BR102014000855B1 - device for preparing biological dressing of autologous fibrin - Google Patents

Abstract

abstract "device for preparing biological dressing of autologous fibrin", consists of a device (1) composed of a cylindrical bottom container (2) with lateral inclinations (a) in the direction of a central channel (4) with sag (ß), which directs the liquid sealant (5), remaining from the pressing of the fibrin clot (6) through the sieve (7), in the direction of the outlet nozzle (8) and from there to the multipath collection system (9 ).

Description

(54) Title: DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING (51) Int.CI .: A61L 26/00; A61F 13/00.

(52) CPC: A61L 26/0042; A61L 26/0057; A61F 13/00987.

(73) Holder (s): FERNANDO MENDONÇA ORNELLAS; SÉRGIO SOARES LACERDA; HÉLIO NOGUEIRA DA SILVA JUNIOR.

(72) Inventor (s): HÉLIO NOGUEIRA DA SILVA JUNIOR.

(57) Abstract: SUMMARY DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING, consists of a device (1) composed of a cylindrical bottom container (2) with lateral inclinations (a) towards a channel (4) center with drop (β), which directs the liquid sealant (5), remaining from the pressing of the fibrin clot (6) through the sieve (7), towards the outlet nozzle (8) and from there to the collection system multipath (9).

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DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING

Brief Presentation [0001] The present application for an Invention Patent deals with an unprecedented disposable device made of biocompatible material with human blood, configuring a closed system that, due to its particularities, allows the pressing of the fibrin clot, making the separation of the solid sealant from the liquid sealant, thus creating an autologous dressing, that is, with the patient's own blood.

Field of Application [0002] The device is used by health professionals in the most varied procedures, elective or not, whether in clinics and medical and dental offices, highly complex hospital units, emergency rooms, basic health units, and even in remote locations with little infrastructure, such as combat fronts, oil platforms, rural areas, etc.

Contextualization [0003] Blood is a fluid tissue, formed by a cellular portion that circulates in suspension in a liquid medium, the plasma. This is composed of 92% in water, and the remaining 8% consists of proteins, salts and other dissolving organic components. The cell phase is composed of red blood cells (erythrocytes), white blood cells (leukocytes) and platelets that are incomplete cells formed only by portions of the cytoplasm of the cells that give rise to them (megakaryocytes).

[0004] Platelets, in addition to participating in the coagulation process, also have an active function in the wound repair process, being the first components present at the trauma site, and have anti-inflammatory and regenerative properties. Once activated, platelets release growth factors.

[0005] In this context, the biological sealant is the liquid part added to the Platelet Rich Plasma (PRP), and reproduces the final blood clotting phase, in which fibrinogen is converted to fibrin in the presence of thrombin (factor XIII), fibronectin and ionized calcium (plasma proteins). Thrombin and fibrinogen promote the sealing of the surgical area.

Petition 870190122795, of 11/25/2019, p. 14/23

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State of the Art [0006] Generally, the preparation of a biological dressing does not have the conditions to be carried out in an autologous way, but only in a heterologous way with the blood collected from third parties.

[0007] This is because the most used resource to perform this procedure is totally improvised, with a high degree of handling by the professional, and because the components are made of stainless steel, with acidic pH, they do not present biocompatibility with human pH blood. discretely alkaline.

[0008] Operationally, the product from a blood bank is subjected to a centrifugation process to obtain a fibrin clot. With the aid of tweezers and scissors, the PRP is cut over a stainless sieve and set aside in a separate container of the same material. Then, the PRP is pressed onto a stainless steel plate with holes that drain the liquid part into a flat bottom vessel.

[0009] In short, the preparation of dressing with biological sealant as explained has the main drawbacks:

S It makes it impossible to prepare the dressing autologously;

S It is not possible to standardize the form and consistency of the dressing

- manual process, with application of different compression forces;

S Contamination risk - as it is an open process;

S Waste - the remaining liquid part of the compression is lost, since the container in which it is deposited has a flat bottom and does not have means for routing, draining and storing the fluid;

S Effectiveness of the product compromised - the hydrogen potential differential between stainless steel and blood causes partial clot neutralization, inactivating much of the final product.

[0010] The current state of the art anticipates some patent documents dealing with autologous means for preparing dressings, as in US 20050236325, which comprises a centrifuge with a reservoir to receive and separate a blood sample from a patient, forming and separating a plasma

Petition 870190122795, of 11/25/2019, p. 15/23

3/5 platelet-rich plasma low in platelets and red blood cells. In the first chamber, an activating agent forming a clot is added, which is crushed and the resulting serum containing autologous thrombin is collected. This is mixed in the second chamber with the platelet-rich plasma in the second chamber forming the sealant.

[0011] The above equipment, despite allowing the autologous preparation of the dressing, is of complex construction and of complicated asepsis / cleaning. This limits its massive employment, and use in places without infrastructure.

Objectives of the Invention [0012] It is a first objective to propose a disposable device, made of material biocompatible with human blood, easy to handle and highly mobile, which allows the preparation of consistent and homogeneous dressings from fibrin extracted from the blood of the blood itself patient.

[0013] It is a second objective to promote the complete capture and use of the remaining liquid part of the pressing of the fibrin clot.

