Packaged Catheter Arrangement

Abstract

A packaged catheter arrangement having a soft and pliable latex rubber catheter for body orifice use and having its shaft slidably removably disposed within a relatively rigid tube sheath of plastic to form a catheter handling assembly which is enclosed as a unit within a peripherally sealed peel-apart dual sheet overpackage.

Description

This invention relates to an improved packaged catheter arrangement, and particularly to a packaged catheter arrangement which enables opening of the package and subsequent aseptic handling of the catheter in a manner that substantially reduces the likelihood of possible contamination of the catheter shaft prior to insertion into a patient.

It is conventional practice to furnish catheters in individual packages, so as to enable the catheters to be maintained in sterile condition until the desired time of use. Various packaging arrangements have been proposed and used for this purpose. It is a feature of the present invention to provide an improved packaging arrangement for point-of-use opening, and which enables subsequent rehandling of the catheter on a subassembly basis after opening of the overpackage, without seriously endangering the sterility of the catheter shaft.

It is a further feature of the invention to provide a packaging arrangement for catheters in which a catheter is reliably held in an extended position within a longitudinal overpackage, through the medium of a relatively rigid tube sheath which encompasses the insertion shaft of the catheter, thereby preventing the catheter from sliding down in the package and possibly kinking, and also making the catheter much easier to handle after removal from the overpackage, by grasping the tube sheath, rather than the insertion shaft of the catheter.

Still other objects, features and attendant advantages will become apparent to those skilled in the art from a reading of the following detailed description of a preferred embodiment constructed in accordance with the invention, taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view illustrating a preferred embodiment of the invention.

FIG. 2 illustrates the removal of the catheter from the tube sheath of FIG. 1, and the handling of the catheter by an operator during this removal operation.

In the preferred embodiment as illustrated in FIG. 1, a catheter, generally indicated at 11, is inserted with its shaft 13 extending through a major extent of the length of a relatively rigid tube sheath 21, and the catheter 11 and tube sheath 21 are in turn contained within a peripherally sealed sterile zone pocket formed within an overpackage 31.

The catheter 11 is merely an illustrative form of catheter, and may be of any suitable or desired catheter construction. In the illustrative catheter construction, the catheter has the conventional form of a patient insertion shaft 13 with a drainage eye 13b adjacent the insertion tip 13a, and connecting with a drainage arm 15, the catheter further having a branch arm 17 which is conventionally utilized for other fluid passage such as the passage of inflation fluid to and from a balloon zone (not shown) adjacent the forward end of the catheter shaft 13. Conventionally, the catheter is formed of soft latex rubber or other suitable soft and flexible material, thereby providing a problem in packaging of the catheter so as to retain the shaft 13 in a desired generally straight condition from the time of packaging to the time of use. The present invention facilely enables such a packaging and handling of the catheter 11.

Tube sheath 21 is formed of material which is relatively rigid as compared to the highly flexible and bendable soft latex rubber insertion shaft 13 of the catheter 11. It is desirable that the material be selected for the tube sheath 21 such that the tube sheath will retain its own cylindrical tube form, yet be sufficiently elastically flexible to enable subsequent pinching of the tube shaft for control during removal of the catheter shaft 13 from the tube sheath, as will be later discussed. To this end, it has been found that a suitable material for the tube sheath 21 is extruded polyethylene tubing. As an example, a catheter having a shaft 13 of 1/4 inch O.D. has been assembled in a tube sheath of extruded polyethylene having an I.D. of approximately 9/32 inch, and a wall thickness of approximately 0.02-0.03 inch. The particular thickness, diameter, and clearance are not critical, so long as the desired rigidity is provided for a given tube sheath material, and provided that such clearance is provided between the catheter shaft and the inside of the tube sheath to enable the desired control and ease of assembly and disassembly of the catheter relative to the tube sheath. It is desirable that the tube sheath be translucent or transparent, as this provides aesthetic appeal to the overall package, although in some instances the tube sheath may, if desired, be formed of opaque or relatively opaque and/or colored material.

