Embedding electronic component circuit in elongate flexible device

Abstract

The invention relates to an elongated device and a manufacturing method thereof. The elongate device has an elongate body and a sensor array having a flexible printed circuit (FPC) and a plurality of electronic components positioned on the FPC. The sensor array is helically wound on the elongated body, and the plurality of electronic components are aligned with respect to a longitudinal axis of the elongated body.

Description

[0001] Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 415,696, filed on October 13, 2022, and further claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 536,465, filed on September 4, 2023. The contents of these two U.S. Provisional Patent Applications are incorporated herein by reference in their entirety. Technical Field

[0003] Some embodiments of the present invention relate to flexible printed circuits, and more specifically but not exclusively, to flexible printed circuits for elongated devices. Background Art

[0004] Some medical devices contain electronic components. For example, the tip of many endoscopes is equipped with an electrical image sensor, which is usually equipped with one or more light-emitting diodes (LEDs). In this case, for example, the image sensor and the LEDs are usually powered by a power source located outside the endoscope and residing in a host station, and are connected to the endoscope using electrical conductors such as insulated wires inside a cable. The sensor image is streamed to the host station using one or more electrical conductors such as insulated shielded wires.

[0005] There are other types of devices that utilize passive electronic components. For example, in a traditional electromagnetic (EM)-based tracking system, an EM coil-based sensor can include ultra-fine enameled copper wire wound around a small magnetic core (e.g., ferrite) and placed at the tip of the EM catheter being tracked. Then, the two ends of the copper wire can extend in a twisted pair manner and return to the host system as differential signals. Typically, each EM coil requires two differential wires. For example, a standard 3D EM coil-based sensor consists of three vertical coils with a total of six wires. For standard multi-sensor EM applications, the number of wires grows linearly with the number of EM sensors in the device.

[0006] There are also other types of devices and tools that contain electronic components and sensors, such as but not limited to: pressure sensors, strain sensors, force sensors, imaging sensors, etc. For example, in the medical field, such devices and tools can be: intravascular ultrasound devices (such as REBUS, IVUS); other intravascular imaging (such as OCT and spectroscopic devices); ablation devices (e.g., RF probes, microwave probes, cryoablation devices); electrocoagulation and foreign body removal; flexible intravascular surgical tools; ultrasonic tissue fragmentation and other types of therapeutic ultrasound devices; electrocautery. Most electrical devices and tools require power supply, connection, and placement of electrical components inside the device.

[0007] Additional background art includes U.S. Patent No. 11,712,309, which discloses an EM shape sensor consisting of a sensor array made up of multiple discrete digital 3D magnetometers assembled on a flexible printed circuit (FPC). The sensor array can be embedded in a manual or robotic endoscope (or other tubular device) to enable EM shape sensing of the endoscope. SUMMARY OF THE INVENTION

[0008] The following is a non-exclusive list of some examples including embodiments of the present invention. The present invention also includes embodiments with fewer features than all the features in the examples and embodiments using features from multiple examples, even if not explicitly listed below.

[0009] Example 1. An elongate device comprising:

[0010] a. A handle;

[0011] b. An elongate body having a proximal end and a distal end; the proximal end being connected to the handle;

[0012] c. One or more sensor arrays, each sensor array comprising:

[0013] i. One or more flexible printed circuits (FPCs); and

[0014] ii. A plurality of electronic components positioned on the one or more FPCs;

[0015] The one or more sensor arrays are helically wound around the elongate body; and wherein the plurality of electronic components are aligned with respect to the longitudinal axis of the elongate body.

[0016] Example 2. The elongate device according to Example 1, wherein the plurality of electronic components include one or more of sensors, capacitors, resistors, integrated circuits, electromagnetic sensors, digital sensors, digital magnetometers, and optical sensors.

[0017] Example 3. The elongate device according to Example 1 or Example 2, wherein each of the plurality of electronic components is oriented on the one or more FPCs at an orientation angle with respect to the longitudinal axis of the one or more FPCs.

[0018] Example 4. The elongate device according to any one of Examples 1-3, wherein the orientation angle is configured such that when the one or more FPCs are helically wound around the elongate body, each of the plurality of electronic components is aligned with respect to the longitudinal axis of the elongate body.

[0019] Example 5. The elongate device according to any one of Examples 1-4, wherein the orientation angle is opposite to the winding angle of the one or more sensor arrays.

[0020] Example 6. The elongate device according to any one of Examples 1-5, wherein the one or more sensor arrays are helically wound around the elongate body, characterized by the winding angle.

[0021] Example 7. The elongate device according to any one of Examples 1-6, wherein the winding angle is defined by the angle between the longitudinal axis of the one or more FPCs and the longitudinal axis of the elongate body.

[0022] Example 8. The elongate device according to any one of Examples 1-7, wherein the winding angle is 45 degrees.

[0023] Example 9. The elongate device according to any one of Examples 1-8, wherein the winding angle is from 30 degrees to 60 degrees.

[0024] Example 10. The elongate device according to any one of Examples 1-9, wherein the one or more FPCs include a proximal end and a distal end; and wherein the proximal end and / or the distal end are characterized by being diagonally cut at the same angle as the winding angle.

[0025] Example 11. The elongate device according to any one of Examples 1-10, wherein the elongate body is characterized by rigidity, and wherein the winding angle affects the rigidity.

[0026] Example 12. The elongate device according to any one of Examples 1-11, wherein the rigidity increases when the winding angle approaches 90 degrees.

[0027] Example 13. The elongate device according to any one of Examples 1-12, wherein the rigidity increases when the winding angle approaches 0 degrees.

[0028] Example 14. The elongate device according to any one of Examples 1-13, wherein the winding angle is fixed along the entire length of the elongate body.

[0029] Example 15. The elongate device according to any one of Examples 1-14, wherein the winding angle varies along the length of the elongate body.

[0030] Example 16. The elongate device according to any one of Examples 1-15, wherein all of the electronic components among the plurality of electronic components are located on one side of the one or more FPCs.

[0031] Example 17. The elongate device according to any one of Examples 1-16, wherein some of the plurality of electronic components are located on one side of the one or more FPCs, and other of the plurality of electronic components are located on the other side of the one or more FPCs.

[0032] Example 18. The elongate device according to any one of Examples 1-17, wherein the one or more sensor arrays are wound in a spiral around the elongate body, and at least a portion of the plurality of electronic components faces the elongate body.

[0033] Example 19. The elongate device according to any one of Examples 1-18, wherein the elongate body includes one or more openings; and wherein at least a portion of the plurality of electronic components facing the elongate body is inserted into the one or more openings.

[0034] Example 20. The elongate device according to any one of Examples 1-19, wherein at least a portion of the plurality of electronic components is shielded from external electrical interference when inserted into the one or more openings.

[0035] Example 21. The elongate device according to any one of Examples 1-20, wherein the one or more FPCs are adhered to the elongate body by at least one adhesive.

[0036] Example 22. The elongate device according to any one of Examples 1-21, wherein the one or more FPCs are widened at positions on the one or more FPCs around each of the plurality of electronic components.

[0037] Example 23. The elongate device according to any one of Examples 1-22, wherein the one or more FPCs are narrowed between positions on the one or more FPCs where each of the plurality of electronic components is located.

[0038] Example 24. The elongate device according to any one of Examples 1-23, further comprising one or more conductive wires wound in a spiral around the elongate body.

[0039] Example 25. The elongate device according to any one of Examples 1-24, wherein the positions of the one or more conductive wires wound in a spiral around the elongate body are different from the positions of the one or more sensor arrays wound in a spiral around the elongate body.

[0040] Example 26. The elongate device according to any one of Examples 1-25, wherein the one or more conductive wires are one or more insulated conductive wires.

[0041] Example 27. The elongate device according to any one of Examples 1-26, wherein one or more electronic components are connected to the one or more conductive wires.

[0042] Example 28. The elongate device according to any one of Examples 1-27, wherein the one or more conductive wires are printed conductive ink.

[0043] Example 29. The elongate device according to any one of Examples 1-28, wherein the electronic components from the plurality of electronic components are located on a different FPC from the one or more FPCs.

[0044] Example 30. The elongate device according to any one of Examples 1-29, further comprising a dedicated FPC for the optical sensor.

[0045] Example 31. The elongate device according to any one of Examples 1-30, wherein all of the electronic components of the plurality of electronic components are located on the same FPC.

[0046] Example 32. The elongate device according to any one of Examples 1-31, wherein the one or more FPCs include small copper weights.

[0047] Example 33. The elongate device according to any one of Examples 1-32, wherein the one or more FPCs include small holes to allow plastic material to flow through the one or more FPCs during a reflow process.

[0048] Example 34. The elongate device according to any one of Examples 1-33, wherein at least some of the plurality of electronic components are SMT components; and wherein the SMT components are soldered to plated holes in the one or more FPCs.

[0049] Example 35. The elongate device according to any one of Examples 1-34, wherein the one or more FPCs include a solder mask between pads.

[0050] Example 36. The elongate device according to any one of Examples 1-35, further comprising at least one camera.

[0051] Example 37. The elongate device according to any one of Examples 1-36, wherein the power supply, clock, and data signals of the camera are disposed on the same FPC together with the one or more sensor arrays.

[0052] Example 38. The elongate device according to any one of Examples 1-37, wherein the power supply, clock, and data signals of the camera are disposed on a separate dedicated FPC.

[0053] Example 39. The elongate device according to any one of Examples 1 - 38, wherein the camera clock and the digital / analog data signals are shielded from electrical interference.

[0054] Example 40. The elongate device according to any one of Examples 1 - 39, further comprising a dedicated camera power supply and a ground plane, the dedicated camera power supply and the ground plane being configured to shield the elongate device from other camera signals.

[0055] Example 41. The elongate device according to any one of Examples 1 - 40, wherein the one or more FPCs are multi-layer FPCs.

[0056] Example 42. The elongate device according to any one of Examples 1 - 41, wherein the one or more FPCs contain only camera traces but do not contain actual camera components.

[0057] Example 43. The elongate device according to any one of Examples 1 - 42, further comprising an electrical connector attached to at least one of the proximal and distal ends of the one or more FPCs.

[0058] Example 44. The elongate device according to any one of Examples 1 - 43, wherein the one or more FPCs include a male connector on at least one of the proximal and distal ends of the one or more FPCs.

[0059] Example 45. The elongate device according to any one of Examples 1 - 44, further comprising an Inter-Integrated Circuit (I2C) or an Improved Inter-Integrated Circuit (I3C) bus.

[0060] Example 46. The elongate device according to any one of Examples 1 - 45, wherein the one or more FPCs are connected to components in the handle.

[0061] Example 47. The elongate device according to any one of Examples 1 - 46, wherein the one or more FPCs include one or more creases in one or more connection regions between the solder components.

[0062] Example 48. The elongate device according to any one of Examples 1 - 47, wherein the one or more creases include a Kresling Pattern.

[0063] Example 49. The elongate device according to any one of Examples 1 - 48, wherein the one or more creases include a concertina-type hinge.

[0064] Example 50. The elongated device according to any one of Examples 1-49, wherein the one or more FPCs are not used, and wherein the printed circuit design is printed directly onto the elongated body of the elongated device.

[0065] Example 51. The elongated device according to any one of Examples 1-50, wherein the printed circuit design includes only conductors.

[0066] Example 52. The elongated device according to any one of Examples 1-51, wherein the printed circuit design includes conductors and components.

[0067] Example 53. The elongated device according to any one of Examples 1-52, wherein the FPC is wound helically while maintaining the flexibility of the elongated body.

[0068] Example 54. The elongated device according to any one of Examples 1-53, further comprising a plurality of small-diameter shielded cables wound around the elongated body.

