MULTI-COMPARTMENT PACKAGE ASSEMBLY FOR MEDICAL IMPLEMENTS
A package is provided to include first and second sheets being releasably sealed together in a manner to define multiple compartments, each having one or more medical implements. A perimeter sealed region can have a seal width greater than an intermediate sealed region. A longitudinal intermediate sealed region and a transverse intermediate sealed region can be arranged within the perimeter sealed region. Formation of the perimeter sealed region along first and second ends of the package can be subsequent to the perimeter sealed region along third and fourth ends of the package. Before the formation, compartments having an opening facing the first end can receive medical implements, and compartments having an opening facing the second end can receive medical implements. The medical implements can remain uncovered by individual pouches when inserted into the respective compartments, thereby reducing manufacturing costs and environmental wastes.
The present disclosure relates to a package for medical implements, and more particularly, to a multi-compartment package assembly for receiving medical implements.
BACKGROUNDMedical device companies provide assemblies and kits containing medical implements such as needles, syringes, sutures, wire guides, introducer sheath assemblies, and the like to clinicians to be used for particular medical procedures. Commonly, at least some of the medical implements are obtained from external suppliers, which are then combined with the others to form the assemblies and the kits prepared for an end user typically for an intended medical procedure. All of the implements regardless of their source are sterilized, for example by an ethylene oxide (ETO) process, during the assembling process and/or during prior to use by the end user.
Each medical implement is placed either in a single sealed pouch that is combined with other single sealed pouches within a larger sealed outer pouch, or directly within an outer tray with a sealed lid. However, for low volume packaging, outer tray packaging can be relatively expensive per unit cost. Because of the high relative costs, outer pouch sealing can become more commercially viable option.
For outer pouch packages, the assembler typically seals each medical implement within its own single pouch, and then seals a specific combination of medical implements within the outer pouch. To seal within a single pouch, an assembler will insert each medical implement within an individual pouch in a first step. The individual pouches, which are typically purchased from a supplier, are shaped and sized to receive the medical implement therein. The individual pouches are pre-sealed from the supplier along three sides and have an opening at a fourth side to receive the medical implement. After insertion of the medical implement, a seal is formed along the fourth side of each individual pouch by an assembler in a second step. The first and second steps of the assembling process require additional time and labor during the assembling process, and thus results in additional manufacturing costs per assembly or kit.
To seal the single sealed pouches within a larger outer pouch, an assembler will insert all of the individually sealed pouches within a larger outer barrier pouch in a third step. The outer barrier pouch, which is typically purchased from a supplier, has a single compartment that is sized to contain all of the individually sealed pouches which contain the medical implements. The outer barrier pouch is pre-sealed from the supplier along three sides and have an opening at a fourth side to receive all of the individually sealed pouches. A seal is then formed along the fourth side of the outer barrier pouch by an assembler in a fourth step.
To access the medical implements contained within the assembly or kit prior to a medical procedure, the end user would first have to open the outer pouch. The end user would then have to open each of the individual pouches that contain the medical implements. Consequently, each individual pouch is a single use item and discarded as waste. Hence, what is needed is an assembly or a kit for containing medical implements that can be packaged less expensively than the prior art. In particular, multiple medical implements can be assembled within the assembly or the kit in fewer process steps and/or with less material so that the assembly or the kit is environmentally friendly and results in reduced environmental wastes and costs of recycling for end users.
BRIEF SUMMARYIn one embodiment, a multiple compartment package for medical implements or kit is provided herein. The package can include a polymeric first sheet and a gas permeable bacteria resistant second sheet overlaying the first sheet. The first and second sheets can be releasably sealed together to define a perimeter sealed region formed along first, second, third, and fourth ends of the package. Further, the first and second sheets can be releasably sealed together to define intermediate sealed regions formed in an intermediate region of the package defined between the first, second, third, and fourth ends of the package. The perimeter sealed region can have a first width greater than a second width of each intermediate sealed region. The intermediate sealed regions can include at least one longitudinal intermediate sealed region, which extends in a longitudinal direction at least partially between the first and second ends. Further, the intermediate sealed regions can include at least one transverse intermediate sealed region, which extends in a transverse direction at least partially between the third and fourth ends. The intermediate sealed regions can be arranged relative to the perimeter sealed region to define a plurality of compartments. At least one of the compartments has an opening facing the first end of the package to receive at least one first medical implement therein, and at least one of the compartments has an opening facing the second end of the package to receive at least one second medical implement therein prior to formation of the perimeter sealed regions corresponding to the first and second ends of the package.
