WO1998002195A1

WO1998002195A1 - Replaceable flexible protective cover for an infusion device

Info

Publication number: WO1998002195A1
Application number: PCT/US1996/012420
Authority: WO
Inventors: Melanie E. Matyas
Original assignee: Matyas Melanie E
Priority date: 1996-07-16
Filing date: 1996-07-16
Publication date: 1998-01-22
Also published as: AU6640796A

Abstract

This invention is a replaceable, flexible protective cover (12) for an infusion device formed of a transparent membrane with an adhesive on one side affixable to the skin to surround an infusion device.

Description

S P E C I F I C A T I O N REPLACEABLE FLEXIBLE PROTECTIVE COVER FOR AN INFUSION DEVICE

BACKGROUND OF THE INVENTION

1. Field of the Invention. This invention relates to a replaceable protective cover to cover an infusion device that is flexible and secured on a person to protect the device as well as waterproof it.

2. Description of the Prior Art. o Applicant is of course familiar with her earlier patent No. 5,336,204 which is also directed to a protective cover for infusion devices. While the patent is certainly practical for protection due to its rigid body, it may have a slight disadvantage for proper adhesion on body contours due to its rigidity. In addition, the structure in the earlier patent was primarily for use to cover existing dressings that retain the catheter.

U.S. Patent No. 3,900,026 employs a rigid body member. U.S. Patent No. 3,782,378 requires a waist band to maintain an intravenous feeding tube where the tube passes under the shield which may allow moisture to penetrate beneath the shield. These are undesirable features.

SUMMARY OF THE INVENTION

One of the objects of the present invention is to provide a protective cover that is formed of soft pliable material that may easily seek the body contour and infusion devices where it is applied to seal the area and prevent moisture from entering the area to be protected. Another object of the present invention is to provide a flexible protective cover that includes a plastic window that will allow visible inspection of the apparatus within the cover, such as a catheter or conventional Heparin lock.

A further object of the present invention is to provide a flexible protective cover that includes an opening therein to receive apparatus wherein it is waterproof and moisture cannot enter the protected area wherein a catheter is inserted.

A still further object of the present invention is to provide a flexible protective cover that includes a tab that contains a waterproof opening.

A yet further object of the present invention is to provide a flexible protective cover that includes a clear flexible plastic membrane to allow visual inspection and also can be stretched to conform to the apparatus inserted into the skin of a patient such as a Heparin lock.

Another object of the present invention is to provide a flexible protective cover that may include foam material such as cellular white foam of a cross linked polyurethane material .

A further object of the present invention is to provide a flexible protective cover that includes hypoallergenic adhesive to effect a waterproof adherence to the skin without skin irritation.

A still further object of the present invention is to provide a flexible protective cover capable of being mass produced in quantities by stamping out the same.

These and other objects and advantages will become apparent from the following part of the specification wherein details have been described for the competence of disclosure, without intending to limit the scope of the invention which is setforth in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS These advantages may be more clearly understood from the following detailed description and by reference to the drawing in which:

Figure 1 is a top environmental view of the present invention in place upon the forearm of a patient;

Figure 2 is a side environmental view of the present invention is place upon the forearm of a patient;

Figure 3 is a prospective view of a protective cover of the present invention;

Figure 4 is a cross sectional view of the present invention taken on lines 4-4 of Figure 3; Figure 5 is a cross sectional view of the invention taken on line 5-5 on Figure 1;

Figure 6 is a bottom plan view of the present invention;

Figure 7 is a prospective view of a protective cover with a modified waterproof opening;

Figure 8 is a view taken on lines 8-8 of figure 7;

Figure 9 is another modification of the protective cover;

Figure 10 is an illustration of how the protective cover may be fabricated from large sheets of material; and Figure 11 is another modification of the protective cover;

Figure 12 is taken on line 12-12 of Figure 11; and Figure 13 is a side elevational view in section of the modification of Figure 11.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT A flexible protective cover generally designated

12 is seen as it is mounted on the forearm 14 of a person to protect infusion devices designated 16.

