The present application relates to the field of antibiotic delivery systems. More particularly, the application relates to the delivery of antibiotic powder during surgery, such as orthopedic surgery, spinal surgery, cardiovascular surgery, craniotomies, and other major surgeries, to reduce the need for revision surgery.
Delivering an antibiotic powder (such as Vancomycin) directly into a surgical wound prior to closure is a relatively novel concept. When applied during surgical procedures such as spinal surgery, delivery of an antibiotic powder has been shown to dramatically decrease the number of reoperations for deep spinal infections. This result has been shown in several major scientific articles, including “Intrawound Application of Vancomycin for Prophylaxis in Instrumented Thoracolumbar Fusions,” SPINE, Vol. 36, No. 24, pp. 2084-2088 (2011) and “Reduced Surgical Site Infections in Patients Undergoing Posterior Spinal Stabilization of Traumatic Injuries Using Vancomycin Powder,” The Spine Journal, Vol. 11, pp. 641-646 (2011). In these “case versus control” studies, there were significant differences in post-operative infections requiring an operation to treat the infection depending on the use of antibiotic powder directly into the surgical wound. The use of an antibiotic powder leads to lower operative infection rates. The low potential for developing resistance due to poor systemic uptake of the antibiotic and lack of side effects makes the use of antibiotic powder directly into surgical wounds very appealing. The cost savings to the healthcare system by using a fairly inexpensive antibiotic is tremendous as revision surgery, at least for spinal surgeries, can cost several hundreds of thousands of dollars per instance.
Current methods of delivering antibiotic powders locally to the surgical wound have had a high potential for contamination and are inefficient, leading to wasted time in the operating room. Typically, a non-sterily gowned person (e.g. anesthesiologist or circulating nurse) pours the antibiotic powder using a non-sterile technique into some type of open sterile plastic container. This container is held by a sterile scrubbed person (e.g. the surgeon or scrub nurse). This individual must further crush the antibiotic powder. After the powder is crushed it is sprinkled into the wound by grasping some of the crushed powder by hand and then releasing into the wound. There are numerous points of potential contamination and accidental spilling that can occur in this process, and this method may be imprecise in terms of the quantity of powder present in the open wound.
Some prior delivery devices for antibiotic powders require attaching a prepared vial of antibiotic powder to a delivery device, which does not necessarily correct the deficiencies of the methods described above. In addition, these prior art delivery devices use pressurized gas or liquid that effectively aerates the powder or turns it into an aerosol to dispense the antibiotic powder into the wound, which may affect the efficacy of the dosage of the antibiotic.
Accordingly, there exists a need for a powder delivery device that is self-contained to reduce the potential for contamination and that allows for a practitioner to dispense a desired amount of the powder into a surgical wound.
USPTO Backgrounds
USPTO Backgrounds