Abstract:
A method is provided. The method includes placing a magnetic field viewing film over a region of tissue; inserting at least one of a medical device or a medical instrument comprising at least one magnetic element into the region of the tissue; and determining a location of at least one of the medical device or the medical instrument based on a visualization by the magnetic field viewing film of a magnetic field produced by the at least one magnetic element.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/708,670, filed Oct. 2, 2012, the entire disclosure of which is incorporated by reference herein. 
     
    
     BACKGROUND 
       [0002]    1. Technical Field 
         [0003]    The present disclosure relates to systems, apparatuses and methods for tracking medical devices. More particularly, the present disclosure relates to systems, apparatuses and methods for tracking invasive medical devices using magnetic field sensitive viewing films. 
         [0004]    2. Background of Related Art 
         [0005]    During invasive surgery it is often desired to track location of medical devices (e.g., surgical instruments, implants, sponges, etc.) and internal features (e.g., tissue, organs, blood vessels, etc.) within the patient. Conventional tracking usually involves magnetic resonance or X-ray fluoroscopy systems. These systems rely on sophisticated and expensive equipment such as computers and displays for visualizing location of the medical devices. Further, in the case of X-ray fluoroscopy the patient and the attending medical staff are exposed to undesirable X-ray radiation. 
         [0006]    There is continual need for medical device tracking systems, apparatuses and methods that provide for safe, accurate, real-time tracking of medical devices that do not require additional computing and visualization equipment. 
       SUMMARY 
       [0007]    The present disclosure provides for a method including: placing a magnetic field viewing film over a region of tissue; inserting at least one of a medical device or a medical instrument including at least one magnetic element into the region of the tissue; and determining a location of at least one of the medical device or the medical instrument based on a visualization by the magnetic field viewing film of a magnetic field produced by the at least one magnetic element. 
         [0008]    According to one aspect of the present disclosure, the medical device is selected from the group consisting of a mesh, a stent, a sponge, a fastener, a sling, a suture, a clip, and combinations thereof. 
         [0009]    According to one aspect of the present disclosure, the medical instrument is selected from the group consisting of an endoscope, a catheter, a grasper, a balloon, a sealer, a tissue stapler, a vessel sealer, a clip applier, a biopsy instrument, an ablation probe, and combinations thereof. 
         [0010]    According to one aspect of the present disclosure, the medical device is at least one of a hernia mesh or a stent including a plurality of magnetic microparticles disposed thereon in a predetermined pattern. 
         [0011]    According to one aspect of the present disclosure, the magnetic field viewing film includes at least one flexible sheet and a plurality of magnetic particles responsive to the magnetic field produced by the at least one magnetic element. 
         [0012]    According to one aspect of the present disclosure, the method further includes adjusting the location of at least one of the medical device or the medical instrument based on the visualization by the magnetic field viewing film of the magnetic field produced by the at least one magnetic element. 
         [0013]    The present disclosure provides for a method including: placing a magnetic field viewing film over a region of tissue; guiding a medical device using a medical instrument into the region of the tissue, wherein at least one of the medical device or the medical instrument comprises at least one magnetic element; and determining location of at least one of the medical device or the medical instrument based on a visualization by the magnetic field viewing film of a magnetic field produced by the at least one magnetic element. 
         [0014]    According to one aspect of the present disclosure, features relevant to targeting the procedure, tissue or the medical device may be sketched on the magnetic field viewing film using a magnetized stylus or “pen”. 
         [0015]    According to one aspect of the present disclosure, the medical device is selected from the group consisting of a mesh, a stent, a sponge, a fastener, a sling, a suture, a clip, and combinations thereof. 
         [0016]    According to one aspect of the present disclosure, the medical instrument is selected from the group consisting of a endoscope, a catheter, a grasper, a balloon, a sealer, a tissue stapler, a vessel sealer, a clip applier, a biopsy instrument, an ablation probe, and combinations thereof. 
         [0017]    According to one aspect of the present disclosure, the medical device is selected from the group consisting of a hernia mesh and a stent including a plurality of magnetic microparticles disposed thereon in a predetermined pattern. 
         [0018]    According to one aspect of the present disclosure, the method further includes adjusting the location of the medical device based on the visualization by the magnetic field viewing film of the magnetic field produced by the at least one magnetic element. 
         [0019]    According to one aspect of the present disclosure, the magnetic field viewing film includes at least one flexible sheet and a plurality of microspheres encapsulating at least one magnetic particle responsive to the magnetic field produced by the at least one magnetic element. 
