Systems and methods for tissue coagulation

Abstract

A medical device may include a handle having a handle lumen extending therethrough. The medical device may also include a first body shaft including a first body shaft lumen in direct communication with the handle lumen, and an RF electrode tip may be located at a distal end of the first body shaft. The RF electrode tip may include a lumen extending therethrough and in direct communication with the lumen of the first body shaft. In addition, an energy delivery line may be electrically coupled to the RF electrode tip.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This patent application claims the benefit of priority under 35 U.S.C. §119 to U.S. Provisional Patent Application No. 62 / 682,603, filed on June 8, 2018, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] The present disclosure generally relates to medical systems, devices and related methods. More specifically, the present disclosure relates to medical systems and / or devices for treating tissue within a patient's body. Background Art

[0004] Optical fiber can be used in medical laser systems to deliver laser energy to the treatment site. For example, lasers have been used in urology, neurology, otolaryngology, general anesthesia ophthalmology, dentistry, gastroenterology, cardiology, gynecology, chest and plastic surgery. An example of an operation that can be performed using a laser system is laser cautery of tissue to promote healing. Sometimes, laser fiber cautery may not be as effective as RF electrocautery, depending on the specific patient anatomy. For example, laser fiber cautery that interacts with blood hemoglobin may not be as effective as RF electrocautery in cauterizing tissue to coagulate proteins in tissue. Due to the difference in the mode of action, laser fiber cautery may not be as successful as RF electrocautery. In this case, a medical professional may wish to remove the laser fiber device from an insertion device (e.g., an endoscope) and insert an RF electrode. Removing the laser fiber device and then rerouting the RF electrode through the insertion device may add a lot of time and therefore increase the cost of the medical operation.

[0005] The systems, devices, and methods disclosed herein may correct some of the above-mentioned deficiencies or address other aspects of the prior art. Summary of the invention

[0006] Examples of the present disclosure relate particularly to medical devices.Each example disclosed herein may include one or more features described in conjunction with any other disclosed example.

[0007] A medical device may include a handle having a handle lumen extending therethrough. The medical device may also include a first body shaft including a first body shaft lumen in direct communication with the handle lumen, and an RF electrode tip may be located at a distal end of the first body shaft. The RF electrode tip may include a lumen extending therethrough and in direct communication with the lumen of the first body shaft. In addition, an energy delivery line may be electrically coupled to the RF electrode tip.

[0008] The medical device may further include one or more of the following features. The energy delivery line may extend along the radial outer surface of the first main body shaft toward the handle. The handle may further include a channel, and the energy delivery line may extend through the channel for connection with the RF generator. The medical device may further include a second main body shaft defining a second main body shaft lumen, and the first main body shaft may be received in the second main body shaft lumen. The RF electrode tip may extend distally of the second main body shaft. The energy delivery line may be at least partially received in the second main body shaft lumen of the second main body shaft. The second main body shaft may include an electrically insulating material. The RF electrode tip may include a pair of RF electrodes. The energy delivery line may be a first energy delivery line electrically connected to a first electrode in the pair of RF electrodes, and the medical device may further include a second energy delivery line electrically connected to a second electrode in the pair of RF electrodes. Both the first energy delivery line and the second energy delivery line may extend through the channel of the handle for connection with an RF generator plug. The pair of RF electrodes may be arranged for bipolar delivery of RF energy. The pair of RF electrodes may be electrically connected for monopolar delivery of RF energy. The handle may further include an RF plug socket for connection with an RF generator. The proximal end of the handle lumen may include a tapered, flared, or chamfered surface.A sealing cap may be coupled to the proximal end of the handle.

