U.S. patent application number 11/544503 was filed with the patent office on 2008-07-17 for medical device package.
Invention is credited to Joshua B. Stopek.
Application Number | 20080171972 11/544503 |
Document ID | / |
Family ID | 39283855 |
Filed Date | 2008-07-17 |
United States Patent
Application |
20080171972 |
Kind Code |
A1 |
Stopek; Joshua B. |
July 17, 2008 |
Medical device package
Abstract
The present disclosure provides a medical device package
including a container for receiving a medical device having an area
configured for storing at least one agent and a port for permitting
the passage of a contact material between the outside the container
and the area configured for storing the agent.
Inventors: |
Stopek; Joshua B.;
(Yalesville, CT) |
Correspondence
Address: |
Tyco Healthcare Group LP
60 MIDDLETOWN AVENUE
NORTH HAVEN
CT
06473
US
|
Family ID: |
39283855 |
Appl. No.: |
11/544503 |
Filed: |
October 6, 2006 |
Current U.S.
Class: |
604/85 |
Current CPC
Class: |
A61L 17/005 20130101;
A61L 2300/00 20130101; A61B 2017/00893 20130101; A61B 50/30
20160201; A61L 27/54 20130101; A61B 2017/06152 20130101; A61B
2017/00526 20130101; A61L 31/16 20130101; A61B 2017/06147 20130101;
A61B 17/06133 20130101; A61B 2050/3005 20160201 |
Class at
Publication: |
604/85 |
International
Class: |
A61M 37/00 20060101
A61M037/00 |
Claims
1. A medical device package comprising: a container having an area
configured for receiving a medical device, an area configured for
storing at least one agent; and a port for permitting the passage
of a contact material between the outside of the container and the
area of the container for storing the at least one agent.
2. The medical device package of claim 1 further comprising a
medical device selected from the group consisting of sutures,
staples, clips, grafts, stents, meshes, sternum closures, pins,
screws, tacks, and combinations thereof.
3. The medical device package of claim 2 wherein the medical device
is a suture.
4. The medical device package of claim 1 further comprising at
least one agent.
5. The medical device package of claim 4 wherein the at least one
agent is selected from the group consisting of drugs, coating
materials, wound healing agents, adhesives, sealants, blood
products, blood components, preservatives, colorants, dyes,
ultraviolet absorbers, ultraviolet stabilizers, photochromic
agents, anti-adhesives, proteins, polysaccharides, peptides,
genetic material, viral vectors, nucleic acids, nucleotides,
plasmids, lymphokines, radioactive agents, metals, alloys, salts,
growth factors, growth factor antagonists, cells, hydrophobic
agents, hydrophilic agents, immunological agents, anti-colonization
agents, diagnostic agents, imaging agents, radiopaque agents, and
combinations thereof.
6. The medical device package of claim 4 wherein the at least one
agent is a drug.
7. The medical device package of claim 6 wherein the drug is
selected from the group consisting of antiseptics, anesthetics,
muscle relaxants, antihistamines, decongestants, antimicrobial
agents, anti-viral agents, anti-fungal agents, antimatarials,
amebicides, antituberculosal agents, antiretroviral agents,
leprostatics, antiprotazoals, antihelmitics, antibacterial agents,
steroids, hematopoietic agents, antiplatelet agents,
anticoagulants, coagulants, thrombolytic agents, hemorrheologic
agents, hemostatics, plasma expanders, hormones, sex hormones,
uterine-active agents, bisphosphonates, antidiabetic agents,
glucose-elevating agents, growth hormones, thyroid hormones,
inotropic agents, antiarrhythmic agents, calcium channel blockers,
vasodilators, sympatholytics, antihyperlipidemic agents,
vasopressors, angiotensin antagonists, sclerosing agents,
anti-impotence agents, urinary alkanizers, urinary acidifiers,
anticholinergics, diuretics, bronchodilators, surfactants,
antidepressants, antipsychotics, antianxiety agents, sedatives,
hypnotics, barbiturates, antiemetic agents, analgesics, stimulants,
anticonvulsants, antiparkinson agents, proton pump inhibitors,
H.sub.2-antagonists, antispasmodics, laxatives, antidiarrheals,
antiflatulents, digestive enzymes, gallstone solubilizing agents,
antihypertensive agents, cholesterol-lowering agents, radiopaque
agents, immune globulins, monoclonal antibodies, antibodies,
antitoxins, antivenins, immunologic agents, anti-inflammatory
agents, antineoplastic agents, alkylating agents, antimetabolites,
antimitotic agents, radiopharmaceuticals, vitamins, herbs, trace
elements, amino acids, enzymes, chelating agents, immunomodulatory
agents, immunosuppressive agents and combinations thereof.
