Surgical protection system

Abstract

The present invention relates to a surgical protection system. A device comprises: (a) one or more markers, some or all of which are expandable circular members that can be expanded from a storage state to an expanded state, and when in the expanded state, each of the expandable circular members expands to move into contact with a cavity in an organ; and (b) one or more tissue tags connected to the expandable circular members, or the expandable circular members are made of a magnetized material; and, wherein the expandable circular member is configured to be positioned in an insertion mechanism and deployed from the insertion mechanism into the cavity of the organ.

Description

Technical Field

[0001] The present teachings relate to a surgical system that facilitates marking features of interest such that the features of interest or areas surrounding the features of interest can be avoided. Specifically, the surgical protection system includes one or more markers, one or more tissue tags, one or more device tags, or combinations thereof deployable into a cavity, and the marker, tissue acting element, or both can include one or more tags (e.g., device tags or tissue tags) made of a magnetizable material or including magnets to indicate the position of the marker or tag within the cavity. Background Art

[0002] Attempts have been made to move two or more surgical components away from each other during tissue dissection to protect a location of interest from accidental contact with surgical instruments. A catheter having a first polarity can be positioned within an organ or tissue, and a tool including the first polarity can be used such that when the tool moves toward the catheter, the tool is moved away from the organ or tissue, thereby protecting the organ or tissue. Examples of some tools can be found in U.S. Pat. Nos. 5,827,269, 6,293,952, 7,567,159, and 9,320,539; U.S. Patent Application Publications Nos. 2004 / 0002626, 2004 / 0260273, and 2008 / 0097501; and International Patent Application Publications Nos. WO2015 / 138708, WO2012 / 130956, and WO2019 / 010007, the entire contents of which are incorporated herein by reference in their entirety for all purposes.

[0003] It would be attractive to include a surgical device containing one or more markers that are expandable to be positioned at a location of interest and preferably within a cavity of an organ. One or more markers made of a magnetizable material or including magnetism are needed such that the one or more markers mark the features of interest or provide a target within the features of interest and / or protect the features of interest. A surgical system including one or more markers and one or more insertion mechanisms for deploying the locator to a predetermined location is needed. A method of marking one or more features of interest or protecting a location proximate to the features of interest would be attractive. Summary of the Invention

[0004] The present disclosure meets one or more needs by providing a device including: (a) one or more markers, some or all of the markers being expandable circular members capable of expanding from a stored state to an expanded state, and each of the expandable circular members expanding to move into contact with a lumen in an organ when in the expanded state; and (b) one or more tissue tags connected to the expandable circular members, or the expandable circular members being made of a magnetizable material; and wherein the expandable circular members are configured to be positioned within an insertion mechanism and deployed from the insertion mechanism into the lumen of the organ.

[0005] The present teachings provide a surgical system including one or more surgical devices, the surgical devices including: (a) one or more tissue acting elements; and (b) one or more markers; wherein when the tips of the one or more tissue acting elements include one or more device tags that are a magnetizable material, the one or more markers include tissue tag magnetic sensors; or when one or more of the device tags in the tips of the one or more tissue acting elements include tissue tag magnetic sensors, the one or more markers include one or more tissue tags that are a magnetizable material; and wherein: (i) a display system indicates the proximity of the tips of the one or more tissue acting elements to the one or more markers; (ii) an alarm system provides a signal when the tips are within a predetermined distance of each other from the one or more markers; (iii) power supplied to the tips is removed when the tips are within a predetermined distance of each other from the one or more markers; or (iv) a combination thereof.

[0006] The teachings herein provide a method including: (a) deploying a set of one or more markers having one or more tissue tags into a lumen; (b) inserting a tissue acting element and one or more markers into the same lumen, the tissue acting element having a tip that has one or more device tags; wherein each of the one or more tissue tags is in magnetic communication with the one or more device tags such that: (i) the one or more tissue tags and the one or more device tags repel each other when the one or more tissue tags and the one or more device tags move within a predetermined distance of each other; (ii) a display indicating the proximity of the one or more device tags to the one or more tissue tags is generated on a display system; (iii) a signal is generated when the one or more device tags and the one or more tissue tags are positioned within a predetermined distance of each other; (iv) power supplied to the one or more device tags is removed when the one or more device tags and the one or more tissue tags are within a predetermined distance of each other; or (v) a combination thereof.

[0007] The present teachings provide a surgical device including one or more markers that are expandable to be positioned at a location of interest, and preferably within a lumen of an organ. The present teachings provide one or more markers made of or including magnetic material such that the one or more markers mark a feature of interest or provide a target within and / or protect a feature of interest. The present teachings provide a surgical system including one or more markers and one or more insertion mechanisms for deploying a locator to a predetermined location. The present teachings provide methods of marking one or more features of interest or protecting a location proximate to a feature of interest. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Figure 1 is a marker within a locator in an unexpanded state.

[0009] Figure 2 is a marker outside of a locator in an expanded state.

[0010] Figure 3 is a top view of a marker positioned within a lumen.

[0011] Figure 4A is a marker in an unexpanded state.

[0012] Figure 4B is a marker in an expanded state.

[0013] Figure 5A is a lumen having a target of interest.

[0014] Figure 5B is a lumen having tissue tags positioned before and after a target;

[0015] Figure 5C is a lumen having a tissue tag and a tip of a surgical device, the tip of the surgical device having a device tag, extending through one of the tissue tags and positioned between two tissue tags such that the device tag provides an indication when proximate to the tissue tag;

[0016] Figure 5D is a lumen having a pair of tissue tags, wherein the device tag extends beyond the target.

[0017] Figure 6 shows a magnetic field of a tissue tag repelling a device tag.

[0018] Figure 7 shows a magnetic field of a tissue tag with respect to a tip of a surgical device.

[0019] Figure 8Shows a magnetic field positioned close to a device tag of a marker.

[0020] Figure 9 Shows a device tag within the tip of a surgical device, the tip of the surgical device having extended through a marker with a tissue tag, where the magnetic poles are close to each other. Detailed Description

[0021] The explanations and illustrations presented herein are intended to acquaint other technicians in the field with the teachings, their principles, and their practical applications. Those skilled in the art can apply and use the teachings in various forms, which can best suit the requirements of a particular use. Therefore, the specific embodiments of the teachings set forth are not intended to exhaust or limit the teachings. Accordingly, the scope of the teachings should not be determined with reference to the above description, but should be determined with reference to the appended claims and the full scope of equivalents of the rights enjoyed by those claims. For all purposes, the entire disclosures of all articles and references, including patent applications and publications, are incorporated by reference. Other combinations that can be gathered from the appended claims are also possible, and these combinations are hereby incorporated by reference into this written description.

