The present disclosure relates to a wire assembly with echogenic features.
The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.
Ultrasound imaging is used for visualization in many applications, such as without limitation in-vivo imaging of various electrosurgical instruments. For example, certain electrosurgical instruments used for treating tissue generally may include a guide catheter and an applicator inserted through the catheter. These electrosurgical instruments may be inserted into a body lumen to place the distal end of the applicator at a desired location.
The applicator generally includes one or more electrodes at the distal end. Such electrodes may emit a radiofrequency (“RF”) electric current to surrounding tissue to coagulate and/or ablate the tissue. Monopolar electrosurgical instruments only entail use of one electrode that interacts with a neutral electrode, which is likewise connected to the body of a patient. A bipolar electrosurgical instrument typically includes an applicator with two electrodes (that is, a distal electrode and a proximal electrode). An RF voltage with different potentials is applied to such bipolar instruments so that a current passes from one electrode to the other electrode through the tissue, thereby heating the tissue to coagulate or ablate the tissue.
During the procedure, a sensor (such as an ultrasound transducer, a visual camera, and the like) is used at an end of the catheter to view the applicator's location relative to target tissue. However, the applicator may be difficult to see in images (such as ultrasound video) and a range of angles in which the wire may be seen may be limited in cases where the applicator may include electrodes made of thin wires (such as those on the order of around 20/1000 inch) that may have insufficient echogenic properties.
Disclosed embodiments include a wire assembly having echogenic features, an electrosurgical device, a system for treating tissue, a method for treating tissue, and a method for fabricating a wire assembly having echogenic features.
In an illustrative embodiment, a wire assembly includes: a wire having a finite length and an exterior surface, at least a portion of the wire having at least one depression defined in the exterior surface; and tubing disposed in an airtight manner over the exterior surface of the at least a portion of the wire having the at least one depression defined in the exterior surface, the tubing and the at least one depression forming an air pocket therebetween.
In another illustrative embodiment, an electrosurgical device includes: a needle configured as a first electrode; a flat wire coil extendable through the needle and configured as a second electrode, the flat wire coil being movable relative to the needle and insertable into target tissue, at least a first portion of the flat wire coil being coilable and twistable, at least a second portion of the wire having at least one depression defined in the exterior surface; and tubing disposed in an airtight manner over the exterior surface of the at least a second portion of the wire having the at least one depression defined in the exterior surface, the tubing and the at least one depression forming an air pocket therebetween.
In another illustrative embodiment, a system for treating tissue includes: a source of electrical power; a needle electrically coupled to the source of electrical power and configured as a first electrode; a flat wire coil electrically coupled to the source of electrical power, the flat wire coil being extendable through the needle and configured as a second electrode, the flat wire coil being movable relative to the needle and insertable into target tissue, at least a first portion of the flat wire coil being coilable and twistable, at least a second portion of the wire having at least one depression defined in the exterior surface; and tubing disposed in an airtight manner over the exterior surface of the at least a second portion of the wire having the at least one depression defined in the exterior surface, the tubing and the at least one depression forming an air pocket therebetween.
In another illustrative embodiment, a method for treating tissue includes: positioning an applicator in a passageway; extending a needle through the applicator, the needle being a first electrode; piercing the needle into target tissue; advancing a flat wire coil through the needle, a distal portion of the flat wire coil piercing into the target tissue, at least a first portion of the flat wire coil attaining a coiled configuration and a twisted configuration as the flat wire coil is inserted into the target tissue, at least a second portion of the flat wire coil having at least one depression defined in an exterior surface thereof, the at least a second portion of the flat wire coil having tubing disposed in an airtight manner over an exterior surface thereof, the tubing and the at least one depression forming an air pocket therebetween; and ultrasonically illuminating the flat wire coil.
In another illustrative embodiment, a method for fabricating a wire assembly having echogenic features includes: defining at least one depression in an exterior surface of at least a portion of a wire; and disposing tubing in an airtight manner over the exterior surface of the at least a portion of the wire having the at least one depression defined in the exterior surface, the tubing and the at least one depression forming an air pocket therebetween.
Further features, advantages, and areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. The components in the figures are not necessarily to scale, with emphasis instead being placed upon illustrating the principles of the disclosed embodiments. In the drawings:
The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses.
Given by way of overview and referring to
Now that an overview has been provided, details will be set forth below by way of non-limiting examples and not of limitation.
Referring additionally to
The wire 74 suitably is made from any material as desired for a particular application. For example and without limitation, in various embodiments the wire 74 may be made from copper, aluminum, steel, silver, aluminum, and the like. In some embodiments such as without limitation those with electrosurgical applications, the wire 74 may be made from any suitable material, such as stainless steel, that enables the wire 74 to be corkscrewed into tissue.