In another embodiment, one example of the package can be made by a process including one or more of the following steps. At least one first medical implement can be inserted into at least one first compartment that has an opening facing either of the first or second ends of the intermediate product. A third sealed region of the perimeter sealed region can be formed to intersect the first and second sealed regions to close the opening of the at least one first compartment. At least one second medical implement can be inserted into at least one second compartment that has an opening facing the other of the first or second ends of the intermediate product. A fourth sealed region of the perimeter sealed region can be formed to intersect the first and second sealed regions to close the opening of the at least one second compartment, whereby a final product of the package is formed.
In another embodiment, a method of packaging medical implements is provided. The method can include one or more of the following steps. An intermediate product of a multiple compartment package can be formed initially. A polymeric first sheet and a gas permeable bacteria resistant second sheet overlaying the first sheet are provided to define first and second ends of a unit, and third and fourth ends of the unit interconnecting the first and second ends. The first and second sheets can be releasably sealed together to define first and second portions of a perimeter sealed region formed along portions of the third and fourth ends of the unit. The first and second sheets can be releasably sealed together to define intermediate sealed regions formed in an intermediate region of the sheets. The first and second sealed regions of the perimeter sealed region can have a first width greater than a second width of each intermediate sealed region. The intermediate sealed regions can have at least one longitudinal intermediate sealed region, which extends in a longitudinal direction along the third and fourth ends, and at least one transverse intermediate sealed region, which extends in a transverse direction along the first and second ends. The intermediate sealed regions can be arranged relative to the perimeter sealed region to define a plurality of compartments having compartment openings that face at least one of the first end and the second end of the unit, whereby an intermediate product of a package is formed.
For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same.
In
The first sheet and the second sheet can be made of a variety of polymer and/or fabric materials. For example, the first sheet 12 can be a polymer film such as polyethylene, polyester, polyester (PET) modified low-density polyethylene (LDPE) laminated film, or a laminate (e.g., metalized PET). In one example, the first sheet is dual laminate material with 0.002-inch LDPE and 0.0005-inch polyester. The first sheet 12 is generally impervious to gas, and may also constitute an impassible barrier to moisture, bacteria, viruses, and other substances that may compromise the sterility or are otherwise detrimental to the implements and the packaging. In one example, the first sheet and the second sheet selected are capable of being sealed together in a manner to maintain sterility.
The second sheet 14 can be made of a material configured to facilitate sterilization procedures. In one instance, the first sheet 14 can be a breathable material that is permeable to permit sterilizing gases such as steam, ethylene oxide, or Freon, and/or transparent to permit e-beams and gamma rays used in irradiative sterilization. The second sheet 14 may also constitute an impassible barrier to moisture, bacteria, viruses, and other substances that may compromise the sterility or are otherwise detrimental to the implements and the packaging. One example of a material for the second sheet 14 having one or more of the properties is sold under the trademark TYVEK® (2FS, 1059B and 1073B),which is available from Medical Packaging Division of E.I DuPont de Nemours and Company. TYVEK® is a lightly consolidated or unconsolidated fabric made from spun high-density polyethylene (HDPE), which is also strong, puncture-resistant and tear-resistant.
In
A third sealed region 34 can be formed along the first end 16 of the package assembly 10. The third sealed region 34 can intersect portions of the first and second sealed regions 22, 23, which may be close in proximity to the first ends 24 of the first and second sealed regions. The third sealed region 34 may be contiguous with the first end 16 of the package assembly 10. Preferably, the third sealed region 34 can be spaced from the first end 16 as shown in the figures to define a region 35 where the first and second sheets remain unsealed. The third sealed region 34 can be linear or can be configured into other shapes to facilitate peelability of the first and second sheets along the sealed region, such as a V-shape or shaped like a chevron. A thumb notch 31 can be provided along the first end 16, preferably centrally located. The thumb notch 31 can be circular or rectangular. A hang hole 33 can also be provided along the first end 16, preferably centrally located just below the thumb notch 31.
