Abstract:
An implantable artificial sphincter system provides long-term adjustment via transcutaneous energy transfer (TET), minimizing invasive adjustment through adding or removing fluid via a syringe. An infuser device provides bi-directional fluid transfer via a flexible conduit to a sphincter band, such as a gastric band. Materials are nonferrous and nonmagnetic so as to be magnetic resonance imaging (MRI) safe, being substantially immune to strong magnetic fields and not introducing an electromagnetic interference/compatibility (EMIC) hazard.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS  
       [0001]     The present application is related to and claims the benefit of five co-pending and commonly-owned applications:  
         [0002]     “PIEZO ELECTRICALLY DRIVEN BELLOWS INFUSER FOR HYDRAULICALLY CONTROLLING AN ADJUSTABLE GASTRIC BAND” to William L. Hassler, Jr., Ser. No. 10/857,762, filed 28 May 2004;  
         [0003]     “METAL BELLOWS POSITION FEEDBACK FOR HYDRAULIC CONTROL OF AN ADJUSTABLE GASTRIC BAND” to William L. Hassler, Jr., Daniel F. Dlugos, Jr., Rocco Crivelli, Ser. No. 10/856,971, filed 28 May 2004;  
         [0004]     “THERMODYNAMICALLY DRIVEN REVERSIBLE INFUSER PUMP FOR USE AS A REMOTELY CONTROLLED GASTRIC BAND” to William L. Hassler, Jr., Daniel F. Dlugos, Jr., Ser. No. 10/857,315, filed 28 May 2004;  
         [0005]     “BI-DIRECTIONAL INFUSER PUMP WITH VOLUME BRAKING FOR HYDRAULICALLY CONTROLLING AN ADJUSTABLE GASTRIC BAND” to William L. Hassler, Jr., Daniel F. Dlugos, Jr., Ser. No. 10/857,763, filed 28 May 2004; and  
         [0006]     “ACTUATOR FOR AN IMPLANTABLE BAND” to William L. Hassler, Jr., Daniel F. Dlugos, Jr., Ser. No. 11/036,460, filed 14 Jan. 2005, the disclosure of all five being hereby incorporated by reference in their entirety. 
     
    
     FIELD OF THE INVENTION  
       [0007]     The present invention relates, in general, to medically implantable, remotely-controlled devices that are safe in a magnetic resonance imaging (MRI) environment, and more particularly to such devices that incorporate internal fluid control to adjust an artificial sphincter.  
       BACKGROUND OF THE INVENTION  
       [0008]     Since the early 1980s, adjustable gastric bands have provided an effective alternative to gastric bypass and other irreversible surgical weight loss treatments for the morbidly obese. The gastric band is wrapped around an upper portion of the patient&#39;s stomach, forming a stoma that restricts food passing from an upper portion to a lower portion of the stomach. When the stoma is of the appropriate size, food held in the upper portion of the stomach provides a feeling of fullness that discourages overeating. However, initial maladjustment or a change in the stomach over time may lead to a stoma of an inappropriate size, warranting an adjustment of the gastric band. Otherwise, the patient may suffer vomiting attacks and discomfort when the stoma is too small to reasonably pass food. At the other extreme, the stoma may be too large and thus fail to slow food moving from the upper portion of the stomach, defeating the purpose altogether for the gastric band.  
         [0009]     An artificial sphincter may be utilized in any number of applications within a patient&#39;s body where it is desirable to vary the size of an orifice or organ. Depending upon the application, artificial sphincters may take the form of a flexible, substantially non-extensible band containing an expandable section that is capable of retaining fluids. The expandable section would be capable of expanding or contracting, depending upon the volume of fluid contained therein. One particular example of an artificial sphincter is an adjustable gastric banding device, such as described in U.S. Pat. Nos. 4,592,339, 5,226,429, 6,102,922, and 5,449, 368, the disclosure of each being hereby incorporated by reference. Adjustable gastric band implants have a hollow elastomeric balloon with fixed end points encircling a patient&#39;s stomach just inferior to the esophago-gastric junction. When saline solution is delivered into the hollow balloon, the gastric band swells and constricts the stomach, for example, for obesity reduction. Different degrees of constriction are desired, and adjustment is required over time as the patient&#39;s body adapts to the constriction.  