[0022] The present teachings relate to a surgical system. The surgical system is used to perform a procedure on or to a target (e.g., tissue, region, area, anatomical feature). The surgical system can act on the target such that all or a part of the target is excised, coagulated, removed, or a combination thereof. The surgical system can include one or more surgical devices to perform a surgical procedure. The surgical system can include one or more surgical protection systems to assist in performing the procedure. The surgical system can include one or more surgical devices, one or more indicators, one or more computers, one or more surgical protection systems, one or more markers, one or more tissue acting elements, or a combination thereof. Preferably, the surgical system includes a surgical device and a surgical protection system.

[0023] The present disclosure relates to surgical devices. The surgical device can be a non-electrical device (i.e., can provide only mechanical functions, e.g., mechanical cutting or grasping). The surgical device can be a cryogenic device. The surgical device can be a laser device. The surgical device can be a microwave device. Preferably, the surgical device is an electrosurgical device. The electrosurgical device can provide one or more therapeutic currents. The surgical device can include one or more needles, one or more jaws, one or more blades, one or more probes, an endoscope, a bronchoscope, a catheter, or a combination thereof. The therapeutic current can pass between the jaws (e.g., bipolar power). The therapeutic current can pass from the jaws to the blade and vice versa. The therapeutic current (e.g., monopolar power) can pass from the blade to a remote electrode (e.g., a grounding pad). The therapeutic current (e.g., bipolar power) can pass from two electrodes on the same jaw or blade. The electrosurgical device can provide microwave, cryogenic, laser, bipolar power, monopolar power, or a combination thereof to a feature of interest. The electrosurgical device can apply power before, after, or simultaneously with a mechanical technique (e.g., grasping or cutting). When power is applied, anatomical features can be cut, cauterized, sealed, coagulated, or a combination thereof. The power provided can cut tissue, cauterize tissue, coagulate tissue, or a combination thereof. The electrosurgical device can include a distal end and a proximal end. The distal end can include a portion of a tweezer device (e.g., jaws, blade, or both). The distal end can be the portion of the surgical device that is furthest from the user. The proximal end can be a portion grasped by the user (e.g., a handpiece or housing) or the portion closest to the user. The surgical device can be one or more tissue-acting elements or include one or more tissue-acting elements.

[0024] One or more tissue-acting elements can be used to test, remove, coagulate, stimulate, treat a target and preferably test, remove, coagulate, stimulate, treat target tissue. One or more tissue-acting elements can be a surgical device extending from a delivery device (e.g., an endoscope, a bronchoscope, a catheter, or a combination thereof). One or more tissue-acting elements can mechanically treat. One or more tissue-acting elements can electrically treat. One or more tissue-acting elements can be a blade, a jaw, a probe, a needle, a debrider, a dissector, an absorber (vacuum), a fluid source, or a combination thereof. One or more tissue-acting elements can mechanically and electrically treat a target. One or more tissue-acting elements can include a portion of a surgical protection system. One or more tissue-acting elements can include a portion extending into a cavity. All tissue-acting elements can extend into the cavity. The tissue-acting elements can extend from a sheath, a bronchoscope, an endoscope, a catheter, or a combination thereof into the cavity to act on a target. One or more tissue-acting elements can communicate with an indicator or a computer.

[0025] An indicator or a computer can be used to control one or more tissue-acting elements, provide feedback to the user, control a part of the surgical protection system, or a combination thereof. The indicator or the computer can communicate with the surgical device, the surgical protection system, or both, and can provide specific feedback to the user. The indicator can include a computer or be connected to a computer. The indicator can provide a signal (e.g., a tactile signal, an audio signal, a visual signal, or a combination thereof). The indicator can be connected to a computer screen, which can display to the user the position of the tip of the tissue-acting element relative to the marker, the target, or both, such that the user can know when the tip is approaching the protected area or tissue. The computer may not include an indicator or provide any indication. If the surgical device approaches the marker, the protected area or tissue, or both, the computer can stop the surgical device. For example, if the surgical device is an electrical device, if the surgical device is moved out of the area close to the target, the current can be disconnected. The computer can be connected to an indicator located in the computer, in the surgical device, or both. The indicator can provide an indication to the user from the surgical device. The indicator can provide an indication from the computer. The indicator can cause the surgical device to vibrate. The indicator can beep. The indicator can flash. The indicator can be separated from the surgical device and connectable to the surgical device. The indicator can be reusable. The indicator can be located entirely outside the cavity, outside the surgical device, outside the delivery device, or a combination thereof. The indicator can be a part of the surgical protection system.

[0026] The surgical protection system can be used to protect tissue, a zone, an area, or a combination thereof (e.g., the protected tissue) outside the target or in the target area or zone. If the user attempts to move the surgical device into the protected area or zone, the surgical protection system can provide resistance to the surgical device. The resistance can be a physical resistance or a mechanical force that resists the movement of the surgical device in the direction towards the protected tissue. The surgical protection system can include one or more magnets, magnetized materials, magnetic field sensors, locators, insertion mechanisms, markers, tissue tags, device tags, or a combination thereof. The surgical protection system can extend within the cavity. Preferably, the surgical protection system protects the same cavity in which the surgical device, the tissue-acting element, or both are located or perform the procedure. The surgical protection system can have a part that is inserted into the cavity and remains in the cavity for a period of time while the procedure is being performed. The surgical protection system can have a part that is movable out of the cavity. All or part of the surgical protection system can be located in the delivery device, extend from the delivery device, be connected to the delivery device, or a combination thereof. The surgical protection system can have a part that is placed in the cavity by one or more locators.

