U.S. patent application number 15/434294 was filed with the patent office on 2018-08-16 for anatomical adaptable drape device.
The applicant listed for this patent is MAVRIK DENTAL SYSTEMS, LTD.. Invention is credited to Daniel Sanders.
Application Number | 20180228574 15/434294 |
Document ID | / |
Family ID | 63105803 |
Filed Date | 2018-08-16 |
United States Patent
Application |
20180228574 |
Kind Code |
A1 |
Sanders; Daniel |
August 16, 2018 |
ANATOMICAL ADAPTABLE DRAPE DEVICE
Abstract
An anatomical drape (1 a or 1b), such as a dental drape, for
covering a treatment area of an anatomical part, the drape
comprising an elastomeric material capable of conforming to the
contours of the anatomical part and including a curing agent (9)
contained within internal channels distributed in the drape; and
wherein activation of the curing agent, for example by a light
source, causes hardening of the material to at least partially set
the drape in a configuration conforming to the anatomical part. The
semi-rigid set drape is liquid impermeable but gas permeable. A
method of manufacturing the drape is also disclosed.
Inventors: |
Sanders; Daniel; (Ra'anana,
IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MAVRIK DENTAL SYSTEMS, LTD. |
Ra'anana |
|
IL |
|
|
Family ID: |
63105803 |
Appl. No.: |
15/434294 |
Filed: |
February 16, 2017 |
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61C 2201/00 20130101;
A61C 19/003 20130101; A61C 5/82 20170201; A61C 19/06 20130101; A61B
46/40 20160201; A61C 19/066 20130101; A61B 46/20 20160201; A61C
19/063 20130101 |
International
Class: |
A61C 5/82 20060101
A61C005/82; A61B 46/00 20060101 A61B046/00; A61B 46/20 20060101
A61B046/20; A61C 13/15 20060101 A61C013/15; A61C 19/06 20060101
A61C019/06 |
Claims
1. An anatomical drape for covering a treatment area of an
anatomical part, the drape comprising: an elastomeric material
capable of conforming to the contours of the anatomical part; and
one or more internal channels containing uncured curing material;
wherein the uncured curing material is adapted to be cured, thereby
becoming hardened to at least partially set the drape in a
configuration conforming to the anatomical part.
2. An anatomical drape as claimed in claim 1, wherein the
elastomeric material of the drape is substantially liquid
impermeable and gas permeable, both before and after curing of the
curing material contained within the internal channels of the
drape.
3. An anatomical drape as claimed in claim 1, wherein the drape is
configured to generally conform to an oral anatomy.
4. An anatomical drape as claimed in claim 3, wherein the drape
conforms to a gum ridge anatomy, wherein the drape forms an
enclosed protective cover over the gum ridge with optional holes
for passage of erupted teeth there through.
5. An anatomical drape as claimed in claim 3, wherein the drape
conforms to a portion of the gum ridge anatomy, wherein the drape
forms an enclosed protective cover over the gum ridge with optional
holes for passage of erupted teeth there through.
6. An anatomical drape as claimed in claim 3, wherein the drape
conforms to the gum ridge anatomy, wherein the drape forms an
enclosed protective cover over the gum ridge with optional holes
for passage of erupted teeth there through and substantially full
coverage over portion of the gum ridge that are edentulous.
7. An anatomical drape as claimed in claim 1, wherein a curing
material is distributed inside the internal channels to conform the
drape to the anatomical structure covered by the drape.
8. An anatomical drape as claimed in claim 1, further comprising an
external energy source usable to activate the curing material.
9. An anatomical drape as claimed in claim 8, wherein the energy
source is one or more sources selected from the set including heat
and/or light
10. An anatomical drape as claimed in claim 7 wherein the curing
material is a light curable agent selected from the group
consisting of blended mixtures of oligomers, fillers and
photo-initiators.
11. An anatomical drape as claimed in claim 1 wherein the drape can
be stretched to the level of the gum line of each individual tooth
on either its buccal or lingual/palatal aspects or stretched for a
group of teeth and wherein the drape in its stretched form can be
constrained to remain in its stretch form when the curing agent
contained in the channels adjacent to the tooth or teeth is
hardened.
11. An anatomical drape as claimed in claim 1 wherein one or more
treatment material layers are included on at least one surface of
the drape.
12. A kit of parts for covering a treatment area, the kit
comprising one or more drapes according to claim 1, and a light
source.
13. The kit of claim 12, further comprising one or more therapeutic
sources.
14. The kit of claim 12, further comprising one or more treatment
sources.
15. A method for the manufacture of an anatomical drape for
covering a treatment area of an anatomical part, the method
comprising the steps of: (a) configuring a drape device by
preparing a set of inserts that mirror the shape of internal
channels and septum plugs of the drape device; (b) molding
elastomeric materials onto the set of inserts in order to produce a
set of elastomeric spacers; (c) inserting the set of inserts with
spacers into a second mold; (d) over-molding with similar
elastomeric materials to create outer aspects of the elastomeric
drape, (e) removing the set of inserts where the spacers remain to
prepare a set of internal channels and self-sealing septum plugs
inside the body of the drape; and (f) inserting one or more uncured
curing material(s) through the set of self-sealing septum plugs
into the internal channels of the drape so as to at least partially
fill the internal channels with uncured curing materials.
