Flexible circuit arrangement for thermocouples in catheters
By employing a thermocouple assembly with a flexible circuit arrangement at the end of the conduit, the difficulties in thermocouple manufacturing and positioning were solved, thus achieving accuracy in conduit temperature readings and reliability in the ablation process.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- BIOSENSE WEBSTER (ISRAEL) LTD
- Filing Date
- 2025-11-25
- Publication Date
- 2026-05-29
AI Technical Summary
In existing conduit systems, thermocouples are difficult to manufacture and position, resulting in inaccurate temperature readings and a high scrap rate, which affects the accuracy and efficiency of the ablation process.
The thermocouple assembly, which employs a flexible circuit layout, includes conductive traces and a junction. It is connected to a printed circuit board via the flexible circuit to ensure accurate positioning and fixation of the thermocouple assembly at the end of the conduit, providing temperature sensing capability.
This improved the manufacturing efficiency and positioning accuracy of thermocouple assemblies, reduced the scrap rate, and ensured the accuracy of the temperature readings at the end of the conduit and the reliability of the ablation process.
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Figure CN122096950A_ABST
Abstract
Description
Background Technology
[0001] Cardiac arrhythmias, such as atrial fibrillation, occur when areas of cardiac tissue abnormally conduct electrical signals. Treatment protocols for these arrhythmias involve surgically disrupting the conduction pathways used for such signals. By selectively ablating cardiac tissue with energy (e.g., alternating current or direct current), it is possible to stop or alter the propagation of unwanted electrical signals from one part of the heart to another. The ablation process can provide a blockage of unwanted electrical pathways by forming an electrically insulating lesion or scar tissue that effectively blocks the communication of abnormal electrical signals across tissues.
[0002] In some procedures, catheters with one or more electrodes are used to deliver ablation within the cardiovascular system. The catheter may be inserted into a major vein or artery (e.g., the femoral artery) and then advanced to position the electrodes within the heart or in cardiovascular structures adjacent to the heart (e.g., the pulmonary veins). One or more electrodes may be positioned to contact cardiac or other vascular tissue and then activated with electrical energy to ablate the contacted tissue. In some cases, the electrodes may be bipolar. In other cases, a monopolar electrode may be used in conjunction with a grounding pad or other reference electrode in contact with the patient. Flushing may be used to absorb heat from the ablation components of the ablation catheter and to prevent blood clots from forming near the ablation site.
[0003] Examples of ablation catheters are described in the following documents: U.S. Patent No. 10,743,932, entitled "Integrated Ablation System using Catheter with Multiple Irrigation Lumens," published August 18, 2020, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,660,700, entitled "Irrigated Balloon Catheter with Flexible Circuit Electrode Assembly," published May 26, 2020, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 11,559,349, entitled "Ablation Catheter with a Flexible Printed Circuit Board," published January 24, 2023, the disclosure of which is incorporated herein by reference in its entirety; and Catheter with Bipole Electrode Spacer and Related..., published July 7, 2020. The disclosures of U.S. Patent No. 10,702,177 entitled “Methods” are incorporated herein by reference in their entirety; the disclosures of U.S. Patent No. 10,130,422 entitled “Catheter with SoftDistal Tip for Mapping and Ablating Tubular Region”, published November 20, 2018, are incorporated herein by reference in their entirety; the disclosures of U.S. Patent No. 8,956,353 entitled “Electrode Irrigation Using Micro-Jets”, published February 17, 2015, are incorporated herein by reference in their entirety; and the disclosures of U.S. Patent No. 9,801,585 entitled “Electrocardiogram Noise Reduction”, published October 31, 2017, are incorporated herein by reference in their entirety.
[0004] Some catheter ablation procedures can be performed after electrophysiological (EP) mapping to identify tissue areas that should be targeted for ablation. Such EP mapping may involve the use of sensing electrodes on a catheter (e.g., the same catheter used to perform the ablation or a dedicated mapping catheter). These sensing electrodes monitor electrical signals emanating from conductive endocardial tissue to precisely locate the site of abnormally conductive tissue leading to arrhythmias. Examples of EP mapping systems are described in U.S. Patent No. 5,738,096, entitled “Cardiac Electromechanics,” issued April 14, 1998, the disclosure of which is incorporated herein by reference in its entirety. Examples of EP mapping catheters are described in the following documents: U.S. Patent No. 9,907,480, entitled “Catheter Spine Assembly with Closely-Spaced Bipole Microelectrodes,” published March 6, 2018, the disclosure of which is incorporated herein by reference in its entirety; U.S. Patent No. 10,130,422, entitled “Catheter with Soft Distal Tip for Mapping and Ablating Tubular Region,” published November 20, 2018, the disclosure of which is incorporated herein by reference in its entirety; and U.S. Patent No. 10,702,177, entitled “Catheter with Bipole Electrode Spacer and Related Methods,” published July 7, 2020, the disclosure of which is incorporated herein by reference in its entirety.
[0005] When using ablation catheters, it may be desirable to monitor the temperature at one or more distal regions of the catheter, which can further indicate the temperature of the tissue in contact with the distal end of the catheter. Temperature monitoring can be performed using one or more thermocouples integrated into the catheter. Each thermocouple may be able to indicate the measured temperature to a processor. In some cases, thermocouples used for catheters may be difficult to manufacture and may be difficult to position to obtain accurate temperature readings due to their small size. This difficulty may tend to result in an undesirable high scrap rate during manufacturing.
[0006] Although several catheter systems and methods have been manufactured and used, it is believed that no one had manufactured or used the inventions described, shown and claimed herein before the inventors. Attached Figure Description
[0007] The following figures and detailed descriptions are intended to be illustrative only and are not intended to limit the scope of the invention as contemplated by the inventors.
[0008] Figure 1A schematic diagram depicts a medical procedure for inserting a catheter assembly into a patient's body. Figure 2 Depicting Figure 1 A perspective view of the distal portion of the catheter, with additional components shown schematically; Figure 3 Depicting Figure 1 Exploded perspective view of the distal components and flexible circuitry of the conduit. Figure 3A Depicting Figure 3 A perspective view of the end component, in which Figure 3 A flexible circuit is inserted, and a portion of the end member is shown in cross-section; Figure 4 Depicting along Figure 3A The line 4-4 was cut Figure 3 A cross-sectional side view of the end components and flexible circuitry; Figure 5 Depicting Figure 1 Exploded perspective view of the end components of the conduit, flexible circuitry, and printed circuit board. Figure 6 Depicting Figure 3 A cross-sectional side view of the distal portion of the flexible circuit; Figure 7 Depicting along Figure 3A The line 7-7 was cut Figure 3 Cross-sectional end view of the end components and flexible circuit; Figure 8 Depicting Figure 3 An exploded perspective view of the end component and the second flexible circuit, wherein the distal portion of the fourth flexible circuit is in a pre-folded configuration. Figure 8A Depicting Figure 3 A perspective view of the end component, in which Figure 8 A second flexible circuit is inserted, and a portion of the end member is shown in cross-section; Figure 9 Depicting along Figure 8A The line 9-9 was cut off Figure 8 Cross-sectional side view of the end component and the second flexible circuit; Figure 10 Depicting Figure 3 An exploded perspective view of the end component and the third flexible circuit, wherein the distal portion of the fourth flexible circuit is in a pre-folded configuration. Figure 10A Depicting Figure 3 A perspective view of the end component, in which Figure 10 A second flexible circuit is inserted, and a portion of the end member is shown in cross-section; Figure 11 Depicting along Figure 10A The line 11-11 cut Figure 10 Cross-sectional end view of the end component and the third flexible circuit; Figure 12 Depicting Figure 3 An exploded perspective view of the end component and the fourth flexible circuit, wherein the distal portion of the fourth flexible circuit is in a pre-folded configuration. Figure 12A Depicting Figure 3 end components and Figure 12 Another exploded perspective view of the fourth flexible circuit, in which a portion of the end member is shown in cross-section; Figure 13 Depicting along Figure 12A The line 13-13 is cut off Figure 12 Cross-sectional end view of the end component and the fourth flexible circuit; Figure 14 Depicting Figure 3 An exploded perspective view of the end component and the fifth flexible circuit, wherein the distal portion of the fourth flexible circuit is in a pre-folded configuration. Figure 14A Depicting Figure 3 A perspective view of the end component, in which Figure 14 The fifth flexible circuit is inserted, and a portion of the end member is shown in cross-section; and Figure 15 Depicting along Figure 14A The line cut at 15-15 Figure 14 Cross-sectional end view of the end component and the fifth flexible circuit. Detailed Implementation
[0009] The following description of certain examples of the invention is not intended to limit the scope of the invention. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the invention. The principles of the invention are illustrated in detail by way of example and not by way of limitation. Other examples, features, aspects, embodiments, and advantages of the invention will be apparent to those skilled in the art from the following description, which is shown by way of example, and a best mode is contemplated for carrying out the invention. It will be appreciated that the invention can have other different or equivalent aspects, all of which do not depart from the invention. Therefore, the drawings and descriptions should be considered substantially illustrative and not restrictive.
