Aspects of the present disclosure generally relate to medical devices and procedures. In particular, some aspects relate to surgical guidance devices, systems and methods.
Non-invasive surgical procedures advantageously allow a surgeon to treat an internal area of a body without having to create a large physical opening in the exterior skin of the body. Many non-invasive procedures are specialized to treat a particular area of the body, such as an organ. Percutaneous nephrolithonomy (or “PCNL”), for example, is one such procedure, wherein an object, such as a needle, is inserted through the body and into a kidney for removal of a kidney stone. Precise placement of the needle is required to avoid damaging the kidney. Therefore, medical imaging techniques, such as fluoroscopy, may be used in PCNL procedures to both locate a kidney and track the location of the needle with respect to the located kidney.
Many imaging technologies are limited to producing an image of the body within a single imaging plane. For fluoroscopy, the imaging plane is defined with respect to the imaging plane of an x-ray beam. These technologies may be used to locate an organ, and determine a distance between an object and the organ; however, they are often ill-suited for guiding the object to the organ. For example, a PCNL needle may be pushed out of the imaging plane by bodily tissue, requiring the surgeon to either reposition the imaging plane with respect to the needle and the kidney, which is time consuming; or navigate the body based solely on tactile sensation, which is imprecise and potentially harmful to the body. Moreover, because many of these imaging technologies produce a two dimensional image of a three dimensional body, they may skew or blur the geometrical relationship between the object and the body. In PCNL procedures, for example, these limitations can make it difficult for the surgeon to determine whether the needle is being advanced towards the kidney along a desired insertion angle.
Aspects of the present disclosure are related to surgical guidance devices, systems, and methods. Numerous aspects of the present disclosure are now described.
One aspect is a guidance device. An exemplary guidance device may comprise: a tracking pad with a guiding opening, and a plurality of sensors operable with at least one beacon on a needle to track the disposition of the needle at least when a distal end of the needle is inserted into the guiding opening.
According to this aspect, the at least one beacon may include a magnetic element, and each of the plurality of sensors may be a transducer. For example, each transducer may be a Hall effect sensor. The tracking pad may define three positions arranged triangularly about the guiding opening, and the plurality of sensors may comprise at least one sensor placed at each of the three positions. The device may further comprise a marking element configured to indicate a target insertion point, inside the guiding opening, for the distal end of the needle. For example, the marking element may be configured to project at least two beams of light into the guiding opening, and the target insertion point may be indicated by a point of intersection between the at least two beams of light.
The plurality of sensors may be configured to determine an actual insertion point, inside the guiding opening, of the distal end of the needle. The plurality of sensors also may be configured to determine an actual insertion angle of the needle relative to the opening. In some aspects, the device may further comprise a guiding element on the tracking pad that indicates whether the actual insertion angle aligns with a target insertion angle. For example, the guiding element may comprise a plurality of indicators, each indicator being configured to indicate a direction of movement for aligning the actual insertion angle with the target insertion angle. The plurality of sensors may be further configured to determine the distance between the guiding opening and the distal end of the needle when the distal end is inserted into the opening.
The at least one beacon may comprise a first beacon located at the distal end of the needle and a second beacon located at a proximal end of the needle, wherein the disposition of the needle is tracked relative to either or both of the first and second beacons. In some aspects, the device may further comprise a transmitter configured to communicate an actual disposition of the needle to a processor, a receiver configured to receive a target disposition of the needle from the processor, and a guiding element configured to indicate a direction of movement for synchronizing the actual disposition with the target disposition. The guiding element may comprise a display configured to show the actual disposition relative to the target disposition; and/or the processor may be configured to establish the direction of movement and activate the guiding element.
Another aspect is another guiding device. According to this aspect, an exemplary guiding device may comprise a tracking pad with a guiding opening, and a plurality of sensors operable with at least one portion of a needle to generate a motion signal at least when a distal end of the needle is inserted into the guiding opening.
At least one portion of the needle may include a magnetic element, and each of the plurality of sensors may include a transducer operable with the magnetic element to generate the motion signal. For example, each transducer may be Hall effect sensor. The proximal end of the needle may include an interface with a polygonal gripping surface engageable with a forceps, and the device may further comprise a marking element configured to indicate a target insertion point, inside the guiding opening, for the distal end of the needle. The motion signal may communicate an actual insertion angle for the needle relative to guiding opening, wherein the device may further comprise a first guiding element configured to indicate a direction of movement for synchronizing the actual insertion angle with a target insertion angle. The motion signal also may communicate an actual distance between the guiding opening and the distal end of the needle, wherein the device further comprises a second guiding element configured to indicate when the actual distance approaches a target distance. For example, the plurality of sensors may be in communication with a processor configured to determine the target insertion point, the target insertion angle, and the target distance, and activate the first and second guiding elements.
