Abstract:
A surgical tool for doing work inside the body is powered by an electroactive polymer in the form of a transducer. The electroactive polymer is connected to an electrical power source and deforms from an initial position to a different second position upon electrical stimulation. The transducer can make a cavity in bone for internal splints or power a pump.

Description:
BACKGROUND OF THE INVENTION  
       [0001]     1. Field of the Invention  
         [0002]     This invention is related to the field of surgery and, particularly, to the use of an electroactive polymer in a tool to accomplish work within the body. One example is in orthopedic surgery, as a bone tamp for bone fractures and in the procedure referred to as vertebroplasty. Another example is in variable volume implantable pumps to collect or deliver materials.  
         [0003]     2. Description of the Prior Art  
         [0004]     Vertebroplasty is a percutaneous technique for repairing spinal compression fractures by injecting bone cement into the vertebrae. The bone cement is used to shore up the collapsing vertebrae which relieves pain associated with undue pressure on the spinal nerves. The procedure is now broadened in application to osteoporotic patients as a surgical alternative to a regimen of narcotics and immobilization. A needle is inserted through the skin on a posterior-lateral tract and penetrates the hard shell of the vertebrae. A cannula is inserted over the needle and the needle is withdrawn leaving a pathway for the treatment material to be deposited within the marrow of the vertebral body. The material is inserted by either high pressure or low pressure mechanical, electrical or manual pumps. The procedure is monitored by fluoroscopy to monitor the injection to prevent the material from penetrating into the spinal canal or other unwanted areas.  
         [0005]     Rather than using the injected material to form the cavity within the vertebrae, later devices use a balloon to form the space and control the spread of the bone cement. This gives in better control of the size and shape of the cavity and the resultant size and shape of the cement.  
         [0006]     In addition to or, in place of, the bone cement for structural support, other ingredients may be included in the material, such as BMP, bone morphogenic proteins, DBM, demineralized bone matrix, BOTOX, and other viral vectors, any bone marrow aspirate, platelet rich plasma, compositie ceramic hydroxyapatite, tricalcium phosphate, glass resin mixtures, resorbable highly purified polylactides/polylactides-co-glycolides and others. U.S. Pat. No. 6,582,439 issued to Sproul on Jun. 24, 2003, incorporated herein by reference, teaches this procedure.  
         [0007]     The Reiley et al patent, U.S. Pat. No. 6,248,110, teaches the use of an inflatable balloon within the marrow of most bones in the body, including the vertebrae. The balloon fashions a cavity within the bone as well as providing enough force to adjust the cortical bone to relieve compression or deformation. The cavity and the new contour of the bone may be filled with bone cement There is a possibility of rupture of the balloon within the vertebrae and the escape of the inflating material into the body.  
         [0008]     U.S. Pat. No. 6,632,235 to Weikel et al issued on Oct. 14, 2003 teaches the use of an inflatable balloon to be inserted within the vertebral body and expand the space for treatment. The balloon may be removed before the treatment material is injected into the space or the balloon may be a container for the material. There is a possibility of rupture of the balloon within the vertebrae and the escape of the inflating material into the body. U.S. Pat. No. 6,586,859 issued Jul. 1, 2003 to Kornbluh et al teaches the use of electroactive polymers (EAP) as transducers for animating figurines. The polymers act as artificial muscles. The polymers are connected to movable elements of the figure and, upon electrical stimulation, the polymers change shape thereby moving the attached figurine parts.  
         [0009]     U.S. Pat. No. 3,731,681 and U.S. Pat. No. 5,176,641 disclose pumps implantable in the body for administering medicaments over long term. The pumps are powered by air pressure or elasticity of a foam to express the medicament from the reservoir. The reservoirs are refillable from outside the body.  
         [0010]     An article in the October, 2003 edition of,  Scientific American , entitled, “Artificial Muscles,” by Steven Ashley, gives an overview of the research accomplished with electroactive polymers (EAP). The general thrust of the research is the replacement of mechanical, hydraulic and electrical, “actuators,” with polymers that can change shape upon electrical stimulation. The article also suggests that the EAP can expand and contract as well as generate force equivalent to muscle.  
         [0011]     Published U.S. Patent application, U.S. 2003/0006669, published Jan. 9, 2003, discloses rolled electroactive polymer (EAP) capacitors, along with the necessary electronic apparatus, bi-directionally used as actuators, sensors and other devices generating mechanical force and strain when electrically excited or generating electrical pulse when mechanically flexed.  
