Tissue Ablation Cannula Assembly
20230000544 · 2023-01-05
Assignee
Inventors
Cpc classification
A61B18/148
HUMAN NECESSITIES
A61B2018/124
HUMAN NECESSITIES
A61B2018/1475
HUMAN NECESSITIES
A61B2090/0811
HUMAN NECESSITIES
International classification
Abstract
An assembly for radiofrequency ablation of tissue. The assembly includes a cannula and an electrode. A cannula body includes a cannula bend, and a single side opening radially positioned on an outer side of the cannula body. The outer side may be opposite an inner side on which a tip terminates at a point. A cannula hub may include indicia on a face that corresponds to the inner side. An electrode bend of an electrode body may be formed at a same axial location along its length as the cannula bend is formed along the length of the cannula body. The electrode may include a thermocouple near a distal end of the electrode body to be either directed through the single side opening in a dual active tip mode, or seated in a distal section of the cannula body in a single active tip mode.
Claims
1. An assembly for radiofrequency ablation of tissue, the assembly comprising: a cannula comprising a cannula hub, and a cannula body extending from the cannula hub, wherein the cannula body comprises a cannula bend, and a tip terminating at a point, wherein the cannula body defines a lumen, and a single side opening radially positioned on an outer side of the cannula body that is opposite a direction of the cannula bend; and an electrode comprising an electrode hub, and electrode body extending from the electrode hub, wherein the electrode body comprises an electrode bend formed at a same axial location along a length of the electrode body as the cannula bend is formed along a length of the cannula body, wherein a rotational orientation of the electrode bend relative to the cannula bend is configured operate the assembly in one of a dual active tip mode in which the electrode body extends through the single side opening, and a single active tip mode in which the electrode body extends past the single side opening within the lumen.
2. The assembly of claim 1, wherein the single side opening is axially located on the cannula bend.
3. The assembly of claim 1, wherein the tip is a beveled tip terminating at the point on an inner side of the cannula body that is opposite the outer side.
4. The assembly of claim 1, wherein the cannula further comprises indicia, and wherein the electrode further comprises first and second indicia positioned on opposing hub faces of the electrode hub with a singular one of the first and second indicia configured to be aligned with the indicia on the cannula hub.
5. The assembly of claim 4, wherein the second indicia of the electrode is a V-shaped icon that is correlated to the dual active tip mode to represent the V-shape formed by the electrode body extending out of the single side opening.
6. The assembly of claim 4, wherein the first indicia of the electrode is an I-shaped icon that is correlated to the single active tip mode to represent the I-shape formed by the electrode body remaining with the lumen of the cannula body.
7. The assembly of claim 1, wherein the electrode further comprises an insulative sleeve including a distal end positioned proximally rearward to the single side opening, and a proximal end disposed within the electrode hub.
8. The assembly of claim 1, wherein the electrode further comprises a thermocouple near a distal end of the electrode body such that the thermocouple is configured to be directed through the single side opening in the dual active tip mode.
9. The assembly of claim 8, wherein thermocouple is seated in a cannula distal section and spaced approximately the same distance from the tissue in the single active tip mode as in the dual active tip mode.
10. An assembly for radiofrequency ablation of tissue, the assembly comprising: a cannula comprising a cannula hub, and cannula body extending from the cannula hub, wherein the cannula hub comprises a cannula bend, and a tip terminating at a point on an inner side of the cannula body, wherein the cannula body defines a lumen, and a single side opening radially disposed on an outer side of the cannula body opposite the inner side, and wherein the cannula hub comprises indicia on a face of the cannula hub that corresponds to the inner side of the cannula body; and an electrode comprising an electrode hub, and an electrode body extending from the electrode hub, wherein the electrode hub comprises indicia configured to be aligned with the indicia on the face the cannula hub to operate the assembly in a dual active tip mode in which the electrode body extends through the single side opening.
11. The assembly of claim 10, wherein the indicia of the electrode is a V-shaped icon that is correlated to the dual active tip mode to represent the V-shape formed by the electrode body extending out of the single side opening.
