FIELD OF INVENTION:
The present invention relates to packaging of a medical devices and more
particularly to a method of packing and packaging for treated (drug coated)
stents which minimize the level of exposure of the stents to oxygen, moisture,
polutants and light.
BACKGROUND OF THE INVENTION:
A stent is a tube, often made of metals or occasionally plastic materials that are
inserted into a vessel or a passage in the body to keep the lumen of the vessel
open and to prevent closure due to a stricture or extemal compression.
Prior art packaging systems for treated stents have typically comprised a
thermofomi tray Insert in a foil pouch, or a themiofomi tray having a Tyvek ® lid
in a foil pouch, into which the stent is packed. Such conventional packaging for
stents do not provide for regulation of ambient conditions such as circulation of
air or exposure to light and oxygen. Without such appropriate regulation, the
efficacy of the drug and/or drug coating maybe reduced. Moreover, these
packages tend to be heavier than those of the present invention, they utilise
more material and they require more operator handling time to pack and so are
more labour intensive to produce.
Alternatively, medical devices specially coronary stent systems are packed in a
Tyvek ® pouch which consists of 1073B grade Tyvek and Poly Vinyl Chloride
(PVC) on another side. The process of packing is carried out in a clean room
environment and then sealed pouches are sterilized by Ethylene Oxide (Eto) gas.
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The active material is light, heat, moisture & pollutant-sensitive and to prevent
from Uiese external forces alone Tyvei< pouch is not sufficient as these forces are
permeable to Tyvek. Therefore, after sterilization, these pouches are packed in
Aluminium-foil pouches witfi High-density polyethylene (HOPE) lining, which
protect Uie inner pouch for long term from light, environment & external
mechanical damages. However, as a result of this dual packaging, it becomes
inconvenient to use as two pouches need to be opened in the operation theati^e.
Besides, tiiis alternative method is still time-consuming, uses more material, and
has less shelf-life and more weight.
FurUier, the conventional packaging does not have any indication for sterilization.
Therefore, there is a need for a time-saving, cost-effective and reliable singlepouch
packaging for a medical device.
SUMMARY OF THE INVENTION
An objective of Uie invention is to provide a method for packaging a medical
device, which is time-saving, cost-effective and reliable.
AnoUier object of the invention is to provide a packaging for a medical device
which is convenient to open/use and provides a barrier to oxygen, moisture and
light.
It is a furtfier object of tiie invention Uiat the packaging maintains a level of
environmental control within the sterile banier. The package must also be
suitable for sterilisation by ethylene oxide (EtO).
Accordingly, tiie present invention provides a process for packaging a medical
device which includes cutting a predetermined length of a metallic foil and
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breathable membrane; folding the cut foil and the cut breathable membrane;
placing the open edges of the breathable membrane and the foil together, the
folded breathable membrane being enveloped by the folded metallic foil; sealing
the metallic foil to the breathable membrane along the open edges placed
together; sealing the metallic foil along one of rest of two open edges; placing the
medical device within a pouch formed by the metallic foil; sealing the metallic foil
along the other of the two open edges; sterilizing at least the pouch through the
breathable membrane; placing at least one absorber pack within an enclosure
fornied by the breathable membrane; and sealing the metallic foil along all
remaining edges.
The invention also provides a packaging for a medical device which includes a
metallic foil pouch canTing the medical device, which is formed by folding a
predetemnined length of a metallic foil and sealing the remaining three edges;
and a breathable membrane enclosure carrying an absorber pack, which is
formed by folding a predetermined length of a breathable membrane and sealed
to the metallic pouch at the remaining three edges of the breathable membrane
along one of the edges of the metallic pouch.
Hence, the process of packaging and the packaging so provided is more
convenient, and saves time and material.
BRIEF DESCRIPTION OF THE DRAWINGS
So that the manner in which the above recited features of the present invention
can be understood in detail, a more particular description of the invention, briefly
summarized above, may be had by reference to various embodiments, some of
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which are illustrated in the appended drawings. It is to be noted, however, that
the appended drawings illustrate only typical embodiments of this invention and
are therefore not to be considered limiting of its scope, for the invention may
admit to other equally effective embodiments.
Fig. 1 is a flowchart depicting the process for packaging a medical device in
accordance with an embodiment of the invention.
Fig. 2, 3 and 4 illustrate various steps of the process of packaging a medical
device, in accordance with an embodiment of the invention.
Fig. 5 is a packaging for a medical device in accordance with an embodiment of
the invention.
DETAILED DESCRIPTION OF THE INVENTION
Various embodiments of the invention provide a packaging for a medical device
and the process thereof.
Figure 1 is a flowchart depicting the process for packaging a medical device in
accordance with an embodiment of the invention.
At step 102, a predetermined length of a metallic foil and breathable membrane
is cut. In an embodiment, the metallic foil is an aluminum foil coated with HOPE.
The breathable membrane is made of sheets of impenneable membrane such as
Tyvek ®.
Tyvek ® material is commercially available from DuPont and consists of multiple
spun woven extruded polyethylene strands, compressed under high pressure to
form a complex system of microscopic porous channels which provides a
tortuous porous path within a thin flexible opaque sheet. Other breathable
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membranes, such as paper, that suitably provide a barrier to microbes but allow
the passage of air and other gases and moisture could also be used. Tyvek ®
material has the advantage of having greater tear strength than paper and so is
less likely to tear on application of the vacuum.
