Sintered porous polymeric caps and vents for components of medical devices
The present application provides a device and methods of making and using these devices. The devices comprise porous caps and porous vents made from sintered porous polymeric media comprising plastic particles, elastomeric particles or a combination thereof. These devices are used with medical devices or components thereof to provide ease of use, resistance to infection, sterilization and venting.
1. A device for covering an opening of a medical device, the device comprising a sintered porous cap body comprising a device cooperating end integral with a porous closed end, the entirety of the sintered porous cap body comprising a combination of plastic particles and elastomeric particles producing a substantially uniform mixture that is sintered in a mold in the shape of the cap body, the porous cap having a porosity of between 10% to about 90% after sintering such that sterilizing gas can pass through the porous cap, the porous closed end providing a physical cover over the opening of the medical device in use, the porous cap comprising a bacterial filtration efficiency of over 95% based on the ASTM 2101 test method and an air flow having a Gurley number less than 200 seconds measured using the TAPPI T460 method.
2. The device of claim 1 , further comprising an antimicrobial additive, a color change indicator, an antiseptic, an absorbent material or a combination thereof.
3. The device of claim 1 , wherein the sintered porous cap is configured to be screwed onto an access port, capped onto an access port by stretching, or plugged into an access port by a frictional fit.
4. The device of claim 1 , wherein the sintered porous cap permits sterilizing gas to pass through the porous cap and contact the portion of the medical device.
5. The device of claim 1 , wherein the medical device is a liquid access port.
6. The device of claim 5 , wherein the liquid access port has a luer fitting or a connector.
7. The device of claim 5 , wherein the liquid access port is connected to an intravascular line, a cerebrovascular line, a gastrointestinal line, a peripherally inserted central catheter, a urinary catheter, a drainage tube, a shunt, a PEG tube, a PEG-J tube, a nasogastric tube, or an endotracheal tube or another tube.
8. The device of claim 1 , wherein the sintered porous cap prevents microbes from entering the medical device, thereby retarding or preventing microbial contamination of the medical device.
9. The device of claim 1 , wherein the sintered porous cap comprises an average pore size ranging from about 1 μm to about 200 μm.
10. The device of claim 1 , wherein the sintered porous cap comprises a density ranging from about 0.1 g/cm 3 to about 1 g/cm 3 .
11. The device of claim 1 , wherein the sintered porous cap comprises a polyolefin.
12. The device of claim 11 , wherein the polyolefin comprises polyethylene, ultrahigh molecular weight polyethylene, or high density polyethylene.
13. The device of claim 1 , wherein the medical device is a liquid access port, connector, line, catheter or tube selected from the group consisting of an intravascular line, a cerebroventricular line, a gastrointestinal line, a peripherally inserted central catheter, a urinary catheter, a drainage tube, a shunt, a PEG tube, a PEG-J tube, a nasogastric tube, and an endotracheal tube.
14. The device of claim 1 , wherein the device cooperating end comprises an attachment feature for attachment of the sintered porous cap body to the opening of the medical device.
15. The device of claim 14 , wherein the attachment feature comprises threads, a stretchable cap portion, a friction fit portion, or a snap fit and lock mechanism.
16. A device for covering an opening of a medical device, the device comprising a sintered porous cap body comprising a device cooperating end integral with a porous closed end, the entirety of the sintered porous cap body comprising a combination of plastic particles and elastomeric particles wherein the sintered porous cap comprises an average pore size ranging from about 1 μm to about 200 μm, the porous closed end providing a physical cover over the opening of the medical device in use, the porous cap comprising a bacterial filtration efficiency of over 95% based on the ASTM 2101 test method and an air flow having a Gurley number less than 200 seconds measured using the TAPPI T460 method.
17. A device for covering an opening and side portions of a medical device, the device comprising a sintered porous cap body comprising a device cooperating end integral with a porous closed end, the entirety of the sintered porous cap body comprising a combination of plastic particles and elastomeric particles, wherein the sintered porous cap comprises a porosity that permits sterilizing gas to pass through the porous cap and contact the opening and side portions of the medical device, the porous cap comprising a bacterial filtration efficiency of over 95% based on the ASTM 2101 test method and an air flow having a Gurley number less than 200 seconds measured using the TAPPI T460 method.