Patent Application
20070135706
The invention relates to a method, device and kit for washing and debridement of a lesion. More particularly, the invention relates to an irrigation method, device and kit for debridement of an osteolytic lesion.
Osteolysis is a common complication in total hip arthroplasty and a common cause of component failure. Osteolysis is a response to wear debris. It can develop around a hip or knee implant as a result of the presence of bearing surface wear debris, access of wear debris particles to an implant-bone interface and a biologic osteolytic response of a host bone to debris laden synovial or other physiological fluids to the wear particles. Osteolysis is mediated primarily by macrophages. Fibroblasts and endothelial cells also play a role. These cells are activated by the bearing surface wear debris, primarily polyethylene, but also metal and polymethylmethacrylate particles. The biologic reaction to these particles is a nonspecific foreign-body reaction. Particles in the submicron size range undergo phagocytosis by macrophages and release a variety of cytokines which ultimately stimulate osteoclasts to resorb bone. The most common source of wear debris is adhesive-abrasive wear between a femoral head and polyethylene liner. This wear can produce as many as 500,000 particles per gait cycle.
Osteolysis can be asymptomatic until the lesions become very large. While some osteolytic lesions may be cleansed by washing and conventional debridement, surgery is a typical treatment. The surgery both treats the lesions and removes particles with attendant biofilm that could generate recurrence. With a stable acetabular component in acceptable alignment and with a modular liner, debridement and bone grafting of the lesions with retention of the acetabular shell and replacement of the polyethylene liner can be successful. However, if the acetabular shell is loose or malpositioned, then revision of the component is indicated.
While washing and debridement procedures are preferred approaches to lesion management, these less invasive procedures are not uniformly successful. Lesions can be difficult to debride, particularly osteolytic lesions. Osteolytic lesions are often located in tortuous and remote anatomy that is difficult to access using traditional instruments and these lesions are often filled with obstructing bony spicules, gelatinous masses of necrotic and fibrous tissue. This tissue can be adherent or non-adherent to surrounding intact tissue that defines the border of the lesion.
There is a need for an improved debridement method for osteolytic bone lesions that is minimally invasive and that does not require removal of a well-fixed previous implant. There is a need for a debridement method to effectively debride lesions in difficult anatomic locations and a need for a method to effectively break up soft tissue, clean the lesion edge and evacuate lesions that result with hip or knee implant procedures. There is a need for a device capable of breaking up the soft tissue, cleaning the lesion edge, removing the biofilms and evacuating the area through a substantially non-evasive arthroscopic methodology.
The invention relates to a debridement method, device and system or kit to effectively debride a lesion, particularly an osteolytic lesion resulting from a hip or knee arthroplasty. According to the invention, a method for treatment of a lesion, comprises: delivering an effective amount of a debridement fluid with suspended particulate abrasive to a lesion area within body tissue to debride the lesion; and intermittently aspirating the fluid from the area.
In an embodiment, the invention is a method for removing unwanted material from a body cavity comprising: providing a fluid reservoir with abrasive particle-containing debridement fluid and a device comprising a tubular flexible line having a pickup end and an delivery/aspirator end, an inner cannula and an outer second cannula that extend concentric with one another longitudinally as part of the tubular flexible line; the inner cannula having at least one orifice at the delivery/aspirator end of the tubular flexible line to deliver the debridement fluid with suspended particulate abrasive from the fluid reservoir to a lesion area in need of debridement; and the outer cannula substantially open at the delivery/aspirator end of the tubular flexible line to aspirate fluid from the area; and delivering an effective amount of a debridement fluid with suspended particulate abrasive from the reservoir by the inner cannula into the lesion area to debride the lesion; and aspirating fluid from the area by the outer cannula.
Another embodiment comprises a device for treatment of an osteolytic lesion, comprising: a fluid reservoir; abrasive particle-containing debridement fluid contained within the fluid reservoir; and a tubular conduit having a pickup end and delivery/aspirator end; an inner cannula and an outer cannula extending concentric to one another longitudinally as part of the tubular conduit, the inner cannula having at least one orifice at the delivery/aspirator end of the tubular conduit to deliver or aspirate debridement fluid with suspended particulate abrasive to or from a lesion area in need of debridement; and the outer cannula substantially open at the delivery/aspirator end of the tubular flexible line to deliver or aspirate fluid from the area.
In yet another embodiment, the invention is a kit or system for treatment of a lesion, comprising: a fluid reservoir; abrasive particle-containing debridement fluid contained within the fluid reservoir; a tubular conduit having a pickup end and delivery/aspirator end an inner cannula and an outer cannula, extending concentric to one another longitudinally as part of the tubular conduit; the inner cannula having at least one orifice at the delivery/aspirator end of the tubular conduit to deliver debridement fluid with suspended particulate abrasive from the fluid reservoir to a lesion area in need of debridement; and the outer cannula substantially open at the delivery/aspirator end of the tubular flexible line to aspirate fluid from the area; and an imaging device to monitor delivery of the debridement fluid to the lesion area and aspiration of fluid from the area.
In the invention, a lesion is irrigated with a fluid with suspended particulate abrasive by an irrigation process, preferably by pulse irrigation (also called “pulse lavage”).
