Hybrid biopsy ablation device

The hybrid biopsy-ablation device addresses the dual-puncture challenge by using a single insertion path for biopsy and ablation, reducing bleeding and tract seeding risks through a combined introducer needle and slidable ablation antenna.

WO2025151648A1PCT designated stage expired Publication Date: 2025-07-17UNIVERSITY OF KANSAS
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Patent Information

Application Number
PCT/US2025/010955
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-01-09
Filing Date
2025-01-09
Publication Date
2025-07-17

AI Technical Summary

Technical Problem

In Interventional Radiology, performing both biopsy and ablation on the same tissue requires two tissue punctures, increasing the risk of bleeding and tract seeding of potentially cancerous cells.

Method used

A hybrid biopsy-ablation device with an introducer needle and a removably slidable ablation antenna that allows for a single insertion path, enabling biopsy sample collection and subsequent tissue ablation without removing the needle, and coagulating the insertion path to minimize bleeding and tract seeding.

Benefits of technology

The device reduces the risk of bleeding and tract seeding by allowing a single insertion, thereby improving safety and efficiency in biopsy and ablation procedures.

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Abstract

A method includes inserting an introducer needle into a tissue to be biopsied. A biopsy sample is obtained through the introducer needle from the tissue and the tissue proximate a tip of the introducer needle is ablated by an ablation antenna without removing the introducer needle. When removing the introducer needle from the tissue, the method may include coagulating blood in or cauterizing an insertion path in the tissue with the ablation antenna as the introducer needle is removed from the tissue. The insertion path is formed by the insertion of the introducer needle into the tissue.
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Description

HYBRID BIOPSY ABLATION DEVICECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of United States Provisional Patent Application Serial No. 63 / 618,958, filed January 9, 2024, which is hereby incorporated by reference in its entirety.BACKGROUND

[0002] In the field of Interventional Radiology (IR), it is common practice to perform image guided biopsies as well as image guided microwave ablations. Often, IR doctors are asked to perform both a biopsy and an ablation on the same tissue or organ. In order to do this, IR doctors must puncture the tissue twice, once for the biopsy and once for the ablation. This practice results in increased risk for bleeding, as it causes two tissue punctures. Further, there is a risk of tract seeding of potentially cancerous cells by drawing the biopsy needle and the ablation instrument back along the insertion path.BRIEF SUMMARY

[0003] In some embodiments, a device includes an introducer needle with an introducer needle tip and a central shaft. The device further includes an ablation antenna sized to removably slide within the central shaft and includes a radiating tip.

[0004] In other embodiments, a device includes an introducer needle with an ablation antenna, a radiating tip formed proximate an end of the introducer needle, and a central shaft extending through the radiating tip.

[0005] In yet other embodiments, a method includes inserting an introducer needle into a tissue to be sampled. The introducer needle includes an introducer needle tip and a central shaft. The method further includes obtaining a biopsy sample through the introducer needle from the tissue and inserting an ablation antenna through the central shaft of the introducer needle without removing the introducer needle from the tissue after obtaining the biopsy sample. The ablation antenna is sized to removably slide within the central shaft and includes a radiating tip. The method also includes ablating the tissue surrounding the radiating tip with the ablation antenna.

[0006] In another embodiment, a method includes inserting an introducer needle into a tissue to be sampled. The introducer needle includes an ablation antenna, a radiating tipformed proximate an end of the introducer needle, and a central shaft extending through the radiating tip. The method also includes obtaining a biopsy sample through the introducer needle from the tissue and ablating the tissue surrounding the radiating tip with the ablation antenna.

[0007] This summary is provided to introduce a selection of concepts that are further described below in the detailed description. This summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to be used as an aid in limiting the scope of the claimed subject matter.

[0008] Additional features and advantages of embodiments of the disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of such embodiments. The features and advantages of such embodiments may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. These and other features will become more fully apparent from the following description and appended claims, or may be learned by the practice of such embodiments as set forth hereinafter.BRIEF DESCRIPTION OF DRAWINGS

[0009] In order to describe the manner in which the above-recited and other features of the disclosure can be obtained, a more particular description will be rendered by reference to specific implementations thereof which are illustrated in the appended drawings. For better understanding, the like elements have been designated by like reference numbers throughout the various accompanying figures. While some of the drawings may be schematic or exaggerated representations of concepts, at least some of the drawings may be drawn to scale. Understanding that the drawings depict some example implementations, the implementations will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0010] FIG. 1 is a schematic diagram of a cross sectional side view of a device inserted into a tissue, according to at least one embodiment of the present disclosure;

[0011] FIG. 2 is a schematic diagram of a top view of an introducer needle with a stylet installed and an ablation antenna, according to at least one embodiment of the present disclosure;

[0012] FIG. 2A is a schematic diagram of a magnified top view of an introducer needle tip of the introducer needle and a stylet tip of a stylet of FIG. 2, according to at least one embodiment of the present disclosure;

[0013] FIG. 2B is a schematic diagram of a magnified side view of an introducer needle tip of the introducer needle and a stylet tip of a stylet of FIG. 2, according to at least one embodiment of the present disclosure;

[0014] FIG. 2C is a schematic diagram of a top view of an introducer needle with the ablation antenna installed and the stylet of FIG. 2, according to at least one embodiment of the present disclosure;

