US20080116106A1

US20080116106A1 - Packing and sterilizing a pen in a kit

Info

Publication number: US20080116106A1
Application number: US11/562,247
Authority: US
Inventors: Fred Lampropoulos; Randy Fratto; Matt Wold; Jesse Hansen
Original assignee: Merit Medical Systems Inc
Current assignee: Merit Medical Systems Inc
Priority date: 2006-11-21
Filing date: 2006-11-21
Publication date: 2008-05-22

Abstract

Sterile packaging of pens for use in a medical environment may include labels packaged along with a pen in a pen and label (PAL) kit. The present invention also relates to methods of packaging a pen and/or the PAL kit. In particular, the method of packaging includes the steps of placing a writing instrument into packaging configured to be sealed such that the writing instrument is contained in a sealed portion of the packaging, sealing the package, and sterilizing the writing instrument and the package using gamma sterilization such that all portions of the writing instrument are sterilized.

Description

BACKGROUND OF THE INVENTION

The present invention relates to sterilized medical packaging. In particular, the present invention relates to packaging a sterilized writing instrument, such as a pen, and labels, which may be contained in a pen and label kit (PAL) kit.
One problem often encountered in modern medicine relates to the need to identify and correctly label medical devices and products in a sterile fashion. Such medical devices and products may include therapeutic agents, (i.e., saline infused with a medicine), tissue samples, blood samples, used medical implements, and other medically related devices and products. The use of a sterile pen in such environments can prevent infection that might otherwise occur due to handling of a non-sterile implement. Because pens are routinely used by medical personnel, the risk of unintended exposure to dangerous agents resulting from the use of a non-sterile pen has been identified as problematic in the medical field.
Similarly, using sterile labels may reduce the risk of exposure or contamination by dangerous agents in a sterile environment, or by health-care professionals wearing sterile gloves. In some instances, touching a seemingly innocuous label that is not sterile may put patients at risk of infection. Such risks may be overlooked by the medical professionals because of the common use of such labels and because such labels must be used to correctly identify certain objects and materials.
One approach to addressing this problem has been to provide sterile PAL kits or pens along with certain medical products, or alone, for use by medical personnel. Some traditional methods of sterilization may include heat, chemical dipping and/or ultrasonic treatment. These traditional methods of sterilization may cause problems when used in attempts to sterilize a pen and labels, as the heat may melt the pen and the label adhesive, chemical dipping may damage the pen and labels, and ultrasonic treatment may not be as effective as other processes in killing all dangerous agents.
Sterilization using EtO (Ethylene Oxide) gas effectively kills bacteria and has been used to sterilize medical products since the 1960's. In a typical EtO cycle, a product is placed in an air tight chamber from which the air can be evacuated. EtO gas is then pumped into the chamber for an extended period of time. Temperature (heat) and humidity are also part of the cycle to enhance the kill time. After a certain period of time, the chamber recycles and pulls the EtO out and replaces it with clean air, as EtO gas is harmful to breathe. EtO sterilization usually requires about a day to prepare for a cycle, a day to run through the sterilizer, and about a week to wait for sterilization confirmation using a Petri dish sample test, making the EtO sterilization somewhat time consuming and expensive. Another problem with sterilizing pens using EtO sterilization is that drawing a vacuum in a volume containing a pen may cause the pen to leak, creating a mess.
What is needed is a sterilized PAL kit that can be processed quickly, while minimizing losses due to damaged or leaking pens.

BRIEF SUMMARY OF EMBODIMENTS OF THE INVENTION

Embodiments of the present invention relate to packaging a writing instruments, such as a pen, including the steps of placing the writing instrument into packaging configured to be sealed such that the writing instrument is contained in a sealed portion of the packaging, sealing the package, and sterilizing the writing instrument and the package using gamma sterilization such that all portions of the writing instrument are sterilized. Gamma sterilization is effective at sterilizing all components of the PAL kit, including the interior of any pen cap or lid and even the ink inside of a pen. Similarly, gamma irradiating labels ensures that the labels, including any adhesive layer, are sterilized throughout.
In some embodiments, the packaging is an inner packaging, and the method further includes the steps of placing the sealed inner packaging into an outer packaging, placing at least one other item into the outer packaging, sealing the outer packaging such that the sealed inner packaging and the additional items are contained in a sealed portion of the outer packaging, and sterilizing the contents of the outer packaging. In some embodiments, EtO sterilization is employed.
Another embodiment of the present invention is directed to a kit that includes packaging, a writing instrument, and labels configured to be written on by a user with the writing instrument. At least the writing instrument is sealed in the packaging, and at least the packaging and the writing instrument are sterilized using gamma sterilization.
In some embodiments, the packaging may be inner packaging, the kit further including outer packaging and at least one other item. The writing instrument is sealed in the inner packaging. The labels, and the at least one other item are sealed in the outer packaging, and the outer packaging and the contents of the outer packaging are sterilized, such as by using EtO sterilization, for example.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other aspects of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1A is a top view of a PAL kit including a pen and labels in a package according to one embodiment of the invention;

