Biofilm genetic and algorithm test for medical devices

Abstract

A method of detecting the risk of biofilm development comprising: taking a blood sample from a patient; analysing the blood sample by performing human leukocyte antigen (HLA) genotyping; determining i

Description

The problem this patent application seeks to resolve. Each year millions of successful operations take place which involve the insertion of a medical device into the patient such as Hip replacements, knee replacements, surgical mesh, breast surgery, stents. Whilst many of these procedures are very successful and display excellent long term outcomes, some of the patients suffer infections following the surgery. In some cases these infections may lead to the patient requiring further medical intervention, or antibiotics or in severe cases the devices may need to be removed followed by long term use of antibiotics. In some surgical procedures (particularly orthopaedics) the widespread use of antibiotics is used prophylactically to assist in a successful out one. Antibiotics are given the patient in different forms eg intravenous, orally, on surface coatings of the device or in the fixation mediums such as cement in the case of orthopaedic devices. There has been strong evidence that the overuse of antibiotics can lead to multi-resistant bacteria and there has been a drive to reduce the use of antibiotics generally in order to maintain there overall effectiveness in the fight against infections. By identifying patients who are more likely to have an infection allows the more targeted use of antibiotics prophylactically in these patients groups whilst those patients who are less likely to suffer an infection would not be required to have antibiotics unless infection developed. This would save money and would also ensure the overuse of antibiotics in whichever medium is significantly reduced. The product Therefore we have developed a novel and unique test which clearly identifies the genetic susceptibility to infection and or biofilm formation. The test identifies the specific genetics which can lead to biofilm formation. The test will look at the genetic make up of patients who have had an infection after having a medical device. In addition we propose a genetic test for the increased likelihood of infection in combination with an algorithm of risk factors to give a percentage chance or other such indicator for the likelihood of infection / biofilm formation. The test will identify the HLA alleles associated with development of Biofilm. The test will be used in those patients who are due to have a medical device inserted in order to assess whether those patients require prophylactic treatment or other clinical intervention and or monitoring. The test will rely on using patients genetic data to determine if they are susceptible to infection following the insertion of a medical device I foreign body based on their genetics alone and I or in combination with their risk factors. The risk factors will be considered in the fomr of an algorithm which will include but not limited to The outcome of such a test In doing so this test will enable to identify which patients are more likely to require prophylactic antibiotics or other antibiotic additives etc will also identify these patients who are less likely to require antibiotic therapies. Risk factors of infection and biofilm formation are believed to be The operation site on the body Patients co-morbidity condition If the patient is immunosuppressed Smoking, alcohol abuse and drug addiction Malnutrition Obesity Patient on corticosteroids or corticosteroid treatment Dental, skin, urinary or respiratory infection Old age Revision surgery Trauma surgery Oncology surgery Length of the procedure Type of biofilm risk tests The test consists of a blood sample or saliva (“spit”) test which would be analysed. The test would consist of any genetic material from the patient which could be utilised to analyse the patients geneThe method of blood sample or saliva would include all standard methods of such collection. The testing would be undertaken as single gene testing, panel testing, large scale genetic or genomic testing (including exome sequencing and / or genome sequencing. The development of the test would also include Chromosomes and gene expression. The testing results would provide whether. Positive -. HLA alleles associated with development of Biofilm. The test demonstrates that a patient is likely to develop an infection if a medical device is inserted into them. The positive results suggests that a biofilm is likely to occur and / or the test would reveal whether the implant is likely to become infected based on the patients genetics alone. Therefore the patient would be given prophylactic antibiotics. Negative - HLA alleles associated with development of Biofilm. The test does not find a genetic change known to lead to a infection when a medical device is inserted. The test result suggests a biofilm is unlikely to occur and / or an infection is unlikely to occur, based on the patients genetics alone. Uncertain - The test shows there is insufficient information from the test results to determine the outcome and it cannot be determined if a Biofilm will form or infection will form. The testing results combined with risk factors would have one of the following results:-Positive - the test demonstrates that a patient is likely to have an infection if a medical device is inserted into them. The test results determines a biofilm will form around the medical device. Therefore in this instance the patient would be given prophylactic antibiotic treatment. Negative - The test does not find a genetic change known to lead to a infection when a medical device is inserted however when combined with the risk factors there is either a high or low chance that infection may still occur. The result demonstrates that whilst there is no genetic change which suggests a biofilms will form however when combined with the risk factors it may be likely or it may be unlikely a biofilm will form. Uncertain - the test result was inconclusive and the risk factors also are inconclusive. The test will be capable in all its forms to be used in conjunction with a specifically developed app and in used in conjunction will all types of genetic analysis.

Claims

The claim 1.A blood sample will be taken from the patientThe patient sample will be analysed for its genetic make-up and compared to known genetic biofilm riskHLA genotyping will be conducted on the sampleThe outcome will be used to determine if any treatment regimens need to be implemented pro-phylaticThe test will confirm if type HLA alleles associated with development of Biofilm exist in the patient.The claim 2The blood sample will be taken from the patientThe patients DNA will be analysedThe DNA will be compared with known DNA risk profileThe outcome will be combined with known statistical biofilm risksAn algorithm will be produced for the individualThe overall outcome will be reported to the surgeonThe surgeon will use this out comment determine if any prophylactics are required to ensure the patient does or dies not have a high risk of developing a biofilm based on clinical risks and the patients DNA / genetic makeup.The test will confirm if appropriate type HLA alleles exist in the patientThe claim 3A Nasal swab test and or saliva tests would be used to collect DNA samplesThe genetic test described in 1 &2 above would be conductedThe test will confirm if the HLA alleles exist in the patientThe claim 4The development of an App to be used in conjunction with the genetic test and all appropriate equipment to allow the genetic test in the Lab or in a portable format.The development of an App which would be used for the purpose of developing a suitable algorithm including and excluding the genetic outcome.