Yet another aspect is a guidance system. An exemplary guidance system may comprise: a needle with at least one beacon; a tracking pad with a guiding opening and a plurality of sensors operable with the at least one beacon to track the disposition of the needle when the distal end of the needle is inserted into the guiding opening; a transmitter configured to communicate an actual disposition of the needle to a processor; a receiver configured to receive a target disposition of the needle; and a guiding element configured to indicate a direction of movement for synchronizing the actual disposition of the needle with the target disposition of the needle.
In this aspect, the guiding element may comprise a display configured to show the actual disposition of the needle and the target disposition of the needle. The guiding element may further comprise a plurality of indicators on the tracking pad. Each indicator may be configured to indicate the direction of movement for the needle. The system may further comprise an access guide comprising a base attached to the tracking pad, the base including an opening coaxial with the guiding opening, and a holder moveably attached to the base. For example, the holder may include a bore configured to receive the needle and define the insertion axis. The system may further comprise a probe that is attached to the base or the holder, and/or configured to generate a motion signal when the needle is inserted through the bore along the insertion axis. The system may further comprise a probe with a base sized for receipt within the guiding opening of the pad. For example, the probe may be configured to generate a motion signal when the needle is inserted through the bore along the insertion axis. The image may be generated in an imaging plane of the probe.
Still yet another aspect is a guidance method. An exemplary guidance method may comprise: placing a tracking pad adjacent a body, the pad including a guiding opening and a plurality of sensors; locating a distal end of a needle inside of the guiding opening at an insertion point adjacent the body, the needle including at least one beacon; operating the plurality of sensors with the at least one beacon to track the actual disposition of the needle; establishing a target disposition; moving the needle in a direction of movement to synchronize the actual disposition with the target disposition; and inserting the distal end of the needle into the body along an insertion axis.
The tracking pad may include a marking element configured to establish a target insertion point inside the guiding opening of the pad, wherein the method further comprises establishing the target insertion point, and placing the distal end of the needle adjacent the target insertion point. The plurality of sensors may be configured to track an actual insertion angle of the needle relative to the guiding opening, wherein the method further comprises establishing a target insertion angle, and moving the needle so as to align the actual insertion angle with the target insertion angle. The plurality of sensors may be further configured to track the distance between the guiding opening and the distal end of the needle relative to the guiding opening, wherein the method further comprises establishing a target distance between the guiding opening and the distal end of the needle, and inserting the distal end of the needle into the body until the target distance is obtained.
In some aspects, the method may comprise recalibrating the plurality of sensors to define the target distance after moving the needle so as to align the actual insertion angle with the target insertion angle. The method may further comprise transmitting the actual disposition of the needle to a processor; receiving a target disposition for the needle from the processor; and indicating a direction of movement for the needle with a guiding element associated with the tracking pad.
It may be understood that both the foregoing summary and the following detailed description are exemplary and explanatory only, neither being restrictive of the present disclosure unless claimed below.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects that, together with the written descriptions, serve to explain the principles of this disclosure.
The present disclosure is now described with reference to exemplary aspects of a system for tracking the location of an object relative to a body. Some aspects are described with reference to a procedure using an elongated object, while other aspects incorporate a medical imaging technology. For example, some aspects may be depicted and/or described with reference to the tracking of a needle relative to a kidney. Any reference to a particular procedure (such as PCNL), object (such as a needle), area of the treatment (such as a kidney), or medical imaging technology (such as x-ray) is provided for convenience and not intended to limit the present disclosure. Accordingly, the concepts and novelty underlying each aspect may be utilized for or with any analogous type of procedure, object, area of treatment, or imaging technology, medical or otherwise.
Numerous axes are described below, for example, with reference to an opening having an axis Y-Y transverse therewith. These directional terms are provided to establish a coordinate system with reference to the present disclosure. The directional terms “proximal” and “distal” are used herein to refer to the relative components and features of the present disclosure. The term proximal refers to a position closer to the exterior of the body or a user, whereas the term distal refers to a position closer to the interior of the body or further away from the user. The term “elongated” as used herein refers to any object that is substantially longer in relation to its width, such as an object having a length that is at least two times longer than its width. Some elongated objects, for example, are axially extending in a proximal or distal direction along an axis. Unless they appear in the appended claims, such terms are provided for convenience and not intended to limit the present disclosure.
As used herein, the terms “comprises,” “comprising,” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term “exemplary” is used in the sense of “example,” rather than “ideal.”
