The present disclosure relates to medical instruments and, more particularly, to medical instruments for inserting an object within the body of a patient.
For many medical applications, a needle or other delivery device or deployable object is deployed using a medical instrument, such as a catheter based system. Such medical instruments often have deflectable tips to assist inserting them into position. As a result, a fundamental problem with such systems is determining the distance that the deployable object extends beyond the distal tip of the medical instrument. For example, compression of the tip of the medical instrument during deflection may cause the extension distance of the deployable object not to be the same as the distance set at the proximal end of the medical instrument. For example, for a deflectable catheter that comprises both a needle delivery system and a pull-wire, the pull-wire force results in compression of the softer segment of the distal catheter tip when the tip is deflected. After compression, the needle injection depth set at the proximal end of the catheter does not correspond to the actual needle injection depth at the distal end of the catheter. This can be particularly problematic when the tissue injection depth must be very precise, such as when used with thin tissues, where the injection depth must be accurate.
One method of controlling the extension of a needle delivered by a catheter employs a collar on the needle and a stop inside the lumen of the catheter at the distal tip. In such a system, the needle can only be advanced until the collar on the needle abuts against the stop inside the catheter lumen. While such a system prevents the needle from being overextended, it does not allow the operator to select a desired amount of extension but rather the operator is limited to the amount of extension provided by the relative positions of the collar and the stop.
Aspects and features of the present invention will be appreciated as the same becomes better understood by reference to the following detailed description of the embodiments of the invention when considered in connection with the accompanying drawings, wherein:
a-5c are cross-sections of a deployable object within a catheter according to embodiments of the invention; and
The following detailed description is exemplary in nature and is not intended to limit the scope, applicability, or configuration of the invention in any way. Rather, the following description provides practical illustrations for implementing exemplary embodiments of the present invention.
Embodiments of the present disclosure are useful with medical instruments for inserting deployable objects within the body of a patient. After placing the medical instrument into a patient's body, a deployable object, which is disposed and moveable within the medical instrument, is extended from the medical instrument and into the patient's body. Such medical instruments include catheters, such as rigid and flexible catheters, endoscopes such as neuroendoscopes, bronchoscopes, chronic total occlusion catheters and surgical robots, for example. The deployable objects which may be delivered through the medical instrument include, for example, needles and other delivery devices, guide wires such as for cardiac leads, chronic total occlusion crossing guidewires, biopsy tools, ablation probes, and sensors. An exemplary needle system which may be used is disclosed in U.S. patent application Publication Number 2007/0164900 and 2005/0277889, the relevant portions of which are hereby incorporated by reference. When the deployable object is a delivery device, it may be used to deliver therapeutic fluids including biological agents such as genetic vectors, cells, proteins or chemical agents such as drugs. The deployable object may be a needle for ablation such as radiofrequency ablation for local necrosis of tissue such as small tumors or for cardiac rhythm management. For such uses, accurate placement of the deployable object such as placement of a needle at a precise depth in the tissue is particularly important so that the delivered substances can be precisely placed in the desired locations and at the desired depth in the tissue. Therefore embodiments of the present disclosure allow for the use of medical instruments for accurate control over the delivery of substances into tissue.
In catheters and other medical instruments having a deflectable tip, the deflectable tip is comprised of a material softer than the more proximal shaft. In such medical instruments, the difference in stiffness between the distal and more proximal portions of the instrument allows the tip to deflect more than the shaft, such as under the force of a pull-wire, resulting in an overall deflection of the tip. However, in addition to bending, the softer distal segment also compresses under the deflecting force. An example of this compression is shown in
Embodiments of the present disclosure comprise a system to measure the distance that an object is deployed from the distal tip of a medical instrument at the distal end of the instrument. Measuring the distance of extension of a deployable object at the distal tip of the medical instrument is more complicated than measuring extension at the proximal end because the distal tip is within the body of the patient, such as within the heart, at the time of deployment and therefore extension cannot be measured directly. Certain embodiments of the present disclosure therefore use an electromagnetic system and current induction to track and measure the extension of the deployable object beyond the distal tip of the medical instrument.