16. A method according to claim 15, further comprising applying a
second additive into the internal channels.
17. An oral drape for covering a treatment area of an oral cavity,
the drape comprising an elastomeric material capable of conforming
to the contours of the oral anatomical part and including a curing
agent contained within internal channels distributed with in the
drape wherein activation of the curing agent causes hardening of
the material to at least partially set the drape in a configuration
conforming to the anatomical part, the set drape being
substantially gas permeable but liquid impermeable.
18. The oral drape of claim 17, where the drape is adapted to be
applied and conformed to a gum ridge and to a mouthpiece that
substantially covers the teeth and gum ridge or ridges, to provide
for a continuous fluid seal of the mouthpiece treatment cavities to
the drape(s).
Description
FIELD OF THE INVENTION
[0001] The present invention relates to methods and devices useful
in providing drapes or covers for anatomical parts, such as during
treatment of the parts, particularly but not exclusively to oral
drapes for dental treatments.
BACKGROUND OF THE INVENTION
[0002] In dental medicine, many treatment materials are typically
placed within the oral cavity on the hard (teeth) tissues and soft
(inner mucosal epithelium of the cheek, lips, and gingiva and the
tongue) tissues.
[0003] These treatment materials are placed topically on these
tissues or may be inserted (injected) in the space between them,
for example, in the naturally occurring sulcus at the tooth/gum
line.
[0004] These treatment materials are typically applied to the
tissues in an "open" manner, namely, without any covering material
or containment device. This significantly reduces their desired
therapeutic effect as the materials are immediately exposed to
saliva contamination (containing numerous pathogenic
microorganisms) and salivary washout (or fluid/solids ingestion
washout) in a very short time. This time range can be as short as a
few seconds to around 10 minutes or more, depending on salivary
flow, the viscosity of the treatment material or whether the
patient ingests solids or liquids after application of the
treatment material.
[0005] Additionally, currently known devices use a cover device
that covers both the teeth and the gums. These are typically custom
made to a specific patient using the following fabrication method.
Dental molds are taken of the patient's teeth and surrounding gums
and dental stone cast models are poured and allowed to harden.
These cast models are removed from the molds and a vacuum-formed
thin plastic custom made tray for that specific patient is formed
and trimmed to cover over both the teeth and a narrow portion of
the surrounding gums. These typically leak the treatment material
out of them and also allow saliva to seep inside of them as the
stiff material of the tray is difficult to adapt closely to the
undulating and varied topography of the teeth and surrounding gums
of each individual patient which they are meant to cover.
[0006] Additionally, patches onto whose inner surface a thin layer
of treatment layer has been adhered are used to cover small areas
of the gum tissue. Due to their size they can only treat very
limited areas of the soft tissues of the oral cavity and cannot be
used to treat the teeth as they cannot be adhered to the teeth
structure. They are also easily dislodged by the tongue or contact
with the inner cheek and lip muscles.
[0007] Additionally, light curable foam materials are manually
applied to the gingiva to create a protective barrier against high
concentration applications of peroxide for professional teeth
whitening treatments. The application of these materials are
manually intensive and require a high skill level to apply.
Additionally, they are often highly brittle and tend to break or
fall off the gingiva and are easily dislodged when even slight
pressure or flexing force is applied to them. They are therefore
unsuitable to use a gingival barrier in conjunction with an
intra-oral mouthpiece.
[0008] Additionally, rubber dam barriers consisting typically of
some form of latex or rubber sheet or barrier are applied to
provide for a "dry field" so as to prevent saliva ingress or
moisture contamination during many dental procedures. The rubber
dams are typically made of latex rubbers and require manually
punched holes by the dentist to allow for them to be placed through
the anatomical crown portions of the teeth so as to allow them to
drape over the surrounding gum tissue and other oral structures of
the oral cavity. These rubber dam barriers are typically fixed or
retained in the mouth by using some type of clamping apparatus to
secure or anchor the dam barrier in the mouth. These devices are
typically very cumbersome and very large, uncomfortable for the
patient and due to their size and coverage of large areas of the
intra-oral anatomical structures, preclude their use in conjunction
with the insertion of an intra-oral mouthpiece in the mouth.
[0009] It is an object of the present invention to provide an
improved device that aims to overcome or at least alleviate the
above mentioned drawbacks.
SUMMARY OF THE INVENTION
[0010] In accordance with a first aspect of the present invention,
there is provided an anatomical drape for covering a treatment area
of an anatomical part, the drape comprising an elastomeric material
capable of conforming to the contours of the anatomical part and
including a curing agent wherein activation of the curing agent
causes hardening of the material to set the drape in a
configuration conforming to the anatomical part.
[0011] In some embodiments an anatomical drape is provided for
covering a treatment area of an anatomical part, the drape
comprising: an elastomeric material capable of conforming to the
contours of the anatomical part; and one or more internal channels
containing uncured curing material;
wherein the uncured curing material is adapted to be cured, thereby
becoming hardened to at least partially set the drape in a
configuration conforming to the anatomical part.
