Patent Application
20190209432
The present invention relates to a biomedical device for the production, storage, traceability and administration of biological products, in particular blood components, adhered onto biocompatible three-dimensional scaffolds (or substrate).
In order to prepare biocompatible scaffold (or substrate) for cell culture comprising biological material, currently sterile bags, tubes or flasks are assembled, followed by the transfer of the biological material onto the scaffold (or substrate).
Unfortunately, such a method is not free from several drawbacks, which limit its application in the therapeutic field.
In fact, it implies several procedural steps, wherein each one is inherently subject to possible errors; moreover, each handling step is a potential source of microbial contamination.
The fact that the sequence of steps is time expensive should also not be ignored.
Moreover, this procedure is not able to ensure a complete traceability of the biological product and of the devices used, which nowadays is an essential requirement of any manufacturing process, especially when applied in the medical field.
It is therefore well-known the need to develop a system for the preparation of blood components, which ensure sterility of the product and of the final products, which is compatible with large-scale production needs, which is fast, economically advantageous and which allows the entire production chain and each steps of the manufacturing process to be controlled and tracked.
The problems known in the art are thus solved by the present invention, which in a first object describes a system of multiple bags for the preparation of blood components from umbilical cord blood.
In a second object, it is described a method for preparing blood components by using a system of multiple bags.
Each element of the system of multiple bags does represent a further object of the present invention.
In particular, a bag of said system comprising a biocompatible scaffold (or substrate) to which a blood component can adhered thereto is one of the preferred aspects.
In a further object, the invention discloses a bag of said system of multiple bags, which comprises means for the facilitated opening of the bag.
According to a further object, there is described the use of the system according to the present invention, or of any one of its components, in the medical treatment and, in particular, in the treatment of tissue repair processes.
According to another object, the use of the system of the invention, or of one of its components, as a culture chamber for cells is described.
According to the first object of the invention, it is disclosed a system of multiple bags for the preparation of blood components from blood.
In a preferred aspect, said blood component is an umbilical cord blood component.
For the present purposes, “umbilical blood component” refers to a product obtained from umbilical cord blood, and in particular it is represented by platelet-rich plasma (PRP) or platelet concentrate (PC) or platelet-poor plasma (PPP) or a culture medium for cell cultures or a platelet gel or a platelet gel activated with calcium gluconate, thrombin or batroxobin, or stem cells or plasma proteins, etc.
The application of the present patent application is to be understood to be extended also to the preparation of blood derivatives and other biological products obtainable from blood, which is not umbilical cord blood.
For simplicity and ease of reading, hereinafter reference will be made to “blood components”.
According to the present description, the system of the inventions is referred to with reference 1 and comprises a bag 6 (to which reference will be made as “bag C”) for the preparation of a biocompatible scaffold (or substrate) to which a blood component is adhered.
Such a blood component, in particular, is obtained with the procedure described hereinafter.
In particular, the procedure may include the use of one or more additional bags 3,4,5, so that a system of multiple bags 1 is realized.
For the present purposes, the system 1 comprises bags 3,4,5,6 suitably connected to one another, so that a fluid connection is created among them.
In a preferred aspect of the invention, suitable connections 10 are provided (shown in
That means that during the whole procedure for the preparation of the blood component, the sterility of system of bags and of the products contained therein is maintained, even after the detachment or assembly, and during the entire storage period.
Accordingly, the connections 10 are sterile connections (SC).
Said purpose is achieved primarily through the use of sterile bags 3,4,5,6 and appropriate sterile connections (SC) between the bags, which are capable of maintaining the sterility.
It is therefore correct to assume that not only bag C 6, but each bag 3,4,5 and the entire system 1 of the invention meet the GMP (Good Manufacturing Practices) requirements.
An example of the multiple bag system 1 of the invention is depicted in
In particular it comprises:
In a preferred aspect of the invention, the system may further comprise:
In one embodiment of the invention, the bags 3,4,5,6 described above are also connected to a further bag 2 (bag CB) for the collection and/or the storage of a blood sample, preferably umbilical cord blood, isolated from a subject.