         [0020]    The present disclosure provides for a kit including: a magnetic field viewing film; and at least one of a medical instrument or a medical device, wherein at least one of the medical instrument or the medical device includes at least one magnetic element configured to produce a magnetic field that is visualized by the magnetic field viewing film. 
         [0021]    According to one aspect of the present disclosure, the kit further includes instructions for use of the kit, the instructions including: placing the magnetic field viewing film over a region of tissue; inserting at least one the medical device or the medical instrument into the region of the tissue; and determining location of at least one of the medical device or the medical instrument based on a visualization by the magnetic field viewing film of the magnetic field produced by the at least one magnetic element. 
         [0022]    According to one aspect of the present disclosure, the instructions further include adjusting the location of at least one of the medical device or the medical instrument based on the visualization of the magnetic field viewing film. 
         [0023]    According to one aspect of the present disclosure, the medical device is selected from the group consisting of a mesh, a stent, a sponge, a fastener, a sling, a suture, a clip, and combinations thereof. 
         [0024]    According to one aspect of the present disclosure, the medical instrument is selected from the group consisting of an endoscope, a catheter, a grasper, a balloon, a sealer, a tissue stapler, a vessel sealer, a clip applier, a biopsy instrument, an ablation probe, and combinations thereof. 
         [0025]    According to one aspect of the present disclosure, the medical device is a hernia mesh including a plurality of magnetic microparticles disposed thereon in a predetermined pattern. 
         [0026]    According to one aspect of the present disclosure, the medical device is a stent including a plurality of magnetic microparticles disposed thereon in a predetermined pattern. 
         [0027]    According to one aspect of the present disclosure, the magnetic field viewing film includes at least one flexible sheet and a plurality of magnetic particles responsive to the magnetic field produced by the at least one magnetic element. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]    Various embodiments of the present disclosure are described herein with reference to the drawings wherein: 
           [0029]      FIG. 1  is a side, cross-sectional view of a magnetic field visualization film according to the present disclosure; 
           [0030]      FIG. 2  is a side, cross-sectional view of a magnetic microsphere of the magnetic field visualization film of  FIG. 1  according to the present disclosure; 
           [0031]      FIG. 3A  is a perspective view of the magnetic field visualization film of  FIG. 1  disposed over abdominal cavity according to the present disclosure; 
           [0032]      FIG. 3B  is a cross-sectional view of the abdominal cavity with the magnetic field visualization film of  FIG. 1  disposed outside of the cavity and a hernia mesh with a medical instrument disposed within the cavity according to the present disclosure; 
           [0033]      FIG. 4  is a perspective view of the magnetic field visualization film of  FIG. 1  in the presence of a magnetic field produced by the medical instrument according to the present disclosure; 
           [0034]      FIG. 5A  is a perspective view of the hernia mesh of  FIG. 3B  having a plurality of magnetic elements according to the present disclosure; 
           [0035]      FIG. 5B  is a perspective view of the hernia mesh of  FIG. 3B  having a magnetic pattern according to the present disclosure; 
           [0036]      FIG. 5C  is a perspective view of the hernia mesh of  FIG. 3B  having a linear magnetic pattern according to the present disclosure; 
           [0037]      FIG. 6A  is a perspective view of the magnetic field visualization film of  FIG. 1  in the presence of a magnetic field produced by the hernia mesh of  FIG. 5B  according to the present disclosure; 
           [0038]      FIG. 6B  is a perspective view of the magnetic field visualization film of  FIG. 1  in the presence of a magnetic field produced by the hernia mesh of  FIG. 5C  according to the present disclosure; 
           [0039]      FIG. 7  is a cross-sectional view of a blood vessel with a magnetic stent and a magnetic catheter disposed therein and the magnetic field visualization film of  FIG. 1  disposed over the tissue according to the present disclosure; 
           [0040]      FIG. 8  is a perspective view of the magnetic stent of  FIG. 8  according to the present disclosure; and 
           [0041]      FIG. 9  is a top view of a surgical kit according to the present disclosure. 
       
    
    
     DETAILED DESCRIPTION 
       [0042]    Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. 
         [0043]    The present disclosure provides for a system and method for visualization of location of internal tissue features and/or medical devices. The system includes a magnetic field visualization film disposed on an exterior portion of the patient (e.g., outside the abdominal cavity). The film is configured to change visually (e.g., darken) when brought in proximity of a magnetic field. Medical devices that are to be visualized are magnetized and/or include magnetic elements disposed thereon such that the magnetic field is visualized by the film. Visualization of internal tissues may be accomplished by locating one or more magnetic elements in proximity and/or contact with the internal tissues that are desired to be visualized. Changes in the color density of the film allow the user to locate and/or track location of the medical device. 
