Title of the invention: A ready to use biodegradable and biocompatible
device and a method of preparation thereof
Field' of the invention:
The present invention felates to the field of Medical Biotechnology.
Particularly, the present inventio'n provides a ready to use biodegradable and
biocompatible device.
More particularly, the invention relates to a device for wound bleeding stoppage
purposes.
Even more particularly, the invention relates to medical nonwoven textiles.
The present invention provides a porous scaffold meant as a therapeutic carrier,
more specifically as a Hemostasis product.
The invention is a sterile wound dressing product to carry the therapeutic
and/or bioactive molecules with preference to accelerate the process of stopping
bleeding of the wounds.
The present invention also relates to a method of preparing such a device for
medical field.
Backaround of the invention:
Hemostatic products are used to accelerate the process of stopping the bleeding
(hemostasis) from surgical or traumatic wounds. Bleeding of the wound may result
into loss of blood which in turn may lead to hypovolemic shock leading to tissue and
organ damage. I n order to stop the bleeding of the wounds several active
ingredients like Thrombin, Gelatin, Collagen, Fibrin, Synthetic, etc. are used for
manufacturing products which would accelerate the process of stopp~ng the
bleeding from wounds. There are several such products known in the art.
Reference may be made to. United States Patent number 8,133,484, titled
"Hemostatic materials and dressing" by Preiss-Bloom, et al. dated 13.03.2012. This
invention relates to an adhesive material comprising gelatin and a non-toxic crosslinking
material such as transglutaminase. The adhesive material is useful for
medical purposes as hemostatic products. The hemostatic products are useful for
the treatment of wounded tissue.
Reference may be made to United States Patent number 8,337,879, titled
"Absorbable implants and methods for their use in hemostasis and in the treatment
of osseous defects" by Kronenthal dated 25.12.2012. This invention relates to
mechanically hemostatic body-absorbable compositions having a putty-like
consistency. The compositions preferably comprise a finely powdered, carboxyl~c
acid salt and a liquid block copolymer of ethylene oxide and propylene oxide.
Reference may be made to United States Patent number 8,252,344, titled "Partially
hydrated hemostatic agent" by Hursey dated 28.08.2012. This invention relates to
a composition for promoting the formation of clots in blood comprises a zeolite and
a binder. The zeolite is adjusted to have a specific moisture content. Processes by
which the moisture content is adjusted include drying, re-hydrating, and
combinations of drying and re-hydrating. A method of forming the composition
comprises the steps of providing a zeolite and adjusting the moisture content such
that upon application of the composition to a wound, a heat of hydration is reduced
and heat transferred to the wound is reduced. A method of clotting blood flowing
from a wound comprises the steps of applying the zeolite to the wound and
maintaining the zeolite in contact with the wound for a predetermined amount of
time, the zeolite having adjusted moisture content and being capable of producing
. .
a controllable exothermic effect on, the wound.
Reference may be made to United States Patent number 8,668,899, titled
"Advanced functional biocompatible foam used as a hemostatic agent for
compressible and non-compressible acute wounds" by Dowling, et al. dated
11.03.2014. This invention relates to a sprayable polymeric foam hemostat for both
compressible and non-compressible (intracavitary) acute wounds. The foam
comprises hydrophobically-modified polymers, such as hm-chitosan, or other
amphiphilic polymers that anchor themselves within the membrane of cells in the
vicinity of the wound. By rapidly expanding upon being released from a canister
-0 AUG 2011
pressurized with liquefied gas propellant, the foam is able to enter injured body
cavities and staunch bleeding. The seal created is strong enough to substant~ally
prevent the loss of blood from these cavities. Hydrophobically-modified polymers
inherently prevent microbial infections and are suitable for oxygen transfer required
during normal kbund metabolism. The amphiphilic polymers form solid gel
networks with blood cells to create a physical clotting mechanism that prevent loss
of blood.
However, none of the products in prior art are as peculiar as the one covered in
present invention. The product of present invention is more effective in solving the
purpose as discussed above. The present invention provides a single platform for
polyelectrolyte complex (to have a combined advantageous features of more than
one polymers) to be used as a carrier for multi-therapeuticals (e.g. thrombin,
calcium, tranexamic acid to initiate and intensify the immediate clott~ng and
stabilizing) and other bioactive molecules (e.g. D+Glucosamine to further enhance
the platelets and blood cells entrapment). Additionally, this provides a smart
. .
executive biomaterial to have even growth promoting effects and antimicrobial
feature also. No prior art is available on a device that would satisfy such need.