[0009] In another example, a method for delivering energy to tissue may include, in a first configuration, positioning an RF electrode tip of an energy delivery device distal to an insertion device that is located within a patient's body. Additionally, the method may include delivering RF energy to tissue within the patient's body via the RF electrode tip, and stopping the delivery of RF energy via the RF electrode tip. Additionally, the method may include, in a second configuration, retracting the RF electrode tip to a position within an inner cavity of the insertion device, and advancing a laser fiber through the inner cavity of the RF electrode tip and the distal side of the insertion device. The method may further include any one or more of the following features. The method may include delivering laser energy via a laser fiber. The method may include retracting the laser fiber to a position within the laser energy device. The method may include dissipating heat from the RF electrode tip to the insertion device in the second configuration.

[0010] In another example, a system for energy delivery may include an insertion device including a lumen extending therethrough. Additionally, the system may include an RF energy delivery device including a handle, a first body shaft, and an RF electrode tip. Additionally, the RF energy device may include a lumen extending through the handle, the first body shaft, and the RF electrode tip. Additionally, the laser fiber may be at least partially received within the lumen of the RF energy delivery device.

[0011] Examples of the system may further include one or more of the following features. The RF electrode tip may include a pair of RF electrodes printed or chemically etched thereon. In addition, a first energy delivery line may be electrically coupled to a first electrode in the pair of RF electrodes, and a second energy delivery line may be electrically coupled to a second electrode in the pair of RF electrodes, and both the first energy delivery line and the second energy delivery line may extend toward the handle along a radially outer surface of the first body shaft. The system may further include a second body shaft, and at least a portion of the first body shaft may be positioned within the lumen of the second body shaft, and the RF electrode tip may extend distally of the second body shaft.

[0012] The foregoing general description and the following detailed description are merely exemplary and illustrative, and are not limitations on the claimed features. As used herein, the terms "comprises," "including," "having," "comprising," or other variations thereof are intended to cover non-exclusive inclusions, such that a process, method, article, or device that includes a series of elements includes not only those elements, but may also include other elements that are not explicitly listed or inherent to such a process, method, article, or device. In addition, the term "exemplary" is used herein in the sense of "example," rather than in the sense of "ideal." As used herein, unless otherwise indicated, the terms "approximately," "substantially," and "roughly" represent values ​​within a range of + / - 5% of the stated value. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary features of the disclosure and, together with the description, serve to explain the principles of the disclosure.

[0014] Figure 1A An exemplary medical system according to the present disclosure is shown;

[0015] Figure 1B It is taken along route 1A-1A Figure 1A A cross-sectional view of the healthcare system;

[0016] Figure 2A An RF electrode arrangement according to aspects of the present disclosure is shown;

[0017] Figure 2B Shows Figure 2A An enlarged view of the electrode tip of the RF electrode device;

[0018] Figure 2C yes Figure 2A A cross-sectional view of an RF electrode device;

[0019] Figure 3A The exemplary medical system of FIG. 1 is shown in a laser energy delivery configuration;

[0020] Figure 3B showing the exemplary medical system of FIG. 1 in an RF energy delivery configuration; and

[0021] Figure 4 is a cross-sectional view of an RF electrode device according to another aspect of the present disclosure. DETAILED DESCRIPTION

[0022] Examples of the present disclosure relate to medical systems for treating internal regions of a patient's body.Each medical system described herein can include a laser energy delivery device and an RF electrode device.

[0023] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to refer to the same or like parts.

[0024] The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical device or insertion device. When used herein, "proximal" refers to a position relatively closer to the outside of a patient or closer to a medical professional using the medical device or insertion device. In contrast, "distal" refers to a position relatively farther away from a medical professional using the medical device or insertion device or closer to the inside of a patient.

[0025] Figure 1A An exemplary medical system 10 is shown. Medical system 10 includes an insertion device 12. Insertion device 12 may include any device configured to allow a user to access and view an internal area of ​​a subject's body, such as, for example, a ureteroscope, a hysteroscope, a hysteroscope, a bronchoscope, a cystoscope, and the like. Insertion device 12 may include a plurality of lumens extending therethrough. For example, Figure 1B As shown in , the insertion device 12 may include a first lumen 14 arranged to receive the optical device 16, a second lumen 18 for receiving the RF electrode device 20, a third lumen 22, and a fourth lumen 24. It should be understood that in some arrangements, the insertion device 12 may include other lumens not shown, or may not include at least the third lumen 22 and / or the fourth lumen 24, without departing from the scope of the present disclosure.