The catheter 11 and the tube sheath 21 are disposed within the peripherally sealed pocket of the package 31, with one end 23 of the tube 21 adjacent one end of the longitudinal package, and the opposite open end 25 of the tube sheath 21 and the extending arms 15, 17 of the catheter 11 disposed adjacent the opposite closed end of the package 31.

The package 31 preferably takes the form of a sandwich of two peelably separable sheets 33, 35. The two sheets 33, 35 may be suitably formed respectively of a gas permeable paper sheet 33 and a cover sheet 35 of mylar and polyethylene. The mylar/polyethylene cover sheet 35, which is preferably transparent except for such printing as may be placed thereon, may itself be a bonded sandwich of an outer layer of mylar and a bottom layer of polyethylene, so as to provide the benefit of both materials, including the strength of mylar and the thermoplastic bonding and ease of sheet handling of polyethylene.

Prior to assembly of the catheter 11 and tube sheath 21 with the overpackage 31, the overpackage may be and is preferably partially pre-formed, by thermoplastic or other suitable peripheral bonding of the plastic cover sheet 35 to the paper base sheet 33, as indicated generally at 37, preferably employing spaced multiple parallel seal lines to aid in preventing bacterial tunneling, and thereby providing a longitudinally extending central pocket sealed on three sides and with an open unsealed end at one longitudinal end of the dual-sheet package. The assembled catheter 11 and tube sheath 21 may then be inserted through the open end of the pocket, to the position as shown in FIG. 1, and thereupon the previously open end may be sealed shut, as indicated at 39, as by heat-sealing of the thermoplastic cover sheet 35 to the paper base sheet 33 across this end. The entire package assembly 11, 21, 31 may then be subjected to gas sterilization, and if desired sterilization steps may be effected prior to or after various ones of the preceding assembly operations.

The peripheral seal zone of the package 31, as provided by the seal lines 37, 39, provides an unsealed end flap zone, with corners 35a, 37a which may be easily separated and pulled apart to peel the two sheets apart and expose the catheter 11 and tube sheath 21 for removal from the pocket 31p of the package 31. This peeling back of the cover sheet 35 is generally schematically indicated in broken lines at the upper end of the package as shown in FIG. 1.

Upon peeling of the two sheets 33 and 35 apart, the operator may thereupon grasp the tube sheath 21 and remove the tube sheath and catheter assembly, preparatory to operator insertion of the tube sheath into a patient. In removing the catheter 11 from the tube sheath 21, the operator may proceed as illustrated in FIG. 2, grasping tube sheath 21 adjacent the end 25 with the normally contaminated gloved hand of the operator, while initially grasping the extended and exposed arm section 15, 17 with the opposite sterile gloved hand. In this respect it will be appreciated that in the course of preparing the patient for catheterization the operator will have normally contaminated one gloved hand while leaving the other gloved hand sterile. The catheter is then withdrawn from the end 25 of the sheath 21, and the operator may readily control this withdrawal by pinching the tube 21 to a desired extent, as indicated at 21a in FIG. 2, the catheter being indicated by broken lines in the process of being withdrawn from the tube sheath 21, and in full lines in a typical withdrawn position. Thus, a desired frictional retarding force is exerted on the catheter shaft 13 to prevent the shaft from uncontrollably and undesirably slipping out of the tube sheath 21 and striking a foreign object or falling on the floor prior to or while wrapping of the shaft about the fingers of the operator to a position as shown in full lines in FIG. 2, preparatory to further manipulation of the catheter by the operator for insertion of the tip end 13a into a patient.

