Abstract:
Various stimulation catheters are disclosed to lie along and stimulate tissue. The electrodes on the leads are various sizes to conserve the battery as well as allowing a more defined area of stimulation. It may also include multiple channels or passages for delivery of drugs, thermal or photonic energy.

Description:
CROSS-REFERENCE  
       [0001]    This application claims priority of Provisional Application serial No. 60/225,732 filed Aug. 17, 2000. 
     
    
     
       BACKGROUND AND SUMMARY OF THE INVENTION  
         [0002]    The present invention relates to an implanted tissue stimulator system and catheters.  
           [0003]    The concept of using electronic stimulation systems for the purpose of controlling nerves or muscles is well known. These systems typically utilize an implantable or an external pulse generator. The external systems consist of a transmitter and antenna which transmits energy and/or stimulation signals transcutaneously through a patient&#39;s skin to an implanted receiver. The receiver provides signal processing of the received pulses and transmits the energy derived therefrom to activate electrodes implanted adjacent to specific types of tissue to be stimulated. A system like the one described above has been disclosed previously in U.S. Pat. No. 3,727,616. It is also known in prior art where more than one pair of electrodes are activated such as U.S. Pat. No. 3,449,768.  
           [0004]    Problems arise in these prior art systems where electrode placement fails to provide the desired physical response. It may also occur later if a change in patient condition or electrode position occurs. This failure may also be caused by improper polarity of the stimulated electrodes relative to one another. Furthermore, it is often required that the electrodes be implanted surgically adjacent to one or more nerve fibers. This type of procedure involves inherent risks due to the fact that it is often performed in close proximity to the brain or spinal cord or other sensitive nerves or tissues. It is therefore desirable to perform the electrode implantation only once to minimize the surgical risks to the patient as well as the financial burdens. Moreover, even when a plurality of electrodes have been utilized, such that repeated surgical procedures are not required, the prior art systems did not provide for dynamic programming and reprogramming of different electrodes after surgery until U.S. Pat. No. 4,459,989 to Borkan.  
           [0005]    The Borkan patent &#39;989 disclosed an external stimulator system which allowed noninvasive programming of the stimulated electrodes. Each electrode was capable of assuming a positive, negative or open circuit status with respect to the other electrodes. This effectively allowed the electrodes to be “repositioned” non-invasively. That same programming ability (plus/minus/off) was later applied to totally implantable systems as well. The system had mono/biphasic control also. Further improvements are described in U.S. Pat. No. 4,612,934 also to Borkan.  
           [0006]    The application of spinal cord stimulation has shown itself to be effective in the treatment of pain and is under study for various other medical conditions. Initially, the leads were implanted by laminectomy and applied to the dura in the epidural space. The next generation of electrodes were positioned by percutaneous implantation. These were either placed into the intrathecal space or the epidural space  
           [0007]    An example of a mutlielectrode catheter assembly for spinal cord stimulation is shown in U.S. Pat. No. 4,379,462 to Borkan.  
           [0008]    The recent use of totally implantable stimulator systems with an implanted power source have resulted in increased emphasis on the amount of power required to deliver an effective stimulation regimen. In addition, use of multi-electrode systems has put an even greater strain on the limited resources of an implanted power cell.  
           [0009]    Various stimulation catheters are disclosed to lie along and stimulate tissue. The electrodes on the leads are various sizes to conserve the battery as well as allowing a more defined area of stimulation. It may also include multiple channels or passages for delivery of drugs, thermal or photonic energy.  
           [0010]    One embodiment envisions epidural, nerve root or intrathecal stimulation leads that include a sheath having at least three in-line electrodes spaced along the exterior of a distal end of the sheath to lie inline along the tissue. In this embodiment, the electrodes extend no greater than 270° about the exterior of the sheath. The electrodes can extend anywhere in the range of 30°-270°. The radius of the electrode maybe smaller than the radius of the sheath This reduces the surface area of the electrodes and therefore the power required by the battery. It also allows the electrodes to have a more defined or localized stimulation. Wherein the electrodes extend less than 360° about the exterior of the sheath, the length of the each electrode along the sheath should be typically at least three millimeters. If the electrode contact extends 360° about the sheath, the length of the electrodes along the sheath typically would be three millimeters or less. The energy delivered to each electrode is distributed over the entire surface area of the electrode.  