A fourth sealed region 36 can be formed along the second end 18 of the package assembly 10. The fourth sealed region 36 can intersect portions of the first and second sealed regions 22, 23, which may be close in proximity to the second ends 26 of the first and second sealed regions. The fourth sealed region 36 may be contiguous with the second end 18 of the package assembly 10 or may be spaced from the second end 18 as shown in the figures. The first, second, third and fourth sealed regions can be portions that define a perimeter sealed region 39 of the package assembly 10. In
Referring back to
The compartments can have compartment openings facing at least one of the first and second ends 16, 18 to receive one or more medical implements therein before the third and fourth sealed regions 34, 36 are formed. After the third and fourth sealed regions are formed, it is desirable to open the package assembly from the first end 16 by peeling the first and second sheets 12, 14 away from one another.
In
The intermediate sealed region 40 may include a second transverse intermediate sealed region 56 that extends generally in a same direction as the first and second ends of the package assembly 10. Preferably, the second transverse intermediate sealed region 56 can extend substantially transverse to the first longitudinal intermediate sealed region 50. The second transverse intermediate sealed region 56 can intersect the first longitudinal intermediate sealed region 50 and/or one of the first and second sealed regions 22, 23 to form more than one compartment on either side. For example, a second compartment B can be formed having a compartment opening 57A facing the second end 18 of the package assembly 10 before the third and fourth sealed regions 34, 36 are formed, thereby forming a compartment for wider medical implements. A third compartment C can also be formed having a compartment opening 58A facing the first end 16 of the package assembly before the third and fourth sealed regions 34, 36 are formed. The second transverse intermediate sealed region 56 can be linear or can be configured into other shapes to facilitate peelability of the sheets along the sealed region, such as a V-shape or shaped like a chevron. Additional transverse intermediate sealed regions, such as region 59 shown in dashed lines, can be formed, e.g., to further segment the compartment B into more compartments. This can beneficially provide compartments containing sterile medical implements that can be subsequently opened later in the medical procedure.
The intermediate sealed region 40 may also include a third longitudinal intermediate sealed region 60 that extends generally in a same direction as the third and fourth ends 20, 21. The third longitudinal intermediate sealed region 60 can intersect the second transverse intermediate sealed region 56 and one of the third and fourth sealed regions 34, 36 to further segment the second compartment B or the\ third compartment C into additional compartments. Before the third and fourth sealed regions 34, 36 are formed, the further segmented compartments of the first or second compartments B, C can have compartment openings facing only the first end or only the second end of the package, respectively. For example, in
It can be appreciated by those skilled in the art that other compartment arrangements than what is shown in the figures are possible, including more or fewer longitudinal and/or transverse intermediate regions. It is also contemplated that each sealed region can be linear and substantially in alignment with the ends to define four-sided compartments as shown in the figures, but can also be non-linear, diagonal, or even asymmetric to define other geometrically shaped compartments or irregularly shaped compartments.
With additional reference to
In
One or more first medical implements 102 can be inserted into compartments only having compartment openings that face one of the first end 16 or the second end 18. Typically, one medical implement is inserted within one compartment.
The first and second sheets can be sealed to one another with a sealer at a predetermined temperature, time, and pressure that is sufficient to seal the materials of the first sheet and the second sheet together. One such sealer can be found at Sencorp Systems (Hyannis, Mass.). The sealer can include a die that is shaped for the intended shape of the sealed region. It is contemplated that the medical implements can be individually sealed into pouches having similar materials as the first and second sheets before being inserted into the compartments. However, it is preferred that the medical implements be directly inserted within the multiple compartments of the package assembly without pouches. As a result, additional time and labor, as well as materials (i.e., no individual pouches for medical implements), to individually seal each medical implement in its own pouch can be eliminated. This arrangement can result in a single package with multiple medical implements and in a reduction in manufacturing costs per a single package assembly or kit.
The first and second medical implements can remain non-sterile during insertion into the respective compartments. Thereafter, the final product package assembly 10 and the medical implements received therein can be sterilized by various means known in the art. For example, the final package assembly 10 can be exposed to sterilizing gases such as steam, ethylene oxide (ETO), or Freon, and/or radiation such as e-beams and gamma rays used in irradiative sterilization. Since the first and second sheets are configured to prevent the passage of bacteria, the first and second medical implements of the package assembly will remain sterile until the seal formed by the respective sealed regions is broken.