For the purposes of the present invention, a “subject” is intended to be a human being.
Veterinary applications involving the use of umbilical cord blood or blood which is not umbilical cord blood, from an animal are not excluded from the purposes of the present invention.
Among animals, mammals are preferred embodiments of the invention.
In a particular embodiment shown for example in
In a preferred aspect of the invention, the bag system 1 may be assembled from a kit which comprises (according to the definitions above):
In an even more preferred aspect, such a kit further comprises bag 2.
The preparation of the kit for use requires that bag 2 is suitably connected with sets 1 and 2 above.
The connections between the three parts are obtained, as said, by means of suitable sterile connections (SC, 10), for instance in the form of connection pipes, using means known in the field of the invention, such as radio-frequency welding, which are able to ensure and maintain the sterility of the system.
The kit may further comprise suitable means for interrupting, in a reversible manner, the fluid communication between the bags 3,4,5,5′,6,6′,6″ during centrifugation (as for example shown in
Such means are for example represented by clips 11 applicable to the connections 10.
As for the bags 2,3,4,5,5′,6,6′,6″ they may be represented by bags commonly employed in the medical field for the collection and storage of blood and blood components.
Therefore, the bags 2,3,4,5,5′,6,6′,6″ may be made of PVC or other biocompatible plastic material approved for such a use and application.
In a preferred aspect, said material does not contain phthalates and, in particular, the plasticizer bis(2-ethylhexyl) phthalate (DEHP).
Moreover, at least bags A (bag 3), B (bag 4) and D (bag 5 or 5′) must be made of a material resistant to centrifugations up to 3000 rpm and to temperatures up to −80° C.
In a particular aspect of the invention, the material of the inner (internal) surface of a bag 2,3,4,5,5′,6,6′,6″ is treated with suitable anti-fouling procedures in order to prevent the formation of bacterial biofilms which could seriously compromise and impair the safety of the blood component stored within.
In another particular aspect of the invention, the material of the inner (internal) surface of a bag 2,3,4,5,6 is treated with anti-adhesive methods so as to prevent the adhesion of cells, especially platelets, which circumstance would reduce the number of platelets available for the production of the blood component.
In a preferred aspect of the invention, the material surface is subjected to suitable anti-thrombotic treatments in order to prevent the clumping of platelets.
Such treatments, for example, may cause surface modifications by means of plasma etching procedures, carried out with techniques and according to methods known in the field.
Moreover, bag A (bag 3) shall contains a predetermined amount of an anticoagulant agent or a mixture of agents therein.
In particular, the anticoagulant mixture comprises citrate, phosphate and dextrose (known as CPD solution).
More in detail, such a mixture may have the following composition:
Said anticoagulant agent or mixture of anticoagulant agents is preferably included in an amount of about 10-60% (volume/volume of blood component).
Even more preferably, said agent or mixture of agents is included in an amount of about 15 or 20 or 25 or 30 or 35 or 40 or 45 or 50 or 55% (volume/volume of blood component) and even more preferably of about 50% (volume/volume of blood component).
In one embodiment of the invention, the disclosed system of multiple bags 1 is further provided with a traceability system.
For said purpose, one or more bags 2,3,4,5,5′,6,6′,6″ are provided with a traceability system or device which may be represented by a microchip, a smart-code, a radio-frequency micro-transponder or one of the equivalent systems known in the art.
Preferably, the system or device used for the purposes of the present invention is represented by a micro-transponder.
In particular, such a system or device is applied to the outer wall of the bag or can be embedded in the polymer material of the bag 2,3,4,5,5′,6,6′,6″.
The traceability system or device allows to record and store several data about the bag 2,3,4,5,5′,6,6′,6″, its production process (batch, production date) and the production process of the blood component and patient to whom the product is assigned.