[0010] Any or more of the teachings, expressions, types, examples, etc., described herein may be combined with any or more of the other teachings, expressions, types, examples, etc., described herein. Therefore, the following teachings, expressions, types, examples, etc., should not be considered separate from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[0011] As used herein, the term “about” or “approximately” for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of values within ±10% of the listed values; for example, “about 90%” may refer to a range of values from 81% to 99%. Furthermore, as used herein, the terms “patient,” “recipient,” “user,” and “examinee” refer to any human or animal examinee and are not intended to limit the system or method to human use, but the use of the subject matter invention in human patients represents a preferred embodiment.
[0012] I. Overview of Examples of Ablation Catheter Systems Figure 1 Examples of medical protocols and associated components for cardiac ablation catheter systems that can be used to deliver the cardiac ablation procedures mentioned above are shown. Specifically, Figure 1 The image shows a physician (PH) grasping the handle (110) of the catheter assembly (100), wherein the end actuator (140) of the catheter (120) of the catheter assembly (100) is located in... Figure 2 Shown but not in Figure 1 (shown in the image) is placed inside the patient (PA) to ablate tissue in or near the patient's (PA) heart (H). As used herein, the term "ablation" is intended to include radiofrequency ablation, irreversible electroporation, or any other suitable ablation modality. The catheter assembly (100) includes a handle (110), a catheter (120) extending distally from the handle (110), and an end effector (140) located at the distal end of the catheter (120).
[0013] As will be described in more detail below, the end effector (140) of this example is operable to deliver electrical energy to a target tissue site, provide EP mapping functionality, track external forces applied to the end effector (140), track the position of the end effector (140), and disperse flushing fluid. The user input feature (190) is configured to deflect the distal portion of the end effector (140) and the catheter (120) away from the central longitudinal axis (LL).
[0014] like Figure 2As shown, the catheter (120) includes an elongated flexible sheath (122) with an end effector (140) positioned at the distal end of the sheath (122). The end effector (140) and various components housed within the sheath (122) will be described in more detail below. The catheter assembly (100) is coupled to the guidance and actuation system (10) via a cable (30). The catheter assembly (100) is also coupled to a fluid source (42) via a fluid conduit (40). A set of field generators (20) is positioned below the patient (PA) and coupled to the guidance and actuation system (10) via another cable (22). The field generators (20) are optional only.
[0015] The boot and drive system (10) of this example includes a console (12) and a display (18). The console (12) includes a first drive module (14) and a second drive module (16). The first drive module (14) is coupled to the conduit assembly (100) via a cable (30). In some variations, the first drive module (14) is operable to receive EP mapping signals obtained via microelectrodes (138) of an end effector (140), as described in more detail below. The console (12) includes a processor (not shown) that processes such EP mapping signals and thereby provides EP mapping as known in the art.
[0016] The first driver module (14) of this example is also operable to provide RF power (as will be described in more detail below) to the distal end member (142) of the end effector (140), thereby ablating tissue. The second driver module (16) is coupled to the field generator (20) via a cable (22). The second driver module (16) is operable to activate the field generator (20), thereby generating an alternating magnetic field around the heart (H) of the patient (PA). For example, the field generator (20) may include coils that generate the alternating magnetic field within a predetermined working volume accommodating the heart (H).
[0017] The first driver module (14) is also operable to receive a position indication signal from a navigation sensor assembly (not shown) in the end effector (140). In this type, the processor of the console (12) is also operable to process the position indication signal from the navigation sensor assembly to determine the position of the end effector (140) within the patient (PA). By way of example only, the navigation sensor assembly may include one or more coils operable to generate a signal indicating the position and orientation of the end effector (140) within the patient (PA). The coils may be configured to generate an electrical signal in response to the presence of an alternating electromagnetic field generated by the field generator (20). Other components and techniques that may be used to generate real-time position data associated with the end effector (140) may include wireless triangulation, acoustic tracking, optical tracking, inertial tracking, and the like. Alternatively, the end effector (140) may not have a navigation sensor assembly.
[0018] The display (18) is coupled to the processor of the console (12) and is operable to present images of the patient's anatomy. Such images may be based on a set of images obtained before or during surgery (e.g., CT or MRI scans, 3D mapping, etc.). The view of the patient's anatomy provided by the display (18) may also change dynamically based on signals from the navigation sensor assembly of the end effector (140). For example, as the end effector (140) of the catheter (120) moves within the patient (PA), corresponding positional data from the navigation sensor assembly may enable the processor of the console (12) to update the view of the patient's anatomy in the display (18) in real time to depict the area of the patient's anatomy around the end effector (140) as the end effector (140) moves within the patient (PA). Furthermore, the processor of the console (12) may drive the display (18) to display the location of abnormally conductive tissue sites detected via electrophysiological (EP) mapping using the end effector (140) or otherwise (e.g., using a dedicated EP mapping catheter, etc.). The processor of the console (12) can also drive the display (18) to overlay the current position of the end effector (140) onto an image of the patient's anatomy by means of overlaying illuminated points, crosshairs, graphical representations of the end effector (140) or some other form of visual indication.
[0019] The fluid source (42) in this example comprises a bag containing brine or some other suitable flushing fluid. The conduit (40) includes a flexible tube further coupled to a pump (44) operable to selectively drive fluid from the fluid source (42) to the conduit assembly (100). Such flushing fluid may be discharged through an opening (158) in the distal end member (142) of the end actuator (140). Such flushing can be provided in any suitable manner that will be apparent to those skilled in the art, referring to the teachings herein.
[0020] II. Examples of end actuators for catheter assemblies Figures 2 to 4 Examples of components of the end effector (140) and other components of the distal portion of the catheter (120) are shown in more detail. The end effector (140) includes a distal end member (142) and a distal portion of a flexible circuit (200) having a thermocouple assembly (210). A pair of push-pull cables (160, 170) extend along the length of the catheter (120) to reach the end effector (140). The push-pull cables (160, 170) allow the physician (PH) to selectively laterally deflect the end effector (140) away from the central longitudinal axis (LL), thereby enabling the physician (PH) to actively manipulate the end effector (140) within the patient (PA). Various mechanisms that can be used to drive the push-pull cables (160, 170) in a simultaneously longitudinally relative manner will be apparent to those skilled in the art, referring to the teachings herein. A flexible sheath (122) surrounds a portion of the push-pull cable (160, 170) and a portion of the flexible circuit (200).
