U.S. patent application number 16/188974 was filed with the patent office on 2019-03-21 for orthopedic cast and splint bandages with encapsulated hardening medium and method.
The applicant listed for this patent is BSN medical, Inc.. Invention is credited to John C. Evans.
Application Number | 20190083293 16/188974 |
Document ID | / |
Family ID | 51062920 |
Filed Date | 2019-03-21 |
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United States Patent
Application |
20190083293 |
Kind Code |
A1 |
Evans; John C. |
March 21, 2019 |
ORTHOPEDIC CAST AND SPLINT BANDAGES WITH ENCAPSULATED HARDENING
MEDIUM AND METHOD
Abstract
A medical bandaging product that includes a flexible medical
material including an elongate knitted fabric, a reactive system,
and microspheres. In certain aspects, a component of the reactive
system is homogeneously impregnated into or coated throughout the
flexible medical material without being encapsulated in the
microspheres such that the reactive system remains stable and
non-activated in the absence of an activating agent, and hardens
upon activation by exposure to the activating agent to form a
rigid, self-supporting structure. In this aspect, the microspheres
are homogeneously impregnated into or coated throughout the
flexible medical material, the microspheres encapsulate an
activating agent and are configured to release the activating agent
to form the rigid, self-supporting structure.
Inventors: |
Evans; John C.; (NR
Rochdale, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BSN medical, Inc. |
Charlotte |
NC |
US |
|
|
Family ID: |
51062920 |
Appl. No.: |
16/188974 |
Filed: |
November 13, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14285815 |
May 23, 2014 |
10159593 |
|
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16188974 |
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61840841 |
Jun 28, 2013 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 5/058 20130101;
A61L 15/12 20130101; C08L 75/04 20130101; A61F 13/04 20130101; C08L
75/04 20130101; A61L 15/08 20130101; A61L 15/12 20130101 |
International
Class: |
A61F 5/058 20060101
A61F005/058; A61L 15/12 20060101 A61L015/12; A61F 13/04 20060101
A61F013/04; A61L 15/08 20060101 A61L015/08; C08L 75/04 20060101
C08L075/04 |
Claims
1. A medical bandaging product comprising: an elongate knitted
fabric homogenously impregnated or coated with a reactive system
and including a plurality of micelles or polymeric microspheres
having an activating agent encapsulated therein that are
impregnated or coated on the elongate knitted fabric, wherein: the
reactive system remains stable in the absence of an activating
agent and hardens upon exposure to the activating agent, and
wherein the activating agent is encapsulated in the plurality of
microspheres.
2. The medical bandaging product of claim 1, wherein the plurality
of microspheres are configured to rupture to release the activating
agent.
3. The medical bandaging product of claim 1, wherein the elongate
knitted fabric is a knitted fabric including monofilament or
multifilament yarns including at least one of fiberglass,
polyester, polyolefin, aramid, and polyamide.
4. The medical bandaging product of claim 3, wherein each filament
of the monofilament or multifilament yarns has a diameter from 0.3
mm to 2 mm.
5. The medical bandaging product of claim 1, wherein the elongate
knitted fabric is surrounded by at least one of a non-woven
material, an open cell foam material, or a reticulated foam
material.
6. The medical bandaging product of claim 1, wherein the reactive
system comprises a polyurethane moisture curing system.
7. The medical bandaging product of claim 6, wherein the reactive
system comprises a prepolymer, a polyol, or a combination thereof
not encapsulated within the plurality of microspheres.
8. The medical bandaging product of claim 7, wherein the prepolymer
is an organic isocyanate selected from the group consisting of
methylene diphenyl diisocyanate, toluene diisocyanate,
hexamethylene diisocyanate, and isophorone diisocyanate.
9. The medical bandaging product of claim 1, wherein the plurality
of microspheres comprise micelles or polymeric microspheres have a
diameter from 200 .mu.m to 2000 .mu.m and encapsulate water, a
catalyst, or a combination thereof.
10. The medical bandaging product of claim 1, wherein the plurality
of microspheres encapsulate an organic isocyanate selected from the
group consisting of methylene diphenyl diisocyanate, toluene
diisocyanate, hexamethylene diisocyanate, and isophorone
diisocyanate.
11. The medical bandaging product of claim 1, wherein the plurality
of microspheres are polymeric microspheres comprising at least one
of a polyoxyethylene, polypropylene oxide, polylactic acid,
polyethylene, polystyrene, poly(methyl methacrylate), polyvinyl
pyrrolidone, and polycaprolactone.
12. The medical bandaging product of claim 1, wherein the plurality
of microspheres are homogeneous in composition.
13. The medical bandaging product of claim 1, wherein the plurality
of microspheres are heterogeneous in composition.
14. The medical bandaging product of claim 1, further comprising an
antimicrobial agent coated on the elongate knitted fabric.
15. The medical bandaging product of claim 14, wherein the
antimicrobial agent is in the range from 1 g/m.sup.2 to 10
g/m.sup.2.
16. A method of activating a medical bandaging product comprising
an elongate knitted fabric homogenously impregnated or coated with
a reactive system including a plurality of microspheres, wherein
the reactive system remains stable in the absence of an activating
agent and hardens upon exposure to the activating agent, and
wherein the activating agent is encapsulated in the plurality of
microspheres, the method comprising physically manipulating the
elongate knitted fabric to rupture the plurality of microspheres to
release the activating agent.
17. The method of claim 16, wherein the elongate knitted fabric
includes monofilament or multifilament yarns including at least one
of fiberglass, polyester, polyolefin, aramid, and polyamide.
18. The method of claim 16, wherein the reactive system comprises a
prepolymer, a polyol, or a combination thereof not encapsulated
within the plurality of microspheres.
19. The method of claim 18, wherein the prepolymer is an organic
isocyanate selected from the group consisting of methylene diphenyl
diisocyanate, toluene diisocyanate, hexamethylene diisocyanate, and
isophorone diisocyanate.