Further, the preparation of the said PEC is achieved using a specifically designed
aspect ratio of a system for agitation/homogenization followed by combrnatron of
air dry and freeze dry.
However, none of the inventions discussed above comprises of a
hemostatic product and a method to prepare the same as covered in the
present invention. The distinguishing features of the present invention as
compared to prior art discussed above are very significant and prominent,
hence the present invention is novel and inventive over the prior art.
The present invention comprises of a porous scaffold which comprises absorbent
gelatin - chitosan polyelectrolyte complex (GCPEC) which is highly porous and
impregnated with substances promoting blood clotting. The present invention
provides solutions for stopping bleeding quickly and immediately. The device of
present invention comprises excellent ventilation features prevent~ng ~nfect~ons
which may be caused due to open bleeding wound.
Obiects of the invention:
The main objective of the invention is to provide a device for stopping bleeding
immediately and quickly.
Another main objective of the invention is to provide a ready to use b~odeyrdddble
and biocompatible device.
Another objective of the invention is to provide a method of preparation of such
device.
A further objective of the invention is to provide a porous scaffold meant as
therapeutic carrier, more specific as a Hemostasis product.
Another objective of the invention is to provide a sterile wound dress~ng product to
carry the therapeutic/bioactive molecules with preference to accelerate the process
of stopping bleeding of the wounds.
Summarv of the invention:
The present invention provides a ready to use biodegradable and biocompatible
device and a method of preparation thereof. The device of present invention
. .
comprises a novel' porous scaffold composed of Polyelectrolyte complex (PEC) as
carrier of plurality of therapeutics to quickly stop bleeding from any type of wounds,
i.e. surgical or non-surgical.
Further the present invention comprises combined application of air dry and freeze
dry method in order to develop the device.
The device of present invention comprises of excellent ventilation features which
prevents infections which may be caused due to bleeding.
Further the scaffold under the present invention comprises of differential porosity
and regulated pores on the same platform in a molecularly integrated PEC matrix.
Brief descri~tiono f the drawinas:
Fig. 1 shows the matrix and its micro structure with vesicular voids. The schematic
diagram shows the constituents are held in the matrix of DLS Haemostat.
Fig. 2 shows the Schematic representation-Constituents of DLS Haemostat scaffold
and the coagulation cascade.
Fig. 3 shows the SEM photographs of the device showing differential porosity and
pore size.
Fig. 4 shows the SEM photograph of the scaffold without drug.
Fig. 5 shows the close magnified SEM photograph of the scaffold without drug.
Fig. 6 shows the ,SEM photograph of the scaffold with loaded drug.
. .
Fig. 7 shows the close magnified SEM photograph of the scaffold with loaded drug.
Statement of the invention:
Accordingly the present invention provides a ready to use biodegradable and
biocompatible device and a method of manufacturing thereof, said device
comprising natural porous scaffold micro-matrix based structure mainly of
Polyelectrolyte complex (PEC) acting as carrier of plurality of therapeutics and
pharmaceuticals to quickly stop bleeding; said matrix based structure comprising of
a plurality of polymers and manufactured as a scaffold comprising differential
porosity and regulated pores with interconnected small voids on the same platform
in a molecularly integrated matrix; such that said device acts as a drug carrier and
transporter to supply and transfer said therapeutics and pharmaceuticals into
wounds in order to quickly stop bleeding and to reduce ambient contamination,
whenever applied on the wound.
Detailed descri~tiono f the invention:
0 6 AKG 2011 It should be noted that the particular description and embodiments set forth in t e
specification below are merely exemplary of the wide variety and arranaement of
instructions which can be employed with the present invent~on. The present
invention may be embodied in other specific forms without departing from the spirit
or essential characteristics thereof. All the features disclosed in this specification
may be replaced by similar other or alternative features performing similar or same
or equivalent purposes. Thus, unless expressly stated otherwise, they all are within
the scope of present invention. Various modifications or substitutions are also
possible without departing from the scope or spirit of the present invention.