Pulse lavage or pulse irrigation is one procedure for wound and lesion management. In this procedure, pulsating water is directed toward the wound or lesion area. This procedure is effective in removing debris and bacteria from wound and lesion areas. Pulse irrigation is used as part of a number of orthopedic procedures such as prosthetic joint replacement, in which it is used to remove bone fragments from an area of prosthesis. A controllable pulsating stream of liquid to a wound or lesion can provide a therapeutic action that promotes healing and decreases infection.
Various fluids are used with lavage or irrigation procedures to induce proper healing. In McCarthy U.S. Pat. No. 3,288,140, for example a method and apparatus for treatment of surface wounds by fluids is disclosed. Saline is the McCarthy preferred fluid. Further, Vad U.S. Pat. No. 6,527,760 uses normal saline in combination with an antibiotic
The debridement fluid of the invention can be water and other aqueous compositions, including any other typical irrigating or debridement solution. Preferably the fluid is a clear biocompatible debridement fluid such as warm isotonic saline or normal saline in combination with an antibiotic. However, many variations are possible. The solution may include buffers and a bicarbonate, citric acid and tanic acid in very low concentrations. Or the fluid can be a gas and liquid mixture. The gas can be oxygen or carbon dioxide or hydrogen peroxide useful for sterilization purposes. The fluid can include steroid and anti-inflammatory medicaments.
A preferred debridement fluid comprises a mixture of inorganic salts and, optionally minerals, compounded to mimic an electrolyte concentration and a body fluid mixture in an isotonic state. The fluid typically comprises a halide salt of lithium, sodium, potassium, calcium, and other cations. Typically the halide is fluoride, chloride, bromide, or iodide, and most typically chloride. A typical electrolyzed solution of the present invention has a pH within the range of about 2 to about 5, an oxidation reduction potential within the range of about +600 mV to about +1200 mV, and hypohalous acid concentration in the range of about 10 ppm to about 200 ppm. The solution can have bactericidal, fungicidal, and sporicidal properties.
The particulate abrasive can be a biosorable material, which preferably dissolves within several days. Preferably, the abrasive is resorbable and capable of passing through small gauge needles under lavage pressure. Calcium sulfate (CaSO4) is a preferred material. The particulate abrasive can be present in the debridement fluid in a percent by weight between 0.1% and 65%; desirably between 1% and 40% and preferably between 3% and 15%.
Other possible bioabsorbable materials can be injectable solid forms of: calcium phosphate, tri-calcium phosphate, hydroxyapatite, coral hydroxyapatite, demineralized bone matrix, and mineralized bone matrix. Further, the bioabsorbable material can be an injectable solid form of a biopolymer, for example, polylactic acid, polyglycolic acid, polygalactic acid, polycaprolactone, polyethylene oxide, polypropylene oxide, polysulfone, polyethylene, polypropylene, hyaluronic acid or bioglass.
Though preferably the material is bioabsorbable, it is also possible that the material be merely bioimplantable, e.g., hydroxyapatite or PMMA. Material selection is based on the application. Hence, other abrasives may include calcium carbonate, perlite (an expanded silica abrasive), a colloid-forming clay, quartz, pumice, feldspar, tripoli and calcium phosphate, dextranomor microbeads, silicates of aluminum, calcium, lithium magnesium, lithium magnesium sodium, magnesium aluminum, magnesium, sodium and zirconium, attapulgite, bentonite, fuller's earth, hectorite, kaolin, montmorillonite, pyrophyllite, and zeolite. Other suitable particulate abrasives include biocompatible (resorbable and non-resorbable) ceramic and polymer particles such as hydroxyapatite, tetra-tri-calcium phosphate, tri-calcium phosphate, calcium sulfate, calcium aluminate and polymethylmethacrylate.
In some embodiments, particle size of the abrasive may be important. For example, in some applications, a fine particle size that forms a viscous suspension with a particular lavash fluid may be desirable, in other instances, the fluid may be too viscous for effective delivery to a lesion site. In some applications, where heavy abrasive may be desirable, in other instances, the particle size may be too large to pass through the orifice of a delivery device. The abrasive useable in the invention is of a particulate size as to be capable of passing through small gauge needles such as arthroscopic size syringes like the injection syringe of a device of the invention. The particulate abrasive in water preferably is of an average particle size between 0.1 microns and 1500; desirably between 10 microns and 1000 microns and preferably between 50 microns and 400 microns.