20. The method of claim 16, wherein the plurality of microspheres
are polymeric microspheres comprising at least one of a
polyoxyethylene, polypropylene oxide, polylactic acid,
polyethylene, polystyrene, poly(methyl methacrylate), polyvinyl
pyrrolidone, and polycaprolactone.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This Continuation Application claims priority from U.S.
patent application Ser. No. 14/285,815 filed on May 23, 2014, which
claims priority from U.S. application No. 61/840,841 filed Jun. 28,
2013, the entirety of which are incorporated herein by
reference.
TECHNICAL FIELD AND BACKGROUND OF THE INVENTION
[0002] The present invention generally relates to medical bandage
products. In particular, the present invention relates to an
orthopedic splinting product and a casting product, both utilizing
a substrate that can be used to stabilize a fracture or sprain or
any other injury that requires a rigid or semi-rigid support and
that includes a unique manner of transforming the products from a
soft, conformable state to a rigid state suitable for immobilizing
a wounded limb. A method of manufacturing and using the bandages is
also disclosed.
[0003] Medical bandages for use in the treatment of injuries, such
as broken bones requiring immobilization of a body member, are
generally formed from a strip of fabric or scrim material
impregnated with a substance which hardens into a rigid structure
after the strip has been wrapped around the body member.
[0004] Conventional practice has been to fabricate a cast or splint
upon an injured limb by initially applying to the limb a protective
covering of a cotton fabric or the like, and then overwrapping the
covering and limb with a substrate impregnated with
plaster-of-paris or a substrate formed from flexible fiberglass
fabric layers impregnated with a moisture-curable resin. Casts or
splints formed from these materials possess several disadvantages.
In particular, casts or splints formed using plaster-of-paris
impregnated substrates have a relatively low strength to weight
ratio. This results in a finished cast or splint having low
strength that is very heavy and bulky. Furthermore,
plaster-of-paris casts or splints are slow to harden, requiring 24
to 72 hours to reach maximum strength. Because plaster-of-paris
breaks down in water, bathing and showering are difficult. Even if
wetting due to these causes can be avoided, perspiration over an
extended period of time can break down the plaster-of-paris and
create a significant problem with odor and itching.
[0005] In order to alleviate the above-discussed disadvantages of
the conventional cast or splint utilizing plaster-of-paris
impregnated substrates, moisture-curable resin impregnated
fiberglass substrates and resin-impregnated non-glass substrates
formed from a knitted or woven fabric have been devised. The
knitted fabric substrate provides a cast or splint that exhibits
particularly good conformability, possesses sufficient rigidity
when cured, and shows relatively little or no loss of strength.
[0006] Current synthetic splinting and casting products utilize
moisture-curable resins to harden the cast tape or splint upon
application. Because the chemistry is designed to harden upon
exposure to moisture, these products are required to be packaged in
low moisture conditions and maintained in a moisture-proof
condition until just prior to application. The hardening reaction
is typically initiated by wetting the product with water and then
promptly applying and conforming the product to the limb as
required before the cast or splint hardens.
[0007] This water hardenable resin is usually activated by either
spraying water on the resin or cast or splint or dunking the device
in water and squeezing the water into the bandage. In all these
practices it is essential to saturate the casting tape or splint
with water to ensure proper activation of the resin and hardening
of the cast or splint.
[0008] These products have been very successful, but require
specialized packaging in low moisture conditions and in relatively
expensive multilayer plastic and metal foil packages. Even then,
these products can become hard over a period of time or lead to
deactivation of the chemical components (e.g., catalyst) as a
result of trace amounts of moisture in the packaging, or because of
moisture intrusion during removal of portions of the bandage
material from roll-form type packaging. Cast tape and splint roll
products manufactured and sold by BSN medical, Inc. under the
trademark Orthoglass.RTM. comprise such products. Therefore, there
is a need for a simpler, less-expensive yet easy to use moisture
curable bandage, such as cast tape and splints.
BRIEF SUMMARY OF THE INVENTION
[0009] Therefore, it is an object of the invention to provide
initially flexible casting and splinting products. These flexible
bandages may include microspheres that contain water that when
ruptured initiates hardening of the bandage.
[0010] It is another object of the invention to provide initially
flexible bandages, such as casting and splinting products that
include microspheres that contain a catalyst that when ruptured
initiates hardening of the bandage.
[0011] It is an object of the invention to provide a medical
bandaging product, that includes a flexible medical material
including an elongate fabric, a reactive system, and microspheres.
In certain aspects, a component of the reactive system is
homogeneously impregnated into or coated throughout the flexible
medical material without being encapsulated in the microspheres
such that the reactive system remains stable and non-activated in
the absence of an activating agent, and hardens upon activation by
exposure to the activating agent to form a rigid, self-supporting
structure. In this aspect, the microspheres are homogeneously
impregnated into or coated throughout the flexible medical
material, the microspheres encapsulate an activating agent and are
configured to release the activating agent to form the rigid,
self-supporting structure.
[0012] In certain aspects, the elongate fabric of the medical
bandaging product includes a knitted material formed from
monofilament or multifilament yarns including at least one of
fiberglass, polyester, polyolefin, aramid, and polyamide.
[0013] In certain aspects, each filament of the monofilament or
multifilament yarn has a diameter from 0.3 mm to 2 mm.
[0014] In certain aspects, the elongate fabric is surrounded by a
non-woven material, an open cell foam, or a reticulated foam.
[0015] In certain aspects, the reactive system includes a
polyurethane moisture curing system.
[0016] In certain aspects, the component of the reactive system
that is homogeneously impregnated into or coated throughout the
flexible medical material without being encapsulated in the
microspheres includes a prepolymer, a polyol, or a combination
thereof.
[0017] In certain aspects, the component of the reactive system
that is homogeneously impregnated into or coated throughout the
flexible medical material without being encapsulated in the
microspheres includes a prepolymer, the prepolymer is at least one
organic isocyanate selected from the group consisting of methylene
diphenyl diisocyanate, toluene diisocyanate, hexamethylene
diisocyanate, and isophorone diisocyanate.