[0026] The optical device 16 may include any suitable device configured to provide a visual image of an internal position of the patient's body. For example, the optical device 16 may include one or more optical elements (e.g., lenses, cameras, etc.) (not shown). In addition, the optical device 16 may include a socket 26 configured to receive an optical cable so as to provide illumination light to a position in the patient's body. The optical device 16 may be selectively inserted into the first lumen 14 and removed from the first lumen. In addition, the RF electrode device 20 may be selectively inserted into the second lumen 18, removed from the second lumen, or axially translated relative to the second lumen through the compression band 19, as will be described in further detail below. In addition, the third lumen 22 may be connected to a source of a flushing fluid 28 (e.g., water, saline, etc.) via a stopcock 30, and the fourth lumen 24 may be connected to a source of a suction fluid 32 via a stopcock 34. Both the third lumen 22 and the fourth lumen 24 may start at the connector interface 37 of the insertion device 12 and terminate at the distal end of the insertion device 12. In use, if deemed necessary or desirable, a medical professional may manually adjust one or both of the stopcocks 30 and 34 to introduce the irrigation fluid 28 and / or the aspiration fluid 32, respectively. Optionally, in some arrangements, the sensor 36 may be disposed on the distal end 38 of the insertion device 12 (e.g., Figure 1A as shown) or within the end (as shown Figure 1B 4. The sensor 36 may sense one or both of pressure or temperature at a location within the patient's body and may communicate with the controller 40 to automatically control the delivery of one or more of the irrigation fluid 28 or the aspiration fluid 32. In this case, the stopcocks 30 and 34 may be omitted and the delivery of the irrigation fluid 28 and / or the aspiration fluid 32 may be controlled via one or more valves (not shown) or the like.

[0027] Figure 2A-2C RF electrode device 20 is shown. As shown, RF electrode device 20 includes a handle 50 and a body 52 that terminates in an RF electrode 54. A sealing cap 56 may surround the proximal end of handle 50. As shown, sealing cap 56 may include a slit or opening 58 ( Figure 2C) so that one or more devices (e.g., a laser fiber) can be inserted through the sealing cap 56 and into the inner cavity 60 of the handle 50. The sealing cap 56 can be formed of any suitable material (e.g., polymers, silicon, etc.), and the sealing cap is arranged to bend, bend, or otherwise deform to enable one or more devices to be inserted into the inner cavity 60. In some arrangements, the sealing cap 56 can retain the medical device in a specific axial position relative to the inner cavity 60. That is, in the absence of a distal propulsion (e.g., pushing) force or a proximal retraction (e.g., pulling) force applied to the medical device in the inner cavity 60, the sealing cap 56 can maintain or maintain the position of the medical device relative to the handle 50. In addition, the sealing cap 56 can be made of a material sufficient to prevent fluid from flowing proximally through the slit 58. That is, the sealing cap 56 can prevent any fluid from leaking or passing from a position distal to the slit 58 to a position proximal to the slit 58. In other arrangements, if necessary, the sealing cap 56 can be replaced with a sealing and compression gland. As Figure 2C As shown in , for example, the proximal end of lumen 60 can include a tapered, chamfered, or flared opening 62 to assist a medical professional in delivering (eg, guiding) a medical device (eg, a laser fiber) into lumen 60 .