         [0012]     The fundamental principals of Maxwell stress and the electroactive polymer (EAP) capacitors are well understood. Basically, the devices are made up of polymeric film, such as dielectric elastomers, with electrodes on both sides forming a capacitor. Electrical energy flowing through the electrodes causes the polymers to deflect along the field lines in compression, when the electrical charges on the opposing electrodes attract each other, and expand perpendicular thereto. Such conversion of electrical energy to mechanical movement is in the nature of a transducer. Of course, the electrodes must be flexible to maintain good contact with the interposed film.  
         [0013]     The capacitors also operate in the opposite fashion in that if they are flexed or strained by a mechanical force, the electrodes have different potential producing electrical energy. As a capacitor stores the electrical energy applied to deform it, it releases that charge as it returns to its original shape and size. The change in the size and shape may be used to produce mechanical work and the electrical release may also perform electrical work.  
         [0014]     The prior art vertebroplasty systems, such as shown in  FIG. 2 , include a series of stylets or guide needles to make a pathway from the skin to the cortical wall W of the vertebrae. A cannula  10  is introduced along the pathway and through the cortical wall and a balloon  11  is introduced into the cancellous bone C or marrow. The balloon is introduced into the cancellous bone C in a reduced state and then inflated thereby performing work to create a cavity  12  within the cortical bone by compressing the cancellous bone. The cavity is filled through a cannula with a flowable material, for example, polymethylmethacrylate (PMMA), which becomes rigid. In the case of a collapsed vertebrae, the pressure used in the procedure may be high enough to expand the vertebrae to its original state. Usually, the balloon is inflated with a liquid then deflated and removed before the introduction of the bone cement. However, the balloon may remain as a container for the cement.  
         [0015]     Transducers of the prior art, as disclosed by Kornbluh et al, in the form of capacitors, are shown in  FIGS. 1A and 1B . The transducer  100  is made up of electrodes  104  and  106  separated by an electroactive polymer film  102 . When the transducer of  FIG. 1A  is electrically charged, it deforms as shown in  FIG. 1B . The area increases and the thickness  112  decreases.  
         [0016]     The polymer film may be any polymer or rubber or combination thereof that deforms in response to an electrostatic force or whose deformation results in a change in electric field, eg., NuSil CF19-2186 made by NuSil Technology of Carpenteria, Calif., silicone polymers made by Dow Corning of Midland, Mich., acrylic elastomers, VHB 4910 made by 3M Corp. of St. Paul, Minn., polyurethanes, thermoplastic elastomers, pressure-sensitive adhesives, fluoroelastomers, and the like. Thickness may range from 1 micrometer upwards. To increase the deformation capability, the polymer film can be pre-stretched, either directionally or isotropically. Films may be pre-stretched from 100 to 600%.  
         [0017]     Differential stretching is also used for special effects. Further, the polymers may be restrained on one or more margins to gain increased deflection in the unrestrained margins. The transducers and polymers are not limited to any particular shape, geometry, or type of deflection. The transducers may be rolled, layered, or folded.  
         [0018]     The monolithic transducer has more than one active area on a single EAP. Each active area has a set of electrodes separated by the active area of the polymer. These areas may be arranged to produce a particular result in shape, size, strain or deflection. The electrodes may be of different sizes and the electric charge to different electrodes may differ through charge control circuitry.  
         [0019]     Other examples of EAP include electrostrictive polymers, electronic EAP and ionic EAP. Electrostrictive polymers are characterized by the non-linear reaction of an EAP relating to deflection. Electronic EAP change shape or dimensions due to migration of electrons in response electric field, usually dry. Ionic EAP change shape or dimensions due to migration of ions in response to an electric field, usually wet and including an electrolyte. The ionic EAP are usually encapsulated to maintain the environment.  
         [0020]     The electrodes are compliant, flexible and expandable to maintain contact with the film during deformation. Suitable materials include graphite, carbon black, colloidal suspensions, thin metals including silver and gold, silver filled and carbon filled gels and polymers, and ionically or electrically conductive polymers. Structured electrodes may also be used, such as, metal traces and charge distribution layers, textured electrodes comprising out of plane dimensions. Also conductive greases, such as carbon or silver greases and other high aspect ratio conductive materials such as carbon fibrils and carbon nanotubes and mixtures of ionically conductive materials.  
         [0021]     The electrodes may be subjected to electrical charge through direct wiring coupled with suitable electronics for control of the stress and strain produced by the transducer. The source of the electrical power may be an electrical grid or battery or any other device developing an electrical charge. The electrodes may be charged wirelessly by RF, microwave, ultrasonically or other system. For example, the electric fields may range from 0 v/m to 440 Mv/m and the work output deformation pressure may be 0 Pa to 10 MPa. The transducers are capable of pressures similar to muscle hence the nickname, “Artificial Muscles.” 