One aspect of the present disclosure is depicted in
As shown in
Tracking pad 10 has one or more marking elements 17 configured to establish a target insertion point for the distal end 24 of needle 20. As shown in
A cable 16 extends away from pad 10 in
An exemplary needle 20 is illustrated in
At least one beacon 30 is attached to needle 20. In
As shown in
Methods of using system 1 of
An exemplary guiding method 60 is also disclosed. In addition to the steps described above, method 60 may comprise a step 61 (
Alternative aspects of system 1 and their associated methods are also disclosed, each aspect being part of the present disclosure. Tracking pad 10, for example, is described as a triangular, flexible element, yet may assume any shape or rigidity. Although depicted as circular in
Sensors 12A-C have been described as Hall effect sensors coupled to pad 10, but this is not required. For example, to generate a motion signal according to the present disclosure, one or more of sensors 12A-C may alternatively be a sensing coil that utilizes magnetic fields, such as those based on very low frequencies, induction balancing, pulsed induction, beat-frequency oscillators, or like technologies. Any of sensors 12A-C may also be a radar sensor that utilizes sound waves, a lidar sensor that utilizes laser energy, an optical sensor that utilizes shape or signal recognition, or any other type of known sensing technology suitable for use in accordance with this disclosure. Any number of sensors, or combination of sensor types may be used.
Beacon 30 may be configured to operate with any sensor type, including those described herein. For example, beacon 30 may be a made of a conductive material with a inductance and/or resistance suitable for use with sensors 12A-C. Alternatively, beacon 20 may have a reflective surface configured to reflect sound waves or lasers, or a coded surface readable by an optical sensor. Alternatively still, beacon 30 may be a coil, a small resonant RC circuit, or even a magnetostrictive element that is momentarily excited by sensors 12A-C, activating briefly to provide and excite a magnetic field. Either beacon 30 or sensors 12A-C may generate a motion signal by listening for the inductively activated resonant signal to settle, and then measure time of flight or resonant signal strength. In this regard, beacon 30 may be an active, albeit non-powered element of needle 20. Beacon 30 may also be a powered element. For example, although described as solid, magnetic element 36 may be an electromagnetic coil that is powered to, for example, produce a stronger magnetic field.
Needle 20 of
Cable 16 may also be modified. For example, in some aspects, pad 10 may comprise a wireless transceiver, such as a radio frequency transceiver, configured to send/receive the signals to/from processor 40, such that cable 16 is used exclusively as a power source for each element of pad 10. In still other aspects, Pad 10 may further comprise an internal battery so as to eliminate cable 16 entirely.
Processor 40 is described as a separate element, but may integral with pad 10. For example, processor 40 may be housed inside of pad 110. As noted above, any aspect of processor 40 may be used to receive motion signals from sensors 12A-C and track, via triangulation, the disposition of needle 20. Any number of sensors may be used. Thus, processor 40 may be configured to utilize the additional motion signals within any location determining algorithm.
Methods 50 and 60 may be modified for use with processor 40. For example, method 50 (
Additional aspects of the present disclosure are now described with reference to a system 100, a system 200, a system 300, and associated methods. Wherever possible, each element of systems 100, 200, and 300 is described using reference numbers similar to those of system 1. Any feature described with reference to systems 100, 200, or 300 may be combined with any feature described with reference to system 1, each potential variation being an exemplary aspect.
System 100 is depicted in
As shown in
The disposition of needle 120 and probe 180 may also be adjusted. Access guide 170 of
As shown in
System 200 is similar to system 100, but with an alternate access guide 170, depicted
Access guide 270 is depicted in
An assembled view of system 200 is provided in
Pad 110, similar to pad 10, utilizes a cable 116 as a power source and transceiver. Probe 280 utilizes a cable 286 extending therefrom for a similar purpose. Accordingly, as shown in
System 300 is depicted in
As shown in
Methods 50 and 60 described above may be used with systems 100, 200, 300. For tracking method 50, step 51 (
For tracking method 60, the steps 61 and 62 (
Another method 90 is disclosed with respect to systems 100, 200, and 300. Method 90 may comprise a step 91 (
Alternative aspects system 100, 200, and 300 are also disclosed, each aspect being part of the present disclosure. Numerous alternative aspects for system 1 have been described above, any of which may be incorporated into systems 100, 200, or 300. System 100, for example, is described with an access guide 170 pivotally and rotationally mounted to pad 110 (
A self-sealing membrane may be incorporated into systems 100, 200, and 300. For example, in systems 100 or 300, such a membrane may be attached to pad 110 or 310, as above with pad 10. For system 200, a similar membrane on base surface 270C of access guide 270 (
Each of probes 180, 280, and 380 have been described as an ultrasonic probe, although this is not required. For example, any probing technology may used to generate a motion signal, including those base on light, x-rays, microwaves, or like technologies. Any such probing technology may be combined with any sensing technology described herein. Although described as a single probe, a plurality of probes may also be used. For example, probe 380 of system 300 (
Various cables 116, 216, 286, and 316 have been described as either a power source or transceiver for systems 100, 200, or 300. Similar to above, any aspect of pad 100, 200, or 300 may be comprise a wireless transceiver or internal power source so as to modify or eliminate these cables.