[0012] In some embodiments an anatomical drape in provided, wherein
the elastomeric material of the drape is substantially liquid
impermeable and gas permeable, both before and after curing.
[0013] In some embodiments an anatomical drape is provided, wherein
the drape is configured to generally conform to an oral
anatomy.
[0014] In some embodiments an anatomical drape is provided, wherein
the drape conforms to a gum ridge anatomy, wherein the drape forms
an enclosed protective cover over the gum ridge with optional holes
for passage of erupted teeth there through.
[0015] In some embodiments an anatomical drape is provided, wherein
the drape conforms to a portion of the gum ridge anatomy, wherein
the drape forms an enclosed protective cover over the gum ridge
with optional holes for passage of erupted teeth there through.
[0016] In some embodiments an anatomical drape is provided, wherein
the drape conforms to the gum ridge anatomy, wherein the drape
forms an enclosed protective cover over the gum ridge with optional
holes for passage of erupted teeth there through and substantially
full coverage over portion of the gum ridge that are
edentulous.
[0017] In some embodiments an anatomical drape is provided, wherein
a curing material is distributed inside the internal channels to
conform the drape to the anatomical structure covered by the
drape.
[0018] In some embodiments an anatomical drape is provided, further
comprising an external energy source usable to activate the curing
material.
[0019] In some embodiments an anatomical drape is provided, wherein
the energy source is one or more sources selected from the set
including heat and/or light.
[0020] In some embodiments an anatomical drape is provided, wherein
the curing material is a light curable agent selected from the
group consisting of blended mixtures of oligomers, fillers and
photo-initiators.
[0021] In some embodiments an anatomical drape is provided, wherein
one or more treatment material layers are included on at least one
surface of the drape.
[0022] In some embodiments a kits of parts for covering a treatment
area is provided, the kit comprising one or more drapes as
described herein and a light source
[0023] In some embodiments the kit further comprises one or more
therapeutic sources.
[0024] In some embodiments the kit further comprises one or more
treatment sources.
[0025] In some embodiments a method for the manufacture of an
anatomical drape for covering a treatment area of an anatomical
part is provided, the method comprising the steps of: (a)
configuring a drape device by preparing a set of inserts that
mirror the shape of internal channels and septum plugs of the drape
device; (b) molding elastomeric materials onto the set of inserts
in order to produce a set of elastomeric spacers; (c) inserting the
set of inserts with spacers into a second mold and clamping them in
place in the second mold; (d) over-molding with similar elastomeric
materials to create outer aspects of the elastomeric drape, (e)
removing the set of inserts where the spacers remain to prepare a
set of internal channels and self-sealing septum plugs inside the
body of the drape; and (f) inserting one or more flowable uncured
curing material(s) through the set of self-sealing septum plugs
into the internal channels of the drape so as to at least partially
fill the internal channels with uncured curing materials.
[0026] In some embodiments the method further comprises applying a
second or additive into the internal channels.
[0027] In some embodiments an oral drape for covering a treatment
area of an oral cavity is provided, the drape comprising an
elastomeric material capable of conforming to the contours of the
oral anatomical part and including a curing agent contained within
internal channels distributed with in the drape wherein activation
of the curing agent causes hardening of the material to at least
partially set the drape in a configuration conforming to the
anatomical part, the set drape being substantially gas permeable
but liquid impermeable.
[0028] In some embodiments the drape is adapted to be applied and
conformed to a gum ridge and to a mouthpiece that substantially
covers the teeth and gum ridge or ridges, to provide for a
continuous fluid seal of the mouthpiece treatment cavities to the
drape(s).
DESCRIPTION OF THE DRAWINGS
[0029] The principles and operation of the system, apparatus, and
method according to the present invention may be better understood
with reference to the drawings, and the following description, it
being understood that these drawings are given for illustrative
purposes only and are not meant to be limiting, wherein:
[0030] FIG. 1 is a top and side view of gum drape inserts 6 with
molded insert spacers 7, according to some embodiments;
[0031] FIG. 2 is a transparent top and side view according to some
embodiments of a lower (mandibular) oral drape 1a;
[0032] FIG. 3 is a transparent top and side view according to some
embodiments of an upper (maxillary) oral drape 1b;
[0033] FIG. 4 is a transparent bottom view according to some
embodiments of a lower oral drape 1a;
[0034] FIG. 5 is a bottom view according to some embodiments of a
lower oral drape 1a;
[0035] FIGS. 6A and 6B are transparent top and side views according
to some other embodiments of a lower oral drape 1a;
[0036] FIG. 7 is a transparent top and side view according to some
other embodiments of a lower oral drape 1a;
[0037] FIG. 8a is a top and side view according to some other
embodiments of an upper oral drape 1b;
[0038] FIG. 8b is a top view according to some other embodiments of
an upper oral drape 1b;
[0039] FIG. 9a is a top and front view of a model of the maxillary
jaw oral structures 20;
[0040] FIG. 9b is a top view of a model of the mandibular jaw oral
structures 21, and the lower oral drape 1a applied onto the
mandibular gum ridge 17; and
[0041] FIG. 10 is a side view of some embodiments of an upper oral
drape 1b and lower oral drape 1a.