12. The assembly of claim 10, wherein the single side opening is axially located on the cannula bend.
13. The assembly of claim 10, wherein the electrode bend formed at a substantially same axial location along a length of the electrode body as the cannula bend is formed along a length of the cannula body.
14. The assembly of claim 10, wherein the electrode further comprises an insulative sleeve including a distal end positioned proximally rearward to the single side opening, and a proximal end disposed within the electrode hub.
15. The assembly of claim 10, wherein the electrode further comprises a thermocouple near a distal end of the electrode body such that the thermocouple is configured to be directed through the single side opening in the dual active tip mode.
16. The assembly of claim 15, wherein the assembly is further configured to be operated in a single active tip mode in which the thermocouple is seated in a cannula distal section and spaced approximately the same distance from the tissue as in the dual active tip mode.
17. An assembly for radiofrequency ablation of tissue, the assembly comprising: a cannula comprising a cannula hub, and a cannula body extending from the cannula hub, wherein the cannula body comprises a cannula bend, and a tip terminating at a point, wherein the cannula body defines a lumen, and a single side opening radially positioned on an outer side of the cannula body; and an electrode comprising an electrode hub, an electrode body extending from the electrode hub, and a thermocouple disposed near a distal end of the electrode body, wherein the assembly is configured to be operated in a dual active tip mode in which a portion of the electrode body that includes the thermocouple is directed through the single side opening to be positioned outside the lumen of the cannula body, and wherein the assembly is further configured to be operated in a single active tip mode in which the thermocouple is seated in a section of the cannula body distal to the cannula bend such that the thermocouple spaced approximately the same distance from the tissue in the single active tip mode as in the dual active tip mode.
18. The assembly of claim 17, wherein the electrode body comprises an electrode bend, wherein the thermocouple is positioned distal to the electrode bend.
19. The assembly of claim 18, wherein the electrode bend formed at a substantially same axial location along a length of the electrode body as the cannula bend is formed along a length of the cannula body.
20. The assembly of claim 17, wherein the electrode further comprises an insulative sleeve including a distal end positioned proximally rearward to the single side opening, and a proximal end disposed within the electrode hub.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The invention is pointed out with particularity in the claims. The above and further features and advantages of this invention are understood by reference to the following Detailed Description taken in conjunction with the accompanying drawings in which
[0018]
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
DETAILED DESCRIPTION
[0028]
[0029] The cannula and the cannula and electrode assembly 32, as seen in
[0030] Cannula 42, now described by reference to
[0031] A cannula body 50 extends distally forward from hub 44. Cannula body 50 is tube-shaped and formed from a flexible conductive material such as stainless steel. The cannula body 50 has opposed proximal and distal ends, the proximal end being the end disposed in hub 44. In many versions of the invention cannula body 50 is of size 18 gage or smaller (1.25 mm or less in outer diameter.) In still other versions of the invention, cannula body is of size 20 gage or smaller (0.9 mm or less in outer diameter). Cannula body 50 has an axially extending lumen 52. The proximal end of body 50 is mounted to the hub 44 so the proximal portion of lumen 52 is coaxial with hub bore 46. Lumen 52 extends from the proximal to the distal end of the body 50. Not identified is the distal end opening in the distal end of body 50 that opens into lumen 52. In some versions of the invention the most proximal section of body 50, including the proximal end, is heat staked or adhesively secured in cannula hub 44.
[0032] Cannula 42 is further constructed so that body 50 is not straight along the whole of the length of the body. In some versions of the invention, the body is shaped so the first 80% to 90% of the body that extends forward from hub is linear in shape. Through this portion of the body, body lumen 52 is coaxial with hub bore 46. Forward of this linear section, the cannula body is formed with a bend 54. Bend 54 has a radius of curvature of 40 to 60 mm Forward of bend 54, cannula body has a distal section, section 56. Cannula body distal section 56 is generally linear in shape. The distal section has a length of approximately 5 to 10 mm. The cannula body 50 is further formed to a side opening 58. Side opening 58 is located on the side of the body that forms the outer surface of bend 54. The cannula body 50 is formed so that the lumen 52, in addition to extending through the proximal section of the body, also extends through bend 54 and distal section 56. Side opening 58 thus opens into the body lumen 52.