8. The medical device package of claim 1 wherein the area
configured for storing at least one agent is a reservoir positioned
within the container.
9. The medical device package of claim 1 wherein the area
configured for receiving the medical device and the area configured
for storing at least one agent are the same area within the
container.
10. The medical device package of claim 1 wherein the at least one
agent is self-contained.
11. The medical device of claim 10 wherein at least one agent is
self-contained in a capsule.
12. The medical device package of claim 1 wherein the contact
material is water.
13. The medical device package of claim 12 wherein the contact
material is saline.
14. The medical device package of claim 1 wherein the port is an
injection port.
15. A medical device package comprising: a container having an area
configured for receiving a medical device, a reservoir positioned
therein for storing at least one agent; and a port for permitting
the passage of a contact material between the outside of the
container and the reservoir storing the at least one agent.
16. The medical device package of claim 15 further comprising a
medical device selected from the group consisting of sutures,
staples, clips, grafts, stents, meshes, sternum closures, pins,
screws, tacks, and combinations thereof.
17. The medical device package of claim 15 wherein the medical
device is a suture.
18. The medical device package of claim 15 further comprising at
least one agent selected from the group consisting of drugs,
coating materials, wound healing agents, adhesives, sealants, blood
products, blood components, preservatives, colorants, dyes,
ultraviolet absorbers, ultraviolet stabilizers, photochromic
agents, anti-adhesives, proteins, polysaccharides, peptides,
genetic material, viral vectors, nucleic acids, nucleotides,
plasmids, lymphokines, radioactive agents, metals, alloys, salts,
growth factors, growth factor antagonists, cells, hydrophobic
agents, hydrophilic agents, immunological agents, anti-colonization
agents, diagnostic agents, imaging agents, radiopaque agents, and
combinations thereof.
19. The medical device package of claim 18 wherein the at least one
agent is a drug.
20. The medical device package of claim 19 wherein the drug is
selected from the group consisting of antiseptics, anesthetics,
muscle relaxants, antihistamines, decongestants, antimicrobial
agents, anti-viral agents, anti-fungal agents, antimatarials,
amebicides, antituberculosal agents, antiretroviral agents,
leprostatics, antiprotazoals, antihelmitics, antibacterial agents,
steroids, hematopoietic agents, antiplatelet agents,
anticoagulants, coagulants, thrombolytic agents, hemorrheologic
agents, hemostatics, plasma expanders, hormones, sex hormones,
uterine-active agents, bisphosphonates, antidiabetic agents,
glucose-elevating agents, growth hormones, thyroid hormones,
inotropic agents, antiarrhythmic agents, calcium channel blockers,
vasodilators, sympatholytics, antihyperlipidemic agents,
vasopressors, angiotensin antagonists, sclerosing agents,
anti-impotence agents, urinary alkanizers, urinary acidifiers,
anticholinergics, diuretics, bronchodilators, surfactants,
antidepressants, antipsychotics, antianxiety agents, sedatives,
hypnotics, barbiturates, antiemetic agents, analgesics, stimulants,
anticonvulsants, antiparkinson agents, proton pump inhibitors,
H.sub.2-antagonists, antispasmodics, laxatives, antidiarrheals,
antiflatulents, digestive enzymes, gallstone solubilizing agents,
antihypertensive agents, cholesterol-lowering agents, radiopaque
agents, immune globulins, monoclonal antibodies, antibodies,
antitoxins, antivenins, immunologic agents, anti-inflammatory
agents, antineoplastic agents, alkylating agents, antimetabolites,
antimitotic agents, radiopharmaceuticals, vitamins, herbs, trace
elements, amino acids, enzymes, chelating agents, immunomodulatory
agents, immunosuppressive agents and combinations thereof.