[0018] In certain aspects, the microspheres include micelles or
polymeric microspheres having a diameter of from 200 .mu.m to 2000
.mu.m that encapsulate water, a catalyst, or a combination
thereof.
[0019] In certain aspects, the microspheres further encapsulate a
prepolymer, the prepolymer is at least one organic isocyanate
selected from methylene diphenyl diisocyanate, toluene
diisocyanate, hexamethylene diisocyanate, and isophorone
diisocyanate.
[0020] In certain aspects, the microspheres are polymeric
microspheres made from a polyoxyethylene, polypropylene oxide,
polylactic acid, polyethylene, polystyrene, poly(methyl
methacrylate), polyvinyl pyrrolidone, polycaprolactone, or any
combination thereof.
[0021] In certain aspects, the microspheres are homogeneous meaning
that each microsphere encapsulates substantially the same chemical
components/materials.
[0022] In certain aspects, the microspheres are heterogeneous
meaning that two or more separate types of microspheres (i.e.,
microsphere mixtures) are present. The heterogeneous microspheres
may include microspheres made from different chemical components
(i.e., different polymers) and/or the heterogeneous microspheres
may encapsulate different chemical components/materials when
compared to one another.
[0023] In certain aspects, the disclosed medical bandage further
includes an antimicrobial agent coated on the flexible medical
material from 1 g/m.sup.2 to 10 g/m.sup.2.
[0024] In certain aspects, the flexible bandages are provided in
packaging. The packaging may preferably be resealable. In certain
aspects, the packaging may be moisture proof to potentially ensure
longer shelf life of the bandaging product. However, in other
aspects, the bandaging product may be packaged in inexpensive
packaging that is not moisture proof. It is another object of the
invention to provide initially flexible casting and splinting
products that are light weight and conformable.
BRIEF DESCRIPTION OF THE DRAWINGS
[0025] Some of the objects of the invention have been set forth
above. Other objects and advantages of the invention will appear as
the invention proceeds when taken in conjunction with the following
drawings, in which:
[0026] FIG. 1 shows a perspective view of a cast product including
a storage package and a medical cast bandage;
[0027] FIG. 2 is a perspective view of the medical cast bandage
according to an embodiment of the invention;
[0028] FIG. 3 is an enlarged view of the surface of the medical
bandage of FIG. 2, showing microspheres contained in the structure
of the medical bandage;
[0029] FIGS. 4-7 are sequential views of the steps by which the
cast bandage is prepared and applied to a lower leg;
[0030] FIG. 8 is a view of the cast bandage as applied to a
forearm;
[0031] FIG. 9 is a perspective view showing a splint product
according to another embodiment of the invention being dispensed
from a dispenser;
[0032] FIG. 10 is a perspective view with parts broken away of a
cut length of the splint product;
[0033] FIG. 11 is a perspective view of a length of the splint
material with the substrate layer exposed for clarity;
[0034] FIG. 12 is an enlarged view of the surface of the medical
bandage of FIG. 11, showing microspheres contained in the structure
of the medical bandage;
[0035] FIG. 13 shows wringing the bandage to rupture the
microspheres before application;
[0036] FIG. 14 shows smoothing and straightening of the splint
material before application;
[0037] FIGS. 15 and 16 are perspective views of the splint material
being placed on an injured limb and being secured into place by a
covering wrap; and
[0038] FIG. 17 is a perspective view of a pre-cut splint product
stored for use in an envelope until ready for use.
DETAILED DESCRIPTION OF THE INVENTION
[0039] Disclosed is a medical bandaging product, that includes a
flexible medical material including an elongate fabric, a reactive
system, and microspheres. In certain aspects, a component of the
reactive system is homogeneously impregnated into or coated
throughout the flexible medical material without being encapsulated
in the microspheres such that the reactive system remains stable
and non-activated in the absence of an activating agent, and
hardens upon activation by exposure to the activating agent to form
a rigid, self-supporting structure. In this aspect, the
microspheres are homogeneously impregnated into or coated
throughout the flexible medical material, the microspheres
encapsulate an activating agent and are configured to release the
activating agent to form the rigid, self-supporting structure.
[0040] Flexible Medical Material
[0041] The flexible medical material may include an elongate fabric
constructed of a woven material (e.g., knitted material), non-woven
material, or a combination thereof. For example, in certain
aspects, the flexible medical material is a knitted elongate
fabric. In certain aspects, the flexible medical material is a
non-woven material. In certain aspects, the flexible medical
material is an elongate fabric that includes a woven material
forming the core of the flexible medical material and further
including a non-woven material that surrounds the woven
material.
[0042] The flexible medical material may be formed from fibers that
include, but are not limited to, cotton, glass, fiberglass,
polyester, polyolefin, aramid, para-aramid, polyamides, or any
combination thereof. Examples of polyolefins include, but are not
limited to, polyethylene, polypropylene, polybutene-1, or any
combination thereof. For example, in certain aspects, the
polyolefins may include linear low density polyethylene (LLDPE),
low density polyethylene (LDPE), polyethylene (PE), linear high
density polyethylene (LHDPE), or any combination thereof. In
certain aspects, the polyester includes, but is not limited to,
polyethylene terephthalate, polyglycolic acid, polylactic acid,
polybutylene terephthalate, polytrimethylene terephthalate, or any
combination thereof. Examples of polyamides include, but are not
limited to, nylon (e.g., nylon-6,6, nylon-6, nylon-6,9, nylon-6,10,
nylon-11, and nylon-4,6) In certain aspects, the fibers that form
the flexible medical material are hydrophobic, and in a further
aspect, these fibers may include a hydrophobic coating including,
but not limited to, silicone based water-repellant coating or a
fluorochemical (e.g., polytetrafluoroethylene) at a concentration
ranging from 1 to 100 g/m.sup.2, 1 to 50 g/m.sup.2, 1 to 10
g/m.sup.2, 1 to 5 g/m.sup.2, 1 to 4 g/m.sup.2, 1 to 3 g/m.sup.2, 5
to 80 g/m.sup.2, 7 to 50 g/m.sup.2, 7 to 30 g/m.sup.2, 8 to 20
g/m.sup.2, 8 to 10 g/m.sup.2.