[0015] FIG. 3 is a schematic diagram of a top view of an introducer needle with a stylet installed, according to at least one embodiment of the present disclosure;

[0016] FIG. 3A is a schematic diagram of a cross sectional view of portion A-A of the introducer needle and an ablation antenna of FIG. 3, according to at least one embodiment of the present disclosure;

[0017] FIG. 3B is an alternative schematic diagram of a cross sectional view of portion A- A of the introducer needle and an ablation antenna of FIG. 3, according to at least one embodiment of the present disclosure;

[0018] FIG. 4 is a schematic diagram of a top view of a device, according to at least one embodiment of the present disclosure;

[0019] FIG. 5 is a schematic diagram of a side view of a device and a grounding pad, according to at least one embodiment of the present disclosure;

[0020] FIG. 6 is a flow chart illustrating a method according to at least one embodiment of the present disclosure; and

[0021] FIG. 7 is a flow chart illustrating a method according to at least one embodiment of the present disclosure.DETAILED DESCRIPTION

[0022] This disclosure generally relates to the field of Interventional Radiology (IR), it is common practice to perform image guided biopsies as well as image guided microwave ablations. Often, IR doctors are asked to perform both a biopsy and an ablation on the same lesion at the same time. In order to do this, IR doctors, must puncture the tissue twice, once for the biopsy and once for the ablation. This practice results in increased risk for bleeding,as it causes two tissue punctures over one puncture. Further, there is a risk of tract seeding of potentially cancerous cells by drawing the needle back along the insertion path.

[0023] As used in this disclosure, “tissue” means the tissues, organs, membranes, tumors, and other structures that the device embodiments described in this disclosure may pass through and enter in order to collect a biopsy sample.

[0024] FIG. 1 is a schematic diagram of an ultrasound side view of a device 100, shown in greater detail in FIG. 2, inserted into tissues 10. The tissues 10 as shown includes skin 12, other tissues 14, such as fat, muscle, and other organs, and a tumor 16. When inserted, the device 100 creates an insertion path 20 through the tissues 10 from the skin 12 through the other tissues 14 and into the tumor 16.

[0025] The device 100 includes an introducer needle 110 with a stylet 140 installed in the introducer needle 110. The stylet 140 is used to obtain a biopsy sample of the tumor 16 and may be withdrawn from the introducer needle 110. Once the stylet 140 is removed, an ablation antenna 150 (shown in FIG. 2) is slid into the introducer needle 110 to ablate the tumor 16. As the introducer needle 110 is removed from the tissues 10, the ablation antenna 150 may be used to coagulate blood in and / or cauterize the insertion path 20. Cauterization of the insertion path 20 may reduce bleeding from the insertion path 20. Cauterization of the insertion path 20 may also kill any cells from the tumor 16 that may be pulled into the insertion path during removal of the introducer needle and may prevent tract seeding along the insertion path 20.

[0026] FIG. 2 is a schematic diagram of a top view of a device 100 for obtaining a biopsy and an ablation through a single insertion path 20 in a tissue 10 shown in FIG. 1. The device 100 includes an introducer needle 110. The introducer needle 110 includes a tubular body 112 defining a central shaft 114 that extends through an introducer needle tip 116. The tubular body 112 may optionally include depth markings 118 on its outer surface. The depth markings 118 may be used to facilitate insertion into tissue by indicating the insertion depth of the introducer needle 110.

[0027] Optionally, the introducer needle 110 may include a thermocouple 120 disposed near the introducer needle tip 116. The thermocouple 120 may be used to measure a temperature near the introducer needle tip 116.

[0028] As shown, the introducer needle 110 includes a connector 122 that connects the introducer needle 110 to a body 124. The body 124 includes a handle 126 and a shaft extension 128. In this embodiment, the central shaft 114 is connected to the shaft extension 128. The body 124 may also include an electrical connection 130 that connects thethermocouple 120 with a system 132 for displaying and / or recording the temperature measured by the thermocouple 120.

[0029] The device 100 may also include a stylet 140 for obtaining a biopsy sample. As shown the stylet may include a handle 142 and extends through the shaft extension 128, the central shaft 114, and the introducer needle tip 116.

[0030] The device 100 also includes an ablation antenna 150, which may be generally known as an ablation probe. The ablation antenna 150 includes a rod 152 that ends in a radiating tip 154. The radiating tip 154 may be configured as a slot, monopole, dipole, triaxial, or choked design.

[0031] The ablation antenna 150 extends from a housing 156 that includes an electrical connector 158. As shown, the ablation antenna 150 is connected via an electrical connector 158 to a microwave signal generator 160. When in use, the microwave signal generator 160 sends a microwave signal that is passed through the electrical connector 158 and the ablation antenna 150 to the radiating tip 154. As the microwave signal radiates from the radiating tip 154, the microwave signal heats the surrounding tissue to encourage coagulation, cauterize the surrounding tissue, or kill the surrounding cells of the tissue.

[0032] FIG. 2A is a schematic diagram of a magnified top view of an introducer needle tip 116 of the introducer needle 110 and a stylet tip 144 of the stylet 140. As shown, the stylet 140 includes a cutter 145, a specimen notch 146. As shown, the stylet 140 is fully inserted into the introducer needle 110 and has a throw length 148 of about 10 to 20 mm. The throw length 148 is the distance from the tip of the introducer needle 110 to the cutter 145 when the stylet 140 is fully inserted into the introducer needle 110. When in use, the stylet 140 is withdrawn from the introducer needle 110 allowing the cutter 145 to cut a biopsy from the tissue. The biopsy may be held in the specimen notch 146 as the stylet 140 is withdrawn from the introducer needle 110.