[0028] like Figure 2C As shown in the figure, the body 52 includes a first (e.g., inner) main body shaft 70, which defines a lumen 72. The lumen 72 is directly connected to the lumen 60 of the handle 50. That is, when a medical device (e.g., a laser device) is introduced through the sealing cap 56, the medical device can be advanced through the lumen 60 and into the lumen 72. The first main body shaft 70 can be formed of a flexible material (such as a polymer). The distal end of the first main body shaft 70 can terminate in the RF electrode tip 54. The RF electrode tip 54 can be a tubular member having a lumen 55 extending therethrough, and can include a ceramic tip having only one (e.g., monopolar) or a pair (e.g., bipolar) RF energy electrodes 54A, 54B. The RF electrode tip 54 can be integrally formed with the distal end of the first main body shaft 70, or can be coupled to the distal end of the first main body shaft 70 in any suitable manner (e.g., via interference or other such fit) or adhesive bonding.

[0029] Each electrode (e.g., 54A, 54B) can be additionally coated on the ceramic substrate or applied by an etching removal process. Each electrode 54A, 54B can be connected via an electrical conductor, lead or wiring 74 (e.g., only Figure 2C54A and 54B are electrically connected to the RF generator 76 via the RF plug socket 78. When activated, RF energy can be delivered from the RF generator 76 to the electrodes 54A and 54B along the body 52 via the wiring 74 in a bipolar arrangement (e.g., the first wiring 74 can be electrically connected to the first electrode 54A, and the second wiring 74 can be electrically connected to the second electrode 54B). In the bipolar electrode arrangement, one of the first electrode 54A or the second electrode 54B is arranged as an energy delivery (e.g., heat) electrode, and the other is arranged as a return electrode. Optionally, the electrodes 54A and 54B can be electrically "short-circuited" (e.g., electrically connected) via the connection between the wiring 74 to form a monopolar energy delivery device. In this case, an additional return electrode of the RF generator 76 can be connected to the patient's body (e.g., adhered to the patient's skin). Alternatively, RF electrode tip 54 may include only a single electrode (e.g., electrode 54A) and only one wiring 74. In this manner, electrode 54A is arranged as an energy delivery electrode, while an additional return electrode of RF generator 76 may be connected to the patient's body (e.g., adhered to the patient's skin).

[0030] In addition, the body 52 includes a second (e.g., external) body shaft 80. The second body shaft 80 may include a polymer sleeve, sheath or film positioned (e.g., surrounded, encircled, etc.) around the first body shaft 70 and the wiring 74. That is, the second body shaft 80 is defined with an inner cavity 82, and at least a portion of the first body shaft 70 and the wiring 74 is received in the inner cavity. The second body shaft 80 can electrically insulate the body 52 and the wiring 74 from the inner surface of the insertion device 12 (e.g., the surface of the second inner cavity 18 of the insertion device 12), and the wiring 74 can be retained, maintained or otherwise fixed against the radial outer surface of the first body shaft 70. As shown, the RF electrode tip 54 extends distally to the second body shaft 80. Therefore, RF energy can be delivered from the RF generator 76 along one or two wirings 74, through the tip 54, and delivered toward the tissue in the patient's body without accidentally shorting one or more parts of the insertion device 12.

[0031] In use, a medical professional may deem it medically necessary or desirable to deliver laser energy to tissue of a patient's body. For example, a medical professional may deliver laser energy to treat benign prostatic hyperplasia (BPH) to reduce the size of the prostate (e.g., by vaporizing tissue) and / or to cauterize tissue. In such an arrangement, a Figure 3A As shown, the medical system 10 can be arranged in a laser energy delivery configuration. In the laser energy delivery configuration, as Figure 3AAs shown by the middle arrow 65, the laser fiber 90 can pass through the sealing cover 56 and enter the inner cavity 60 ( Figure 2C ), through the lumen 72 of the first main body shaft 70, through the lumen 55 of the RF electrode tip 54 and the distal side of the RF electrode tip 54. At the same time, the RF electrode tip 54 can be retracted proximally (as shown by arrow 64) or otherwise received in the second lumen 18 ( Figure 1B ) and electrically insulated to prevent accidental electrical actuation. In this arrangement, the RF electrode tip 54 is not activated.