         [0022]     The transducers include electronic drivers that function to regulate the electrical power supplied to and/or from the electrodes. With regard to the monolithic transducers, the particular active area that is charged and in which sequence may also be controlled. The electronic control system may operate proportionally in that the deflection can be controlled by the electrical power supplied to the capacitor. For example, each transducer may be driven by alternating current or direct current, such as, a dc-dc converter as supplied by EMCO High Voltage of Sutter Creek, Calif., model Q50, with a maximum output of 5 kV and 500 mW of power coupled with a processor such as the PIC18C family of processors made by Microtechnology Inc. of Chandler, Ariz. In order to produce greater pressures the thickness of the EAP may be increased. Other parameters may also be changed individually or collectively, such as changing the dielectric constant of the EAP, decreasing the modulus of elasticity of the EAP, layering multiple EAPs, and others.  
       SUMMARY OF THE PRESENT INVENTION  
       [0023]     Therefore, an objective of this invention is to provide an electroactive polymer (EAP) in a tool to be used as a surgical instrument to produce work in the body, either singularly or repetitively.  
         [0024]     Another objective of this invention is to provide a surgical instrument to produce a cavity within a bone with the instrument remaining in place as a prosthesis or removed to provide space for the introduction of treatment materials.  
         [0025]     A further objective of this invention is to provide a cannula with a transducer attached to the leading end.  
         [0026]     Yet another objective of this invention is to provide a power source for a surgical instrument for aspiration or infusion of body fluids or medicaments. 
     
    
     SHORT DESCRIPTION OF THE DRAWINGS  
       [0027]      FIG. 1A  is a perspective of an electroactive polymer capacitor of the prior art without electrical potential applied;  
         [0028]      FIG. 1B  is a perspective fo the capacitor of  FIG. 1A  with electrical bias;  
         [0029]      FIG. 2  is a top view, partially in section, of a vertebrae and balloon of the prior art;  
         [0030]      FIG. 3  is a perspective, partially in section, of a vertebrae with a cannula and bone tamp of this invention;  
         [0031]      FIG. 4  is a top view of a vertebrae an another embodiment of the bone tamp of this invention;  
         [0032]      FIG. 5  is a perspective of another embodiment of the bone tamp of this invention;  
         [0033]      FIG. 6  is a cross section of an implanted infusion pump of this invention; and  
         [0034]      FIG. 7  is a cross section of an implanted aspiration pump of this invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0035]      FIG. 3  illustrates one embodiment of a vertebroplasty cannula  21  with a EAP transducer  120  deployed under electrical charge. The transducer  120  is permanently mounted in the cannula and the EPA  23  spans an aperture  24  in the cannula  21 . In the initial position, without electrical charge, the transducer is housed within the cannula. The procedure may or may not include a guide cannula (not shown) through which the cannula  21  accesses the cancellous bone area within any skeletal bone. Once the cannula  21  is in a desired location, an electrical charge is directed along cable  25  which connects the transducer, through the cannula, from the electronic control  26  unit. The EPA of the tranducer  120  is deformed by the charge to a second position, as shown in the  FIG. 3 . The EAP  23  may or may not be pre-strained before attachment about the aperture  24  to increase the deformation. The deformation results in the cancellous bone being compressed or tamped and forming a cavity within the cortical bone. The electrical stimulation is turned off by the control unit  26  and the transducer returns to its first position within the cannula  21 . The cannula  21  can then be withdrawn. Another cannula may be inserted through the guide cannula and PMMA or other biological material may be introduced to the cavity.  
         [0036]     Because the transducer is initially housed within the cannula  21 , the cannula may be introduced without a guiding cannula. Further, the cannula  21  is shown with a second aperture  27  which can house another transducer  121 . This transducer  121  may be deployed simultaneously or independently with the first transducer  120  from the control unit. The cannula  21 , useful for vertebroplasty or other procedures, may have only one aperture or more than two. The cannula may have multiple bores for introducing or aspirating materials during the procedure, including PMMA, and/or carrying electrical cables.  
         [0037]     The transducer  120 , as shown, is a monolithic transducer in that it has only one EAP  23  between separate electrodes  30 ,  30 ′;  31 ,  31 ′ and  32 ,  32 ′ forming several active areas. These electrodes may be excited in various sequences or simultaneously by control unit  26 . The electrodes may produce differing effects because of each shape or the electrical charge.  