           [0011]    In epidural spinal cord stimulation, a great deal of energy is wasted since the target neural tissue lies in only one direction. Use of an electrode with a limited circumferential electrode contact will allow better use and direction of stimulation energy. The currently preferred electrode contact length is two to four millimeters. Use of an electrode with, for instance, a 180 degree electrode allows the same stimulation field to be generated at one half the power required for a standard electrode contact of the same length. Alternatively, it allows the longer (4 mm) electrode contact to be used at the same power consumption as a smaller (2 mm) electrode. The larger electrodes are more forgiving in terms of precise positioning and are more desirable but often not chosen due to the tradeoff between implant battery life and lead size.  
           [0012]    In another embodiment, an additional electrode spaced along the length of the sheath from at least three in-line electrodes at the distal end of the sheath. By positioning the additional lead on the sheath it is closer to the distal electrodes and thereby reduces the current path compared to using the stimulator casing as the additional lead in a monopolar mode. The additional electrode has a surface area on the sheath greater than the surface area on the sheath of each the at least three electrodes. The additional electrode is typically at least twice the surface area of each of the at least three electrodes and may be spaced, for example, at least 10 millimeters from the other electrodes. The increase in surface area can be by varying the electrode length along the sheath or diminishing the circumference around the sheath of the electrodes. The lead may be activated in either a bipolar mode using two of the at least three electrodes and in a monopolar mode using the additional electrode as a common anode and at least one of the other electrodes as a cathode.  
           [0013]    The sheath may include a fixing element configured to fix the electrode in place along the tissue. The fixing element may include at least one of the following: inflatable balloons, nitinol, tines and the sheath shape.  
           [0014]    The invention also anticipates an embodiment Wherein the electrodes extend no greater than 60° about the exterior of the sheath, the electrodes are positioned along the nerve root where it enters the spinal cord(dorsal root entry zone). Alternatively, where the electrodes extend no greater than 90° about the exterior of the sheath, the electrodes may be positioned along the mid-line of the spinal cord to stimulate only the longitudinal and not the bending nerve fibers.  
           [0015]    The sheath may also include a passage extending from an inlet at the proximal end of the sheath to one or more outlets at the distal end of the sheath. The outlets may be located at one or more locations including, but not limited to the tip of the distal end, the area between the electrodes and on the electrodes. This passage may be used for dispensing of drugs or other fluids, for example, adhesive. It may also be an optical channel or for a stilet to be used during positioning of the lead. This may be used without fixing elements.  
           [0016]    Alternatively, one or more optical channels can be provided extending from a port at the proximal end of the sheath to a port at the distal end of the sheath. The port for the optical channel at the distal end may located at one or more of the tip of the distal end, the area between the electrodes and on the electrodes. The optical channel can provide photonic energy to the tissue as well as functioning as a lens for a remote camera. The passage which extends from inlet of the proximal end of the sheath to one or more outlets at the distal end of the sheath may be used with at least one electrode along the exterior of the sheath to lie along the tissue to be stimulated.  
           [0017]    Other objects, advantages and novel features of the present invention will become apparent from the following detailed description of the invention when considered in conjunction with the accompanying drawings. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]    [0018]FIG. 1 is a cross-sectional view of a backbone and spinal cord.  
         [0019]    [0019]FIG. 2 is a perspective view of a catheter lead having 270° electrodes incorporating the principles of the present invention.  
         [0020]    [0020]FIG. 3 is a perspective view of a catheter lead with 90° electrodes positioned on the spinal cord.  
         [0021]    [0021]FIG. 3A is a perspective view of the 90° electrode.  
         [0022]    [0022]FIG. 4 is a perspective view of a catheter lead with a 60° electrode positioned on the spinal cord.  
         [0023]    [0023]FIG. 4A is a perspective view of the 60° electrode.  
         [0024]    [0024]FIG. 5 is a perspective view of a catheter lead with an additional common anode electrode according to the principles of the present invention.  
         [0025]    [0025]FIG. 6 is a perspective view of another catheter lead with an additional common anode electrode.  
         [0026]    [0026]FIG. 7 is a perspective view of a catheter lead including a passage having an outlet at the tip of the electrode and a balloon fixation device. Provision for an optional stilet is also shown.  
         [0027]    [0027]FIG. 8 is a perspective view of a catheter lead with an outlet between the electrodes and a nitinol fixation device deployed according to the principles of the present invention.  
         [0028]    [0028]FIG. 8A shows the nitinol fixation device in position prior to deployment.  
         [0029]    [0029]FIG. 9 is a perspective view of a catheter lead with a passage having an outlet on the electrode and a tine fixation device according to the principles of the present invention.  
         [0030]    [0030]FIG. 10 is a perspective view of a catheter lead wherein the passage is external the sheath according to the principles of the present invention.  
         [0031]    [0031]FIG. 11 is a perspective view of a catheter electrode with a passage as well as two optical channels according to the principles of the present invention.  
