ABDOLLAHIAZAR NADIEH (IR)
ABDOLLAHIAZAR NADIEH (IR)
| WO2009086270A1 | 2009-07-09 |
| US20160089335A1 | 2016-03-31 |
NADEEMUL HODA ET AL.: "Clinical use of the resorbable bioscaffold poly lactic co-glycolic acid (PLGA) in post-extraction socket for maintaining the alveolar height: A prospective study", JOURNAL OF ORAL BIOLOGY AND CRANIOFACIAL RESEARCH, vol. 6, no. 3, September 2016 (2016-09-01), pages 173 - 178, XP055687896, ISSN: 2212-4268, DOI: 10.1016/j.jobcr.2016.03.001
CHING-WEN CHANG ET AL.: "Development of Swellable Local Implants of a Polyethyleneimine- Poly(Vinyl Pyrrolidone) (PEI-PVP) Hydrogel as a Socket Filler", JOURNAL OF BIOMATERIALS SCIENCE , POLYMER EDITION, vol. 23, no. 17, 2012, pages 2171 - 2184, XP055687898, ISSN: 0920-5063, DOI: 10.1163/092050611X611684
| CLAIMS: 1. The Invention of absorbable scaffold containig slow-release lidocaine includes: • The production of lidocaine with a slow-release characteristic · The preparation of surgicel Matrix and placement of lidocaine and PLGA polymer upon it 2. The invention of number one claim in which the production of lidocaine with the slow-release characteristic is as follows: • Water is mixed with pure lidocaine powder and placed in Bain-Marie device and application of the heat for better mixture of solution (mixture number one) • Acetone is mixed with PLGA polymer and placed in Bain-Marie device in order to be mixed well but this time heat is not used because of the presence of acetone (mixture number two) · Every test tube passes through paper filter and is capped with a lid. • Surgicel pads are cut in different dimensions. • Mixture number one is added on each of the surgicel pads and is left for an hour to be dried • Mixture number two is added on the pads which have been dried and is left for another hour till the scaffolds dry. • After scaffolds dry, mixture number two is once more added and another hour is allowed till it dries. 3. The invention of number one claim whose usage is as follows: At the end of the operation before the flap is a sutured, the surgeon places the transferred scaffold in the operation field by the method explained below: • All these tips should be done under sterilized conditions. • Operation field should be dried before scaffold insertion so that it can have most intake amount of anesthetics. Then, the scaffold can be rolled in the form of a cylinder and this cylinder is put vertically in the place of the socket. It's important at the base of the scaffold should be in contact with the base of the socket and the upper part of the scaffold should stick out of the socket at least for some millimeters and should contact the gum which covers the socket. 4. The invention of number one claim in which minimum lidocaine dose which is applied because of the direct presence of slow-releases scaffold in operation field. 5. The invention of number one claim in which slow-release lidocaine starts being released after 2 to 3 hours in a period of 48 to 72 hours and surgicel pad which has been used as a scaffold gets absorbed in the body after two weeks. 6. The invention of number one claim which control and reduction or eliminate of total analgesic drugs need in patients. 7. The Invention of number one claim in which is slow-release of drugs is one of the characteristics. 8. The Invention of number one claim in which surgicel pads used as a scaffold absorb in the body. 9. The invention of number one claim which can be used in the operation of impacted molar teeth or other human surgeries with the purpose of pain reduction and reduction in pain longevity with a method of drug slow- release which can be absorbed by the body. |
LIDOCAINE
TECHNICAL FIELD:
The present invention is related to the medical field and pain studies. It is also related to a method and means for slow absorb of anti-pain medicines by body after surgery in general and teeth surgery in particular.
