Abstract: A titanium test tube, having a transparent window to aid in visibility and distinction of organized Platelet Rich Fibrin with in the test tube. The window extends longitudinally, i.e., along the vertical axis of the apparatus (along the length of the apparatus and between the said bottom and said brim) such that the bodily fluid or various compositions thereof, stored inside the apparatus is visible from the outside the apparatus.
Claims:I/We claim:
1. An apparatus for storing and centrifuging bodily fluids, the apparatus comprising:
a longitudinal body;
a transparent window;
a brim; and
a bottom.
2. The apparatus as claimed in claim 1, wherein the said apparatus is made of titanium metal.
3. The apparatus as claimed in claim 1, wherein the said apparatus is made of Grade-IV titanium.
4. The apparatus as claimed in claim 1, wherein the said apparatus is used for preparing Titanium-prepared Platelet-Rich Fibrin (T-PRF).
5. The apparatus as claimed in claim 1, wherein the said longitudinal body is tubular or cylindrical in shape and extends between the said bottom and the said brim.
6. The apparatus as claimed in claim 1, wherein said transparent window is fabricated on the said longitudinal body and extends along the vertical axis of the apparatus and between the said bottom and said brim such that the bodily fluid stored inside the apparatus are visible from the outside the apparatus.
7. The apparatus as claimed in claim 1, wherein the said transparent window is made of a transparent material.
8. The apparatus as claimed in claim 1, wherein the said brim is circular in shape.
9. The apparatus as claimed in claim 1, wherein the said bottom is flat in shape.
10. The apparatus as claimed in claim 1, wherein the said bottom is curved in shape
, Description:TECHNICAL FIELD
[0001] The present disclosure relates to improvement in titanium test tubes. In particular, it relates to an improved titanium test tubes provided with a pure glass transparent window for the purpose of transparency that aids in visibility and distinction of organized Platelet Rich Fibrin with in the test tube.
BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] In the recent years there has a been a growing interest in the use of Platelet Rich Products for the treatment of many clinical conditions in dentistry. Platelet Rich Fibrin is one such product that has proved its worth and has edged past the others and has been tagged as a healing biomaterial. The platelet concentrates have been used for the improvement of reparation and regeneration of the soft and hard tissues after various Periodontal surgical procedures.
[0004] Platelet-rich fibrin was first developed as an autologous leukocyte and platelet-rich fibrin (L-PRF) biomaterial in France since 2001. Unlike other platelet rich products, this technique requires neither an anticoagulant nor bovine thrombin (nor any other gelling agent). Without an anticoagulant, most platelets are activated within a few minutes after contacting the tube walls, which initiates the coagulation cascade.
[0005] Fibrinogen is initially concentrated in the upper part of the tube, before the circulating thrombin transforms it into fibrin. A fibrin clot is then formed in the middle of the tube, just between the red corpuscles at the bottom and the acellular plasma at the top. Quick handling is the only way to obtain a clinically usable PRF clot.
[0006] PRF is the second-generation platelet concentrate widely used to accelerate soft and hard tissue healing is a strictly autologous fibrin matrix containing a large quantity of platelet and leukocyte cytokines. Ross et al. were amongst the pioneers who first described a growth factor from platelets. Growth factors are released after activation from the platelets trapped within fibrin matrix and have been shown to stimulate the mitogenic response in the periosteum for bone repair during normal wound healing.
[0007] Clinical Implications of PRF has wide applications both extraorally and intraorally as described below.
• PRF and PRF membrane have been used in combination with bone grafts to hasten
the healing in lateral sinus floor elevation procedures [29].
• Protection and stabilization of graft materials during ridge augmentation procedures
• Socket preservation after tooth extraction or avulsion
• PRF membrane has been used for root coverage with single and multiple teeth recession
• Regenerative procedures in treatment of 3-walled osseous defect.
• In the treatment of combined periodontic endodontic lesion.
• Treatment of furcation defect.
• PRF enhances palatal wound healing after free gingival graft.
• Filling of cystic cavity.
[0008] Extraoral Clinical Applications- Use of PRF in periodontology and oral and maxillofacial surgery has been largely described.
• PRF promotes dentinogenetic by stimulating cell proliferation and differentiation of Dental Pulp Cells
• To augment Achilles tendon repair.
• PRFM can provide significant long-term diminution of deep nasolabial folds.