         [0010]     Adding or removing saline solution from the adjustable gastric band is typically accomplished by injection through a fluid injection port to achieve a desired diameter. Since adjustable gastric bands may remain in the patient for long periods of time, the fluid injection port is typically installed subcutaneously to reduce the likelihood of infection. Adjusting the amount of fluid in the adjustable gastric band is achieved by inserting a Huber tip needle through the skin into a silicon septum of the injection port. Once the needle is removed, the septum seals against the hole by virtue of compressive load generated by the septum. A flexible conduit communicates between the injection port and the adjustable gastric band.  
         [0011]     While subcutaneously implanted injection ports are a successful approach to readily adjusting a gastric band, and are a desirable feature to retain for initial installation or as a backup, it would be desirable to remotely adjust the gastric band. Although minimally invasive, insertion of the Huber needle to adjust the saline solution volume does introduce increased risk of infection. In addition, this procedure typically entails the inconvenience and expense of scheduling time with a surgeon.  
         [0012]     Incorporating remote control of an implanted artificial sphincter would be desirable; however, adjustable gastric bands such as those described above are currently fabricated out of material that does not pose significant limitations on the patient. In particular, increasingly Magnetic Resonance Imaging (MRI) is used as a diagnostic tool and as an aid in performing minimally invasive surgical procedures. MRI operates by creating a strong DC magnetic field (e.g., 0.5-1.5 Teslas) and then disturbing the DC magnetic field with magnetic impulses that induce a weak radio frequency (RF) signal to be emitted by the tissue of a patient. Thus, it is desirable that implantable medical devices contain no ferrous material that would be attracted by the strong DC magnetic field. Otherwise, tissue damage, patient discomfort, or malfunction of the implantable medical device may occur. Further, it is desirable that the medical device not interfere with the weak radio frequency that is produced by the patient, or else artifacts may be created in the diagnostic image that degrade its value.  
         [0013]     Efforts have been made to produce other types of implantable devices with actuators that can endure the environment of an MRI machine to some degree. For example, it is known to implant a drug dispensing infuser pump that operates with an electrical DC motor. The deleterious effects of magnetizing the ferrous materials of the DC motor therein is countered by a degree by over-building the device such that operation may continue in a degraded condition. Further, the size of the structural attachments to the DC motor have to be greatly increased to withstand the magnetic attraction that the MRI machine imposes, as well as avoid tissue damage and discomfort by increasing the overall size of the implant, which is not otherwise a desirable design constraint.  
         [0014]     It is also known to incorporate MRI safe devices such as a piezoelectric motor into an peristaltic pump, also for drug dispensing. However, peristaltic pumps are unsuitable for long-term intermittent bidirectional fluid control. Even modest leakage past the peristaltic pump during inactive periods would prove unsuitable for fluid control of implants.  
         [0015]     Consequently, a significant need exists for a remotely controllable implantable artificial sphincter apparatus that would be MRI safe.  
       BRIEF SUMMARY OF THE INVENTION  
       [0016]     The invention overcomes the above-noted and other deficiencies of the prior art by providing an artificial sphincter assembly that includes an external programmer portion that is at least intermittently in communication with an implantable artificial sphincter portion for remote adjustment thereof. The implantable artificial sphincter portion has an artificial sphincter band formed of biocompatible and nonferromagnetic material sized to encompass a body lumen. Once implanted and adjusted to an initial internal circumference, control circuitry is responsive to adjustment commands from the external programmer portion that in turn are used to activate an MRI safe actuator to selectively bi-directionally adjust the artificial sphincter. A power source powers both the control circuitry and the actuator. Thereby, a remotely controllable artificial sphincter is provided that does not require piercing the skin with a needle. Further, the implantable portion of the device is MRI safe, allowing the recipient to take advantage of this important diagnostic tool.  
         [0017]     In one aspect of the invention, the artificial sphincter apparatus incorporates an MRI safe piezoelectric motor that is activated by the control circuitry to selectively bi-directionally adjust the artificial sphincter.  
