1. Field of the Invention
The invention relates to the field of mechanical deployment and actuation of minimally invasive medical catheter tools by the transfer of electromagnetic forces into linear mechanical motion.
2. Description of the Related Art
Interventional medicine is the collection of medical procedures in which access to the treatment area is made by navigating through a patient's blood vessels, body cavities, or lumens.
Minimally invasive technologies have long been applied to surgical instruments such as pliers, forceps, and shears, and are applied to a variety of medical procedures.
Prior art actuators have traditionally used the transfer of mechanical forces applied to the proximal end of the tool in order to actuate or engage the working end, or distal end of the tool. Prime examples of this can be found in U.S. Pat. No. 6,551,302 (“Rosinko”) and U.S. Pat. No. 7,229,421 (“Jen”) where energy used in the mechanical rotation of an inner deflection knob or inner key becomes translated into linear motion by the actuator. The linear motion produced by the actuator is then used to operate or activate the medical tool located on the distal end of the catheter.
Other presently available interventional devices include robotically controlled actuators which provide the physician with greater precision and control of the applied forces that are used while performing a desired action.
While the catheter and magnetic actuators presented above have had successes in their respective fields, they are not without their drawbacks and limitations, particularly when it comes to the field of medicine.
In actuators that are used on medical catheters by providing power to an actuator by manually rotating a handle, the actuator procedure is open to human error and can lead to imprecise tool activation or other errors. Additionally, in a situation where a magnetic invasive surgery takes place, it can be cumbersome and inefficient for an operating physician to manually active an actuator while also trying to avoid bumping into or hitting other equipment such as electromagnets, and any other medical apparatuses at the same time.
Magnetic actuators for use in liquid or gas pipelines or in construction work have not been envisioned to work within the limited space that is available on a medical catheter. Nothing in the prior art suggests that a magnetic actuator may be reduced in size and specifically adapted for operating a medical tool located on the distal tip of a catheter for use in a invasive surgery.
These and other problems are solved by a linear actuator that is magnetically-controlled and specifically designed to be placed on a medical catheter and work with an entire multitude of medical tools, thus giving the operating physician greater control and precision of his medical instruments with less possibility for error or mistake.
Using the linear forces that are provided by an electromagnetic solenoid applied near the distal end of a medical catheter, various surgical instruments can be actuated or deployed for use in interventional medicine. The linear actuator uses the principles of magnetic repulsion and attraction to produce forces for moving a bobbin that can be attached to various types of moving components that translate linear movements into the actuation of a tool that is attached to the linear actuator. Using independent solenoid coils, movement modality is increased from two possible positions to three or more.
The solenoid is a coil of wire designed to create a sufficiently strong magnetic field inside of the coil. By wrapping the same wire many times around cylinder, the magnetic field produced by the wires can become quite strong. The number of turns N refers to the number of loops the solenoid has. More loops will bring about a stronger magnetic field. Ampere's law can be applied to find the magnetic field inside of a long solenoid as a function of the number of turns per unit length, N/L, and the current I as shown in equation (1):
The term (N/L)x represents the number of loops enclosed by the path. Only the upper portion of the path contributes to the sum because the magnetic field is zero outside the solenoid and because the vertical paths are perpendicular to the magnetic field and thus do not contribute. By dividing x out of both sides of equation (1), one finds:
The magnetic field inside a solenoid is proportional to both the applied current and the number of turns per unit length. There is no dependence on the diameter of the solenoid or even on the shape of the solenoid. More importantly, the magnetic field is relatively constant inside the solenoid which means that any path placed within the solenoid will receive substantially the same amount of magnetic flux.
In one embodiment, the described solenoid winding is also wrapped around a bobbin which in turn is placed around a cylindrical rare earth permanent magnet with a predetermined size and length. The magnet has a hollow core so as to facilitate the passage of liquids to and from the catheter. The bobbin used is shorter than the permanent magnet and is free to slide along the magnet surface.