In some embodiments, the present disclosure is used for accurately injecting a needle into thin tissue a known distance. For example, the present disclosure may be used in thin tissues such as the right atrium, infarcted myocardium which has undergone remodeling, or vascular tissue. Such tissues may be injected with pacemaker cells, for example. In some applications, the tissue into which the material is injected may be only 3 or 4 mm, which is possible due to the accurate injection depth provided by embodiments of the present disclosure.
Certain embodiments of the present disclosure use an electromagnetic source and electromagnetic detectors or receivers for detecting the amount of extension of a deployable device. A generator is positioned external to the patient that sets up an oscillating magnetic field in the general area of the patient where the catheter will be deployed and acts as a transmitting source. The medical instrument or the deployable device includes an electromagnetic receiver, such as a receiver coil. In some embodiments, the transmitting source could be a coil, such as a coil which is about the size of the receiver coil, with the transmitting source in close proximity to the receiver coil, such as about 1 or 2 centimeters proximal to the receiver coil. The medical instrument is inserted into a patient's body, and the oscillating magnetic field induces a current in the receiver, within the body of the patient disposed within the magnetic field. Within the medical instrument and deployable object, the system uses high magnetic permeability cores, such as ferrous cores, which move relative to the receivers due to the motion of the deployable object. This motion results in a varying inductance in the receiver coil circuit. The electromagnetic field causes a current in the receiver coils, but this current is also effected by the high magnetic permeability cores, such as ferrous cores. For example, as the high magnetic permeability cores may begin at a position centered relative to the receiver coils, where the inductance of the combined cores and coils is highest. As deployable object is extended, the cores and coil are moved away from each other and the inductance (and therefore the current induced by the magnetic field) decreases. By monitoring the changes in the induced current or the inductance, the system can therefore determine the location of the high magnetic permeability cores relative to the receiver coils. This distance determination is then used to determine how far the deployable device has been moved away from the medical instrument.
In one embodiment of the present disclosure, one or more high magnetic permeability cores are located on the deployable object and one or more receivers comprising receiver coils are located at or near the distal tip of the medical instrument. An example of this embodiment is shown in
In the embodiment shown in
High magnetic permeability cores 80 are comprised of high permeability magnetic material. This includes material which can be magnetized in response to a magnetic field. Such material may have a relative permeability of about 28,000 or more, for example. The high permeability magnetic core 80 may be comprised of one or more materials including cobalt, nickel, steel, iron, purified iron, silicon iron, mumetal, supermalloy, METGLAS®, AISI 400 Series stainless steel, or other similar material.
Embodiments of the present disclosure include one or more extension electromagnetic receiver coils 50 for assessing extension, also referred to herein as extension receiver coils 50. In the embodiment shown in
One or more electromagnetic sources or transmitters emit a magnetic field into the space occupied by a patient undergoing catheterization. Examples of appropriate sources include the electromagnetic source used in the Medtronic StealthStation and the electromagnetic source disclosed in U.S. patent application Publication Number 2004/0097804, the relevant portions of which are hereby incorporated by reference.
One embodiment of the present disclosure is shown in
The combination of a receiver coil 50 with a moveable internal high permeability material creates a variable inductance that may be measured. If the high permeability material is mounted to or forms part of the deployable object 40, the inductance level may be used to determine the relative location of the receiver coil 50 and the deployable object 40.