         [0018]     In another aspect of the invention, an artificial sphincter made of biocompatible and nonferromagnetic material is sized to encompass a body lumen that is responsive to a transmission to convert an actuator motion from an MRI safe actuator to an adjustment of the inner circumference of the artificial sphincter band.  
         [0019]     These and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof. 
     
    
     BRIEF DESCRIPTION OF THE FIGURES  
       [0020]     The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention, and, together with the general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the present invention.  
         [0021]      FIG. 1  is a front diagrammatic view of an implantable artificial sphincter apparatus encircling an upper portion of a patient&#39;s stomach to form a remotely adjustable stoma for treatment of morbid obesity.  
         [0022]      FIG. 2  is a functional block diagram of the implantable artificial sphincter apparatus of  FIG. 1 .  
         [0023]      FIG. 3  is a control diagram of an alternative artificial sphincter apparatus of  FIG. 2 .  
         [0024]      FIG. 4  is a diagrammatic view of an alternative remotely controlled artificial sphincter apparatus having integral piezoelectric actuation. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0025]     In  FIG. 1 , an artificial sphincter system is used to constrain a bodily lumen. More particularly, in the illustrative version, an adjustable gastric band (AGB) apparatus  10  is used to treat morbid obesity. Advantageously, the various components of an implanted portion  11  of the AGB apparatus  10  comprise materials that are at least Magnetic Resonance Imaging (MRI) safe, being nonferrous and nonferromagnetic. Yet, the implanted portion  11  may be intermittently remotely adjusted transcutaneously in response to an external portion  12  that need not be MRI safe. Between adjustments, the implanted portion  1  remains at a current setting for long durations.  
         [0026]     To that end, a gastric band  14  encircles and constrains a stomach  15 , forming a stoma that is remotely adjustable between a larger diameter depicted at  16  and a narrower diameter depicted at  18 . The gastric band  14  may be held in place by drawing a flap  20  of a lower portion  22  of the stomach  15  over the gastric band  14  and suturing the flap  20  to an upper portion  24  of the stomach  15 . The gastric band  14  thus encourages weight loss by limiting the patient to small meals because the stoma  18  slows movement of food from the upper portion  24  to the lower portion  22  of the stomach  15 . Additionally, food remaining in the upper portion  24  of the stomach  15  stimulates nerves that indicate fullness.  
         [0027]     The inner diameter of the gastric band  14  is responsive to movement of a motion transfer medium  26  guided within a conduit  28 . The motion transfer medium  26  may be a fluid (e.g., saline) or a translating or rotating cable. This movement is in response to an implanted actuator  30  that generates this movement of the transfer medium  26 . It should be appreciated for clinical flexibility and clarity in the description herein that the implanted actuator  30  is spaced apart from the gastric band  14 . However, the implanted actuator  30  may be integrally attached to the gastric band  14 , reducing significantly any length of required transmission elements such as conduit  28  and motion transfer medium  26 .  
         [0028]     The implantable portion  11  of the AGB apparatus  10  is remotely controllable by an emitter  40  which is controlled by a programmer  42 , both part of the external portion  12  of the AGB apparatus  10 . In particular, the emitter  40  sends transcutaneous signals (e.g., AC magnetic field, RF broadcast, coded message on an ultrasonic carrier, etc.)  44  that are received by the implantable portion  11 . Feedback as to the desired inner circumference of the gastric band  14  and/or size of the stoma  14 ,  16  may be deduced by an amount of movement corresponding to the motive transfer medium  26  movement that is internally sensed by the implantable portion  11 . Alternatively or in addition, a noninvasive imaging device, such as an endoscope  46 , is inserted down the esophagus  48  and/or an ultrasonic transceiver  49  ( FIG. 2 ).  
         [0029]     An advantageous approach to further reducing the necessary size of the implantable actuator  30  is to utilize transcutaneous energy transfer (TET) for powering motive adjustment operations. Telemetry may also be utilized for functions such as commanding and/or monitoring the current position and/or amount of adjustment travel available, especially if completing closed-loop adjustment control of the gastric band  14  external to the patient.  