From the data stored in the traceability system or device it is thus possible to trace the entire production and distribution process of the bag system 1 even after the delivery to hospitals, pharmacies or patients.
In a preferred aspect of the invention, one or more of the bags 2,3,4,5,5′,6,6′,6″ of the system 1 further comprise means for the facilitated opening of the bag itself.
In a more preferred embodiment, bag C (bag 6, 6′, 6″) is provided with such a system.
Said suitable welding of the two sheets 31 and 32 creates an edge 50.
In the embodiment of the invention wherein it is provided, bag C (6,6′,6″,30) contains a scaffold (or substrate) 100 according to the disclosure here below.
For instance,
Bag C (6,6′,6″,30) is connected to the system 1 of the invention through appropriate in 44 and out 45 manifold tubes.
According to the present invention, the upper sheet 31 of bag C (6,6′,6″,30) comprises a facilitated breakage portion 34 for the same sheet 31.
In a preferred embodiment, also the lower sheet 32 comprises a facilitated breakage portion 34′.
In one embodiment of the invention, such a facilitated breakage portion 34,34′ comprises a partial engraving in the thickness of the sheet 31 and/or 32 (that means that the thickness of the polymeric material of the sheet is partially cut), which is obtained by welding-and-engraving techniques known in technical field.
In other words, the facilitated breakage portion 34,34′ may be represented by one or a plurality of partial engravings in the thickness of the sheet 31 and/or 32.
In other embodiments, the facilitated breakage portion 34,34′ may comprise of one or more, rectilinear or curvilinear engraving realized on one or on both sheets 31,32.
Obviously, such a welding-and-engraving is realized by suitable techniques capable to keep the sterility of the bag and its content and, therefore, of the entire system according to the present invention.
According to one embodiment of the invention shown for example in
The facilitated breakage portion 34,34′ of the present invention allows to divides sheet 31 and/or 32 of bag C (6,6′,6″,30) in two portions: a fixed portion 38,42 and an opening portion 39,43.
A complete opening of bag C 6,6′,6″,30 (or of any bag provided with said facilitated breaking portion) advantageously allows the facilitated extraction of the content from bag C 6,6′,6″,30.
The complete opening allows a method of extraction of the content, which is quick and safe, thus preventing possible contamination of the content by the operator, with their hands or gloves.
Moreover, in one embodiment of the invention, auxiliary opening means of the bag C 6,6′,6″,30 may also be provided, especially for the manual opening.
Said means may represented by one or more gripping portions 40 which allow the fixed portions 38,42 to be retained with one hand by the operator.
Advantageously, this allows to exert a certain retention force and, therefore, a more convenient and easy opening of bag C 6,6′,6″,30.
In one aspect of the invention, such means are coupled to the fixed portions of the upper 38 and/or lower 42 sheet of the bag C 6,6′,6″,30.
In a preferred embodiment, the auxiliary opening means 40 are close to the facilitated opening portion 34,34′ and possibly close to the in manifold pipe 44.
Such auxiliary opening means are for example represented by the tab 40 shown in
In one embodiment of the invention, said auxiliary opening means 40 may represented by a suitable portion of the edge 50 of the bag C 6,6′,6″,30.
The bag C 6,6′,6″,30 of the invention may further comprise additional auxiliary opening means.
Such additional auxiliary opening means may represented by one or more gripping portions 41 which allow to grip and hold the opening portions 39,43 of bag C 6,6′,6″,30.
Advantageously, these additional auxiliary opening means allow to exert a tearing force on the facilitated opening portion 34,34′ and, therefore, render an even more comfortable and easy opening of bag C 6,6′,6″,30.
In a particular aspect, such additional auxiliary opening means are coupled to the opening portion of the upper and/or lower sheets 39,43.
In a preferred embodiment, the additional auxiliary opening means are close to the facilitated breakage portion 34.