Tyvek allows the absorber packs to Interact with the medical device but at the
same time prevents direct contact between the absorber packs and the medical
device. The advantage of not putting the moisture absorber packs Into direct
contact with the medical device is that there is a possibility that tiny amounts of
content residue would be present on the outside of each pack, and this residue
would adversely interact with the drug coating.
At step 104, the cut foil and the cut breathable membrane are folded.
At step 106, the open edges of the breathable membrane and the foil are placed
together. As shown in figure 2a and 2b the folded breathable membrane is
enveloped by the folded metallic foil.
At step 108, the metallic foil is sealed to the breathable membrane along the
open edges placed together by clamping the open edges (placed together at step
106) ktetween upper and lower jaws of a preheated sealing device. The sealing is
done with continuance edge sealing machine with an upper seal roller
temperature of 110 to 200 degree. Centigrade, and a lower seal roller
temperature of 60 to 100 degree Centigrade and the seal pressure may be from
30 to 100 psi; sealing a pouch in 3 to 10 second
Simllariy, at step 110, the metallic foil is sealed along one of rest of two open
edges. (Fig 4a)
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At step 112, the medical device Is placed within a pouch formed by the metallic
foil. (Fig. 4b)
At step 114, the metallic foil is sealed along the other of the open edges. This Is
the same edge through which the medical device is put into the pouch fomned by
the metallic foil at step 112.
At step 116, at least the pouch is sterilized through the breathable membrane.
The sterilization may be earned out using an inert gas such as nitrogen, ethylene
oxide and moisture in an ETO sterilizer.
At step 118, at least one absort>er pack is placed within an enclosure formed by
the breathable membrane.
In an embodiment, the absorber pack is a desiccant bag (developed by
Dessicare Inc.; approved by US FDA) with a predetennined amount of silica and
active carbon. This helps in removing and controlling the moisture, odour,
residual Eto and other pollutants generated from the product.
Other absorber packs are commercially available from Mitsubishi Gas chemical
company, lnc./(Pharmakeep KD-20w), and Silgel LtdV (4g Molecular Sieve
sachets), respectively.
At step 120, the metallic foil is sealed along all remaining edges.
In an embodiment, a v-cut is provided at one of the edges of the packaging as
shown in fig. 5, before the packaging is sent for secondary packing and labeling.
The v-cut assists in easy tearing of the packaging in the operation theatre.
Thus, it can be seen that the packaging is time-saving, cost-effective, reliable
and convenient to use/open in an operation theatre as it is a single-pouch
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packaging. Further, no aseptic packing technique is required after sterilization.
Packing is tamper proof and for one-use only.
While the foregoing is directed to embodiments of the present invention, other
and further embodiments of the invention may be devised without departing from
the basic scope thereof, and the scope thereof is determined by the claims that
follow.

We Claim:
1. A process for packaging a medical device comprising:
a. cutting a predetemiined length of a metallic foil and breathable membrane;
b. folding the cut foil and the cut breathable membrane;
c. placing the open edges of the breathable membrane and the foil together,
the folded breathable membrane being enveloped by the folded metallic
foil;
d. sealing the metallic foil to the breathable membrane along the open edges
placed together;
e. sealing the metallic foil along one of rest of two open edges of the metallic
foil;
f. pladng the medical device within a pouch formed by the metallic foil;
g. sealing the metallic foil along the other of the two open edges;
h. sterilizing at least the pouch through the breathable membrane;
i. placing at least one absorber pack within an enclosure formed by the
breathable membrane; and
j . sealing the metallic foil along all remaining edges.
2. The process for packaging a medical device as claimed in claim 1, wherein
sterilizing the pouch through the breathable membrane includes flushing with an
inert gas.
3. The process for packaging a medical device as claimed in claim 1, wherein the
breathable membrane is one selected from a group consisting of Tyvek*^ and
paper.
4. The process for packaging a medical device as claimed In claim 1, wherein the
absorber pack is a desiccant bag containing silica and carbon.
5. The process for packaging a medical device as claimed in claim 1 further
comprising making a cut mark at a predetermined location on the packaging to
enable opening of the packaging.
6. The process for packaging a medical device as claimed in claim 1, wherein the
medical device Is a stent.
7. A packaging for a medical device, the packaging comprises:
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a. a metallic foil pouch formed by folding a predetemiined length of a metallic
foil and sealing the remaining three edges, the metallic pouch carrying the
medical device; and
b. a breathable membrane enclosure fomried by folding a predetermined
length of a breathable membrane, the enclosure being sealed to the
metallic pouch at the remaining three edges of the breathable membrane
along one of the edges of the metallic pouch, the enclosure carrying an
absorber pack.
8. A packaging for a medical device as claimed in claim 7, wherein the medical
device is a stent.
9. A packaging for a medical device as claimed in claim 7, wherein the metallic foil
is plastic coated.
10. A packaging for a medical device as claimed in claim 7, wherein a cut is provided
for opening the packaging.
11. A packaging for a medical device as claimed in claim 7, wherein the breathable
membrane has an indicator to indicate the sterilization state of the packaging.
12. A packaging for a medical device as claimed in claim 7, wherein the packaging
is sterilized before sealing all the edges of the metallic pouch.
13. A packaging for a medical device as claimed in claim 7, wherein the absorber
pack contains silica and carbon.
Dated this 4**' January, 2012