[0033] FIG. 2B is a schematic diagram of a magnified side view of an introducer needle tip 116 of the introducer needle 110 and the stylet tip 144 of a stylet 140 of FIG. 2. This perspective may better illustrate the stylet 140. As shown, the stylet 140 includes a cutter 145 that may be formed as part of a recessed bowl 147. The recessed bowl 147 provides the cutter 145 a better blade angle for cutting the tissue to be biopsied. Once cut, the biopsy sample may be held in the specimen notch 146 as the stylet 140 is removed from the introducer needle 110.

[0034] FIG. 2C is a schematic diagram of a top view of the device 100 with the ablation antenna 150 fully inserted into the shaft extension 128 of the body 124 and the central shaft114 of the introducer needle 110. The stylet 140 is shown removed from the introducer needle 110. With the ablation antenna 150 inserted, the tissue may be ablated to kill the cells of the tissue surrounding the radiating tip 154. Once the ablation procedure is completed, the introducer needle 110 and the ablation antenna 150 may be removed from the tissue along an insertion path. As the introducer needle 110 and the ablation antenna 150 are removed, a microwave signal from the microwave signal generator 160 may be provided to coagulate or cauterize the insertion path formed by the introducer needle 110 when it was originally inserted into the tissue.

[0035] FIG. 3 is a schematic diagram of a top view of a device 200. The device 200 includes an introducer needle 210 with a stylet 240 installed. The introducer needle 210 includes an integral ablation antenna 250 that extends along the introducer needle 210 from the radiating tip 254 to the body 224. The ablation antenna 250 is connected through the electrical connector 158 to a microwave signal generator 260.

[0036] Optionally, the introducer needle 210 may include a thermocouple 220 that may be used to measure the temperature of the tissue surrounding the radiating tip 254. By knowing the temperature, a more precise ablation of tissue may be obtained. The thermocouple 220 may be electrically connected through the body and the electrical connection 258 to the microwave signal generator 260. The measured temperature of the thermocouple 220 may be displayed on a display of the microwave signal generator 260 and may also be used to adjust the microwave signal generated by the microwave signal generator 260. For example, the thermocouple 220 may measure a temperature below the desired temperature for the ablation procedure, so the microwave signal generator 260 may be adjusted to increase the energy being radiated by the radiating tip 254. In the event that the measured temperature increases above a desired temperature, the microwave signal generator 260 may be adjusted to decrease the energy being radiated by the radiating tip 254.

[0037] FIG. 3A is a schematic diagram of a cross sectional view of portion A-A of the introducer needle 210 and the integral ablation antenna 250 of FIG. 3. As shown, a central shaft 214 is filled by the stylet 240. Surrounding the central shaft 214 is a first metal antenna portion 262 of the ablation antenna 250. The ablation antenna 250 further includes second metal antenna portion 266 and a dielectric material 264 separating the first metal antenna portion 262 from the second metal antenna portion 266. The first metal antenna portion 262 and the second metal antenna portion 266 may be coaxially arranged about the central shaft 214.

[0038] Optionally, the introducer needle 210 may include an integral thermocouple 220. As shown in this diagram, a first insulated conductor 219 of the thermocouple 220 is separated from a second insulated conductor 221 of the thermocouple 220. In some configurations, the second insulated conductor 221 may be disposed opposite of the first insulated conductor 219 about the central shaft 214.

[0039] A protective insulative cover 268 may extend over the introducer needle 210 except at the exposed thermocouple 220 and the radiating tip 254.

[0040] FIG. 3B is an alternative schematic diagram of a cross sectional view of portion A- A of the introducer needle and an ablation antenna of FIG. 3. This arrangement does not include the thermocouple 220. Further, the central shaft 214 may be defined by a metal sheath 261 surrounded by dielectric material 264 that also radially separates the first metal antenna portion 262 and the second metal antenna portion 266 of the ablation antenna 250. A protective insulative cover 268 may extend over the introducer needle 210 except at the exposed radiating tip 254.

[0041] FIG. 4 is a schematic diagram of a side view of a device 300. The device 300 includes an introducer needle 310. The introducer needle 310 is connected by a connector 322 to a sample housing 341. The sample housing 341 includes a sample chamber 343 that may optionally contain a substance 349. The substance 349 may be a fixative or a stab to protect a biopsy sample during transport and storage. The sample chamber 343 may contain a vacuum or lower pressure volume of air or other gas than ambient pressure. The sample chamber 343 may be sealed by a rubber gasket (not shown) that may be punctured by an end of the introducer needle 310 that extends into the connector 322.

[0042] When the introducer needle 310 is inserted into a tissue and properly positioned for biopsy, the sample housing 341 may be connected to the introducer needle 310. The lower pressure or vacuum of the sample chamber 343 draws cells from the tissue through the introducer needle 310 into the sample chamber 343. Once a sufficient sample has been collected, the sample housing 341 may be disconnected from the introducer needle 310.