[0021] like Figures 3 to 4 As shown, the distal end member (142) of this example is conductive and includes a cylindrical body (156) having a dome end (146). Multiple openings (158) are formed through the cylindrical body (156) and communicate with the hollow interior of the distal end member (142). Thus, the openings (158) allow flushing fluid to be delivered from the interior of the distal end member (142) through the cylindrical body (156). The cylindrical body (156) and the dome end (146) are also operable to apply RF electrical energy to tissue, thereby ablating the tissue. Such RF electrical energy can be delivered from the first driver module (14) to the cylindrical body (156) via a cable (30) and any number of conductive components (not shown) (e.g., wires, traces in flexible circuits, etc.) inserted between the cylindrical body (156) and the cable (30).
[0022] As from Figures 3 to 4As best seen in the example, the distal end member (142) of this example also includes a first set of holes (162) and a second set of holes (164). The holes (162, 164) are formed in the cylindrical body (156) and are spaced apart from each other at an angle about the central longitudinal axis (LL) in an alternating arrangement. The holes (162) terminate distally within the cylindrical body (156) such that the holes (162) constitute blind holes that do not extend through the dome end (146). The holes (164) extend completely through the cylindrical body (156) and the dome end (146). The holes (162) receive thermocouple assemblies (210) configured to provide temperature sensing capability, as will be described in more detail below. The holes (164) receive EP mapping electrodes (138). The EP mapping microelectrodes (138) are configured to pick up potential from tissue in contact with the EP mapping microelectrodes (138). Based on the teachings of the various references cited herein, the first driver module (14) can process EP mapping signals and provide the physician (PH) with corresponding feedback indicating the location of abnormal electrical activity.
[0023] As described above, the conduit assembly (100) is configured such that flushing fluid can be delivered from the fluid source (42) to the conduit (120) via the fluid conduit (40), thereby providing discharge of the flushing fluid through the opening (158) of the distal end member (142). In some configurations, the fluid path for the flushing fluid includes a flushing tube (not shown) positioned within the sheath (122) and coupled to the fluid conduit (40) (e.g., at the shank (110) of the conduit assembly (100)). Such a flushing tube may extend along the length of the conduit (120) to reach the end actuator (140). In some configurations, the flushing fluid may be delivered from the distal end of the flushing tube through a central channel formed by a centrally aligned orifice of the aforementioned features, ultimately reaching the hollow interior of the distal end member (142) before flowing out from the opening (158).
[0024] III. A First Example of a Flexible Circuit As mentioned above, some types of thermocouples may be difficult to manufacture, may be difficult to position to obtain accurate temperature readings due to their small size, and / or may tend to provide undesirable high scrap rates during manufacturing. However, the thermocouple assemblies (210) of this example and their arrangement within the end effector (140) tend to alleviate such problems. In other words, the construction and arrangement of the thermocouple assemblies (210) within the end effector (140) tend to provide faster and / or more cost-effective manufacturing compared to conventional thermocouples, tend to provide easier positioning to obtain accurate temperature readings compared to conventional thermocouples, and / or tend to provide lower scrap rates during manufacturing compared to conventional thermocouples.
[0025] Figures 3 to 4The distal end of a flexible circuit (200) is shown, which includes a thermocouple assembly (210) positioned inside a hole (162) in the distal end member (142). Although only one flexible circuit (200) is shown, three flexible circuits (200) (or any other suitable number of flexible circuits (200)) may be provided, with the thermocouple assembly (210) of each flexible circuit (200) positioned within a corresponding hole (162) in the distal end member (142). In some forms, the three discrete flexible circuits (200) may extend separately from each other along the length of the sheath (122). In some other forms, the three flexible circuits (200) may be joined together within the sheath (122) (e.g., near the end effector (140)) or within the end effector (140) to form a single flexible circuit that may then extend along the remaining proximal length of the sheath (122).
[0026] The thermocouple assembly (210) of this example includes a first conductive trace (212), a second conductive trace (215), and a third conductive trace (219). The first and second traces (212, 215) extend along the upper surface of an electrically insulating substrate (217). By way of example only, the substrate (217) may comprise polyimide and / or any other suitable material. The third trace (219) extends along the lower surface of the substrate (217). The traces (212, 215, 219) and the substrate (217) extend along the length of the sheath (122). These features of the flexible circuit (200) are flexible to allow the catheter (120) to be easily flexed during physician (PH) operations, such as when the catheter (120) traverses a tortuous path within the patient (PA) and when the physician (PH) deflects the distal region of the catheter (120).
[0027] The distal end of the first trace (212) includes a first thermal contact (213), and the distal end of the second trace (215) includes a second thermal contact (216). The thermocouple assembly (210) is sized to fit inside the aperture (162), wherein the first and second thermal contacts (213, 216) are radially outward. Figure 4 As shown, once the thermocouple assembly (210) is fully inserted into the hole (162), proper positioning is achieved, with the distal end of the thermocouple assembly (210) just near the dome end (146).
[0028] like Figure 4 and Figures 6 to 7As shown, the first thermal contact (213) is electrically coupled to the third trace (219) via a joint (223); while the second thermal contact (216) is electrically coupled to the third trace (219) via a joint (225). The joints (223, 225) extend through the entire thickness of the insulating layer (217). In this example, each of the first trace (212) (including the first thermal contact (213)) and the second trace (215) (including the second thermal contact (216)) contains a first conductive material (e.g., copper, etc.), while the third trace (219) contains a second conductive material (e.g., constantan or a copper-nickel alloy, etc.). Due to the difference in conductive materials, temperature changes at the joints (223, 225) will provide temperature gradients between the first trace (212) and the third trace (219) and between the second trace (215) and the third trace (219), respectively. These temperature gradients can generate thermoelectric voltages that are proportional to the temperature difference between the distal ends of the first and second traces (212, 215) and the corresponding region of the third trace (219). Such thermoelectric voltages can be read by the processor of the console (12), as will be described in more detail below. It should also be understood that these temperature changes in the joints (223, 225) can be caused by temperature changes in the thermal contacts (213, 216), which can be caused by heating or cooling of the distal end member (142).
[0029] Although in this example both thermal contacts (213, 216) are electrically coupled to the third trace (219) via corresponding joints (223, 225), some other configurations may provide a fourth trace positioned on the underside of the insulating layer (217) and separate from the third trace (219). In some such variations, the first thermal contact (213) is electrically coupled to the third trace (219) via joint (223); while the second thermal contact (216) is electrically coupled to the fourth trace via joint (225). In such variations, the fourth trace may contain a conductive material different from that of the second trace (215).
[0030] In some configurations, at least a portion of each trace (212, 215) and thermal contact (213, 216) is coated with an electrically insulating coating (not shown), thereby electrically insulating the traces (212, 215) and thermal contacts (213, 216) relative to the distal end member (142). However, such an electrically insulating coating may be thermally conductive, allowing the thermal contacts (213, 216) to be in thermal communication with the distal end member (142). Specifically, the thermal contacts (213, 216) may thermally contact the inner sidewall of the bore (162) without being electrically connected to the inner sidewall of the bore (162), while maintaining thermal communication with the inner sidewall of the bore (162). Additional features of the thermocouple assembly (210) that further facilitate thermal coupling between the thermal contacts (213, 216) and the distal end member (142) will be described in more detail below.