[0069] Example 55. The elongated device according to any one of Examples 1-54, wherein the plurality of shielded cables are stranded into a single stranded cable group.

[0070] Example 56. The elongated device according to any one of Examples 1-55, wherein the plurality of shielded cables are paired and stranded.

[0071] Example 57. The elongated device according to any one of Examples 1-56, wherein the plurality of shielded cables are small-diameter enameled copper wires.

[0072] Example 58. The elongated device according to any one of Examples 1-57, wherein the first FPC layer includes assembled components and the second FPC layer includes data signals.

[0073] Example 59. The elongated device according to any one of Examples 1-58, wherein power signals and ground signals are arranged as two planes on the FPC.

[0074] Example 60. The elongated device according to any one of Examples 1-59, wherein power signals and ground signals are arranged on the top layer.

[0075] Example 61. The elongated device according to any one of Examples 1-60, wherein each of the digital magnetometers uses four pads: voltage, ground, clock, and data.

[0076] Example 62. An elongated device, comprising:

[0077] a. A handle;

[0078] b. An elongated body that includes a proximal end and a distal end; the proximal end is connected to the handle;

[0079] c. One or more sensor arrays, each sensor array comprising:

[0080] i. One or more printed circuits; and

[0081] ii. A plurality of electronic components positioned on said one or more printed circuits;

[0082] Said one or more sensor arrays are spirally wound around said elongated body; and wherein said plurality of electronic components are aligned relative to the longitudinal axis of said elongated body,

[0083] wherein the printed circuit design is directly printed onto the elongated body of said elongated device.

[0084] Example 63. A method of manufacturing an elongated device comprising one or more sensor arrays; said one or more sensor arrays comprising one or more flexible printed circuits (FPCs) and a plurality of electronic components positioned on said one or more FPCs; the method comprising spirally winding one or more sensor arrays around said elongated device;

[0085] wherein the method comprises positioning said plurality of electronic components along said one or more FPCs such that when said one or more sensor arrays are wound around said elongated device, said plurality of electronic components are aligned relative to the longitudinal axis of said elongated device.

[0086] Example 64. The method according to Example 63, wherein at least one of said FPCs has a spiral-shaped FPC design and can be spirally wound onto an elongated device.

[0087] Example 65. The method according to Example 63 or Example 64, wherein all of said plurality of electronic components are aligned relative to the longitudinal axis of said elongated device.

[0088] Example 66. The method according to any one of Examples 63-65, wherein said plurality of electronic components comprise one or more of sensors, capacitors, resistors, integrated circuits, electromagnetic sensors, digital sensors, digital magnetometers, and optical sensors.

[0089] Example 67. The method according to any one of Examples 63-66, further comprising orienting each of said plurality of electronic components at an orientation angle relative to the longitudinal axis of said one or more FPCs on said one or more FPCs.

[0090] Example 68. The method according to any one of Examples 63 - 67, wherein the orientation angle is configured such that when the one or more FPCs are helically wound around the elongate device, each of the plurality of electronic components is aligned relative to the longitudinal axis of the elongate body.

[0091] Example 69. The method according to any one of Examples 63 - 68, wherein the orientation angle is opposite to the winding angle of the one or more sensor arrays.

[0092] Example 70. The method according to any one of Examples 63 - 69, wherein the one or more sensor arrays are helically wound around the elongate body characterized by being helically wound at a winding angle.

[0093] Example 71. The method according to any one of Examples 63 - 70, wherein the winding angle is defined by the angle between the longitudinal axis of the one or more FPCs and the longitudinal axis of the elongate body.

[0094] Example 72. The method according to any one of Examples 63 - 71, wherein the winding angle is 45 degrees.

[0095] Example 73. The method according to any one of Examples 63 - 72, wherein the winding angle is from 30 degrees to 60 degrees.

[0096] Example 74. The method according to any one of Examples 63 - 73, wherein the one or more FPCs include a proximal end and a distal end; and wherein the proximal end and / or the distal end are characterized by being diagonally cut at the same angle as the winding angle.

[0097] Example 75. The method according to any one of Examples 63 - 74, wherein the elongate body is characterized by rigidity, and wherein the winding angle affects the rigidity.

[0098] Example 76. The method according to any one of Examples 63 - 75, wherein when the winding angle approaches 90 degrees, the rigidity increases.

[0099] Example 77. The method according to any one of Examples 63 - 76, wherein when the winding angle approaches 0 degrees, the rigidity increases.

[0100] Example 78. The method according to any one of Examples 63 - 77, wherein the winding angle is fixed along the entire length of the elongate body.

[0101] Example 79. The method according to any one of Examples 63 - 78, wherein the winding angle varies along the length of the elongate body.

[0102] Example 80. The method according to any one of Examples 63 - 79, wherein positioning the plurality of electronic components includes positioning all of the plurality of electronic components on one side of the one or more FPCs.

[0103] Example 81. The method according to any one of Examples 63 - 80, wherein positioning the plurality of electronic components includes positioning some of the plurality of electronic components on one side of the one or more FPCs while positioning other ones of the plurality of electronic components on the other side of the one or more FPCs.

[0104] Example 82. The method according to any one of Examples 63 - 81, wherein the helically winding includes winding the one or more sensor arrays around the elongate device with at least a portion of the plurality of electronic components facing the elongate device.

[0105] Example 83. The method according to any one of Examples 63 - 82, further comprising adding one or more openings along the elongate device; and further comprising inserting at least a portion of the plurality of electronic components facing the elongate body into the one or more openings.

[0106] Example 84. The method according to any one of Examples 63 - 83, further comprising shielding at least a portion of the plurality of electronic components from external electrical interference by inserting at least a portion of the plurality of electronic components into the one or more openings.

[0107] Example 85. The method according to any one of Examples 63 - 84, further comprising adhering the one or more FPCs to the elongate device by at least one adhesive.

[0108] Example 86. The method according to any one of Examples 63 - 85, further comprising widening the one or more FPCs around the locations where each of the plurality of electronic components is positioned on the one or more FPCs.

[0109] Example 87. The method according to any one of Examples 63 - 86, further comprising narrowing the one or more FPCs between the locations where each of the plurality of electronic components is positioned on the one or more FPCs.

[0110] Example 88. The method according to any one of Examples 63 - 87, further comprising helically winding one or more conductive wires around the elongate device.

[0111] Example 89. The method according to any one of Examples 63 - 88, wherein the one or more helically wound conductive wires are located at positions different from the positions of the one or more helically wound sensor arrays.

[0112] Example 90. The method according to any one of Examples 63 - 89, wherein the one or more conductive wires are one or more insulated conductive wires.

[0113] Example 91. The method according to any one of Examples 63 - 90, wherein one or more electronic components are connected to the one or more conductive wires.

[0114] Example 92. The method according to any one of Examples 63 - 91, wherein the one or more conductive wires are printed conductive ink.

[0115] Example 93. The method according to any one of Examples 63 - 92, wherein positioning the plurality of electronic components includes positioning at least a portion of the plurality of electronic components on a flexible printed circuit (FPC) different from the one or more FPCs.

[0116] Example 94. The method according to any one of Examples 63 - 93, further comprising providing a dedicated FPC for the optical sensor.

[0117] Example 95. The method according to any one of Examples 63 - 94, wherein positioning the plurality of electronic components includes positioning all of the plurality of electronic components on the same FPC.

[0118] Example 96. The method according to any one of Examples 63 - 95, further comprising adding small copper weight pieces to the one or more FPCs.

[0119] Example 97. The method according to any one of Examples 63 - 96, further comprising adding small holes to the one or more FPCs to allow plastic material to flow through the one or more FPCs during a reflow process.

[0120] Example 98. The method according to any one of Examples 63 - 97, wherein at least some of the plurality of electronic components are surface mount technology (SMT) components; and further comprising soldering the SMT components to plated holes in the one or more FPCs.

[0121] Example 99. The method according to any one of Examples 63 - 98, wherein the one or more FPCs include a solder mask between pads.

[0122] Example 100. The method according to any one of Examples 63 - 99, further comprising adding at least one camera.

[0123] Example 101. The method according to any one of Examples 63 - 100, further comprising placing a power supply, a clock, and data signals of a camera on the same FPC having the one or more sensor arrays.

[0124] Example 102. The method according to any one of Examples 63 - 101 further includes placing the power supply, clock, and data signals of the camera on a separate dedicated FPC.

[0125] Example 103. The method according to any one of Examples 63 - 102 further includes shielding the camera clock and digital / analog data signals from electrical interference.

[0126] Example 104. The method according to any one of Examples 63 - 103 further includes providing a dedicated camera power supply and ground plane configured to shield the elongated device from other camera signals.

[0127] Example 105. The method according to any one of Examples 63 - 104, wherein the one or more FPCs are multi - layer FPCs.

[0128] Example 106. The method according to any one of Examples 63 - 105, wherein the one or more FPCs contain only camera traces and do not contain actual camera components.

[0129] Example 107. The method according to any one of Examples 63 - 106 further includes an electrical connector attached to at least one of the proximal and distal ends of the one or more FPCs.

[0130] Example 108. The method according to any one of Examples 63 - 107 further includes providing male connectors for the one or more FPCs on at least one of the proximal and distal ends of the one or more FPCs.

[0131] Example 109. The method according to any one of Examples 63 - 108 further includes providing an Inter - Integrated Circuit (I2C) or Improved Inter - Integrated Circuit (I3C) bus.

[0132] Example 110. The method according to any one of Examples 63 - 109 further includes connecting the one or more FPCs to components in the handle.

[0133] Example 111. The method according to any one of Examples 63 - 110 further includes providing one or more creases for the one or more FPCs in one or more connection areas between the soldered components.

[0134] Example 112. The method according to any one of Examples 63 - 111, wherein the one or more creases include a Kresling pattern.

[0135] Example 113. The method according to any one of Examples 63 - 112, wherein the one or more creases include an accordion - type hinge.

[0136] Example 114. The method according to any one of Examples 63 - 113, wherein the method includes directly printing a printed circuit design onto the elongate device instead of using the one or more FPCs.

[0137] Example 115. The method according to any one of Examples 63 - 114, wherein the printed circuit design includes only conductors.

[0138] Example 116. The method according to any one of Examples 63 - 115, wherein the printed circuit design includes conductors and components.

[0139] Example 117. The method according to any one of Examples 63 - 116, wherein the winding is performed while maintaining the flexibility of the elongate device.

[0140] Example 118. The method according to any one of Examples 63 - 117, wherein the winding is performed manually.

[0141] Example 119. The method according to any one of Examples 63 - 118, wherein the winding is performed by a winding machine.

[0142] Example 120. The method according to any one of Examples 63 - 119, wherein the winding machine includes an adhesive dispenser, and the method includes applying an adhesive to the electronic circuit and / or applying an adhesive to the elongate device by the adhesive dispenser before the winding.

[0143] Example 121. The method according to any one of Examples 63 - 120, wherein the one or more FPCs are twisted about their own axes before being wound around the elongate device.

[0144] Example 122. The method according to any one of Examples 63 - 121, wherein the winding is performed on a template elongate device to generate a wound electronic circuit; and the method further includes transferring the wound electronic circuit into the elongate device.

[0145] Example 123. The method according to any one of Examples 63 - 122, wherein the applying of the adhesive to the electronic circuit is performed after the winding on the template elongate device.

[0146] Example 124. The method according to any one of Examples 63 - 123, wherein the plurality of sensors are positioned onto the one or more FPCs after the one or more FPCs are helically wound around the elongate device.

