VI - Density Life Platelets PRP-Tubes
VI - Density Life Platelets is a pack of 10 packed PRP tubes. VI Density Life Platelets is a modular, medical product that is used to produce platelet-rich plasma (PRP). It can be used for many indications for the treatment of damaged limbs and joints.
VI - Density Life Platelets - PRP-Tubes
VI - Density Life Platelets It is a modular medical device for the preparation of Platelet Rich Plasma (PRP) from the collected patient's blood.
These are pre-labeled tubes with red caps containing anticoagulant (ACD); each labeled tube for example 9 ml capacity has a pre-calibrated vacuum for ~ 9 ml of blood sample.
In the case there are one or two test tubes, in each ones there is a separating gel based on an inert polymer and an anticoagulant (named for simplicity of understanding, type 1 test tube, necessary for the separation between serum enriched with platelets (injectable liquid enriched with growth factors) and the concentration of red blood cells (clot) which is determined after centrifugation.
VI - Density Life Platelets is designed to allow the preparation of blood components (platelet gel, fibrin gel, bone marrow cell gel) in an easy, safe and fast way.
The medical device is intended for the handling of autologous blood products.
The rationale for the use of the medical device for wound healing and tissue repair is to administer locally high concentrations of growth factors and tissue repair as found in the platelet concentrate, possibly also providing cells involved in the repair. tissue and a temporary fibrin scaffold capable of supporting cell migration.
PRP Tubes must be used by specially trained medical and nursing staff under medical responsibility. Therapeutic effcacy depends on the intrinsic quality of the preparation of the blood component.
The medical device allows the preparation and activation (gelation) of the blood component; the medical device is not therapeutic in itself. The most important indications for the use of the medical device include the treatment of acute wounds, chronic ulcers involving skin, subcutaneous or mucocutaneous tissues, and bone injuries, subcutaneous flling, strengthening of the hair bulb.
The method based on this preparation is called "BUFFY COAT" with a glass test tube, which differs from the "EMPTY TEST" test (simple vacuum blood collection tube), which doesn’t obtain a concentrate but a serum; it is not able to separate the blood with high precision and to obtain a high concentration of PRP and does not allow to extract only the intermediate layer (PRP).
In addition, the plastic of the test tubes contains micronized silicone which can also generate platelet activation.
All this translates into a platelet-free serum after the centrifugation process which cannot be used for PRP.
VI - Density Life Platelets is not produced with plastic that contains micronized silicone; it has an optimal composition for a maximum biological effect.
Platelet Rich Plasma (PRP), also known as platelet autologous, (Autologous Platelet Gel), a growth factor rich plasma (PRGF) or platelet concentrate (PC), is essentially an increase of the concentration of autologous platelets suspended in a small amount of plasma after centrifugation of the patient's blood. The tubes are available in the following vacuum capacities: 9 ml.
Areas of application
MAXILLO - FACIAL SURGERY
mandibular reconstructions, dental implants, tonal and oropharyngeal fissures
neck and head surgery, facial or nasal fractures; lesions of the dental alveolus; breast enhancement; mandibular reconstruction; bone graft;
oro-nasal fistula; lip repair; rhinoplasty and septum-rhinoplasty; facial fractures;
PLASTIC, RECONSTRUCTIVE, AESTHETIC SURGERY
skin flaps, muscle-skin reconstructions, mammoplasty;
face and neck lifting; musculocutaneous ¬flaps and reconstruction; chronic ulcers; breast reconstruction and mammoplasty; cranio-facial reconstruction; support for laser facial treatments
pseudoarthrosis, osteosynthesis, bone implants, titanium prosthesis implants
vertebral reconstructions; Burr holes and craniectomy; cerebrospinal fluid loss
VASCULAR AND CARDIOTORACIC SURGERY
sternum repair; arterial bypass; rterial reconstruction; broncho-pleural fistula;
corneal ulcers and wounds; macular lesion repairs (with hyperconcentrated platelets)
hair bulb regeneration
GENERAL MEDICINE, GERIATRIA, DIABETOLOGY, HAEMATOLOGY, GENERAL SURGERY, DERMATOLOGY, RADIOTHERAPY
are all specialized areas in which ulcers or acute or chronic cracks, primary or secondary, could find a therapeutic support in the use of platelet gel.
