Device and method for the vacuum infusion of a porous medical implant
View Patent ↗Disclosed is a novel device for the vacuum infusion of a porous medical implant contained therein with one or more pharmaceutical substances and a method for the device's use. The device is deformable, and capable of adjusting to the outer contour of a porous medical implant to facilitate packaging, shipping and storage of the implant contained within the device. In addition, the device is unbreakable, easily disposed of after use, maintains the implant in a sterile condition before and after infusion and minimizes the quantity of pharmaceutical substance needed for infusion. Use of the device provides for rapid and complete infusion of a variety of pharmaceutical substances into a porous implant prior to surgery.
1. A device for the infusion of a liquid into a porous medical implant at reduced pressure, the device comprising:
a deformable pouch with an interior surface,
a sterile porous medical implant that is sealed within the interior of the pouch by heat-sealing or by a biocompatible adhesive, and
a band member conforming to the exterior of the pouch about a circumference of the porous medical implant and capable of forming at least a partial seal between the pouch and the implant;
wherein the pouch is constructed of a biocompatible material comprising a biodegradable polymer and its interior is sterile;
wherein the pouch comprises a multifunctional orifice suitable for the introduction of the liquid and for connecting to a vacuum, said multifunctional orifice is fitted with a self-sealing, semi-permeable membrane configured to permit the passage of gases and resist the passage of liquids, said multifunctional orifice is further fitted with a coupling member comprising an inner surface defining a passageway as well as a valve that is disposed entirely within the passageway, wherein the valve comprises an open position for evacuating the interior of the pouch or drawing liquid into the interior of the pouch and a closed position for maintaining a reduced internal pressure; and
wherein the internal surface of the pouch contacts and is configured to conform to the entire exterior surface of the porous medical implant when pressure is reduced in the interior of the pouch so as to allow infusion of the liquid into the porous medical implant when the liquid is introduced into the interior of the pouch.
2. The device of claim 1 , wherein the coupling member is a threaded union.
3. The device of claim 2 , wherein the threaded union is a luer lock.
4. The device of claim 2 , wherein the biocompatible material is selected from the group consisting of polylactic acid and polyglycolic acid.
5. The device of claim 4 , wherein the biocompatible material has a thickness of between 0.002 and 0.008 of an inch.
6. The device of claim 4 , wherein the porous medical implant is constructed from a porous material selected from the group consisting of calcium phosphate ceramics, porous metals, ceramic polymer composites, human allografts, cadaver bones and porous polymers.
7. The device of claim 6 , wherein the porous material is a calcium phosphate ceramic.
8. The device of claim 2 , further comprising a liquid that includes pharmaceutical substance.
9. The device of claim 8 , wherein the pharmaceutical substance is selected from the group consisting of osteoinductive factors, growth factors, nutrients, drugs, antimicrobial agents, calcium containing compounds and blood proteins.
10. A device for vacuum infusion of a liquid into a porous medical implant, the device comprising:
a deformable pouch having a volume between 0.061 to 1.220 cubic inches that has a sterile interior surface and is constructed from a biocompatible material comprising a biodegradable polymer, the pouch comprises:
a first orifice that is suitable for receiving a porous medical implant;
a second orifice adapted for the introduction of the liquid and for connecting to a vacuum, wherein the second orifice is fitted with a self-sealing, semi-permeable membrane configured to permit the passage of gases and resist the passage of liquids, said second orifice is further fitted with a coupling member comprising an inner surface defining a passageway as well as a valve that is disposed entirely within the passageway, wherein the valve comprises an open position for evacuating the interior of the pouch or drawing liquid into the interior of the pouch and a closed position for maintaining a reduced internal pressure;
a sterile porous medical implant having an exterior surface, wherein the interior surface of the pouch contacts and is configured to conform to the entire exterior surface of the porous medical implant when pressure is reduced in the interior of the pouch so as to allow infusion of the liquid into the porous medical implant when the liquid is introduced into the interior of the pouch; and
a band member conforming to the exterior of the pouch about a circumference of the porous medical implant and capable of forming at least a partial seal between the pouch and the implant.
11. The device of claim 10 , wherein the biocompatible material is selected from the group consisting of polylactic acid and polyglycolic acid.
12. The device of claim 11 , wherein the biocompatible material has a thickness of between 0.002 and 0.008 of an inch.
13. The device of claim 12 , wherein the coupling member is a threaded union.
14. The device of claim 13 , wherein the threaded union is a luer lock.
15. The device of claim 10 , wherein the device contains a pharmaceutical substance selected from the group consisting of osteoinductive factors, growth factors, nutrients, drugs, antimicrobial agents, calcium containing compounds and blood proteins.
16. The device of claim 15 , wherein the porous medical implant is constructed from a porous material selected from the group consisting of calcium phosphate ceramics, porous metals, ceramic polymer composites, human allografts and porous polymers.
17. The device of claim 16 , wherein the porous material is a calcium phosphate ceramic.
18. The device of claim 17 , wherein the first orifice is closed due to a heat-sealing process.
19. The device of claim 17 , wherein the first orifice is closed due to a biocompatible adhesive.
20. The device of claim 17 , wherein the first orifice is fitted with a zip-lock mechanism and is closed due to the actuation of the zip-lock mechanism.