[0043] In certain aspects, the fibers that form the flexible
medical material may include monofilament or multifilament yarns
having various diameters. These yarns may include textured,
filamented, or fibrillated yarn. In certain aspects, each filament
of the monofilament or multifilament yarns is from 0.03 mm to 2 mm,
0.04 mm to 1.5 mm, 0.05 mm to 1.0 mm, or any diameter range
occurring within these endpoints.
[0044] In certain aspects, the flexible medical material is a
knitted elongate fabric having between 100 and 1000
windows/cm.sup.2, 100 and 750 windows/cm.sup.2, 100 and 500
windows/cm.sup.2, 100 and 250 windows/cm.sup.2, 100 and 150
windows/cm.sup.2, 100 and 125 windows/cm.sup.2, 200 and 750
windows/cm.sup.2, 200 and 500 windows/cm.sup.2, 200 and 300
windows/cm.sup.2, 200 and 250 windows/cm.sup.2, 250 and 500
windows/cm.sup.2, 250 and 300 windows/cm.sup.2, 300 and 400
windows/cm.sup.2, 400 and 500 windows/cm.sup.2. In certain aspects,
the flexible medical material is formed of a single layer of an
elongate knitted double fabric configured to be impregnated
(preferably homogeneously impregnated) with the reactive system and
microspheres discussed below. In one preferred embodiment the
splint or casting tape comprises a warp knitted double fabric
impregnated with a moisture curable polyurethane resin (e.g., a
component of the reactive system and the microspheres). In certain
aspects, the warp knitted double fabric can be constructed using
any of the materials listed above. The yarn count ranges are
preferably between 20 Tex to 136 Tex, 25 Tex to 136 Tex, 30 Tex to
136 Tex, 40 Tex to 136 Tex, 44 Tex to 136 Tex, 50 Tex to 120 Tex,
60 Tex to 110 Tex, 70 Tex to 100 Tex, 80 Tex to 90 Tex.
[0045] In certain embodiments, the knitted elongate fabric of the
flexible medical material is knitted on a double bed warp knitted
machine with six guide bars. The preferred fabric notation is an
inlay with a chain stitch on the surface and a "V," butterfly or
atlas stitch in the center. The yarns are knitted into a substrate
having sufficient weight and thickness to keep the resin within the
substrate (e.g., knitted elongate fabric). For example, the
thickness may include 0.5 mm to 10 mm, 0.5 mm to 7.5 mm, 0.5 mm to
5 mm, 0.5 mm to 2.5 mm, 1 mm to 10 mm, 1 mm to 8 mm, 1 mm to 6mm, 1
mm to 4 mm, 1 mm to 2 mm, 2.5 mm to 7.5 mm, 2.5 mm to 5 mm, 3 mm to
6 mm, 3 mm to 4 mm, 4 mm to 5 mm.
[0046] In certain aspects, the knitted elongate fabric of the
flexible medical material comprises 450-580 courses per meter, with
a preferred range of 500-550 courses per meter and 50-90 wales per
10 centimeters, with a preferred range of 65-75 wales per 10
centimeters, and a most preferred value of 70 wales per 10
centimeters. Preferred knitted fabric widths of the flexible
medical material range between 2.5 to 60 centimeters, 2.5 to 30
centimeters, 2.5 to 20 centimeters, 2.5 to 10 centimeters, 2.5 to
7.5 centimeters. The fabric thickness is an important feature as it
affects the final rigidity and is also important aesthetically for
patient's comfort and ease of use. The final fabric weight will
depend on various factors such as fabric construction, yarns used
and other factors. In the most preferred structure the fabric
weight will vary in the range of 500 to 3000 g/m.sup.2 and even
more preferably in the range of 1000 to 1800 g/m.sup.2.
[0047] In certain aspects, the flexible medical material includes a
non-woven material that surrounds the knitted elongate fabric
described above. In certain aspects, the non-woven material is
formed from a polyolefin including, but not limited to,
polypropylene or polyethylene. In certain aspects, the knitted
elongate fabric may also be surrounded by open cell or reticulated
foam, closed cell foam, soft flexible films (e.g., thermoplastic
films).
[0048] In certain aspects, the flexible medical material further
includes an antimicrobial agent. The antimicrobial agent can be
either homogenously incorporated into, for example, the yarns used
to form the knitted elongate fabric or the antimicrobial agent can
be coated onto portions of the flexible medical material. For
example, the antimicrobial agent may be coated on the woven
materials, non-woven materials, or any combination thereof. In
certain aspects, the flexible medical material includes 1 to 10
g/m.sup.2, 1 to 8 g/m.sup.2, 1 to 5 g/m.sup.2, 1 to 4 g/m.sup.2, or
1 to 3 g/m.sup.2 of the antimicrobial agent. The antimicrobial
agent may include copper, copper salts, silver, silver salts,
nickel, nickel salts, or any combination thereof.
[0049] Reactive System
[0050] The medical bandaging product includes a reactive system
that sufficiently hardens and aids in forming a desired cast or
splint. In certain aspects, the reactive system chemically reacts
to partially or completely harden the flexible medical material
within 10 minutes to 3 hours, 10 minutes to 1 hour, 20 minutes to 2
hours, 20 minutes to 30 minutes after the activation of the
reactive system, preferably during the application of the medical
bandaging product to a user.
[0051] In certain aspects, the reactive system includes moisture
curing systems having prepolymers, various chemical components with
reactive groups, and a reaction initiator (e.g., an activating
agent). These reactive groups may be capable of cross-linking
and/or polymerizing reactions to form the desired polymer that
hardens the flexible medical material when forming a splint or
cast. For example, these reactive groups may include, but are not
limited to, reactive amine groups, reactive hydroxyl groups,
reactive thiol groups, reactive carboxylic acid groups, a reactive
aldehyde group, a reactive ether group, a reactive ester group, or
any combination thereof.