[0027] One or more locators are used to deploy one or more markers to one or more locations of interest. One or more locators can be used to extend from one or more delivery devices. One or more locators can insert a portion of the surgical protection system into a cavity. One or more locators can position a portion of the surgical protection system (e.g., a marker) into the cavity. One or more markers can grasp tissue. One or more markers can generate a radially outward force to hold the marker in place. One or more locators can deploy one or more markers into the cavity at one or more predetermined locations. One or more locators can position the marker along the cavity. One or more locators can compress the marker, expand the cavity, or both. One or more locators can be part of a delivery device (e.g., an endoscope, a bronchoscope, a catheter, a port of an endoscope, or a combination thereof). One or more locators can deploy the marker precisely into the cavity. One or more locators can include a compressed marker. One or more locators can include a solid marker. The one or more locators can be monitored by ultrasound, X-ray, MRI, contrast fluoroscopy, a camera, or a combination thereof. One or more locators can accommodate one or more markers, and one or more markers can be fully positioned within the locator. One or more locators can be deployed by an insertion mechanism that moves one or more markers out of the locator.

[0028] One or more insertion mechanisms can be used to move one or more devices (e.g., markers, tissue tags) from the locator to a location of interest or a predetermined location. One or more insertion mechanisms can be a push rod. One or more insertion mechanisms can be a driver. One or more insertion mechanisms can hold the device in place while the locator is retracted. One or more insertion mechanisms can insert one or more markers or a plurality of markers into the cavity. The insertion mechanism can move one or more markers, one or more expandable circular members, or both into the cavity. The insertion mechanism can move the marker in a stored state, an expanded state, or both to a predetermined location.

[0029] One or more markers may be used to mark one or more locations of interest within a cavity. Preferably, one or more markers are positioned within a single cavity. More preferably, two or more markers are positioned within a single cavity. When two or more markers are presented, the markers may enclose a protected region, protected tissue, location of interest, or a combination thereof. One or more markers may be solid (e.g., may have a predetermined size that does not change when the marker is outside of a locator). One or more markers may be solid and not change shape, expand, contract, or a combination thereof. One or more markers may be solid to completely block the cavity. The marker may maintain the same size during deployment, use, movement, or a combination thereof. The marker may prevent movement through the cavity without moving the marker. Preferably, at least one of the one or more markers includes a hollow center or hollow portion such that an actuation element may extend through the marker. The hollow center may be an opening through which a device label, surgical device, tissue actuation element, or a combination thereof may extend through the marker, tissue label, or both. The hollow center may be shaped such that the marker is doughnut-shaped, circular, annular, or a combination thereof. One or more markers may have a center that allows an actuation element to pass therethrough. For example, the center region of the marker may be void of material. One or more markers may preferably be an expandable circular member. The expandable circular member may have a shape complementary to the shape of the cavity. The expandable circular member may conform to the shape of the cavity or approximate the shape of the cavity. The cavity may have a cross-sectional shape that is circular, oval, ovoid, or a combination thereof, and the expandable circular member may conform to the shape of the cavity. The expandable circular member may have a continuous outer portion (e.g., an outer portion that has no beginning and no end). The expandable circular member may have an outer portion that has unconnected ends (e.g., an unconnected beginning end and termination end). The expandable circular member may have overlapping portions (e.g., one end may extend over the other end). The expandable circular member may be expandable to accommodate cavities of different sizes (e.g., cavities 1 mm or greater and 5 mm or greater). The expandable circular member may fill (e.g., match the perimeter) a cavity that is approximately 1 mm or greater, approximately 3 mm or greater, approximately 5 mm or greater, approximately 10 mm or greater, approximately 2 cm or greater, approximately 5 cm or greater. The expandable circular member may fill a cavity that is approximately 20 mm or less, approximately 15 mm or less, or approximately 10 mm or less. The expandable circular member may extend more in one direction (e.g., a primary cross-sectional direction) than a second direction (e.g., a secondary cross-sectional direction). The expandable circular member may be movable between a stored state and an expanded state.

[0030] The marker can have a stored state, where the marker is adapted to be fitted in a locator (e.g., a channel of the locator). The stored state can be a compressed state of the marker. The stored state can be a state where a part of the marker is wound around itself once or more times. The stored state can be a state where the marker is elastically deformed. The stored state can be a state where the marker is compressed and fitted in the locator, and the locator restricts the size of the marker. The stored state can be a state before deployment, after deployment, or both. For example, the marker can be made of nitinol and can be stored in a first shape or state, and then once conditions are applied to the marker, the marker can change shape to a second shape or state (e.g., an expanded state). In the stored state, the marker can be maintained under tension or compression, and once removed from the locator, the marker can expand into an expanded state. The marker can be subjected to conditions (e.g., heat, electricity) to change the marker from the expanded state back to the stored state, and the marker can also be subjected to conditions (e.g., heat, electricity) to change the marker from the stored state back to the expanded state. The stored state can be a compressed expanded state. The expanded state can be a state where the marker is adapted to contact all or a part of the cross-section of the cavity such that the marker remains at a predetermined position in the cavity. In the expanded state, the marker can expand the cavity. In the expanded state, the marker can expand until the cavity prevents further expansion of the marker, and the marker generates a force acting on the cavity that will substantially maintain the position of the marker in the cavity. The marker in the expanded state can have a cross-sectional length less than the maximum cross-sectional length. The cross-sectional length of the marker can vary according to the cross-sectional length of the cavity such that one marker can be fitted in anatomical cavities of a certain size range. The cavity can be a capillary, vein, artery, trachea, oral cavity, nasal passage, bronchus, esophagus, stomach, colon, rectum, vagina, cervix, uterus, urethra, ureter, and bladder. When in the expanded state, the marker can expose one or more magnets, one or more tissue tags, or both.