[0031] like Figure 5 As shown, the proximal end (230) of the flexible circuit (200) includes pads (244, 245, 246) arranged in a straight line. A first trace (212) is electrically connected to pad (244), a second trace (215) is electrically connected to pad (246), and a third trace (216) is electrically connected to pad (245). A printed circuit board (PCB) (240) is coupled to the proximal end (230) of the flexible circuit (200). Specifically, the PCB (240) includes a set of pads (242) electrically coupled to the corresponding pads (244, 245, 246) of the flexible circuit (200). The PCB (240) may be positioned in an end effector (140), an elongated flexible sheath (122), or a handle (110). The PCB (240) is also electrically coupled to the processor of the console (12) via a cable (30) and any number of conductive components (not shown) (e.g., wires, traces in flexible circuits, etc.) inserted between the PCB (240) and the cable (30). Thus, the PCB (240), cable (30), and intervening conductive components provide a pathway for transmitting voltage from the thermocouple assembly (210) to the processor of the console (12). This allows the processor of the console (12) to process temperature indication data picked up via the thermocouple assembly (210) to sense the temperature of the end effector (140), which can further indicate the temperature of the tissue in contact with the end effector (140).
[0032] The end effector (140) may include a plurality of individual thermocouple assemblies (210) spaced at an angle to each other in a distal end member (142), wherein each thermocouple assembly (210) is positioned in a corresponding aperture (162). Each thermocouple assembly (210) may be incorporated into a corresponding discrete flexible circuit (200). Each flexible circuit (200) may also be coupled to a corresponding PCB (240). Alternatively, each flexible circuit (200) may be attached to a common PCB (240), wherein the PCB (240) has multiple rows of PCB pads (242) complementary in number to the thermocouple assemblies (210). By way of example only, if the PCB (240) is positioned in the proximal portion of the shank (110) or the elongated flexible sheath (122), the flexible circuit (200) may extend to 2 meters or longer. Each flexible circuit (200) may have the same length as any other flexible circuit (200). By individually electrically communicating with each thermocouple assembly (210) of each flexible circuit (200) via the PCB (240), the PCB (240) may be able to distinguish temperature readings on the distal end member (142) and transmit these readings to the processor of the console (14). The flexible circuit (200) may also include a reference lead (not shown) extending from the pad (245) to the thermocouple assembly (210), which can be used to detect signal noise that can subsequently be removed or taken into account when evaluating the voltage readings of the thermocouple assembly (210).
[0033] The PCB (240) may comprise a flat single-layer or multi-layer circuit board such that the flexible circuits (200) are twisted relative to each other to attach to the distal end member (142), while each thermocouple assembly (210) is also positioned radially outward at an angle as described above. In this example, the extension length of the flexible circuit (200) relative to the diameter of the elongated flexible sheath (122) is given, and the bending of the elongated flexible sheath (122) tends to cause a certain degree of traction of each flexible circuit (200) relative to the distal end member (142). When the flexible circuit (200) is stretched due to the bending of the sheath (122), the adhesive holding the thermocouple assembly (210) inside the hole (162) is sufficient to resist the thermocouple assembly (210) from being stretched out of the hole. To further ensure minimal tension at the thermocouple assembly (210), the flexible circuit (200) may also be longer than the length between the PCB (240) and the hole (162) to provide slack that accommodates variations caused by deflection along the effective length of each flexible circuit (200). In other words, the flexible circuit (200) may be bundled along the length from the PCB (240) to the hole (162).
[0034] like Figures 4 to 7As shown, the region of the flexible circuit (200) forming the thermocouple assembly (210) also includes an additional electrically insulating spacer layer (221) positioned below the third trace (219). Thus, the third trace (219) is interposed between the layers (217, 221). By way of example only, the spacer layer (221) may comprise polyimide and / or any other suitable material. In this example, the spacer layer (221) is substantially thicker than the base layer (217). With the spacer layer (221) present, the thermocouple assembly (210) is too large relative to the aperture (162), such that at least a portion of the thermocouple assembly (210) must be compressed or otherwise deformed to fit within the aperture (162). In this example, the spacer layer (221) is compressible, such that the outer corners of the spacer layer (221) deform against the inner sidewalls of the aperture (162), as... Figure 7 As shown. The spacer layer (221) can be elastically biased toward a non-deformable state, such that compression of the spacer layer (221) within the aperture (162) tends to provide a firm hold for the thermocouple assembly (210) within the aperture (162). Furthermore, this compression of the spacer layer (221) within the aperture (162) tends to push the upper portion of the thermocouple assembly (210) radially outward relative to the central longitudinal axis (LL). This effect, in turn, minimizes the distance between the thermal contacts (213, 216) and the outer surface of the cylindrical body (156), thereby maximizing the sensitivity of the thermal contacts (213, 216) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). This, in turn, maximizes the sensitivity of the joints (223, 225) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). Therefore, the spacer layer (221) can promote thermal conductivity between the thermocouple assembly (210) and the cylindrical body (156).
[0035] While in some cases, as described above, the thermocouple assembly (210) can be properly secured within the bore (162) by friction, the securing of the thermocouple assembly (210) within the bore (162) can be further supplemented by an adhesive. By way of example only, such an adhesive can be provided via a thermoplastic polyurethane elastomer introduced into the bore (162) after the thermocouple assembly (210) has been fully seated within it. By way of another example only, such a thermoplastic polyurethane elastomer can be doped with diamond powder and can be cured with ultraviolet light. Alternatively, any other suitable type of adhesive can be used, and any other suitable process can be used to bond the thermocouple assembly (210) relative to the distal end member (142).
[0036] IV. A Second Example of Flexible Circuits Figures 8 to 9A second example of a flexible circuit (300) is shown, which is substantially identical in form and function to the flexible circuit (200) except for any differences described below. Therefore, the flexible circuit (200) can be replaced by the flexible circuit (300). Like the flexible circuit (200), this example of the flexible circuit (300) includes a thermocouple assembly (310) comprising a first conductive trace (312), a second conductive trace (315), and a third conductive trace (321). The first and second traces (312, 315) extend along the upper surface of an electrically insulating substrate layer (317). By way of example only, the substrate layer (317) may comprise polyimide and / or any other suitable material. The third trace (321) extends along the lower surface of the substrate layer (317). The traces (312, 315, 321) and the substrate layer (317) extend along the length of a sheath (122).
[0037] The distal end of the first trace (312) includes a first thermal contact (313), and the distal end of the second trace (315) includes a second thermal contact (316). The first thermal contact (313) is electrically coupled to the third trace (321) via a bonding portion (323); and the second thermal contact (316) is electrically coupled to the third trace (321) via a bonding portion (325). The bonding portions (323, 325) extend through the entire thickness of the substrate layer (317). In this example, each of the first trace (312) (including the first thermal contact (313)) and the second trace (315) (including the second thermal contact (316)) contains a first conductive material (e.g., copper, etc.), while the third trace (321) contains a second conductive material (e.g., constantan or a copper-nickel alloy, etc.). Due to the differences in conductive materials, temperature changes at the junctions (323, 325) will provide temperature gradients between the first trace (312) and the third trace (321), and between the second trace (315) and the third trace (321), respectively. These temperature gradients can generate thermoelectric voltages. The thermocouple assembly (310) can therefore provide temperature sensing in a manner similar to that described above with respect to the thermocouple assembly (210).
[0038] like Figure 8A and Figure 9As shown, an electrically insulating coating (329) may be positioned above at least a portion of the thermal contacts (313, 316) and the traces (312, 315). In some cases, the coating (329) extends further along the length of the traces (312, 315). The coating (329) electrically insulates the traces (312, 315) and the thermal contacts (313, 316) relative to the distal end member (142). However, the coating (329) is thermally conductive, allowing the thermal contacts (313, 316) to be in thermal communication with the distal end member (142). Specifically, the thermal contacts (313, 316) may thermally contact the inner sidewall of the hole (162) without being electrically connected to the inner sidewall of the hole (162), while maintaining thermal communication with the inner sidewall of the hole (162).