In
This action is continued until the transverse intermediate sealed region 56 is broken for external access to the compartments adjacent such region. As a result, medical implements, such as the medical implement 104B, within these adjacent compartments having compartment openings along the transverse intermediate sealed region, such as compartment B, can be removed. The package assembly 10 can provide a multiple compartment package where external access to medical implements can be gained with only a single peel action. Some medical implements can remain sealed within compartments, while other medical implements are being used during the procedure. When individual pouches for the medical implements are not used, the end user can quickly access the sterilized medical implements without opening additional pouches. Furthermore, the additional wastes created by the individual pouches can be avoided. Hence, the assembly or the kit can be more environmentally friendly with the reduction of environmental wastes and costs of recycling for end users.
It is contemplated that other package or kit arrangements are possible. One kit package assembly 200 is shown in
Drawings in the figures illustrating various embodiments are not necessarily to scale. Some drawings may have certain details magnified for emphasis, and any different numbers or proportions of parts should not be read as limiting, unless so-designated in the present disclosure. Those skilled in the art will appreciate that embodiments not expressly illustrated herein may be practiced within the scope of the present invention, including those features described herein for different embodiments may be combined with each other and/or with currently-known or future-developed technologies while remaining within the scope of the claims presented here. It is therefore intended that the foregoing detailed description be regarded as illustrative rather than limiting. And, it should be understood that the following claims, including all equivalents, are intended to define the spirit and scope of this invention.
Claims
1. A multiple compartment package for medical implements, comprising:
- a polymeric first sheet; and
- a gas permeable bacteria resistant second sheet overlaying the first sheet to define first and second ends of the package, and third and fourth ends of the package interconnecting the first and second ends;
- the first and second sheets being releasably sealed together to define a perimeter sealed region formed along the first, second, third, and fourth ends of the package, and releasably sealed together to define intermediate sealed regions formed in an intermediate region of the package defined between the first, second, third, and fourth ends of the package, the perimeter sealed region having a first width greater than a second width of each intermediate sealed region, wherein the intermediate sealed regions comprise at least one longitudinal intermediate sealed region which extends in a longitudinal direction at least partially between the first and second ends, and at least one transverse intermediate sealed region which extends in a transverse direction at least partially between the third and fourth ends, wherein the intermediate sealed regions are arranged relative to the perimeter sealed region to define a plurality of compartments,
- wherein at least one of the compartments has an opening facing the first end of the package to receive at least one first medical implement therein, and at least one of the compartments has an opening facing the second end of the package to receive at least one second medical implement therein prior to formation of the perimeter sealed regions corresponding to the first and second ends of the package.
2. The package of claim 1, wherein the at least one longitudinal intermediate sealed region comprises one or more first segments that intersect portions of the perimeter sealed regions corresponding to the first and second ends of the package to define one or more first compartments with openings facing both of the first and second ends of the package before said formation.
3. The package of claim 2, wherein one of the first segments is adjacent to a portion of the perimeter sealed region along one of the third and fourth ends of the package.
4. The package of claim 2, wherein the at least one transverse intermediate sealed region intersects one of the third and fourth ends and the first segment to define a second compartment with an opening facing the first end of the package before said formation, and to define a third compartment with an opening facing the second end of the package before said formation.
5. The package of claim 1, wherein the at least one longitudinal intermediate sealed region comprises one or more third segments that intersect both of portions of the perimeter sealed region along either the first end or the second end of the package and the at least one transverse intermediate sealed region to define one or more third compartments with an opening facing either of the first end or the second end of the package before said formation.
6. The package of claim 1, wherein a portion of the perimeter sealed region along the first end of the package has a chevron shape.
7. The package of claim 1, wherein the at least one transverse intermediate sealed region has a chevron shape.
8. The package of claim 1, wherein the first polymeric sheet comprises a low-density polyethylene (LDPE) layer and a polyester layer.
9. The package of claim 1, wherein the second sheet comprises a high-density polyethylene spun fabric.
10. The package of claim 1, wherein the at least one transverse intermediate sealed region is disposed such that when the first and second sheets are peeled, one of the compartments formed by the at least one transverse sealed region remains sealed while other compartments are opened to provide external access to the respective medical implement contained therein.
11. The package of claim 1, wherein the at least one transverse intermediate sealed region comprises a first transverse intermediate sealed region and a second transverse intermediate sealed region.