[0031] One or more tissue tags can be used to connect to a marker. One or more tissue tags can add a magnetizable material, a magnet, a magnetic sensor, or a combination thereof to the marker. One or more tissue tags can be the magnetic part of the marker. One or more tissue tags and the marker can be an integral structure. For example, the marker can be made of a magnetized magnetic material such that the marker serves as a tissue tag. One or more tissue tags can be connected to the marker. One or more tissue tags can be inserted into the marker. One or more tissue tags can be connected on the outside of the marker. One or more tissue tags can include one or more magnets. One or more tissue tags can each have a predetermined magnetic orientation such that when installed, the first polarity (e.g., south) faces one direction and the second polarity (e.g., north) faces the opposite direction. The magnetic orientation can be aligned with the axis of the cavity. For example, the north pole can face the distal end and the south pole can face the proximal end, or the south pole can face the distal end and the north pole can face the proximal end. The magnetic orientation can be changed when installed such that a desired magnetic orientation can be selected. The magnetic orientation can be changed by physically repositioning the tissue tag (e.g., magnet), remagnetizing the magnet, reversing the current direction, or a combination thereof. The tissue tag can have the same magnetic orientation as the device tag (e.g., such that they are attracted to each other). For example, the magnets of the tissue tag and the device tag can have their polarities facing the same direction. Preferably, the tissue tag has a magnetic orientation opposite to that of the device tag (e.g., such that the two repel each other). For example, the north pole of the tissue tag can face the distal end and the north pole of the device tag can face the proximal end such that the south poles face each other to generate a repulsive force axially along the cavity. The polarities of the tissue tag, the device tag, or both can be separated along the axis of the cavity. The tissue tag can repel the device tag in the axial direction along the cavity. The repulsive force can move the device tag in the axial direction of the cavity or repel it away from the tissue tag. The device tag and the tissue tag can be deployed in the same cavity simultaneously. The tissue tag can be at least partially embedded in the marker such that the tissue tag is supported by the marker and held in position within the cavity. The tissue tag can be located on the inside (e.g., inner circumference) of the marker. The tissue tag can be positioned substantially collinear with the position of the device tag. For example, the tissue tag can be in an annular shape and can be an annular ring forming the hollow center of the marker, and the device tag can be located in the same plane or line as the tissue tag. A part of the device can extend through the tissue tag. The tissue tag can be rectangular, square, oval, circular, or a combination thereof. Each marker can include one tissue tag. Each marker can include multiple tissue tags. One or more tissue tags can be centrally located on the marker. One or more tissue tags can be positioned evenly spaced along the circumference of the marker.One or more tissue tags may extend along the axis of the lumen from a first end region to a second end region such that the first end region has a portion of the marker with a first polarity and the second end region has a portion of the marker with a second polarity. One or more tissue tags may be made entirely of a magnetizable material. One or more tissue tags may have magnetized portions. One or more tissue tags may be sensors that sense the magnetic orientation, magnetic field strength, or both (e.g., determine which direction the polarity faces (e.g., distal or proximal)) from a device tag. The tissue tag may have a magnet made of or including the following materials: iron, nickel, cobalt, rare earth metals, samarium cobalt, neodymium iron boron, lanthanides, or combinations thereof. The tissue tag may produce a magnetic orientation (e.g., the direction the magnetic pole faces) that can be detected by the device tag, repel the device tag, attract the device tag, or combinations thereof.

[0032] A magnetic field may be used to create one or more partitions, discrete portions, of the lumen, alerting the user of the movement of the device tag or tissue acting element towards the protected area or protected tissue. For example, the discrete portions may be along the longitudinal axis of the lumen. The magnetic field may be separated along the axis of the lumen. For example, one side (e.g., the distal side) of the marker may have a first magnetic field (e.g., a north or south pole) and a second side (e.g., the proximal side) of the marker may have a second magnetic field (e.g., a polarity opposite the first side, so if the first side is a north pole, the second side is a south pole). The magnetic field may extend a predetermined distance from the marker. The magnetic field of one tag (e.g., the device tag) may repel the magnetic field of another tag (e.g., the tissue tag) or be repelled by the magnetic field of another tag (e.g., the tissue tag) with a predetermined amount of force or strength. The strength of the magnetic field may vary according to the type of procedure, the location of the procedure, user expectations, or combinations thereof. The magnetic field strength (e.g., the repulsive force) may provide a resistance or motive force of about 0.5 N or greater, about 1 N or greater, about 1.5 N or greater, or about 2 N or greater. The magnetic field strength may have a resistance or motive force of about 25 N or less, about 20 N or less, about 15 N or less, or about 10 N or less. The magnetic field may extend far enough from the marker, the tissue tag, or both such that the magnetic field of the tissue tag is recognized before the device tag contacts the marker. The magnetic field may be strong enough to move tissue or the protected tissue. The magnetic field may be detectable over a distance of about 1 mm or greater, about 3 mm or greater, about 5 mm or greater, about 7 mm or greater, or about 1 cm or greater. The magnetic field may be detectable over a distance of about 10 cm or less, about 7 cm or less, about 5 cm or less, or about 3 cm or less. A tissue tag magnetic field sensor may be used instead of the magnet on the tissue tag.

[0033] One or more tissue tag magnetic field sensors may be connected to one or more tissue tags. The tissue tags may be tissue tag magnetic field sensors. One or more tissue tag magnetic field sensors may be used in place of magnets. One or more tissue tag magnetic field sensors may provide feedback to a user such that if a surgical device or an operative element extends outside of a target area or region into a protected area or region, the user is alerted. One or more tissue tag magnetic field sensors may be connected to an indicator, a computer, or both or may communicate with an indicator, a computer, or both. One or more tissue tag magnetic field sensors may be wirelessly connected to an indicator, a computer, or both. One or more tissue tag magnetic field sensors may be wired connected to an indicator, a computer, or both. The tissue tag magnetic field sensors may be an electronic magnetometer, a microchip, a Hall effect sensor, a magnetic diode, a magnetic transistor, an AMR magnetometer, a GMR magnetometer, a magnetic tunnel junction magnetometer, a magneto-optical sensor, a MEMS compass, a fluxgate magnetometer, or a combination thereof. The tissue tag magnetic field sensors may sense the distance between a tissue tag and a device tag and may provide a signal or alert to the user once the distance drops below a predetermined distance. For example, if the tissue tag and the device tag are within 5 cm of each other, an audible signal, a tactile signal, a visual indication, or a combination thereof may be generated. The tissue tag magnetic field sensors may provide feedback when the distance between the tissue tag and the device tag is about 50 cm or less, about 40 cm or less, 30 cm or less, about 20 cm or less, or about 10 cm or less. The tissue tag magnetic field sensors may provide feedback when the distance is about 5 mm or greater, about 1 cm or greater, or about 5 cm or greater. The tissue tag magnetic field sensors may provide feedback to a monitor such that the monitor may display the distance between the device tag and the tissue tag. For example, the monitor may display the distance between two markers and may show the tissue tag when the device tag is close to the tissue tag such that the user is visually aware of the proximity of the tissue tag and the device tag relative to each other.