The flexible protective cover 12 is preferably elongated with an arcuate front end 18, a pair of spaced apart generally parallel side walls 20 and 22 and an end wall 24 joining the side walls 20 and 22. The cover, of the structure shown is Figures 1-9, is of a soft pliable material preferably cellular white foam of a cross linked polyurethane material that may be cut to the shape described above and illustrated. The exterior shape of the cover 12 is not critical as long as it is sufficiently elongated to cover an infusion device and catheter.

In addition there is a cut out 26 that leaves the material to form the above referred to arcuate front end, side walls and a rear wall. Thus the cover 12 is open in the interior portion. While the cutout 26 preferably conforms to the exterior shape, it may be of any shape just as long as there is a sufficient opening to view apparatus to be described through the cut out 26.

Also in the preferred embodiment, Figures 3 and 4 it will be seen that there is a flexible mounting tab 30 with a hole 32 there-through that projects into the cut out 26 from the rear wall 24.

The bottom 34 of the cover 12 includes an adhesive

36 around the rim or walls for affixing the cover to a patient. Preferably there is a protectable adhesive cover 38 that may be peeled off so that the adhesive 36 is exposed and may be applied.

The adhesive 36 is also preferably hypoallergenic to avoid skin irritation and is waterproof so that the area of the skin within the cut out 26 will be free of moisture that might cause infection.

Over the entire cover 12 there is secured by adhesive or other means a clear relatively thin tough layer of plastic or membrane 42 that also covers to mounting tab 30. The infusion device 16 includes a conventional catheter needle 46, see Figures 5, which is inserted into the skin 48 of a patient into a vein. The needle 46 includes a conventional Heparin lock hub 50 so that a syringe (not shown) with an appropriate drug such as Heparin may be fitted to the lock hub 50 and the drug injected into the patient.

Due to the fact that Heparin users do not have to have a constant continuous infusion of Heparin, a lock has been developed so that the catheter may be left in the arm and the dosage may be applied when required without the need to make new punctures in the skin 48.

With the relative permanency of the Heparin lock it is necessary to prevent moisture from entering the catheter at the skin and causing infection.

The present invention will accomplish the intended purpose. The plastic sheet or membrane 42 in the vicinity of the hole 32 of tab 30 is cut to conform to the hole 32 or it may be cross cut.

The diameter of the hole 32 is preferably slightly less that the diameter of the annular recess 52 of the shank 54 of the Heparin lock 50.

Thus in practice the catheter needle 46 may be inserted into the skin 48 and the protective paper 38 of the cover 12 is then removed. The tab 30 of the cover 12 is bent upwardly, see Figure 5, and the Lock hub 50 is inserted through the opening 32. The material of the cover 12 being resilient, the material around the opening 32 may be contorted and stretched so that a portion of the lock 50 may pass through the hole 32 and will seat in the lock annular recess 52. With the hole 32 diameter being slightly smaller that the recess 52 a good waterproof seal may be achieved.

As can be seen in Figures 1, 2 and 5 the hub 50 projects outward of the tab 30 so easy access is available for administering the required dosages at the times necessary yet leaving the infusion device free of moisture. With the tab 30 elevated it will be noted that the clear plastic film being relatively tight on the cover device

12, it will adhere to the parts of the lock 50 thereunder, see Figure 5. This will not only assure a greater water proofing, but will also act to stabilize the infusion device 16 while it is on a patient's body.

As the flexible cover 12 is secured to the skin 48 by means of the adhesive 36 and the seal around the Heparin lock tab shank 54 seals the interior, a complete water proof interior is available. In that way infusion devices 16 may be maintained on a patient's body for a longer period than usual as the chances of infection are reduced and the chances of the device being dislodged are reduced.

The modified tab 30' as seen in Figures 7 and 8 includes a soft plastic annular donut seal 60 that may be secured on the tab 30' around the hole 32' . The annular opening 62 of the seal 60 is preferably slightly less that the diameter of shank 54 of the Heparin lock hub 50 so that when the lock 50 is inserted further water proofing is achievable.

In Figure 9 there is illustrated a further modification of the protective cover 12' . Here the mounting tab 30 may be eliminated. However there is still a frame formed of the arcuate front end 18, parallel side walls 20' and 22' and rear wall 24' forming a cut out 26' . The Figure 9 structure still includes the adhesive 36' applied to the frame and the sheet plastic 42' applied as a top cover over all of the frame of the cover 12 :

The opening 32" for the Heparin lock 50 may be a cross cut as illustrated or an annular hole. In the case of this modification the lock 50 is mounted through the opening 32" and the sheet plastic 42' being flexible it will stretch around the infusion device 16, which in turn will help to water proof the device while surrounded by the protection device 12.