In various embodiments, all or a portion of the wire 74 may be made from a shape memory alloy (also known as smart metal, memory metal, memory alloy, muscle wire, and smart alloy) for its super-elastic properties and/or its shape memory features. A suitable shape memory alloy may include, without limitation, nitinol (NiTi), copper-aluminum-nickel alloys, copper-zinc-aluminum alloys, iron-manganese-silicon alloys, and the like, as desired for a particular application. Given by way of non-limiting example and as will be discussed below, in embodiments that entail an electrosurgical application the wire 74 may include at least a portion that is made of the shape memory alloy nitinol. When the wire 74 is made of shape memory alloy and is implemented for its shape memory properties, the portion of the wire 74 made of shape memory alloy may have multiple configurations or states. Accordingly, when the wire 74 is in one of the configurations and then heated, the wire 74 returns to another pre-defined configuration. Subsequently, if the wire 74 is cooled, the wire 74 returns to the configuration it had when unheated. When a portion of the wire 74 is made of shape memory alloy and other portions of the wire 74 are made of other materials (such as those discussed above), the depressions 82 may be located in the portion made of shape memory alloy, if desired, and may be located in the other portions made of other materials, as desired for a particular application.
The depressions 82 may be formed in any shape as desired. For example and without limitation, the depressions 82 may have cross-sectional shapes that are circular, elliptical, ovoid, random, or the like. The depressions 82 may have any suitable size as desired for a particular application and as appropriate for size of the wire 74. For example and given by way of illustration and not of limitation, in some embodiments with electrosurgical applications the wire 74 may have a thickness on the order of around 20/1000 inch. In such embodiments, the depressions 82 may have a depth of around 1/1000 inch and may have a cross-sectional dimension on the order of around 4/1000 inch. It will be appreciated that such dimensions are illustrative only and are not limiting in any manner whatsoever.
Referring additionally to
The depressions 82 may be formed by any suitable method as desired. For example and without limitation, the depressions 82 may be formed by processes such as without limitation laser etching, acid etching, shot peening, abrasive blasting, water blasting, and the like. It will be appreciated that the process to form the depressions 82 may be selected, in part, based upon factors such as compatibility of the process and/or process reactants and/or blasting media, as applicable, with material from which the wire 74 is made, ability to make and/or repeat patterns such as those shown in
The tubing 46 performs two functions. As discussed above, firstly the tubing 46 forms an airtight seal around the portions of the wire 74 that includes the depressions 82 and cooperates with the depressions 82 to form air pockets between the exterior surface 80 of the depressions 82 and the tubing 46. Secondly, the tubing 46 is an electrical insulator. With the two functions discussed above in mind, in various embodiments the tubing 46 includes heat-shrink tubing. The heat shrink tubing may include polyester, such as without limitation polyethylene terephthalate (“PET”) and the like. In some embodiments with electrosurgical applications, the heat-shrink tubing may have a thickness on the order of around 1/1000 inch or so. However, it will be appreciated that the tubing 46 may have any thickness as desired for a particular application.
In various embodiments the depressions 82 are sized (as discussed above) such that the tubing 46 remains out of contact with the exterior surface 80 of the depressions 82. In embodiments in which the tubing 46 includes heat-shrink tubing, the heat-shrink tubing shrinks to the exterior surface 80 of the wire 74 but does not shrink into the depressions 82. Thus, air is trapped in the void (that is, the depression 82) between the tubing 46 and the exterior surface 80 of the depression 82, thereby forming an air pocket. As also discussed above, the large difference in density between density of material from which the wire 74 is made and density of air in the air pocket increases echogenicity of the wire assembly 44 and can help enhance ultrasound illumination of the wire assembly 44.
Embodiments of the wire assembly 44 may be made by any suitable process as desired for a particular application. Given by way of illustration and not of limitation, in various embodiments the wire assembly 44 may be made according to the following illustrative method that is given by way of example only and not of limitation. At least one depression 82 is defined in an exterior surface 80 of at least a portion of a wire 74. Tubing 46 is disposed in an airtight manner over the exterior surface 80 of the at least a portion of the wire 74 having the at least one depression 82 defined in the exterior surface 80, and the tubing 46 and the at least one depression 82 form an air pocket therebetween.
In some embodiments the at least one depression 82 may be defined in the exterior surface 80 of at least a portion of the wire 74 via a process such as laser etching, acid etching, shot peening, abrasive blasting, water blasting, and the like.
In some embodiments the at least one depression 82 is sized such that the tubing 46 remains out of contact with the exterior surface 80 of the at least one depression 82.
It will be appreciated that the wire assembly 44 may be used for any purpose as desired. It will also be appreciated that some embodiments of the wire assembly may be used in electrosurgical settings. For example and without limitation, in some such embodiments the wire assembly 44 may be used as an electrode in an electrosurgical system. An illustrative system environment for an electrosurgical application of a non-limiting embodiment of the wire assembly 44 is set forth below by way of illustration and not of limitation. In the example set forth below, the wire assembly 44 is referred to as a coil 44 and the tubing 46 is referred to as a layer of insulation 46.
