Patent Grant
7856272
The invention relates to the field of implantable systems for selecting therapy elements to monitor the status of and/or delivery therapy to tissue within a patient. More particularly, the invention provides convenient, non-invasive or minimally-invasive selection of a subset from a surplus of therapy elements previously implanted into tissue for connection with a (subset) of device conduits. The interface system may enable communication in a bi-directional manner (from device to tissue and from tissue to device) using the same therapy element(s) and/or conduits(s).
Electrical stimulation of the brain has been used to treat any number of neurological disorders including, for example, pain and movement disorders. Electrical leads having many electrodes are implanted in the brain such that one or more cathodal electrodes and one or more anodal electrodes are in optimal locations to produce benefits or to minimize undesirable side effects. An implantable pulse generator (IPG) generates signals to deliver electrical stimulation to the brain tissue via the electrodes. These electrodes or electrodes in other leads, may be also used to record electrical signals that, once adequately processed and analyzed using implantable or portable devices, may be used to monitor the state of the tissue or organ and to also deliver a therapy when this state is approaching abnormalcy. Additionally or alternatively, sets of inputs catheters carrying drugs may be selectively connected to sets of output catheters for drug delivery to surrounding tissue.
Depending on the disorder, sensing and or therapy systems may utilize a large number of electrodes or catheters to monitor and treat the disorder. Accordingly, the treating physician may configure the system with a spatial configuration of cathodes and anodes or of catheters that is best suited for any particular disorder or patient. If required, the treating physician may later optimize the electrode or catheter spatial configuration by selecting different electrodes or catheters from those originally chosen. Also, leads/electrodes or catheters may shift or migrate (in reference to the intended monitoring or therapy target) after being implanted, the chosen electrodes or catheters may “break,” or the intended target site may change over time. To either improve the therapeutic benefits or to replace malfunctioning or off-target electrodes or catheters in prior-art implanted medical devices often requires a major surgical procedure.
Therefore, it is desirable to: a) implant more sensing and/or therapy elements than those actually used (i.e., those which sense electrical signals and/or through which currents or drugs are actually delivered to tissue) so that, by switching certain elements OFF and others ON, electrical currents or drugs continue to be delivered to the intended target or to a new one located within the spatial domain/reach of the sensing and/or therapy elements; and b) accomplish these tasks without further surgery.
Therefore, there exists a need in the art for implantable interfaces for electrical monitoring and/or stimulation and/or for drug delivery having a plurality/surplus of electrodes or catheters that may be selectively chosen and coupled to monitor tissue electrical signals and deliver electrical stimulation or drugs to desired neural tissue, without exceeding or violating size constraints for implantability and/or without requiring additional surgeries.
The following represents a simplified summary of some embodiments of the invention in order to provide a basic understanding of various aspects of the invention. This summary is not an extensive overview of the invention. It is not intended to identify key or critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some embodiments of the invention in simplified form as a prelude to the more detailed description that is presented below.
In accordance with aspects of the invention, an implantable interface system for a medical device system is disclosed. The interface system enables the flexible and efficient utilization of a surplus of sensing and/or therapeutic elements (i.e., therapy elements), allowing an optimal subset of these elements to be selected for use (and later modified if necessary) without major surgery that would otherwise be required to reposition, replace or activate more therapy elements. The interface system thus enables, for example, an increase in the available size of the electrical field or of the area to which drugs are delivered, while keeping the size of the hardware/device small so that it can be safely and ergonomically implanted. The interface system provides selective, re-programmable interconnectivity between a plurality/surplus of inputs and a plurality/surplus outputs that may be operated bi-directionally (inputs become outputs and vice-versa) depending on the application. These therapy elements may be implanted into or near an organ of a patient, for example, a brain. The interface system enables the use of a surplus of therapy elements so that treatment to the same site (in the case of electrode migration or failure), or to different sites but within the spatial domain of the interface's elements may be delivered through the spare/excess therapy elements without the need for additional major surgical procedures. For example, without further major surgery, the interface system may be used to select from a surplus of therapy elements to selectively determine which subset is used to provide input to a monitoring device. Alternatively, the interface system also enables selection of a subset of therapy elements (e.g., stimulation contacts or catheters) to be used as outputs to deliver therapy (e.g., stimulation or drugs, respectively.