[0039] The flexible circuit (300) in this example also includes a distal portion (318) of the base layer (317) extending distally beyond the thermal contacts (313, 316). Figure 8A As shown, the distal portion (318) can be folded in the proximal direction before entering the thermocouple assembly (310) insertion hole (162). The folded distal portion (318) can act as a spring, similar to the partially compressed spacer layer (221) of a flexible circuit (200), to elastically bias the thermocouple assembly (310) radially outward relative to the central longitudinal axis (LL). This effect, in turn, minimizes the distance between the thermal contacts (313, 316) and the outer surface of the cylindrical body (156), which maximizes the sensitivity of the thermal contacts (313, 316) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). This, in turn, maximizes the sensitivity of the joints (323, 325) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). Therefore, the folded distal portion (318) can promote thermal conductivity between the thermocouple assembly (310) and the cylindrical body (156).
[0040] Furthermore, the folded distal portion (318) may tend to provide fixation of the thermocouple assembly (310) within the bore (162) by expanding the effective cross-sectional profile of the thermocouple assembly (310). In some cases, the elastic bias of the folded distal portion (318) towards the flat / unfolded construction pushes the distal portion (318) against the inner sidewall of the bore (162), thereby enhancing friction to fix the thermocouple assembly (310) within the bore (162).
[0041] The positioning and fixation of the thermocouple assembly (310) within the aperture (162) may be further supplemented by an adhesive (327) to adhere the flexible circuit (300) relative to the distal end member (142). In some cases where an adhesive is used, and although not shown in this figure, at least some of the adhesive may occupy the space formed between the folded distal portion (318) and the underside of the third trace (321) and the base layer (317) (or the underside of an additional electrical insulating layer (not shown) positioned below the third trace (321)). By way of example only, such an adhesive may be provided via a thermoplastic polyurethane elastomer introduced into the aperture (162) after the thermocouple assembly (310) has been fully positioned in the aperture (162). By way of another example only, such a thermoplastic polyurethane elastomer may be doped with diamond powder and may be cured with ultraviolet light. Alternatively, any other suitable type of adhesive may be used, and any other suitable process may be used to bond the thermocouple assembly (310) to the distal end member (142).
[0042] V. A Third Example of Flexible Circuits Figures 10 to 11 A third example of a flexible circuit (400) is shown, which is substantially identical in form and function to the flexible circuits (200, 300) except for any differences described below. Therefore, the flexible circuit (200) can be replaced by the flexible circuit (400). Like the flexible circuit (200), this example of the flexible circuit (400) includes a thermocouple assembly (410) comprising a first conductive trace (412), a second conductive trace (415), and a third conductive trace (421). The first and second traces (412, 415) extend along the upper surface of an electrically insulating substrate layer (417). By way of example only, the substrate layer (417) may comprise polyimide and / or any other suitable material. The third trace (421) extends along the lower surface of the substrate layer (417). The traces (412, 415, 421) and the substrate layer (417) extend along the length of the sheath (122).
[0043] The distal end of the first trace (412) includes a first thermal contact (413), and the distal end of the second trace (415) includes a second thermal contact (416). The first thermal contact (413) is electrically coupled to the third trace (421) via a bonding portion (not shown); and the second thermal contact (416) is electrically coupled to the third trace (421) via a bonding portion (425). The bonding portion (425) extends through the entire thickness of the substrate layer (417). In this example, each of the first trace (412) (including the first thermal contact (413)) and the second trace (415) (including the second thermal contact (416)) contains a first conductive material (e.g., copper, etc.), while the third trace (421) contains a second conductive material (e.g., constantan or a copper-nickel alloy, etc.). Due to the differences in conductive materials, temperature changes at the junction (425) will provide temperature gradients between the first trace (412) and the third trace (421) and between the second trace (415) and the third trace (421), respectively. These temperature gradients can generate thermoelectric voltages. The thermocouple assembly (410) can therefore provide temperature sensing in a manner similar to that described above with respect to the thermocouple assembly (210).
[0044] like Figure 10A and Figure 11 As shown, an electrically insulating coating (429) may be positioned above at least a portion of the thermal contacts (413, 416) and the traces (412, 415). In some cases, the coating (429) extends further along the length of the traces (412, 415). The coating (429) electrically insulates the traces (412, 415) and the thermal contacts (413, 416) relative to the distal end member (142). However, the coating (429) is thermally conductive, allowing the thermal contacts (413, 416) to be in thermal communication with the distal end member (142). Specifically, the thermal contacts (413, 416) may thermally contact the inner sidewall of the hole (162) without being electrically connected to the inner sidewall of the hole (162), while maintaining thermal communication with the inner sidewall of the hole (162).
[0045] The flexible circuit (400) in this example also includes a lateral portion (418) of the substrate layer (417) that projects laterally relative to an adjacent portion of the substrate layer (417). Thermal contacts (413, 416) are positioned on the lateral portion (418), wherein distal portions of traces (412, 415) extend along the lateral portion (418) to reach the thermal contacts (413, 416). A third trace (421) also extends along the lateral portion (418). Figures 10A to 11As shown, the lateral portion (418) is folded to position the lateral portion (418) below an adjacent region of the base layer (417). The folded lateral portion (418) can act as a spring, similar to the partially compressed spacer layer (221) of the flexible circuit (300) and the folded distal portion (318) of the flexible circuit (200), to elastically bias the thermocouple assembly (410) radially outward relative to the central longitudinal axis (LL). This effect, in turn, minimizes the distance between the thermal contacts (413, 416) and the outer surface of the cylindrical body (156), which maximizes the sensitivity of the thermal contacts (413, 416) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). This, in turn, maximizes the sensitivity of the joint (425) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). Therefore, the folded lateral portion (418) can promote thermal conductivity between the thermocouple assembly (410) and the cylindrical body (156).
[0046] Furthermore, the folded lateral portion (418) may tend to provide fixation of the thermocouple assembly (410) within the bore (162) by expanding the effective cross-sectional profile of the thermocouple assembly (410). In some cases, the elastic bias of the folded lateral portion (418) pushes the lateral portion (418) toward the flat / unfolded configuration such that the lateral portion (418) abuts against the inner sidewall of the bore (162), thereby enhancing friction to fix the thermocouple assembly (410) within the bore (162).
[0047] The positioning and fixation of the thermocouple assembly (410) within the bore (162) may be further supplemented by an adhesive (427) to adhere the thermocouple assembly (410) relative to the distal end member (142). In some cases where an adhesive is used, and although not shown in this figure, at least some of the adhesive may occupy the space formed between the folded lateral portion (418) and the underside of the third trace (421) and the base layer (417) (or the underside of an additional electrical insulating layer (not shown) positioned below the third trace (421)). By way of example only, such an adhesive may be provided via a thermoplastic polyurethane elastomer introduced into the bore (162) after the thermocouple assembly (410) has been fully positioned in the bore (162). By way of another example only, such a thermoplastic polyurethane elastomer may be doped with diamond powder and may be cured with ultraviolet light. Alternatively, any other suitable type of adhesive may be used, and any other suitable process may be used to bond the thermocouple assembly (410) to the distal end member (142).
[0048] VI. Fourth example of flexible circuits Figures 12 to 13A fourth example of a flexible circuit (500) is shown, which is substantially identical in form and function to flexible circuits (200, 300, 400) except for any differences described below. Therefore, flexible circuit (200) can be replaced by flexible circuit (500). Like flexible circuits (200, 300, 400), the flexible circuit (500) of this example includes a thermocouple assembly (510) comprising a first conductive trace (512), a second conductive trace (515), and a third conductive trace (521). The first and second traces (512, 515) extend along the upper surface of an electrically insulating substrate layer (517). By way of example only, the substrate layer (517) may comprise polyimide and / or any other suitable material. The third trace (521) extends along the lower surface of the substrate layer (517). The traces (512, 515, 521) and the base layer (517) extend along the length of the sheath (122).
