Periodic Reporting for period 2 - ExtruLub (Commercialisation of Advanced Extrusion Technologies through Materials Innovation to Enhance the Performance Functionality of Catheter Based Medical Devices)
Período documentado: 2018-12-01 hasta 2020-02-29
One of the major goals of ExtruLub to produce a technology which could reduce the friction on the ID & OD of extruded tubes was achieved in soft polymers after EO sterilisation & 2 years accelerated aging. This feature resulted in the added advantage of substantially reducing thrombus formation on surface of the tubing during blood loop testing (see Figures 2 & 4), a test which is commonly utilised in the industry.
However, the classification of VAD devices utilising soft polymers as implants rightly stipulate that the device is subjected to a higher level of biocompatibility scrutiny & testing, due to the higher level of risks the patient may be exposed to. Unfortunately the tubing narrowly failed cytotoxicity testing after longer periods of testing.
We believe that this problem can be overcome with further, intensive research and development work. However, such intensive R&D effort would be outside the scope of this work programme & therefore the grant was terminated prematurely.
However, the classification of VAD devices utilising soft polymers as implants rightly stipulate that the device is subjected to a higher level of biocompatibility scrutiny & testing, due to the higher level of risks the patient may be exposed to. Unfortunately the tubing narrowly failed cytotoxicity testing after longer periods of testing.
We believe that this problem can be overcome with further, intensive research and development work. However, such intensive R&D effort would be outside the scope of this work programme & therefore the grant was terminated prematurely.
The goal to produce a technology which could reduce the friction on the ID & OD of extruded tubes (see Figure 1) was achieved in soft polymers. As stated the classification of VAD devices differs from the originally targeted harder polymers. Softer polymers are commonly utilised in longer term implants, over 30 days (e.g.) central venous catheters (CVCs), peripherally inserted central catheters (PICCs), Ports & the like, whereas hard polymers are utilised in more transient use (up to 28 days) catheters like stent delivery systems. Therefore, when biocompatibility testing was conducted on soft polymers over longer durations, cytotoxicity was an issue. We believe that this problem could be overcome with more R&D work outside the scope of this work programme. As the SME Instrument is primarily a grant to commercialise, the DiaNia board made the decision to terminate the grant early due to this deviation from the grant scope.
From an exploitation perspective, two patents were applied for covering seven main territories.
Dissemination of the initial results obtained with soft polymers had begun, involving discussions with high level executives of multinational, market leading medical devices companies in the vascular access device market. However on obtaining the negative biocompatibility results, these discussions were terminated & planned marketing of initial results decelerated. Finally a decision was made to terminate the H2020 SME Instrument grant as more R&D work is required before commercialisation of the technology could be re-commenced.
From an exploitation perspective, two patents were applied for covering seven main territories.
Dissemination of the initial results obtained with soft polymers had begun, involving discussions with high level executives of multinational, market leading medical devices companies in the vascular access device market. However on obtaining the negative biocompatibility results, these discussions were terminated & planned marketing of initial results decelerated. Finally a decision was made to terminate the H2020 SME Instrument grant as more R&D work is required before commercialisation of the technology could be re-commenced.
3.0 Socio-Economic Impact of the Project
3.1 Better Medicine Benefiting Patients & Surgeons
The rigorous market research conducted on the VAD market included attempting to fully understand the needs of the patients, physicians treating these patients & other health care staff whom attempt to maintain these devices for as long as possible. It was clear that there is a need for the type of technology envisaged with ExtruLub. The market intelligence compiled suggested the technology had the capacity to yield better medicine benefiting patients’ quality of life, as well as potentially extending life. Clinicians we spoke with clearly articulated the advantages of a device which had anti-thrombus surface while eliminating the failure modes of current devices. Patients treated with VADs fall into different categories including, dialysis patients, emergency patients, whereby a clinician needs swift access to a patients’ bloods, terminally ill patients suffering from cancer, some of whom suffer from collapsed veins. Common VADs complications & potential benefits of ExtruLub technology included:
• Phlebitis – Inflammation of vessel wall caused by irritation. Phlebitis with respect to an implanted catheter can be due to the catheter material, placement technique, choice of vessel, drugs infused through catheter, duration of treatment, etc. Injury & inflammation could be reduced with lower device insertion forces due to the slippery surface of ExtruLub technology.
• Occlusion & Clotting – may cause obstruction of flow in the catheter lumens eventually leading to loss of catheter functionality, which is a common problem. Late occurrences are most often related to the formation of a thrombus. Several types of thrombi may occ ur, differing by location & their mechanism of formation. The most common is the fibrin sheath thrombus. This should be treated in the early stages to avoid complications as injection of critical medicines or withdrawal of blood samples can be impossible. Due to the difficulty in placing a device, physicians do not like removing them. Therefore they will commonly flush the device with clot reducing medications, adding to treatment costs. A device with an anti-thrombus surface would reduce the incidences of this complication.
• Thrombosis due to device surface can travel through the heart to the lungs, a condition known as pulmonary embolism.