[0034] One or more device tags can be used to connect to a surgical device. Preferably, the device tag indicates the most distal position, the position of the operating portion of the medical device, or a combination thereof. One or more device tags can be positioned at one or more locations of the tissue acting element or on one or more locations of the tissue acting element. One or more device tags can be positioned in one or more ends of the tissue acting element. One or more device tags can be positioned proximate to the end of the tissue acting element. The tissue acting element can include two or more device tags. For example, one device tag can be in the distal end of the tissue acting element and can communicate with a first tissue tag, and a second device tag can be proximate to the distal end and can communicate with a second tissue tag, such that the user is guided to the target area between the two tissue tags. In addition to the device tags being incorporated into the surgical device or the tissue acting element, one or more device tags can be substantially the same as the tissue tags. One or more device tags can include a magnetized material, a magnet, a magnetic sensor, or a combination thereof of the surgical device or the tissue acting element that can be added to the surgical device. One or more device tags can be a magnetic portion of the surgical device or the tissue acting element. The magnetic orientation of one or more device tags can be aligned along the axis of the cavity or the longitudinal direction. One or more device tags and the surgical device or the tissue acting element can be an integral structure. For example, a portion of the surgical device or the tissue acting element (e.g., the end) can be made of a magnetized magnetic material such that the device serves as a device tag. One or more device tags can be connected to the surgical device or the tissue acting element. One or more device tags can be inserted into the surgical device or the tissue acting element. One or more device tags can be connected externally on the surgical device or the tissue acting element. One or more device tags can include one or more magnets. One or more device tags can have a predetermined polar direction such that when mounted or inserted into the cavity, the first polarity (e.g., the south pole) faces one direction and the second polarity (e.g., the north pole) faces the opposite direction. The device tag and the tissue tag can have a common polarity (i.e., both are north poles or both are south poles). When the device tag and the tissue tag have a common polarity, the device tag and the tissue tag can have increased resistance when the user attempts to move the device tag toward the tissue tag. The common polarity can produce a repulsive force. As the distance between the device tag and the tissue tag becomes smaller, the repulsive force can produce increased haptic resistance. The repulsive force can produce a force that is an increased applied force against the device tag to limit the device from contacting the protected tissue, the protected area, the protected zone, or a combination thereof. The repulsive force can produce a force that is an increased applied force against the tissue marker and displace the tissue marker and the associated protected tissue away from the device end.The repulsive force can be strong enough such that the marker, tissue tag, feature of interest, tissue to be protected, or a combination thereof moves when the device tag approaches the marker, so as to prevent the tip of the surgical device from contacting the tissue to be protected. For example, if the cavity is the colon and the device tag approaches the tissue tag, the colon can move so as to prevent the surgical device from contacting the tissue to be protected. The magnetic orientation can be changed during installation such that a desired magnetic orientation can be selected (e.g., the north pole can be changed from the distal end to the proximal end or from the proximal end to the distal end). The magnetic orientation can be changed by physically repositioning the device tag (e.g., the magnet), remagnetizing the magnet, reversing the direction of the current, or a combination thereof. The tissue tag can have the same magnetic orientation as the magnetic orientation of the device tag (e.g., such that they are attracted to each other). Preferably, the tissue tag has a magnetic orientation opposite to the magnetic orientation of the device tag (e.g., such that the two repel each other). The device tag can be at least partially embedded in the surgical device or the tissue acting element such that the tissue tag is supported by the surgical device or the tissue acting element and moves in the cavity. The device tag can be positioned on the inside (e.g., inside the tip or the probe) of the surgical device or the tissue acting element. The tissue tag can be positioned substantially collinearly with the position of the device tag. The device tag can be positioned on each side of the tissue tag. The device tag can be rectangular, square, oval, circular, or a combination thereof. Each surgical device or tissue acting element can include one device tag. Each surgical device or tissue acting element can include multiple device tags. One or more device tags can be centrally positioned on the surgical device or the tissue acting element. Preferably, the device tag is positioned in the tip of the surgical device or the tissue acting element. One or more device tags can be evenly spaced along the surgical device or the tissue acting element (e.g., the probe). One or more device tags can be made entirely of magnetized material. One or more device tags can have magnetized portions. One or more device tags can be sensors that sense the magnetic orientation from the tissue tag. The device tag can have a magnet made of or including the following materials: iron, nickel, cobalt, rare earth metals, samarium cobalt, neodymium iron boron, lanthanide series elements, or a combination thereof. The device tag can generate a magnetic orientation that can be detected by the tissue tag, causing a repulsive force between the device tag and the tissue tag, generating an attractive force between the device tag and the tissue tag, or a combination thereof. One or more device tags can be partially or entirely positioned in the surgical device or the tissue acting element. One or more device tags can be partially or entirely positioned outside the surgical device or the tissue acting element. Preferably, the device tag is positioned in or on the tip or tip region of the surgical device or the tissue acting element. The tip of the device can be the most distal end of the surgical device or the tissue acting element.The device label can be positioned close to the active part of the surgical device, above, before, after, over, or a combination thereof, of the active part of the surgical device. For example, if the surgical device is a debrider, the active part is the blade of the debrider. If the surgical device is a scalpel, the active part is the blade. If the surgical device is a needle, the active part is the tip of the needle. If the surgical device is an electronic device (e.g., bipolar or monopolar), the active part is any part of the device that delivers a treatment current to the target. The device label can protect the target by providing an indication to the user when the active part is positioned near, close to, moving towards, or a combination thereof, the protected site around the target. The active part can be positioned close to the distal end of the surgical device or the tissue acting element. The device label can have a magnetic orientation of the device label that extends to the tip, the active part, or the distal ends of both, such that an indication or a signal (e.g., resistance of opposing magnets, visual signal, audible signal, tactile signal, pull of opposing magnets) is provided before the acting element contacts the marker or before the acting element extends beyond the protected area or protected tissue.