While principles of the present disclosure are described herein with reference to illustrative aspects for particular applications, it should be understood that the disclosure is not limited thereto. Those having ordinary skill in the art and access to the teachings provided herein will recognize additional modifications, applications, aspects, and substitution of equivalents all fall within the scope of the aspects described herein. Accordingly, the present disclosure is not to be considered as limited by the foregoing description.
This patent application is a continuation under 37 CFR § 1.53(b) of U.S. application Ser. No. 15/400,367, filed Jan. 6, 2017, which claims the benefit of priority under 35 U.S.C. § 119 to U.S. Provisional Patent Application No. 62/276,567, filed Jan. 8, 2016, the disclosure of all of which are herein incorporated by reference in their entireties.
Number | Name | Date | Kind |
---|---|---|---|
1581706 | White | Apr 1926 | A |
1581707 | White | Apr 1926 | A |
1581708 | White | Apr 1926 | A |
1581709 | White | Apr 1926 | A |
1581710 | White | Apr 1926 | A |
2451077 | Emsig | Oct 1948 | A |
3110956 | Fischer, Jr. | Nov 1963 | A |
4899756 | Sonek | Feb 1990 | A |
5592939 | Martinelli | Jan 1997 | A |
5758650 | Miller et al. | Jun 1998 | A |
5848986 | Lundquist et al. | Dec 1998 | A |
5871446 | Wilk | Feb 1999 | A |
6006126 | Cosman | Dec 1999 | A |
6607529 | Jones | Aug 2003 | B1 |
8361066 | Long et al. | Jan 2013 | B2 |
8640940 | Ohdaira | Feb 2014 | B2 |
20020052610 | Skakoon et al. | May 2002 | A1 |
20020111615 | Cosman et al. | Aug 2002 | A1 |
20020156372 | Skakoon et al. | Oct 2002 | A1 |
20060079885 | Rick | Apr 2006 | A1 |
20070250075 | Skakoon et al. | Oct 2007 | A1 |
20070250076 | Skakoon et al. | Oct 2007 | A1 |
20070250077 | Skakoon et al. | Oct 2007 | A1 |
20070255275 | Skakoon et al. | Nov 2007 | A1 |
20080082108 | Skakoon et al. | Apr 2008 | A1 |
20080269602 | Csavoy et al. | Oct 2008 | A1 |
20090053003 | Clark | Feb 2009 | A1 |
20090062788 | Long et al. | Mar 2009 | A1 |
20090306652 | Buysse et al. | Dec 2009 | A1 |
20100179530 | Long et al. | Jul 2010 | A1 |
20100292686 | Rick et al. | Nov 2010 | A1 |
20110022058 | Skakoon et al. | Jan 2011 | A1 |
20110022059 | Skakoon et al. | Jan 2011 | A1 |
20110258843 | Dukesherer et al. | Oct 2011 | A1 |
20110282188 | Burnside et al. | Nov 2011 | A1 |
20110295108 | Cox et al. | Dec 2011 | A1 |
20120143029 | Silverstein et al. | Jun 2012 | A1 |
20120149982 | Fonger et al. | Jun 2012 | A1 |
20130006102 | Wilkes et al. | Jan 2013 | A1 |
20130066192 | Sarvestani et al. | Mar 2013 | A1 |
20140031674 | Newman et al. | Jan 2014 | A1 |
20140046261 | Newman et al. | Feb 2014 | A1 |
20140107475 | Cox et al. | Apr 2014 | A1 |
20140163356 | Burnside et al. | Jun 2014 | A2 |
20150100064 | Skakoon et al. | Apr 2015 | A1 |
20150297114 | Cox et al. | Oct 2015 | A1 |
20170020561 | Cox et al. | Jan 2017 | A1 |
20170079548 | Silverstein et al. | Mar 2017 | A1 |
20170079681 | Burnside et al. | Mar 2017 | A1 |
20180168559 | Hautvast et al. | Jun 2018 | A1 |
20190117187 | Patel et al. | Apr 2019 | A1 |
Number | Date | Country |
---|---|---|
103635146 | Mar 2014 | CN |
104853799 | Aug 2015 | CN |
105662402 | Jun 2016 | CN |
2567668 | Mar 2013 | EP |
2002-502276 | Jan 2002 | JP |
2003-260064 | Sep 2003 | JP |
2005-323669 | Nov 2005 | JP |
Entry |
---|
International Search Report and Written Opinion for International Application No. PCT/US2017/012541, dated Mar. 23, 2017 (13 pages). |
Number | Date | Country | |
---|---|---|---|
20200214738 A1 | Jul 2020 | US |
Number | Date | Country | |
---|---|---|---|
62276567 | Jan 2016 | US |
Number | Date | Country | |
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Parent | 15400367 | Jan 2017 | US |
Child | 16820820 | US |