Such additional auxiliary opening means are for example represented by tab 41 shown in
In one embodiment of the invention, said additional auxiliary opening means 41 are represented by a suitable portion of the edge 50 of the bag C 6,6′,6″,30.
According to an alternative embodiment of the invention which is represented in
For said purposes, the bag C 6,30,130 shown in
Said suitable welding of the two sheets 131 and 132 creates an edge 150.
Inside the bag C 6,30,130 there may be contained the scaffold (or substrate) 100 according to the present invention.
Bag C 6,30,130 is connected to the system 1 of the invention through appropriate in 144 and out 145 manifold tubes.
In a preferred embodiment, the upper sheet 131 of bag C 6,6′,6″,30 comprises a facilitated breaking portion 134 of the same sheet 131.
In one embodiment, also the lower sheet 132 of the bag C 6,6′,6″,30 comprises a facilitated breaking portion 135 of the same sheet 132.
According to one embodiment of the invention, said facilitated breaking portion 134,135 comprises a partial engraving in the thickness of the sheet 131 and/or 132 (that means that the thickness of the polymeric material of the sheet is partially cut), which is obtained by welding-and-engraving techniques known in the technical field.
According to the present invention, the upper sheet 131 of bag C 6,30,130 may comprise elements for the facilitated breaking and opening of the bag C 160.
In an alternative embodiment, also the lower sheet 132 comprises elements 163 for the facilitated opening of the bag C.
The elements for the facilitated breaking and opening of the bag 160,163 allows to easily divide sheet 131 and/or 132 of bag C 6,6′,6″,30,130 into two portions: a fixed portion 138,142 and an opening portion 139,143.
Preferably, said elements for the facilitated breaking and opening of the bag 160,163 is suitably welded in correspondence with the facilitated breaking portion 134 and/or 135 (as shown in
In a preferred aspect, said elements for the facilitated opening of the bag 160,163 may be represented by a peel-off system.
Said elements for the facilitated opening of the bag 160,163 can be manually actuated with a gripping element, for example represented by a tab 161,162 on each sheet of the bag 131,132.
In one alternative embodiment, the elements for the facilitated opening of the bag 160,163 may comprise a rupture element (not shown in the figures) embedded in the polymeric material of the sheet 131 and/or 132 capable of cutting the polymeric sheet 131 and/or 132.
According to a preferred aspect of the invention, the bag C 6,6′,6″,30,130 of the system 1 comprises a scaffold (or substrate) 100 to which a blood component can adhere.
In a preferred aspect of the invention, the blood component is represented by a platelet concentrate (PC) or a derivative of platelets, such as a platelet gel.
With reference to the scaffold (or substrate) 100 of the invention, it is represented by a matrix, possibly a biocompatible matrix.
For said purpose, a material can be used among:
In particular:
Other materials that may be used as scaffold (or substrate) 100 include: ceramic (hydroxyapatite).
In a preferred aspect, the material of scaffold (or substrate) 100 is fibroin.
According to a preferred embodiment, the scaffold (or substrate) 100 can be subjected to sterilization.
According to a preferred embodiment, the scaffold (or substrate) 100 is not allergenic (capable of eliciting an allergic reaction).
In a particular aspect of the invention, such a scaffold (or substrate) 100 is obtained by means of the 3D printer technology.
According to one embodiment of the invention, the scaffold (or substrate) 100 may be in the form of a patch; alternatively, it may have a cylindrical shape, such as cigarette, suppository, or it may be made in any other appropriate three-dimensional shape suitable for specific therapeutic needs.
In fact, in a particular aspect, the invention discloses the preparation of a shaped scaffold (or substrate) 100 capable of filling a predetermined body cavity, such as a bone cavity.
The information needed to produce a scaffold (or substrate) 100 having precise size and shape may be obtained by means of diagnostic imaging techniques, such as computed tomography.
This allows to create a special-purpose product to meet the needs of a specific patient, as part of the so-called “personalized medicine”.