[0035] The device label magnetic orientation is used to repel the device label or attract the device label towards the tissue label. Preferably, the device label has an orientation such that the device label and the tissue label repel each other. The device label magnetic orientation can be opposite to the magnetic orientation of the tissue label (e.g., the north pole side and the south pole side can be positioned apart from each other (e.g., the north pole of the device label can face the proximal end, and the north pole of the tissue label can face the distal end, such that the south magnetic poles are aligned, and the device label and the tissue label repel each other)). The device label magnetic orientation can be the same as the magnetic orientation of the tissue label (e.g., both the north poles will face the distal end or the proximal end). The teachings herein for the magnetic orientation of the tissue label are expressly incorporated herein by reference for the device label, and likewise, the teachings herein for the magnetic orientation of the device label are expressly incorporated herein by reference for the tissue label. The device label magnetic orientation can be used to create one or more partitions, separate portions, of the cavity to alert the user when the device label or the tissue acting element moves close to the protected area or protected tissue. For example, the separate portions can be along the longitudinal axis of the cavity. The magnetic orientation can separate along the axis of the cavity. For example, one side of the surgical device or the tissue acting element can have a first magnetic orientation (or polarity), and the second side of the surgical device or the tissue acting element can have a second magnetic orientation (or polarity). The magnetic orientation can extend a predetermined distance from the marker. The device label magnetic orientation can extend far enough from the surgical device or the tissue acting element such that the magnetic field of the tissue label is recognized before the device label contacts the marker. A device label magnetic field sensor can be used instead of a magnet on the device label.

[0036] A device label magnetic sensor can be used to sense a tissue label, a position relative to the tissue label, a target, a field of the tissue label, or a combination thereof, and provide an indication when positioned within a predetermined distance of the tissue label. One or more device label magnetic sensors can be connected to one or more device labels or positioned within one or more device labels. The device label can be a device label magnetic sensor. One or more device label magnetic sensors can be used in place of a magnet. One or more device label magnetic sensors can provide feedback to a user such that if a surgical device or an operative element extends outside of a target area or region into a protected area or region; if the device label moves too close to a target label; or both, the user is alerted. One or more device label magnetic sensors can be connected to an indicator, a computer, or both or can communicate with an indicator, a computer, or both. One or more device label magnetic sensors can be wirelessly connected to an indicator, a computer, or both. One or more device label magnetic sensors can be wired connected to an indicator, a computer, or both. The device label magnetic sensor can be an electronic magnetometer, a microchip, a Hall effect sensor, a magnetic diode, a magnetic transistor, an AMR magnetometer, a GMR magnetometer, a magnetic tunnel junction magnetometer, a magneto-optical sensor, a MEMS compass, a fluxgate magnetometer, or a combination thereof. The device label magnetic sensor can sense the distance between the tissue label and the device label and can provide a signal or alert to the user once the distance drops below a predetermined distance. For example, if the tissue label and the device label are within 5 cm of each other, an audible signal, a tactile signal, a visual indication, or a combination thereof can be generated. The device label magnetic sensor can provide feedback when the distance between the tissue label and the device label is about 50 cm or less, about 40 cm or less, 30 cm or less, about 20 cm or less, or about 10 cm or less. The device label magnetic sensor can provide feedback when the distance is about 5 mm or greater, about 1 cm or greater, or about 5 cm or greater. The device label magnetic sensor can provide feedback to a monitor such that the monitor can display the distance between the device label and the tissue label. For example, the monitor can display the distance between two markers and can show the tissue label when the device label is close to the tissue label such that the user is visually aware of the proximity of the tissue label and the device label relative to each other. The tissue label magnetic sensor, the device label magnetic sensor, or both can provide an indication or a signal when a surgical device, a tip, an operative tissue element, or a combination thereof moves within a restricted area.

[0037] A restricted area can be an area proximate to a protected area or zone that is used to generate a signal, generate an indication, overlap two magnetic fields, or a combination thereof. The restricted area can be an area where the target area overlaps or intersects the protected area. The restricted area can be an area where the power of an electrosurgical device is cut off, the power of the surgical device is disconnected, the magnetic poles of the tissue tag and the device tag repel each other, or a combination thereof. The restricted area can be an area within approximately 10 cm or less, approximately 7 cm or less, or approximately 5 cm or less (e.g., within approximately ±5 mm) of the tissue tag. The restricted area can be an area within approximately 1 mm or greater, approximately 3 mm or greater, approximately 5 mm or greater, approximately 7 mm or greater, or approximately 1 cm or greater. The surgical protection system can include one or more restricted areas. The surgical protection system can include a restricted area that predetermines the tip of the device tag such that the device tag can operate in the area created by the tissue tag, the device tag can only allow the surgical device to operate between the restricted zones, the device tag can repel towards the target, or a combination thereof. The restricted area can be located on one or both sides of the tissue tag. The restricted area can protect an organ, a protected area or organ, a protected area of a cavity, or a combination thereof.

[0038] An organ can be any organ that includes a cavity, forms a cavity, includes tissue that needs to be protected, is positioned proximate to sensitive tissue, or a combination thereof. The organ can be one or more of the rectum, ear canal, throat, nasal passage, urethra, vaginal cavity, artery, vein, small intestine, large intestine of the gastrointestinal tract; the respiratory system; or the urinary system. Preferably, the organ is the colon, and the colon is a cavity. A cavity can be any generally tubular anatomical feature that is part of an organ. The cavity can have a generally circular cross-sectional shape. The cavity can include one or more natural openings. For example, the cavity can be accessed without cutting any tissue. The cavity can include one or more targets. A target can be an area of concern. A target can be an area of the object of the surgery. A target can be an area, zone, or both of the cavity. The target can be partially removed or completely removed. The target can be located near or around one or more protected areas, protected zones, or a combination thereof. The protected area or zone can be part of a healthy cavity or surrounding structure, can contaminate the surgical site, can be sensitive to the procedure being performed, or a combination thereof. The protected area can be located on one or both sides of the target. The protected area or zone can be separated by one or more targets.