The devices are to be used only by experienced personnel with handling requirements.
Use the PRP with particular caution in the following cases:
• acute or chronic infections at the surgical site;
• uncontrolled metabolic pathologies, such as diabetes, osteomalacia, thyroid dysfunction, severe kidney or liver pathologies;
• long-term cortisone therapy;
• autoimmune diseases;
Patients with congenital or acquired functional platelet defects may release fewer growth factors in relation to the platelet defect. In the case of thrombocytopenia it is very difficult to obtain a sufficiently rich platelet concentrate for clinical use. The platelet gel is reabsorbed in a few days.
No toxicity phenomenon is described in the gel treated tissues. Normal surveillance procedures or prophylaxis against infectious complications should be applied.
Growth factors of platelet origin induce cell proliferation. The use of platelet gel is contraindicated in case of suspected lesions of malignant degeneration.
To ensure tissue regeneration, the PRP must be inserted exclusively in vital tissue and in direct contact with the same (if necessary, by making micro-openings on the surface of the tissue).
By following these instructions for use, this medical device with a set of accessories allows to obtain a PRP with a platelet concentration 4-5 times higher than the original blood sample (1 x 106 platelets / microliter ± 20%).
Growth factors and chemotactic mediators of platelet origin are mainly released passively (that is without platelet activation). Therefore, platelet gel can be prepared from the blood of patients taking oral anticoagulants, heparin, calcium heparin, platelet aggregation inhibitors, cyclooxygenase inhibitors.
However, just because a part of the release of growth factors could depend on the state of activability of the platelets, it is rational to wait for a delay in the release of the growth factors if the patient takes cyclooxygenase inhibitors or anti-cling platelets.
There are no known interactions with systemic or topical agents. The intended use does not include adding medications to the platelet gel. If platelet gel is used for bone regeneration, the gel can be associated with human bones, animal bones certified for human use, other biocompatible materials certified for human use.
VI - Dense Life Platelets - APPLICATION PROTOCOL
The preparation of the PRP consists in the collection of autologous venous blood (that is of the patient himself) which is subsequently subjected to centrifugation and concentrated (method called BUFFY COAT).
Basically, the patient's blood is drawn, collected and centrifuged at variable speeds until it separates into three layers:
- platelet-poor plasma (platelet poor plasma PPP)
- platelet rich plasma (platelet rich plasma PRP)
- red blood cells
Immediately before application, a platelet activator / agonist (based on calcium chloride) can be added to activate the cascade of coagulation, producing a platelet gel. The whole process takes about 12 minutes and produces a platelet concentration 2 to 4 times that of the native plasma.
Set the centrifuge to the following parameters:
1200 RCF (g) (For Hettich EBA 200 to 3400 rpm) for 7 minutes for angle or inclined rotor centrifuges.
To determine the relative centrifugal acceleration (RCF), or to calculate the revolutions per minute (RPM), you can use our converters.
VI - Density Life Platelets PRP tubes is a new generation product manufactured with advanced technology to improve the quality and efficiency of their use. They are all CE marked (93/42/EEC, updated by Directive 2007/47/EEC) and then validated according to numerous ISO certifications such as ISO 9001: 2008, EN ISO 13485: 2012 and EN ISO14971: 2009, ISO 10993 -1: 2009, ISO 10993-3: 2005 and SFDA.
The PRP tubes are sterile primary packaging. Their packaging takes place in a laminar flow environment and is certified as a Class IIb medical device registered with the Ministry of Health under the national registration number with the CND classification.