Therefore it is to be understood that this specification has been described by way of
the most preferred embodiments and for the purposes of illustration and not
limitation.
The present invention provides a ready to use biodegradable and b~ocompat~ble
device and method of preparation thereof. The device of present invention is a
novel porous scaffold to stop bleeding immediately and permanently when applied
on the wound. he' present invention basically relates to the efficient deployment of
a biodegradable, biocompatible medical aid through a novel highly porous scaffold
that can be deployed at the point of proposed use. The scaffold under the present
invention will allow the medical aid with the ability to quickly stop bleeding and also
reduce ambient contamination that could cause secondary infection, preserve tissue
after injury and facilitate surgical speed.
The present invention is a biodegradable and biocompatible dressing, preferably
having chitosan and gelatin as base, for control of traumatic bleeding. The readyto-
use patch under the present invention cons~sts of a Gelat~n and Chltosdii :odnl,
impregnated with clotting agents such as but not limited to thrombin, calcium
chloride (CaCI*) and Tranexamic Acid. These constituents are held in the vesicular
voids of the matrix,on the internal surface of the sponge which are able to act
rapidly when blood flows into the dressing. Once the scaffold under the present
invention is in contact with blood, the dressing enables sealing and stabilization of
wound surfaces.
The novel scaffold under the present invention provides an executive and exclusive
device for the natural micro-matrix composed of Polyelectrolyte complex for carrier
of more than one type of therapeutics relating to quickly stop bleeding. Further the
present scaffold comprises of combined technology of air dry and freeze dry method
which provides excellent ventilation property to the scaffold and exudates
absorbency to the scaffold of the present invention.
The present invention aims to overcome the problems in the ex~st~npgr~ ora rts and
provides the novel and unique features in the scaffold by providing on-demand
services for differential porosity and regulated pores on the same platform in a
molecularly integrated matrix. The technologies involved are the timed patterned
physico-chemical treatment of the two or more polymers viz. gelatin and chitosan
using a very simplified process to obtain a stable molecular interaction and
orientation between the molecules of at least two of the preferred polymers, which
results into a highly porous matrix. The used technology provides the proper
interaction and orientation between the functional groups of the polymers used,
resulted into a typical polyelectrolyte complex (PEC). The most favourable cat~on,
NH3+, rapidly attracts platelets and erythrocytes in blood flow, ~ n ~ t ~caotaegu lat~on
mechanism and form strong blood clots at wound site.
Further under the present invention the novel technology to prepare the scaffold
provides two faces'to the device. One is more porous with larger pore size and the
other is less porous with small pore sizes. The later feature helps to prevent the
loss of blood components while the earlier feature allow the blood to enter within
the voids of the scaffold resulting into immediate clot generation and migration
towards the bleeding site, further interconnected vesicular micro voids hold the
drug inside and as a result the encapsulated drugs do not come out of the matrix at
significant level.
Further the highly porous structure of the present invent~on results ~nto
interconnected small voids, provide a large surface area and mlcro-areas for
reactions to occur and thus exert a pseudo-catalytic effect on blood clott~ng. The
whole blood clotting process, the coagulation cascade is activated. The microenvironment
aided with drugs viz. thrombin, calcium and tranexamic acid, initiate
and intensify the clotting pathway by converting inactive precursor to its active
form, so as to form the clot. The co-factor supports the blood clotting process. Antifibrinolytic
agent in the present invention stabilizes the blood clot and also
triggers intrinsic thrombin generation; hence, prolonged compression is not
necessary.
The PEC micro-mesh and body's fibrinogen converted into fibrin forms an
efficacious plug and prevents the loss of blood and stops the loss of clotting factor.
The novel device of the present invention makes the product light weighted, to be
more physical and also altering the blood clotting mechanism. The scaffold of the
present invention can be removed easily usually without 1 d,.\lr~(j
additional/secondary hemorrhage. The present invention could prevent wound
infection due to the antibacterial capability of chitosan.
The novel porous kaffold of the present invention is also capable of being used as a
carrier for other therapeutics/ bioactive molecules/ cell (primary or stem cell)
towards tissue engineering and other biomaterial applications. Moreover, the
scaffold of the present invention is also capable of being used as a cover for the
compromised tissues either as acellular or cellular product.
