News Column

Patent Issued for Device and Method for the Vacuum Infusion of a Porous Medical Implant

August 13, 2014



By a News Reporter-Staff News Editor at Journal of Engineering -- Warsaw Orthopedic, Inc. (Warsaw, IN) has been issued patent number 8790677, according to news reporting originating out of Alexandria, Virginia, by VerticalNews editors.

The patent's inventor is McKay, William F. (Memphis, TN).

This patent was filed on December 17, 2004 and was published online on July 29, 2014.

From the background information supplied by the inventors, news correspondents obtained the following quote: "Porous medical implants are commonly infused with a variety of pharmaceutical substances including osteoinductive and nutritional factors, drugs, antimicrobial agents, calcium containing compounds, blood proteins and related materials; and growth factors to facilitate the implant's incorporation within the body and avoid unwanted complications resulting from surgery or the condition being treated. The infusion of substances into established materials such as collagen sponges is rapid upon contact with a solution or dispersion of the pharmaceutical substance. However, many of the newer load bearing materials, such as porous calcium phosphate ceramic, absorb pharmaceutical substances slowly and incompletely.

"A number of techniques have been employed to eliminate gases from a porous implant and improve infusion of a variety of materials therein. U.S. Pat. No. 5,181,903 (Vann, et al.) issued on Jan. 26, 1993, discloses a method for eliminating undissolved gases and the incorporation of therapeutic agents into a biomaterial utilizing hydrostatic pressure. Prior to the application of pressure, the solution containing the therapeutic agent and optionally the biomaterials are degassed at reduced pressure, the biomaterial is submerged in the therapeutic agent and hydrostatic pressure is applied to all surfaces of the biomaterial.

"U.S. Pat. No. 6,063,117 (Perry) issued on May 16, 2000, discloses a non-polyethylene orbital implant that can comprise a porous ceramic material and a method for infusing either gentamicin or a fibroblast growth factor prior to implantation. The implant was placed in a sterile 30 mL syringe, filled with enough solution to immerse the implant, the syringe capped and the plunger withdrawn to create a mild vacuum. Residual air was released upon slight agitation of the syringe barrel and by continued contact with the solution overnight at 4.degree. C.

"U.S. Pat. No. 5,769,897 (Harle) issued on Jun. 23, 1998, discloses a vacuum vessel that can be utilized for treating, storing and transporting an artificial bone material. The vessel disclosed is constructed of a rigid plastic, has an opening for insertion of the bone material, a lid to close and seal the opening and has two ports, one for connecting to a vacuum source and the other sealed with a self-sealing rubber membrane for the introduction of a pharmaceutical substance.

"In spite of these advances, the need exists for an improved device for storing, transporting and infusing a porous implant and a method for the improved device's use."

Supplementing the background information on this patent, VerticalNews reporters also obtained the inventor's summary information for this patent: "One object of the present invention is to provide a novel deformable vacuum infusion device suitable for packaging and for rapid and complete vacuum infusion of a liquid, typically a saline solution or a solution of a pharmaceutical substance, into a porous medical implant. Preferred embodiments of the device provides an environment wherein a sterile implant sealed within the device at manufacture or thereafter remains sterile, can be infused prior to surgery with a minimal quantity of one or more pharmaceutical substances and can be maintained in its sterile condition until implanted.

"In addition, because of the preferred device's lightweight construction and ability to approximately conform to the approximate shape of the implant, packaging, shipping and storage of the implant and device is facilitated. Finally, the preferred device's design and materials of construction facilitate removal of the implant from the device and disposal of the used device by standard methods.

"In one aspect of the present invention a device for vacuum infusion of one or more pharmaceutical substances into a porous medical implant is provided, the device comprising: a deformable pouch constructed from a biocompatible material, the pouch containing the porous medical implant and having an orifice suitable for the introduction of the pharmaceutical substance and an orifice suitable for connecting to a vacuum. A single multifunctional orifice can be provided for both the introduction of the pharmaceutical substance and for connecting to a vacuum or multiple orifices can be provided having task specific designs. In a second aspect of the present invention a device is provided for vacuum infusion of a pharmaceutical substance into a porous medical implant, the device comprising a deformable pouch having a volume between about 1 to about 20 cubic centimeters constructed from a biocompatible material, the pouch having at least two orifices; the first orifice having an open condition suitable for receiving a porous medical implant and suitable for subsequent closure; the second orifice having a coupling member suitable for the introduction of a pharmaceutical substance and for connecting to a vacuum.

"It is a further object of this invention to provide a method utilizing the novel device to vacuum infuse medical implants with solutions of saline or pharmaceutical substances prior to implantation. In one aspect of the present invention a method is provided for infusing a porous medical implant with one or more pharmaceutical substances, the method comprising providing a porous medical implant sealed within a deformable pouch, the pouch constructed from a biocompatible material; contacting the implant with a pharmaceutical substance; causing the pressure within the sealed pouch to be reduced to less than the pouch's external pressure and maintaining this reduced pressure condition until a desired level of infusion has been accomplished. Utilization of this method for the infusion of pharmaceutical substances into a porous medical implant maintains the implant's sterile condition from manufacture to implantation, provides for rapid and complete infusion utilizing a minimum quantity of pharmaceutical substance and allows the infused implant to remain infused, sterile and ready for implantation until needed.

"It is still a further object of this invention to provide a porous medical implant infused with a pharmaceutical substance according to the novel method of this invention. In one aspect of the present invention, porous implants infused to a desired level with pharmaceutical substances to facilitate incorporation into the body are available to the surgeon as needed in a convenient form and in a sterile condition.

"Related objects and advantages of the present invention will be apparent from the following description."

For the URL and additional information on this patent, see: McKay, William F.. Device and Method for the Vacuum Infusion of a Porous Medical Implant. U.S. Patent Number 8790677, filed December 17, 2004, and published online on July 29, 2014. Patent URL: http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=8790677.PN.&OS=PN/8790677RS=PN/8790677

Keywords for this news article include: Biomedical and Dental Materials, Warsaw Orthopedic Inc, Biocompatible Materials.

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Source: Journal of Engineering


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