21. The medical device package of claim 15 wherein the reservoir is
removable from the container.
22. The medical device package of claim 16 wherein at least a
portion of the medical device is positioned within the
reservoir.
23. The medical device package of claim 16 wherein at least a
portion of the medical device passes through the reservoir.
24. The medical device package of claim 15 wherein the contact
material is water.
25. The medical device package of claim 15 wherein the contact
material is saline.
26. The medical device package of claim 15 wherein the port is an
injection port.
27. A medical device package comprising: a container having an area
configured for receiving a medical device, at least one
self-contained agent; and a port for permitting the passage of a
contact material between the outside of the container and the at
least one self-contained agent.
28. The medical device package of claim 27 further comprising a
medical device selected from the group consisting of sutures,
staples, clips, grafts, stents, meshes, sternum closures, pins,
screws, tacks, and combinations thereof.
29. The medical device package of claim 28 wherein the medical
device is a suture.
30. The medical device package of claim 27 wherein the at least one
self-contained agent is selected from the group consisting of
drugs, coating materials, wound healing agents, adhesives,
sealants, blood products, blood components, preservatives,
colorants, dyes, ultraviolet absorbers, ultraviolet stabilizers,
photochromic agents, anti-adhesives, proteins, polysaccharides,
peptides, genetic material, viral vectors, nucleic acids,
nucleotides, plasmids, lymphokines, radioactive agents, metals,
alloys, salts, growth factors, growth factor antagonists, cells,
hydrophobic agents, hydrophilic agents, immunological agents,
anti-colonization agents, diagnostic agents, imaging agents,
radiopaque agents, and combinations thereof.
31. The medical device package of claim 27 wherein the at least one
self-contained agent is a drug.
32. The medical device package of claim 31 wherein the drug is
selected from the group consisting of antiseptics, anesthetics,
muscle relaxants, antihistamines, decongestants, antimicrobial
agents, anti-viral agents, anti-fungal agents, antimatarials,
amebicides, antituberculosal agents, antiretroviral agents,
leprostatics, antiprotazoals, antihelmitics, antibacterial agents,
steroids, hematopoietic agents, antiplatelet agents,
anticoagulants, coagulants, thrombolytic agents, hemorrheologic
agents, hemostatics, plasma expanders, hormones, sex hormones,
uterine-active agents, bisphosphonates, antidiabetic agents,
glucose-elevating agents, growth hormones, thyroid hormones,
inotropic agents, antiarrhythmic agents, calcium channel blockers,
vasodilators, sympatholytics, antihyperlipidemic agents,
vasopressors, angiotensin antagonists, sclerosing agents,
anti-impotence agents, urinary alkanizers, urinary acidifiers,
anticholinergics, diuretics, bronchodilators, surfactants,
antidepressants, antipsychotics, antianxiety agents, sedatives,
hypnotics, barbiturates, antiemetic agents, analgesics, stimulants,
anticonvulsants, antiparkinson agents, proton pump inhibitors,
H.sub.2-antagonists, antispasmodics, laxatives, antidiarrheals,
antiflatulents, digestive enzymes, gallstone solubilizing agents,
antihypertensive agents, cholesterol-lowering agents, radiopaque
agents, immune globulins, monoclonal antibodies, antibodies,
antitoxins, antivenins, immunologic agents, anti-inflammatory
agents, antineoplastic agents, alkylating agents, antimetabolites,
antimitotic agents, radiopharmaceuticals, vitamins, herbs, trace
elements, amino acids, enzymes, chelating agents, immunomodulatory
agents, immunosuppressive agents and combinations thereof.