FIG. 1B is a top view of the PAL kit including a pen and labels in a package of FIG. 1A according to one embodiment of the invention;

FIG. 2 is a view of a PAL kit including a pen in a package according to one embodiment of the invention;

FIG. 3 is view of a kit including a PAL kit and additional packaging and components according to one embodiment of the invention; and

FIG. 4 is a process diagram of packaging a PAL kit according to one embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The present invention relates to sterile packaging of writing instruments, such as pens, for use in a medical environment. The sterile packaging may include labels packaged along with a pen in a pen and label (PAL) kit. The present invention also relates to methods of packaging a pen and/or the PAL kit. In particular, the method of packaging includes the steps of placing a writing instrument into packaging configured to be sealed such that the writing instrument is contained in a sealed portion of the packaging, sealing the package, and sterilizing the writing instrument and the package using gamma sterilization such that all portions of the writing instrument are sterilized.
In some embodiments, the packaging is an inner packaging, and the method further includes the steps of placing the sealed inner packaging into an outer packaging, placing at least one other item into the outer packaging, sealing the outer packaging such that the sealed inner packaging and the additional items are contained in a sealed portion of the outer packaging, and sterilizing using EtO sterilization such that the contents of the outer package are sterilized.
Some embodiments of the present invention relate to a kit including packaging, a writing instrument, and labels configured to be written on by a user with the writing instrument. In such embodiments, at least the writing instrument is sealed in the packaging, and at least the packaging and the writing instrument are sterilized using gamma sterilization.
In some embodiments, the packaging may be inner packaging, the kit further including outer packaging and at least one other item. In such embodiments, the outer packaging is sealed to include the sealed inner packaging containing the writing instrument, labels, and the at least one other item. The outer package contents are sterilized using EtO sterilization.
FIGS. 1A and 1B show a PAL kit 100 according to one embodiment of the present invention. The PAL kit 100 includes packaging 110, pen 120, and labels 130. Packaging 110 has a first layer 112 and a second layer 114 that may be sealed together at or adjacent to their respective peripheries. First layer 112 may be made of semi-permeable material such as Tyvek® or other gas-permeable material that would allow gasses to flow in and out without allowing contaminants to penetrate the material, maintaining the sterility of the interior and contents of PAL kit 100. The material of first layer 112 may also allow printing on the surface of first layer 112. Such printing may include, for example, identification and/or instructions. One example of such printing is shown in FIG. 1B.
Second layer 114 may be made of a gas and liquid impermeable transparent plastic material or any other suitable material. Second layer 114 may have a depression formed in the material to create a pocket or space for pen 120 and labels 130. Similarly a pocket may be formed in first layer 112. Alternatively, the pocket may be defined by neither layer, and may be implemented as a space defined between joined layers 112 and 114.
First layer 112 and second layer 114 of packaging 110 may be joined at a periphery to create a hermetically sealed interior pocket capable of holding contents such as pen 120, or labels 130, or both. Such packaging may be multivac blister packaging. The layers 112 and 114 may be joined using any conventional joining processes including adhesives, welding, etc. In some embodiments, layers 112 and 114 may also be joined together to form more than one interior pocket allowing for production of several packages with continuous sheets of material, or allowing pen 120 and labels 130, or other objects, to be placed in separate pockets.
Layers 112 and 114 may also be joined such that on at least one side, the joined portion is located in from an edge of packaging 110 to enable a user to grasp the layers 112 and 114 individually and then separate the joined layers. In other embodiments, a periphery of packaging 110 may include a notch to allow the package to be easily torn open for use.
Pen 120 may be any conventional pen, such as a fine-tip, permanent ink pen. Pen 120 may be provided in a non-sterile initial state, prior to being placed and packaged in packaging 110 and sterilized. While pen 120 is illustrated in the Figures, any suitable writing instrument may be substituted for pen 120, such as a marker, pencil, electronic writing instrument, etc.
Labels 130 may be any labels that would accept and hold ink from pen 120, or otherwise lend themselves to being marked by a writing instrument. Labels 130 may include printing directed to the anticipated use of PAL kit 100. For example, as shown in FIG. 1A, at least one of labels 130 may be pre-printed with “HEP./SALINE” or other lettering such as “CONTRAST,” “SALINE,” “PREP SOLUTION,” “LIDOCAINE,” or any other printing. Similarly, labels 130 may be pre-printed with designated spaces for writing, such as spaces for date and initials to indicate when a product was prepared or administered, or when a sample was taken, and who completed the procedure. More generally, labels 130 may include any printed information that may be useful to a medical professional using a PAL kit.
In preparing PAL kit 100 as shown in FIGS. 1A and 1B, pen 120 and labels 130 are placed in packaging 110. Packaging 110 is then sealed to encapsulate pen 120 or labels 130, or both, in packaging 110. Packaging 110 may be hermetically sealed. After packaging 110 is sealed to include pen 120 or labels 130, or both, to create PAL kit 100, PAL kit 100 is sterilized using gamma sterilization. A printing process may also be performed to label PAL kit 100. The sealing and printing processes may be performed simultaneously to reduce production time.