         [0044]    With reference to  FIG. 1 , a magnetic field visualization film  10  is shown. The film  10  includes a top sheet  12   a  and a bottom sheet  12   b,  which may be formed from any non-magnetic, flexible, transparent or translucent material that allows for transmission of magnetic fields and light to pass therethrough. Suitable materials for forming the sheets  12   a,    12   b  include thermoplastics, such as acrylics, celluloid, cellulose acetate, cyclic olefin copolymer, ethylene-vinyl acetate, fluoropolymers, ionomers, polyoxymethylene, polyacrylates, polyacrylonitrile, polyamide, polyamide-imide, polyaryletherketon, polybutadiene, polybutylene, polybutylene terephthalate, polycaprolactone, polychlorotrifluoroethylene, polyethylene terephthalate, polycyclohexylene dimethylene terephthalate, polycarbonate, polyhydroxyalkanoates, polyketones, polyester, polyethylene, polyetheretherketone, polyetherketoneketone, polyetherimide, polyethersulfone, chlorinated polyethylene, polyimide, polylactic acid, polymethylpentene, polyphenylene oxide, polyphenylene sulfide, polyphthalamide, polypropylene, polystyrene, polysulfone, polytrimethylene terephthalate, polyurethane, polyvinyl acetate, polyvinyl chloride, polyvinylidene chloride, styrene-acrylonitrile, and combinations thereof. One type of such magnetic field visualization film is commercially available under the trade name Magne-View from Magne-Rite, Inc. 
         [0045]    The film  10  includes a plurality of microspheres  14  disposed between the sheets  12   a ,  12   b.    FIG. 2  shows an enlarged, cross-sectional view of the microsphere  14  including a membrane  15  enclosing a viscous fluid  16  and a plurality of magnetic particles  18  dispersed and suspended therein. The microspheres  14  may be formed by any suitable microencapsulation methods, such as emulsion-based solvent evaporation and/or extraction methods including, but not limited to, single-emulsion methods such as oil-in-water (o/w) and water-in-oil (w/o), double-emulsion methods such as water-in-oil-in-water (w/o/w) and solid-in-oil-in-water (s/o/w), and non-emulsion based methods, such as fluidized-bed, spray-drying, and casting/grinding methods. After encapsulations, the microspheres  14  may be deposited on the sheets  12   a,    12   b  and cross-linked. 
         [0046]    The fluid  16  may be an oil having an absolute viscosity at room temperature from about 50 centipoise (P) to 1,000 about cP, in embodiments from about 100 cp to about 500 cp. Suitable oils include, but are not limited to, petroleum-based oils, such as light, medium or heavy mineral oils (e.g., mixtures of alkanes having from about 40 carbons to about 60 carbons), plant-based oils, such as cottonseed oil, silicone-based oils, and combinations thereof. The fluid  15  may be used as a continuous phase fluid during the emulsification processes. 
         [0047]    The magnetic particles  18  may be from about 10 angstroms (Å) to about 1000 Å, in embodiments from about 25 Å to about 500 Å. The magnetic or magnetized particles  18  formed from any suitable ferromagnetic or magnetizable material including, but not limited to, ferrite, strontium ferrous oxide, neodymium (NdFeB, optionally including dysprosium), samarium, cobalt, aluminum, nickel, copper, iron, titanium, and combinations thereof. In embodiments, magnetic particles  18  may have any suitable shape, such as, cylindrical, polygonal, (e.g., square or hexagonal cross-section), and the like. In further embodiments, the magnetic particles  18  may be reflective (e.g., have one or more reflective surfaces) such that alignment of the particles  18  in the presence of a magnetic field makes the film  10  appear brighter or darker based on the spatial orientation of the film  10  relative to the magnetic field. 
         [0048]    During use, the film  10  is placed outside the patient (e.g., abdominal cavity “C” of  FIGS. 3A-B ) or over a region of tissue in which a surgical procedure is being performed. In embodiments, the film  10  may be used internally over organs and other tissue to track location of medical devices therein. Localization and/or tracking of medical devices is accomplished by monitoring changes in color (e.g., darkness level) of the film  10  as described in further detail below with respect to  FIGS. 4 ,  6  A-B, and  7 , 
         [0049]    Suitable medical devices include medical implants, such as, meshes, stents, sponges, fasteners (e.g., staplers), slings, clips, sutures, combinations thereof, and the like. In embodiments, the magnetic elements may be electromagnets. In further embodiments, the medical devices may include one or more components (e.g., housing, shaft, etc.) that are magnetized or include a coating of magnetic microparticles. 