         [0030]     In  FIG. 2 , the emitter  40  is depicted as comprising a TET transceiver further comprising an external TET coil  50  and a co-axial external telemetry coil  52 ; the two coils  50 ,  52  are electrically separate and have a different resonant frequency for simultaneous TET and telemetry through the skin  54  of the patient. A ferrite core  56  may be placed along the axis of the coils  50 ,  52  to further enhance the efficient depth of TET to correspond to an implanted TET coil  60  and a co-axial implanted telemetry coil  62  which are incorporated into the implanted portion  11  of the AGB apparatus  10 .  
         [0031]     Efficient power coupling of external and implanted TET coils is described in four co-pending and commonly-owned patent applications filed on 24 Jun. 2004, all of which are hereby incorporated by reference in their entirety, (1) “TRANSCUTANEOUS ENERGY TRANSFER PRIMARY COIL WITH A HIGH ASPECT FERRITE CORE”, Ser. No. 10/876,313; (2) “MEDICAL IMPLANT HAVING CLOSED LOOP TRANSCUTANEOUS ENERGY TRANSFER (TET) POWER TRANSFER REGULATION CIRCUITRY”, Ser. No. 10/876,038; (3) “SPATIALLY DECOUPLED TWIN SECONDARY COILS FOR OPTIMIZING TRANSCUTANEOUS ENERGY TRANSFER (TET) POWER TRANSFER CHARACTERISTICS”, Ser. No. 10/876,057; and (4) “LOW FREQUENCY TRANCUTANEOUS ENERGY TRANSFER TO IMPLANTED MEDICAL DEVICE”, Ser. No. 10/876,307.  
         [0032]     The implanted portion  11  includes transceiver circuitry  80  that sends data parameters and receives control commands by inductive coupling of the external telemetry coil  62  with the external telemetry coil  52 . The implanted TET coil  60  is in electrical communication with power regulation/storage circuitry  82  for recharging on-board power storage and/or buffering. Control circuitry  84 , powered by the power regulation/storage circuitry  82  and responsive to commands received by transceiver  80 , bi-directionally activates a motive device  86  that effects movement of a bi-directional displacement actuator  88 . Examples of a motive device that effects a bi-directional displacement actuator are described in the above-referenced patent application Ser. No. 10/857,762 and 10/857,315 wherein MRI safe electromechanical devices such as piezoelectric motors and thermodynamically adjusted bellows accumulators are described.  
         [0033]     For motive devices  86  that do not impose an inherent locking effect to the bi-directional displacement actuator  88  when deactivated, the control circuitry  84  may advantageously also activate a brake  92  to release the bi-directional displacement actuator  88  during adjustment. An example of a brake is described in the above-referenced application Ser. No. 10/857,763, wherein a piezoelectrically released brake caliber allows a bellows accumulator to change volumes.  
         [0034]     This adjustment may advantageously be monitored by an internal position sensor  94  so as to determine a differential change in a first variable volume  96  and a second variable volume  98 . An example of monitoring volumes is described in the above-referenced patent application Ser. No. 10/856,971 wherein the first volume is contained within a bellows accumulator that is coupled to a position sensor within an encompassing case. It should be appreciated that sensing may be incorporated into a motive element, a transmission element, or a parameter of the artificial sphincter representative of its adjusted size. It should be appreciated that the volume adjustment may be contained within an implanted device spaced apart from the artificial sphincter band as described in the above-referenced patent application Ser. No. 11/036,460 wherein a first volume in a bellows accumulator controls a second volume in a bellows piston accumulator that elongates within a conduit to selectively push and pull an elongate flexible rod whose motion affects the adjustment of the band.  
         [0035]     In  FIG. 3 , an alternative adjustable gastric band (AGB) apparatus  110  that is remotely controllable is used to treat morbid obesity. Advantageously, the various components of an implanted portion  111  of the AGB apparatus  110  comprise materials that are at least Magnetic Resonance Imaging (MRI) safe, being nonferrous and nonferromagnetic. Yet, the implanted portion  111  may be intermittently remotely adjusted transcutaneously in response to an external portion  112  that need not be MRI safe. Between adjustments, the implanted portion  111  remains at a current setting for long durations.  