         [0032]    [0032]FIG. 12 is a nerve cuff lead employing the common anode principles of the present invention.  
         [0033]    [0033]FIG. 13 is a cross-sectional view of another catheter electrode with a 90° electrode of reduced area according to the principles of the present invention.  
         [0034]    [0034]FIG. 14 is a perspective view of a catheter electrode having a bent distal end according to the principles of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0035]    Electrodes used for spinal cord stimulation are typically implanted in the epidural space  23  between the vertebra  24  and the dura  22  , shown in FIG. 1. This is done for various reasons, including reduced complexity of the surgery, reduced potential complications, and increased stability of the implant. However, implantation in the epidural space requires a significant amount of additional stimulation power since the signal must be transmitted through the dura  22  and epidural space  23  and cerebrospinal fluid in order to reach its desired neural targets in the spinal cord  20 . Anterior roots  25  and posterior roots  26  of the spinal cord  20  and Rami Communicantes  27  are also shown. A stimulator lead  28  is shown in the intrathecal space  21  between the spinal cord  20  and the dura  22 .  
         [0036]    A stimulation lead of the present invention is designed to dramatically increase the life of existing implantable stimulators. Current neurostimulation leads are placed in the epidural space and the power required to generate functional stimulation is determined directly by the size, shape, configuration and orientation of the active electrode contacts. Decreasing the surface area of the electrode results in decreased power requirements from the stimulator in order to create the same functional effect due to increased field density. Therefore, an electrode could be designed with two millimeter contacts (as opposed to currently utilized three or four millimeters), as long as sufficient electrodes were available to allow placement in the exact correct location (an eight or sixteen contact electrodes are suitable for this purpose). Alternatively, non-circumferential electrodes allow fewer and larger contacts to achieve similar results.  
         [0037]    A first embodiment is illustrated in FIG. 2. A catheter lead  30  includes a sheath  32  having a plurality of electrodes  34  at a distal end  36  of the catheter  30 . A proximal end  38  of the catheter  30  have contacts  39  to be connected to a stimulator, not shown. There is one contact  29  for each electrode  34 . The length of the electrodes L 1  are generally two to four millimeters. The distance D 1  between the electrodes is typically six millimeters, for example. The electrodes are shown to extend 270° about the circumference of the catheter.  
         [0038]    In order to achieve increased battery life, the surface area of the active electrode contacts needs to be reduced. An electrode with a specific orientation adjacent to the spinal cord would allow a 30°-270° electrode as opposed to the 360° electrode used in all current catheter electrodes. This would also enable the electrodes to remain at the preferred three or four millimeters in length, making it easier for physicians to hit the desired target and requiring fewer electrode contacts in the lead (also allowing a smaller lead). Different means could be used to stabilize the electrode in place, including (1) inflatable balloons, (2) nitinol, (3) novel shape electrodes, (4) mechanical system whereby tines are deployed upon removal of the stilet, (5) mechanical system of flexible tines.  
         [0039]    A 270° electrode is illustrated in FIG. 2, a 90° electrode is illustrated in FIG. 3A and a 60° electrode is illustrated in FIG. 4A.  
         [0040]    The small radius electrode, for example, 90° or less, allows a focused electrical stimulation field along the physiological midline PM L  of the spinal cord  20  and reduces the effective stimulation field in the area of the bending fibers. As illustrated in FIG. 3, the electrode  34  may also be placed at the nerve root midline NRM L  It is well known that bending fibers are preferentially stimulated when compared to longitudinal fibers. Thus, by positioning the lead adjacent to the desired longitudinal fibers, a focused stimulation of the longitudinal fibers will take place. Placement along a nerve tract for peripheral nerve, phrenic and sacral nerve stimulation, for instance, also benefit from the non-circumferential electrode design since the active contact directly faces the neural target.  
         [0041]    The small electrodes in the range of 30°-60° also allows selective activation of the fibers. This is particularly useful where the nerve enters the cord. Such placement is illustrated in FIG. 4, where the 60° electrode  34  is adjacent to the nerve roots  25 ,  26 .  
         [0042]    For any of the above lead designs, an additional method of decreasing power requirements is to use monopolar stimulation. A large surface area common anode electrode is used in conjunction with a single electrode in the desired stimulation area on the electrode contact array. Monopolar stimulation is not new, but does provide the opportunity to decrease the power requirements for effective stimulation.  