Gamma sterilization requires a short cycle time, typically taking about one minute. PAL kit 100 is bombarded with gamma radiation, which penetrates through all materials in packaging 110, pen 120 and labels 130, sterilizing each component both internally and externally. As some materials are sensitive to gamma radiation, such that they become brittle and/or discolored, the materials selected for PAL kit 100 may be selected for their resistance to damage by gamma radiation. By using gamma sterilization, each portion of the PAL kit is sterilized, including all inside portions of pen 120, or other writing instrument, including the ink and inside of any lid or cap covering pen 120. Gamma sterilization also allows PAL kit 100 to be packaged without using a vacuum. This approach to packaging may limit manufacturing loss due to pen leakage and failure that can be caused by drawing a vacuum on pen 120. However, in some embodiments, vacuum packaged PAL kits may also be sterilized using gamma sterilization.
In FIG. 2, PAL kit 200 includes packaging 210 and pen 220. While labels may be included in PAL kit 200, PAL kit 200 as illustrated does not include labels in packaging 210 along with pen 220. Packaging 210 includes first layer 212 and second layer 214. In the embodiment illustrated in FIG. 2, layers 212 and 214 are made from impermeable metal foil or semi-metallic material. Layers 212 and 214 may also be made from any other suitable material that allows for gamma sterilization. Layers 212 and 214 are joined around a peripheral edge such that a hermetically sealed interior space is created for containing pen 220. Layers 212 and 214 may by joined using any suitable conventional joining process including, for example, adhesive, pressing, crimping, melting, and welding. Similar to pen 120 of PAL kit 100, pen 220 may be any pen or writing instrument, such as a fine-tip, permanent ink pen.
In preparing PAL kit 200 as shown in FIG. 2, pen 220 may be placed in packaging 210. Excess air in the packaging may then be withdrawn by drawing a vacuum on packaging 210. The vacuum may be a relatively low vacuum sufficient to evacuate some or all of the internal air from packaging 210, while minimizing manufacturing losses due to pen failure. PAL kit 200 may then be hermetically sealed and gamma radiated in a process similar to process described in connection with PAL kit 100 above.
FIG. 3 shows medical kit 250. In this example embodiment, medical kit 250 includes outer packaging 260, PAL kit 200, as discussed above, labels 230 and additional components 240. Packaging 260 includes a first outer layer 262 and a second outer layer 264, first outer layer 262 may be made of semi-permeable material such as Tyvek® or other suitable material to allow gasses to flow in and out without allowing contaminants to penetrate the material, thereby maintaining the sterility of the interior and contents of medical kit 250 after performance of a sterilization process. The material of first outer layer 262 may also allow printing on the surface of first outer layer 262, so that identification and/or instruction to be printed on the packaging. The sealing and printing processes may be performed simultaneously to reduce production time.
Second outer layer 264 may be made of a non-permeable transparent plastic material or any other suitable material. Second outer layer 264 may have a depression formed in the material to create a pocket or space for PAL kit 200, labels 230, and additional components 240. Similarly, a pocket may be formed in first outer layer 262 or in neither layer, existing only as a space between joined layers 262 and 264.
First outer layer 262 and second outer layer 264 of packaging 260 may be joined at a periphery to create a hermetically sealed interior pocket capable of holding contents such as PAL kit 200, labels 230, and additional components 240. Such packaging may be multivac blister packaging. Outer layers 262 and 264 may be joined using any conventional joining processes, such as adhesives and welding. In some embodiments, layers 262 and 264 may also be joined to form more than one interior pocket, allowing for production of several packages with continuous sheets of material. In some embodiments, each of the items contained in medical kit 250 may be placed in a separate respective pocket.
Outer layers 262 and 264 may also be joined such that on at least one side, the joined portion is located in from the edge to provide a user access to grasp outer layers 262 and 264 separately and separate the joined layers. In other embodiments, a periphery of packaging 260 may include a notch to allow the package to be torn open for use.
In some embodiments, labels 230 may be included inside of PAL kit 200, or may be included both inside PAL kit 200 along with pen 220 and in outer packaging 260, separate from PAL kit 200. Labels 230 may be conventional labels as discussed above with regard to labels 130. Additional components 240 may include any components for any medical kit that may require labeling, such as with a PAL kit, and may be as numerous or as few as desired in the particular medical kit 250. For example, additional components 240 may include a catheter kit including an introducer sheath, syringes, tubing, guidewire, and collection receptacle.
In preparing medical kit 250 as illustrated in FIG. 3, PAL kit 200, previously sterilized, labels 230, and additional components 240 are placed in outer packaging 260. Outer layers 262 and 264 are then hermetically sealed. Sterilization is then performed on the medical kit 250, such as by EtO sterilization. Because PAL kit 200 includes foil packaging 210, EtO sterilization does not penetrate PAL kit 200, but does sterilize the external surfaces of packaging 210. During the EtO sterilization, EtO gas penetrates through outer layer 262 and seeps through the open lumens of any tubing and other components contained in medical kit 250.
In some embodiments, medical kit 250 may include PAL kit 100 as described above instead of PAL kit 200.
FIG. 4 shows a process diagram of process 400 listing some exemplary steps to create a PAL kit. As shown, packaging is provided in box 410. Box 420 includes the step of placing a writing implement in the packaging. The packaging is sealed to contain the writing instrument in box 430, creating a PAL kit. The PAL kit is sterilized in box 440. Thus, a PAL kit may be created by including at least a writing instrument in packaging, sealing the packaging to contain the writing instrument, and sterilizing the PAL kit.
The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