• Application in facial plastic surgery
[0009] PRF preparation requires only a plain glass tube to activate the intrinsic coagulation pathway to form a fibrin clot. However, this simple prerequisite has ironically proven problematic in the clinical setting, since the production of plain glass tubes has been discontinued by major medical device manufacturers, restricting a stable supply of the tubes for clinicians. Instead, clinicians tend to use silica-coated plastic blood collection tubes, as the tubes are produced by major manufacturers and are readily available.
[0010] The necessity for glass tubes and the alternative use of silica-coated tubes are explained by the activation of coagulation factor XII by the negatively charged silanol groups on the glass surface. The surface of silica, which is a major component of glass, is also negatively charged. Thus, it can be substituted for glass. Silica microparticles used for surface coating can be easily detached upon blood collection and act ubiquitously to activate the coagulation cascade more efficiently than glass.
[0011] Hideo Masuki et al., demonstrated using spectrophotometric and microscopic methods that silica microparticles detached from the inner wall are immediately incorporated into the PRF matrix, which will be consequently incorporated into the implantation sites. These microparticles can be released like growth factors as fibrin clots are degraded by plasmin or other non-specific endogenous proteases and may influence the surrounding tissues and cells.
[0012] Increasing numbers of studies have demonstrated that crystalline silica particles induce toxic effects on cultured cells. The mechanism of its cytotoxicity is thought to be injury of the plasma membrane by silica-dependent production of reactive oxygen species. During and after preparation of PRF matrix, silica microparticles may also over-activate or disrupt platelets and other blood cells in the PRF matrix to reduce its therapeutic potency and efficacy. Thus, it is plausible to suggest that tissue regeneration could be hampered or disrupted.
[0013] The major advantages of PRF are low cost and high safety. Introducing possible silica hazards to this balance seems risky and may hamper the advances in PRF therapy. L-PRF has been widely used over the years with success but the discovery of potential risk and cytotoxicity
associated with the silica contained in the end product due to glass tube centrifugation process (O’Connell et al., 2007) led to the discovery of T-PRF
[0014] Titanium-prepared platelet-rich fibrin (T-PRF) is the third-generation platelet concentrate, developed by Tunali et al. in 2011. It is a platelet leukocyte rich fibrin similar to that obtained from the classical L-PRF method, but the usage of titanium tubes in the centrifugation makes it safer and biocompatible. The T-PRF method is based on the hypothesis that titanium may be more effective in activating platelets than the silica activators used with glass tubes in Choukroun’s L-PRF method. T-PRF is used to avoid any short- and/or long-term negative effects of dry glass or glass-coated plastic tubes and to eliminate the concerns regarding silica.
[0015] T-PRF is prepared in Grade IV titanium tubes Titanium is one of the corrosion resistant materials which forms an adhesive oxide layer and becomes passive in vitro, creating an excellent functional network with the underlying bone and exhibiting osseointegration (Takemoto et al., 2004). Hemocompatability of titanium makes it suitable for biomedical devices and grafts used in surgeries
[0016] Fibrin network created with T-PRF was more tightly woven and thicker because titanium helped in formation of better polymerized fibrin structure as compared to the silica present in L-PRF which interfered with the polymerization procedure (Tunali et al., 2014).
[0017] T-PRF shows increased duration of release of growth factors as compared to L-PRF, due to its stronger fibrin network and longer resorption rate in the tissues, can be used in conjugation with bone grafts as it offers excellent wound healing, bone growth, haemostasis and better handling of graft materials
[0018] T-PRF is shown to upgrade phosphorylated extracellular signal regulated protein kinase expression and suppression of osteoclasts by promoting the secretion of osteoprotegenin in
osteoblastic cultures. It stimulates osteogenic potential by differentiation of human dental pulp cells by upgrading the alkaline phosphatases
[0019] Healing with TPRF is shown to increase tissue thickness and resemble primary healing rather than secondary healing thus, having an excellent soft tissue closure due to stronger cellular matrix which promotes cell migration and growth factor release (Dohan Ehrenfest et al., 2010). T-PRF creates a more homogenous environment with stronger tissue matrix and improves osseointegration, bone regeneration and decreases periimplantitis and bone defects.
[0020] PREPARATION OF T-PRF CLOT/ MATRIX:
Recently, Tumali and his co-workers developed a simple method to prepare T PRF but without exogenously adding supplements.