In an embodiment, the interface system may include two plates. A first plate may be coupled to the conduits via one or more first plate contact points. The second plate may be coupled to the therapy element via one or more second plate contact points. One or more connecting elements may be positioned between the first and second plates, wherein each connecting element provides a robust electrical connection between a selected conduit and a selected therapy element. In an embodiment, the connecting element provides physical contact between the first plate contact point associated with the selected conduit and the second plate contact point associated with the selected therapy element. In an embodiment, a middle plate may be provided between the first and second plates to facilitate positioning of the connecting elements. In an embodiment, a spring mechanism may also be provided within the interface system to ensure adequate electrical connection provided by the connecting elements. The interface system may be encapsulated in a housing that may include a cover such as a membrane so as to ensure a fluid-tight seal.
In accordance with another aspect of the present invention, one or more valves may be provided to couple one or more inlet tubes with a plurality of delivery/outlet tubes. In an embodiment, an inlet tube may be adjustably connected to a plurality of delivery tubes. A series of valves may be coupled together in a module so that fluid from a reservoir may be selectively delivered to one or more delivery tubes so as to delivery fluid to the patient in a desired two dimensional or three dimensional pattern. The amount of fluid being delivered to each delivery tube may be adjustable. The system can also be used bi-directionally, for example, to sample fluids from a plurality of sites and store them in chambers.
The present invention is illustrated by way of example and not limited in the accompanying figures in which like reference numerals indicate similar elements and in which:
a-9b illustrate an embodiment of an access template system in accordance with one or more aspects of the present invention.
a-c illustrate embodiments of access templates in accordance with one or more aspects of the present invention.
a-18c illustrate an embodiment of a valve in different configurations in accordance with one or more aspects of the present invention.
a-19d illustrate cross-sections of an embodiment of a valve in different configurations in accordance with one or more aspects of the present invention.
a-25c illustrate an embodiment of a delivery tube capable of delivering an adjustable flow rate to adjustable/different sites in accordance with one or more aspects of the present invention.
Aspects of the invention may be embodied in any implantable medical device system wherein a component of the system is to be implanted within a patient to monitor tissue electrical signals and/or provide therapy in the form of electrical stimulation or drug delivery. The implantable interface system discussed herein may have physical attributes (length/width/thickness, consistency and weight) that will allow implantation avoiding or minimizing the potential for causing injury to the brain or spinal cord or discomfort to the patient, while maximizing precision and degree of contact between the device elements and the therapy targets or sites. An embodiment of the invention may utilize various treatment therapies for treating nervous system disorders. Treatment therapies can include any number of possibilities alone or in combination including, for example, electrical stimulation, drug delivery and/or providing a warning of impending undesirable events to the patient or to caregivers.
Each of these treatment modalities may be operated using closed-loop feedback control or using open-loop therapy. Such closed-loop feedback control techniques receive one or more signals that carry information about a symptom or a condition of a nervous system disorder. Such signals can include, for example, electrical signals (such as EEG, ECoG and/or EKG), bio-chemical signals (such as change in quantity of neurotransmitters), temperature signals, pressure signals (such as blood pressure, intracranial pressure or cardiac pressure), respiration signals, heart rate signals, pH-level signals, and/or peripheral nerve signals (cuff electrodes on a peripheral nerve). Such signals may be recorded using one or more monitoring elements such as monitoring electrodes or sensors. For example, U.S. Pat. No. 6,227,203, assigned to Medtronic, Inc., provides examples of various types of monitoring elements that may be used to detect a symptom or a condition or a nervous system disorder and responsively generate a neurological signal.
In accordance with one set of embodiments, the implantable interface system is associated with a therapy delivery element or a monitoring element or a combination of both (dual function).
As used herein, the term “therapy elements” refers generally to the structures of the medical device system providing therapy and/or monitoring a condition. For example, therapy elements include therapy delivery elements 130 and/or monitoring elements 140. As another example, discussed herein, therapy elements may include catheters (or tubes) for delivering fluid to the patient or receiving fluid from the patient.
The implantable device 120 may continuously or intermittently communicate with an external programmer 123 (e.g., patient or physician programmer) via telemetry using, for example, radio-frequency signals and having a coil 124 and a lead 122 coupling the programmer 123 with the coil 124. The external programmer 123 may be any general-purpose computing device (e.g., personal computer, hand-held device, etc.) having an operating system configured with custom external system application software.
In an embodiment where the medical device system 100 includes a brain stimulation system, the medical device system 100 delivers electrical stimulation to the brain through the therapy delivery elements 130. In the event that the medical device system 100 also utilizes closed-loop feedback control, the medical device system 100 monitors Brain Electrical Activity (BEA) or some other signal from the monitoring elements 140, conditions the brain signals for processing, determines the onset, presence, and/or intensity of any neurological event, configures the parameters for delivering electrical stimulation through the therapy delivery elements 130 if any should be provided.
The medical device system 100 also includes an implantable interface system interconnecting therapy elements 130 and/or 140 with the conduits 150.