[0033] Cannula body 50 is further formed so that distal end is both open and has a flared tip 60. More particularly the tip is flared so that the most distal portion of the body is a point forward of the inner side of bend 54. The cannula 42 itself is constructed so that body 50 extends forward from the hub 44 so that portion of the body forming the inner surface of bend 54 is directed towards the face 41 of the hub on which indicia 43 is located.
[0034] A sleeve 64, seen only in
[0035] The electrode 66, now described by reference to
[0036] A tube like body 74 formed of conductive material that has both flexible and elastic characteristics extends forward from hub 68. More particularly, the material is elastic so that, when subjected to deformative strain up to 3% and in some situations up to 6% deformative strain from its initial shape, the body will not permanently deform and return to its initial shape. In one version of the invention, body 74 is formed from a nickel titanium alloy known as Nitinol. Body 74 has an overall length such that when electrode 66 is inserted in the cannula 42 so that the electrode hub 68 abuts cannula hub 44, the distal end tip of the electrode body is extends forward of at least a portion of the face forming the flared tip 60 of the cannula body 50. The distal end tip of the electrode body does not extend beyond the distalmost end of the cannula body 50. In some versions of the invention, when the electrode 66 is fully seated in the cannula 42, the distal end top of the electrode body is located approximately 0.4 to 1.4 mm rearward of the distalmost tip of the cannula body 50. The electrode body 74 has an outer diameter dimensioned so that when the electrode body 74 seats in cannula lumen 52, there is contact between the inner surface of the cannula body 50 that defines lumen 52 and the outer surface of electrode body 74.
[0037] Electrode body 74 is further designed to have a bend 80. In
[0038] A thermocouple 84, represented by an oversized dot in
[0039] A cable 92 (
[0040] Control console 36 includes a power supply (not illustrated) capable of sourcing a variable current to the electrode assembly 32. Ground pad 34 functions as the return conductive terminal for the power source. Typically, the current is AC current. Control console 36 is configured to allow the practitioner to adjust the frequency, current and voltage levels of the sourced current. The specific structure of the control console 36 is not part of the present invention. Features of control consoles that can be employed as control console 36 of system 30 this invention are disclosed in the incorporated by reference US Pat. Pubs. No. 2005/0267553 SYSTEM AND METHOD FOR CONTROLLING ELECTRICAL STIMULATION AND RADIOFREQUENCY OUTPUT FOR USE IN AN ELECTROSURGICAL PROCEDURE published Dec. 1, 2005 and No. 2007/0016185, MEDICAL BIPOLAR ELECTRODE ASSEMBLY WITH A CANNULA HAVING A BIPOLAR ACTIVE TIP AND A SEPARATE SUPPLY ELECTRODE AND MEDICAL MONOPOLAR ELECTRODE ASSEMBLY WITH A CANNULA HAVING A MONOPOLAR ACTIVE TIP AND A SEPARATE TEMPERATURE-TRANSDUCER POST published Jan. 18, 2007.
[0041] Electrosurgical system 30 of this invention is prepared for use by adhering the ground pad 34 to the patient. A cable 35 connects the ground pad 34 to control console 36.
[0042] Cannula 42 is inserted into the patient adjacent the subcutaneous tissue that is to be subjected to the ablation process. In the insertion process the flared distal end tip 60 of the cannula is the portion of the electrode assembly 32 that punctures the skin. In this step, electrode 66 is not fitted to the cannula 42. Instead, a flexible stylet (not illustrated) is seated in the cannula lumen 52. The stylet inhibits the cannula body 50 from bending to the extent that such bending results in the permanent deformation of the cannula.