DETAILED DESCRIPTION OF THE INVENTION
[0042] The following description is presented to enable one of
ordinary skill in the art to make and use the invention as provided
in the context of a particular application and its requirements.
Various modifications to the described embodiments will be apparent
to those with skill in the art, and the general principles defined
herein may be applied to other embodiments. Therefore, the present
invention is not intended to be limited to the particular
embodiments shown and described, but is to be accorded the widest
scope consistent with the principles and novel features herein
disclosed. In other instances, well-known methods, procedures, and
components have not been described in detail so as not to obscure
the present invention.
[0043] The word "drape" as used herein may encompass various
protective materials with or without adhesives that may be utilized
to cover, dress or place over a target area or object(s) while
undergoing a treatment, to cover or protect a target area, and
optionally prevent the flow of liquids or materials from or to the
target area.
[0044] In accordance with a first aspect of the present invention,
there is provided an anatomical drape for covering a treatment area
of an anatomical part, the drape comprising an elastomeric material
capable of conforming to the contours of the anatomical part and
including a curing agent wherein activation of the curing agent
causes hardening of the material to set the drape in a
configuration conforming to the anatomical part. The anatomical
part preferably comprises an oral anatomy. However, it is to be
appreciated that a drape may be provided to cover any anatomical
part, such as a limb (or portion of a limb).
[0045] More preferably, the drape conforms to a gum ridge anatomy
with the drape forming an enclosed protective cover over the gum
ridge or part of the gum ridge. The drape may comprise a partial or
full U-shaped arch which is then tailored to the actual oral
anatomy to provide a high level of conformity. The drape, in some
embodiments, may be provided with pre-perforated holes for easy
removal and passage of the anatomical crown portions of the teeth
there-through or pre-configured cut-out holes may be provided of
varying shapes and dimensions for receipt of anatomical crown
portions of the erupted teeth there-through whereby the anatomical
crown portions of the teeth remain substantially uncovered and
exposed to the oral cavity whilst the surrounding gum tissue and
gum ridge are substantially covered by the drape. Some portions of
the gum ridge may be edentulous and the gum drape in these segments
may not have cut out holes so as to substantially cover these
segments of the gum ridge. This embodiment of the oral drape may be
advantageous to apply over newly placed dental implant sites.
[0046] The preformed shape of the drape is formed to generally
conform to the shape of a portion of the oral cavity or other body
part to facilitate easy and rapid insertion and removal of the
drape from the target area.
[0047] The preformed drape may cover only the gum ridge or a
portion of the gum ridge whilst in the main or entirely not
covering the hard or soft palate, mucco-buccal folds, tongue, inner
surfaces of the cheek or lips, and the floor of the mouth or
airway.
[0048] The curing agent/material may be distributed inside the
drape in internal channels of various configurations within the
body of the drape. When the curing agent is polymerized, this will
provide a semi-rigid drape that conforms to a particular individual
anatomy while allowing its removal and enhancing comfort to the
user.
[0049] Preferably, the elastomeric material of the drape is
substantially liquid impermeable and gas permeable, both before and
after curing. In some embodiments, the elastomeric material has
high tear strength properties.
[0050] More preferably, the drape is comprised of an elastomeric
material with a relatively low modulus of Young, relatively high
elongation, relatively high tear strength and relatively low recoil
properties. Any suitable curing agent/material may be used but
preferably the curing agent/material is a flowable material
suitable for insertion into the empty internal channels of the
drape and may be activated (cured/polymerized) by an external
source, such as heat and/or light source or combination
thereof.
[0051] Preferably the mechanical properties of the drape resist
tearing when placing the tooth holes over and through the
anatomical crowns of the teeth and allowing for the interdental
bridges of the drape between the teeth to be snapped through the
interproximal (interdental) teeth contact areas between the teeth
without tearing the bridges while allowing the bridges to seat
firmly down between the teeth (interproximally/interdentally) at
the level of the gum line.
[0052] Preferably the mechanical properties of the drape
interdental bridges allow them to be stretched so as to thin them
and allow for easy insertion of the interdental bridges through the
contact areas between the teeth.
[0053] The seating of the intact interdental bridge portions below
the contact areas is vital for achieving a snug circumferential fit
of the drape around the cervical necks of the anatomical crown
portions of the erupted teeth and a good seal of the surrounding
gum tissue at the level of the gum line with the drape of the
present invention.
[0054] The drape's internal channels may preferably be filled in
with uncured curing agent/material at their manufacturing site and
packaged in light impermeable sleeves or bags. The curing
agent/material in its uncured form should ideally allow for a
sufficient working time for the operator to apply the drape
properly in the mouth once the drape is removed from its protective
packaging. The curing material or agent upon hardening should
preferably be capable of constraining the stretched buccal and
lingual aspects of the drape to the gum lines of the teeth while
providing for a drape that still remains flexible to a degree that
provides patient comfort and ease of removal after use.