The coil creates a magnetic field which drives flux through the magnet, around the bobbin of the solenoid, through an air gap, and then back into the magnet. The reluctance of this path is mostly made up by the air gap. When the bobbin is off center to the magnet, the air gap is wide so the reluctance is quite high and the inductance is low. However, when a current is applied to the coil, the bobbin moves in the direction where reluctance of the circuit is reduced. The formulas for coil inductance and coil impedance are given in equations (3) and (4) respectively below:
The current that is driven through the coil is the voltage divided by the impedance given in equation (5) below:
In one embodiment, each solenoid has its own independent interconnecting wires which are connected to an outside power source. In one embodiment, one or more common wires are shared by one or more coils. This configuration allows electric currents to be driven in opposite directions within each solenoid and provides the necessary opposing magnetic flux for bringing the bobbin back to its original position and completes the movement of the medical tool.
When an electric current is applied from the outside source through each solenoid, a uniform magnetic field is produced which pushes or pulls the magnet in a predetermined linear direction. Coupled to the magnet is a small actuator arm which in turn is coupled by way of a series of hinges and pins to any variety of working tools such as jaws or clamps, needles, blades, or mapping and ablation probes.
In one embodiment, an actuated set of jaws or forceps is summarized further. For example, when an electric current is sent through the solenoid, a magnetic flux is created which pushes the magnet back towards the proximal end of the catheter. The actuator arm that is coupled to the magnet which had been set at an angle within the device is then straightened out until it is nearly parallel to the longitudinal axis of the catheter. The straightening of the actuator arm pulls on the upper jaw proximally, rotating the upper jaw about a central hinge in a clockwise direction and effectively opening the jaws. When the jaws are closed, the electric current in the solenoid is reversed in direction thus changing the direction of the magnetic flux and pushing the magnet back towards the distal end of the catheter. The actuator arm is then placed back into its original position and the upper jaw rotates counterclockwise around on the central hinge until it comes into contact with the sample tissue or the lower jaw portion of the device.
Using Maxwell's equations, the electromechanical force can be calculated using equation (6):
F=(Fm)2 μ0A/(2 g2) (6)
Equation (6) is used to calculate that for 7 to 12 French size catheters, 35 grams (or more) of constant force with a peak of 55 grams of force (or more) can be produced. Additional force can be produced by increasing the number of turns in the coil, by increasing the current, and/or increasing the strength of the permanent magnet.
While the apparatus and method has or will be described for the sake of grammatical fluidity with functional explanations, it is to be expressly understood that the claims, unless expressly formulated under 35 USC 112, are not to be construed as necessarily limited in any way by the construction of “means” or “steps” limitations, but are to be accorded the full scope of the meaning and equivalents of the definition provided by the claims under the judicial doctrine of equivalents, and in the case where the claims are expressly formulated under 35 USC 112 are to be accorded full statutory equivalents under 35 USC 112.
In general, the linear actuator for the deployment of catheter tools uses the principles of magnetic repulsion and attraction to produce forces for moving a bobbin that is attached to various types of moving components that translate the linear movements of the bobbin into the actuation of a tool that is coupled to the linear actuator on the distal tip of the catheter. Using independent coils that are coupled around the solenoid at different points allows the movement modality to be increased from two possible positions to three or more.
The magnetic linear actuator 101 as shown in
The operating physician can manipulate the amount the tool is actuated by adjusting the amount of current that is sent through the wires or altering the direction in which the current travels.
When the operating physician wishes to close or disengage the medical tool and return it to its original position as depicted in
The CGCI unit 1500 includes a magnetic chamber 501, an adaptive regulator, a joystick haptic device for operator control, and a method for detecting a magnetically-tipped catheter 26 is described in U.S. Pat. No. 7,280,865 titled “System and Method for Radar-Assisted Catheter Guidance and Control”, U.S. patent application Ser. No. 11/140,475 titled “Apparatus and Method for Shaped Magnetic Field Control for Catheter, Guidance, Control, and Imaging”, U.S. patent application Ser. No. 11/331,944 titled “Apparatus and Method for Generating a Magnetic Field”, U.S. patent application Ser. No. 11/331,485 titled “System and Method for Magnetic Catheter tip,” U.S. patent application Ser. No. 10/621,196 titled “Apparatus and Method for Catheter Guidance Control and Imaging”, U.S. patent application Ser. No. 11/331,781 titled “System and Method for Controlling Movement of a Surgical Tool”, U.S. patent application Ser. No. 11/697,690 titled “Method and Apparatus for Controlling Catheter Positioning and Orientation”, and U.S. patent application Ser. No. 11/362,542 titled “Apparatus for Magnetically Deployable Catheter With MOSFET Sensor and Method for Mapping and Ablation” all of which are hereby incorporated by reference. The above magnetic navigation system 1500 is further augmented by the magnetic linear actuator 101 so as to improve the efficiency and utility of the CGCI magnetic chamber 1500 which enables the embodiments of the magnetic linear actuator 101 and catheter tip 26 to perform the intended functions as noted above in the current application.