[0049] The distal end of the first trace (512) includes a first thermal contact (513), and the distal end of the second trace (515) includes a second thermal contact (516). The first thermal contact (513) is electrically coupled to the third trace (521) via a bonding portion (523); and the second thermal contact (516) is electrically coupled to the third trace (521) via a similar bonding portion (not shown). The bonding portion (523) extends through the entire thickness of the substrate layer (517). In this example, each of the first trace (512) (including the first thermal contact (513)) and the second trace (515) (including the second thermal contact (516)) contains a first conductive material (e.g., copper, etc.), while the third trace (521) contains a second conductive material (e.g., constantan or a copper-nickel alloy, etc.). Due to the differences in conductive materials, temperature changes at the junction (523) will provide temperature gradients between the first trace (512) and the third trace (521) and between the second trace (515) and the third trace (521), respectively. These temperature gradients can generate thermoelectric voltages. The thermocouple assembly (510) can therefore provide temperature sensing in a manner similar to that described above with respect to the thermocouple assembly (210).
[0050] like Figure 12A and Figure 13As shown, an electrically insulating coating (529) may be positioned above at least a portion of the thermal contacts (513, 516) and the traces (512, 515). In some cases, the coating (529) extends further along the length of the traces (512, 515). The coating (529) electrically insulates the traces (512, 515) and the thermal contacts (513, 516) relative to the distal end member (142). However, the coating (529) is thermally conductive, allowing the thermal contacts (513, 516) to be in thermal communication with the distal end member (142). Specifically, the thermal contacts (513, 516) may thermally contact the inner sidewall of the hole (162) without being electrically connected to the inner sidewall of the hole (162), while maintaining thermal communication with the inner sidewall of the hole (162).
[0051] Thermal contacts (513, 516) are positioned on the distal portion (518) of the base layer (517) in the flexible circuit (500) of this example. Figure 12A As shown, the distal portion (518) can be folded in the proximal direction before entering the thermocouple assembly (510) insertion hole (162). The folded distal portion (518) can act as a spring, similar to the partially compressed spacer layer (221) of a flexible circuit (200), to elastically bias the thermocouple assembly (510) radially outward relative to the central longitudinal axis (LL). This effect, in turn, minimizes the distance between the thermal contacts (513, 516) and the outer surface of the cylindrical body (156), which maximizes the sensitivity of the thermal contacts (513, 516) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). This, in turn, maximizes the sensitivity of the joints (323, 325) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). Therefore, the folded distal portion (518) can promote thermal conductivity between the thermocouple assembly (510) and the cylindrical body (156).
[0052] Furthermore, the folded distal portion (518) can tend to provide fixation of the thermocouple assembly (510) within the bore (162) by expanding the effective cross-sectional profile of the thermocouple assembly (510). In some cases, the elastic bias of the folded distal portion (518) towards the flat / unfolded construction pushes the distal portion (518) against the inner sidewall of the bore (162), thereby enhancing friction to fix the thermocouple assembly (510) within the bore (162).
[0053] The positioning and fixation of the thermocouple assembly (510) within the hole (162) may be further supplemented by an adhesive (527) to adhere the flexible circuit (500) relative to the distal end member (142). In some cases where an adhesive is used, and although not shown in this figure, at least some of the adhesive may occupy the space formed between the folded distal portion (518) and the underside of the third trace (521) and the base layer (517) (or the underside of an additional electrical insulating layer (not shown) positioned below the third trace (521)). By way of example only, such an adhesive may be provided via a thermoplastic polyurethane elastomer introduced into the hole (162) after the thermocouple assembly (510) has been fully positioned in the hole (162). By way of another example only, such a thermoplastic polyurethane elastomer may be doped with diamond powder and may be cured with ultraviolet light. Alternatively, any other suitable type of adhesive may be used, and any other suitable process may be used to bond the thermocouple assembly (510) to the distal end member (142).
[0054] VII. Fifth example of flexible circuits Figures 14 to 15 A fifth example of a flexible circuit (600) is shown, which is substantially identical in form and function to flexible circuits (200, 300, 400, 500) except for any differences described below. Therefore, flexible circuit (200) can be replaced by flexible circuit (600). Like flexible circuit (200), the flexible circuit (600) of this example includes a thermocouple assembly (610) comprising a first conductive trace (612), a second conductive trace (615), and a third conductive trace (621). The first and second traces (612, 615) extend along the upper surface of an electrically insulating substrate layer (617). By way of example only, the substrate layer (617) may comprise polyimide and / or any other suitable material. The third trace (621) extends along the lower surface of the substrate layer (617). The traces (612, 615, 621) and the base layer (617) extend along the length of the sheath (122).
[0055] The distal end of the first trace (612) includes a first thermal contact (613), and the distal end of the second trace (615) includes a second thermal contact (616). The first thermal contact (613) is electrically coupled to the third trace (621) via a bonding portion (not shown); and the second thermal contact (616) is electrically coupled to the third trace (621) via a bonding portion (625). The bonding portion (625) extends through the entire thickness of the substrate layer (617). In this example, each of the first trace (612) (including the first thermal contact (613)) and the second trace (615) (including the second thermal contact (616)) contains a first conductive material (e.g., copper, etc.), while the third trace (621) contains a second conductive material (e.g., constantan or a copper-nickel alloy, etc.). Due to the differences in conductive materials, temperature changes at the junction (625) will provide temperature gradients between the first trace (612) and the third trace (621), and between the second trace (615) and the third trace (621), respectively. These temperature gradients can generate thermoelectric voltages. The thermocouple assembly (610) can therefore provide temperature sensing in a manner similar to that described above with respect to the thermocouple assembly (210).
[0056] like Figure 14A and Figure 15 As shown, an electrically insulating coating (629) may be positioned above at least a portion of the thermal contacts (613, 616) and the traces (612, 615). In some cases, the coating (629) extends further along the length of the traces (612, 615). The coating (629) electrically insulates the traces (612, 615) and the thermal contacts (613, 616) relative to the distal end member (142). However, the coating (629) is thermally conductive, allowing the thermal contacts (613, 616) to be in thermal communication with the distal end member (142). Specifically, the thermal contacts (613, 616) may thermally contact the inner sidewall of the hole (162) without being electrically connected to the inner sidewall of the hole (162), while maintaining thermal communication with the inner sidewall of the hole (162).
[0057] The flexible circuit (600) of this example also includes a lateral portion (618) of the substrate layer (617) that laterally projects relative to an adjacent portion of the substrate layer (617). Thermal contacts (613, 616) are positioned on the adjacent portion of the substrate layer (617) such that the thermal contacts (613, 616) are located on the side of the lateral portion (618), wherein the distal portions of traces (612, 615) extend along the substrate layer (617) to reach the thermal contacts (613, 616). A third trace (621) extends along the lateral portion (618). Figures 14A to 15As shown, the lateral portion (618) is folded to position the lateral portion (618) below an adjacent region of the base layer (617). The folded lateral portion (618) can act as a spring, similar to the partially compressed spacer layer (221) of the flexible circuit (200), the folded distal portion (318) of the flexible circuit (300), and the folded lateral portion (418) of the flexible circuit (400), to elastically bias the thermocouple assembly (610) radially outward relative to the central longitudinal axis (LL). This effect, in turn, minimizes the distance between the thermal contacts (613, 616) and the outer surface of the cylindrical body (156), which maximizes the sensitivity of the thermal contacts (613, 616) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). This, in turn, maximizes the sensitivity of the joint (625) to the temperature of the cylindrical body (156) and the tissue in contact with the cylindrical body (156). Thus, the folded lateral portion (618) promotes thermal conductivity between the thermocouple assembly (610) and the cylindrical body (156).