12. A multiple compartment package for medical implements, wherein the package includes an intermediate product having a polymeric first sheet, and a gas permeable bacteria resistant second sheet overlaying the first sheet to define first and second ends of the intermediate product, and third and fourth ends of the intermediate product interconnecting the first and second ends, the first and second sheets being releasably sealed together to define first and second sealed regions of a perimeter sealed region that are formed along portions of the respective third and fourth ends of the intermediate product, and releasably sealed together to define intermediate sealed regions formed in an intermediate region of the intermediate product, the first and second intermediate sealed regions of the perimeter sealed region having a first width greater than a second width of each intermediate sealed region, wherein the intermediate sealed regions comprise at least one longitudinal intermediate sealed region which extends in a longitudinal direction, and at least one transverse intermediate sealed region which extends in a transverse direction, wherein the intermediate sealed regions are arranged relative to the first and second sealed regions of the perimeter sealed region to define a plurality of compartments having compartment openings that face at least one of the first end and the second end of the intermediate product, the package made by a process comprising:
- inserting at least one first medical implement into at least one first compartment that has an opening facing either of the first or second ends of the intermediate product;
- forming a third sealed region of the perimeter sealed region that intersects the first and second sealed regions to close the opening of the at least one first compartment;
- inserting at least one second medical implement into at least one second compartment that has an opening facing the other of the first or second ends of the intermediate product; and
- forming a fourth sealed region of the perimeter sealed region that intersects the first and second sealed regions to close the opening of the at least one second compartment, whereby a final product of the package is formed.
13. The package of claim 12, wherein the at least one longitudinal intermediate sealed region comprises one or more first segments that intersect portions of the perimeter sealed region along the first and second ends of the package to define one or more first compartments with openings facing both of the first and second ends of the package prior to the forming steps.
14. The package of claim 13, wherein one of the first segments is adjacent to a portion of the perimeter sealed region along one of the third and fourth ends of the package.
15. The package of claim 13, wherein the at least one transverse intermediate sealed region intersects one of the third and fourth ends and the first segment to define a second compartment with an opening facing the first end of the package before said formation, and to define a third compartment with an opening facing the second end of the package prior to the forming steps.
16. The package of claim 12, wherein the at least one longitudinal intermediate sealed region comprises one or more third segments that intersect both of portions of the perimeter sealed region along either the first end or the second end of the package and the at least one transverse intermediate sealed region to define one or more third compartments with an opening facing either of the first end or the second end of the package prior to the forming steps.
17. A method of packaging medical implements comprising the step of forming an intermediate product of a multiple compartment package by the steps of:
- providing a polymeric first sheet, and a gas permeable bacteria resistant second sheet overlaying the first sheet to define first and second ends of a unit, and third and fourth ends of the unit interconnecting the first and second ends;
- releasably sealing the first and second sheets together to define first and second portions of a perimeter sealed region formed along portions of the third and fourth ends of the unit; and
- releasably sealing the first and second sheets together to define intermediate sealed regions formed in an intermediate region of the sheets, the first and second sealed regions of the perimeter sealed region having a first width greater than a second width of each intermediate sealed region, wherein the intermediate sealed regions comprise at least one longitudinal intermediate sealed region which extends in a longitudinal direction along the third and fourth ends, and at least one transverse intermediate sealed region which extends in a transverse direction along the first and second ends, wherein the intermediate sealed regions are arranged relative to the perimeter sealed region to define a plurality of compartments having compartment openings that face at least one of the first end and the second end of the unit, whereby an intermediate product of a package is formed.
18. The method of claim 17, further comprising the steps of:
- inserting at least one first medical implement into at least one first compartment that has an opening facing either of the first or second ends;
- forming a third sealed region of the perimeter sealed region that intersects the first and second sealed regions to close the opening of the at least one first compartment;
- inserting at least one second medical implement into at least one second compartment that has an opening facing the other of the first or second ends of the intermediate product; and
- forming a fourth sealed region of the perimeter sealed region that intersects the first and second sealed regions to close the opening of the at least one second compartment, whereby a package is formed.
19. The method of claim 18, wherein at least one of the first and second medical implements remains uncovered by an individual pouch when inserted into the respective compartments.
20. The method of claim 19, further comprising sterilizing the first and second medical implements as the last step.
Type: Application
Filed: Apr 25, 2011
Publication Date: Oct 25, 2012
Inventor: Sony Agrawal (Bloomington, IN)
Application Number: 13/093,347
International Classification: A61B 19/02 (20060101); B65B 51/10 (20060101); B65B 55/02 (20060101); B65B 5/02 (20060101);