         [0050]      FIGS. 3A-B  show a system (e.g., kit)  30  for repairing a hernia according to an embodiment of the present disclosure. The system  30  includes the film  10  that is disposed over the abdominal cavity “C” (e.g., over an abdominal wall “W”) and a mesh  32 . Since the film  10  is formed from flexible sheets  12   a,    12   b,  the film  10  may be conformed to the abdominal wall “W.” The system  30  also includes a medical instrument  34  having one or more magnetic elements  34  disposed thereon. The instrument  34  may be any suitable open or endoscopic surgical instrument, such as, endoscopes, catheters, graspers, balloons, sealers, tissue staplers, vessel sealers, clip appliers, biopsy instruments, ablation probes, combinations thereof, and the like. The medical instrument  34  includes one or more magnetic elements  36 , which may be formed from any suitable ferromagnetic or magnetizable material. The magnetic elements  36  are permanently or temporarily (e.g., via adapters) secured to the medical instrument  34 . 
         [0051]    Features relevant to targeting the procedure, tissue or the medical device may be sketched on the magnetic field viewing film using a magnetized stylus or “pen”. 
         [0052]    Suitable magnetic materials may be temporary magnetic materials or permanent magnetic materials, ceramic, crystalline, or flexible magnetic materials (e.g., a polymeric substance such as thermoplastics or rubber) combined with magnetic ferrite (e.g., heat-treated mixtures of oxides of iron and one or more other metals having complex crystals with magnetic properties). Suitable magnetic materials include, but are not limited to, ferrite, strontium ferrous oxide, neodymium (NdFeB, optionally including dysprosium), samarium, cobalt, aluminum, nickel, copper, iron, titanium, and combinations thereof. Magnetic elements  36  may have any suitable shape, such as, cylindrical, polygonal, (e.g., square or hexagonal cross-section), and the like. In embodiments, the magnetic element  36  may be an electromagnet. In further embodiments, the surgical instrument  34  may include one or more components (e.g., housing, shaft, etc.) that are magnetized or include a coating of magnetic microparticles (e.g., magnetic particles described above). 
         [0053]    During use, the mesh  32  is inserted into the abdominal cavity “C” and is advanced to the site of the hernia site using any suitable methods and/or instruments. Once the mesh  32  is in position, the surgical instrument  34  is used to point to different areas of the mesh  32 . With reference to  FIG. 4 , as the surgical instrument  34  is brought into contact with the mesh  32 , the film  10  reacts to the proximity of the magnetic element  36  of the instrument  34  by changing color, which is indicative of the location of the medical devices. In particular, the magnetic particles  18  of the film  10  are free to move within the fluid  16  in response to external magnetic fields generated by the magnetic elements  36 . 
         [0054]      FIG. 4 , illustrates the film  10  with multiple areas  38  indicative of the location of the magnetic element  36 . When magnetic lines of force of the magnetic element  36  are parallel to the surface of the film  10 , the surfaces of the magnetic particles  18  that are reflective are aligned toward the plane defined by the film  10 , and appear bright. When lines of force of the magnetic field are perpendicular to the sheet, the magnetic particles  18  appear darker, since the reflective surfaces thereof are rotated away from the horizontal plane defined by the film  10 . The user may keep adjusting the position of the mesh  32  and keep pointing the magnetic element  36  to various positions of the mesh  32  (e.g., corners, perimeter, center, etc.) until the mesh  32  is disposed over the desired location. 
         [0055]    With reference to  FIG. 5A , the mesh  32  may include one or more magnetic elements  46  disposed thereon. The magnetic elements  46  may be disposed in any suitable configuration, such as corners, center, perimeters, and combinations thereof. In further embodiments, the mesh  32  may include a plurality of magnetic microparticles disposed on and/or within the mesh  32 . As shown in  FIGS. 5B and 5C , the microparticles may be applied in a flower-shaped pattern  33   a  to a mesh  32   a,  a pattern  33   b  having a plurality of lines to a mesh  32   b.  The microparticles may be applied to the mesh  32  using any suitable method, such as spraying, dipping, incorporating into the polymer solution prior to forming the mesh  32 , and combinations thereof. The microparticles may be applied to the mesh  32  in any suitable pattern that identifies the shape of the mesh  32 . 