[0147] Example 125. The method according to any one of Examples 63 - 124, wherein the plurality of sensors are soldered to the one or more FCPs before the one or more FCPs are helically wound around the elongate device.

[0148] Example 126. The method according to any one of Examples 63 - 125, further comprising reflow soldering the pads after the winding.

[0149] Example 127. The method according to any one of Examples 63 - 126, wherein the reflow is performed by one or more of a soldering iron, a hot air gun, and a reflow oven.

[0150] Example 128. The method according to any one of Examples 63 - 127, further comprising automatically assembling the plurality of electronic components using a pick - and - place machine.

[0151] Example 129. The method according to any one of Examples 63 - 128, further comprising manually assembling the electronic components.

[0152] Example 130. The sensor array according to Example 1.

[0153] Example 131. The method of manufacturing a sensor array according to the method of Example 63.

[0154] Example 132. A winding machine configured to wind an electronic circuit into an elongate device, comprising:

[0155] a. A rotor configured to rotate the elongate device about the longitudinal axis of the elongate device;

[0156] b. A feeder for providing the electronic circuit during the winding operation;

[0157] c. A controller including instructions for rotating the rotor at a certain speed and for moving the feeder.

[0158] Example 133. The winding machine according to Example 132, wherein the winding machine includes an adhesive dispenser configured to apply an adhesive to the electronic circuit before winding the electronic circuit.

[0159] Example 134. The winding machine according to Example 132 or Example 133, wherein the electronic circuit includes a flexible printed circuit (FPC) and a plurality of sensors attached to the FPC; and wherein the FPC is fed into the winding machine by the feeder.

[0160] Example 135. The winding machine according to any one of Examples 132 - 134, wherein when the electronic circuit is wound around the elongated device in a spiral shape, the plurality of sensors on the FPC face the elongated device.

[0161] Example 136. The winding machine according to any one of Examples 132 - 135, wherein the plurality of sensors are oriented to face the elongated device such that the plurality of sensors are shielded from external electrical interference.

[0162] Example 137. The winding machine according to any one of Examples 132 - 136, wherein a conductive wire is fed into the winding machine.

[0163] Example 138. The winding machine according to any one of Examples 132 - 137, wherein the conductive wire is an insulated conductive wire.

[0164] Example 139. The winding machine according to any one of Examples 132 - 138, wherein the feeder is fixed and the elongated device rotates about its axis.

[0165] Example 140. The winding machine according to any one of Examples 132 - 139, wherein the elongated device is fixed and the feeder rotates around the device.

[0166] Example 141. The winding machine according to any one of Examples 132 - 140, wherein the feeder is configured to twist the electronic circuit about its own axis; and wherein the electronic circuit is twisted about its own axis before being wound around the elongated device.

[0167] Example 142. The winding machine according to any one of Examples 132 - 141, wherein the feeder feeds the electronic circuit at an angle with respect to the elongated device.

[0168] Example 143. The winding machine according to any one of Examples 132 - 142, wherein the angle is a fixed angle.

[0169] Example 144. The winding machine according to any one of Examples 132 - 143, wherein the fixed angle is a 45 - degree angle.

[0170] Example 145. The winding machine according to any one of Examples 132 - 144, wherein the angle is an angle that changes during the winding.

[0171] Example 146. The winding machine according to any one of Examples 132 - 145, wherein the angle varies between 30 degrees and 60 degrees.

[0172] Example 147. A winding machine according to any one of Examples 132 - 146, wherein the controller includes instructions for synchronizing the winding process such that the linear speed and the angular speed are synchronized according to the winding angle.

[0173] Example 148. A winding machine according to any one of Examples 132 - 147, further comprising monitoring means for monitoring the winding.

[0174] Example 149. A spiral - shaped FPC design that is wound in a spiral form around an elongated device.

[0175] Example 150. The spiral - shaped FPC design according to Example 149, wherein the FPC is designed to have a diameter between 50 mm and 100 mm.

[0176] Example 151. The spiral - shaped FPC design according to Example 149 or Example 150, wherein the spiral FPC is encapsulated into an FPC panel in a hexagonal tiling pattern.

[0177] Example 152. A hexagonal spiral - shaped FPC.

[0178] Example 153. An FPC that contributes to the mechanical properties of a device.

[0179] Example 154. The FPC according to Example 153, wherein the FPC is used in an elongated device such as a catheter to replace a support structure such as a braid or a coil.

[0180] According to aspects of some embodiments of the present invention, an electronic circuit is provided, which is applied in a spiral winding around the center (along the longitudinal axis) of an elongated flexible device. In some embodiments, a potential advantage of using a spiral winding is that it potentially maintains the flexibility of the elongated flexible device while providing electrical conductivity.

[0181] According to some embodiments of the present invention, the winding is performed manually.

[0182] According to some embodiments of the present invention, the winding is performed by a winding machine.

[0183] According to some embodiments of the present invention, the winding machine includes an adhesive dispenser configured to provide an adhesive to the electronic circuit.

[0184] According to some embodiments of the present invention, the adhesive is applied to the electronic circuit before winding.

[0185] According to some embodiments of the present invention, the adhesive is applied to the electronic circuit after winding.

[0186] According to some embodiments of the present invention, the winding machine includes a feeding device.

[0187] According to some embodiments of the present invention, a flexible printed circuit (FPC) is fed into a winding machine via a feeding device.

[0188] According to some embodiments of the present invention, each layer of a smaller copper weight component is used to increase the mechanical flexibility of the FPC (e.g., 0.5 ounce of copper).

[0189] According to some embodiments of the present invention, the FPC includes small holes to allow plastic material to flow through the FPC during a reflow process.

[0190] According to some embodiments of the present invention, the FPC is diagonally cut at the distal end at the same angle as the winding angle.

[0191] According to some embodiments of the present invention, the FPC is fed in an inverted manner such that when the electronic circuit is wound, the FPC shields the components from external electrical interference.

[0192] According to some embodiments of the present invention, the substrate has a cutout so that when the FPC is wound in an inverted manner, the components are assembled into the cutout.

[0193] According to some embodiments of the present invention, conductive wires are fed into the winding machine.

[0194] According to some embodiments of the present invention, the conductive wires are insulated.

[0195] According to some embodiments of the present invention, the feeder is fixed and the elongated flexible device rotates along its axis.

[0196] According to some embodiments of the present invention, the elongated flexible device is fixed and the feeder rotates around the device.

[0197] According to some embodiments of the present invention, the feed material is twisted around its own axis before winding.

[0198] According to some embodiments of the present invention, the angle between the winding device and the feeder is controlled.

[0199] According to some embodiments of the present invention, the angle is fixed, e.g., 45°, to produce a fixed winding pitch.

[0200] According to some embodiments of the present invention, the angle is varied to produce a helix with different winding angles (which correspond to different winding pitches).

[0201] According to some embodiments of the present invention, the winding machine includes a controller that synchronizes the winding process such that the linear speed and the angular speed are synchronized according to the winding angle.

[0202] According to some embodiments of the present invention, the winding is visually monitored, for example, by an external camera providing a top view, to control the winding parameters.

[0203] According to some embodiments of the present invention, the winding is visually supervised, for example, by an external camera providing a top view, to control the winding parameters such that electronic components (such as sensors, capacitors, etc.) will be positioned at a predetermined position and angle along the conduit after winding (e.g., will be aligned along a single axis along the conduit).

[0204] According to some embodiments of the present invention, the winding is performed on a template elongated device (such as a core axis) that is not the final assembly device before being transferred to the final device.

[0205] According to some embodiments of the present invention, glue is applied to the assembly after winding.

[0206] According to some embodiments of the present invention, the electronic components are assembled into an electronic circuit.

[0207] According to some embodiments of the present invention, the electronic components are soldered to the FPC before their winding.

[0208] According to some embodiments of the present invention, the electronic components are positioned and oriented on the FPC such that after winding, they are all located on the same axis.

[0209] According to some embodiments of the present invention, the electronic components are oriented on the FPC at an angle opposite to the winding angle such that after being wound, they occupy the minimum space and relieve the strain on their pads.

[0210] According to some embodiments of the present invention, the electronic components are oriented on the FPC at an angle that supports the clockwise winding of the FPC.

[0211] According to some embodiments of the present invention, the electronic components are oriented on the FPC at an angle that supports the counterclockwise winding of the FPC.

[0212] According to some embodiments of the present invention, the FPC widens around the components and the gap between the components narrows.

[0213] According to some embodiments of the present invention, the SMT components are soldered to the plated holes in the FPC.

[0214] According to some embodiments of the present invention, the SMT components are soldered to the plated holes in the FPC, and the plated holes are not covered (not covered by the solder mask) on the reverse side of the FPC to allow air flow during soldering such that the solder of the SMT will flow through the plated holes to the reverse side.

[0215] According to some embodiments of the present invention, the FPC has a solder mask between the pads for the components.

[0216] Optionally, the electronic components are soldered to the FPC assembly after their winding.

[0217] According to some embodiments of the present invention, electronic components are assembled onto a pre-wound FPC such that the pads assume the shape of the curved tube around which they are wound.

[0218] According to some embodiments of the present invention, the pads of the components (e.g., ball grid array (BGA) solder bumps) can be further reflowed after being wound helically, for example using a soldering iron, a hot air gun, a reflow oven, or any other suitable method.

[0219] According to some embodiments of the present invention, electronic components are soldered to conductive wires.

[0220] According to some embodiments of the present invention, conductive wires can be printed using conductive ink

[0221] According to some embodiments of the present invention, electronic components are automatically assembled using a pick-and-place machine.

[0222] According to some embodiments of the present invention, electronic components are manually assembled.

[0223] According to some embodiments of the present invention, electronic components are assembled along one or more specific axes.

[0224] According to some embodiments of the present invention, components are assembled along one axis.

[0225] According to some embodiments of the present invention, the components are visually supervised, for example by an external camera providing a top view, to control the placement position of each component to be placed along a selected axis of the device.

[0226] According to some embodiments of the present invention, one or more electronic components are assembled onto one or more dedicated individual circuits.

[0227] According to some embodiments of the present invention, shielded cables with a small diameter are used.

[0228] According to some embodiments of the present invention, the wires are stranded into a single stranded wire group

[0229] According to some embodiments of the present invention, the wires are stranded in pairs to provide shielding for the electrical signals carried.

[0230] According to some embodiments of the present invention, the wires are small-diameter enameled copper wires (e.g., wires with a thickness of 36 AWG or thinner).

[0231] According to some embodiments of the present invention, multiple FPCs are used.

[0232] According to some embodiments of the present invention, the component is a camera.

[0233] According to some embodiments of the present invention, components combine digital and analog image sensors on the same circuit.

[0234] According to some embodiments of the present invention, the camera cable is spirally wound inside the device.

[0235] According to some embodiments of the present invention, the camera is connected via traces on the same FPC as the sensor array or on a separate dedicated FPC.

[0236] According to some embodiments of the present invention, the camera power supply (e.g., VCC and GND), as well as the clock and data signals, are placed on the same FPC as the sensor array or on a separate dedicated FPC.

[0237] According to some embodiments of the present invention, the camera clock and digital / analog data signals are shielded to protect them from electrical interference.

[0238] According to some embodiments of the present invention, dedicated camera power supply and ground planes are used to shield other camera signals (clock and data).

[0239] According to some embodiments of the present invention, the camera and the sensor share the same power supply and ground plane to reduce the size of the FPC.

[0240] According to some embodiments of the present invention, the FPC is a multi-layer FPC, such as a four-layer FPC, so that the addition of camera signals does not increase its width.

[0241] According to some embodiments of the present invention, the sensor array and camera traces are divided into two sub-FPCs, such that the sensor array and camera traces are each located on a dedicated FPC.