[0055] The drape containing the uncured curing agent/material may
be individually stretched by the operator to the level of the gum
line of each individual tooth on either its buccal or
lingual/palatal aspects or stretch and constrained for a group of
teeth in the following manner. Applying a curing light to
polymerize the curing agent/material will harden this segment of
the internal channel(s) of the drape and constrain the recoil
properties of this segment of the drape material from returning to
their un-stretched shape. This procedure may be repeated
independently on both either or both of the buccal and lingual
aspects of the tooth or teeth so as to sequentially conform the
drape structure and adapt it to the specific gum lines of any
patient both for the upper and or lower full dental gum ridges or
portions of the upper and or lower gum ridges.
[0056] Other internal channels may be incorporated in the drape and
filled with uncured curing agent/material. When cured, these will
allow the operator to intimately conform the drape to the specific
gum ridge anatomy of any patient and so allow for a very snug fit
of the drape to the patient's specific gum ridge anatomy so as to
provide for a superior seal of the drape on the gum ridge from any
external caustic agents such as high concentration peroxide
whitening agents or alternatively, to effectively contain and
prevent the leakage or saliva washout of medicaments or therapeutic
agents applied underneath the drape prior to placement of the
drape.
[0057] Preferably the uncured curing agent/material allows for a
sufficient working time for the operator (dentist or hygienist) to
place the drape over and through the anatomical crowns of the
teeth, and closely adapt the drape the specific gum lines and gum
ridge anatomy of any patient before hardening the curing agents
contained within the internal channels of the drape.
[0058] The now snugly fitted drape can now also be utilized as an
effective wound dressing or containment barrier for medicaments or
therapeutic agents applied to, for example, the periodontal pockets
of the gums surrounding the teeth and or the gum ridges prior to
insertion and adaptive conformation of the drape as previously
described.
[0059] This allows for these medicaments or therapeutic agents to
be maintained in high concentrations on or in the drape covered
target soft tissues by effectively preventing them from leaking out
and preventing the saliva from diluting and washing them out as
well. Maintaining these medicaments or therapeutic agents in place
at high concentrations on or in the target tissues significantly
extends their exposure time and therefore their therapeutic window
of action. This ability of the drape of the present invention may
allow for achieving significantly enhanced therapeutic outcomes
with these medicaments or therapeutic agents particularly for
patients with impaired healing such as diabetics who suffer from
chronic periodontitis.
[0060] Medicaments or therapeutic agents may also be pre-applied or
pre-impregnated into the inner surfaces of the drape at the time of
manufacture for time released application to the gingival tissues
of the gum ridges or for timed delivery into the periodontal sulcus
of the teeth.
[0061] Suitable drape elastomeric materials include, but are not
limited to TPE's (thermoplastic elastomers; TPU's (thermoplastic
urethanes); elastomeric silicones (RTV, HTV, LSR), the material
preferably being both substantially liquid impermeable and gas
permeable (i.e., breathable). Preferably, the material contains
millions of micro-pores per square cm.
[0062] The drape may include one or more treatment material layers
on at least one surface of the drape, for example for neutralizing
treatment materials. The materials are preferably provided on the
inner surfaces of the drape but may also be provided on the outer
surfaces of the drape.
[0063] According to additional embodiments, a septum type port or
ports may be provided for accessing the internal channels of the
drape for receiving a tool, such as a syringe needle(s) for the
delivery of the uncured curing agent/materials into the
channels.
[0064] These septum type ports or plugs may be made of the same
material as the drape itself and may also be self-sealing so as to
self-seal upon removal of the syringe needle after delivering the
uncured curing agent into the internal channels of the drape.
[0065] A second aspect of the present invention provides a kit of
parts for installing an anatomical drape, the kit comprising a
drape according to the first aspect of the present invention and a
light source, optionally with at least one further drape and/or a
therapeutic or other treatment source.
[0066] A third aspect of the present invention provides a method
for the manufacture of an anatomical drape, preferably being a
drape according to the first aspect of the present invention, the
method comprising the steps of: (a) preparing a set of inserts that
mirror the shape of the internal channels and septum plugs of the
drape device; (b) molding elastomeric materials onto the set of
inserts in order to produce a set of elastomeric spacers (c)
inserting the set of inserts with spacers into a second mold and
clamping them in place in the second mold; (d) over-molding with
the same or similar elastomeric materials to create the "body"
outer inner aspects of the elastomeric drape, (e) removing the set
of inserts where the spacers remain and have now fused with body
material of the drape and where upon removal of the inserts a set
of internal channels and septum plugs now remain inside the body of
the drape; (f) inserting flowable uncured curing agent/material(s)
through the set of septum plugs into the internal channels of the
drape so as to fill the channels with uncured curing
agent/materials.
[0067] Step (f) the septum plugs may be self-sealing and so prevent
leakage out, of the applied uncured curing agents. The step of
introducing the uncured curing agent/materials and packaging the
final product should preferably be accomplished under "red light"
manufacturing conditions to prevent the premature curing of the
curing agent/material(s).
[0068] FIG. 1 is a top side view according to some embodiments;
wherein are depicted a set of gum drape inserts 6 incorporating
insert septum plug segments 6a, onto which have been molded
elastomeric gum drape spacers 7. A drape may be constructed with a
plurality (preferably two or more, more preferably three or more)
of the gum drape spacers 7. For example, the drape may include
three gum drape spacers 7 as shown in FIG. 1.