[0052] In certain aspects, the reactive system includes
prepolymers, various chemical components having reactive groups,
and initiators capable of forming polyurethanes via moisture curing
reactions.
[0053] Examples of prepolymers may include, but are not limited to,
isocyanates, and more specifically, these prepolymers may include
organic polyisocyanates. Organic polyisocyanates include aliphatic
and/or cycloaliphatic diisocyanates. Examples of organic
isocyanates may include, but are not limited to, methylene diphenyl
diisocyanate, toluene diisocyanate, hexamethylene diisocyanate, and
isophorone diisocyanate. Detailed examples include aliphatic
diisocyanates such as ethylene, 1,4-tetramethylene,
1,6-hexamethylene and 1,12-dodecane diisocyanates and
cycloaliphatic diisocyanates such as cyclohexane-1,3 and -1,4
diisocyanates as well as any desired mixture of these isomers,
1-isocyanato-3,3,5-trimethyl-5-isocyanatomethylcyclohexane (IPDI),
2,4- and 2,6-hexahydrotoluene diisocyanate as well as any desired
mixtures of these isomers, 4,4'- and
2,4'-diisocyanatodicyclohexylmethane. In certain aspects, only one
organic polyisocyanate is included in the reactive system. In other
aspects, mixtures ranging from 2 to 10, 2 to 6, 2 to 4, 3 to 5, or
4 to 8 organic polyisocyanates may be included in the reactive
system to ensure that the medical bandage achieves sufficient
hardness.
[0054] As previously discussed, the reactive system further
includes various chemical components with reactive groups. Examples
of these chemical components and reactive groups may include, for
example, polyols. Polyols may include aliphatic polyols, aromatic
polyols, or a combination thereof, and include on average two or
more hydroxyl groups per molecule (R'--(OH).sub.n.gtoreq.2) that
may react with various prepolymers to form, for example,
polyurethanes. In certain aspects, these polyols may include diols.
These polyols may include polyester polyols prepared, for example,
from dicarboxylic acids, preferably aliphatic dicarboxylic acids
having 2 to 12, preferably 4 to 8 carbon atoms in the alkylene
radical and multifunctional alcohols, preferably diols. Examples
include aromatic dicarboxylic acids such as phthalic and
terephthalic acids and aliphatic dicarboxylic acids such as
glutaric acid, pimelic acid, suberic acid, azelaic acid, sebacic
acid, undecanedioic acid, dodecanedioic acid, and, preferably,
succinic acid and adipic acid. Examples of multifunctional,
particularly bi- and tri-functional, alcohols are: ethylene glycol,
diethylene glycol, 1,2-propylene glycol, trimethylene glycol, 1, 3
propanediol, dipropylene glycol, 1,10-decanediol, glycerin,
trimethylolpropane and, preferably, 1,4-butanediol and
1,6-hexanediol. In certain aspects, only one type of polyol is
included in the reactive system. In other aspects, polyol mixtures
ranging from 2 to 10, 2 to 6, 2 to 4, 3 to 5, or 4 to 8 different
types of polyols may be included in the reactive system.
[0055] In certain aspects, these polyols may include a number
average molecular weight ranging from 100 to 3000, 200 to 2,000,
250 to 1,000, 300 to 500, 400 to 700, 500 to 650. If the number
average molecular weight exceeds 3,000, polymerization or
cross-linking of the reactive system may occur too quickly. If the
number average molecular weight falls below 100 to 200,
polymerization or cross-linking of the reactive system may occur
too slowly and result in very poor mechanical properties of the
resulting cast or splint. In certain aspects, the polyols have
hydroxyl numbers of from 2 to 500, 3 to 300, 4 to 100, 5 to 65.
[0056] These reactive systems further preferably include one or
more initiators (e.g., a catalyst) capable of initiating a reaction
among the individual components of the reactive system. These
initiators may include, for example, water, organic dicarboxylic
acids such as succinic acid, adipic acid, phthalic acid and
terephthalic acid and, preferably, multifunctional, particularly
di-and/or tri-functional alcohols such as ethylene glycol,
1,2-propylene glycol, 1,3-propanediol, diethylene glycol,
dipropylene glycol, 1,4-butanediol, 1,6-hexanediol, glycerin,
trimethylolpropane and pentaerythritol.
[0057] If desired, higher boiling solvents and additives may also
be incorporated in the disclosed reactive systems. These include,
for example, fillers, plasticizers, pigments, carbon black,
molecular screens, agents to render the systems thixotropic,
antioxidants, and other similar materials. The advantageous
properties of the systems are not impaired by the addition of these
substances. Also, in certain aspects, anti-foaming agents may be
incorporated into the medical bandage to reduce foaming of the
reactive system and to potentially reduce contact of the reactive
system to a user's skin.
[0058] In certain aspects, one or more components of the reactive
system are homogenously dispersed onto and/or within the flexible
medical material. For example, in certain aspects, one or more
components are homogeneously applied to and dispersed on the
flexible medical material via a coating process. This coating
process may include, but is not limited to, a chemical vapor
deposition process, a physical vapor deposition process, a spray
coating, dip coating, or any combination thereof. In certain
aspects, the fibers and/or yarns of the flexible medical material
may be manufactured to include one or more components of the
reactive system within these fibers and/or yarns.
[0059] Microspheres
[0060] To potentially ensure longer shelf-life of the flexible
medical material before use, it is preferred to separate one or
more components of the reactive system to prevent and/or reduce a
premature reaction and hardening of the bandage. By separating one
or more components of the reactive system, the reactive system
remains latent. To ensure longer shelf-life, one or more components
of the reactive system can be included within microspheres. These
microspheres preferably encapsulate and store the one or more
components of the reactive system until application of the medical
material to a user and/or until one desires to activate the
reactive system to harden the flexible medical material thus
forming the desired cast or splint.