According to an alternative embodiment of the invention, the scaffold (or substrate) 100 for the platelet gel is not represented by an element but it is represented by the inner (internal) surface of the bag itself (it can be considered itself as a patch).
In a preferred embodiment, said inner surface is the inner (internal) surface of bag C 6,6′,6″,30,130.
To this end, the inner (internal) surface is suitably treated with plasma procedures employing a gas of a different nature (oxygen, argon, hydrogen, nitrogen, air, etc.) in order to increase the platelet adhesion.
The plasma treatment is preferably carried out at room temperature (cold plasma) and at atmospheric pressure.
Moreover, such a treatment is conducted under conditions preventing and avoiding any microbial contamination of the substrate.
According to such an embodiment, once opened, two elements (two patches) can advantageously be obtained from the bag C 6,6′,6″,30,130, each comprising part of the bag wall and a portion of platelet gel adhered thereto.
The present invention therefore provides a medical device represented by a patch obtained with the use of a bag comprising a scaffold (or substrate) which scaffold (or substrate) may also consist of the inner surface of the bag itself, to which a blood component, in particular a platelet gel, has adhered to.
Therefore, objects of the present invention are: a bag for blood components comprising a scaffold (or substrate) to which a blood component, in particular a platelet gel, has adhered, a bag for blood components comprising a blood component adhered to the inner surface of the bag itself, both bags being or not provided with a facilitated opening system as one of the systems above described and a multiple bag system comprising each of said bags.
According to a further aspect of the present invention, the bag C 6,6′,6″,30,130 described above, alone or as a part of the bag system disclosed, comprising a biocompatible scaffold (or substrate) according to the definition given above, wherein said scaffold (or substrate) can also be represented by the inner surface of the bag itself, and wherein a blood component has not adhered to said scaffold (or substrate), may be used as a cell culture chamber.
In a preferred aspect, such cells are stem cells.
According to a second object, the present invention describes a method for preparing blood components through the use of the system of multiple bags described herein.
Such a procedure comprises the treatment of an isolated blood sample, preferably umbilical cord blood, collected in a first bag 2.
Inside bag 2, in particular, the sample is contacted with an anticoagulant preparation represented, for example, by a mixture comprising citrate, phosphate and dextrose (known as CPD solution).
More in particular, such a mixture may have the following composition:
Said anticoagulant preparation is included in an amount of about 10-60% (volume/volume of blood component).
Preferably, said preparation is included in an amount of about 15 or 20 or 25 or 30 or 35 or 40 or 45 or 50 or 55% (volume/volume of blood component) and even more preferably of about 50% (volume/volume of blood component).
According to a first step, the blood collected in bag 2 is transferred to a bag A (bag 3) which is subjected to a low-speed centrifugation, obtaining at the end a sediment at the bottom of the bag represented by red blood cells, while the platelet-rich plasma (PRP) is separated as a surnatant.
In particular, such a step is carried out at a speed of about 220 rpm and for a period of about 10 minutes.
In a second step, the sediment of red blood cells is separated from the platelet-rich plasma, which is transferred to a second bag (bag B, bag 4).
In a third step, bag B (bag 4) is subjected to high-speed centrifugation in order to concentrate the platelets in a small volume at the bottom.
Such a step is preferably carried out at a speed of about 2,000 rpm and for a period of about 15 minutes.
The supernatant obtained is represented by platelet-poor plasma (PPP) which is transferred to another bag (bag D, bag 5), while the platelet concentrate (PC) is kept in bag B (bag 4).
In a subsequent step, the excess platelet-poor plasma (5-10 mL) is transferred in a further bag (bag D).
Bag D (bag 5) is then separated from the multiple bag system 1.
According to a preferred aspect of the invention, bag D (bag 5) is connected to a plurality of single-dose bags (D1, D2, Dn, generally referred to as 5′) for the storage and the administration of platelet-poor plasma aliquots (CBPPP).