[0014] It is a third objective to produce a dressing of great quality and efficiency. Summary of the Invention [0015] The device is formed by a cylindrical bottom container with slopes in agreement in the direction of a central channel with posteroanterior drop, which ends in a nozzle and from there to hoses and syringes of a multi-way collection system. A sieve with holes to be positioned inside the container serves as a basis for pressing the fibrin clot generated in a centrifuge with the patient's own blood. The lid of the device exerts a slight compression on the fibrin clot, removing the excess liquid that passes through the orifices, and, as already mentioned, is drained through the central channel towards the multi-way collection system. [0016] Thus, with the clot pressing it is possible to prepare a consistent and homogeneous dressing ready to be used, and with total preservation of the liquid sealant. In the sieve, there are some larger diameter holes that provide for receiving conical molds, thimble type, which filled with the fibrin clot pressed by billet, configure a dressing of a differentiated shape appropriate, for example, to be used in the segment of dental implants .

Petition 870190122795, of 11/25/2019, p. 16/23

4/5 [0017] The invention is explained below with reference to the accompanying drawings, for illustrative and non-limiting purposes in which they are represented:

Fig. 1: Perspective view of the device for preparing biological dressing of autologous fibrin;

Fig. 2: Exploded perspective view of the device for preparing biological dressing of autologous fibrin;

Fig. 3: Anterior sectional view of the device for preparing biological dressing of autologous fibrin;

Fig. 4: Side sectional view of the device for preparing biological dressing of autologous fibrin;

Fig. 5: Side sectional view of the device for preparing biological dressing of autologous fibrin, showing use and originated dressing;

Fig. 6: Side sectional view of the device for preparing biological dressing of autologous fibrin, showing use with the mold and originated alveolar dressing.

Detailed Description of the Invention [0018] THE DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING consists of a device (1) composed of a bottom cylindrical container (2) (3) with lateral inclinations (α) towards a channel (4) ) central with drop (β), which directs the liquid sealant (5), remaining from the pressing of the fibrin clot (6) through the sieve (7), towards the outlet nozzle (8), and from there to the system multi-way collection (9).

[0019] More particularly, the device (1) is made of material biocompatible with human blood, preferably polypropylene sterilized by ethylene oxide, being composed of a cylindrical bottom container (2) with lateral inclinations (α) in the direction of a central channel (4) with posteroanterior slope (β), ending in a nozzle (8) that receives a tip (10) with locks (11) that guarantees its fixation in the referred container (2). From the tip derives a multi-way collection system (9) represented by at least one hose (12) connected to a valve (13) with at least two ways, in turn connected by hoses (14) to the syringes (15) where the sealant liquid (5) remaining from pressing fibrin clot (6) is

Petition 870190122795, of 11/25/2019, p. 17/23

5/5 stored, thus enabling full utilization. On the inner wall of the container (2) there are perimeter toggles (16) that serve as a base for the support of the sieve (7) with two diameters of holes (17 and 18), keeping a spacing (X) in relation to the bottom ( 3), sufficient for the flow of the liquid sealant (5) towards the multipath collection system (9). Therefore, the fibrin clot (6) is placed over the sieve (7) and respective holes (17), being subjected to a slight compression effected by the cap (T) whose handle (19), design and dimensions allow the internal sliding to the container (2), giving rise to a homogeneous, consistent and standardized dressing with symmetry of size and thickness. Finally, the larger diameter holes (18) are suitable for receiving conical molds (21) whose ends are denoted holes (22) for the overflow of the liquid sealant (5) remaining from the clot pressing (6) of fibrin effected by a suitable billet (23), thus giving rise to an alveolar dressing (24). Likewise, the remaining liquid sealant (5) is captured by the multi-way collection system (9), and used in its entirety.

[0020] For the reasons explained above, the original disposable device, manufactured in material biocompatible with human blood, has a high degree of inventiveness since it allows the autologous preparation of the dressing, without any type of loss / waste of biological sealants that travel through a sterile circuit in a closed system with no margin for contamination, which added to the industrial application makes it worthy of the patent privilege of Invention.

Petition 870190122795, of 11/25/2019, p. 18/23

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Claims (5)

1) DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING, made of material biocompatible with human blood characterized by being composed of a bottom container (2) with slopes (α) and a channel with slope (β) in the direction a nozzle (8); toggles (16) support a sieve (7) with two hole diameters (17 and 18) superimposed on the cap (T) for pressing the fibrin clot (6) made with the patient's own blood, which seeps through the holes (17 ) for a multipath collection system (9). 2) DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING according to claim 1, characterized by the multipath collection system (9) derived from a tip (10) with locks (11), being formed by at least one hose (12) connected to a valve (13) with at least two ways connected by hoses (14) to the syringes (15) for suction of the liquid sealant (5). 3) DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING according to claim 1, characterized by the hole (18) receiving a conical mold (21) with holes (22). 4) DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING according to claim 3, characterized in that the pressing of the fibrin clot (6) in the molds (21) is carried out by a billet (23). 5) DEVICE FOR PREPARING AUTOLOGICAL FIBRINE BIOLOGICAL DRESSING according to claim 3, characterized by originating a dressing (20) with the use of the holes (17), and alveolar dressing with the use of the molds (21) in the holes (18) ). Petition 870190122795, of 11/25/2019, p. 19/23 1/5 FIGURE 1

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