[0043] The practitioner steers the cannula 42 so it is located in the vicinity of the target tissue, the tissue that is to be subject to the ablation procedure. Owing to its relatively small diameter of the cannula body 50, the cannula is relatively flexible. This flexibility facilitates the ability of the practitioner to steer the cannula to the vicinity of the target tissue. As part of this steering process, the practitioner positions the cannula so it is in the proper orientation relative to the tissue to be ablated. Once the cannula is properly positioned, the stylet is removed.
[0044] The practitioner then inserts the electrode 66 in the cannula 42. If the particular procedure only requires the sourcing of current through a small volume of tissue adjacent the distal end of the assembly 32, the electrode is seated so as to position the distal section 82 of the electrode body 74 in the cannula body distal section 56 as seen in
[0045] As a consequence of the electrode 66 being so oriented, when the distal section 82 of the electrode body approaches the cannula bend 54, the electrode bend 80 causes the electrode distal section 82 to curve into the cannula body distal section 56. At the end of this insertion process, the distal end tip of the electrode body 74 is depicted in
[0046] Alternatively, the practitioner may want to flow current through a relatively large volume of tissue adjacent the distal end of the assembly 32. To perform this type of procedure, the practitioner seats the electrode 66 so the distal section 82 extends out of cannula body side opening 58. Electrode 66 is so positioned by orientating the electrode body in the cannula so that along the longitudinal axis of the cannula proximal section, the electrode bend 80 has an orientation that is opposite to that of cannula bend 54. Electrode 66 is so oriented by rotating the electrode so electrode indicia 76 is placed in orientation with cannula indicia 43 as seen in
[0047] When current is sourced through assembly as seen in
[0048] The cannula and electrode of this assembly can thus be configured to operate in one of two modes, a mode in which the assembly sources current out of a single active tip or a mode in which the assembly sources current out of plural active tips. This allows the practitioner to, by setting the mode of operating of the assembly, set if the current is flowed through a relatively small volume or relative large volume of tissue adjacent the assembly 32.
[0049] Further, regardless of the mode of operation the electrode 66 is typically fully seated in the cannula 42. Consequently, regardless of the operating mode, the thermocouple 84 is spaced essentially the same distance from tissue through which the current is flowed. The added separation of the thermocouple from the tissue when the electrode distal section 56 of cannula body 50 is minimal. Thus, in either mode of operation, the signal output by the thermocouple 84 representative of tissue temperature, represents the actual temperature of the tissue with the same degree of accuracy. This is useful because a practitioner may want to set the control console to cause a current to be applied to the tissue that ensures that the tissue is heated to a specific temperature. When the system 30 is so configured, the control console 36 employs the output signal from the thermocouple as the signal representative of tissue temperature.
[0050] It is a still further feature of this invention is that, once the cannula 42 is inserted in the patient, the practitioner may reset the mode of operation of the assembly 32. For example, the practitioner may start the procedure by sourcing current from just the single active tip, cannula body distal section 56. The practitioner can then reset the assembly so that the current is formed from both tips, the cannula body distal section and the electrode body distal section. The practitioner performs this switch by first partially withdrawing the electrode body 74 from the cannula lumen 52. The electrode 66 is then rotated to place electrode indicia 76 is placed in registration of cannula indicia 43. The electrode body 74 is then fully reinserted in the cannula lumen 52. This rotation and reinsertion of the electrode body 74 results in the extension of the electrode body distal section out of the cannula body side opening 58. The assembly is then ready for operation in the mode in which the current is sourced from the two active tips.
[0051] Using the technique opposite from which is described above, assembly 32 once fitted to the patient can be switch from the plural active tip operating mode to the single active tip operating mode.
[0052] The above is directed to one specific version of the invention. Other versions of the invention may have features different from what has been described.
[0053] For example, there is no requirement that in all versions of the invention a thermocouple be the component disposed in the electrode that provides a signal representative of temperature. A thermal resistor or other temperature sensitive transducer may perform this function.
[0054] Likewise there is no requirement that in all versions of the invention either the cannula body or electrode body be components formed out of a single section of material. For example, the cannula body may include a proximal section formed from a nonconductive plastic. The bend and the distal section may be formed from metal or another conductive material.