In a preferred aspect, such aliquots have a volume of about 1 mL.
In particular, the single doses of CBPPP are used as eye drops.
As regards the platelet concentrate (PC) in a volume of about 5-10 mL collected in bag B (bag 4), in a subsequent step it is suspended and transferred into bag C (bag 6).
Water or saline is preferably used for the suspension of the platelets.
According to a preferred aspect of the invention, bag C (bag 6) comprises internally a three-dimensional scaffold (or substrate) to which the platelets adhere.
Said scaffold (or substrate) is preferably the scaffold (or substrate) above disclosed.
The activation of the sediment of platelets by means of calcium gluconate, thrombin or batroxobin leads to the formation of a platelet gel (CBPG).
The material of bag C (bag 6) is suitably selected so that it can then be subjected to freezing at a temperature of −90° C./−70° C. and preferably of −80° C. and thus stored.
Alternately, the gel may be subjected to freeze-drying which, when needed, can be reconstituted by the addition of water or saline.
During the steps of the procedure described, the fluid communication between the bags 3,4,5,6 may be suitably (reversibly) interrupted with suitable means, (such as shown in
In one embodiment, such means are represented by appropriate clips 11.
As for the scaffold (or substrate), it is represented by a biocompatible matrix.
Therefore, the following materials can be used:
In particular:
Other materials that may be used as scaffold (or substrate) include: ceramic (hydroxyapatite).
In a preferred aspect, the material of scaffold (or substrate) is fibroin.
According to a preferred embodiment, the scaffold (or substrate) can be subjected to sterilization.
According to a preferred embodiment, the scaffold (or substrate) is not allergenic (capable of eliciting an allergic reaction).
In a particular aspect of the invention, such a scaffold (or substrate) is prepared through the 3D printer technology.
According to one embodiment of the invention, the scaffold (or substrate) may be in the form of a patch; alternatively, it may have a cylindrical shape, such as cigarette, suppository, or it may be made in any other appropriate three-dimensional shape suitable for specific therapeutic needs.
In fact, a particular aspect includes preparing a shaped scaffold (or substrate) so as to fill a predetermined cavity, such as a bone cavity.
The information needed to produce a scaffold (or substrate) having precise size and shapes may be obtained by means of diagnostic imaging techniques, such as computed tomography.
This allows to create a special-purpose product to meet the needs of a specific patient, as part of the so-called “personalized medicine”.
According to an alternative embodiment of the invention, the scaffold (or substrate) for the platelet gel is represented by the inner surface of one of the bag of the system 1 of the invention.
In particular, the inner (internal) surface of the bag C (bag 6,6′,6″) may be used.
To this end, the surface is suitably treated with plasma procedures employing a gas of a different nature (oxygen, argon, hydrogen, nitrogen, air, etc.) in order to increase the platelet adhesion.
The plasma treatment is preferably carried out at room temperature (cold plasma) and at atmospheric pressure.
Such a treatment is conducted so as to prevent and avoid any microbial contamination.
According to one aspect of the invention, the preparation of a blood component from umbilical cord blood is preceded by a step of selection of the isolated blood samples to verify the total nucleated cell counts as an approximation of the content of the hematopoietic stem cells suitable for transplantation and possibly, testing for markers for syphilis, HIV, HCV, HBV, bacteria, fungi.
Therefore, in one aspect of the invention, the umbilical cord blood samples used in the preparation of the blood component described are those samples which do not meet the conditions required for the application in the treatment of blood diseases.
According to a further aspect, a biocompatible scaffold (or substrate) is described to which a blood component, preferably a platelet gel, has adhered inside a bag under complete asepsis conditions.
According to another object of the invention, the use of the medical devices obtained according to the present invention for medical treatment is described.