[0069] FIG. 2 is a transparent top and side view according to some
embodiments of a lower oral drape 1a; wherein are depicted a set of
gum drape inserts 6 before removal from between the upper layer 3a
and lower layer 3b of the lower drape 1a. Also depicted is an
embodiment of the gum drape roll borders 11, the teeth holes 4, and
the gum drape spacers 7 inside the upper layer 3a and lower layer
3b of the lower (mandibular) oral gum drape 1a.
[0070] FIG. 3 is a transparent top and side view according to some
embodiments of an upper (maxillary) oral drape 1b; wherein are
depicted a set of gum drape inserts 6 before removal from between
the upper layer 3a and lower layer 3b of the upper drape 1b; which
upon removal, creates the built in internal channels 9 between the
upper layer 3a and lower layer 3b of the upper drape 1b. Also
depicted is an embodiment of the gum drape roll borders 11, the
teeth holes 4, and the gum drape spacers 7 inside the upper layer
3a and lower layer 3b of the upper oral gum drape 1b as well as
embodiments of gum drape positioning bumps 12 and gum drape
frenulum cut out 13.
[0071] FIG. 4 is a transparent bottom view according to some
embodiments of a lower oral drape 1a; wherein are depicted the
lower drape surface 3b, the gum drape interdental bridges 5, a set
of gum drape inserts 6 before removal from between the upper layer
3a and lower layer 3b of the lower oral drape 1a. Also depicted are
embodiments of the teeth holes 4 and the buccal segments 4a and
lingual segments 4b of the teeth holes 4 as well as the border roll
11.
[0072] FIG. 5 is a solid bottom view according to some embodiments
of a lower oral drape 1a; wherein are depicted the lower drape
surface 3b, the gum drape interdental bridges 5, a set of gum drape
inserts 6 before removal from between the upper layer 3a and lower
layer 3b of the lower oral drape 1a. Also depicted are embodiments
of the teeth holes 4 and the buccal segments 4a and lingual
segments 4b of the teeth holes 4.
[0073] FIG. 6A is a transparent top and side view according to some
other embodiments of a lower oral drape 1a; wherein are depicted
septum plugs 8, a series of built in internal channels 9 between
the upper 3a and lower 3b layers of the gum drape 1a, the roll
border 11, and the frenulum cut out 13, and multiple teeth holes
4.
[0074] FIG. 6B is a transparent top and side view according to some
other embodiments of a lower oral drape 1a; wherein are depicted
septum plugs 8, a series of built in internal channels 9 between
the upper 3a and lower 3b layers of the gum drape 1a, the roll
border 11, and the frenulum cut out 13, with several teeth holes 4,
wherein some teeth holes as per FIG. 4A are missing.
[0075] FIG. 7 is a transparent top and side view according to some
other embodiments of a lower oral drape 1a; wherein are depicted
the curing agents/materials 10 inside the built in internal
channels 9 having been filled into the internal channels 9 through
the septum plugs 8. Also depicted is one embodiment of positioning
bumps 12 and the frenulum cut out 13.
[0076] FIG. 8a is a top and side view according to some other
embodiments of an upper oral drape 1b; wherein are depicted the
buccal aspect 2a, the lingual aspect 2b, and the occlusal aspect 2c
of the gum drape 1b where it is obvious that the gum drape 1a also
has a buccal aspect 2a, a lingual aspect 2b, and an occlusal aspect
2c (not depicted). Also depicted is the roll border 11 of the oral
drape 1b.
[0077] FIG. 8b is a top view according to some other embodiments of
an upper oral drape 1b; wherein are depicted interdental bridges 5
on the occlusal aspect 2c of the oral drape 1b, the positioning
bumps 12, and the buccal aspect 2a and lingual aspect 2b of the
oral drape 1b.
[0078] FIG. 9a is a top and front view of a model of the maxillary
jaw oral structures 20; wherein are depicted the upper oral drape
1b applied over and through the erupted anatomical crown portions
of the maxillary teeth 14 and covering the maxillary alveolar gum
ridge 16 on both its buccal ridge aspect 16a and its palatal ridge
aspect 16b whilst in some embodiments not covering the hard 18 or
soft palate 18a.
[0079] FIG. 9b is a top view of a model of the mandibular jaw oral
structures 21; wherein are depicted lower oral drape 1a applied
over and through the erupted anatomical crown portions of the
mandibular teeth 15 and covering the mandibular alveolar gum ridge
17 on both its buccal ridge aspect 17a and its lingual ridge aspect
17b whilst in some embodiments not covering the floor of the mouth
19 or tongue (not depicted).
[0080] FIG. 10 is a side view of some embodiments of an upper oral
drape 1b and lower oral drape 1a; wherein are depicted the teeth
holes 4 and interdental bridges 5 located on the occlusal ridge
aspects 2c, the septum plugs 8, the internal channels 9 filled with
curing agents/materials 10 located on both the buccal ridge aspects
2a and lingual ridge aspects 2b. Also depicted are the roll borders
11 and frenulum notches 13.