1. A method for packaging a pen, comprising:

placing a writing instrument into packaging configured to be sealed such that the writing instrument is contained in a sealed portion of the packaging;

sealing the packaging; and

sterilizing the writing instrument and the packaging using gamma sterilization, such that all portions of the writing instrument are sterilized.

2. The method of claim 1, wherein the writing instrument is a permanent ink pen.

3. The method of claim 1, wherein the packaging is one of a multivac blister packaging and a foil packaging.

4. The method of claim 1, wherein the writing instrument is non-sterile prior to the sterilizing using gamma sterilization.

5. The method of claim 1, wherein the sealing includes vacuum sealing.

6. The method of claim 1, wherein the packaging is an inner packaging, and wherein the method further comprises the steps of:

placing the sealed inner packaging into an outer packaging;

placing at least one other item into the outer packaging;

sealing the outer packaging such that the sealed inner packaging and the additional items are contained in a sealed portion of the outer packaging; and

sterilizing the contents of the outer package using EtO sterilization.

7. The method of claim 6, wherein the inner packaging is impermeable to the EtO gas.

8. The method of claim 7, wherein the inner packaging is foil packaging.

9. The method of claim 6, wherein the outer packaging is multivac blister packaging.

10. The method of claim 6, wherein the at least one other item includes labels configured to be written on with the writing instrument.

11. The method of claim 10, wherein the at least one other item also includes at least one item configured to be used with a medical procedure.

12. The method of claim 6, wherein labels configured to be written on with the writing instrument are included in at least one of the inner packaging and the outer packaging.

13. The method of claim 1, further comprising the step of printing on the packaging simultaneous to sealing the packaging.

14. The method of claim 6, further comprising the step of printing on the outer packaging simultaneous to sealing the outer packaging.

15. A kit comprising:

packaging;

a writing instrument; and

labels configured to be written on by a user with the writing instrument, wherein at least the writing instrument is sealed in the packaging, and wherein at least the packaging and the writing instrument are sterilized using gamma sterilization.

16. The kit of claim 15, wherein the packaging is inner packaging, and further comprising:

outer packaging; and

at least one other item, wherein the writing instrument sealed in the inner packaging, the labels, and the at least one other item are sealed in the outer packaging, and wherein the outer packaging and the contents of the outer packaging are sterilized using EtO sterilization.

17. The kit of claim 15, wherein the writing instrument is a permanent ink pen.

18. The kit of claim 15, wherein the packaging is one of a multivac blister packaging and a foil packaging.

19. The kit of claim 15, wherein the labels are sealed in the packaging.

20. The kit of claim 16, wherein the inner packaging is impermeable to air such that the EtO gas does not penetrate the inner packaging.

21. The kit of claim 16, wherein the at least one other item is an item configured to be used in medical treatment.