Also, as used herein, the term “conduit” refers generally to the structures of medical device system that interconnects the implantable device to the interface system. For example, conduits may be conduits 310 that provide/receive electrical signals between the implantable device and the interface system. As another example, discussed herein, conduits may include catheters (or tubes) for delivering or receiving fluid between the implantable device and the interface system.
The interface system 403 may be configured so as to comport with the physical contours of the patient's skull. For example, in the embodiment where the interface system 403 is implanted within a cavity 443 within the patient's skull, the interface system 403 may have an inner wall surface that is substantially aligned with a surrounding inner surface of the patient's skull. Such alignment simulates the original physical surroundings of the patient's brain to avoid trauma thereto. If desired for a particular application, dura mater may be removed and the inner wall of the interface system may be placed in direct contact with the subject's cerebral spinal fluid/brain, for example, as described in U.S. patent application Ser. No. 11/339,108 filed on Jan. 25, 2006 and entitled “Anchoring of Medical Device Component Adjacent a Dura of the Brain or Spinal Cord.”
As can be appreciated,
To illustrate the operation of the interface system 600,
One skilled in the art will appreciate that there are many known ways to communicatively connect a desired subset of base contact points 715 to top contact points 720, and the means for connection may vary depending upon the application and may include, but are not limited to, galvanic connections such as may be provided by a connecting wire or solid state relay, optical connections, or fluidic connections such as may be provided by one or more valves. The interface system may enable easy selection of the desired connections, and ensure that the connections are robust. Techniques for selecting desired connections may include, for example, any of the following:
(a) mechanical means, such as by pressing one or more buttons that operate to toggle (or otherwise modify) the state(s) of particular connection(s);
(b) use of telemetry from a programmer device (e.g., using infrared, radio-frequency, or ultrasound) to toggle connections; or
(c) use of an optional middle connecting plate 620, which may be inserted between bottom plate 630 and top plate 615, wherein the connecting plate 620 essentially serves as a mechanism to position one or more connecting pins through apertures geometrically aligned with top and bottom contact points, in order to provide connections between desired contact points when the plates 615, 620, and 630 are assembled together.
Thus,
Turning to
a and 9b illustrate the biased access template 808 positioned above the top plate 820. As depicted, the biased access template 808 includes a plurality of apertures 945 and when the biased access template 808 is aligned with the top plate 820, the apertures 945 coincide with the controller extensions 821. When the biased access template 808 is in a first position as shown in
Turning to
Referring to
Referring back to
In an alternative embodiment, an access template may be provided that is not biased. Regardless of the existence of the biasing element, the access template may be locked in a first position with a locking feature 940 and to move the access template to the second position may require the pressing of one or more buttons so as to allow unlocking of the access template and allow it to translate to the second position. As can be appreciated, the use of more than one optional locking feature 940 provides additional security that incidental contact will not allow the access template to translate into an aligned position. Further security may be provided by requiring the insertion of one or more keys 941 so as to unlock the one or more locking features 940. In addition, multiple access templates may be provided and two different access templates may be configured so that the access templates are each translated in different directions in order to align the apertures with the controller extensions. Thus, looking at
It should be noted that, similar to the embodiment depicted in
It should be noted that if a translating connector pin 1410 is used that is similar to what is disclosed in
As can be appreciated, the ability to control which conduits are coupled to which therapy elements helps minimize the need for surgical replacement or repositioning of therapy elements in the event that they break down, migrate or the patient's monitoring or therapy target(s) or condition changes after the therapy elements are implanted. Instead, the conduits may be coupled to alternative therapy elements.
Thus, in the above two embodiments, connectors from one plate make contact with another plate only when deployed. The deployment of the connectors may be achieved through a variety of techniques including, but not limited to, spring mechanisms (that operate in a manner similar to that of retractable ball-point pens), magnets, radio-frequency tags, ultrasound, and/or infrared light. Where a spring mechanism is utilized, the spring mechanism may be depressed with a “pointer” (e.g., tool 1175 of
It should be noted that in addition to electrical connectors, other types of connectors such as optical connectors can be similarly configured. As can be appreciated, a first light pipe with a plurality of passageways could be aligned with a plurality of light pipes and by selectively connecting the first light pipe to one of the plurality of light pipes, optical signals could be routed as desired.
In an embodiment, the housing of the interface system may include 5 holes in the four corners and center of the outer surface of the skull-mounted connector, where each hole has a pin which is removable and protrudes from the closed scalp. An indelible biocompatible ink (such as a tattoo) or some other fiducial may be used to mark the scalp around the protruding pins and after this has been done, the pins may be removed. These scalp fiducials may be subsequently used to guide alignment with the access template, which will be positioned within the interface system. It should be noted that some other number of fiducials may be used, however, at least three fiducials is preferred so as to ensure a proper orientation.