33. The medical device package of claim 27 wherein the at least one
self-contained agent is a capsule.
34. The medical device package of claim 33 wherein the capsule is
made from a polyvinyl alcohol.
35. The medical device package of claim 27 wherein the contact
material is water.
36. The medical device package of claim 27 wherein the contact
material is a saline.
37. The medical device package of claim 27 wherein the port is an
injection port.
Description
BACKGROUND
[0001] 1. Technical Field
[0002] The present disclosure relates generally to packaging for
medical devices, and more particularly, to a medical device package
including a container having an area configured to receive a
medical device and an area configured for storing at least one
agent and a port for permitting the passage of a contact material
between the outside of the container and the area of the container
configured for storing the agent.
[0003] 2. Background of Related Art
[0004] Combination medical devices, i.e., medical devices coated
with drugs or other bioactive agents, have become more prevalent
commercially in recent years. There are many of these combination
medical devices known to those skilled in the art. Many of these
devices require specialized coatings to facilitate both bioactive
agent elution and, more importantly, maintain or enhance the core
functionality of the medical device. For example, a suture
containing an antimicrobial coating must be able to facilitate the
elution of the antimicrobial agent in the coating and also maintain
a certain tensile strength, handling ability, knot-tying ability,
and degradation rate to ensure the coated suture remains functional
as a wound closure device.
[0005] Further, with the selection of a new coating, drug or any
combination of medical devices comes the challenge of marrying the
selected agents with a coating or medical device that can
accommodate both technical requirements described above, as well as
the manufacturing, sterilizing, and transporting processes involved
in producing such products. This often requires the design of new
coating polymers, which are specialized to be compatible with a
specific agent, as well as new coating, manufacturing, sterilizing
and transporting processes. In addition, designing these new
coatings and processes creates the added pressures of possibly
impacting the shelf-life of the device as well as the end-use of
the combination medical device in a negative manner.
[0006] Also, medical professionals are limited to using the
combination medical device in the dosage and strength produced,
without flexibility to alter the product as needed for their
respective patients.
[0007] Therefore, the present disclosure describes a package for a
medical device aimed at simplifying the design and application of
combination medical device coatings to provide the following
benefits: sensitive agents can be delivered without compromising
standard storage or transport conditions; the ability to later
combine a specific medical device with agents that were unable to
tolerate the required sterilization process for that specific
device, under sterile conditions; the medical professional has
greater control over product selection; and longer shelf-life of
products due to more stable format.
SUMMARY
[0008] Accordingly, a package for a medical device in accordance
with the present disclosure includes a container for receiving a
medical device wherein the container has an area configured for
storing at least one agent and a port for permitting the passage of
a contact material between the outside of the container and the
area of the container configured for storing at least one agent
therein. The area configured for storing the agent may be defined
within the container or as a separate compartment positioned within
or adjacent to the container.
[0009] In another embodiment, a medical device package as described
herein may include a container configured for receiving a medical
device including a reservoir for storing at least one agent and a
port for permitting the passage of a contact material between the
outside of the container and the reservoir configured for storing
the agent. The reservoir is positioned within the container in a
manner capable of applying the agent to at least a portion of the
medical device received in the container. The portion of the
medical device to be contacted by the agent and/or the contact
material may pass through or be positioned within the
reservoir.
[0010] In still another embodiment, a medical device package in
accordance with the present disclosure includes a container for
receiving a medical device having at least one separate,
self-contained agent and a port for permitting the passage of a
contact material between the outside of the container and the
self-contained agent. It is envisioned that the contact material
will interact with the self-contained agent in any manner suitable
for activating and/or releasing the agent stored therein so that
the medical device received by the container may come in contact
with the agent and/or the contact material.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] Various embodiments are described herein with reference to
the drawings wherein:
[0012] FIG. 1 is a top view of a medical device package described
herein, wherein the area configured for storing at least one agent
is defined within the container;
[0013] FIG. 2 is a perspective view of a medical device package
described herein, wherein the area configured for storing at least
one agent is a compartment defined within a portion of the
container; and
[0014] FIG. 3 is a perspective view of a medical device package
described herein, wherein at least one separate, self-contained
agent is positioned within the container.