[0242] According to some embodiments of the present invention, the final FPC only contains camera traces (e.g., power supply, ground points, clock, and data), but does not contain the actual camera components.

[0243] According to some embodiments of the present invention, the FPC includes camera traces and camera component pads, and then the camera is directly assembled on the FPC.

[0244] According to some embodiments of the present invention, an electrical connector is used to connect the wound circuit to the PCB assembly.

[0245] According to some embodiments of the present invention, the wound circuit is connected to the PCB assembly using a male connector at one end of the circuit.

[0246] In some embodiments of the present invention, an I2C (Inter-Integrated Circuit) or I3C (Improved Inter-Integrated Circuit) bus is used.

[0247] In some embodiments of the present invention, the circuit includes more than one layer. One layer (e.g., the top layer) contains assembled components, while the second layer (e.g., the bottom layer) contains data signals (e.g., clock and data in the case of an I2C bus).

[0248] In some embodiments of the present invention, power signals and ground signals are arranged as two planes on the circuit, e.g., on the top layer, to reduce the resistance of the power signals and shield the data signals on another layer.

[0249] In some embodiments of the present invention, the digital magnetometer uses four pads: voltage, ground, clock, and data.

[0250] In some embodiments of the present invention, the digital magnetometer is a BGA component composed of four BGA bumps serving as pads.

[0251] In some embodiments of the present invention, the circuit is longer than the slender device.

[0252] In an aspect of some embodiments of the present invention, an FPC is manufactured to have one or more creases in one or more connection regions between the welded components.

[0253] In some embodiments of the present invention, a Kressling pattern is used.

[0254] In some embodiments of the present invention, an accordion-type hinge is used, such as that used in the bent portion of a drinking straw.

[0255] In an aspect of some embodiments of the present invention, a printed circuit design is directly printed onto the flexible material of a slender flexible device such that the basic flexibility of the device is maintained.

[0256] In some embodiments of the present invention, the printed design includes only conductors.

[0257] In some embodiments of the present invention, the printed design includes conductors and components.

[0258] In an aspect of some embodiments of the present invention, a spiral-shaped FPC design is helically wound around a slender device.

[0259] In some embodiments of the present invention, the spiral-shaped FPC is designed to have a diameter between 50 mm and 100 mm.

[0260] According to some embodiments of the present invention, the spiral FPC is encapsulated into the FPC panel in a hexagonal tiling manner.

[0261] According to aspects of some embodiments of the present invention, a hexagonal spiral-shaped FPC is provided.

[0262] According to aspects of some embodiments of the present invention, an FPC for contributing to the mechanical properties of a device is provided.

[0263] According to some embodiments of the present invention, the FPC is used in an elongated device such as a catheter in place of a support structure such as a braid or a coil.

[0264] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. In addition, the materials, methods, and examples are illustrative only and not necessarily restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0265] Some embodiments of the present invention are described herein by way of example only with reference to the drawings. Now, specifically referring to the drawings in detail, it should be emphasized that the details shown are exemplary and for the purpose of illustrative discussion of the embodiments of the present invention. In this regard, the description in conjunction with the drawings enables those skilled in the art to clearly understand how the embodiments of the present invention can be practiced.

[0266] In the drawings:

[0267] Figure 1 is a schematic diagram of an exemplary intravascular device according to some embodiments of the present invention;

[0268] Figure 2 is a schematic diagram of an exemplary sensor array according to some embodiments of the present invention;

[0269] Figures 3a to 3b is a schematic diagram of an exemplary general incorporation of a sensor array into an elongated device according to some embodiments of the present invention;

[0270] Figure 4a is a schematic diagram of an elongated device having a sensor array with a wound or spiral geometry according to some embodiments of the present invention;

[0271] Figure 4b is a schematic diagram of an exemplary FPC rolled into a cylindrical shape according to some embodiments of the present invention;

[0272] Figure 4c Schematic diagram of an exemplary FPC with a wider area according to some embodiments of the present invention;

[0273] Figure 5 Schematic diagram of an exemplary spiral FPC according to some embodiments of the present invention;

[0274] Figure 6 Schematic diagram of an exemplary hexagonal tiling arrangement of multiple spiral FPCs in an FPC panel according to some embodiments of the present invention;

[0275] Figure 7 Schematic diagram of an exemplary FPC with diagonal distal ends according to some embodiments of the present invention;

[0276] Figure 8 Schematic diagram of an exemplary pre-wound spiral FPC;

[0277] Figures 9a to 9b Schematic diagrams of a through-hole mounting method and a surface mounting method respectively;

[0278] Figures 10a to 10b Schematic cross-sectional view of an exemplary element of an exemplary FPC according to some embodiments of the present invention;

[0279] Figure 11 Schematic front cross-sectional view of an exemplary structure of an exemplary elongated device according to some embodiments of the present invention;

[0280] Figure 12 Schematic diagram of an exemplary method of integrating a sensor array into an elongated body of an elongated device with the sensor facing down according to some embodiments of the present invention;

[0281] Figure 13 Schematic diagram of an exemplary automatic winding machine according to some embodiments of the present invention; and

[0282] Figure 14 Schematic diagram of an exemplary elongated device including a sensor array and a camera according to some embodiments of the present invention. Detailed Description

[0283] The present invention in some of its embodiments relates to flexible printed circuits, and more specifically but not exclusively, to flexible printed circuits for elongated devices.

[0284] Overview

[0285] Aspects of some embodiments of the present invention relate to embedding electronic components and flexible printed circuits (FPCs) into an elongated flexible device. In some embodiments, a sensor array including discrete sensing elements is assembled as an FPC or directly onto the elongated device itself. In some embodiments, the FPC and / or wires are helically wound within the wall of the device. In some embodiments, the device is an endoscope, and the wall of the device defines a working channel of the endoscope. In some embodiments, the FPC and / or wires are helically wound around the working channel of the endoscope. In some embodiments, the components are reflowed into the wall of the device or covered with a polymer tube or a polymer heat shrink tube. In some embodiments, the components assembled along the length of the device are positioned such that they are all on the same axis inside the device or such that they are linearly arranged in groups. In some embodiments, the assembled components can be further reflowed or glued or fixed by a heat shrink tube after being wrapped inside the device. In some embodiments, a potential advantage of reflowing or gluing or fixing by a heat shrink tube is potentially reducing the strain on its pads. In some embodiments, for example, in the case of an endoscope, a conductor or an FPC can be longer than the length of the endoscope (e.g., 1 meter long), such that it extends from the proximal end of the endoscope (or generally, the device) to the handle of the endoscope. In some embodiments, a potential advantage of helically winding an electronic circuit around the center of an elongated flexible device is potentially maintaining the flexibility of the elongated device while providing electrical conductivity. In some embodiments, the FPC can be manufactured in many configurations, such as a straight long FPC or a helical FPC that is disassembled and wrapped during the assembly process. In some embodiments, the FPC optionally includes a shielded conductor, for example, for a digital or analog endoscope camera. In some embodiments, the signals of the camera and the signals of the EM sensing elements can coexist on the same FPC. In some embodiments, the distal end of the FPC can further include a camera. In some embodiments, the camera can be spatially manipulated, for example, by folding, and molded into the tip of the endoscope as part of the assembly process. In some embodiments, the final assembly can optionally include a camera and sensing elements (which can be SMT components) and be automatically assembled using, for example, a pick and place machine. As used herein, the terms SMT (Surface Mount Technology) and SMD (Surface Mount Device) are used as interchangeable terms, and they mean "the entire technology of mounting and soldering electronic components onto an FPC or a PCB". In some embodiments, optionally, a robot assembly machine is used to automatically wrap the FPC or the conductor inside the endoscope.

[0286] Before explaining in detail at least one embodiment of the present invention, it should be understood that the application of the present invention is not necessarily limited to the details of the construction and arrangement of components and / or methods set forth in the following description and / or shown in the drawings and / or examples. The present invention is capable of other embodiments or of being practiced or carried out in various ways.

[0287] One aspect of some embodiments of the present invention relates to providing an elongate flexible device and a method for embedding electronic components and a flexible printed circuit (FPC) in the elongate flexible device.

[0288] Exemplary intracavitary device

[0289] Now refer to Figure 1 , which shows a schematic diagram of an exemplary intracavitary device according to some embodiments of the present invention. In some embodiments, the exemplary intracavitary device 100 includes:

[0290] 1. A handle 102 at the proximal end of the intracavitary device 100;

[0291] 2. An elongate body 104, including a proximal end 106 and a distal end 108. The proximal end 106 is connected to the handle 102. In some embodiments, optionally, the elongate body 102 includes a working channel 110 (the area between the dashed lines);

[0292] 3. A sensor array 112, including a plurality of electronic components 114 (hereinafter only referred to as "sensors 114"), such as sensors, capacitors, resistors, etc. It should be understood that in the following paragraphs, the term "sensor 114" refers to any electronic component 114 that needs to be used on the sensor array 112. In some embodiments, the sensors 114 are deployed along the elongate body 104; and

[0293] 4. Optionally, additional sensors 116, such as optical sensors and / or cameras, are located at the most distal end of the elongate body 102.

[0294] In Figure 1 , the sensor array 112 is schematically shown as a straight "strip" with a plurality of sensors 114. It should be understood that the sensor array 112 is not limited to a straight configuration, as will be further explained below. Additionally, the components 114 are shown as squares, but it should be understood that the components can have any geometric shape: triangular, square, rectangular, etc.

[0295] In some embodiments, the sensors 114 are electromagnetic sensors (EM sensors), and optionally, the sensors 114 are digital 3D magnetometers. In some embodiments, the sensor array 112 is configured to sense the position and / or shape of the elongate body 102.

[0296] Now refer to Figure 2, which shows a schematic diagram of an exemplary sensor array 112 according to some embodiments of the present invention. In some embodiments, as described above, the exemplary sensor array includes a plurality of sensors 114. In some embodiments, the plurality of sensors are mounted on a continuous elongated flexible printed circuit (FPC) 202. In some embodiments, the components 114 are assembled on both sides of the FPC. In some embodiments, the components 114 and / or additional sensors 116 can be connected to either side of the FPC.

[0297] Exemplary embodiments of generally incorporating a sensor array into an elongated device

[0298] Now refer to Figures 3a to 3b , which shows a schematic diagram of an exemplary general incorporation of a sensor array into an elongated device according to some embodiments of the present invention.

[0299] In some embodiments, the sensor array 112 includes an FPC 202 having a plurality of sensors 114, prepared and / or manufactured separately from the elongated device 100. In some embodiments, the sensor array 112 is then mounted onto the elongated device 100, as schematically shown, for example, in Figure 3a .

[0300] In some embodiments, the elongated device 100 is manufactured to have an incorporated FPC 202 but without the plurality of sensors 114. In some embodiments, the plurality of sensors 114 are then incorporated into the FPC 202 of the elongated device, as schematically shown, for example, in Figure 3b . In some embodiments, some of the components 114 are assembled on the FPC 202 before the FPC 202 is incorporated into the device 100, while other components 114 can be assembled after the FPC 202 is incorporated into the device 100.

[0301] In some embodiments, as mentioned, the FPC 202 and / or wire winding (optionally, helically - see below) is within the wall of the device, optionally around the working channel of an endoscope. In the following paragraphs, the general terms "device" or "elongated device" will be used. It should be understood that the term refers to any elongated device having a wall, such as an endoscope having a wall that defines a working channel of the endoscope.