TECHNICAL PROBLEMS AND THE PURPOSE OF THE INVENTION:
Naturally, bleeding and pain, which can sometimes endure, after surgery and third molars extraction may annoy the patient. Concerning third molar surgery, Acetagel and Gelofen pills are prescribed after surgery to reduce pain. Strile Gauze is constantly applied for reducing the bleeding. Also because of strong pain Analgesics lose their effect after some time and should be taken again. In general Opioid drug administration is a common technique and are widely used to reduce pain from surgical trauma. However, the aforementioned drugs have side effects which are unavoidable. Henceforth, the patients are involved in the application of all the mentioned medicines in timing of their intake, right usage and as in many cases the medicines are edible or infusion therapy and need to penetrate the first hepatic pass, high dosage is prescribed, which in turn causes big side effects. As regards all the problems mentioned and in order to get over these problems and defects, a more efficient solution and method is proposed. Lidocaine is a standard way to reduce pain after maxiofacial surgery. It has less side effects in comparison to other medicines. The invention of absorbable scaffold containing direct slow- release Lidocaine in surgery area with the least possible dosage. As the surgeon inserts it in the place before suturing , there leaves no role for the patient to play. In the meantime, both patient and surgeon enjoy its benefits.
The present invention is a means that releases the drug slowly and for a long term . So, there is no need for another intake after six hours as is the case with other analgesics. So the patient can peacefully spend his time recovering. BACKGROUND OF THE INVENTION:
Lidocaine with chemistry formula C14 H22 N2 01 and medical name of Lidocaine as an anesthetic medicine is applied in different cases including small-scale surgeries and dentistry as local anesthesia. Its metabolism happens in liver and to a less extent in kidney. It gains effect in 2 to 5 minutes and its longevity is calculated as medium. It is excretion is the form of metabolite. As told before, after surgery on molar teeth, analgesics or Lidocaine infiltration is used to reduce the pain, which at most endure for six hours and after that they lose their effect and the patient feels the pain again. In this field, some patents have already been granted including an invention titled, ‘Dental Pad’, by Milton J Cohen and registration number of 3,386,440 on 19, October, 1965 in USPTO. It is a kind of dense cellulose pad in the shape of H which takes a circular or spherical shape in the middle. In the mentioned pad, it is not only a structure for preventing bleeding after tooth extraction, but it is also, based on the inventor's claim, a pain relief if it is saturated with the drug. In fact, this pad is externally used. Another invention titled,’ Drug Releaser’, registered on 21, November, 1990 in USPTO by Japanese company,’ ARS’ and with registration number of 5,164,186 offers a drug carrier with a porous structure and compatible with human body, in which Calcium Phosphate and 2-hydroxyethyl methacrylate (pHema) and calcined chitin are applied. In this invention, particles with dimensions measuring roughly micrometer or even smaller are created in the form of pill or cylindrical shapes. The drug penetrates into the career as fluid and is injected to the patient ' s body. By the drug being gradually released from inside the mentioned matrix, the drug ' s impact will endure for a long time on the patient ' s body. Another invention titled,‘Granular Ceramic for administration of medicines and medicine supported therein’ by Kyoto corp. on 12, February, 1980 in USPTO presents a ceramic career in spherical or cylindrical. It can hold the drug in its pores because of its porous structure or keep it in the center as an encapsulated content, and transfer the drug to the tissue by leakage. By the ceramic career being implanted inside the patient ' s body, slow release of the drug is affected.
THE DESCRIPTION OF THE INVENTION:
The present invention is a kind of scaffold saturated with slow-release Lidocaine drug (Fig. No. 1), which is implanted in the body at the end of operation before suturing the area. (Fig. No. 4)
The invention is composed of two phases. The first phase is producing absorbable surgicel matrix which plays the role of a scaffold for carrying the drug. The surgicel can be made of poly Glycolic acid, or Poly-dioxanone or Catgut Chromic or Catgut Plain, which can be absorbed by the body. Surgical does not have any negative effect on the body and is absorbed and excreted out of the body two weeks after the drug leaves it. In the second phase, Lidocaine is converted to a slow-release drug. The production method of the mixture no. 1:
At first water is mixed with pure powder of lidocaine and then placed in Bain- Marie device and is heated for better mixing.
The production method of the mixture no. 2:
Acetone is mixed with polymer PLGA and placed in Bain-Marie in order to be mixed well but this time heat is not used because of the existence of acetone. Acetone plays the role of an accelerator in the reaction and it does not remain in the final product.
Final mixture passes through the paper filter and then it's capped with a lid. Surgicel pads are cut in different dimensions. Mixture is added over each of the surgicel pads and it takes 24 hours for them to dry. After a scaffold dries, second mixture is added to them and another hour passes till it dries. In final stage before flap is sutured, surgeon places the transferred scaffold in operation area as follows: 1- All the steps should be sterilized.