In an embodiment, the debridement fluid includes a proteolytic enzyme (protease) or chemonucleolytic component to further disrupt the matrix of lesion tissue. Suitable enzymes include vibriolysin, krill protease, chymotrypsin, trypsin, collagenase, elastase, dipase, proteinase K, Clostridium multifunctional protease, chymopapain, trypsin, chondroitinase, collagenase, Bacillus subtillis protease or a chemical, such as ethylenediaminetetraacetic acid (EDTA). These proteases are typically employed in therapeutic methods, demonstrate low incidence of undesirable side effects and are commercially available in pure, purified or genetically engineered forms. Other suitable proteases include papain, bromelain, plasminogen activator, plasmin, mast cell protease, lysosomal hydrolase, streptokinase, pepsin, and any or all fungal, bacterial, plant or animal proteases. In this embodiment, the debridement fluid may contain a single protease or a plurality of proteases. These additives are helpful when addressing biofilm or tissue remnants that are in difficult to access areas or areas in which a biofilm or remnant tissue is tightly adhered to the osteolytic lesion or to orthopeadic implant
An embodiment of the invention comprises following progress of the lesion debridement by fluoroscopy. In this embodiment, contrast agent is injected into the lesion area through a catheter, or preferably through the inner expression cannula of the device of the invention along with debridement fluid. In an example, the debridement instrument is inserted directly into the lesion site. The contrast agent migrates so that the lesion can be radiographically imaged with a fluoroscope. The fluoroscope produces a planar (or two dimensional) image of the lesion area that can be evaluated to monitor the debridement method.
Features of the invention will become apparent from the drawings and following detailed discussion, which by way of example without limitation describe preferred embodiments of the invention.
The conduit 14 has a pickup end 16 at lavash fluid reservoir 40 to operatively connect the inner cannula 18 from the reservoir 40 (through fluid transfer pump 50) to fluid aspirator/expression end 26 of rigid section 24. The outer aspirator cannula 20 is operatively connected from the fluid transfer pump 50 to fluid delivery/aspirator end 23 to fluid aspirator/discharge end 26 of rigid section 24. In this example, the fluid within the reservoir 40 is a saline solution. The saline solution comprises 10 weight percent suspended calcium sulfate particulate having a particle size of about 150 microns.
Fluid transfer pump 50 includes a drivable motor 52 having an elongated rotor shaft 54. A fluid pressure generating pump 58 is arranged at a first end 56 of the rotor shaft 54. The pump 58 provides fluid pressure to the dual cannula flexible tube 22 from reservoir 40. A second end 60 of rotatable shaft 54 is attached to a suction pump 62, also located within the housing 12. Suction pump is in fluid communication with a screened disposable collection bottle 34 to provide a vacuum incentive for drainage of fluids to the bag 34. In this embodiment, a common empowered motor 52 with an extended shaft 54 provides drive for both pressure pump 58 and vacuum source 62. The arrangement provides for a dual continuous pulsed feed of fluid to a patient lesion area shown in FIGS. 5 for a continuous withdrawal of fluid from the area after treatment of a wound or lesion.
In an embodiment shown in
First, referring to
Usually lesion 136 is surrounded by cancellous bone 134, and usually also cortical bone 132. And, typical treatment to debride the lesion 136 is significant and invasive, sometimes involving removal of the implant 128, open debridement of the lesion area 136 (which enlarges the intramedullary area even further), and implantation of a revision implant. In another typical treatment, location of the lesion 136 is identified by fluoroscope or other imaging process, first and second holes are bored to access the lesion area and lavage fluid is expressed through one hole and is suctioned out the second hold. This procedure operates blindly without assurance that fluid expressed through the first hole delivers lavage to the lesion area. Additionally, the lesion can be tough and resistant to a typical fluid that would be used in the first and second hole procedure.
The present invention provides a minimally-invasive and accurate approach to treating lesions without removal of implants and revision and without two hole bodily invasion. The invention accurately delivers lavage to assure complete debridement of the lesion. In the present invention, a lavage fluid is utilized that comprises abrasive particles that completely debride even an osteolytic lesion that may be filled with resistant gelatinous masses of nacrotic and fibrous tissue. Additionally, in an embodiment of the invention, insertion of the rigid delivery section 24 of the debridement device into the hip joint, the orientation of the syringe expressing end 70 of the delivery section 24; impingement of expressed debridement fluid the lesion and aspirating of fluid containing the nacrotic and fibrous tissue and spent fluid and particles can be monitored to assure complete debridement.
The lesion debridement is monitored in
In operation, patient 126 is aligned between tube unit 116 and image intensifier 148 so that the internal patient's hip joint 124 is visible on television monitor 116. User 112 performs a puncture of the patient's hip area toward the joint 124 with the elongated rigid delivery section 24 of debridement device 10. The user 112 positions the puncture so that the inserted delivery section 24 syringe end is generally perpendicular to a central axis of an x-ray beam, which is directed upward from fluoroscope x-ray tube unit 116 to image intensifier 148. The fluoroscopic field of view of fluoroscope 116 is then narrowed to display an image on monitor 116 to permit positioning aspirator/expression end 26 of delivery section 24 within the cancellous bone 134 of hip joint 124 at a location of the osteolytic lesion 136.
The user 112 manipulates the aspirator/expression end 26 of delivery section 24, while remaining outside of the path of the x-ray beam between x-ray tube unit 116 and image intensifier 148 as shown in
While preferred embodiments of the invention have been described, the present invention is capable of variation and modification and therefore should not be limited to the precise details of the above examples. For example, the cannulas of the drawings are shown concentric. However, they can be side by side or of any suitable configuration. Also, the invention can relate to a kit that is packaged to include the above-described components for sale, shipment. The invention includes changes and alterations that fall within the purview of the following claims.