[0061] In certain aspects, the microspheres may be manufactured
from natural materials, synthetic materials, or a combination
thereof. For example, the microspheres may include micelles (e.g.,
lipid containing micelles), polymeric microspheres, glass
microspheres, ceramic microspheres, metal microspheres, or any
combination thereof. The microspheres may preferably include
polymeric microspheres or micelles, which are highly susceptible to
mechanical shear. The micelles may include amphiphilic molecules
having a polar, water-soluble part and a nonpolar, water-insoluble
part. Examples of amphiphilic substances include but are not
limited to surfactants, detergents, lipids, certain proteins,
certain polysaccharides, certain modified proteins or
polysaccharides, or any combination thereof. The polymeric
microspheres may be a polymer made from one monomer. In the
alternative, the microspheres may include copolymers, including but
not limited to, alternating copolymers, periodic copolymers, block
copolymers (e.g., diblock copolymers, triblock copolymers, etc.),
graft copolymers, or any combination thereof. The polymeric
microspheres may include, for example, polyethylene oxides (e.g.,
polyethylene glycol), polyoxyethylene (e.g.,_PEG-200, PEG-600,
PEG-1000, PEG-2000), polypropylene oxide, poly lactic acid (e.g.,
poly (L-lactide)), polyethylene, polystyrene, poly(methyl
methacrylate) (PMMA), polyvinyl pyrrolidone (PVP),
polycaprolactone, or any combination thereof.
[0062] The disclosed microspheres have a diameter of from 2 .mu.m
to 2,000 .mu.m, 50 .mu.m to 2,000 .mu.m, 200 .mu.m to 2000 .mu.m ,
75 .mu.m to 1,750 .mu.m, 100 .mu.m to 1,500 .mu.m, 100 .mu.m to
1,200 .mu.m, 100 .mu.m to 1,000 .mu.m, 250 .mu.m to 2,000 .mu.m,
250 .mu.m to 1,600 .mu.m, 250 .mu.m to 1,300 .mu.m, 250 .mu.m to
1,000 .mu.m, 400 .mu.m to 2,000 .mu.m, 400 .mu.m to 1,500 .mu.m,
400 .mu.m to 1,000 .mu.m, 400 .mu.m to 750 .mu.m, 600 .mu.m to
1,800 .mu.m, 600 .mu.m to 1,300 .mu.m, 600 .mu.m to 950 .mu.m, 600
.mu.m to 750 .mu.m, 750 .mu.m to 1,600 .mu.m, 750 .mu.m to 1,400
.mu.m, 750 .mu.m to 1,200 .mu.m, 750 .mu.m to 900 .mu.m, 900 .mu.m
to 1,800 .mu.m, 900 .mu.m to 1,500 .mu.m, 900 .mu.m to 1,300 .mu.m,
900 .mu.m to 1,100 .mu.m, 1,000 .mu.m to 1,750 .mu.m, 1,000 .mu.m
to 1,450 .mu.m, 1,000 .mu.m to 1,250 .mu.m, or 1,000 .mu.m to 1,100
.mu.m.
[0063] In certain aspects, the microspheres include at least one
component of the reactive system. For example, the microspheres may
encapsulate at least one of the reaction initiators (e.g., catalyst
and/or water), prepolymer, at least one chemical component with a
reactive group, or any combination thereof. In preferred
embodiments, the microspheres encapsulate a catalyst and/or water.
In certain aspects, the microspheres may be homogeneous meaning
that all microspheres encapsulate the same chemical components and
all the microspheres are substantially identical. In other aspects,
the microspheres may be heterogeneous mixtures meaning that certain
microspheres differ from other microspheres. For example, in this
heterogeneous microsphere mixture, it is envisioned that one type
of microsphere may encapsulate, for example, the reaction initiator
while another type of microsphere may encapsulate, for example, a
prepolymer. In this heterogeneous microsphere mixture, the
microspheres may be made from different components (e.g., different
polymers, glass, etc.)
[0064] As previously discussed above, in certain preferred aspects,
the reactive system is a moisture curing polyurethane system. In
this aspect, the microspheres may preferably encapsulate at least
water. In a further aspect, the microspheres may encapsulate water
and one additional component selected from the prepolymer, polyol,
and catalyst. It is further envisioned that homogeneous or
heterogeneous microspheres may be used with the moisture curing
polyurethane systems described herein.
[0065] In certain aspects, these microspheres are homogenously
dispersed onto and/or within the flexible medical material. For
example, in certain aspects, one or more components are
homogeneously applied to and dispersed on the flexible medical
material via a coating process. This coating process may include,
but is not limited to, a chemical vapor deposition process, a
physical vapor deposition process, a spray coating, dip coating, or
any combination thereof. In certain aspects, the fibers and/or
yarns of the flexible medical material may be manufactured to
include the microspheres within these fibers and/or yarns.
[0066] It is preferable to select microspheres that are susceptible
to shearing forces via manual manipulation (e.g., wringing the
bandage or applying force via a roller) in order to easily rupture
the microspheres thus releasing the microsphere's contents and
ensuring a homogeneous hardening/curing reaction throughout the
bandage. In the alternative, it is preferable to further include
chemical agents capable of rupturing the microspheres in order to
release the contents encapsulated within the microspheres. In
certain aspects, it may be preferable to include chemical agents
capable of rupturing the microspheres and applying shearing forces
via manual manipulation to ensure release of the microsphere's
contents and to further expedite reactivity of the reactive
system.
EXEMPLARY EMBODIMENTS
[0067] Referring now specifically to the drawings, a medical
bandage product in the form of cast tape according to an embodiment
of the invention is illustrated in FIG. 1 and shown generally at
reference numeral 10. The medical bandage product 10 includes a
storage package, such as a pouch 11, in which is contained a roll
of flexible cast bandage 12. The bandage 12, coated or impregnated
with a curable resin, remains in a flexible condition until the
pouch is opened for use. In contrast with prior moisture-curable
bandages, the pouch 11 need not be moisture-proof, but can be an
inexpensive plastic or coated paper package with sufficient
thickness to withstand packaging, shipment and storage until
use.