[0043] Without removing the introducer needle 310, an ablation antenna 350 may be inserted into the introducer needle 310. The introducer needle 310 may be connected to a microwave signal generator (not shown) via the electrical connector 358. When a microwave signal is applied to the ablation antenna 350, the microwave signal radiates from the radiating tip 354. The tissue surrounding the radiating tip 354 is heated by the microwave signal to ablate the surrounding tissue.

[0044] FIG. 5 is a schematic diagram of a side view of a device 400 and a grounding pad 463. The device 400 includes an introducer needle 410 having a connector 422. An ablation antenna 450 includes a radiating tip 454 and is connected via an electrical connector 458 to a radio frequency generator 461. In this application, radio frequency generator 461 applies a radio signal to the ablation antenna 450 that is radiated outward from the radiating tip 454. As the radio frequency enters the surrounding tissue, energy from the signal is passed into the surrounding tissue heating the tissue to kill the cells of the surrounding tissue. The grounding pad 463 is positioned to complete the circuit and is also connected to the radio frequency generator 461.

[0045] FIG. 6 is a flow chart illustrating a method 500 according to at least one embodiment of the present disclosure. The method includes inserting an introducer needle into a tissue to be sampled at 581. The introducer needle includes an introducer needle tip and a central shaft. The method includes obtaining a biopsy sample through the introducer needle from the tissue at 583. The ablation antenna is sized to removably slide within the central shaft and includes a radiating tip. The method includes inserting an ablation antenna through the central shaft of the introducer needle without removing the introducer needle from the tissue after obtaining the biopsy sample at 585. The method includes ablating the tissue surrounding the radiating tip with the ablation antenna at 595. The method includes removing the introducer needle from the tissue at 597. Optionally, the method may include coagulating blood in or cauterizing an insertion path in the tissue at the radiating tip with the ablation antenna as the introducer needle is removed from the tissue at 599.

[0046] FIG. 7 is a flow chart illustrating a method 600 according to at least one embodiment of the present disclosure. The method includes inserting an introducer needle into a tissue to be sampled, the introducer needle including an ablation antenna at 691. The introducer needle also includes a radiating tip formed proximate an end of the introducer needle, and a central shaft extending through the radiating tip. The method includes obtaining a biopsy sample through a central shaft of the introducer needle from the tissue at 693. The method includes ablating the tissue surrounding the radiating tip with the ablation antenna at 695. The method includes removing the introducer needle from the tissue at 697. Optionally, the method may include coagulating blood in or cauterizing an insertion path in the tissue at the radiating tip with the ablation antenna as the introducer needle is removed from the tissue at 699.INDUSTRIAL APPLICABILITY

[0047] Generally, a biopsy and an ablation may be performed using a single insertion path into tissue. Using a single insertion path may limit and / or prevent tumor seeding and / or bleeding. This may be accomplished by combining the introducer needle with a biopsy system and ablation system.

[0048] To begin, an introducer needle may be inserted into a desired tissue, such as an organ, lesion, tumor, abscess, nodule, or other biological structure. The insertion of the introducer needle may be conducted using ultrasound, magnetic resonance imaging, or other imaging technology.

[0049] Once inserted, a biopsy may be taken through a central shaft of the introducer needle. In some applications, a stylet may extend through the introducer needle and have a throw length of about 10 to 20 mm. As the stylet is withdrawn from the introducer needle, a specimen notch may cut the tissue and obtain a biopsy sample. The biopsy sample may be removed from the introducer needle, stored, labeled, and sent to a lab for review and analysis.

[0050] Alternatively, suction may be applied to the introducer needle to draw cells from the tissue through the introducer needle to a sample chamber. Once the biopsied cells have entered the sample chamber, the suction may be removed. In some configurations, the suction may be applied by connecting a sample housing to the introducer needle. The sample housing includes a sample chamber that contains a lower pressure volume of air or other gas than the ambient pressure. The sample chamber may contain a fixative or other stabilizing substance to protect the biopsy sample. This lower pressure or vacuum draws cells from the tissue through the introducer needle into the sample chamber.

[0051] For example, the sample housing may be a test tube that is enclosed by a rubber gasket that is punctured by an end of the introducer needle associated with the connector. The test tube may contain a vacuum or a lower pressure volume of air or other gas than the ambient pressure. The test tube may also contain a protective or stabilizing substance that protects the biopsy sample as it is stored and transported to a lab for testing and analysis. Once a sufficient sample has been collected, the sample housing may be disconnected from the introducer needle. Once disconnected, the biopsy sample may be labeled and sent to a lab for review and analysis.

[0052] Once the biopsy sample is obtained, the tissue may be ablated. For example, an ablation antenna may be sized to slide inside a central shaft of an introducer needle. Alternatively, an ablation antenna may be integrated into the introducer needle. The antennamay be of a coaxial design or may extend as 2 separate pieces around the central shaft of the introducer needle.

[0053] A microwave signal may be passed through the ablation antenna to a radiating tip of the antenna. While the signal is being passed through the ablation antenna and radiates outward from the radiating tip, the surrounding tissue may be ablated. As the introducer needle is being removed, the ablation signal may continue to be generated so that the signal from the radiating tip may help to coagulate blood in or cauterize the tissues surrounding the insertion path. This continued ablation during removal may heat and kill any cells that may have adhered to the introducer needle or may flow from the biopsied tissue into the insertion path to limit the risk of tract seeding with cells from the biopsied tissue.