[0032] If the medical professional determines that application of RF energy is necessary or desirable (e.g., to perform RF electrocautery of tissue), the medical professional may convert the system 10 into the RF energy delivery configuration, such as Figure 3B As shown. In this manner, the laser fiber 90 can be retracted proximally (as shown by arrow 67) or otherwise positioned so that its distal tip is received within the lumen 72 of the first body shaft 70. In addition, as shown by arrow 66, the RF energy device 20 (e.g., including the handle 50, the body 52, and the RF electrode tip 54) can be advanced distally through the second passage 18 of the insertion device 12 so that at least the RF electrode tip 54 is positioned distally of the tip 38 (or, in an arrangement where the tip 38 is not present, is positioned distally of the distal end surface of the body 52). Once so positioned, the RF energy generator 76 can be activated to deliver RF energy to the tissue through the electrodes 54A, 54B. Because the distal tip or end of the laser fiber 90 is positioned within the lumen 72 of the first body shaft 70, the laser fiber 90 is thermally protected from the RF electrode tip 54 during the delivery of RF energy to the patient's tissue. In this manner, a medical professional can proximally retract 64 or distally advance 66 the RF electrode device 20 in the laser energy delivery configuration ( Figure 3A ) and RF energy delivery configuration ( Figure 3B ) between the two. Because the disclosed arrangement does not require complete removal of the RF energy device 20 or the laser fiber 90 during a procedure, a medical professional can reduce overall procedure time and cost without giving up the dual functionality of RF energy delivery and laser energy delivery. In this way, a medical professional can dynamically customize a medical procedure to suit the needs of an individual patient.

[0033] Figure 41 is a cross-sectional view of an RF electrode device 100 according to another aspect of the present invention. The RF electrode device 100 is similar to the electrode device 20 described above, and therefore, similar components will be described and depicted using the same reference numerals. It is worth noting that the RF electrode device 100 differs from the RF electrode device 20 in the manner in which the RF electrode device 100 is moved relative to the insertion device 12. That is, rather than manually moving the RF electrode device 20 toward the insertion device 12, the RF electrode device 100 is moved relative to the insertion device 12. Figure 3A The laser energy delivery configuration is retracted or the electrode device 20 is moved toward Figure 3B The RF electrode device 100 is not advanced in the RF energy delivery configuration of the insertion device 12, but the RF electrode device 100 incorporates a cam device to advance and retract the RF electrode device 100. The cam device operates in a manner similar to a "click" pen writing instrument or other similar manner, and includes a biasing spring 102, a divider 104 and a cam 106 positioned around a support member 103. The divider 104 may include a plurality of v-grooves arranged to contact a plurality of v-grooves of the cam 106. In addition, the radially outer surface of the cam 106 may include one or more protrusions that are configured to be received in a plurality of grooves located on the inner surface of the insertion device 12 and slide distally and proximally relative to the grooves. The groove (not shown) of the insertion device 12 allows axial translation of the cam 106 and the handle 110 of the RF electrode device 100 while preventing rotation of the cam 106 and the handle 110 relative to the insertion device 12. As in the case of a "press" pen writing instrument, the user can advance or retract the RF electrode device 100 by applying a thrust on a button, recess or actuator 108 of the handle 110 of the RF electrode device 100. When doing so, the spring 102 can be compressed, and the v-groove of the indexer 104 can be rotated relative to the v-groove of the cam 106, thereby adjusting the axial position of the handle 110 of the RF electrode device 100 relative to the handle 110 to an extended axial position. Subsequent actuation of the actuator 108 of the handle 110 can compress the spring again and allow the indexer 104 to rotate relative to the cam 106 so as to return the handle 110 of the RF electrode device 100 to the initial axial position (e.g., a retracted axial position). Optionally, when the RF electrode device 100 is retracted, there is a gap in the electrical connection between the RF generator 76 and the RF electrode 54 of the RF electrode device 100. Due to the gap, current will not be allowed to flow from the RF generator 76 to the RF electrode tip 54. Thus, when in the laser energy delivery configuration ( Figure 3A ), an additional safety measure prevents accidental delivery of energy to the RF electrode tip 54.