The preparation of T- PRF is simple and a protocol for its preparation is discussed below:
• Venous blood is withdrawn from the patient (˜10 ml) and is immediately placed inside a Grade IV Titanium test tube containing no anticoagulant.
• The blood was quickly collected, and the tubes were immediately centrifuged at 2,800 rpm for 12 minutes with a specific table centrifuge.
• Once the centrifugation is complete the test tubes are withdrawn from the centrifuge machine and as a result of centrifugation, three layers are formed through natural clotting in the test tube. The three layers are as follows:
o Acellular platelet-poor plasma accumulates on top of the tube
o The fibrin formed is rich in platelets and leukocytes, that is, PRF clot occurs in the central part of the tube
o The layer of red blood cells gets accumulated at the bottom of the tube
• After centrifugation, the T-PRF clots are removed from the tubes using sterile tweezers, separated from the RBC base using scissors, and placed on sterile woven gauze to release their serum.
• Out of the above 3 layers only the middle layer is required for the formation of T-PRF membrane which has application in dentistry. While the other two layers are discarded. This platelet rich fibrin gel formed in the middle part is rich in 10 platelet and leukocytes, this is, PRF clot which is created through natural coagulation mechanism with centrifugation and it is obtained without any biochemical modifications of blood.
[0021] Choukroun’s method of preparation for L-PRF utilizes dry glass or glass-coated plastic tubes with silica. These tubes are cylindrical hollow-wares with the lowest surface area, compact design, highest mechanical strength and with an optical clarity.
[0022] To eliminate the speculations about the potential negative effects of silica from dry glass or glass-coated plastic tubes, Tunali et al have modified the initial L-PRF method by changing the structure of the tubes and used a more biocompatible material, titanium [20]. Grade IV Titanium tubes were used.
[0023] Grade 4 or Grade-IV is known as the strongest of the four grades of commercially pure titanium. It is also known for its excellent corrosion resistance, good formability and weldability. However, due to the opaque nature of titanium tubes the viewability of the formed PRF clot is lacking. This lack of transparency in the titanium tubes leads to uncertainty whether if surely the PRF clot has formed inside the tube.
PRIOR ART
[0024] For instance, prior art does disclose presence of transparent window in test-tubes. For instance, CN206476995 discloses a pair of PCR test tube, including at least one end open -ended body, be provided with the heat -conducting part on the partial pipe wall of body. The utility model provides a PCR test tube is through reducing the heat -conducting part area, and prevent test tube calorific loss and the intraductal temperature that leads to too reduces. The PCR cuvette according to any one of claims 1 to 8, wherein a window of transparent material is provided on the wall of the tube.
[0025] Further, CN212679115 discloses a disposable simple and easy self-service painless formula blood sampling device which characterized in that: the device comprises an outer shell (1), wherein the outer shell (1) is cylindrical, the inside of the outer shell (1) is divided into an upper cavity (2) and a lower cavity (3) from top to bottom, and an annular silica gel ring (11) is arranged at the bottom of the lower side of the outer shell (1);
[0026] CN109499647 discloses a test tube device for food safety inspection. The test tube device comprises a test tube body, wherein a cover is arranged at the upper end part of the test tube body; a strawis arranged at the bottom of the cover; the test tube device is characterized in that a shell made of a soft material is arranged at the outer side of the test tube body; a transparent observation window is arranged on the shell; a supporting block is hinged to a position, close to the cover, on the test tube body; a clamping plate is arranged at the other side of the supporting block; the supporting block is connected with the clamping plate through a spring; the test tube body is located in the shell made of the soft material; the cover is fixed again through the clamping plate; the test tube body can be prevented from being crushed, the cover has good tightness and can be used for preventing a detected object from being leaked.
[0027] CN109499647 discloses a test tube device for food safety inspection. The test tube device comprises a test tube body, wherein a cover is arranged at the upper end part of the test tube body; a straw is arranged at the bottom.
[0028] Though the prior art test-tubes disclose presence of test-tubes with a transparent window, they are inefficient since they are not made of titanium.
[0029] Therefore, there is a requirement of an improved test-tubes, made of titanium, having means to visualize the fluid contained in the test-tube to prevent the uncertainty related to formation of PRF clot inside the tube.
[0030] All publications herein are incorporated by reference to the same extent as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. Where a definition or use of a term in an incorporated reference is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.