[0081] According to some embodiments, a dental oral drape is
provided, that is flexible to apply and to remove, that is designed
to conform substantially to an anatomic area, and that is both
liquid impermeable and gas permeable. In one example, the dental
oral drape is designed to conform to the gum ridge anatomy or a
portion of the gum ridge, and has pre-configured or perforated
cut-out holes of various shapes and diameters for insertion over
and through anatomical crown portions of the teeth (if the teeth
are present), and for adaptation around or near to the gum line of
the teeth, for example, as described in PCT application number WO
2013/039906 A1, by the same inventor. Of course, drapes as
described herein may be used to cover and/or contain treatment
areas besides the oral area, for example, in or on other bodily
limbs or parts.
[0082] In some embodiments, the device includes a dental oral drape
component for protection against treatment materials (such as a
whitening agent) applied to the teeth that may be exposed as well
to the surrounding gum tissue of the teeth that are covered
(contained) by an oral tooth and/or gum treatment device being used
for a treatment cavity or cavities of a mouthpiece, for example, as
described in PCT patent application number WO 2013/039906 A1, by
the same inventor.
[0083] In some embodiments, the dental oral drape includes a
treatment material layer on one or more surfaces, wherein the
treatment material is suitable for neutralizing treatment
materials.
[0084] In some embodiments, the device includes a dental oral drape
component which includes a gum treatment layer on its inner
surfaces for the delivery of one or more therapeutic treatment
materials or medicinal materials to the gums.
[0085] In some embodiments the oral drape is formed from a variety
of elastomeric materials such as but not limited to: TPE's
(thermoplastic elastomers; TPU's (thermoplastic urethanes);
elastomeric silicones (RTV, HTV, LSR, HCR) that are substantially
both liquid impermeable and gas permeable (i.e., Breathable). For
example, they may contain millions of micro-porosities per sq. cm.
in their structure that are naturally formed during the mixing and
molding process. In some examples, these elastomeric materials
preferably would have a tear strength of 40 kN/m or even 50 kN/m or
more, and preferably a tensile strength of 8-10 Mpa. Embodiments of
these elastomeric materials would preferably have a Shore A
hardness of 40 or even preferably 30 or even 20 Shore A hardness.
Of course, other ranges may be used.
[0086] In some embodiments the elastomeric drape incorporates a
built in set of internal channels into which can be inserted a
flowable curing agent/material (for example, visible or UV light
catalyzed) resin.
[0087] Examples of the light curable materials may include but are
not limited to various blended mixtures of acrylate monomers,
urethane acrylate oligomers, triacrylate cross linkers,
plasticizers, and photo-initiators. Preferably this material is
elastic and may have elongation properties of 10% or even 50% or
possibly even 100% or more.
[0088] According to some embodiments, these incorporated visible or
UV uncured resin filled channels (10, in FIG. 10) can be utilized
to custom shape the oral drape device to a specific patient's
anatomy and immobilize this shape over the target area after
sequentially stretching different segments of the drape to their
desired locations and then hardening the resin filled channels. In
one example: The resultant three-dimensional form can be draped
over varying topography (e.g., each patient's mouth is unique) of
the gum ridge tissues surrounding the erupted teeth (e.g., after
first being pulled over the erupted portions of the teeth in the
dentulous situation), and then selectively patted and or stretched
down over the gum ridge anatomy to achieve a high level of
conformity to the individual gum ridge tissue topography. The
incorporated light curable material can then be hardened around
individual teeth and the gums around them by applying a readily
available dental LED or UV light source to the material. In some
examples the light curable materials may be selectively cured, for
example by applying the light in a segmental manner to specific
areas of the drape so as to immobilize the desired customized final
shape of the drape to the target area.
[0089] In some embodiments, the manufacturing process herein
described provides for using a stock sized pre-formed (molded)
three dimensionally shaped drape device (e.g., that is non-custom
made for a target anatomy) that can be readily and quickly adapted
to each patient's specific anatomy to provide a "custom fit" to
each patient's anatomy. Such a customized drape may provide a
superior substantially semi-rigid barrier that can be used, for
example, in the following applications:
[0090] The drape as described above may be used as a wound dressing
or containment device (with or without impregnating the inner
surface with a therapeutic) or as a delivery device itself (e.g.,
if an additional therapeutic agent is later impregnated on its
inner surface as a coating in a later step of the manufacturing
process) to hold and maintain a desired volume and concentration of
the therapeutic in place onto the target area. Therapeutic
applications include but are not limited to post-periodontal (gum)
surgery, post-dental implant surgery, following deep debridement
such as scaling and root planing (SRP) as part of a periodic
periodontal STM (soft tissue management) regimen for chronic
periodontitis patients.
[0091] In further embodiments, the initial form of the oral drape
may substantially contain the treatment material in a more
effective manner on the target treatment area, and allow for a
significantly longer duration, larger quantity and optimal
concentration and/or larger surface area application of the
treatment material to the applied target area as compared to the
known art. This may be advantageous to substantially prevent or
limit saliva contamination (filled with pathogenic bacteria) and
saliva washout (dilution of the therapeutic in the salivary fluid
and its removal as is the case with the prior art).