The utilization of more than one type of polymer & their properties for multitherapeutics
loaded preparation and impregnation of the same with PEC scaffold, a
system for more than one types of the pharmaceuticals (like clotting factors, cofactors,
clot stabilizers, antibiotics, analgesrcs, antl-allerg~c,d r ~ t ~ o x ~ d d nyt sr o,w th
factors, etc.) to get delivered in phase-wise and controlled manner for extended
period of time.
The novel aspect of the present invention is the sequential timed patterned
physico-chemical treatment of the two polymers by using a very simplified process
to obtain a stable molecular interaction and orientation between the molecules of
the two or more polymers to get highly stabilized porous scaffold without using any
cross-linker or any integrated harmful chemicals. Further, the invention comprises
of the breakdown of stabilized dried air bubbles and the preparation of said PEC is
achieved using a specifically designed aspect ratio of a system for
agitation/homogenization. The scaffold matrix of the present invention may
comprise of adhesion backing impervious or perforated sheet which would
intercalate other matrices in case of large bleeding wound is to be covered.
The present invention comprises Polyelectrolyte complex porous spongi Ttlt~ bdilc
structure of the matrix under the present invention is made from preferably
absorbent gelatin-chitosan polyelectrolyte complex (GCPEC) which is highly porous
and impregnated 'with substances promoting blood clotting. The blood clotting
process occurs within the voids in the presence of co-factor and clotting factors,
further the clot is stabilized by anti-fibrinlytic agent. The porous sponge of GCPEC
provides a very large surface area for the flowing blood.
Further the invention comprises of Thrombin which is a plasma protein catalyzing
the conversion of fibrinogen into fibrin. This process represents the final phase in
the coagulation cascade and leads to the formation of a blood clot. Tranexamic acid
is also comprised in the invention which acts as an anti-fibrinlytic agent and
stabilizes the blood clot. It also promotes the regeneration of thromb~n, and
calcium chloride plays role as clotting factor and supports the coagulation of the
blood coming from the wound. This is also a polymerizing and crosslinking factor for
the fibrin, also t h e ~ n bsu ffer is used as a carrier solution for the drugs.
Preparation process of the scaffold under the present invention is outlined below in
step by step manner:
1. Preaaration of air dried sam~les
Addition of gelatin in a vessel containing purified water
Dissolving and Homogenizing the Solution using Stirrer
+ Casting the homogenized mixture in trays of desired size
+
Allowing the sample for air dry
2. Neutralization of air dried sam~les
Crushing the samples
Soaking the crushed Sam le in neutralization solution P
Washing the samples with water
I
Pat dry/vacuum dry
3. Drua loadina and drvinq
Dissolving required drugs and therapeutic chemicals in Tris buffer to load 1
Lyophilizing the samples to obtain drug loaded porous scaffold device for use as and
when required
So, accordingly the present invention provides a ready to use biodegradable and
biocompatible device and a method of manufacturing thereof, said device
comprising natural porous scaffold micro-matrix based structure mainly of
Polyelectrolyte complex (PEC) acting as carrier of plurality of therapeutics and
pharmaceuticals to quickly stop bleeding; said matrix based structure comprising of
a plurality of polymers and manufactured as a scaffold comprising differential
porosity and regulated pores with interconnected small voids on the same platform
in a molecularly integrated matrix; such that said device acts as a drug carrier and
transporter to supply and transfer said therapeutics and pharmaceuticals into
wounds in order to quickly stop bleeding and to reduce ambient contamination, . .
whenever applied on the wound.
10
In an embodiment, said polymers are preferably selected from but not limited to
gelatin, chitosan, collagen, alginate, polyvinyl alcohol, polyurethane, keratin,
carboxymethyle 'ckl~u~ose,g elatin hydrolysate, chitosan hydrolysate, partially
denatured collagen and/or synthetic or naturally derived molecules such as
phytochemicals.
In another embodiment, said therapeutics and pharmaceuticals are selected from
but not limited to tranexamic acid, calcium chloride, thrombin and/or glucosamine.