[0058] Furthermore, the folded lateral portion (618) tends to provide fixation of the thermocouple assembly (610) within the bore (162) by expanding the effective cross-sectional profile of the thermocouple assembly (610). In some cases, the elastic bias of the folded lateral portion (618) pushes the lateral portion (618) toward the flat / unfolded configuration, causing the lateral portion (618) to abut against the inner sidewall of the bore (162), thereby enhancing friction to fix the thermocouple assembly (610) within the bore (162).
[0059] The positioning and fixation of the thermocouple assembly (610) within the bore (162) may be further supplemented by an adhesive (627) to adhere the thermocouple assembly (610) relative to the distal end member (142). In some cases where an adhesive is used, and although not shown in this figure, at least some of the adhesive may occupy the space formed between the folded lateral portion (618) and the underside of the third trace (621) and the base layer (617) (or the underside of an additional electrical insulating layer (not shown) positioned below the third trace (621)). By way of example only, such an adhesive may be provided via a thermoplastic polyurethane elastomer introduced into the bore (162) after the thermocouple assembly (610) has been fully positioned in the bore (162). By way of another example only, such a thermoplastic polyurethane elastomer may be doped with diamond powder and may be cured with ultraviolet light. Alternatively, any other suitable type of adhesive may be used, and any other suitable process may be used to bond the thermocouple assembly (610) to the distal end member (142).
[0060] VII. Examples of Combinations The following examples illustrate various non-exhaustive ways in which the teachings herein can be combined or applied. It should be understood that the following examples are not intended to limit the scope of any claims that may be provided at any time in this patent application or a subsequent filing thereof. No disclaimer is intended. The following examples are provided merely for illustrative purposes. It is contemplated that the various teachings herein may be arranged and applied in a variety of other ways. It is also contemplated that some variations may omit certain features mentioned in the following examples. Therefore, none of the aspects or features mentioned below should be considered definitive unless otherwise expressly indicated by the inventor or a successor with an interest in the inventor at a later date. If any claim set forth in this patent application or a subsequent filing related to this patent application includes additional features beyond those mentioned below, such additional features should not be presumed to have been added for any reason related to patentability.
[0061] Example 1 An apparatus comprising: (a) a shaft assembly having a distal end; (b) an end effector positioned at the distal end of the shaft assembly, the end effector including an end member operable to apply electrical energy to tissue, the end member defining an orifice having an internal sidewall; and (c) a flexible circuit including a thermocouple positioned within the orifice of the end member, the thermocouple configured to sense a temperature of the end member, the flexible circuit further including a deformable feature that resiliently pushes the thermocouple toward the internal sidewall of the orifice.
[0062] Example 2 According to the device of Embodiment 1, the flexible circuit further includes: (i) a first trace extending to the thermocouple, (ii) a second trace extending to the thermocouple, and (iii) an insulating layer configured to electrically insulate the first trace and the second trace relative to the end member.
[0063] Example 3 The device according to any one of Embodiments 1 to 2 further includes an adhesive, via which the thermocouple is fixed inside the hole of the end member.
[0064] Example 4 According to any one of Embodiments 1 to 3, the deformable feature includes a deformable spacer layer.
[0065] Example 5 According to any one of embodiments 1 to 4, the flexible circuit further includes a flexible substrate, the deformable feature including a distal portion of the flexible substrate, the distal portion being configured to extend distally relative to the thermocouple, the distal portion being bent proximally to elastically push the thermocouple toward the inner sidewall of the aperture.
[0066] Example 6 According to any one of embodiments 1 to 5, the flexible circuit further includes a flexible substrate, the deformable feature including a lateral portion of the flexible substrate, the lateral portion being configured to extend laterally relative to the thermocouple, the distal portion being bent inward to elastically push the thermocouple toward the inner sidewall of the aperture.
[0067] Example 7 According to any one of embodiments 1 to 6, the flexible circuit further includes: (i) a first conductive feature portion comprising a first type of conductive material; (ii) a second conductive feature portion comprising a second type of conductive material, the second type of conductive material being different from the first type of conductive material; (iii) an electrically insulating layer separating the first conductive feature portion from the second conductive feature portion; and (iv) a first coupling portion electrically coupling the first conductive feature portion to the second conductive feature portion.
[0068] Example 8 According to the device described in Embodiment 7, the first type of conductive material includes copper, and the second type of conductive material includes constantan.
[0069] Example 9 In the device according to any one of Examples 7 to 8, the electrical insulating layer comprises polyimide.
[0070] Example 10 According to any one of embodiments 7 to 9, the flexible circuit further includes: (i) a third conductive feature portion comprising a conductive material of the first type, the electrically insulating layer separating the third conductive feature portion from the second conductive feature portion, and (ii) a second coupling portion that electrically couples the third conductive feature portion to the second conductive feature portion.
[0071] Example 11 According to any one of embodiments 1 to 10, the flexible circuit further includes: (i) a distal portion along which the thermocouple is positioned, and (ii) a proximal portion including an arrangement of pads electrically connected to the thermocouple.
[0072] Example 12 According to the device of embodiment 11, the device further includes a printed circuit board, the printed circuit board including an arrangement of contact pads, each pad of the flexible circuit being electrically connected to a corresponding contact pad of the arrangement of contact pads.
[0073] Example 13 The device according to any one of embodiments 1 to 12 further includes a handle, from which the flexible circuit extends through the shaft assembly and to the end actuator.
[0074] Example 14 According to any one of embodiments 1 to 13, the end effector further includes an insulating layer positioned between the end member and the thermocouple, thereby electrically insulating the thermocouple from the end member.
[0075] Example 15 According to any one of Embodiments 1 to 14, the conduit further includes a plurality of thermocouples, the plurality of thermocouples including the thermocouples of the flexible circuit, the plurality of thermocouples being angularly spaced apart from each other within the end member.
[0076] Example 16 An apparatus comprising: (a) a handle including a printed circuit board; (b) a shaft assembly extending distally relative to the handle, the shaft assembly having a distal end; (c) an end effector positioned at the distal end of the shaft assembly; and (d) a flexible circuit extending along the shaft assembly, the flexible circuit having a thermocouple positioned within the end effector, the thermocouple being configured to sense the temperature of the end effector, the distal portion of the flexible circuit deforming within the end effector to elastically promote thermal conductivity between the thermocouple and the end effector, the flexible circuit being electrically connected to the printed circuit board.
[0077] Example 17 According to the device of embodiment 16, the distal portion includes one or more of the following: a compressible spacer, a foldable distal protrusion, or a foldable lateral protrusion.
[0078] Example 18 A method for attaching a thermocouple assembly to an end effector of a conduit, the thermocouple assembly being part of a flexible circuit including a deformable member configured to transition from a non-deformable state to a deformable state, the deformable member being elastically biased toward the non-deformable state, the method comprising: (a) deforming the deformable member of the flexible circuit to provide the deformable member in the deformable state; (b) positioning the thermocouple and the deformable member in an aperture of the end effector while the deformable member is in the deformable state, the deformable member elastically pushing the thermocouple toward a sidewall of the aperture; and (c) fixing the flexible circuit relative to the end effector while the thermocouple and the deformable member are located in the aperture of the end effector.
[0079] Example 19 According to the method of embodiment 18, the deformable member includes a spacer layer, and the action of deforming the deformable member includes compressing at least a portion of the spacer layer.