[0302] In some embodiments, the components (FPC 202 and sensor 114) are then encapsulated within the walls of the device, for example, by a polymer reflow process, covered with a polymer tube or with a polymer heat shrink tube. Alternatively, by heat shrinking or by using an impregnation process. In some embodiments, the encapsulation provides a biocompatible layer that prevents non-biocompatible components from contacting tissue during use. In some embodiments, the encapsulation layer provides electrical insulation for the encapsulated FPC 202 and component 114. In some embodiments, the rectangular cross-section of the FPC 202 allows it to bend in one direction while making it more rigid in the perpendicular direction. In some embodiments, the encapsulation provides EM shielding for the encapsulated FPC 202 and component 114.

[0303] In some embodiments, in either binding method, the assembled components may optionally be further reflowed or glued or fixed by a heat shrink tube after being wrapped inside the device or incorporated into the FPC 202. In some embodiments, the potential advantage of further reflowing or gluing or fixing by a heat shrink tube is that it potentially relieves strain on the pads of the components. In some embodiments, the outer layer includes a composite design, for example, including a woven fabric or other reinforcement.

[0304] Exemplary embodiments of geometrically incorporating a sensor array into an elongate device

[0305] In some embodiments, the sensor array 112, whether manufactured separately and then incorporated or sensors incorporated into the elongate device, is positioned on an elongate device having a specific geometry.

[0306] In some embodiments, the exemplary sensor array 112 is geometrically positioned in a linear configuration, as Figure 1 schematically shown. In some embodiments, the sensor array 112 has a linear geometry such that the elongate device has a relatively rigid line along one side of the elongate device because the FPCs with sensors are all arranged in a line along one side of the elongate device. Although the inventors have found that this straight geometry may be useful for some applications, it may be somewhat limiting for other applications, which will be further explained below.

[0307] In a standard EM tracking device, when using sensors based on standard EM coils, the number of wires in the EM tracking device grows linearly with the number of sensors used. For this reason and other reasons, in most EM tracking devices, a single EM position and orientation sensor (usually made of three perpendicular EM coils) is used. Using multiple coil-based EM sensors in a single device requires handling many wires (e.g., three twisted pairs for each EM sensor), which may be cumbersome or impractical under certain footprint limitations.

[0308] To address this issue and for other reasons, U.S. Patent No. 11,712,309 discloses an EM shape sensor that includes a sensor array made up of multiple discrete sensor elements. Each sensor element can be an SMT 3D digital magnetometer assembled on a flexible printed circuit (FPC). Although it solves the problem of the limited ability to thread an increasing number of wires through a limited space, it can still potentially cause problems with maintaining the mechanical flexibility of the device and the desired footprint. The inventors have found that in order to embed the FPC inside an endoscope, special care needs to be taken to account for electrical and mechanical constraints. For example, if the FPC is to be embedded inside the wall of an endoscope as a long and straight FPC, the result is that due to the FPC's inability to stretch axially and even more so laterally to allow the endoscope to bend, the mechanical flexibility and maneuverability of the resulting device may be impaired. Alternatively, if the FPC is placed inside an open lumen such that it can move freely axially, the device can maintain its flexibility, but it may require a higher footprint, and the sensors are not fixed to a single point on the device, so their functionality may be impaired, for example, the accuracy of shape sensing may be reduced. Thus, in some embodiments, the sensor array 112 is geometrically positioned on the elongated device in a different manner.

[0309] Now referring to Figure 4a , which shows a schematic view of an elongated device having a sensor array with a wound or helical geometry according to some embodiments of the present invention.

[0310] In some embodiments, the exemplary sensor array 112 is geometrically positioned in a wound or helical configuration, as schematically shown in Figure 4a . Figure 4a Shown is the elongated device 100 and the sensor array 112, which includes an FPC 202 having a plurality of sensors 114.

[0311] Now referring to Figure 4b , which shows a schematic view of an elongated device having an FPC wrapped in a cylindrical geometry according to some embodiments of the present invention.

[0312] In some embodiments, the exemplary FPC 202 is geometrically wrapped or bent around the elongated device 100 to form a cylinder, as schematically shown in Figure 4b . Figure 4b Shown is the elongated device 104 and the FPC 202.

[0313] In some embodiments, an exemplary FPC 202 is generated with a dedicated form and / or geometry. In some embodiments, the diamond pattern includes a central wide region 404 configured to receive electronic components 114 (not shown) and is connected between them by one or more connecting bridges 406.

[0314] In some embodiments, a potential advantage of using the wrapping and winding methods disclosed herein is that it potentially overcomes the above problems. In some embodiments, the FPC can be bent in all directions, overcoming the problem that the FPC cannot be stretched. In some embodiments, an FPC incorporating an EM sensor array can maintain a twist about its own axis, rendering the twisted FPC flexible about all axes. In some embodiments, the rectangular cross-section of the FPC allows the FPC to be bent in one direction while making it more rigid in the perpendicular direction. In some embodiments, the FPC is embedded in the wall of an endoscope or a closed-end catheter such that the EM shape-tracking catheter is manipulable in all directions.

[0315] In some embodiments, a potential advantage of using the wrapping or winding methods disclosed herein is that it potentially allows for the control and minimization of cost of goods sold (COGS). For example, in some embodiments, using the wrapping or winding method may help reduce the manual labor involved in manufacturing and assembling tracking medical devices and thus significantly reduce COGS.

[0316] In some embodiments, as described above, a potential advantage of using the wrapped or wound FPC 202 is that it allows for the manipulation of the elongate device 100 in all directions because the FPC 202 itself can withstand the bending required when manipulating the elongate device.

[0317] In some embodiments, additionally or alternatively, a plurality of creases are added to the FPC 202 in the connection region between the solder components. In some embodiments, a potential advantage of adding creases is that it potentially preserves the bending ability of the elongate device. In some embodiments, there can be one or more creases, and the creases can be one or more of the following: single axis, alternating axis, 3D crease patterns (such as the Kresling pattern) and / or accordion-type hinges (such as those found in the bent portion of a drinking straw). Now refer to Figure 4c , which shows a schematic diagram of an exemplary FPC 202 with a wider region according to some embodiments of the present invention. In some embodiments, the FPC 202 is widened 408 at dedicated locations, for example, at the locations where the electronic components 114 are positioned, to support the assembly of these components, and / or to provide sufficient space for the FPC traces to bypass those components, and / or to improve the mechanical support of the assembled components or for any other suitable reason.

[0318] In the following paragraphs, the principles and methods for providing an elongate device having a sensor array in a wrapped or helical configuration are described.

[0319] Exemplary Principle of an Exemplary FPC

[0320] In some embodiments, as described above, the exemplary sensor array 112 includes an FPC 202 having a plurality of sensors 114. In the following paragraphs, specific examples will be used to allow those skilled in the art to understand the present invention. This example is not intended to be limiting in any way. In some embodiments, the sensor array 112 is an EM shape sensor composed of a plurality of discrete sensor elements assembled on a single FPC 202, and each discrete sensor element can be, for example, a 3D digital magnetometer. In some embodiments, in the case of digital magnetometers, all or some of them share the same digital bus within the FPC 202. In some embodiments, the potential advantage of having all or some sensors on the same bus is that it potentially reduces the number of signals required to communicate with the plurality of sensor elements on the FPC 202 to, for example, as few as one signal. In some embodiments, using an I2C (Inter-Integrated Circuit) or I3C (Improved Inter-Integrated Circuit) bus, as few as two signals (clock and data) per bus may be required. In some embodiments, two additional wires can be used to power the sensors (e.g., voltage and ground). In some embodiments, the FPC 202 includes two layers. In some embodiments, one layer (e.g., the top layer) contains the assembled sensors, and the second layer (e.g., the bottom layer) contains data signals (e.g., clock and data in the case of an I2C bus). In some embodiments, each digital magnetometer can have four pads: voltage, ground, clock, and data. In some embodiments, the power signal and the ground signal can be arranged as two planes on the FPC 202, for example, on the top layer, to reduce the resistance of the power signal and shield the data signals on the other layer.

[0321] Exemplary technical features of the exemplary FPC

[0322] In some embodiments, as described above, the FPC 202 includes a length of, for example, >20 cm, or >50 cm, or >1 m; and includes a width of, for example, <2 mm or <1.5 mm or <1 mm. In some embodiments, the FPC 202 includes a thickness of, for example, <0.13 mm or <0.1 mm. In some embodiments, the FPC 202 uses a smaller copper configuration per layer to increase its mechanical flexibility, such as 0.5 ounce copper. In some embodiments, optionally, the FPC 202 contains small holes, apertures, or protrusions to allow plastic material to flow through the FPC 202 during the reflow process. In some embodiments, additionally or alternatively, it allows the adhesive to flow during the reflow process.

[0323] In some embodiments, as described above, to maintain the maneuverability of the final assembled device, the FPC 202 is spirally wound around the working channel of the endoscope within the wall of an elongate device (such as an endoscope), as schematically shown in, for example, FIG. 4.

[0324] Exemplary winding angles of an exemplary sensor array having a wound or helical geometry

[0325] In some embodiments, winding the sensor array 112 around the elongated body 104 of the elongated device 100 is characterized by a winding angle defined as the angle between the longitudinal axis of the sensor array 112 and the longitudinal axis of the elongated body 104. In some embodiments, the sensor array 112 is wound with a fixed winding angle, thus having a uniform winding pitch. In some embodiments, the sensor array 112 is wound with different winding angles, thus having a varying winding pitch along the elongated device. In some embodiments, the greater the winding angle θ between the FPC 202 and the axis of the elongated body 104 of the elongated device 100 (e.g., approaching 60 degrees, or approaching 70 degrees, or approaching 90 degrees), the smaller the winding pitch, and the elongated device is characterized by increased flexibility. In some embodiments, in the case of a smaller winding pitch, the FPC needs to be longer to support the winding of the FPC 202 around the entire or most of the length of the elongated device (e.g., by a factor ). Additionally, in some embodiments, a smaller pitch results in increased rigidity due to an increase in the amount of FPC material (copper, polyimide, components, etc.) in the device. On the other hand, in some embodiments, the smaller the winding angle between the FPC 202 and the axis of the elongated body 104 of the elongated device 100 (close to 0 degrees), the larger the winding pitch, and the more rigid the elongated device (at least on one bending axis). For example, this occurs when the sensor array 112 is positioned almost only along one side of the elongated device (meaning a winding angle close to 0 degrees), thus providing a "rigid component" only to one side of the elongated device. In some embodiments, an intermediate winding angle, such as a winding angle of about 45 degrees, provides a good compromise between the above considerations: providing the necessary amount of flexibility and / or rigidity to the device while not overly increasing the FPC length (the factor by which a longer FPC is required )。In some embodiments, a winding angle in the range of about 30 degrees to about 60 degrees is used. For example, a winding angle of about 60 degrees is used at the tip of the elongate device where flexibility is typically most needed. In some embodiments, when the FPC 202 is wound around the elongate body 104 of the elongate device 100 facing the proximal end of the elongate device, the winding angle then gradually decreases to about 30 degrees, which portion generally requires less flexibility. In some embodiments, the potential advantage of using a dynamic winding pitch along the elongate device is that it potentially allows the FPC 202 to not be too long (e.g., <1.5 m long), while maintaining flexibility at the tip of the elongate device. In some embodiments, after the assembly component 114 is assembled, the FPC 202 is covered with an insulator. In some embodiments, the insulator is selectively applied to the exposed electrical contacts. In some embodiments, the insulator consists of a conformal coating, such as acrylic, PU, parylene, epoxy resin. In some embodiments, the insulator consists of an insulating tape.