In another embodiment, said scaffold is produced by the steps:
a) preparing a homogeneous solution of the polymers with d~fferent ratio In water
and acetic acid and subjecting for air drying to obtain an air dried scaffold;
b) cutting and crushing the above obtained air dried scaffold as per requirement
and subjecting for the stabilization either by ammonia vapor or ammonia
solution or alkali solution;
c) subsequently washing the product as obtained in step (b) with water and
squeezing to remove maximum amount of water;
d) loading the required pharmaceuticaI/therapeutic solution containing different
ratio of drugs as per the requirement to the washed porous scaffold to obtain
the final ready to use product.
In another embodiment, said method involves physico-chemical treatment of sald
polymers using a very simplified process in order to obtain a stable molecular
interaction and orientation between the molecules of the said polymers, causing an
interaction and orientation between the functional groups of the polymers used,
resulting into a typical polyelectrolyte complex (PEC), so as to obtain a highly
porous matrix.
In yet another embodiment, said matrix comprises of combined application of air
dry and freeze dry method.
In another embodiment, said matrix comprises differential porosity and regulated
pores with interconnected small voids, on the same platform in a molecularly
integrated matrix with two faces to the scaffold.
In another embodiment, said scaffold provides an executive and exclusive device
for the natural micro-matrix composed of Polyelectrolyte complex for carrier of
more than one type of therapeutics in order to quickly stop bleeding.
In yet another embodiment, said scaffold IS produced throiigh, p t i yo~ ~1 1~t . r ~ ,+I
treatment of the polymers using simplified process resulting in a stable molecular
interaction and o.r ie. ntation between the molecules of the polymers resulting into a
highly porous matrix.
In another embodiment, said scaffold is capable of being used as a carrier for
multiple categories of therapeutics and pharmaceuticals and is manufactured as per
the requirement.
In another embodiment, said scaffold is efficiently capable of deployment of a
biodegradable, biocompatible medical aid that can be deployed at the point of
proposed use as per the requirement.
In yet another embodiment, said scaffold comprises of two faces wherein one face
is more porous with larger pore size and other face is less porous wtth small pore
sizes.
In another embodiment, said small pores help to prevent the loss of blood
components while the large pores allow the blood to enter within the voids of the
scaffold resulting into immediate clot generation and migration towards the
bleeding site.
In another embodiment, said scaffold comprises of Polyelectrolyte complex 1.e. PEC
micro mesh where body's fibrinogen converted into fibrin forms an efficacious plug
and prevents the loss of blood and stops the loss of clotting factor.
In yet another embodiment, said scaffold comprises interconnected small voids,
providing a large surface area and micro-areas for reactions to occur and tht~qp ~ p r t
a pseudo-catalytic effect on blood clotting.
In another embodiment, said scaffold is capable of being used as a cover for the
compromised tissues either as acellular or cellular product.
In another embodiment, said scaffold is capable of delivering pharmaceuticals and
therapeutics in phase-wise and systematically controlled manner, for extended
period of time, as and when required.
The ready to use biodegradable and biocompatible device and method of
manufacturing thereof results in to novel, unique and lightweight scaffold, which
also possesses the feature of being removed easily usually without causing
additional/secondary hemorrhage.
The ready to use biodegradable and biocompatible device is used to stop the
bleeding.
The ready to use biodegradable and biocompatible device is used as carrier for
multiple and plurality of therapeutics and cells and also used for tissue
The followinu exam~les are for the Durposes of illustration only and
therefore should not be construed to limit the scope of the ~resent
in vention:
Exam~le1 :
Preparation of the air dried samples: First lOOml of ultrapure water IS taken rn
a beaker. Then 3 gm of gelatin is added in to the beaker containing water and
dissolved by heating it. Once the solution is dissolved and heated, it is further
Homogenized using stirrer. Then after this 1 ml of Acetic Acid is added and
homogenized for 1 min and further 1.5 gm of chitosan is added to the solution and
homogenized for 90 min. Once the mixture is homogenized, it is casted in trays and
allowed to air dry. Once the sample is dried, it is cut in to the size e.g. 7cm * 7cm.
Neutralization of the air dried samples:
The crushed samples are soaked in ammonia solution followed by washing and pat
and/or vacuum dry.