[0068] However, in certain aspects, it may be advantageous to store
the disclosed medical bandages within moisture-proof packaging to
further ensure shelf-life of the medical bandage. For example, in
certain aspects, the disclosed medical bandaging product may be
provided within a sleeve formed of moisture-impervious material and
sealable to prevent entry of moisture. The medical material is
preferably positioned in the sleeve and sealed therein against
entry of moisture until use. The medical bandage preferably remains
stable and unreacted when maintained in substantially moisture-free
conditions. In certain embodiments, the moisture-proof packaging is
resealable.
[0069] Referring now to FIG. 2, the bandage 12 is constructed using
a known manufacturing technique, and may be woven, knitted or
nonwoven. Bandage 12 may be constructed using any suitable organic
or inorganic fibers. Examples of suitable fibers include glass,
polyester, polypropylene and blends thereof.
[0070] The bandage 12 has a thickness suitable for use as a medical
bandage. An example of a suitable thickness would be at least about
1 mm, and preferably between about 2 to about 8 mm. The bandage 12
may be designed so that it has a preferential stretch, strength,
and other characteristics in one direction or, in the alternative,
may be designed with the fibers laid randomly so that the bandage
12 exhibits uniform properties in all directions. It may also be
designed with soft longitudinally extending side edges to aid in
the comfort of a patient. The bandage 12 has a weight per unit area
of at least about 5 grams per square meter. It can be used alone or
it can be reinforced with organic or inorganic fillers, stitches,
scrims, laminates, plastic films, or any other suitable
reinforcement to obtain the desired splinting properties.
[0071] Referring now to FIGS. 2 and 3, the bandage 12 is coated or
impregnated with, for example, a curable urethane resin that can be
activated to form a rigid cast. Small hollow microspheres 15 are
coated onto or incorporated into the structure of the bandage 12.
In one preferred embodiment, the microspheres 15 are a polymer type
and have a diameter of from 0.2 to 1.5 mm.
[0072] In one embodiment of the invention, one subset of the
microspheres 15 contains water, and a second subset of the
microspheres 15 contains a catalyst that accelerates the hardening
reaction. In another embodiment of the invention, each microsphere
15 contains both water and catalyst in an appropriate ratio to
achieve the required hardening. In these embodiments the bandage is
chemically latent and does not age at the same rate as when the
catalyst is present with the urethane. In certain aspects, the
number of microspheres is dependent on the size of microspheres and
quantity of catalyst and/or water contained in the
microspheres.
[0073] The disclosed bandage avoids the need to dunk or spray water
onto the bandage, thereby avoiding overuse of water that when held
against the skin can result in skin masceration.
[0074] Two typical formulations of the reaction system is set forth
in the following tables:
TABLE-US-00001 TABLE 1 Isonate .dwnarw. 143L or Mondur .dwnarw. CD
or polyisocyanate 50.0% Rubinate .dwnarw.XI168 Pluracol
.dwnarw.P1010 polyol 46.6% DC-200 Silicone defoaming agent 0.30%
Benzoyl Chloride stabilizer 0.10% Thancat. DM-70 catalyst 3.0%
100%
TABLE-US-00002 TABLE 2 Isonate 143L or Mondur CD or Polysiocyanate
50.0% Carbowax PEG 600, Carbowax PEG 4600 22.0% Carbowax PEG 8000
Voranol 230-238 Voranol 220-110 18.0% Irganox 1010 2.0% Antifoam
1400 4.0% Methane Sulphonic Acid 1.0% DMDEE 3.0% 100%
[0075] As is shown in FIG. 2, the bandage 12 is rolled onto a core
14 for packaging. The core 14 prevents creasing of the bandage 12
and facilitates rapid, controlled, unrolling of the bandage during
application.
[0076] Referring now to FIGS. 4-7, the bandage 12 is applied by
removing it from the storage package 11, FIG. 1. As is shown in
FIG. 4, the bandage is wrung in the hands. This wringing motion
creates enough shear force to shear open or rupture the
microspheres 15 thus releasing the catalyst and water.
Alternatively, the bandage can be first unrolled from the core 14
and rolled with a hard-surface roller to apply enough force to
shear open the microspheres 15. Other methods of shearing
microspheres 15 may be used (or alternatively chemical reagents
that degrade the microspheres may be used to release, for example,
water and/or the catalyst from the microsphere), the only
requirement being that the catalyst and water are released from the
microspheres 15 so that a chemical reaction of the reactive system
is initiated and subsequent hardening (e.g., via a polymerization
reaction and/or a moisture curing reaction) of the bandage 12
begins. The bandage is then immediately applied to the limb
accordingly, FIG. 5. The applied bandage 12 is smoothed and more
closely conformed to the limb while still flexible. Upon hardening,
the bandage 12 is sufficiently rigid to maintain the limb in an
essentially immobile position, but with enough residual softness to
permit slight movement of the limb.
[0077] As shown in FIGS. 7 and 8, the bandage 12 can be applied to
various limbs. For example, the bandage 12 can be applied to a leg,
FIG. 7, or to a forearm, FIG. 8.
Splint
[0078] A medical bandage product 110 for splinting is illustrated
in FIG. 9. Bandage product 110 may be sold in any convenient
length, such as 30 feet, and is rolled into a coil and positioned
in a suitable dispenser 111. Dispenser carton 111 is provided with
a slot 112 at one lower corner through which bandage product 110 is
dispensed.
[0079] The bandage product 110 is formed of an outer elongate
sleeve 113, which need not be moisture proof. Sleeve 113 is sealed
along opposite, parallel extending sides to form an elongate tube.
An elongate medical bandage 114, described in detail below, is
positioned within sleeve 113. The bandage 114 is dispensed by
pulling the needed amount of material, along with the sleeve 113 in
which it is enclosed, out of the carton 111 and severing it with,
for example, scissors. The remaining, raw end of the bandage 114 is
tucked back into the remaining sleeve 113.
[0080] Referring now to FIG. 10, since the appropriate length of
bandage 114 is best determined by measurement, measurement marks
"M" may be printed on one edge of the sleeve 113.