From the foregoing discussion it will be apparent that through the employment of the novel catheter packaging arrangement according to this invention, a total packaging arrangement is provided which facilitates assembling of the catheter within the outer package, which maintains the catheter in a generally straight condition from point of packaging to end use, which provides protection for the sterile catheter shaft in case of undetected puncture of the outer package 31, which facilitates the catheter removal from the outer package and subsequent handling of the catheter preparatory to final operator handling and insertion. In addition, in the event that the catheter is prelubricated, the tube sheath aids in reducing the likelihood of lubricant staining of the outer package or bleeding of the lubricant through the outer package, thereby also better retaining the initial content of lubricant on the catheter shaft in view of the relatively nonporous and low absorption characteristic of the plastic tube sheath, particularly as compared to the paper sheet 33 forming a portion of the overpackage 31. In addition, the smooth extruded plastic tubular sheath reduces the likelihood of pick-up of fibrous or other foreign particles from the paper sheet 33 of the outer package, or from other fibrous or particle sheet material which may be employed, and particularly as has been employed in prior arrangements where cardboard stiffening insert sheets have been utilized to retain the catheter in some semblance of a desired straight configuration.

While the invention has been illustrated and described with respect to a particular illustrative and preferred embodiment, it will be appreciated that various modifications and improvements can be made without departing from the scope and spirit of the invention. For instance, the overpackage might take other forms than as illustrated, such as with both sheets, 15 and 17, being formed of paper. Accordingly, the invention is not to be limited by the particular illustrative embodiment, but only by the scope of the appended claims.

Claims

I claim:

1. A packaged catheter arrangement comprising

a rubber catheter having an easily flexible insertion shaft,

and a longitudinally extended tube sheath which is smoothly curvilinearly annular in cross section and formed of elastic material and which is substantially longitudinally rigid relative to said flexible insertion shaft and thereby provides substantially self-sustained holding of its generally longitudinally extended tubular shape while said easily flexible shaft is disposed therewithin and is likewise similarly held in a longitudinally extended shape,

said catheter having two divergent fluid passage arms connecting with said insertion shaft and having a divergent breadth substantially greater than the interior cross-section of said tube sheath, and extending freely from and beyond one end of said tube sheath for ease of grasping and removal of said catheter from said tube sheath,

said insertion shaft being removably disposed along its length within said tube to a position closely adjacent the zone of connection of said divergent fluid passage arms with said insertion shaft, and being longitudinally generally rigidified by said tube.

2. A packaged catheter arrangement according to claim 1,

said tube sheath being open at both ends.

3. A packaged catheter arrangement according to claim 2,

said tube sheath being a smooth walled extrusion tube of plastic material.

4. A packaged catheter arrangement according to claim 1,

said tube sheath being generally circular in cross-section,

said tube sheath being elastically self-sustaining in its tubular form and longitudinally extended shape and being of sufficiently flexibly elastic material to enable finger pinching thereof to enable frictionally controlled withdrawal of said catheter therefrom.

5. A packaged catheter arrangement according to claim 1,

and a flexible overpackage substantially more flexible than any flexing capability of said tube sheath, and surrounding said catheter and tube sheath and being closed therearound.

6. A packaged catheter arrangement according to claim 5,

said flexible overpackage comprising a base of fibrous gas permeable sheet material and a cover sheet of light-transmitting see-through plastic peripherally bonded to said base sheet about said catheter and tube sheath to form an enclosed loose pocket or cavity for said catheter and tube sheath,

said cover sheet being removably peelably separable from said base sheet, and said sheets having unbonded tab ends at one end of said overpackage for ease in separating said sheets to remove said catheter and tube sheath therefrom.

7. A packaged catheter arrangement according to claim 6,

said sheets being peripherally heat seal bonded.

8. A packaged catheter arrangement according to claim 7,

said tube sheath being a smooth walled extrusion tube of plastic material,

said tube sheath being elastically self-sustaining in its tubular form and being of sufficiently flexibly elastic material to enable finger pinching thereof to enable fractionally controlled withdrawal of said catheter therefrom.

9. A packaged catheter arrangement according to claim 1,

said catheter having a lubricating coating on said insertion shaft thereof and enclosed within said rigid tube sheath.

10. A packaged catheter arrangement according to claim 1,

said tube sheath being generally circular in cross-section.