrical portion of the sheath extending around the applicator tube has an outwardly facing surface, at least a portion of the outwardly facing surface having a pressure sensitive surface thereon. The conjugate according to any one of claims 1, 2 or 3 having the adhesive coating of claim 1. 5. The coupling of any one of claims 1, 2 or 3 wherein the sheath also includes an inner sleeve portion located within the neck portion and exposed at the first end opening of the tube. body. 6. The tube is adjacent to the second opening for grasping and directing the tube with one hand when the outlet portion of the sheath is grasped and pulled by the other hand. The combination of claim 1 having an exposed outer surface portion. 7. A combination external catheter and applicator, the catheter having a generally cylindrical portion that transitions at one end into a tapered neck portion that terminates in a reduced diameter outlet portion. A thin, extensible elastic material sheath, the applicator comprising a relatively rigid tube having inner and outer surfaces and having oppositely facing first and second end openings. Including,
The tube has a length substantially less than the length of the sheath and an outer diameter slightly greater than the maximum inner diameter of the sheath in the unstretched state, the applicator also being substantially A flexible low friction sleeve of substantially longer length than the tube, comprising a tubular mesh of inextensible crossed polymer filaments, the sheath having a neck portion extending within the applicator tube. Adapted to extend axially with its outlet portion extending through the second end of the applicator tube, the sheath extending outwardly through the first end opening, the cylindrical portion Turned over to be disposed about the tube, the sleeve has a first portion disposed within the tube between the neck portion of the sheath and the inner surface of the tube. And a flipped second portion sandwiched between the outer surface of the tube and the cylindrical portion of the sheath, the frictional resistance between the sleeve and the tube being between the sleeve and the sheath. Substantially less than frictional resistance such that the first end opening of the tube is located at the glans of the penis and then the outlet portion of the sheath is pulled from the tube to remove the sheath from the inside of the tube. A combination external catheter and applicator adapted to allow the sheath to be applied to a patient by withdrawing and at the same time turning and advancing the cylindrical portion of the sheath over the penile shaft. 8. The combination of claim 7, wherein the tube is cylindrical. 9. The combination of claim 7, wherein the tube is longer than the cylindrical portion of the sheath. 10. The cylindrical portion of the sheath has an outward facing surface, at least a portion of the outward facing surface having a pressure sensitive adhesive coating thereon. 7. The conjugate according to any one of 7, 8 and 9. 11. The coupling of claim 7, 8 or 9 wherein the sheath also includes an inner sleeve portion disposed within the neck portion and exposed at the first end opening of the tube. body. 12. The second opening for grasping and directing the tube with one hand when the second portion of the draw sleeve is grasped and pulled by the other hand. 8. The combination of claim 7 having an exposed outer surface portion adjacent to. 13. The filaments of the mesh draw sleeve include two sets of spaced parallel filaments, each set of filaments having a direction not parallel to a plane perpendicular to the axis of the applicator tube. Claim 8 extending to
Combination of. 14. The combination according to claim 8, wherein the filament is made of polyolefin.