         [0043]    The incorporation of a large surface area anode electrode some distance away from the active electrodes on the same catheter or along the length of a catheter or laminectomy type lead however has never been performed or attempted. In the prior systems, the casing of the stimulator acted as the anode in a monopolar mode. Its distance from the distal electrodes created a long current path. This new and novel approach reduces the current path, creates a different field and also allows a unitary electrode system so that the stimulator device itself does not have to be made in two different configurations (one with an active case anode and one without) Therefore, a choice between bipolar and monopolar stimulation can be made after implantation using a stimulator (pulse generator) which could normally only provide bipolar stimulation.  
         [0044]    As illustrated in FIG. 5, an additional electrode  35  is provided at the distal end  36  displaced from the other electrodes  34 . The electrodes  34  are shown as 360° electrodes. As illustrated in FIG. 6, catheter electrode  40  includes a sheath  42  with having a plurality of inline electrodes  44  and an additional electrode  45  on the wire or sheath extension  47  extending from the distal end or paddle  46 . The proximal end  48  has contacts  49  connected to each electrode and to a stimulator.  
         [0045]    The electrodes  34 , 44  all have a length L1 and the additional electrode  35 , 45  has a length L2. Length L2 is greater than L1, at least twice its length. Thus, for example, if length L1 is two millimeters, the length L2 is four millimeters. The length L2 may be anywhere between 2-4 times that of the length L1. Also, it should be noted that the additional electrode  35 , 45  is spaced by a distance D2 from the nearest electrode  34 , 44 . Where D1 is approximately six millimeters, the distance D2 is at least 10 millimeters and can be as much as 20 millimeters. With this distance, the electrode acts as a point source when used in conjunction with a second electrode. The electrodes  34 , 44  act as a point source when used in conjunction with the additional electrode  35 , 45  of the increased area.  
         [0046]    Alternatively, a common anode or additional electrode  35  may be the same length as the other electrodes  34 , but have a greater circumferential dimension than that of the electrode  34 . This would increase the surface area of the additional electrode  35  relative to the other electrodes  34 . Therefore, the electrodes  34  may be in the 30° to 270° configuration previously described. The separation difference between the electrodes  34  and that of  35  will allow operation as described with respect to FIG. 5 and  6 . Such an electrode is illustrated in FIG. 12 to be discussed below.  
         [0047]    Electrodes used for spinal cord stimulation are typically implanted in the epidural space  23 . This is done for various reasons, including reduced complexity of the surgery, reduced potential complications, an increased stability of the implant. Although the invention is described primarily for use in epidural spinal cord stimulation it is in no way meant to be limiting. It is anticipated this design may also be utilized in other applications including, for instance, intrathecal placements.  
         [0048]    Other applications might stimulate brain or other nervous tissue with new stimulation paradigms. These stimulation paradigms could include sophisticated programs that switch stimulation between a number of electrodes slowly (over seconds or minutes, hours or days) to avoid accommodation of the stimulation or could be fast (approximately the same speed of the electrical activity of neurons in the spinal cord) artificially generating neural signals along the spinal cord which could be perceived as any other sensory function with signals that travel through the spinal cord. For instance, a signal could be generated that would correspond to heat being applied to a patient&#39;s big toe, or pressure being applied to a patient&#39;s foot, or the sensation of a limb in a different orientation than it actually is.  
         [0049]    Theoretically, tastes, smells, sights or even thoughts could be created in this manner allowing various artificial prosthesis (visual, auditory, etc.) to interface with the human body.  
         [0050]    A catheter lead capable of stimulation electrically as well as dispensing drugs is illustrated in FIGS.  7 - 11 . The catheter lead  50  has a sheath  52  with inline electrodes  54  spaced along the distal end  56 . At the proximal end  58 , terminal contacts  59  are connected internally to each of the electrodes shown. A passage  60  is provided in the sheath  50 . In FIG. 7, an outlet  62  is provided in the tip of the distal end  56  and a balloon fixation device  63  is shown. Provision is also made for an optional stilet which is removable and may be used to assist in placement of the catheter. Various stilets  61  of different shapes and characteristics may be used with these leads.  
         [0051]    In FIG. 8, the outlet  64  is shown in the space between the electrodes  54  and a nitinol fixation device  65  is shown in the deployed condition. In FIG. 8A, nitinol fixation device  65  is shown prior to the deployment through opening  53  in sheath  52 . In FIG. 9, the outlet  64  is shown in or on the electrode  54  and a tine fixation device  67  is shown.  
         [0052]    The drug may be stimulated by electrical energy using the electrodes  54  or by photonic energy using the optic channel  70 . Heat may be produced by either the electrodes  54  or the optical channel  70 . Cold may be produced by a Peltier effect chip or other means, for example gas or liquids. If the drug is responsive to light energy of a specific wavelength, the stimulation uses light energy of that specific wavelength.  