[0034] Furthermore, in some arrangements, the insertion device 12 may include an additional laser fiber lumen through which the laser fiber 90 may extend. That is, instead of the laser fiber 90 being coaxially delivered through the lumens 60, 72 and the RF electrode tip 54 as described above, the laser fiber 90 may be arranged generally parallel to the body 52 of the RF electrode device 20.

[0035] Optionally, one or more of the insertion device 12, the RF electrode device 20, and the optical device 16 can be disposable for single use, or can be equipped for multiple use. For example, in some arrangements, the insertion device 12 can be a sterile single-use component of the system 10, while in other arrangements, the insertion device 12 can be reusable. In the case of a reusable insertion device 12, the RF electrode device 20 can be a sterile single-use component of the system 10. Alternatively, the RF electrode device 20 can be reusable except for the RF electrode tip 54. In this arrangement, the RF electrode tip 54 can be a sterile single-use attachment for the rest of the RF electrode device 54.

[0036] Although the principles of the present disclosure are described herein with reference to illustrative examples for specific applications, it should be understood that the present disclosure is not limited thereto. Those of ordinary skill in the art and those who receive the teachings provided herein will recognize that other modifications, applications, embodiments, and alternatives of equivalents fall within the scope of the features described herein. Therefore, the features claimed should not be considered to be limited by the foregoing description.

Claims

1. A medical device comprising: a handle including a handle lumen extending therethrough; A first main body shaft, the first main body shaft comprising a first main body shaft inner cavity directly communicating with the handle inner cavity; an RF electrode tip located at a distal end of the first body shaft, wherein the RF electrode tip includes a lumen extending therethrough and in direct communication with the lumen of the first body shaft; as well as an energy delivery line electrically coupled to the RF electrode tip, and Wherein, a laser fiber is located within the first body shaft lumen and is configured to extend distally to cauterize tissue and to retract proximally relative to the RF electrode tip, the laser fiber being thermally protected from the RF electrode tip when retracted into the first body shaft lumen.

2. The medical device according to claim 1, wherein: The energy delivery line extends along a radially outer surface of the first body axis toward the handle.

3. The medical device according to claim 2, wherein: The handle further includes a channel, wherein the energy delivery line extends through the channel for connection to an RF generator.

4. The medical device of claim 1, further comprising a second body shaft defining a second body shaft lumen, wherein the first body shaft is received within the second body shaft lumen.

5. The medical device according to claim 4, wherein: The RF electrode tip extends distally of the second body shaft.

6. The medical device according to claim 4, wherein: The energy delivery wire is at least partially received within the second body shaft lumen of the second body shaft.

7. The medical device according to claim 4, wherein: The second body shaft includes an electrically insulating material.

8. The medical device according to claim 1, wherein: The RF electrode tip includes a pair of RF electrodes.

9. The medical device according to claim 8, wherein: The energy delivery line is a first energy delivery line electrically coupled to a first electrode of the pair of RF electrodes, the medical device further comprising: A second energy delivery line is electrically coupled to a second electrode of the pair of RF electrodes.

10. The medical device according to claim 9, wherein: The first energy delivery line and the second energy delivery line both extend through the channel of the handle for connection with an RF generator plug.

11. The medical device according to claim 8, wherein: The pair of RF electrodes are arranged for bipolar delivery of RF energy.

12. The medical device according to claim 8, wherein: The pair of RF electrodes are electrically coupled for monopolar delivery of RF energy.

13. The medical device according to claim 1, wherein: The handle further comprises an RF plug socket for connecting to an RF generator.

14. The medical device according to any one of claims 1 to 13, wherein: The proximal end of the handle lumen includes a tapered, flared, or chamfered surface.

15. The medical device of any one of claims 1-13, further comprising a sealing cap coupled to a proximal end of the handle.

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