The following technology is available for purchase or license from Palmetto Biomedical. In addition to the three technologies shown below, we are working in the areas of orthobiologics, resurfacing total hip replacement and cryotherapy for pain and inflammation control.
1. Implant and Instrument Designs for Resurfacing of the Femoral Head (Abandoned)
Traditionally, end stage arthritic degeneration of the hip joint is treated with placement of a total joint prosthesis consisting of a long femoral stem anchored in the intramedullary canal of the femur, a ball and socket joint, and an acetabular component for anchoring in the pelvis. Currently, one alternative solution to total joint replacement that is gaining in clinical use is use of a less comprehensive femoral resurfacing design with a single short stem in the bone and a hollow portion that covers the bony surface of the femoral head. Additionally, there is a thin metal sleeve that is placed on the acetabular (“cup”) side, most of these implants being metal-on-metal articulations.
Advantages of this approach include: bone conservation, reproduction of native hip biomechanics, greater implant stability and easier revision procedures to convert to a conventional total hip prosthesis later. However, there are some potential problems with the current technology for hip resurfacing including reliance on necrotic bone for support, avascular necrosis of the femoral neck following surgery (compromised blood supply to the femur), more difficult orientation of the implant compared to conventional long stem devices and fracture of the femoral neck.
The single short stem of the current design may not be the ideal mode of fixation. The short stem is anchored in the central bone of the femoral neck, which is a spongy, trabecular structure. The stem may undergo a pivoting, windshield wiper-like motion under in vivo dynamic loading and this can result in loosening and femoral neck fracture. The technology under development applies the clinical experiences with hip and spinal fracture fixation to developing novel stem designs and anchorage means in order to address the limitations of the current short stem resurfacing designs.
2. Instrumentation and Methods for the Arthroscopic Repair of Articular Cartilage (Abandoned)
Currently a variety of diagnostic and therapeutic procedures can be performed on the articular joint space using a series of trocars, cannulas and saline flow to maintain access to the joint space. Saline irrigation is used throughout the arthroscopy procedure to maintain a working space, as well as for flow to remove blood and debris during surgical access, tissue resection, soft tissue and cartilage repair, etc. Many research and industry groups are focused on developing biomaterial-based treatment strategies to enhance the repair of articular cartilage. Many of these materials are flowable gels that can completely and uniformly fill the cartilage defect and may be delivered with small access cannulas.
Since these biomaterials are in a fluid state prior to cross linking (or other transisition) into a more solid state, these procedures are currently performed via an open surgical approach. The defect is filled, then the biomaterial is allowed to solidify prior to irrigation and closing of the joint space incision. There is a need for a way to deliver a fluid-like, flowable biomaterial into a joint space during conventional saline irrigation during joint arthroscopy. While these gel biomaterials may be advantageous for repair or regeneration of articular cartilage, utilization by a broad base of orthopaedic surgeons will require delivery via conventional arthroscopic procedure.
The focus of this invention is on novel methods and instruments for the delivery of a flowable biomaterial to the articular cartilage of the knee, shoulder or other synovial joints via conventional arthroscopic techniques which often involve the copious use of saline irrigation.
3. Delivery of Therapeutic Agents via Artificial Internal Implants (Patent Pending, To Bioshape Solutions)
The present invention relates generally to internal fracture fixation devices and a means for addressing the limitations of the current technology. This methodology could be broadly applied to any artificial internal medical implant where, for example, resistance to infection and/or an enhanced healing environment are desirable. The technology allows for precise, local delivery of a therapeutic agent to the site of interest adjacent the biomedical implant.
The present invention contemplates a procedure and device that is implemented prior to, or following, implantation of an internal fixation implant or other medical device. The invention contemplates implants and methods to allow for local and sustained delivery of a therapeutic agent in the region around an implanted medical device. Applications of the technology are wide ranging, with applications to fracture fixation, spinal fusion and joint arthroplasty described. At least four different designs, incorporating a variety of attachment means, are described in order to best explain the fundamentals of the design concept. Several prototypes have been completed to demonstrate the device concepts.
4. Cosmetic and Protective Covering for an External Fixation Device (Patented, U.S. )
External fixation devices are used for stabilization of bony elements in order to allow for bone healing following a fracture or dislocation. These external fixation devices may also be utilized following a surgical realignment of the bones (osteotomy) as well as for intentional fusion of arthritic joints. Typically, the devices are attached to the peripheral skeletal structures. The invention contemplates devices and methods for providing a protective and cosmetic covering to the external fixation device.
The invention discloses a removable covering that can be secured about an external fixation device on the upper or lower extremity of a patient. The covering protects the fixation device while providing an aesthetic improvement to the limb while it mends. The covering is sized and configured to accommodate varying sizes of external fixation devices and uses readily engageable/releasable closure elements or fasteners to securely engage the covering about the extremity. In some embodiments, a drawstring closure may be provided at the open ends of the covering to tighten the end about the patient's limb. In other embodiments, ventilation features may be provided including vents with and without additional devices to generate air flow through the covering. In another embodiment of the invention, the covering for a lower extremity fixation device is configured to be removably attached to a foot plate. The foot plate itself may also be configured to support components of the fixation device.