[0326] Examples of the mechanical characteristics of an elongate device affected by using an FPC

[0327] In some embodiments, as described above, the FPC 202 is embedded inside the device, such as inside an endoscope, in order to change one or more of the pushability, twistability, steerability, kink resistance, and other mechanical properties of the endoscope. In some embodiments, in such a case, other mechanical characteristics of the elongate device can be modified to account for the mechanical characteristics of the embedded FPC 202. For example, if a braid is used in the structure of the elongate device, a thinner braid with, for example, less pushability can be used. Then, adding the embedded FPC will compensate for the "missing" pushability while reducing the final footprint of the elongate device. For example, since the FPC is embedded in the device, the outer diameter of the device will not increase or will only increase slightly. In some embodiments, the FPC 202 is not only used to add electrical characteristics to the device (such as a sensor array or a camera), but also to intentionally affect the mechanical characteristics of the device. In some embodiments, the FPC 202 is used as a reinforcement of the wall of the device, potentially completely replacing the use of a braid or other reinforcement while providing the desired mechanical performance of the device.

[0328] Exemplary principles for manufacturing an exemplary sensor array

[0329] In some embodiments, the process of manufacturing the exemplary sensor array 112 includes manufacturing a dedicated FPC 202.

[0330] In some embodiments, the FPC 202 can be manufactured in many configurations, such as a straight long FPC 202, or as a spiral FPC 202 that is unpacked and wrapped during the assembly process.

[0331] In some embodiments, optionally, the FPC 202 includes a shielding conductor, such as for a digital or analog endoscope camera. In some embodiments, the signals of the camera and the signals of the plurality of sensors 114 are transmitted along the same FPC 202. In some embodiments, optionally, during the manufacturing process of the FPC, the camera is connected to the distal end of the FPC 202. In some embodiments, the camera can be spatially manipulated, such as by folding, and can be molded into the tip of the elongate device as part of the assembly process. In some embodiments, the final member can optionally include both the camera and the sensor (see the "Exemplary embodiments of generally incorporating a sensor array into an elongate device" above). In some embodiments, the components (camera and / or sensor) are surface mount device (SMD) components and are optionally automatically assembled, for example, using a pick and place machine.

[0332] In some embodiments, an automated assembly machine can be used to automatically wrap the FPC or conductor within the elongate body of the elongate device.

[0333] In some embodiments, the FPC 202 is manufactured to a medium length, such as < 30 cm long. Standard FPC manufacturing processes and pick and place machines typically support FPCs with lengths < 50 cm, such that the manufacture and assembly of long FPCs (e.g., lengths > 50 cm) can be expensive and increase the COGS. However, some medical devices are longer than 50 cm. Specifically, some endoscopes require lengths greater than 50 cm, such as some manual and robotic bronchoscopes. In such cases, an FPC with a size < 50 cm cannot wrap around the entire length of such a device. Additionally, using, for example, a wrap angle θ = 45°, the FP length should be increased by the factor as described above such that, for example, to cover a device with a length of 71 cm, the FPC needs to be at least 1 meter long.

[0334] In some embodiments, the FPC 202 can have a medium length that can be supported by standard FPC manufacturing and assembly processes, such as about 30 cm in length. In such cases, the FPC 202 can be wound around the distal portion of the device. In some embodiments, since the FPC 202 may not be long enough to cover the entire length of the elongate device 100, electrical insulation wires are soldered to the pads exposed on the proximal side of the FPC 202, and the wires can extend to the handle 102 (where they can be connected to controller electronics, etc.). In some embodiments, optionally, the wires continue to wrap around the elongate device in a helical manner to maintain the flexibility of the device, similar to the helix of the FPC 202. In some embodiments, optionally, the wires are stranded into a single stranded wire group or paired-stranded to provide some degree of shielding to the carried electrical signals. In some embodiments, optionally, the wires are small-diameter enameled copper wires (e.g., wires smaller than 36 AWG wires).

[0335] Since soldering wires involves manual labor that increases the COGS, and since simple soldered wires have uncontrollable shielding and other electrical characteristics such as resistance, capacitance, and inductance (even when stranded together), it is preferred to use a single FPC 202 along the entire length of the device. In some embodiments, to produce an FPC 202 long enough to wrap around a long device at an angle that varies between 45 degrees or between 30 - 60 degrees (e.g., an FPC of length 1 meter wrapping around a 70 cm long device, or an FPC of length 1.3 meters wrapping around an 80 cm long device), in some embodiments, a helical-shaped FPC can be used, as Figure 5 schematically shown in

[0336] Now referring to Figure 5 , which shows a schematic diagram of an exemplary helical FPC according to some embodiments of the present invention.

[0337] In some embodiments, the FPC 202 includes a helical configuration (a helical FPC denoted by reference numeral 500). For example, in an exemplary helical configuration, the FPC 500 includes five helical turns. In some embodiments, any suitable number of turns is applicable under various embodiments and as needed. In some embodiments, the sensor 114 is placed on the FPC 500 to match a certain rotational angle of the FPC 500, e.g., to reside on the same axis after the FPC 500 is wound around an axis (such as a working channel). In some embodiments, the exemplary FPC 500 (or any FPC 202 disclosed herein) optionally includes a connector 502 located at the proximal end of the FPC 500. In some embodiments, the helical FPC 500 is manufactured to fit as a helix inside a standard-sized FPC panel. For example, the helix can have a diameter of 70 mm or a diameter less than 80 mm, and can perform five helical turns such that the FPC 500 will have a length of 1 meter, or 1.3 meters, or 1.5 meters or any other suitable length when extended. In some embodiments, the helix can also be, for example, 100 mm in diameter and can make 3 1 / 4 helical turns to obtain a full length of one meter. In some embodiments, the larger the diameter of the helix, the easier it is to wrap it around the device while maintaining a fixed winding angle. In some embodiments, the exemplary diameter of the helix is from about 50 mm to about 100 mm, optionally from about 30 mm to about 200 mm, optionally from about 10 mm to about 500 mm. In some embodiments, the potential advantage of using a diameter from about 50 mm to about 100 mm is that it potentially provides a good compromise between reducing the curvature of the helix for winding and manufacturing a fairly densely packaged FPC panel, because when using a helix with a large diameter, a large portion of the FPC-manufactured panel may not be used.

[0338] Now referring to Figure 6 , which shows a schematic diagram of an exemplary hexagonal tiling arrangement of multiple helical FPCs in an FPC panel according to some embodiments of the present invention. In some embodiments, the exemplary FPC panel 600 is divided into hexagonal blocks, each block containing a helical FPC 500. In some embodiments, the potential advantage of using hexagonal tiling is that most of the panel is used and there is less waste of the main panel material. In some embodiments, other geometric structures are used, such as rectangles, triangles, pentagons, etc. In some embodiments, the FPC is not designed as a circular helix, but is directly designed as a hexagonal helix.

[0339] In some embodiments, as described above, a connector 502 is present at the proximal end of the FPC. In some embodiments, a potential advantage of adding the connector 502 at the proximal end of the FPC is that it potentially further reduces the manual labor in the process of embedding the FPC into the elongated device. In some embodiments, the connector 502 is connected without soldering to an FPC-compatible connector residing on an electronic rigid PCB board in the handle 102 of the elongated device or the mounting interface of the elongated device.

[0340] Now refer to Figure 7 , which shows a schematic diagram of an exemplary FPC with a diagonal distal end according to some embodiments of the present invention.

[0341] In some embodiments, the FPC 202 may include features that guide and assist the winding process. In some embodiments, for example, the distal end of the FPC may terminate at a diagonal line 702 having an angle α corresponding to the winding angle, so that when this edge is aligned with the distal end 108 of the axis 104, the axis of the FPC naturally aligns with the correct winding angle. In Figure 7 , when the FPC 202 is mounted on the axis 104, the sensor 114 on the FPC 202 faces the axis 104 (see also the description below regarding Figure 12 ).

[0342] In some embodiments, optionally, the pads of the components are further reflowed after the spiral winding, for example, using a soldering iron, a hot air gun, a reflow oven, or any other suitable method. In some embodiments, a potential advantage of performing reflow is that it potentially reduces the strain on the pads of the electronic components (including sensor elements) assembled on the FPC. In some embodiments, performing reflow potentially allows the pads to assume the shape of the wrapped curved tube, thereby reducing the strain on the pads.

[0343] In some embodiments, the heating applied to the wrapped FPC can be high heat for reflowing the soldering material or low heat only for relieving the residual stress in the soldering material caused by the winding process. In some embodiments, the specific temperature will vary depending on the components and soldering material used. For example, the high temperature range required for reflow will be higher than the melting temperature of the soldering material, while the low temperature range will be lower than the melting temperature of the soldering material. For example, for a lead-free soldering material commonly used in the biomedical field with a melting point of 217 °C, the high temperature range for reflow can be between 250 - 260 °C, and the low temperature range for stress relief can be between 190 - 200 °C.

[0344] In some embodiments, alternatively, the FPC can be wrapped around some other tube (such as a core axis) for assembling the FPC. In some embodiments, after being wrapped, electronic components (such as sensor 114) are directly assembled on the wrapped FPC such that the pads assume the shape of the curved tube they wrap around. In some embodiments, such a core axis includes a diameter similar to that of the device itself on which the wound FPC will be mounted. In other embodiments, the core axis includes a diameter larger or smaller than that of the device itself on which the wound FPC will be mounted. In some embodiments, after assembly with the components, the assembled FPC can be removed from the core axis in its helical form (“pre-wound” form), as schematically shown in, for example, Figure 8 which is schematically illustrated. In some embodiments, the components are assembled to the FPC before wrapping around the core axis and then reheated as described above to release residual strain before being assembled to the endoscope. In some embodiments, the assembled helical FPC can be assembled, for example, around the working channel (elongated body 104 of the elongated device 100) of the endoscope before being encapsulated within the wall of the endoscope. In some embodiments, as described above, the components 114 are aligned on the same longitudinal axis depicted by the dashed line 802.

[0345] Without being bound by theory, there are two main methods for mounting components onto a PCB: through-hole mounting and surface mounting. Now refer to Figure 9a , which shows a schematic diagram of the through-hole mounting method for mounting components onto a PCB. In through-hole mounting, a dedicated through-hole component 902 includes a plurality of pins (“leads”) 904 configured to enter holes 906 in the PCB 908. The through-hole component is then fixed to the PCB using a welding material 910. Now refer to Figure 9b , which shows a schematic diagram of the surface mounting method for mounting components onto a PCB. In surface mounting, a dedicated surface-mount component (SMT / SMD) 912 is typically soldered to the surface of the pads 914 of the PCB 908 using a welding material 910 located on the bottom portion of the surface-mount component 912.

[0346] In some embodiments, the FPC 202 utilizes a combination of both methods.

[0347] Now refer to Figure 10a and Figure 10b , which show schematic cross-sectional views of exemplary components mounted on an exemplary FPC according to some embodiments of the present invention.

[0348] In some embodiments, the FPC 202 includes plated vias 1002 (also referred to as vias 1002) placed on the pads of the sensor to allow solder material 1004 (from the ball grid array (BGA) bumps of the component itself or added otherwise) to flow through the vias 1002 of the FPC 202, thereby mechanically locking the component 114 to the FPC 202 and potentially increasing its durability to withstand the winding process and bending. In some embodiments, the FPC includes local reinforcements at specific locations along the device. In some embodiments, such reinforcement is achieved by adding layers to the FPC, such as polyimide reinforcement layers or layers of other polymer, metal, or ceramic materials. In some embodiments, the reinforcement is added after the FPC is manufactured in a separate process. In some embodiments, the reinforcement is placed locally under, near, or around the component, potentially increasing its durability to withstand the winding process and bending. In some embodiments, the reinforcement is positioned in selected locations, potentially helping to bond the FPC to the device.