2- Dry the operation area before inserting of scaffold so it can have most of the anaesthetics intake. Then, roll a scaffold to a cylinder (Fig. no.2) and insert this cylindrical scaffold in to socket vertically. (Fig. no.3) it's important that the base of this cylinder should be in contact with the base of socket and the upper part of this cylinder should stick out of the pulled socket for at least some millimeters and contact the gum which covers the socket. It should be mentioned that this invention enjoys the minimum lidocaine dosage because of direct application of slow-release scaffold in operation area.
When the slow-release Lidocaine scaffold presents itself in the blood and interstitial fluid, following things happen:
PLGA, in the body, encompasses lidocaine particles inside the water and nanocapsules are formed. (Fig. no.7)
PLGA nanocapsules enter the cell gradually through fluid phase of pinocytosis as well as through endocytosis by Clathrin.
PLGA nanoparticles escape internal lysosomes fast and within 10-minute incubation period enters Cytoplasm. Facilitated interactions of nanoparticles with vesicle membranes destroys the stability of membranes topically and temporarily And leads the nanoparticles to escape inside Intracellular fluid. (Fig. 8)
As PLGA nanoparticles in laboratory releases anti-genes for a long time. Therefore, PLGA nanoparticles act as delivery system. Therefore, PLGA nanoparticles start gradual release of lidocaine as they are hydrophobic and gradually absorb water ( osmosis method ) and you will enjoy a longer anti-pain impact than normal( fig.9) PLGA itself would be metabolized by Krebs cycle and excreted as water and carbon dioxide. BRIEF DESCRIPTION OF FIGURES:
Figure number one: surgicel scaffold picture
Figure number two: slow-release lidocaine-saturated surgicel
Figure number three: The picture of slow-release lidocaine-saturated surgicel inside tooth cavity.
Figure number four: The picture of a sutured cavity after the slow-release lidocaine-saturated surgicel is placed inside the cavity.
Figure number five: The picture of the drug being released inside the patient's jaw Figure number six: the picture of cavity after surgical absorption in body
Figure number seven: formation method of PLGA nanocapsules inside water Figure number eight: penetration method of PLGA particles to Intracellular fluid. Figure number nine: diagram for the efficiency of anti -pain drug in a longer period
THE DESCRIPTION OF AN APPLIED EXAMPLE:
First, 10 cc water is added to a gram of pure Lidocaine powder in test tube and then it is placed in Bain-Marie device. Heat used for better mixture of the solution. In another test tube, 15 mms of acetone is mixed with 0-75 gram of PLGA and is then placed in Bain-Marie device so that it is mixed well.( heat in this stage is not used) Afterwards, each test tube passes through 0.22pm Whatman paper filter and its lid is capped. Surgicel pads are cut in 2*2 cm dimensions. On each surgicel pad, 200 pm mixture of water and Lidocaine is added by pipette tip and 24 hours are allowed till it dries. After 24 hours, 200 pm (mixture of prepared PLGA and acetone) is added on dried pads by pipette tip and one hour is allowed till a scaffolds dry. After a scaffold dry, 200 pm (mixture of prepared PLGA and acetone) is added by pipette tip and 1 hour is allowed to dry. Altogether, 400pm (mixture of prepared PLGA and acetone) is added to scaffold.
BRIEF DESCRIPTION OF THE ADVANTAGES OF THE INVENTION:
This invention was performed on the 72 patients with impacted third molar as a clinical trial study and following things happen:
Pain reduction by 58% more in comparison to other routine treatments.
The reduction of pain duration by 71% in comparison to other routine treatments.
Bleeding time reduction by 86% because of the use of surgicel
The reduction of the of analgesics administration after the operation by 60 to 70%.
The facilitation of application by the doctor
The facilitation of production
The removal of patient’ s role in reducing the pain after surgery INDUSTRIAL APPLICATION OF THE INVENTION:
The Invention can be used in molar teeth surgeries or other operations in the body in order to reduce the pain and its length after the operation through a technique called slow-release of the drug.