• The biggest issue is infection. The more often a device is replaced, infection rates increase. The placement of VADs predispose a patient to risks of local & systemic infections such as CR-BSIs, septic thrombophlebitis, endocarditis, & other metastatic infections that include lung abscess, brain abscess, osteomyelitis, & endophthalmitis. According to CDC catheter infections are a major concern for ICU patients. Bloodstream infection rates increase 0.5 % for each day a catheter is in place, & when infection occurs, mortality increases by 35 % & hospitalization costs by more than US$ 35,000; prolonged ICU stays lead to prolonged post-hospitalization rehabilitation. Reduction in the occlusion of a device could have a considerable impact on these complications & thereby improve the quality of life &/or life expectancy of the patient.
3.2 Discrete to Lean Manufacturing Benefiting Device Manufacturers
Information obtained through industry sources indicated that the market leading MNEs have many complex manufacturing issues related to internal & external coating of VAD devices. Low yields due to these process steps are common, increasing the device cost. With an in-built reduced friction on both the ID & OD of the extruded tube, the manufacturing cycle would be reduced, yields would be increased & therefore the cost of the device would reduce. Additionally, as higher yields would be achievable with a switch form discrete to lean manufacturing, less environmental waste would be produced.
3.3 Cost Containment & Margin Increase Benefiting Device Manufacturers/ Hospitals/ Healthcare Spend
Decreases in the medical risks for patients on application of these devices, coupled with manufacturing improvements with the device, combined would have a large impact on cost containment for device users. Patients would benefit from lower infection rates, which would have the knock-on effect of reduced hospital inpatient days, less patient complications and therefore lower hospital costs.
3.1 Better Medicine Benefiting Patients & Surgeons
The rigorous market research conducted on the VAD market included attempting to fully understand the needs of the patients, physicians treating these patients & other health care staff whom attempt to maintain these devices for as long as possible. It was clear that there is a need for the type of technology envisaged with ExtruLub. The market intelligence compiled suggested the technology had the capacity to yield better medicine benefiting patients’ quality of life, as well as potentially extending life. Clinicians we spoke with clearly articulated the advantages of a device which had anti-thrombus surface while eliminating the failure modes of current devices. Patients treated with VADs fall into different categories including, dialysis patients, emergency patients, whereby a clinician needs swift access to a patients’ bloods, terminally ill patients suffering from cancer, some of whom suffer from collapsed veins. Common VADs complications & potential benefits of ExtruLub technology included:
• Phlebitis – Inflammation of vessel wall caused by irritation. Phlebitis with respect to an implanted catheter can be due to the catheter material, placement technique, choice of vessel, drugs infused through catheter, duration of treatment, etc. Injury & inflammation could be reduced with lower device insertion forces due to the slippery surface of ExtruLub technology.
• Occlusion & Clotting – may cause obstruction of flow in the catheter lumens eventually leading to loss of catheter functionality, which is a common problem. Late occurrences are most often related to the formation of a thrombus. Several types of thrombi may occ ur, differing by location & their mechanism of formation. The most common is the fibrin sheath thrombus. This should be treated in the early stages to avoid complications as injection of critical medicines or withdrawal of blood samples can be impossible. Due to the difficulty in placing a device, physicians do not like removing them. Therefore they will commonly flush the device with clot reducing medications, adding to treatment costs. A device with an anti-thrombus surface would reduce the incidences of this complication.
• Thrombosis due to device surface can travel through the heart to the lungs, a condition known as pulmonary embolism.
• The biggest issue is infection. The more often a device is replaced, infection rates increase. The placement of VADs predispose a patient to risks of local & systemic infections such as CR-BSIs, septic thrombophlebitis, endocarditis, & other metastatic infections that include lung abscess, brain abscess, osteomyelitis, & endophthalmitis. According to CDC catheter infections are a major concern for ICU patients. Bloodstream infection rates increase 0.5 % for each day a catheter is in place, & when infection occurs, mortality increases by 35 % & hospitalization costs by more than US$ 35,000; prolonged ICU stays lead to prolonged post-hospitalization rehabilitation. Reduction in the occlusion of a device could have a considerable impact on these complications & thereby improve the quality of life &/or life expectancy of the patient.
3.2 Discrete to Lean Manufacturing Benefiting Device Manufacturers
Information obtained through industry sources indicated that the market leading MNEs have many complex manufacturing issues related to internal & external coating of VAD devices. Low yields due to these process steps are common, increasing the device cost. With an in-built reduced friction on both the ID & OD of the extruded tube, the manufacturing cycle would be reduced, yields would be increased & therefore the cost of the device would reduce. Additionally, as higher yields would be achievable with a switch form discrete to lean manufacturing, less environmental waste would be produced.
3.3 Cost Containment & Margin Increase Benefiting Device Manufacturers/ Hospitals/ Healthcare Spend
Decreases in the medical risks for patients on application of these devices, coupled with manufacturing improvements with the device, combined would have a large impact on cost containment for device users. Patients would benefit from lower infection rates, which would have the knock-on effect of reduced hospital inpatient days, less patient complications and therefore lower hospital costs.