[0080] Example 20 According to any one of Embodiments 18 to 19, the deformable member includes a protruding portion of a flexible substrate that protrudes distally or laterally relative to an adjacent region of the flexible substrate, and the action of deforming the deformable member includes folding the protruding portion.
[0081] VII. Miscellaneous Any of the devices described herein may be cleaned and sterilized before and / or after the procedure. In one sterilization technique, the device is placed in a closed and sealed container such as a plastic bag or a TYVEK bag. The container and device may then be placed in a radiation field capable of penetrating the container, such as gamma radiation, X-rays, or high-energy electrons. The radiation kills bacteria on the device and in the container. The sterilized device may then be stored in a sterile container for later use. Any other techniques known in the art may also be used to sterilize the device, including but not limited to beta or gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, and gas-phase sterilization (with or without gaseous plasma or vapor).
[0082] It should be understood that any of the examples described herein may also include various other features in addition to those described above or as alternatives thereto. By way of example only, any of the examples described herein may also include one or more features disclosed in any of the various references incorporated herein by reference.
[0083] It should be understood that any or more of the teachings, expressions, embodiments, examples, etc., described herein can be combined with any or more of the other teachings, expressions, embodiments, examples, etc., described herein. Therefore, the aforementioned teachings, expressions, embodiments, examples, etc., should not be considered in isolation from each other. Various suitable ways in which the teachings herein can be combined will be apparent to those skilled in the art upon reference to the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
[0084] It should be understood that any patent, patent publication, or other public material allegedly incorporated herein by reference, whether in whole or in part, is incorporated only to the extent that the incorporated material does not conflict with the existing definitions, statements, or other public materials listed in this disclosure. Therefore, and to the extent necessary, the disclosures expressly listed herein replace any conflicting material incorporated herein by reference. Any material, or part thereof, allegedly incorporated herein by reference but conflicting with the existing definitions, statements, or other public materials listed herein, will be incorporated only to the extent that the incorporated material does not conflict with the existing public materials.
[0085] While various embodiments of the invention have been shown and described, further improvements to the methods and systems described herein can be achieved by suitable modifications made by those skilled in the art without departing from the scope of the invention. Several such possible modifications have been mentioned, and other modifications will be apparent to those skilled in the art. For example, the examples, types, geometries, materials, dimensions, ratios, steps, etc., discussed above are illustrative and not essential. Therefore, the scope of the invention should be considered in accordance with the following claims and should be understood as not being limited to the details of the structures and operations shown and described in the specification and drawings.
Claims
1. An apparatus, the apparatus comprising: (a) A shaft assembly having a distal end; (b) An end effector located at the distal end of the shaft assembly, the end effector including an end member operable to apply electrical energy to tissue, the end member defining an aperture having an internal sidewall; and (c) A flexible circuit including a thermocouple positioned within the aperture of the end member, the thermocouple being configured to sense the temperature of the end member, the flexible circuit further including a deformable feature that elastically pushes the thermocouple toward the inner sidewall of the aperture.
2. The device according to claim 1, wherein the flexible circuit further comprises: (i) A first trace extending to the thermocouple. (ii) A second trace, the second trace extending to the thermocouple, and (iii) An insulating layer configured to electrically insulate the first trace and the second trace relative to the end member.
3. The device of claim 1, further comprising an adhesive, wherein the thermocouple is secured within the hole in the end member via the adhesive.
4. The device according to claim 1, wherein the deformable feature includes a deformable spacer layer.
5. The device of claim 1, wherein the flexible circuit further comprises a flexible substrate, the deformable feature comprising a distal portion of the flexible substrate, the distal portion being configured to extend distally relative to the thermocouple, the distal portion being bent proximally to elastically push the thermocouple toward the inner sidewall of the aperture.
6. The device of claim 1, wherein the flexible circuit further comprises a flexible substrate, the deformable feature comprising a lateral portion of the flexible substrate, the lateral portion being configured to extend laterally relative to the thermocouple, the distal portion being bent inward to elastically push the thermocouple toward the inner sidewall of the aperture.
7. The device according to claim 1, wherein the flexible circuit further comprises: (i) A first conductive feature portion, the first conductive feature portion comprising a first type of conductive material. (ii) A second conductive feature portion, the second conductive feature portion comprising a second type of conductive material, the second type of conductive material being different from the first type of conductive material. (iii) An electrically insulating layer, said electrically insulating layer separating the first conductive feature from the second conductive feature, and (iv) A first coupling portion, wherein the first coupling portion electrically couples the first conductive feature portion to the second conductive feature portion.
8. The device according to claim 7, wherein the conductive material of the first type comprises copper, and the conductive material of the second type comprises constantan.
9. The device according to claim 7, wherein the electrical insulating layer comprises polyimide.
10. The device according to claim 7, wherein the flexible circuit further comprises: (i) A third conductive feature, the third conductive feature comprising a conductive material of the first type, the electrically insulating layer separating the third conductive feature from the second conductive feature, and (ii) A second coupling portion, wherein the third conductive feature portion is electrically coupled to the second conductive feature portion.
11. The device according to claim 1, wherein the flexible circuit further comprises: (i) The distal portion, along which the thermocouple is positioned, and (ii) A proximal portion, the proximal portion including an arrangement of pads that are electrically connected to the thermocouple.
12. The apparatus of claim 11, further comprising a printed circuit board including an arrangement of contact pads, each pad of the flexible circuit being electrically connected to a corresponding contact pad of the arrangement of contact pads.
13. The device of claim 1, further comprising a handle, the flexible circuit extending from the handle through the shaft assembly and reaching the end actuator.
14. The device of claim 1, wherein the end effector further comprises an insulating layer positioned between the end member and the thermocouple, thereby electrically insulating the thermocouple from the end member.
15. The device of claim 1, wherein the conduit further comprises a plurality of thermocouples, the plurality of thermocouples including the thermocouples of the flexible circuit, the plurality of thermocouples being angularly spaced apart from each other within the end member.
16. An apparatus, the apparatus comprising: (a) A handle, the handle including a printed circuit board; (b) A shaft assembly extending distally relative to the shank, the shaft assembly having a distal end; (c) An end effector, the end effector being positioned at the distal end of the shaft assembly; and (d) A flexible circuit extending along the shaft assembly, the flexible circuit having a thermocouple positioned within the end effector, the thermocouple being configured to sense the temperature of the end effector, a distal portion of the flexible circuit deforming within the end effector to elastically promote thermal conductivity between the thermocouple and the end effector, the flexible circuit being electrically connected to the printed circuit board.
17. The device of claim 16, wherein the distal portion comprises one or more of the following: a compressible spacer, a foldable distal protrusion, or a foldable lateral protrusion.
18. A method of attaching a thermocouple assembly to an end actuator of a conduit, the thermocouple assembly being part of a flexible circuit including a deformable member configured to transition from a non-deformable state to a deformable state, the deformable member being elastically biased toward the non-deformable state, the method comprising: (a) Deform the deformable member of the flexible circuit to provide the deformable member in the deformed state; (b) When the deformable member is in the deformed state, the thermocouple and the deformable member are positioned in the hole of the end effector, and the deformable member elastically pushes the thermocouple toward the sidewall of the hole; as well as (c) When the thermocouple and the deformable member are located in the hole of the end effector, the flexible circuit is fixed relative to the end effector.
19. The method of claim 18, wherein the deformable member includes a spacer layer, and the action of deforming the deformable member includes compressing at least a portion of the spacer layer.
20. The method of claim 18, wherein the deformable member includes a protruding portion of a flexible substrate that protrudes distally or laterally relative to an adjacent region of the flexible substrate, and the action of deforming the deformable member includes folding the protruding portion.
Citation Information
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