In some embodiments, multiple high magnetic permeability cores 80 are mounted to a deployable needle, as shown in
The extension analysis system provides an algorithm which receives the induction or the induced current data and produces data regarding extension of the deployable object 40. In some embodiments, the extension analysis system is a part of the navigation system. In other embodiments, the extension analysis system is provided separate from the navigation system. In some embodiments, the data regarding extension of the deployable object 40 may be provided to the operator in the form of a visual display. Such display may be continuously provided throughout the procedure or may be provided only upon demand by the operator. For example, in one embodiment, the extension analysis system is included in the navigation system. The operator may use the navigation system to position the medical instrument and may then switch the system to receiving and providing data regarding extension of the deployable object 40. Once the extension of the deployable object 40 is complete, the operator may then switch the system back to operating as a navigation system.
In some embodiments of the present disclosure, the use of an electromagnetic source may be eliminated. In such embodiments, the inductance may be measured directly via sending a signal across the receiver coil 50 and measuring the response. That is, the inductance, and therefore the position of the deployable object, is measured electrically by the extension analysis system 70 without the induction of a current into the receiver coil 50 by an electromagnetic source.
Embodiments of the present disclosure may be used in combination with electromagnetic navigation systems such as the navigation system disclosed in U.S. patent application Publication Number 2007/0164900, the relevant portions of which are hereby incorporated by reference. Certain devices are designed to use an electromagnetic source and electromagnetic navigation receiver coils 90 (see
Emitters 110 may also be employed for use with the extension analysis system 70, receiver coil 50, and deployable object 40 with high magnetic permeability cores 80. In some embodiments of the present disclosure, the medical instrument includes one or more extension electromagnetic receiver coils 50 for detection of extension of the deployable object 40 and one or more separate navigation electromagnetic receiver coils 90 for navigation. In such embodiments, the two types of electromagnetic receiver coils need not be the same size. For example, the one or more extension electromagnetic receiver coils 50 for detection of extension of the deployable object 40 may be smaller and therefore closer to the deployable object 40 than the navigation coils 90. An example of such an embodiment is shown in
In some embodiments of the present disclosure, one or more electromagnetic receiver coils are used for detection of both extension of the deployable object and for navigation. In such embodiments, the electromagnetic receiver coil may be connected to both the extension analysis system 70 and the navigation analysis system 100 or the connection may be switched between them. During navigation activities, the receiver coil functions with the navigation analysis system, and during extension analysis, the receiver coil functions with the extension analysis system 70.
In embodiments including navigation, the electromagnetic receiver coils for navigation may be used to provide the location of the medical instrument within the patient. One navigation system useful with embodiments of the present disclosure is a system often called virtual fluoroscopy. In virtual fluoroscopy, an analysis component of the navigation system 100 processes current signals from the navigation electromagnetic receiver assemblies 90 to create a virtual image of the medical instrument. Embodiments may use the known extension of the deployable object 40 as determined by inductance to also create a virtual image of the deployable object 40 as it extends from the virtual image of the distal tip of the medical instrument.
In some embodiments of the present disclosure, the extension analysis system 70 may also include a control mechanism for effecting a particular extension of the deployable object. In such embodiments, the extension analysis system 70 includes a motor or a control signal line to a motor that moves the deployable object relative to the medical instrument. The motor may be of any appropriate type, such as a DC stepper motor. The extension analysis system 70 may also include a user interface where the user may set a desired extension distance. The extension analysis system, when enabled, will then measure the extension and control the motor to effect the proper extension. Alternatively, in some embodiments, the one or more extension electromagnetic receiver coils 50 may be located on the deployable object 40 and the one or more high magnetic permeability cores 80 may be located in the medical instrument. Such embodiments would function to measure extension of the deployable object 40 by measuring induction as the receiver coils 50 on the deployable object move relative to the stationary high magnetic permeability cores 80.
The description of the present invention is merely exemplary in nature and, thus, variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.
This application claims the benefit of U.S. Provisional Application Nos. 61/061,441, filed on Jun. 13, 2008 and 61/196,707, filed on Jul. 31, 2008, which are hereby incorporated by reference in their entirety.
Number | Date | Country | |
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61061441 | Jun 2008 | US | |
61196707 | Mar 2009 | US |