         [0038]     The control unit  26  includes a processor  28  or computer for over all command and control. Depending on the electrical power source, there may be converters, transformers or other modifying components. The control unit includes conditioning electronics  29  to provide or receive electrical energy from the electrodes and function as stiffness control, energy dissipation, electrical energy generation, polymer actuation, polymer deflection sensing, and control logic. The electrical source may be a battery with 1 to 15 volts with step up circuitry  33 . There is step down circuitry  34  to adjust the voltage from the transducer(s). The system may be operated with alternating current. Another bone tamp is shown in  FIG. 4  disposed within the cortical bone of a vertebrae V. The transducer  122  has an electrode on each side of the EAP  23 ′. One margin of the EAP is fixed on a frame  41  to prevent deflection. The transducer may be arranged to deflect into different shapes and sizes either by fabrication or by electrical stimulation. As shown, the transducer  23 ′ is in the second position approximating a wedge. The other margins are shown as straight but could be curved or angled or a combination of both. A cannula  21 ′ is shown as withdrawn from the cancellous bone. The cannula  21 ′ may be introduced into the cancellous bone over a docking needle. The transducer is then inserted after the needle is removed from the cannula. The cannula delivers the transducer in the initial position with the EAP  23 ′ folded or wrapped about the frame  41 . The frame serves as a limiting margin of the cavity to be formed in the vertebrae. Under the influence of electrical energy, the transducer deforms to the second position, shown. The transducer  122  may be controlled, monitored and charged wirelessly from outside the body or by cable. After the cavity has been formed, the power is stopped and the transducer returns to the first position. In vertebroplasty, the expansion of the transducer is such that the end plates of the crushed vertebrae are displaced to a more normal location. Bone cement and/or other materials may be injected into the cavity with the transducer in place. Of course, the transducer may be removed by cannula before the introduction of the materials, if desired.  
         [0039]     In  FIG. 5 , another bone tamp is shown inserted into the neck N of the femur F. The neck is that portion of the femur that extends between the trochanter T and the ball B. A fracture Z of the neck of the femur is common in older people and is difficult to immobilize. A transducer  123  in the form of an internal splint is introduced into the cancellous bone of the neck N in the initial position by cannula. The transducer  123  is pre-stretched about a spring  50  to maintain the stretch and to direct the deformation. The transducer  123  may be charged by cable  25 ′or by RF (radio frequency energy). The transducer assumes the second position and expands against the cortical wall forming an internal splint.  
         [0040]     The transducers may be used for other purposes within the body. For example,  FIG. 6  illustrates an implantable infusion pump  60  inserted beneath the skin S. The transducer  124  is contained within a sheath  61  which serves to separate the transducer from the medicament to be delivered by the pump. The transducer may be wound around a spring or frame that allows expansion and contraction in the longitudinal axis. The sheath may be elastic to expand with the transducer when the electrical charge is applied through the cable  62 . The sheath may be inelastic but sized to accommodate the expanded transducer. The transducer is enclosed within an inelastic sheath. Either sheath may contain a liquid with an electrolyte and the transducer may be ionic. As shown, the transducer  124  and sheath  61  are in the expanded second position with the medicament expressed through the exhaust port  64  from the reservoir  63 .  
         [0041]     The external wall of the pump has a self sealing refill port  67  penetratable by hypodermic needle  69  to resupply the reservoir when the transducer is in the initial position. The transducer  124  is of the type that resumes the initial position upon cessation of electrical power. A one-way valve  65  controls the flow of the medicament from the reservoir to the body from the port  64  through the catheter  68 . The one-way valve may be a slide valve, a flapper valve, a ball valve or other device. The pump casing  66  is a bio-acceptable material, usually a polymer with a smooth external wall. The pump may be used in a timed sequence with the transducer slowly expanding over time and then returning to the initial position for the reservoir to be refilled.  
         [0042]     Another pump is illustrated in  FIG. 7 . As shown, the pump is an aspirator for withdrawing materials from the body. The aspirator pump  70  has a smooth body for implantation within the body with a self sealing port  71  for withdrawing collected materials from the pump reservoir  72 . The pump has a one-way valve  73  for controlling flow into the pump from a catheter  74 . The transducer  125  extends across the reservoir  72  as a diaphragm and bottom wall. As the electrical charge is applied through cable  75 , the transducer will deform into the lower chamber  75  of the pump body producing a negative pressure in the reservoir  72 . The negative pressure may be monitored and controlled over time by the electronic control system. Upon cessation of the electrical stimulation, the transducer will return to the original position.  
         [0043]     Of course, both pumps will operate outside the body and when the one-way valves are reversed perform the opposite function as that described above.  
         [0044]     A number of embodiments of the present invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Accordingly, it is to be understood that the invention is not to be limited by the specific illustrated embodiment but only by the scope of the appended claims.