The CGCI imaging and synchronizations system 701 determines the actual position (AP) of the tool within the patient 1, and specifies the desired position (DP) wherein to guide the magnetically-tipped catheter 26. The CGCI controller 501employs its magnetic chamber to guide the magnetically-tipped catheter 26 from AP to DP in a closed-loop regulated mode, as to deliver the tool to the desired location within the patient. The CGCI catheter detection unit 11 determines that the tool is at the proper location by using the CGCI fiduciary alignment system 12 to normalize the CGCI detection unit data with the patient's position and orientation. The external medical systems 502 provide the corroborating electrophysiological data that assures the physician that the tool is situated at the desired location. The CGCI operation console 13 is then used to issue commands to the magnetic linear actuator 101 by the standard communications interface.
Other embodiments for various medical tools to be deployed on the distal tip of a catheter and actuated by the magnetically controlled linear actuator include a rotating cleaner tool and a mapping and ablation tool, and the like.
In the rotating cleaner tool embodiment, two titanium blades and two “C” shaped permanent magnets are coupled to the bobbin 13. As the external magnetic field rotates around the surgical volume, the “C” magnets will follow accordingly, thus causing the bobbin 13 and blades to rotate and clean the inside of the surgical volume. The blades may be rotated by a variable force with a maximum value of 35 grams.
The final embodiment involving the mapping and ablation catheter involves a MOSFET sensor and RF ablation antennas coupled to the bobbin 13 along with two titanium blades and two “C” shaped magnets. When the external magnetic field rotates around the surgical volume, the “C” magnets will follow accordingly thus causing the bobbin 13, blades, antennas, and sensor to rotate and effectively map and ablate the interior of the surgical volume. Typically, the device employs eight sensors and antenna arms to perform cardiac mapping.
Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the inventions. Therefore, it must be understood that the illustrated embodiment have been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following invention and its various embodiments.
Therefore, it must be understood that the illustrated embodiment have been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following claims. For example, notwithstanding the fact that the elements of a claim are set forth below in a certain combination, it must be expressly understood that the invention includes other combinations of fewer, more or different elements, which are disclosed in above even when not initially claimed in such combinations. A teaching that two elements are combined in a claimed combination is further to be understood as also allowing for a claimed combination in which the two elements are not combined with each other, but may be used alone or combined in other combinations. The excision of any disclosed element of the invention is explicitly contemplated as within the scope of the invention.
The words used in this specification to describe the invention and its various embodiments are to be understood not only in the sense of their commonly defined meanings, but to include by special definition in this specification structure, material or acts beyond the scope of the commonly defined meanings. Thus if an element can be understood in the context of this specification as including more than one meaning, then its use in a claim must be understood as being generic to all possible meanings supported by the specification and by the word itself.
The definitions of the words or elements of the following claims are, therefore, defined in this specification to include not only the combination of elements which are literally set forth, but all equivalent structure, material or acts for performing substantially the same function in substantially the same way to obtain substantially the same result. In this sense it is, therefore, contemplated that an equivalent substitution of two or more elements may be made for any one of the elements in the claims below or that a single element may be substituted for two or more elements in a claim. Although elements may be described above as acting in certain combinations and even initially claimed as such, it is to be expressly understood that one or more elements from a claimed combination can in some cases be excised from the combination and that the claimed combination may be directed to a subcombination or variation of a subcombination.
Insubstantial changes from the claimed subject matter as viewed by a person with ordinary skill in the art, now known or later devised, are expressly contemplated as being equivalently within the scope of the claims. Therefore, obvious substitutions now or later known to one with ordinary skill in the art are defined to be within the scope of the defined elements.
The claims are thus to be understood to include what is specifically illustrated and described above, what is conceptionally equivalent, what can be obviously substituted and also what essentially incorporates the essential idea of the invention.
The present application claims priority to U.S. Provisional Application No. 60/690,941, filed on May 30, 2007, titled “LINEAR ACTUATED CATHETER TOOLS,” the entire contents of which is hereby incorporated by reference.
Number | Date | Country | |
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60940941 | May 2007 | US |