[0031] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about.” Accordingly, in some embodiments, the numerical parameters set forth in the written description and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable. The numerical values presented in some embodiments of the invention may contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.
[0032] As used in the description herein and throughout the claims that follow, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[0033] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (e.g. “such as”) provided with respect to certain embodiments herein is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the invention.
[0034] Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability. When any such inclusion or deletion occurs, the specification is herein deemed to contain the group as modified thus fulfilling the written description of all Markush groups used in the appended claims.
OBJECTS OF THE INVENTION
[0035] A general object of the present disclosure is to an improved test-tube, made of titanium, having means to visualize the fluid contained in the test-tube.
[0036] An object of the present invention is to facilitate T-PRF through a titanium test-tube, having the facility to visualize the fluid contained in the test-tube.
[0037] An object of the present invention is to provide a titanium test tubes with a pure glass vent for the purpose of transparency that aids in visibility and distinction of organized Platelet Rich Fibrin with in the test tube.
[0038] Yet another objective is that the transparent window aids in distinction of the formed Platelet Rich Fibrin from RBC’s formed below and Platelet poor plasma at the bottom.
[0039] Another objective is to facilitate Grade 4 or Grade-IV, commercially pure titanium test-tubes, having excellent corrosion resistance, good formability, weldability, and transparency to obviate the uncertainty related to the formation of PRF clot inside the tube.
SUMMARY
[0040] Aspects of the present disclosure relate to surgical instrument. In particular it relates to an improved test-tube, made of titanium, having means to visualize the fluid contained in the test-tube.
[0041] In an embodiment, the proposed apparatus is used for storing and centrifuging bodily fluids such as blood, plasma, or other similar fluids.
[0042] The apparatus is in the form of conventional test-tubes. The apparatus comprises a longitudinal body, a transparent window, a brim or lip, and a bottom.
[0043] According to an embodiment of the present invention, the transparent window is fabricated on the apparatus body.
[0044] The body of the apparatus is fabricated/casted such that it can house a transparent window. The metallic body of the apparatus can have a longitudinally portion or section, which extends between the bottom and the brim. The transparent window is snug-fitted in the said longitudinal portion.
[0045] The window extends longitudinally, i.e., along the vertical axis of the apparatus (along the length of the apparatus and between the said bottom and said brim) such that the bodily fluid or various compositions thereof, stored inside the apparatus is visible from the outside the apparatus.
[0046] If a person wishes to examine, or simply have a look at, the fluids, perhaps before starting the centrifugation process or afterwards, he can see the fluids through the transparent window.
[0047] Various objects, features, aspects and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.
BRIEF DESCRIPTION OF THE DRAWINGS
[0048] The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.
[0049] FIG. 1 illustrates an exemplary image of the disclosed apparatus for storing and centrifuging bodily fluids, in accordance with the first embodiment of the present disclosure.
[0050] FIGs. 2A & 2B illustrate top views of apparatus, showing different forms/designs of the transparent window, in accordance with embodiments of the present disclosure.
DETAILED DESCRIPTION
[0051] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.
[0052] Each of the appended claims defines a separate invention, which for infringement purposes is recognized as including equivalents to the various elements or limitations specified in the claims. Depending on the context, all references below to the "invention" may in some cases refer to certain specific embodiments only. In other cases, it will be recognized that references to the "invention" will refer to subject matter recited in one or more, but not necessarily all, of the claims.
[0053] Various terms are used herein. To the extent a term used in a claim is not defined, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of filing.
[0054] Referring to figure 1, it depicts an exemplary image of the proposed apparatus 100 for storing and centrifuging bodily fluids such as blood, plasma, or other similar fluids.
[0055] The apparatus 100 comprises a longitudinal body 106, a transparent window 104, a brim or lip 102, and a bottom 108.
[0056] According to an embodiment of the present invention, the transparent window 104 is fabricated on the apparatus body 106. The window 104 extends longitudinally, i.e., along the vertical axis of the apparatus 100 and between the said bottom 108 and said brim 102 such that the bodily fluid stored inside the apparatus are visible from the outside the apparatus, i.e., if someone wish to examine, or simply have a look at, the fluids, perhaps before starting the centrifugation process or afterwards, he can see the fluids through the transparent window.
[0057] According to an embodiment of the present invention, figures 2A and 2B depict exemplary images of the top view of the apparatus, wherein two different versions of the transparent window 202-1 and 202-2 are depicted.