[0054] Further, the introducer needle, the ablation antenna, or a separate device may include a thermocouple. As used in this disclosure, a “thermocouple” is used to generally refer to a thermocouple, thermometer, or other temperature measuring structure. The thermocouple may be used to tract the temperature of the tissue as it is being ablated to ensure that the desired temperatures are reached. The temperature measurement may be used to adjust a microwave or radio frequency signal being passed thorough the ablation antenna to the radiating tip. In the case of a radio frequency signal, a grounding pad may be used in relation to the radiating tip to complete a circuit in the tissue to create the energy deposition at the radiating tip. In some applications, it may be desirable to limit the energy deposition to only cause coagulation. Using at least one embodiment of a device disclosed herein, heavy sedation and / or anesthesia may not be necessary.ASPECTS

[0055] Aspects of the disclosure may be combined to describe different embodiments of the disclosure. An aspect Al includes a device comprising an introducer needle including an introducer needle tip and a central shaft; and an ablation antenna sized to removably slide within the central shaft, wherein the ablation antenna includes a radiating tip.

[0056] A2. The device of aspect Al, further comprising a stylet sized to removably slide within the central shaft, the stylet including a specimen notch.

[0057] A3. The device of aspect A2, wherein when the stylet is fully inserted into the introducer needle, the stylet has a throw length of about 10 mm to 20 mm.

[0058] A4. The device of aspects A2 or A3, wherein the stylet includes a handle.

[0059] A5. The device of aspects Al, A2, A3, or A4, wherein the introducer needle includes depth markings on its outer surface.

[0060] A6. The device of aspects Al, A2, A3, A4, or A5, wherein the introducer needle includes a thermocouple disposed proximate the introducer needle tip to measure a temperature.

[0061] A7. The device of aspects Al, A2, A3, A4, A5, or A6, further comprising a display in communication with the thermocouple to display the temperature measured by the thermocouple.

[0062] A8. The device of aspects Al, A2, A3, A4, A5, A6, or A7, further comprising a body including a handle and a shaft extension, wherein the introducer needle is connected to the body, wherein the central shaft is connected to the shaft extension, wherein when the ablation antenna is fully inserted into the central shaft, the ablation antenna extends through the shaft extension.

[0063] A9. The device of aspects Al, A2, A3, A4, A5, A6, A7, or A8, wherein the ablation antenna includes a thermocouple disposed proximate the radiating tip.

[0064] A10. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, or A9, wherein the introducer needle includes an introducer needle connector disposed remotely from the introducer needle tip.

[0065] All. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, or A10, further comprising a sample housing including sample chamber containing a lower pressure than ambient pressure, wherein the sample housing is connectable to the introducer needle connector.

[0066] A12. The device of aspect All, wherein when the sample housing is connected to the introducer needle, the lower pressure of the sample chamber is applied to the central shaft.

[0067] A13. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, or A12, further comprising a microwave generator, wherein the microwave generator is connected to the ablation antenna and able to pass a microwave signal through the radiating tip.

[0068] A14. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, or A12, further comprising a radio frequency generator and a grounding pad, wherein the radio frequency generator is connected to the ablation antenna and able to pass a radio frequency signal through the radiating tip toward the grounding pad.

[0069] A15. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, A12, A13, or A14, wherein the ablation antenna is a slot antenna.

[0070] A16. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, A12, A13, A14, or A15, wherein the ablation antenna is a monopole antenna.

[0071] A17. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, A12, A13, A14, A15, or A16, wherein the ablation antenna is a dipole antenna.

[0072] A18. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, A12, A13, A14, A15, A16, or A17, wherein the ablation antenna is a triaxial antenna.

[0073] A19. The device of aspects Al, A2, A3, A4, A5, A6, A7, A8, A9, A10, All, A12, A13, A14, A15, A16, A17, or A18, wherein the ablation antenna is a choked antenna.

[0074] An aspect Bl includes a device comprising: an introducer needle including an ablation antenna, a radiating tip formed proximate an end of the introducer needle, and a central shaft extending through the radiating tip.

[0075] B2. The device of aspect Bl, further comprising a stylet sized to removably slide within the central shaft, the stylet including a specimen notch.

[0076] B3. The device of aspect B2, wherein when the stylet is fully inserted into the introducer needle, the stylet has a throw length of about 10 mm to 20 mm.

[0077] B4. The device of aspects B2 or B3, wherein the stylet includes a handle.

[0078] B5. The device of aspects Bl, B2, B3, or B4, wherein the introducer needle includes depth markings on its outer surface.

[0079] B6. The device of aspects Bl, B2, B3, B4, or B5, wherein the introducer needle includes a thermocouple disposed proximate the radiating tip for measuring a temperature.

[0080] B7. The device of aspects Bl, B2, B3, B4, B5, or B6, further comprising a display in communication with the thermocouple to display the temperature measured by the thermocouple.

[0081] B8. The device of aspects Bl, B2, B3, B4, B5, B6, or B7, further comprising a body including a handle and a shaft extension, wherein the introducer needle is connected to the body, wherein the central shaft is connected to the shaft extension.

[0082] B9. The device of aspects Bl, B2, B3, B4, B5, B6, B7, orB8, wherein the introducer needle includes an introducer needle connector disposed remotely from the radiating tip.