[0039] A method can be used to deploy a surgical protection system. The method can be performed using one or more of the steps taught herein, and the steps can be performed in any order unless specifically indicated. One or more locators can be inserted into a cavity. One or more markers can be deployed from the locator by pressing one or more insertion mechanisms. The locator can be removed. The same or a new locator can be inserted into the cavity. Additional markers can be inserted into the cavity. The locator can be axially moved along the cavity to deploy the markers at one or more axial positions along the cavity. When two or more markers are deployed, the markers are axially separated to target an object between the markers. Additional markers can be inserted into the locator while the locator is within the cavity. Additional markers (e.g., one or more, two or more) can be deployed while the locator is positioned within the cavity. The markers can expand automatically. Stimulation can be applied to the markers to expand the markers. One or more surgical devices can be inserted into the same cavity as the markers. The surgical device can extend through one or more of the markers. A tissue-acting element can extend through one or more of the markers. The tissue-acting element can be positioned close to the target. The tissue-acting element can include one or more device tags. When the device tag moves close to the tissue tag, the device tag can generate a resistance, indication, signal, or combination thereof to assist in protecting the protected area, protected region, protected tissue, or combination thereof. The tissue-acting element can be retracted into the surgical device, endoscope, bronchoscope, catheter, or combination thereof. The surgical device can be removed from the cavity. The delivery device can be removed from the cavity. The markers can be removed from the cavity. Stimulation can be applied to the markers to cause the markers to contract. Only one marker can be deployed. The device tag can be repelled relative to the tissue tag. The tissue-acting element having the device tag can be inserted into the same cavity as one or more tissue tags. A display device or display system can display the current position of one or more tissue tags relative to one or more device tags. A signal can be generated when the device tag and the tissue tag are within a certain distance of each other. Power can be removed when the device tag and the tissue tag are positioned within a predetermined distance of each other. Power can be provided when the device tag and the tissue tag are positioned within a predetermined distance of each other or externally. A second marker can be deployed in the same cavity as the first marker. The tip can be inserted through the hollow center of the marker.

[0040] Figure 1 Surgical device 4 of the surgical system is shown inserting marker 10, which is in a stored state 12, into cavity 82 of organ 80. Surgical device 4 is a locator 40 that positions marker 10 at a predetermined site. Marker 10 is ejected from locator 40 via insertion mechanism 42, which moves marker 10 out of locator 40 and into cavity 82.

[0041] Figure 2 Shows the marker 10 in the extended state 14, where the marker 10 is an expandable circular member 20 that is expanded to contact the cavity 82.

[0042] Figure 3 Is a top view of the marker 10 in contact with the cavity 82. The marker 10 includes a magnet 18 or a magnetized tissue tag 22. The marker 10 is an expandable circular member 20 having a hollow center 24.

[0043] Figure 4A Shows the marker 10 in the stored state 12.

[0044] Figure 4B Shows the marker 10 in the extended state 14.

[0045] Figure 5A Shows the cavity 82 having a feature of interest that is the target 84 of the procedure.

[0046] Figure 5B Shows the cavity 82 having a feature of interest that is the target 84 of the procedure. The target 84 is positioned between two markers 10, and the two markers 10 are positioned in the cavity 82.

[0047] Figure 5C Shows the surgical system 2 having the marker 10 positioned in the cavity 82. The cavity 82 includes the target 84 positioned between a pair of markers 10. Each marker 10 includes a tissue tag 22 having a magnetic orientation (e.g., the north pole of the tissue tag 22 faces distally, and the north pole of the device tag 54 faces proximally). The marker 10 is positioned between the target 84 and the area or tissue to be protected 86 such that the marker 10 and the tissue tag 22 protect the area or tissue to be protected 86. The surgical protection system 50 having the tissue acting element 52 has an end 56 that extends between the markers 10 such that the tissue acting element 52 can perform a procedure on the target 84 area or tissue. The end 56 of the tissue acting element 52 includes a device tag 54 that maintains the end 56 between the markers such that the area or tissue to be protected 86 is protected from the action of the tissue acting element 52. The device tag 54 includes a magnetic orientation opposite to that of the tissue tag 22 as shown such that when the end 56 approaches either marker 10, the tissue acting element 52 is repelled.

[0048] Figure 5DAn tissue-acting element 52 with a tip 56 is shown. The tip 56 includes a device tag 54 having a magnetic orientation. There are two markers 10 positioned in a cavity 82. Each marker 10 includes a tissue tag 22 having a magnetic orientation. The markers 10 are positioned between two protected 86 tissues or regions, and a target 84 is positioned therebetween. If the device tag 54 extends into the restricted area 30, the tissue tag 22 will repel the device tag 54, such that the user will feel an increased resistance or the protected tissue will shift away from the tip.

[0049] Figure 6 Shown is the marker 10 positioned within the cavity 82 between the target 84 and the protected 86 region or tissue. The marker 10 includes a tissue tag 22 that is magnetized and generates a magnetic field 28. The surgical protection system 50 includes a tissue-acting element 52, the tissue-acting element 52 including a tip 56 having a device tag 54, the device tag 54 being magnetized or magnetic and generating a device tag magnetic field 58. When the tip 56 approaches the marker 10, the magnetic field 28 and the device tag magnetic field 58 create a restricted area 30 that restricts the movement of the tip 56 toward the protected 86 tissue or region or provides a certain resistance to the movement of the tip 56, or causes the protected tissue to shift away from the tip.

[0050] Figure 7 Shown is the marker 10 positioned within the cavity 82 between the target 84 and the protected 86 region or tissue. The marker 10 includes a tissue tag 22 that is magnetized and generates a magnetic field 28. The tissue-acting element 52 has a tip 56 that includes a device tag 54. The device tag 54 is a device tag magnetic field sensor 60 connected to a computer or indicator 6, and when the tip 56 approaches the magnetic field 28 of the tissue tag 22, the computer or indicator 6 provides a signal to the user, such that the surgeon is alerted, or power is disconnected when the tip 56 approaches the marker 10, and the protected 86 region or tissue is protected.

[0051] Figure 8 Shown is the marker 10 positioned within the cavity 82 between the target 84 and the protected 86 region or tissue. The marker 10 includes a tissue tag 22 that communicates with a computer or indicator 6 via a tissue tag magnetic field sensor 44. The tissue-acting element 52 has a tip 56 that includes a device tag 54 that generates a device tag magnetic field 58. When the device tag 54 approaches the tissue tag 22, the computer or indicator 6 provides a signal to the user, such that the protected tissue or region 86 is not damaged.