Drug loading and drying:
50mM Tris Buffer is prepared and then 490mg of Tranexamic acid and 98 mg of
CaClz in Tris buffer are dissolved, further 588 IU of thrombin is added, the final
volume is 20 ml. Then the drug solution is loaded to the matr~xa nd lyoph~l~zetod
obtain drug loaded porous device of the present invention.
#
usinq in-vitro and in-vivo models.
In-vitro testing of blood clotting efficacy
*:* Procedure adopted was direct visual Method:
Clot formation was assessed in tray ( ~ 2 0cm 2 SA) with 4 ml blood thinned by
50% using equal volume of PBS and a lcrn2 of the product was added to this. A
stop watch is started when the test subjects are affected. The clotting time ;r\i;js
measured by tilting the tray by more than 45 degree every 30 sec until firm
clotting was detected. The time indicated on the watch is the clotting time.
These tests were performed in triplicate.
In vivo efficacy testing for the product
The effect of the prepared Hemostat on bleeding was tested in Capra aegarus
hircus (Domestic Goat). The versions tested are the same in terms of composition
and manufacturing quality as the dressings are being used on patients in clinical
trials.
Goat was refrained from food the night before the experiment but had frcr arrcqq
to water. Animal was anaesthetized by spinal Lignocaine 2%. Non~nvas~vbelo od
pressure and pulse was monitored by oscillornetric method pre and post-surgery. A
scalpel was used .to create an experimental wound and a wide opening in the
femoral artery.
The skin of the inguinal area of the thigh was incised longitudinally to the groin to
expose the femoral artery vasculator. Lidocain 1-2% was spread on the artery to
maximize the dilatation of the vessel. After a brief period of stabilization and
recording of baseline data, a uniform incision was made on the femoral artery to
induce uncontrolled bleeding. Free bleeding of the puncture site was allowed for 30
seconds followed by application of the cotton gauze (control dressing) or prepared
Hemostat for 5 minutes.
The huge uncontrolled bleeding that resulted was stopped completely in a few
minutes by pressing a prepared Hemostat onto the bleeding wound. No secondary
bleeding occurred, even when the dressing was carefully separated from the
wound. However, jt was not possible to stop the bleeding with a control dressing
(cotton gauze). ~Lrthermore,t he. physiological parameters of the tested animal
were stabilized .
Advantaaes of the invention:
The present invention stops bleeding within few minutes.
Prevents secondary bleeding.
The scaffold of the present invention does not st~ckto the wound.
The present invention does not disturb the normal of blood flow.
The present invention comprises of improved wound hygiene.
The scaffold of the present invention is useful in cases of multiple injury
The present invention requires less time to stop bleed~nga nd patlent can be
addressed immediately.
By use of the present scaffold the patient can be transported easily.
The present invention helps in earlier mobilization of the patient.
Ready-to-use bandage for stopping bleeding of wounds and prevents from
loss of life due bleeding.
Can be used in surgical procedures including vascular surgical procedures,
accidental and combat field.
Can be manufactured in any size and shape as per the requirement.
Easy to handle.
~nterconnectedP orous in. str.u cture.
Packed in laminated foil pack to protect it from environmental factors
(sunlight & moisture).
* / -- -- ' ,
Thermostat pack
from getting compressed during transportation or storage.
Multiple bandages can be applied for larger wounds.
Capable of use for at least 24 hours, however, hemostasis achieves within
few minutes only.
Can be removed easily without using saline solution or water.
Long Shelf life at ambient temperature. Can be disposed-off by burning or
degradation.
Environment friendly as it is degradable easily.
.- .I
We Claim:
1. A ready to use biodegradable and biocompatible device and a method of
manufacturing thereof, said device comprising natural porous scaffold micromatrix
based structure mainly of Polyelectrolyte complex (PEC) acting as
carrier of plurality of therapeutics and pharmaceuticals to quickly stop
bleeding; said matrix based structure comprising of a plurality of polymers
and manufactured as a scaffold comprising differential porosity and regulated
pores with interconnected small voids on the same platform in a molecularly
integrated matrix; such that said device acts as a drug carrier and
transporter to supply and transfer said therapeutics and pharmaceuticals into
wounds in order to quickly stop bleeding and to reduce dmb~ent
contamination, whenever applied on the wound.