[0083] B10. The device of aspect B9, further comprising a sample housing including sample chamber containing a lower pressure than ambient pressure, wherein the sample housing is connectable to the introducer needle connector.

[0084] Bll. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, or B10, wherein when the sample housing is connected to the introducer needle, the lower pressure of the sample chamber is applied to the central shaft.

[0085] B12. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, BIO, or Bll, further comprising a microwave generator, wherein the microwave generator is connected to the ablation antenna and able to pass a microwave signal through the radiating tip.

[0086] B13. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, BIO, Bll, or B12, further comprising a radio frequency generator and a grounding pad, wherein the radio frequency generator is connected to the ablation antenna and able to pass a radio frequency signal through the radiating tip toward the grounding pad.

[0087] B14. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, B10, Bll, B12, or B13, wherein the ablation antenna is a slot antenna.

[0088] B15. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, B10, Bll, B12, B13, or B14, wherein the ablation antenna is a monopole antenna.

[0089] B16. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, B10, Bll, B12, B13, B14, or B15, wherein the ablation antenna is a dipole antenna.

[0090] B17. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, B10, Bll, B12, B13, B14, B15, or B16, wherein the ablation antenna is a triaxial antenna.

[0091] B18. The device of aspects Bl, B2, B3, B4, B5, B6, B7, B8, B9, B10, Bll, B12, B13, B14, B15, B16, or B17, wherein the ablation antenna is a choked antenna.

[0092] An aspect Cl includes a method comprising: inserting an introducer needle into a tissue to be sampled, the introducer needle including an introducer needle tip and a central shaft; obtaining a biopsy sample through the introducer needle from the tissue; inserting an ablation antenna through the central shaft of the introducer needle without removing the introducer needle from the tissue after obtaining the biopsy sample, wherein the ablation antenna is sized to removably slide within the central shaft and includes a radiating tip; and ablating the tissue surrounding the radiating tip with the ablation antenna.

[0093] C2. The method of aspect Cl, further comprising: removing the introducer needle from the tissue; and coagulating blood in or cauterizing an insertion path in the tissue at the radiating tip with the ablation antenna as the introducer needle is removed from the tissue, wherein the insertion path is formed by the insertion of the introducer needle into the tissue.

[0094] C3. The method of aspects Cl or C2, wherein obtaining a biopsy sample includes: pushing a stylet through the central shaft of the introducer needle into the tissue to be biopsied, wherein the stylet is sized to removably slide within the central shaft and includes a specimen notch; and pulling the stylet back through the tissue to permit the specimen notch to cut a biopsy sample from the tissue; and removing the biopsy sample and the stylet from the central shaft of the introducer needle.

[0095] C4. The method of aspect C3, wherein when the stylet is fully inserted into the introducer needle, the stylet has a throw length of about 10 mm to 20 mm.

[0096] C5. The method of aspects C3 or C4, wherein the stylet includes a handle.

[0097] C6. The method of aspects C3, C4, or C5, further comprising connecting the introducer needle to a body, the body including a handle and a shaft extension, wherein the central shaft is connected to the shaft extension, wherein when the ablation antenna is fully inserted into the central shaft, the ablation antenna extends through the shaft extension.

[0098] C7. The method of aspects Cl, C2, C3, C4, C5, or C6, further comprising measuring a temperature of the tissue with a thermocouple integrated into the introducer needle and disposed proximate the introducer needle tip.

[0099] C8. The method of aspects Cl, C2, C3, C4, C5, C6, or C7, further comprising measuring a temperature of the tissue with a thermocouple integrated into the ablation antenna and disposed proximate the radiating tip.

[0100] C9. The method of aspects Cl, C2, C3, C4, C5, C6, C7, or C8, further comprising adjusting a signal passed through the ablation antenna based on the temperature measured by the thermocouple.

[0101] CIO. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, or C9, further comprising adjusting a signal including adjusting a microwave generator connected to the ablation antenna that generates a microwave signal that passes through the ablation antenna to the radiating tip.

[0102] Cll. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, or CIO, further comprising adjusting a signal including adjusting a radio frequency generator connected to the ablation antenna that generates a radio frequency signal that passes through the ablation antenna to the radiating tip and radiates outward toward a grounding pad.

[0103] C12. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, or Cll, wherein the introducer needle includes an introducer needle connector disposed remotely from the introducer needle tip, wherein obtaining a biopsy sample through the introducer needle from the tissue includes connecting a sample housing to the introducer needle connector, wherein the sample housing includes a sample chamber containing a lower pressure than ambient pressure, wherein the lower pressure of the sample chamber is applied to the central shaft and draws a biopsy sample through the central shaft of the introducer needle into the sample chamber.

[0104] C13. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, or C12, further comprising disconnecting the sample chamber from the introducer needle connector.

[0105] C14. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, C12, or C13, wherein the ablation antenna is a slot antenna.

[0106] C15. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, C12, C13, or C14, wherein the ablation antenna is a monopole antenna.

[0107] C16. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, C12, C13, C14, or C15, wherein the ablation antenna is a dipole antenna.

[0108] C17. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, C12, C13, C14, C15, or C16, wherein the ablation antenna is a triaxial antenna.

[0109] C18. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, C12, C13, C14, C15, C16, or C17, wherein the ablation antenna is a choked antenna.