         [0053]    The lead  50  as illustrated in FIG. 12 is curved at its distal end  56  which includes the electrodes  54 . Sheath  52  includes a wire extension  57  which includes the additional anode electrode  55  and the electrical contact  59 . The curved distal end  56  wraps around the spinal cord or the nerves. This is another form of a fixing device. The stilet  61  can be inserted through passage  60  to maintain the distal end  56  linear until it is adjacent to the nerve or the spinal cord. The passage  60  may then be used for fluid delivery.  
         [0054]    Different shape stilets may be used (bent tips for example) to improve steerability during positioning of the catheter as illustrated in FIG. 14.  
         [0055]    A modified 90° electrode is illustrated in cross-section in FIG. 13. Electrode  54  has a smaller radius or diameter A than sheath&#39;s  52  radius or diameter B. For example, the diameter A may be 0.045 inches and diameter B may be 0.065 inches. The shape of the sheath and electrode allows introduction through a standard introducer needle. It still offers a reduced area electrode  54  and a stabilizing shape which may be used with or without tines or other fixation means.  
         [0056]    Additional electrode  55  has the same length L1 along the sheath  52  or wire  57  as does the electrodes  54 . The difference is that electrodes  54  are illustrated as 270° electrodes, whereas additional electrode  55  is a 180° electrode. This difference in circumferal dimension provides the difference in surface area. This provides the minimum 2 to 1 surface area as previously discussed. Obviously, the distance D 1  between electrodes  54  is substantially less than the distance D 2  between electrodes  54  and  55 .  
         [0057]    Although one fixation is illustrated on a specific Figure, any fixation device may be used with any of the catheters. Fixation methods may also include devices that are actively deployed and/or retracted (for instance by a stilet) in addition to the methods shown herein. Also, the fixation device may be located at any or more than one location or position along the catheter. A fixation device should be used where the catheter electrode is installed in the intrathecal space. In other uses, the catheters may be used without fixation devices.  
         [0058]    While FIGS.  7 - 9  show the passage  60  internal to the sheath  52 , an external delivery  68  may be used as shown in FIG. 10.  
         [0059]    The electrode catheter  50  may also include a single or pair of optical channels  70  and  72  having outlets or ports in the distal end. The fiberoptic channels and light energy delivered through a clear translucent area in the catheter is illustrated in FIG. 11. One of the channels can provide a source of light to be used as a further source of stimulation. The other channel will form a lens for a camera or other monitoring devices. The camera can be used in positioning the electrode or distal end. Channel  60  with outlet  64  is also shown for a drug delivery.  
         [0060]    It should be noted that only a single optical path can be used to provide a source of light for a photon stimulation without the passage  60  or the outlet  64 . It should also be noted that the passage  60  or external passage  68  for drug delivery may be used in combination with the light channel  70  without the electrodes  54 . Although two channels  70 ,  72  are shown, any number of channels could be used and could include a combination of different types of channels—working channels for instruments , optical channels for light or camera, stilets etc.  
         [0061]    The catheter of FIGS.  7 - 11  may be used in a percutaneous drug treatment method. The drug is administered to the patient and the stimulation cathode is positioned adjacent the tissue to be treated by the drug. The tissue is then stimulated using the catheter. This allows selective and localized drug treatment. Certain compounds change chemically when stimulated. Compounds can also be delivered via electrophoretic means. Also the production of heat in a tissue makes the tissue more susceptible to absorption of the drug. The drug may be administered systematically or administered through the passage  60  or  68 . The source of stimulation an/or the drugs may be external to the body or totally implantable. The implantable system could include a microprocessor , pump, port and an external port for refilling the pump or selection of a different drug or fluid.  
         [0062]    The drug may be stimulated by electrical energy using the electrodes  54  or by photonic energy using the optic channel  70 . Heat may be produced by either the electrodes  54  or the optical channel  70 . Cold may be produced by a Peltier effect chip or other means, for example gas or liquids. If the drug is responsive to light energy of a specific wavelength, the stimulation uses light energy of that specific wavelength.  
         [0063]    Although the invention has been described for use with an implanted stimulator system (externally or internally powered), it should be noted that the same type of stimulation regime can be delivered by a non-implantable device. Applications for such non-implantable systems could include intra-operative testing prior to implantation. An external stimulator system is connected to an implantable electrode for a period of trial stimulation prior to determining whether an implantation should be performed. It can also be used with a totally external system where the electrodes are placed outside the body to deliver stimulation.  
         [0064]    Although the present invention has been described and illustrated in detail, it is to be clearly understood that the same is by way of illustration and example only, and is not to be taken by way of limitation. The spirit and scope of the present invention are to be limited only by the terms of the appended claims.