As noted above, while electrical signals can be recorded and electrical stimulation may be used to treat a patient, pharmaceutical compounds and medicaments may be beneficial in treating a patient. In addition, the ability to collect fluids from various portions of the patient's brain may be helpful in detecting and analyzing the patient's condition.
a-18c illustrate similar configurations without the module 1705. It should be noted that while the valve 1720 is depicted as being closed when button 1721 is depressed, the reverse is also contemplated.
a-19d illustrate embodiments of valves 1720 that include an outer wall 1910, a core 1920 that includes a fluid passageway 1925 and multiple tubes 1710, 1715, 1716. As can be appreciated,
While
It should be noted that
It should be noted that multiple flow passageways may be provided in the core 1920, with each flow passageway stacked on top of another flow passageway. In such a configuration, depressing the button 1721 will align a different flow passageway with associated tubes. This depression can toggle the state of an associated valve, for example, by causing a rotation to allow flow passage in any number of combinations.
As depicted in
a and 25b illustrate another aspect that may be used in accordance with the present invention. These embodiments may be therapy elements where selectivity of fluid delivery is achieved along the body of the therapy elements. A tube 2510 is provided with a plurality of ports 2515 that are closed (i.e., not exposed to fluid) and a number of ports 2516 that are open (i.e., exposed to fluid). A slidable plate 2520 is positioned within the tube 2510 and the position of the slidable plate 2520 may be adjusted with member 2530. Member 2530 may, for example, be associated with a controller extension (discussed above). By translating the slidable plate 2520, more or less of the ports may be blocked or unblocked. Thus, such a system may provide for more fine tuned control over delivery of fluids. As can be appreciated, the slidable plate 2520 can be configured so that it blocks a first set of ports in a first position, blocks a second set of ports in a second position and blocks a third set of ports in a third position.
Although ports are shown in a single line for simplicity, it will be appreciated that the ports 2515 and 2516 may be in any direction along the tube 2510. For example, there may be an array of ports 2515 and 2516 along the entire surface of tube 2510. Moreover, plate 2520 may alternatively be a hollow cylinder to which drugs arrive via a conduit and then plate 2520 delivers fluid only to the adjoining port that it engages. Even further, there may be multiple plates 2520 in tube 2510 to provide additional flexibility. Alternative embodiments are also possible, for example, the embodiment of
In an embodiment, the length of the slidable plate 2520 may be increased so that the slidable plate 2520 extends a substantial length down the tube 2510. In such an embodiment, the slidable plate 2520 may include a pattern of openings that matches a pattern of ports in the tube 2510 such that moving the slidable plate 2520 a small distance causes a substantial change in the number of ports that open or blocked by the slidable plate. As can be appreciated, the ports may be evenly or variable spaced and in a closed position, none of the openings of the slidable plate will be aligned with the ports in the tube 2510.
It will be appreciated that any number of configurations may be implemented in accordance with the invention. For example, as discussed, the interface system (and corresponding layout of the associated components) may take the form of any number of geometric shapes. Moreover, connecting pins 625 may take the form of any number of connecting elements for providing electrical connectivity. In an embodiment, the controller extensions may be translatable via the application of magnet force. As can be appreciated, such a configuration will allow the individual adjusting the delivery of stimulation to adjust which electrodes are connected to which conduits without the need to pierce (with a “needle”) or make a small incision in the patient's tissue.
It should be noted that the control of the position of the valves and position of the connector extension 821 may be automated and controlled via a controller, which may be programmed via a wireless manner with a programmer such as a physician programmer. The advantage of using mechanical controlling is that no electrical power is required to change the configuration.
The interface system disclosed above provides the ability to selectively identify those therapy elements that should be operable by the medical device system. The therapy elements may be selected initially during implant but may also later be modified via use of the key and/or through a minimally invasive procedure. For example, in the embodiment of a circular interface system (
Moreover, the ability of the interface system to connect more than one implanted element in tissue together into a single connection in the device (e.g., as depicted in
The usefulness of the invention should be apparent to one skilled in the art. The use of any and all examples or exemplary language herein (e.g., “such as”) is intended merely to better illuminate the invention and does not pose a limitation on the scope of the invention unless otherwise claimed. No language in the specification should be construed as indicating any non-claimed element as essential to the practice of the invention.
The present invention has sometimes been described in terms of preferred and illustrative embodiments thereof. Numerous other embodiments, modifications and variations within the scope and spirit of the appended claims will occur to persons of ordinary skill in the art from a review of this disclosure.
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