[0110] C19. The method of aspects Cl, C2, C3, C4, C5, C6, C7, C8, C9, CIO, Cll, C12, C13, C14, C15, C16, C17, or C18, wherein the introducer needle is an 18 gauge needle.[OHl] An aspect DI includes a method comprising: inserting an introducer needle into a tissue to be sampled, the introducer needle including an ablation antenna, a radiating tip formed proximate an end of the introducer needle, and a central shaft extending through the radiating tip; obtaining a biopsy sample through the introducer needle from the tissue; and ablating the tissue surrounding the radiating tip with the ablation antenna.

[0112] D2. The method of aspect DI, further comprising: removing the introducer needle from the tissue; and coagulating blood in or cauterizing an insertion path in the tissue at the radiating tip with the ablation antenna as the introducer needle is removed from the tissue, wherein the insertion path is formed by the insertion of the introducer needle into the tissue.

[0113] D3. The method of aspects DI or D2, wherein obtaining a biopsy sample includes: pushing a stylet through the central shaft of the introducer needle into the tissue to be biopsied, wherein the stylet is sized to removably slide within the central shaft and includes a specimen notch; pulling the stylet back through the tissue to permit the specimen notch to cut a biopsy sample from the tissue; and removing the biopsy sample and the stylet from the central shaft of the introducer needle.

[0114] D4. The method of aspects D3, wherein when the stylet is fully inserted into the introducer needle, the stylet has a throw length of about 10 mm to 20 mm.

[0115] D5. The method of aspects D3, or D4, wherein the stylet includes a handle.

[0116] D6. The method of aspects DI, D2, D3, D4, or D5, wherein the introducer needle includes a thermocouple disposed proximate the radiating tip.

[0117] D7. The method of aspects DI, D2, D3, D4, D5, or D6, further comprising measuring a temperature of the tissue with a thermocouple integrated into the introducer needle and disposed proximate the introducer needle tip.

[0118] D8. The method of aspects DI, D2, D3, D4, D5, D6, or D7, further comprising adjusting a signal passed through the ablation antenna based on the temperature measured by the thermocouple.

[0119] D9. The method of aspects DI, D2, D3, D4, D5, D6, D7, or D8, further comprising adjusting a signal including adjusting a microwave generator connected to the ablation antenna that generates a microwave signal that passes through the ablation antenna to the radiating tip.

[0120] D10. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, or D9, further comprising adjusting a signal including adjusting a radio frequency generator connected to the ablation antenna that generates a radio frequency signal that passes through the ablation antenna to the radiating tip and radiates outward toward a grounding pad.

[0121] Dll. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, or D10, wherein the introducer needle includes an introducer needle connector disposed remotely from the introducer needle tip, wherein obtaining a biopsy sample through the introducer needle from the tissue includes connecting a sample housing to the introducer needle connector, wherein the sample housing includes a sample chamber containing a lower pressure than ambient pressure, wherein the lower pressure of the sample chamber is applied to the central shaft and draws a biopsy sample through the central shaft of the introducer needle into the sample chamber.

[0122] D12. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, D10, or Dll, further comprising disconnecting the sample chamber from the introducer needle connector.

[0123] D13. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, D10, Dll, or D12, wherein the ablation antenna is a slot antenna.

[0124] D14. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, D10, Dl l, D12, or D13, wherein the ablation antenna is a monopole antenna.

[0125] D15. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, D10, Dl l, D12, D13, or D14, wherein the ablation antenna is a dipole antenna.

[0126] D16. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, DIO, Dl l, D12, D13, D14, or D15, wherein the ablation antenna is a triaxial antenna.

[0127] D17. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, DIO, Dl l, D12, D13, D14, D15, or D16, wherein the ablation antenna is a choked antenna.

[0128] D18. The method of aspects DI, D2, D3, D4, D5, D6, D7, D8, D9, DIO, Dll, D12, D13, D14, D15, D16, or D17, wherein the introducer needle is an 18 gauge needle.

[0129] One or more specific embodiments of the present disclosure are described herein. These described embodiments are examples of the presently disclosed techniques. Additionally, in an effort to provide a concise description of these embodiments, not all features of an actual embodiment may be described in the specification. It should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous embodiment-specific decisions will be made to achieve the developers’ specific goals, such as compliance with system-related and business-related constraints, which may vary from one embodiment to another. Moreover, it should be appreciated that such a development effort might be complex and time consuming, but would nevertheless be a routine undertaking of design, fabrication, and manufacture for those of ordinary skill having the benefit of this disclosure.

[0130] The articles “a,” “an,” and “the” are intended to mean that there are one or more of the elements in the preceding descriptions. The terms “comprising,” “including,” and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. Additionally, it should be understood that references to “one embodiment” or “an embodiment” of the present disclosure are not intended to be interpreted as excluding the existence of additional embodiments that also incorporate the recited features. For example, any element described in relation to an embodiment herein may be combinable with any element of any other embodiment described herein. Numbers, percentages, ratios, or other values stated herein are intended to include that value, and also other values that are “about” or “approximately” the stated value, as would be appreciated by one of ordinary skill in the art encompassed by embodiments of the present disclosure. A stated value should therefore be interpreted broadly enough to encompass values that are at least close enough to the stated value to perform a desired function or achieve a desired result. The stated values include at least the variation to be expected in a suitable manufacturing or production process, and may include values that are within 5%, within 1%, within 0.1%, or within 0.01% of a stated value.