DETAILED DESCRIPTION
[0015] The medical device packages described herein include a
container having an area configured for receiving a medical device,
an area configured for storing at least one agent and a port for
permitting the passage of a contact material between the outside of
the container and the area configured for storing at least one
agent. In some embodiments, the container may include a single area
configured for receiving both the medical device and the agent.
[0016] It is envisioned that any medical device may be stored
within the package. Some examples include, but are not limited to,
sutures, staples, clips, adhesives, sealants, stents, grafts,
meshes, sternum closures, pins, screws, tacks, and adhesion
barriers.
[0017] The container is dimensioned and configured to receive a
medical device. The container may be any conventional enclosure for
storing medical devices and more than one container may be combined
to form the medical device packages described herein. Some examples
of useful containers include, but are not limited too, pouches,
paper retainers, plastic retainers, bags, trays, envelopes,
Tyvek.RTM. bags, foil-packs, and the like. It is envisioned that
the containers may be sealable, non-sealable, breathable,
non-breathable, peelable, resealable, and combinations thereof.
[0018] The container may be manufactured from any material known to
those skilled in the art which is suitable for receiving or storing
a medical device. Some examples of suitable materials include, but
are not limited to, polycarbonate, high-density polyethylene,
polyethylene, polypropylene, thermoplastic resins,
polytetrafluoroethylene, .epsilon.-caprolactone, glycolide,
1-lactide, d,lactide, 1-lactide, d-lactide, meso-lactide,
trimethylene carbonate, 4,4-dimethyl-1,3-dioxan-2-one, p-dioxanone,
dioxepanone, .delta.-valerolactone, .beta.-butyrolactone,
.epsilon.-decalactone, 2,5-diketomorpholine, pivalolactone,
.alpha.,.alpha.-diethylpropiolactone, 6,8-dioxabicyclooctan-7-one,
ethylene carbonate, ethylene oxalate,
3-methyl-1,4-dioxane-2,5-dione, 3,3-dimethyl-1,4-dioxane-2,5-dione,
polyolefins, polysiloxanes, polyalkylene glycols, polyacrylates,
aminoalkyl acrylates, polyvinylalcohols, polyvinylpyrrolidones,
polyoxyethylenes, polyacrylamides,
poly(2-hydroxy-ethylmethacrylate), polymethacrylamide, dextran,
alginic acid, sodium alginate, polysaccharides, gelatin and
copolymers, homopolymers, and block copolymers thereof.
[0019] As further described herein, the container includes an area
configured for storing at least one agent. The area for storing the
agent is positioned within or adjacent to the package and/or the
container in a manner which allows the agent to interact with at
least a portion of the medical device. It is envisioned that the
agent or agents may be stored in the area configured for storing
the agent at any time between the manufacturing of the package and
the end-use or withdrawal of the medical device. In some
embodiments, the area configured for storing the agent may be
intended to keep the agent from prematurely reacting with the
medical device prior to use by medical personnel or the
introduction of the contact material via the port.
[0020] In some embodiments, the area configured for storing the
agent may be defined within the container (See FIG. 1). In some
embodiments, the area configured for storing the agent may be
defined within a portion of the container (See FIG. 2). In still
other embodiments, the container may include at least one separate,
self-contained agent positioned anywhere within or adjacent to the
container (See FIG. 3).