2. The ready to use biodegradable and biocompatible device as claimed in claim
1, wherein said polymers are preferably selected from but not limited to
gelatin, chitosan, collagen, alginate, polyvinyl alcohol, polyurethane, keratin,
carboxymethyle cellulose, gelatin hydrolysate, chitosan hydrolysate, partially
denatured collagen and/or synthetic or naturally derived molecules such as
phytochemicals.
3. The ready to use biodegradable and biocompatible device as claimed in claim
1, wherein said therapeutics and pharmaceuticals are selected from but not
limited to tranexamic acid, calcium chloride, thrombin and/or glucosamine.
4. The ready to use biodegradable and biocompat~ble dev~ce and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold is
produced by the steps:
a. preparing a homogeneous solution of the polymers with different ratio
, .
in water and acetic acid and subjecting for air drying to obtain an air
dried scaffold;
b. cutting and crushing the above obtained air dried scaffold as per
requirement and subjecting for the stabilization either by ammonia
vapor or ammonia solution or alkali solution;
c. subsequently washing the product as obtained in step (b) with water
and squeezing to remove maximum amount of water;
d. loading the required pharmaceutical/therapeutic solution containing
different ratio of drugs as per the requirement to the washed porous
scaffold to obtain the final ready to use product.
5. The ready .t.o use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 4, wherein said method involves
physico-chemical treatment of said polymers using a very simplified process
in order to obtain a stable molecular interaction and orientation between the
molecules of the said polymers, causing an interaction and orientation
between the functional groups of the polymers used, resulting into a typical
polyelectrolyte complex (PEC), so as to obtain a highly porous matrix.
6. The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 4, wherein said rnatriv cornpriscs
, of combined application of air dry and freeze dry method.
7. The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claim. e.d in claim 1, wherein said matrix comprises
differential porosity and.regulated pores with interconnected small voids, on
the same platform in a molecularly integrated matrix with two faces to the
scaffold.
8. The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold provides
an executive and exclusive device for the natural micro-matrix composed of
Polyelectrolyte complex for carrier of more than one type of therapeutics in
.order to quickly stop bleeding.
9: The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 4, wherein said scaffold is
produced through physico-chemical treatment of the polymers using
simplified process resulting ,in a stable molecular interaction and orientation
between the molecules of the polymers resulting into a highly porous matrix.
10.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold is capable
of being used as a carrier for multiple categories of therapeutics and
pharmaceuticals and is manufactured as per the requirement.
1l.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold is
efficiently capable of deployment of a b~odegradable, blocornpat~ble med~cal
aid that can be deployed at the point of proposed use as per the
requirement.
12.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold comprises
of two faces wherein one face is more porous with larger pore size and other
face is less porous with small pore sizes.
13.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said small pores help to
prevent the loss of blood components while the large pores allow the blood to
enter within the voids of the scaffold resulting into immediate clot generation
and migration towards the bleeding site.
14.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold comprises
of ~ o l ~ e l e c t r o l ~cot em plex i.e. PEC micro mesh where body's fibrinogen
. .
converted into fibrin forms an efficacious plug and prevents the loss of blood
and stops the loss of clotting factor.
15.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold comprises
interconnected small voids, providing a large surface area and micro-areas
for reactions to occur and thus exert a pseudo-catalytic effect on blood
clotting.
16. The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold is capable
of being used as a cover for the compromised tissues either as acellular or
cellular product.
17.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in claim 1, wherein said scaffold is capable
of delivering pharmaceuticals and therapeutics in phase-wise and
systematically controlled manner, for extended period of time, as and when
required.
18.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof as claimed in any of the proceeding claims, resulting
in to novel, unique and lightweight scaffold, which also possesses t h f~~ a t u r e
. of being removed easily usually without causing additional/secondary
hemorrhage.
19.The ready to use biodegradable and biocompatible device, as and when used
to stop the bleeding.
20.The ready to use biodegradable and biocompatible device, as carrier for
multiple and plurality of therapeutics and cells, as and when used for tissue
repair/regeneration/engineering .
21.The ready to use biodegradable and biocompatible device and method of
manufacturing thereof, substantially as hereinbefore claimed in any of the
proceeding claims, specification and drawings.