[0131] A person having ordinary skill in the art should realize in view of the present disclosure that equivalent constructions do not depart from the spirit and scope of the present disclosure, and that various changes, substitutions, and alterations may be made to embodiments disclosed herein without departing from the spirit and scope of the present disclosure. Equivalent constructions, including functional “means-plus-function” clauses are intended to cover the structures described herein as performing the recited function, including both structural equivalents that operate in the same manner, and equivalent structures that provide the same function. It is the express intention of the applicant not to invoke means-plus-function or other functional claiming for any claim except for those in which the words ‘means for’ appear together with an associated function. Each addition, deletion, and modification to the embodiments that falls within the meaning and scope of the claims is to be embraced by the claims.

[0132] The terms “approximately,” “about,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” and “substantially” may refer to an amount that is within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of a stated amount. Further, it should be understood that any directions or reference frames in the preceding description are merely relative directions or movements. For example, any references to “up” and “down” or “above” or “below” are merely descriptive of the relative position or movement of the related elements.

[0133] The present disclosure may be embodied in other specific forms without departing from its spirit or characteristics. The described embodiments are to be considered as illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than by the foregoing description. Changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims

CLAIMS1. A device comprising: an introducer needle including an introducer needle tip and a central shaft; and an ablation antenna sized to removably slide within the central shaft, wherein the ablation antenna includes a radiating tip.

2. The device of claim 1, further comprising a stylet sized to removably slide within the central shaft, the stylet including a specimen notch.

3. The device of claim 1, further comprising a thermocouple disposed proximate the radiating tip.

4. The device of claim 1, further comprising a sample housing including sample chamber containing a lower pressure than ambient pressure, wherein the introducer needle includes an introducer needle connector disposed remotely from the introducer needle tip, wherein the sample housing is connectable to the introducer needle connector, wherein when the sample housing is connected to the introducer needle, the lower pressure of the sample chamber is applied to the central shaft.

5. A device comprising: an introducer needle including an ablation antenna, a radiating tip formed proximate an end of the introducer needle, and a central shaft extending through the radiating tip.

6. The device of claim 5, further comprising a stylet sized to removably slide within the central shaft, the stylet including a specimen notch.

7. The device of claim 5, further comprising a thermocouple disposed proximate the radiating tip for measuring a temperature.

8. The device of claim 5, further comprising a body including a handle and a shaft extension, wherein the introducer needle is connected to the body, wherein the central shaft is connected to the shaft extension.

9. The device of claim 5, further comprising a sample housing including sample chamber containing a lower pressure than ambient pressure, wherein the introducer needle includes an introducer needle connector disposed remotely from the radiating tip, wherein the sample housing is connectable to the introducer needle connector, wherein when the sample housing is connected to the introducer needle, the lower pressure of the sample chamber is applied to the central shaft.

10. A method comprising: inserting an introducer needle into a tissue to be sampled, the introducer needle including an introducer needle tip and a central shaft; obtaining a biopsy sample through the introducer needle from the tissue; ablating the tissue proximate the introducer needle tip with an ablation antenna through a radiating tip, without removing the introducer needle from the tissue after obtaining the biopsy sample; and removing the introducer needle from the tissue.

11. The method of claim 10, further comprising inserting the ablation antenna through the central shaft of the introducer needle, wherein the ablation antenna is sized to removably slide within the central shaft.

12. The method of claim 10, wherein the introducer needle is integrated with the ablation antenna, the radiating tip formed proximate the introducer needle tip, wherein the central shaft extends through the radiating tip.

13. The method of claim 10, further comprising coagulating blood in or cauterizing an insertion path in the tissue at the radiating tip with the ablation antenna as the introducer needle is removed from the tissue, wherein the insertion path is formed by the insertion of the introducer needle into the tissue.

14. The method of claim 10, wherein obtaining a biopsy sample includes: moving a stylet through the central shaft of the introducer needle into the tissue to be biopsied, wherein the stylet is sized to removably slide within the central shaft and includes a specimen notch;moving the stylet through the tissue to permit the specimen notch to cut a biopsy sample from the tissue; and removing the biopsy sample and the stylet from the central shaft of the introducer needle.

15. The method of claim 10, further comprising measuring a temperature of the tissue with a thermocouple integrated into the introducer needle and disposed proximate the introducer needle tip.

16. The method of claim 10, further comprising measuring a temperature of the tissue with a thermocouple integrated into the ablation antenna and disposed proximate the radiating tip.

17. The method of claim 10, further comprising adjusting a microwave generator connected to the ablation antenna that generates a microwave signal that passes through the ablation antenna to the radiating tip.

18. The method of claim 10, further comprising adjusting a radio frequency generator connected to the ablation antenna that generates a radio frequency signal that passes through the ablation antenna to the radiating tip and radiates outward toward a grounding pad.

19. The method of claim 10, wherein the introducer needle includes a introducer needle connector disposed remotely from the introducer needle tip, wherein obtaining a biopsy sample through the introducer needle from the tissue includes connecting a sample housing to the introducer needle connector, wherein the sample housing includes a sample chamber containing a lower pressure than ambient pressure, wherein the lower pressure of the sample chamber is applied to the central shaft and draws a biopsy sample through the central shaft of the introducer needle into the sample chamber.

20. The method of claim 19, further comprising disconnecting the sample chamber from the introducer needle connector.

Citation Information

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