[0021] The area configured for storing the agent is capable of
storing the agent in any suitable form. The agent may be stored as
solid, liquid, semi-solid, gas, or any combination thereof. The at
least one agent may be selected from any bioactive and/or
non-bioactive agent suitable for combination with the medical
device. Suitable agents include, but are not limited to, drugs,
such as antiseptics, anesthetics, muscle relaxants, antihistamines,
decongestants, antimicrobial agents, anti-viral agents, anti-fungal
agents, antimatarials, amebicides, antituberculosal agents,
antiretroviral agents, leprostatics, antiprotazoals, antihelmitics,
antibacterial agents, steroids, hematopoietic agents, antiplatelet
agents, anticoagulants, coagulants, thrombolytic agents,
hemorrheologic agents, hemostatics, plasma expanders, hormones, sex
hormones, uterine-active agents, bisphosphonates, antidiabetic
agents, glucose-elevating agents, growth hormones, thyroid
hormones, inotropic agents, antiarrhythmic agents, calcium channel
blockers, vasodilators, sympatholytics, antihyperlipidemic agents,
vasopressors, angiotensin antagonists, sclerosing agents,
anti-impotence agents, urinary alkanizers, urinary acidifiers,
anticholinergics, diuretics, bronchodilators, surfactants,
antidepressants, antipsychotics, antianxiety agents, sedatives,
hypnotics, barbiturates, antiemetic agents, analgesics, stimulants,
anticonvulsants, antiparkinson agents, proton pump inhibitors,
H.sub.2-antagonists, antispasmodics, laxatives, antidiarrheals,
antiflatulents, digestive enzymes, gallstone solubilizing agents,
antihypertensive agents, cholesterol-lowering agents, radiopaque
agents, immune globulins, monoclonal antibodies, antibodies,
antitoxins, antivenins, immunologic agents, anti-inflammatory
agents, antineoplastic agents, alkylating agents, antimetabolites,
antimitotic agents, radiopharmaceuticals, vitamins, herbs, trace
elements, amino acids, enzymes, chelating agents, immunomodulatory
agents and immunosuppressive agents; coating materials such as
lubricants, and non-bioabsorbable substances such as silicone,
beeswax, or polytetrafluoroethylene, as well as absorbable
substances such as collagen, chitosan, chitin,
carboxymethylcellulose, and homopolymers and/or copolymers of
polyalkylene glycols, and higher fatty acids or salts or esters
thereof, glycolic acid, a glycolide, lactic acid, a lactide,
p-dioxanone, valerolactone and other lactones derived from linear
aliphatic hydroxycarboxylic acids, .alpha.-hydroxybutyric acid,
ethylene carbonate, ethylene oxide, propylene oxide, propylene
carbonate, malic acid ester lactones, succinic acid, adipic acid
and other linear aliphatic dicarboxylic acids, and linear aliphatic
diols such as butanediol and hexanediol; wound healing agents;
adhesives; sealants; blood products; blood components;
preservatives; colorants; dyes; ultraviolet absorbers; ultraviolet
stabilizers; photochromic agents; anti-adhesives; proteins;
polysaccharides; peptides; genetic material; viral vectors; nucleic
acids; nucleotides; plasmids; lymphokines; radioactive agents;
metals; alloys; salts; growth factors; growth factor antagonists;
cells; hydrophobic agents; hydrophilic agents; immunological
agents; anti-colonization agents; diagnostic agents; imaging
agents; diluents, such as water, saline, dextrose; and combinations
thereof.
[0022] In addition to the container and the area configured for
storing at least one agent, the package includes a port. The port
is designed to permit the passage of at least one diluent between
the outside of the container and the area configured for storing
the agent. It is envisioned that the port may be any type of port
or hub, known to allow the passage of a diluent therethrough. The
port may be made of any size, shape or dimension and may be
composed of any rubber, gel, metallic, polymeric, or thermoplastic
material known to those skilled in the art. The port may also be
sealable, non-sealable, resealable, stationary, movable, peelable,
self-puncturable and combinations thereof.
[0023] The port may be positioned along any side, edge or corner of
the container. In embodiments wherein the package includes more
than one container, the port may be positioned along any side, edge
or corner of any of the containers included in the package. In
addition, the package may contain more than one port and/or more
than container may share a common port.