[0349] In some embodiments, the solder material of the BGA bumps flows into the vias, allowing the sensor to rest closely against the FPC, thereby reducing the total height of the FPC and the sensor. In some embodiments, a light pressure can be applied to the component during the reflow process to assist the solder material in flowing into the vias. In some embodiments, after reflow, the excess solder material is removed from the side of the FPC opposite the component, for example, by using a soldering iron, a solder removal tool, or by mechanical means. In some embodiments, the solder material of the BGA bumps flowing into the vias provides a strong contact between the BGA bumps and the FPC, thereby reducing the risk of contact breakage, especially during the winding of the FPC when forces are applied to the pads.

[0350] In some embodiments, in the gap 1008 between the pads 1010 of the electronic component 114, the solder mask layer 1006 (or solder mask) is not completely removed from the FPC 202, thereby potentially reducing the risk of solder material flowing between the pads and causing a short circuit. In some embodiments, the solder mask layer is partially or completely removed on the side of the FPC opposite the component to allow the trapped air to flow out of the vias, while the solder material of the BGA bumps will be able to flow into the vias. In some embodiments, the solder mask layer is not completely removed on the side of the FPC opposite the component. In some embodiments, the solder mask layer is completely removed on the sides of the component in the area directly below the component, potentially allowing it to sink further to the height of the conductor layer of the FPC.

[0351] Exemplary arrangement of components along the length of the device

[0352] In some embodiments, components (such as sensor 114) assembled along the length of the device are positioned on the FPC 202 such that they are all on the same axis, as schematically shown in, for example, FIG. 4 and depicted by the dashed line 402. In some embodiments, optionally, a discrete number of sensors 114 are linearly grouped.

[0353] In some embodiments, optionally, as Figure 5 schematically shown in, the sensors 114 and other sensing elements / components are designed and assembled on the FPC at a rotational angle relative to the FPC axis that corresponds to the wrap angle of the FPC inside and / or on the elongate device. In some embodiments, for example, for a helical wrap angle of θ = 45°, the discrete components can be designed and assembled to rotate -θ = -45° relative to the FPC axis on the FPC (which depends on the wrap direction: clockwise versus counterclockwise). In some embodiments, the positioning angle of the components relative to the longitudinal axis of the FPC varies along the length of the FPC. In some embodiments, a potential advantage of varying the positioning angle of the components on the FPC is that it can potentially be used to match the variation in the wrap angle of the FPC along the length of the device. In some embodiments, optionally, regardless of the helical or non-helical configuration of the FPC, an angle relative to the longitudinal axis of the FPC can be provided to the components. In some embodiments, a potential advantage of assembling the components at a rotational angle opposite to the wrap angle is that it potentially ensures that the components are straight (aligned with the axis of the device) after wrapping, as schematically shown in, for example, FIG. 4. In some embodiments, a potential advantage of keeping the components aligned relative to the device is that it can potentially reduce the force exerted on the pads of the components due to the tight wrapping of the FPC around the device, thereby enabling the soldered sensor elements and other electronic components to better withstand the bending of the device, for example, to withstand a bending radius of 20 mm, 15 mm, 10 mm, or any other desired bending radius. In some embodiments, positioning components that rotate relative to the axis of the FPC may require an increase in the width of the FPC, which may negatively affect the mechanical properties of the device, for example, increasing the rigidity of the device. Thus, in some embodiments of the present disclosure, the width of the FPC can vary along its length, increasing in width near and around the electronic components to support the assembly of the rotating components and decreasing in width in the gaps between the components.

[0354] In some embodiments, the electronic components 114 positioned on the FPC 202 are positioned to occupy as little space as possible on the FPC 202. In some embodiments, the potential advantage of positioning the electronic components 114 such that they occupy as little space as possible on the FPC 202 is that it potentially reduces the final footprint of the final elongate device, and more specifically, reduces the outer diameter (OD) of the elongate device. In some embodiments, the sensor elements 114 (and other electronic components such as SMT capacitors, resistors, integrated circuits, etc.) are placed on the FPC 202 such that after being wrapped into a helix, they lie on the same axis, as schematically shown in FIGS. 4, 7, and 8. In some embodiments, for a given wrap angle θ, and a given wrap radius R (the radius around which the FPC will be wrapped), the distance between the sensor elements 114 on the FPC 202 is calculated. In some embodiments, the distance between the sensor elements changes along the FPC to match the wrap angle or the wrap radius that changes along the length of the device. In some embodiments, the potential advantage of calculating the distance between the electronic components is that it potentially ensures that each sensor assembly is placed on the same axis after the sensor array is wrapped around the device. For example, the sensor elements 114 (and other components) are placed on the FPC 202 at a spacing of 2πR / sinθ, where R is the wrap radius and θ is the wrap angle, as described above. In some embodiments, as described elsewhere herein, the electronic components 114 are oriented on the FPC 202 at an angle opposite to the wrap angle such that after being wrapped around the working channel of the endoscope (the elongate body 104 of the elongate device 100), the electronic components 114 will occupy as little space as possible and relieve the strain on their pads. In some embodiments, as described above, the electronic components 114 can be non-square components, such as rectangular. In some embodiments, the non-square components are rotated at an angle such that after being wrapped, they will have a minimum cross-sectional area. For example, a rectangular-shaped component can be placed such that after being wrapped, its long side is parallel to the longitudinal axis of the elongate device and its short side is parallel to the cross-sectional plane of the elongate device.

[0355] Exemplary general arrangement of a sensor array on an elongate device

[0356] Now refer to Figure 11 , which shows a schematic front cross-sectional view of an exemplary structure of an exemplary elongate device according to some embodiments of the present invention.

[0357] In some embodiments, the sensor elements 114 are positioned and oriented on the FPC 202 such that after being helically wrapped around the elongated body 10 (the elongated body 10 defining, for example, the working channel of an endoscope), the sensor elements 114 all lie on the same axis, e.g., on a single axis outside the working channel 1104 and optionally next to the optional camera 116 or optional additional sensor 1102. In some embodiments, the longitudinal axis passing through the center of the elongated body 104 (e.g., the longitudinal axis passing through the center of the working channel) and the longitudinal axis of the entire resulting elongated device (including the elongated body 104, the sensor array 112, and the housing for the entire elongated device 100) do not coincide (there is a certain offset between them). In some embodiments, a potential advantage of the non - coincidence of the longitudinal axes is that it potentially leaves more space for the assembled components and the optional camera 116 / additional sensor 1102. In Figure 11 it, four embedded pull - wires 1106 are also shown side - by - side with the assembled FPC, which may be advantageous for, e.g., a robot - manipulable endoscope. In some embodiments, an electronic component (such as a sensor or a camera) is positioned to be aligned with one of two or more pull - wires 1106. In some embodiments, a potential advantage of the alignment between the sensor / camera and one of two or more pull - wires 1106 is that the input received from the sensor / camera is aligned with the bending direction of the elongated device. In some embodiments, the electronic component is positioned along the elongated body between two or more pull - wires 1106. In some embodiments, a potential advantage of positioning the electronic component along the elongated device between two or more pull - wires 1106 is that it potentially reduces the total cross - sectional footprint of the elongated device. In some embodiments, both the camera and the sensor are aligned on one of the pull - wires. In some embodiments, both the camera and the sensor are aligned in the space between two pull - wires. In some embodiments, the camera and the sensor can be positioned along the elongated device and relative to two or more pull - wires 1106 in any other configuration.

[0358] It should be understood that although Figure 11 a 4 - pull - wire design is shown, the alignment components as described above can be accomplished with 2 or more pull - wires.

[0359] In some embodiments, the camera 116 and / or the sensor 114 are located between two adjacent pull - wires 1106.

[0360] Now referring to Figure 12 which shows a schematic diagram of an exemplary method of incorporating a sensor array into the elongated body of an elongated device according to some embodiments of the present invention.

[0361] In some embodiments, as described above, the sensor array 112 is wrapped so that the electronics (e.g., sensors 114 or other components) face the elongated body 104 of the elongated device 100 (a "face down" configuration). In some embodiments, potential advantages of positioning the sensor array in this manner are one or more of: potentially shielding the sensors, potentially reducing the outer diameter of the complete device (mechanical considerations), and potentially increasing the bending resistance of the welded assembly.

[0362] In some embodiments, the FPC 202 is wrapped around a flexible or semi-rigid mechanism positioned along the elongated body 104 of the elongated device 100, for example, around a deflectable section of an endoscope or around a steerable catheter. In some embodiments, such a flexible section may be comprised of a separate link, and in other cases, of a semi-rigid mechanism, such as a laser cut metal hypotube, a similarly designed cylindrical polymer component that includes a thin point that can be elastically deformed to allow the tubular section to bend. In some embodiments, in any of these cases, these bendable mechanisms are designed to include openings 1202 and / or cutouts (not shown) in the wall of the elongated body 104. In some embodiments, the size of the openings is optionally matched to the size of the three-dimensional form of the electronic component to be inserted therein. In some embodiments, when the FPC 202 is wrapped upside down as described herein, the assembly 114 is aligned with the opening 1202 in the flexible mechanism (or the portion of the elongated body to which the opening 1202 is added), thereby not increasing the cross-sectional footprint of the device, optionally increasing by no more than the thickness of the FPC (e.g., 0.1 mm). In some embodiments, some electronic components are positioned on one side of the FPC 202, while other electronic components are positioned on the other side of the FPC 202. In some embodiments, a plurality of electronic components 114 are mounted on the FPC 202 facing upward and are wound to a diameter that is smaller than the diameter of the elongated body 104. Then, in some embodiments, the FPC 202 is inserted into the elongated body 104 and then allowed to unwind, thereby allowing the plurality of components 114 to enter the openings 1202 on the elongated body 104. In this case, the FPC 202 is positioned within the elongated body 104 rather than "on the elongated body."

[0363] Example of using wire without substrate

[0364] In some embodiments, the ability to bend is maintained by printing the circuit design directly onto the flexible material of the elongated device itself so that the basic flexibility of the device is retained, such as by printing the circuit using conductive ink.

[0365] In some embodiments, a similar helical winding method is used, where instead of an FPC, the wires (without a substrate) are directly adhered (by methods such as using glue, resin, heating, cooling, ultrasonic treatment, or other bonding methods) to the surface of the elongate device itself. In some embodiments, a potential advantage of doing so is that, compared to using an FPC, it potentially allows for a reduction in mechanical constraints on the elongate device. In some embodiments, another potential advantage is that manufacturing may be simpler in some setups and potentially allows for changing the winding pitch of the conductors. In such cases, the electronic components, sensors, and other SMTs are then manually or automatically welded by a machine in a linear pattern or any other desired pattern. In some embodiments, optionally, a protective coating may be applied as needed. In some embodiments, a potential advantage of this method is that the elongate device itself serves as the FPC substrate for the components and conductors.

[0366] Exemplary additional features

[0367] In some embodiments, optionally, the conductor or FPC is longer than the length of the elongate device 100, for example, about 1 meter to about 2 meters longer (in the case of winding the FPC and / or winding the conductor, the length of the FPC or conductor means the absolute length along one axis, such as the absolute length of the wound FPC along the longitudinal axis of the device 100), such that the conductor or FPC extends from the proximal end of the elongate body 104 to the handle 102 or to the mounting interface of the elongate device (in the case of, for example, a robotic elongate device).