[0081] As shown in FIG. 11, the bandage 114 comprises a substrate
116, which may be woven, knitted or nonwoven. Substrate 116
preferably has a weight per unit area of at least about 50 grams
per square meter, and preferably between about 200 to about 700
grams per square meter. The substrate 116 is contained within a
tubular wrapping 118 that may be formed of a soft, flexible
non-woven fiber such as polypropylene. This provides a cushioning
protective layer between the skin of the patient and substrate 116.
The wrapping 118 may also be selected from a wide range of other
materials such as open cell or reticulated foam, closed cell foam,
soft flexible films and nonwoven materials. Alternatively, the
substrate 116 may be packed in the sleeve 113 and enclosed within a
protective cushioning layer just before application. This may be
accomplished by folding a length of cushioning material around the
substrate 116 and securing it in place with, for example, tape or
another form of adhesive.
[0082] Referring now to FIGS. 11 and 12, the bandage 114 is coated
or impregnated with a curable urethane resin that can be activated
to form a rigid cast. Small hollow microspheres 119 are then coated
onto or incorporated into the structure of the bandage 114. In one
preferred embodiment, the microspheres 119 are a polymer type and
have a diameter of 0.2 to 1.5 mm.
[0083] In one embodiment of the invention, one subset of the
microspheres 119 contains water, and a second subset of the
microspheres 119 contains a catalyst that accelerates the hardening
reaction. In another embodiment of the invention, each microsphere
119 contains both water and catalyst in an appropriate ratio to
achieve the required hardening. In these embodiments the bandage is
chemically latent and does not age at the same rate as when the
catalyst is present with the prepolymer (e.g., urethane) and other
reactive components.
[0084] The number of microspheres 119 is dependent on the size of
microspheres 119 and quantity of catalyst and/or water contained in
the microspheres 119.
[0085] The disclosed bandage potentially avoids the need to dunk or
spray water onto the bandage, thereby avoiding overuse of water
that when held against the skin can result in skin masceration.
[0086] Two typical formulations of the reaction system is set forth
in the following tables:
TABLE-US-00003 TABLE 3 Isonate .dwnarw. 143L or Mondur .dwnarw. CD
or polyisocyanate 50.0% Rubinate .dwnarw.XI168 Pluracol
.dwnarw.P1010 polyol 46.6% DC-200 Silicone defoaming agent 0.30%
Benzoyl Chloride stabilizer 0.10% Thancat. DM-70 catalyst 3.0%
100%
TABLE-US-00004 TABLE 4 Isonate 143L or Mondur CD or Polysiocyanate
50.0% Carbowax PEG 600, Carbowax PEG 4600 22.0% Carbowax PEG 8000
Voranol 230-238 Voranol 220-110 18.0% Irganox 1010 2.0% Antifoam
1400 4.0% Methane Sulphonic Acid 1.0% DMDEE 3.0% 100%
[0087] As is shown in FIGS. 13-14, the bandage 114 is activated by
wringing and massaging the bandage. This wringing and massaging
creates enough shear force to open or rupture the microspheres 119
thus releasing the catalyst and water onto the substrate 116 such
that a chemical reaction of the reactive system is initiated and
subsequent hardening (e.g., via a polymerization reaction and/or
moisture curing reaction) begins. Alternatively, the bandage 114
can be rolled with a hard-surface roller to create enough shear
force to open or rupture the microspheres 119 thus releasing the
catalyst and/or water onto the substrate. Other methods of shearing
the microspheres 119 may be used (or alternatively chemical
reagents that degrade the microspheres may be used to release, for
example, water and/or the catalyst from the microspheres), the only
requirement being that the catalyst and water are released from the
microspheres 119 so that a chemical reaction of the reactive system
is initiated and subsequent hardening (e.g., via a polymerization
reaction and/or moisture curing reaction) of the bandage 114
begins. The bandage 114 is smoothed before application, FIG.
14.
[0088] Referring now to FIG. 15, an appropriate length of bandage
114 is formed to the shape of the body member to be immobilized.
This particular type of splint, known as a posterior short leg
splint, is formed by molding a length of the bandage 114 to the
calf and up over the heel and onto the foot. Then, bandage 114 is
overwrapped with a known elastic bandage "B", as is shown in FIG.
16.
[0089] Referring now to FIG. 17, a pre-cut embodiment of a medical
bandage product 140 is shown. The medical bandage product 140
comprises an envelope 141 in which is packaged a pre-cut length of
the medical bandage 114. The medical bandage 114 is sized according
to the desired end use and is labeled as such. The medical bandage
114 may be removed from the envelope 141 and used as is, or cut and
shaped as needed to meet the medical requirements of the treating
physician and technician.
[0090] By way of a further alternative, the resin-coated or
impregnated substrate 116 may be packaged in the sleeve 113 without
a tubular wrapping. The substrate 116 is removed from the sleeve
113, the microspheres 119 are sheared as described above, and then
applied to the patient. To facilitate application of the wrapping,
the wrapping may be in the form of a flat sheet of cushion material
of sufficient width to extend around the substrate 116 to form a
tubular enclosure. The cushion material may be held in its tubular
condition around the substrate by, for example, double-sided
adhesive tape.
[0091] In each of the embodiments disclosed above, the microspheres
may be mixed into the resin formulation and applied to the
substrates with the resin, being held within the viscous structure
of the resin. Alternatively, the microspheres may be distributed
(e.g., homogeneously dispersed) through the fabric, embedded in the
surface or apertures and openings of the fabric construction. In
either case, the surface tension between the resin and the
extremely small microspheres is sufficient to maintain the
microspheres in contact with the substrate.
[0092] In certain aspects, the medical bandage can be packaged as a
kit. In this aspect, the kit may include the packaged medical
bandage and a roller that aids in applying shear force to the
bandage for rupturing the microspheres.
[0093] Medical bandage products are described above. Various
details of the invention may be changed without departing from its
scope. Furthermore, the foregoing description of the preferred
embodiments of the invention and the best mode for practicing the
invention are provided for the purpose of illustration only and not
for the purpose of limitation.
* * * * *