[0052] Figure 9A marker 10 is shown positioned between a target 84 and a protected 86 region or zone. The marker 10 includes a tissue tag 22 having a magnetic field 28. A tissue acting element 52 extends through the marker 10 such that the tissue acting element can act on the target 84. The tissue acting element 52 has an end 56 that includes a device tag 54, and the device tag 54 has a device tag magnetic field 58. The device tag magnetic field 58 and the magnetic field 28 of the marker 10 create a restricted region 30 when they are close to each other, where the tissue tag 22 and the device tag 54 are repelled.

[0053] Any numerical values recited herein include all values from the lower value to the upper value in increments of one unit, provided that there is a separation of at least two units between any lower value and any upper value. For example, if the amount of a component or the value of a process variable such as, for example, temperature, pressure, time, etc., is stated as, for example, from 1 to 90, preferably from 20 to 80, more preferably from 30 to 70, it is intended to specifically recite herein, for example, values such as 15 to 85, 22 to 68, 43 to 51, 30 to 32, etc. For values less than 1, one unit is appropriately considered 0.0001, 0.001, 0.01, or 0.1. These are merely examples for specific purposes, and all possible combinations of numerical values between the recited minimum and maximum values will be considered to be specifically recited in this application in a similar manner.

[0054] Unless otherwise stated, all ranges include both endpoints and all values therebetween. Unless otherwise stated, teachings with the terms "about" or "approximate" in combination with a numerical quantity include the recited quantity and teachings of approximate values of the recited quantity. For example, the teaching of "about 100" includes the teaching within the range of 100 + / - 15.

[0055] For all purposes, the disclosures of all articles and references, including patent applications and publications, are incorporated by reference. The term "consisting essentially of" describing a combination will include the identified elements, ingredients, components, or steps, as well as other elements, ingredients, components, or steps that do not materially affect the basic and novel characteristics of the combination. When using the terms "comprising" or "including" to describe combinations of elements, ingredients, components, or steps herein, embodiments consisting essentially of the elements, ingredients, components, or steps are also contemplated. By using the term "may" herein, it is intended that any described attribute that "may" be included is optional.

[0056] Multiple elements, components, parts, or steps may be provided by a single integrated element, component, part, or step. Alternatively, a single integrated element, component, part, or step may be divided into separate multiple elements, components, parts, or steps. The disclosure of "a" or "one" with respect to an element, component, part, or step is not intended to exclude additional elements, components, parts, or steps.

[0057] It should be understood that the above description is intended to be illustrative and not restrictive. Once the above description is read, many embodiments and many applications will be apparent to those skilled in the art, in addition to the examples provided. Therefore, the scope of the present teachings should not be determined with reference to the above description, but rather should be determined with reference to the appended claims and the full scope of equivalents to which those claims are entitled. For all purposes, the disclosures of all articles and references, including patent applications and publications, are incorporated by reference. The omission of any aspect of the subject matter disclosed herein from the appended claims is not a disclaimer of that subject matter, nor should it be considered that the inventors did not regard that subject matter as part of the disclosed inventive subject matter.

[0058] 2 Surgical System

[0059] 4 Surgical Device

[0060] 6 Indicator / Computer

[0061] 10 Marker

[0062] 12 Storage State

[0063] 14 Extended State

[0064] 18 Magnet

[0065] 20 Expandable Circular Member

[0066] 22 Tissue Tag

[0067] 24 Hollow Center

[0068] 26 Solid Marker

[0069] 28 Magnetic Field

[0070] 30 Restricted Area

[0071] 40 Locator

[0072] 42 Insertion Mechanism

[0073] 44 Tag Magnetic Field Sensor

[0074] 50 Surgical Protection System

[0075] 52 Tissue Acting Element

[0076] 54 Actuating element marker device label

[0077] 56 End

[0078] 58 Device label field

[0079] 60 Actuating magnetic field sensor

[0080] 80 Organ

[0081] 82 Cavity

[0082] 84 Target

[0083] 86 Protected

Claims

1. A surgical system, comprising: one or more tissue acting elements including tips; one or more device tags having a spatial relationship and a magnetic orientation relative to the tips of the one or more tissue acting elements, and an insertion mechanism including a device, the device comprising: one or more markers, some or all of the one or more markers being expandable circular members capable of expanding from a stored state to an expanded state, and each of the expandable circular members expanding when in the expanded state to move into contact with a lumen in an organ; and one or more tissue tags connected to the expandable circular members, each of the one or more tissue tags being magnetized or including a magnet; wherein the expandable circular members are configured to be positioned within the insertion mechanism and to be deployed from the insertion mechanism into the lumen of the organ at a predetermined position relative to the target tissue, wherein the one or more device tags present a magnetic field of a common polarity with the one or more tissue tags of the device, such that the one or more device tags provide an increased tactile resistance to the tips of the tissue acting elements moving towards the one or more tissue tags, and when the one or more device tags move towards the protected tissue and the one or more tissue tags, the protected tissue and the one or more tissue tags are displaced.

2. The surgical system according to claim 1, wherein, the lumen in the organ is a natural body cavity and the entry of the one or more markers passes through the natural body cavity.

3. The surgical system according to claim 1, wherein, all or a part of the expandable circular members are made of nitinol alloy.

4. The surgical system according to claim 1, wherein, the expandable circular members include a hollow center.

5. The surgical system according to claim 1, wherein, some of the one or more markers include one or more solid markers deployed into the lumen.

6. The surgical system according to claim 1, wherein, the device has a magnetic orientation that repels the device tags.

7. The surgical system according to claim 6, wherein, the tissue acting element is a blade or a needle.

8. The surgical system according to claim 1, wherein, at least one of the following situations exists: a display system indicates the proximity of the tips of the one or more tissue acting elements to the one or more markers; when the tips are within a predetermined distance of each other from the one or more markers, an alarm system provides a signal; or when the tips are within a predetermined distance of each other from the one or more markers, the power supplied to the tips is removed.

9. The surgical system according to claim 8, wherein, the signal is an auditory, visual, tactile, or a combination thereof signal.

10. The surgical system according to claim 8, wherein, Electrically cutting tissue, cauterizing tissue, coagulating tissue, or a combination thereof provided to the tip.

11. The surgical system according to claim 8, wherein, the one or more tissue tags and the one or more markers are inserted into the same cavity, and surgery is performed on the cavity.

12. The surgical system according to claim 8, wherein, the one or more markers are two markers that enclose the surgical site, and the device tag is positioned between the two markers.

Images