         [0056]    With reference to  FIGS. 6A and 6B , two exemplary embodiments of the patterns  33 A and  33 B on the film  10  are shown.  FIG. 7A  shows a flower-shaped pattern  35   a,  which is suitable for identifying the center and/or perimeter of the mesh  32   a  of  FIG. 5B  as it is brought into proximity with the film  10 .  FIG. 7B  shows a pattern  35   b  having a plurality of lines corresponding to the pattern  33   b  of the mesh  32   b,  which is suitable for identifying thickness of the tissue disposed between the mesh  32  and the film  10 , with the lines acting like contour lines. 
         [0057]      FIG. 7  shows another embodiment of a surgical instrument (e.g., catheter  40 ) inserted into a blood vessel “V.” The catheter  40  may be any suitable catheter having a flexible longitudinal body  42 . The catheter  40  includes one or more magnetic elements  56  disposed on the longitudinal body  42 . In embodiments, the magnetic element  56  may be disposed at a distal end thereof. In use, the catheter  40  is inserted into the vessel “V” with the film  10  disposed over the treatment site. The magnetic elements  56  cause the film  10  to change in color as described above. 
         [0058]    With reference to  FIGS. 7 and 8 , the catheter  40  may be used to deliver various medical devices into the vessel “V,” such as a stent  60 . The stent  60  includes a plurality of interconnected struts  62 . The stent  60  may include one or more magnetic elements  66  disposed thereon. The magnetic elements  66  may be disposed in any suitable configuration. In further embodiments, the stent  60  may include a plurality of magnetic microparticles disposed on (e.g., applied as a pattern  68 ) and/or within the stent  60 . The microparticles may be applied to the stent  60  using any suitable method, such as spraying, dipping, incorporating into the polymer solution prior to forming the stent  60 , and combinations thereof. The microparticles may be applied to the stent  60  in any suitable pattern. 
         [0059]    The present disclosure also provides for a surgical kit  100 , having one or more magnetic field visualization films  10  and one or more of the following: the mesh  32 , the surgical instrument  34 , the catheter  40 , and the stent  60 . In embodiments, the surgical kit  100  may include any other medical instruments and/or devices having magnetic elements, magnetized components, or other means suitable for generating magnetic fields (e.g., electromagnets) that are detectable by the film  10 . 
         [0060]    The kit  100  may include a tray  102  having a plurality of planar surfaces and a plurality of recesses that may be disposed within the planar surfaces. The tray  102  may be formed of any suitable material, for example the tray  102  may be molded from a transparent or translucent substantially rigid plastic material (i.e., PETG). The tray  102  may have side walls defining a depth of the tray  102 . The planar surfaces may be vertically offset within the tray  102 . The tray  102  including its features (e.g., planar surfaces, recesses, walls, etc.) may be formed by molding or any other suitable techniques. 
         [0061]    The plurality of recesses are adapted to hold articles or implements (e.g., films  10 , the mesh  32 , the surgical instrument  34 , the catheter  40 , the stent  60 , etc.) that are useful in performing the intended surgical procedures described above. Each recess may be adapted to hold one or more articles (e.g., a plurality of films  10  or meshes  32  arranged in a stack). The recesses may also include detents, protrusions, or the like to frictionally engage the articles and positively retain the articles within the respective recesses. 
         [0062]    The kit  100  may also include a cover (not shown) to enclose the articles therein. A corner  104  of the tray  102  may be configured so that the cover is not adhered to the corner  104 . In such an embodiment, a user may grasp the cover that is positioned adjacent to the corner  104  to remove the cover from the tray  102 . The cover may be attached or configured with the tray by any suitable method, including but not limited to adhesives, heat sealing, sonic or thermal welding, solvents, etc. After all of the articles have been placed in the tray  102  and the cover sealed to the tray, the kit is subjected to an ETO (ethylene oxide) gas sterilization process. A suitable cover material is TYVEK™ a spunbond polyolefin, from DuPont of Wilmington, Del. Any number of other permeable web materials suitable for sterilization (ETO), such as Kraft paper, may be used as the cover. The kit  100  may also include a pamphlet (not shown) that includes various information, such as directions for using the kit  100 . 
         [0063]    While several embodiments of the disclosure have been shown in the drawings and/or described herein, it is not intended that the disclosure be limited thereto, as it is intended that the disclosure be as broad in scope as the art will allow and that the specification be read likewise. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.