Figure 10 illustrates a sheet of plastic 12 from which a quantity of the protective devices 12 may be formed.

Figures 11, 12 and 13 illustrate a second modification of the protective device 12'''. This is a relatively simple but effective device that includes the plastic or membrane 42' in the shape shown or any other shape sufficient to cover the lock 50 (see Figure 13).

The membrane 42' is coated on the underside with adhesive 36 that is preferably hypo-allergenic to avoid skin irritation. Placed to cover the adhesive 36 is a backing or cover 38' that may be peeled off so that the cover 12''' may be secured to the patient over lock 50. In addition there is preferably a cross cut 32''' that extends through the plastic 42', adhesive 36 and backing 38' to receive the lock 50.

One method of operation is for the Heparin lock 50 to be inserted through the cross cut 32''' as seen in Figure

13, then the backing 38' is removed and the infusion device inserted into the skin and the cover 12''' is secured to the skin and molded around the infusion device to assure a waterproof seal .

The invention and its attendant advantages will be understood from the foregoing description and it will be apparent that various changes may be made in the form, construction and arrangements of the parts without departing from the spirit and scope thereof or sacrificing its material advantages, the arrangements herein before described being merely by way of example. I do not wish to be restricted to the specific forms shown or uses mentioned, except as defined in the accompanying claims, wherein various portions have been separated for clarity of reading and not emphasis.

EU HE 26

Claims

I claim :

1. A replaceable flexible protective cover for an infusion device wherein said infusion device may include a Heparin lock with an annular shank portion and an annular sealing recess there around presenting an exterior hub portion and an interior portion and catheter means inserted within the skin of a person and joined to said interior portion all angled relative to the surface of said skin said cover comprising: a resilient transparent water proof membrane covering adapted to be stretched and distorted by said Heparin lock to engage portions there of, cover and to waterproof and stabilize said device; an opening within said membrane covering of one lateral dimension adapted to be contorted to allow said interior portion of said lock to pass therethrough and said look to seat in said annular sealing recess of a lesser lateral dimension wherein a water proof seal is created; an adhesive on said membrane covering for releasably affixing said protective cover to the skin of a person and to conform to and adhere to said lock; and a removable backing to said adhesive to protect said adhesive until it is desired to affix the covering.

2. A replaceable flexible protective cover as defined in claim 1 wherein: there is a flexible frame member of a size adequate to surround and cover said interior portion of said Heparin lock and having two sides.

3. A replaceable flexible protective cover as defined in claim 2 wherein: said flexible frame member is formed of cellular white foam of a cross linked polyurethane.

4. A replaceable flexible protection cover as defined in claim 2 wherein: the frame includes an arcuate front end, a pair of parallel spaced apart side walls and an end wall remote from said arcuate wall extending between said side walls.

5. A replaceable flexible protection cover as defined in claim 1 wherein: said opening is an annular opening in said membrane .

6. A replaceable flexible protection cover as defined in claim 1 wherein: said opening is a cross cut opening.

7. A replaceable flexible protection cover as defined in claim 3 wherein: a mounting tab having a top and bottom surface and of the same material as said frame appends inwardly from said end wall into the space within said frame, and an opening therethrough and said mounting tab adapted to be bent upwardly to present a face generally normal to the angle of said Heparin lock wherein said lock passes through said opening with said opening received in said annular sealing recess sealing the interior of said frame against the entry

SUBSmUTE SHEET RULE 26 of moisture with said exterior hub portion outside of said tab to receive a needle with an appropriate drug to be inserted into said infusion device and into said person.

8. A replaceable flexible protection cover as defined in claim 1 wherein: the adhesive on said frame is hypoallergic and is covered with a removable protection sheet until ready for use.

9. A replaceable flexible protection cover as defined in claim 7 wherein: an annular seal member is mounted on said bottom surface of said mounting tab surrounding said opening to increase thickness and impart further waterproof quality to said cover where said Heparin lock is inserted therein.