Referring additionally to
In some embodiments, the system 10 includes an applicator 12, an electrosurgical RF generator 14, an infusion pump 16, and a bronchoscope 18. The applicator 12 electrically communicates with the generator 14 though a lead 30. In some embodiments, the lead 30 is connected to a generator outlet 31 when the system is operated in a bipolar mode. In some other embodiments, the system 10 can be operated in a monopolar mode when the lead 30 is connected to an outlet 33 with an adapter as desired. The applicator 12 is further connected to the infusion pump 16 with a tube 32 that facilitates the flow of liquid, for example saline solution, from the pump 16 to the applicator 12.
The generator 14 can be operated with the use of a foot operated unit 20 electrically connected to the generator 14. The foot operated unit 20 includes a pedal 22 that instructs the generator 14 to apply an RF potential to electrode(s) (described below) to cut and/or ablate tissue and a pedal 24 that instructs the generator 14 to apply a lower RF potential to the electrode(s) to coagulate tissue.
In various embodiments the bronchoscope 18 includes an insertion tube 19. At a distal end 36 (
Referring additionally to
The coil 44 includes a coiled portion 70, a non-coiled portion 72, and a layer of insulation 46 that covers the non-coiled portion 72 of the coil 44 to help electrically isolate the coil 44 from the needle 28. The layer of insulation 46 extends to the applicator 12. Accordingly, in this arrangement, the needle 28 operates as a proximal electrode and the coil 44 operates as a distal electrode when the system 10 is operated in a bipolar mode. The non-coiled portion 72 of the coil 44 includes the depressions 82 (not shown in
The tip 38 is used for piercing tissue and may include one or more echogenic features. During the penetration of the needle 28 into tissue, only the needle 28 (that is, not the coil 44) is energized in a monopolar mode (for example, with the patient grounded to a patient pad to complete the circuit) with the generator 14 at a first power level. If a penetration force exceeds that which is expected by the physician, then the energized needle tip 38 causes tissue vibration so that it can be visualized ultrasonically. The echogenic features further enhance the ultrasonic visualization of the needle 28.
Referring additionally to
As shown in
To energize the electrodes (that is, the needle 28 and the coil 44) for coagulating the tissue 50, the physician sets the generator 14 to a desired second power level and pushes the pedal 24 of the foot unit 20 to apply an RF potential to the electrodes. The second power level is greater than the first power level. As such, RF electrical current passes between the needle 28 and the coil 44 through the tissue 50 as indicated by the arrows 52. The level of RF electrical current is set by the physician to control the desired extent of the coagulation region 54 in the tissue 50. It will be appreciated that that, anytime during the procedure, the physician can activate the infusion pump 16 to supply saline solution to the applicator 12 so that the saline solution flows through the needle 28 and the sheath 27 to the location of interest in the tissue 50. The saline solution is employed to cool the electrodes (that is, the needle 28 and/or the coil 44) and to prevent dehydration of the tissue 50.
In embodiments in which at least a portion of the wire 74 is made of shape memory alloy, the wire 74 is shape set to attain coiled and/or twisted shapes when reaching a predetermined temperature. The predetermined temperature is the austenite finish temperature for the wire 74. Because of the twisted configuration, the flat surface of the wire 74 includes a normal vector that will have different angular relationships with an ultrasound illumination device located at the distal end 36 of the insertion tube 19. In some orientations of the flat surface, the normal vector will be perpendicular or nearly perpendicular to an ultrasound signal produced by the ultrasound illumination device, thereby helping to produce significant ultrasound feedback. Significant ultrasound feedback may occur over the length of the non-coiled portion 72 portion of the coil 44, depending upon the number of depressions 82 in the coil 44. As a result, the non-coiled portion 72 of the coil 44 may produce a more pronounced ultrasonic image than would a straight portion without trapped air pockets. It will be appreciated that a similarly pronounced ultrasonic image may be produced by the coiled portion 70 of the coil 44 in embodiments in which air pockets are provided therein.
After treatment of the tissue 50 is completed, the physician turns off the generator 14 and moves the needle 28 forward to the position prior to deployment of the coil 44. The coil 44 is then retracted into the needle 28. The needle 28 and the coil 44 are then retracted into the insertion tube 19 within the bronchoscope 18, and the bronchoscope 18 is withdrawn from the patient.
It will be appreciated that the detailed description set forth above is merely illustrative in nature and variations that do not depart from the gist and/or spirit of the claimed subject matter are intended to be within the scope of the claims. Such variations are not to be regarded as a departure from the spirit and scope of the claimed subject matter.
Filing Document | Filing Date | Country | Kind |
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PCT/US2017/012225 | 1/4/2017 | WO | 00 |