         [0036]     To that end, an artificial sphincter  14  encircles and constrains a body lumen (not shown in  FIG. 3 ). The implantable portion  111  of the AGB apparatus  110  is remotely controllable by an external programmer  142 , which sends TET signals  144  that are received by the implantable portion  111 . In particular, an external TET coil  150  and an external telemetry coil  152  are electrically separate and have a different resonant frequency for simultaneous TET and telemetry through skin  154  of the patient to an implanted TET coil  160  and an implanted telemetry coil  162  respectively incorporated into the implanted portion  111  of the AGB apparatus  110 .  
         [0037]     The implanted portion  111  includes transceiver circuitry  180  that sends data parameters and receives control commands by inductive coupling of the implanted telemetry coil  162  with the external telemetry coil  152 . The implanted TET coil  160  is in electrical communication with power regulation/storage circuitry  182  for recharging on-board power storage and/or power buffering. Control circuitry  184  is powered by the power regulation/storage circuitry  182  and is responsive to commands received by transceiver  180  and to a position sensor  194  to bi-directionally activate an actuator  186  that acts through a transmission  187  to adjust the artificial sphincter  114 . Confirmation of adjustment may be sent via a message initiated by control circuitry  182  through telemetry transceiver  180  through the implanted telemetry coil  162  to the external telemetry coil  152  to the external programmer  142 . The depicted actuator  186  and transmission  187  have an inherent locking effect such that when deactivated, the artificial sphincter  114  retains the adjusted size.  
         [0038]     In  FIG. 4 , an illustrative version of an AGB apparatus  210  that integrates many features in an implantable portion  211 , and more particularly an MRI safe electromechanical adjustment system  290 , is incorporated into an adjustable artificial sphincter  214  that encompasses a body lumen  215  to form a narrowed or closed stoma  216 . A controller housing  285  advantageously incorporates a stored power source  282  that powers both control circuitry  284 , that is responsive to external adjustment commands, and a piezoelectric motor  286 , whose selectively oscillating drive tip  287  directly adjusts the circumference of a band  292 , inherently acting as both transmission during adjustment and a brake when deactivated.  
         [0039]     The band  292  is formed of biocompatible and MRI safe material (e.g., silicone) that may be sized for the intended initial circumference by trimming a first end  294  or selecting a band  292  of appropriate length. The controller housing  285  is attached to an external surface of the first end. For versions wherein the first end  294  is trimmed, the controller housing  285  may include attachment features  295  that engage the band  292  at an appropriate location. The other end  293  of the band  292  is passed through a buckle  298  attached to the first end  294 . The other end  293  terminates in a ceramic actuated tab  296  and is pinched between the first end  294  and the driving tip  287  of the piezoelectric motor  286  that responds to oscillations in one direction from the driving tip  287  by drawing more of the band  292  through the buckle  298  and to the other direction by pushing more of the band  292  back through the buckle  298 .  
         [0040]     It should be appreciated with the benefit of the present disclosure that in  FIG. 4  the active components may be spaced away from the band  292 , mechanically coupled thereto by a control cable (not shown) that communicates by either rotation or translation.  
         [0041]     While the present invention has been illustrated by description of several embodiments and while the illustrative embodiments have been described in considerable detail, it is not the intention of the applicant to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications may readily appear to those skilled in the art.  
         [0042]     For example, it will become readily apparent to those skilled in the art that the above invention has equal applicability to other types of implantable bands. For example, bands are used for the treatment of fecal incontinence. One such band is described in U.S. Pat. No. 6,461,292, which is hereby incorporated herein by reference. Bands can also be used to treat urinary incontinence. One such band is described in U.S. patent application 2003/0105385, which is hereby incorporated herein by reference. Bands can also be used to treat heartburn and/or acid reflux. One such band is described in U.S. Pat. No. 6,470,892, which is hereby incorporated herein by reference. Bands can also be used to treat impotence. One such band is described in U.S. patent application Publ. No. 2003/0114729, which is hereby incorporated herein by reference.