[0024] In some embodiments, the port may be an injectable-hub, or
injection port, which is designed to remain sealed by self-sealing
action to ensure no liquid, semi-solid, or gas medium can escape
and also so no pathogens can breach the container. In some
embodiments, the port may be a hub designed in such a way that only
a particular injector can mate with the port, i.e., male/female or
lock/key type hubs. These types of ports provide more safety to the
user of the port because the port does not necessarily require the
use of a sharp injector or needle.
[0025] The contact material is intended to be delivered from
outside the container, via the port, to the area configured for
storing at least one agent. In embodiments where the container
includes at least one agent, the contact material may be introduced
to initiate or enhance the interaction, penetration, impregnation,
or coating of the medical device by the stored agent. The term
"contact material" is meant to include any material, i.e., solid,
liquid, semi-solid, gas, or combination thereof which interacts
with the agent, the medical device, or the container itself. In
some embodiments, the contact material may be any of the bioactive
or non-bioactive agents described herein. In particularly useful
embodiments, contact materials include diluents or wetting agents,
such as water, saline, dextrose and lactated ringers.
[0026] Turning now to FIG. 1, package 10 is shown including
container 20 having a single area 40 configured for storing at
least one agent and receiving the medical device, and a port 60 for
permitting the passage of a contact material between the outside of
container 20 and area 40 configured for storing the agent. In some
embodiments, at least a portion of medical device 30, i.e., a
suture, may be in contact or coated with an agent 50 prior to be
received and stored within container 20. Port 60 is positioned on
an outer edge of container 20 and is connected to area 40. It is
envisioned that an injector may be connected to port 60 to deliver
a contact material through port 60 and into area 40 to interact
with agent 50. Since at least a portion of medical device 30 is
positioned within area 40, the contact material and agent 50 may
coat, impregnate, react with, or be absorbed by medical device
30.
[0027] In another embodiment, as shown in FIG. 2, container 20
includes an area configured for receiving a medical device 25, an
area configured for storing at least one agent 40 and a port 60.
The area configured for storing an agent 40 is shown as a reservoir
or compartment positioned within container 20. In some embodiments,
the reservoir or compartment may be designed as a hollow chamber
configured for storing agent 50. In some other embodiments, the
reservoir may be used to apply agent 50 to specific portions of
medical device 30. In still other embodiments, the reservoir may be
used to apply agent 50 to at least a portion of medical device 30
as it is withdrawn from container 20.
[0028] It is also envisioned that the reservoir may be detachable
or removable from container 20. It is envisioned that the reservoir
is capable of storing from about 0.01 microliters to about 10,000
microliters. In some embodiments, the reservoir 40 does not contain
an agent. Rather, an agent or a contact material or both may be
added to reservoir 40 via port 60 by the end-user of the medical
device immediately prior to withdrawal of the medical device.
[0029] Turning now to FIG. 3, package 10 is shown including
container 20 having an area configured for receiving a medical
device 25, at least one separate, self-contained agent 50 and a
port 60. It is envisioned that the self-contained agent is capable
of being dissolved, reconstituted, emulsified, suspended,
vaporized, melted, and the like, by the contact material to
initiate or enhance the interaction, penetration, impregnation, or
coating of the medical device. In some embodiments, the
self-contained agents may take the form of or be stored within
capsules, tablets, pellets, particulate matters, pressed powders,
organized gels, and the like. The self-contained agents may include
materials such as gelatin, polyvinyl alcohols, hydrophilic,
hydrophobic, and amphiphilic materials. As shown in FIG. 3, a pair
of self-contained agents 50, in the form of gelatin capsules, will
not interact with medical device 30 until the introduction of a
contact material via port 60. Port 60 is capable of permitting the
passage of the contact material between the outside of the
container and self-contained agents 50 It is well understood that
various modifications may be made to the embodiments disclosed
herein. Therefore, the above description should not be construed as
limiting, but merely as exemplifications of particularly useful
embodiments. Those skilled in the art will envision other
modifications within the scope and spirit of the claims appended
hereto.
* * * * *