[0092] According to some embodiments, the oral drape device may be
placed over the teeth so as to expose the erupted portions of the
teeth to the oral cavity (if present) and substantially cover the
surrounding gums and or gum ridge after prior application
(injecting) of a therapeutic treatment either onto the surface of
the gum tissue, onto the tooth surface near the gum line, or into
the natural (healthy or diseased) space (sulcus) between the gums
and the teeth which often (i.e. prevalence rates of 50-70% in the
adult population of industrialized nations) harbor pathogenic
bacteria that cause gum disease (gingivitis and periodontitis).
This improved exposure of the treatment material to the target
treatment area may enable enhanced effectiveness in halting
progression of the gum disease or aid in regeneration of healing
tissue post-surgery that may reverse the disease state or promote
healing of surgically incised tissue so as to bring the gums back
to a state of health.
[0093] In further embodiments, if applied to the tooth structure
near the gum line that may be partially covered by the oral drape,
the treatment material may aid in more effectively re-mineralizing
the demineralized (eroded) tooth structure that typically causes
temperature (hot and cold) sensitivity to the teeth of patients who
have these tooth erosions.
[0094] In accordance with further embodiments, a drape device that
has been pre-impregnated on its inner surface with a treatment
material at the time of fabrication or prior to insertion in the
mouth, may have substantially all the advantages of the embodiments
described above, while additionally enabling delivery of the
therapeutic treatment material effectively and safely to a target
location. In some examples this may obviate the need to first apply
a treatment material onto or into the tissue to be treated. Such an
embodiment may enhance the prevention and/or minimization of saliva
contamination (filled with pathogenic bacteria) and saliva washout
(dilution of the therapeutic in the salivary fluid and its
removal).
[0095] As mentioned above, in some embodiments, the elastomeric
materials used to form the pre-formed body structure of the oral
draping device may be engineered to be differentially permeable
(permeable to oxygen to permit "breathing" of the tissue under it
and yet impermeable to fluids so as to prevent saliva contamination
and washout).
[0096] In still further embodiments the oral drape device described
herein may enable application to a patient anatomy to act as a
barrier to prevent moisture contamination of the tooth structure by
the surrounding soft tissues, thereby creating what is commonly
known in the field of dentistry as a "dry field" (i.e. a
substantially moisture-free work area), which is often a very
important requirement for properly placing many dental restoratives
(fillings etc.) into the teeth. In the currently described
embodiment, application of the device may compliment and/or replace
the typical rubber dam (typically a flat latex sheet drape), which
is relatively cumbersome, time consuming to place (typically
requires manually punching holes in it to cover the teeth,
placement of a clamping device on one of the teeth to keep the
rubber dam in place and often attachment of the rubber dam to an
external frame to keep its otherwise loose unsupported sections
away from the work area). The currently known rubber dam devices
are typically uncomfortable for the patient and challenging for
usage by the dentist for the above reasons.
[0097] In accordance with some embodiments, the oral drape device
may be fabricated in full arch forms to cover all the teeth and
surrounding gums of the upper or lower dental arches. It can also
be fabricated to cover segments (e.g., anterior or posterior) or
fabricated to cover a single tooth or only a few teeth and adjacent
surrounding gum tissue.
[0098] In accordance with some embodiments, the oral drape device
may be fabricated with a varying number of perforated or
pre-configured cut out teeth holes as well as varying sizes and
shapes for said perforated or pre-configured cut out teeth
holes.
[0099] In additional embodiments, the drape device may be applied
outside of the oral cavity, for example, by molding the material to
a different shape (such as a sleeve or cuff), for covering a body
part (e.g., the knee, elbow, ankle, neck etc.), by manually
adapting so as to conform portions of the material to the surfaces
of that body part so as to achieve excellent conformity and a
"custom fit" of the material to that body surface, and then
hardening at least some of the impregnated light curable material
incorporated in its surfaces so as to achieve a semi-rigid cast or
drape.
[0100] In further embodiments the drape device may also be formed
in stock sized molded sections (e.g., to cover a limb, a portion of
a limb, or a portion of the torso) and so may be used to treat a
body area. In one example the drape device may be used to treat
skin burn victims by effectively covering and partially
immobilizing the damaged body parts substantially (especially in
areas where there is normally joint movement of that body part),
without the need for applying heavy plaster-type casts. In another
example this application may be used where a treatment material may
have first been applied separately to the damaged tissue or the
treatment material may have been applied to the inner surface of
the device prior to placing and adapting the device in a "custom
fit manner to the desired treatment area".
[0101] In still further embodiments, the treatment material to be
applied with the drape device may be formulated so that its
therapeutic effect is in a time released manner or the treatment
material may be first inserted into a manually or electronically
controlled pumping device that has first been placed on the
treatment area surface and then covered with the therapeutic
draping device of the present invention.
[0102] The foregoing description of the embodiments of the
invention has been presented for the purposes of illustration and
description. It is not intended to be exhaustive or to limit the
invention to the precise form disclosed. It should be appreciated
by persons skilled in the art that many modifications, variations,
substitutions, changes, and equivalents are possible in light of
the above teaching. It is, therefore, to be understood that the
appended claims are intended to cover all such modifications and
changes as fall within the true spirit of the invention.
* * * * *