In particular, such a treatment relates to skin ulcers and decubitus ulcers and corneal diseases such as: dry eye syndrome, graft-versus-host disease (GVHD), injuries caused by chemical burns, neurotrophic keratitis, Sjogren's syndrome, systemic sclerosis, rheumatoid arthritis and autoimmunity, corneal ulcers, keratoconjunctivitis.
For the purposes of the present invention, such devices are represented by the bag, the bag system, the patch and the scaffold (or substrate) bearing the platelet gel.
The several advantages offered by the present invention will be apparent from the description above.
First, the system allows to apply a method for simultaneously obtaining two important blood components: a platelet-poor plasma and a platelet gel.
As regards the first product, this can be used in place of synthetic preparations used to treat certain corneal diseases: the so-called “artificial tears”.
Moreover, while there are eye drop preparations obtained from autologous blood serum, these are not without drawbacks and contraindications.
In fact, on the one hand, the patient's blood collection is required, which procedure is not always easy in children and elderly people.
Moreover, while autologous serum offers potential advantages with respect to allogeneic products (compatibility and low risk of transmission of pathogens), it presumably exposes the patients themselves to altered biologic mediators related to their disease.
Therefore, the preparation of allogeneic eye drops is a great opportunity for an alternative use of the scrap units of placental blood, which in about 80-90% of cases is not suitable for use in transplantation in severe blood diseases.
On the other hand, as regards the use of the platelet gel, this can be included in the treatment protocols of skin ulcers and decubitus ulcers, for which the present invention provides a solution which meets current and future therapeutic needs of the health service.
In fact, recent data indicate that about 3% of the population in advanced economies countries is suffering from chronic skin lesions and sores.
A recent evaluation done in Italy (ADNKronos Salute, Mar. 6, 2014) indicates that about 4% of the total costs of the national health system is dedicated to the treatment of about 2 million patients suffering from these diseases, with an absolute cost of nearly 1 billion euros per year.
These costs are generated by 15-20% by the purchase of materials, by 30-35% by the time of the nursing staff and by the remaining 50% by the hospitalization of patients.
Other data from American hospitals indicate that the occurrence of pressure injuries can prolong hospital stays up to 5 times, with an expenditure increase of $ 2,000-11,000 per patient.
The prevention and early treatment of these injuries not only offers the opportunity to reduce morbidity and mortality in these patients, but also significant savings of economic resources.
In addition to reducing costs, a shorter hospital stay almost always is preferred by the patients themselves.
Moreover, it was surprisingly found that a blood component, in particular a platelet gel, adhered to a biocompatible scaffold (or substrate), and especially fibroin, has greater stability over time, retaining its therapeutic properties for a longer time.
An important advantage provided by the multiple bag system of the invention and by the method for preparing blood components and scaffold (or substrate)s bearing blood components is the ability to carry out the entire procedure under aseptic conditions and in compliance with the Good Manufacturing Practices (GMP).
Moreover, the facilitated opening bag allows to store the platelet gel adhered to the scaffold (or substrate) under sterile conditions and therefore is a decidedly practical system for transport and distribution of the same until administration to the patient.
Those skilled in the art will be able to make changes and adaptations to the present invention, without however departing from the scope of the following claims.
| Number | Date | Country | Kind |
|---|---|---|---|
| 102015000020415 | Jun 2015 | IT | national |
| 102015000020430 | Jun 2015 | IT | national |
This application is a divisional of U.S. patent application Ser. No. 15/170,219, filed on Jun. 1, 2016, entitled “System of multiple bags and method for the preparation of hemocomponents,” which claims the benefit of and priority to Italian patent application number 102015000020415 filed on Jun. 4, 2015, Italian patent application number 102015000020430 filed on Jun. 4, 2015, and also claims the benefit of and priority to U.S. Provisional Patent Application No. 61/171,353, filed on Jun. 5, 2015, all of which are incorporated by reference in their entirety herein.
| Number | Date | Country | |
|---|---|---|---|
| 62171353 | Jun 2015 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15170219 | Jun 2016 | US |
| Child | 16354934 | US |
