Metallic implant drug/device combinations for controlled drug release in orthopaedic applications.

The management of post-traumatic long bone osteomyelitis remains challenging [1]. While significant progress has been made over the past 10–20 years, many simple questions such as optimal duration or route of antibiotics administration remain unanswered [2]. General principles of early aggressive management, optimization of host factors and wide debridement of affected tissues with later reconstruction are commonly accepted. These principles share similarities with those applied in tumor surgery [3]. Unfortunately, specific diagnostic and treatment strategies are ill-defined and lack prospective evidence. In this paper, we highlight some of the limitations that remain regarding the prevention, diagnosis and treatment of post-traumatic long bone osteomyelitis. Numerous variables in the disease and host type

/pdf/difficulties-and-challenges-to-diagnose-and-treat-post-2qfsuyxdci.pdf

Difficulties and challenges to diagnose and treat post-traumatic long bone osteomyelitis.

Biocompatible mesh materials are employed to make implants for repairing or replacing a bone or for soft tissue repair. The mesh materials can be comprised of bioabsorbable materials, non-bioabsorbable materials or bioabsorbable and non--bioabsorbable materials. Pharmaceutical actives, bone growth enhancers and the like can be combined with the implants.

Implantable mesh for musculoskeletal trauma, orthopedic reconstruction and soft tissue repair

Intra-operatively customized implant coating strategies for local and controlled drug delivery to bone.

Medical devices are increasingly used worldwide for an expanding ­repertoire of patient clinical needs. Biomaterials and medical device designs have become progressively more complex to accommodate diverse demands for performance and safety in vivo. While a majority of these implants satisfy their clinical expectations with safety and efficacy in their specific applications, a minority of implants induce serious adverse events with substantial health and economic consequences. One recognized challenge is the growing clinical problem with implant-associated infections. Increasing number and types of implants used in patients have resulted in increasing numbers of biomaterial-associated infections. Researchers and medical device manufacturers have responded to this challenge with intensified attention to innovating device designs, surgical implantation protocols, and biomaterials to minimize infection opportunities. Medical devices with claims to limit microbial adhesion and colonization using combinations of pharmacological, topological, and materials chemistry approaches have been brought into clinical use with the intent of reducing device-related infections. Many types of catheters, stents, orthopedic devices, contact lenses, surgical meshes, shunts, sutures, cardiovascular replacements, and many other device categories offer antimicrobial enhancements. Approaches include different biomaterials chemistries that intrinsically resist microbial colonization or that deter active growth on contact, surface modifications that produce topologies observed to limit pathogen attachment, medicinal, antiseptic or bioactive coatings, direct antimicrobial attachment to surfaces, or drug impregnation within the biomaterial, and extended release strategies that control antimicrobial agent release from the device over time after implantation.

Antimicrobial Medical Devices in Preclinical Development and Clinical Use

A drug-impregnated sleeve for encasing a medical implant is provided. In one embodiment, the sleeve may include a body made of a biologically-compatible material that defines an internal cavity configured to receive the medical implant. In one embodiment, the biologically-compatible material is bioresorbable. The body may include a plurality of apertures, such as perforations or holes, extending from the cavity through the body. The sleeve may further include a first end, a second end, and a drug impregnated into the resorbable sheet. In one possible embodiment, the first end of the sleeve may be open for receiving the medical implant therethrough and the second end may be closed. The implant may be encased in the sleeve and implanted into a patient from which the drug is dispensed in vivo over time to tissue surrounding the implantation site. In one embodiment, the body is made from at least one sheet of a biologically-compatible material, hi one embodiment, the sleeve may be made in least in part from caprolactone to add stretchability to the sleeve.

Drug-impregnated encasement

Objective

To evaluate biocompatibility of biodegradable sleeves containing antimicrobial agents, designed for local drug delivery to prevent implant-related infection.



Study Design

Synthetic polyester sleeves (a copolymer of glycolide, caprolactone, trimethylene carbonate, lactide) were cast as thin films. The antimicrobial agents incorporated in the sleeves included gentamicin sulfate, triclosan, or a combination of these drugs.



Animals

Adult sheep (n = 15).



Methods

Two limited contact dynamic compression plates (LC-DCP) with or without sleeves were implanted on tibiae (bilateral) of 15 sheep. Sleeves were placed over the plates before implantation. Beneath half of the plates, 5-mm drill hole defects were made in the near cortex. Samples were harvested 4 weeks later for histology and microradiography.



Results

Macroscopically, no irritation of bone or adjacent tissue was seen. Small remnants of sleeves were visible on histology, and positively correlated with the presence of macrophages and foreign body cells. Thick sections showed no difference between the test samples and controls in terms of fibrous capsule formation, periosteal remodeling, and defect remodeling. Inflammatory cells, macrophages, and foreign body cells were more prominent in sections with sleeves, but were not statistically significantly different from controls. Cell numbers were within normal physiologic limits normally seen as cellular response to foreign bodies consisting of polymers.



Conclusion

The normal healing response indicated that the biodegradable sleeves demonstrate tissue biocompatibility.

Biodegradable sleeves for metal implants to prevent implant-associated infection: an experimental in vivo study in sheep.

Provided are porous, biocompatible implant bodies and materials. These materials suitably comprise a population of randomly arranged thermoplastic constituents, with at least some of the constituents being bonded to one another The implant bodies are capable of being manipulated at room temperature from a first shape to a second shape, and of maintaining the second shape at about internal body temperature. Also provided are related methods of fabricating such implants and installing the implants into a subject.

Porous implant materials and related methods

A flexible body comprises a polymer film having a first surface and an opposing second surface. The polymer film has a plurality of apertures extending from the first surface to the second surface and a plurality of raised lips protruding from the first surface such that each of the plurality of apertures is surrounded by one of the plurality of raised lips. A method of producing a polymer film comprises placing a polymer solution into a one sided mold having a plurality of protrusions extending from a bottom of the mold wherein the polymer solution is characterized by a viscosity that inhibits the unaided flow of the polymer throughout the mold; urging the polymer solution around each of the plurality of protrusions; and solidifying the polymer solution.

Films and methods of manufacture

PROBLEM TO BE SOLVED: To provide an improved sleeve impregnated with medicine.SOLUTION: The sleeve impregnated with medicine wraps a medical implant. The sleeve defines an inner cavity for receiving medical implant, and includes a body made of biocompatible material. The biocompatible material has bioresorbability. The body may include a plurality of openings such as holes and bores extending from the cavity through the body. The sleeve may further include a first end, a second end, and a resorbable sheet impregnated with medicine. The first end of the sleeve may be open for reception of a medical implant therethrough, and the second end may be closed. The implant is wrapped in the sleeve so as to be embedded in a patient. With passing of time, the medicine is dosed from the embedded sleeve to the tissues around the embedded portion in vivo.

Container impregnated with medicine

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