[0058] According to the first embodiment of the proposed invention, figure 2A depicts that the transparent window 202-1 is housed inside the apparatus and extends only/within the interior of the apparatus.
[0059] According to the second embodiment of the proposed invention, figure 2B depicts that transparent window 202-2 extends horizontally, i.e., towards the surface of the brim 204-2 such that the outer surface of the transparent window aligns with it the outer surface of the brim.
ADVANTAGES OF THE INVENTION
[0060] The present disclosure provides an improved test-tube, made of titanium, having means to visualize the fluid contained in the test-tube.
[0061] The present disclosure facilitates T-PRF through a titanium test-tube, having the facility to visualize the fluid contained in the test-tube.
[0062] The present disclosure provides a titanium test tube with a pure glass window for the purpose of transparency that aids in visibility and distinction of organized Platelet Rich Fibrin with in the test tube.
[0063] The present disclosure provides a test-tube with a transparent window, incorporating the glass aids in distinction of the formed Platelet Rich Fibrin from RBC’s formed below and Platelet poor plasma at the bottom.
[0064] The present disclosure facilitates Grade 4 or Grade-IV, commercially pure titanium test-tubes, having excellent corrosion resistance, good formability, weldability, and transparency to obviate the uncertainty related to the formation of PRF clot inside the tube.
[0065] CLAIMS
I/We claim:
1. An apparatus for storing and centrifuging bodily fluids, the apparatus comprising:
a longitudinal body;
a transparent window;
a brim; and
a bottom.
2. The apparatus as claimed in claim 1, wherein the said apparatus is made of titanium metal.
3. The apparatus as claimed in claim 1, wherein the said apparatus is made of Grade-IV titanium.
4. The apparatus as claimed in claim 1, wherein the said apparatus is used for preparing Titanium-prepared Platelet-Rich Fibrin (T-PRF).
5. The apparatus as claimed in claim 1, wherein the said longitudinal body is tubular or cylindrical in shape and extends between the said bottom and the said brim.
6. The apparatus as claimed in claim 1, wherein said transparent window is fabricated on the said longitudinal body and extends along the vertical axis of the apparatus and between the said bottom and said brim such that the bodily fluid stored inside the apparatus are visible from the outside the apparatus.
7. The apparatus as claimed in claim 1, wherein the said transparent window is made of a transparent material.
8. The apparatus as claimed in claim 1, wherein the said brim is circular in shape.
9. The apparatus as claimed in claim 1, wherein the said bottom is flat in shape.
10. The apparatus as claimed in claim 1, wherein the said bottom is curved in shape.
| # | Name | Date |
|---|---|---|
| 1 | 202121047586-STATEMENT OF UNDERTAKING (FORM 3) [20-10-2021(online)].pdf | 2021-10-20 |
| 1 | Abstract1.jpg | 2022-01-25 |
| 2 | 202121047586-FORM 1 [20-10-2021(online)].pdf | 2021-10-20 |
| 2 | 202121047586-FORM 13 [15-12-2021(online)].pdf | 2021-12-15 |
| 3 | 202121047586-FORM-9 [22-10-2021(online)].pdf | 2021-10-22 |
| 4 | 202121047586-COMPLETE SPECIFICATION [20-10-2021(online)].pdf | 2021-10-20 |
| 4 | 202121047586-DRAWINGS [20-10-2021(online)].pdf | 2021-10-20 |
| 5 | 202121047586-DECLARATION OF INVENTORSHIP (FORM 5) [20-10-2021(online)].pdf | 2021-10-20 |
| 6 | 202121047586-COMPLETE SPECIFICATION [20-10-2021(online)].pdf | 2021-10-20 |
| 6 | 202121047586-DRAWINGS [20-10-2021(online)].pdf | 2021-10-20 |
| 7 | 202121047586-FORM-9 [22-10-2021(online)].pdf | 2021-10-22 |
| 8 | 202121047586-FORM 1 [20-10-2021(online)].pdf | 2021-10-20 |
| 8 | 202121047586-FORM 13 [15-12-2021(online)].pdf | 2021-12-15 |
| 9 | 202121047586-STATEMENT OF UNDERTAKING (FORM 3) [20-10-2021(online)].pdf | 2021-10-20 |
| 9 | Abstract1.jpg | 2022-01-25 |