[0055] Further the described cannula is what is referred to as a monopolar cannula. The cannula has a single conductive surface. In an alternative version of this invention, the cannula may be a bipolar cannula. This type of cannula has two conductive surfaces that are electrically insulated from each other. The assembly of this version of the invention is used to perform what is known as a bipolar ablation procedure. The cannula second conductive surface functions as the return conductive terminal.
[0056] In this version of the invention, when the assembly is operated in the plural active tip mode, the exposed distal section 82 of the electrode 66 and one of the exposed sections of the cannula form a pair of common active tips. The second exposed section of the cannula serves as the return conductive terminal.
[0057] Likewise the electrode body may be formed from plural sections of different material. For example the electrode body may have a proximal section formed from an elastic plastic. This plastic portion of the electrode body may be formed with the flexible bend. Distal to bend, the electrode may have a tip formed from a relatively inflexible conductor. An advantage of this version of the is that when the assembly is configured to operate in the plural active tip mode and the electrode is deployed out of the cannula side opening, the relatively inflexible exposed distal end may be less prone to breakage.
[0058] Further, there is no limitation that the invention solely be used in what are referred to as a monopolar procedure, a procedure in which the ground pad functions as the return electrode. Assembly 32 of this invention may be used to perform what is referred to as a parallel bipolar ablation procedure. In this type of procedure two cannula and electrode assemblies are inserted in the patient. These assemblies are positioned on opposed sides of the tissue through which the current is to be flowed. In this type of procedure, the second cannula and electrode assembly serves as what is referred to as the return electrode.
[0059] In these types of procedure, there is no requirement that both cannula and electrode assemblies be of the type of this invention. In this type of procedure it is recommended that the assembly 32 of this invention be orientated so that the electrode bend 80 is positioned so that the electrode distal section 82 be directed towards the tissue through which the current is to be filed. This recommendation applies when the assembly 32 is operated either the single or active tip mode or the plural active tip mode. This orientation of the electrode 66 is suggested to ensure that the thermocouple 84 is positioned relatively close to the tissue through which the current is to be flowed. This increases the extent to which the thermocouple outputs a signal that, as closely as possible, represents the temperature of the tissue through which the current is flowed.
[0060]
[0061] The electrode of
[0062] The cannula-and-electrode assembly of this invention can be thus operated as either a monopolar unit or a standalone bipolar unit. The assembly is operated as a monopolar unit by seating electrode 102 in cannula 42 so that the electrode body distal section 82 seats in cannula body distal section 56. When the assembly is operated in this state, there is only a need to connect the electrode 102 to the control console 36. The assembly in this state is operating with a single active tip; the insulation free portion of the electrode distal section 82. Ground pad 34 functions as the return terminal.
[0063] Alternatively, the practitioner may want to operate the assembly is a standalone bipolar unit. The assembly is so configured by orientating electrode 102 so that when the body is inserted in the cannula lumen 52, the electrode body distal section protrudes out of cannula side opening 58. It should be understood that when the electrode 102 is so positioned, the distal most portion of sleeve 104 also protrudes out of the cannula side opening 58. Thus when the assembly is so configured, the cannula body distal section 56 and the electrode body distal section 82 are electrically insulated from each other. To operate the assembly in this configuration, it is further necessary to connect the cable that extends from the cannula hub 44 to the control console 36.
[0064] To operate the assembly in this configuration, current is flowed from the console power supply through the cannula. The exposed cannula body distal section 56, which is one of the active tip, functions as the active tip. The exposed electrode body distal section 82 functions as the return terminal. By so configuring the assembly of this invention, the practitioner can if desired, flow current through the small volume of tissue that surrounds the exposed tips.
[0065] An alternative embodiment of this version of the invention can be formed by provide the cannula with a liner that extends around the interior wall of the body that defines lumen 52. This linear also cover the outer surface of the cannula that defines side opening 58.
[0066] Accordingly, it is an object of the appended claims to cover all such modifications and variations that come within the true spirit and scope of this invention.