[0368] In some embodiments, as described above, the FPC-based sensor array extends from the tip of the elongate device up to the handle. In some embodiments, the FPC includes sensing elements (sensors), which may be 3D digital magnetometers. In some embodiments, the FPC may also combine digital or analog image sensors on the same FPC. In another embodiment, the FPC may be helically wrapped inside the elongate device, and the components may be assembled at carefully selected positions and orientations on the FPC to reduce the footprint of the embedded sensor array inside the elongate device. In some embodiments, the FPC may be used for all the electronics inside the elongate device (a full EM sensor array for EM shape sensing, digital / analog cameras, and other types of sensors). In some embodiments, the FPC is long enough (e.g., 1 - 2 meters long) such that no additional wires are needed inside the elongate device. In some embodiments, the FPC is automatically assembled using a pick and place machine.

[0369] Exemplary thermal requirements

[0370] In some embodiments, electronic components have thermal requirements. For example, soldering materials require high temperatures and specific thermal cycles during the reflow soldering process, and for some components, the maximum temperature they can withstand or the maximum duration of certain temperatures they can withstand before degradation and damage is limited. In some embodiments, other processes, such as the reflow of thermoplastic polymers commonly used in the manufacture of steerable axes, have other thermal requirements, such as the minimum temperature and duration that allow the polymer to flow properly. In some embodiments, the polymer reflow material and the soldering material are selected such that the reflow temperature of the polymer material is lower than the melting / soldering temperature of the soldering material, and the melting / soldering temperature of the soldering material is lower than the allowable temperature of the electronic component. In some embodiments, the electronic component is protected with a high melting point material (such as a high temperature epoxy resin) to protect the electronic component and the soldering material during the polymer reflow process.

[0371] Although the focus throughout this disclosure is on wrapping an FPC around a medical device to achieve EM shape sensing in the fields of endoscopes and catheters, it should be understood that similar applications can achieve any sensing in any other elongated flexible device. For example, an FPC containing a sensor array can be embedded inside an elongated device for general use in a spiral manner, such as being embedded in a VR / AR tracking line for training or simulation, or being embedded in a robotic arm and its control mechanism. Additional examples of sensors that can be similarly integrated into a device using this method are, for example, imaging sensors, thermometers, flow meters such as speedometers, ultrasonic transducers and receivers, radiation emitters and radiation detectors, pressure and strain sensors, piezoelectric or other force sensors, and other types of sensors.

[0372] As used herein, with respect to a quantity or value, the term "about" means "within ±20%".

[0373] The terms "comprising", "including", "having" mean "including but not limited to".

[0374] The term "consisting of" means "including and limited to".

[0375] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or parts, but only if the additional ingredients, steps, and / or parts do not materially alter the basic and novel features of the claimed composition, method, or structure.

[0376] As used herein, unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" include plural referents. For example, the term "a compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0377] Throughout this application, embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present invention. Thus, the description of a range should be considered to have specifically disclosed all possible sub-ranges as well as individual values within that range. For example, a description of a range such as "1 to 6" should be considered to have specifically disclosed sub-ranges such as "1 to 3", "1 to 4", "1 to 5", "2 to 4", "2 to 6", "3 to 6", etc.; and individual numbers within that range, for example 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0378] Whenever a numerical range is indicated herein (e.g., "10 - 15", "10 to 15", or any pair of numbers linked by another such range indication), unless the context clearly dictates otherwise, it is intended to include any number (fractional or integer) within the indicated range limitations, including the range limitations. The phrases "range / range of values / range between" between a first indicated number and a second indicated number and "range / range of values / range from... to..." from a first indicated number "to", "until", "up to", or "through" (or another such range indication term) a second indicated number are used interchangeably herein and are intended to include the first and second indicated numbers as well as all fractions and integers therebetween.

[0379] Unless otherwise indicated, the numbers and any numerical ranges based thereon used herein are approximations within the reasonable measurement precision and rounding errors understood by those skilled in the art.

[0380] It should be understood that, for clarity, certain features of the present invention described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, the various features of the present invention described in the context of a single embodiment may also be provided separately or in any suitable sub-combination, or appropriately in any other described embodiment of the present invention. Certain features described in the context of various embodiments are not considered to be essential features of those embodiments unless the embodiment is inoperative without those components.

[0381] The various embodiments and aspects of the present invention as described above and as claimed in the following claims are supported in the following embodiments.

[0382] Examples

[0383] Now refer to the following examples, which, together with the above description, illustrate some embodiments of the present invention in a non-limiting manner.

[0384] In some embodiments, the assembled FPC is manually wound helically around a device (e.g., around the working channel of an endoscope). In some embodiments, the FPC is wrapped at a winding angle of approximately θ = 45° or, for example, 30 - 60 degrees, such that each assembled component (specifically, each sensor element) is positioned along the same axis after winding, as schematically shown, for example, in FIG. 4. In some embodiments, maintaining a fixed winding angle while positioning each sensor along the axis of the same device provides a degree of control over the winding process. In some embodiments, it allows the assembly worker to use each sensor element as a reference or fixed point for winding to supervise the winding process. Optionally, in another embodiment, to reduce COGS, the winding of the FPC can be automatically performed by a winding machine.

[0385] Now refer to Figure 13 , which shows a schematic view of an exemplary automatic winding machine according to some embodiments of the present invention. In some embodiments, one or more FPCs 202 can be fed into a feeder slider 1302, for example, in one or more roll axes (not shown) containing the FPC 202. In some embodiments, the device 1304 around which the FPC 202 is to be wrapped can be rotated about its axis at a controlled angular velocity 1306 synchronous with the linear movement speed of the feeder 1302. In some embodiments, the automatic winding machine can include an adhesive dispenser 1308 to apply adhesive to the FPC 202 or the device 1304. In some embodiments, the FPC 202 is held at a fixed angle (e.g., 45°) or a variable control angle (e.g., 30 - 60 degrees) to allow variable pitch winding. In some embodiments, the automatic winding machine can also have a device 1304 fixed to the automatic winding machine and causing the feeder 1302 to rotate (and linearly move) around (and along) the device axis 1306. In some embodiments, the winding process is controlled by a controller 1310 that synchronizes the linear speed with the angular velocity according to the winding angle. In some embodiments, optionally, the process can be visually supervised, for example, by an external camera 1312 providing a top view, to ensure that each sensor element is placed along the same axis of the device. In some embodiments, this can be done using automatic image processing techniques. In some embodiments, the automatic winding machine can use the sensor positions detected in the image as feedback for the winding process, for example, by slightly rotating or translating the roll axis containing the FPC to slightly increase or decrease the winding pitch.

[0386] In some embodiments, a similar winding machine is used to wind a pair or more pairs of wires instead of the FPC 202 and maintain the same ability to vary the winding angle, thereby achieving any fixed or variable winding pitch. In some embodiments, after winding the wires, the components are then manually or automatically welded such that they are on the same axis or different axes.

[0387] Now refer to Figure 14 , which shows a schematic diagram of an exemplary elongated device including a sensor array and a camera according to some embodiments of the present invention. In some embodiments, as described above, the final elongated device includes a camera 116. For example, the device can be an endoscope that includes an endoscope camera 116 at its tip. In some embodiments, the camera 116 can be connected to an external processing unit using a small-diameter dedicated shielded cable 1402, where the dedicated shielded cable 1402 extends separately from the sensor array 112 (the FPC 112 that includes the electronic components / sensors 114). In some embodiments, the camera cable 1402 can be spirally wrapped inside the device. In the case of a device that includes a sensor array, the camera cable can be spirally wrapped inside the device together with the spirally wrapped sensor array, as Figure 14 schematically shown in

[0388] In some embodiments, instead of using a separate dedicated camera cable, the camera can be connected via traces on the same FPC 202 as the sensor array 114 or via traces on a separate dedicated FPC. In this embodiment, the camera power supply as well as the clock and data signals can be placed on the same FPC 202 as the sensor array 114 or on a separate dedicated FPC. In some embodiments, the camera clock and digital / analog data signals are shielded to protect them from electrical interference. In some embodiments, dedicated camera power supplies and ground planes are used to shield other camera signals (clock and data). In some embodiments, these power supplies and ground planes can be dedicated to the camera to reduce crosstalk with other signals on the FPC (such as sensor data signals). In some embodiments, the camera and the sensor can share the same power supply and ground plane to reduce the FPC size. In some embodiments, the FPC can be a multi-layer FPC, such as a four-layer FPC, such that the addition of camera signals does not necessarily increase its width. In some embodiments, the final wrapped FPC can consist of two separate sub-FPCs - one for the sensor array and one for the camera. In some embodiments, the two FPCs can be connected using a small bridge to produce the final wrapped FPC composed of both of them. In some embodiments, compared to a single solid FPC, using a small bridge to connect two sub-FPCs increases the flexibility of the wider FPC for final integration. In some embodiments, the two sub-FPCs can be separate such that the sensor array and camera traces are each located on a dedicated FPC. In some embodiments, the final FPC can only contain camera traces (e.g., power supply, ground, clock, and data), but may not contain the actual camera components. In this case, the camera can be assembled separately (e.g., on another small dedicated FPC) and can be connected to the camera traces on the FPC via a short wire between the exposed camera pads on the camera dedicated FPC and the sensor array FPC. In some embodiments, the sensor array FPC can include camera traces and camera component pads, and the camera can then be directly assembled on the sensor array FPC. In some embodiments, as described above, the camera can then be spatially manipulated, such as by folding, and molded into the tip of the device as part of the assembly process. In some embodiments, the FPC can be fully automatically assembled using a pick and place machine. This includes all the electronic components on the FPC, which can include: a sensor array (which can consist of multiple SMT 3D digital magnetometers), passive components (such as SMT capacitors, resistors, ferrite beads, etc.), and a camera (e.g., an SMT camera). Using a single integrated FPC for the sensor array and camera that is assembled automatically or semi-automatically or even manually can potentially reduce the COGS of the device.

[0389] In some embodiments, rather than embedding the FPC within the wall of the endoscope, the FPC can be wrapped within the wall of a hollow, attachable, shrink-like flexible fixture. In some embodiments, the fixture can then be attached to any existing device, such as an endoscopic device, to enhance its tracking capabilities.

[0390] Although the invention has been described in connection with specific embodiments thereof, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0391] Applicant intends that all publications, patents, and patent applications mentioned in this specification be incorporated by reference in their entirety into this specification, as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference herein. Furthermore, the citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art with respect to the present invention. In the case of the use of section headings, they shall not be construed as necessarily limiting. Additionally, any priority document of this application is incorporated by reference in its entirety herein.

Claims

1. An elongate device, comprising: a. A handle; b. An elongate body having a proximal end and a distal end, the proximal end being connected to the handle; c. One or more sensor arrays, each sensor array comprising: i. One or more flexible printed circuits FPC; and ii. A plurality of electronic components located on the one or more FPCs, wherein the one or more sensor arrays are wound helically around the elongate body, and wherein the plurality of electronic components are aligned relative to the longitudinal axis of the elongate body.

2. The elongate device according to claim 1, wherein The plurality of electronic components include one or more of sensors, capacitors, resistors, integrated circuits, electromagnetic sensors, digital sensors, digital magnetometers, and optical sensors.

3. The elongate device according to claim 1 or 2, wherein, Each of the plurality of electronic components is oriented on the one or more FPCs at an orientation angle relative to the longitudinal axis of the one or more FPCs.

4. The elongate device according to claim 3, wherein, The orientation angle is configured such that when the one or more FPCs are wound helically around the elongate body, each of the plurality of electronic components is aligned relative to the longitudinal axis of the elongate body.

5. The elongate device according to claim 3, wherein, The orientation angle is opposite to the winding angle of the one or more sensor arrays.

6. The elongate device according to any one of claims 1-5, wherein, The helical winding of the one or more sensor arrays around the elongate body is characterized by a winding angle.

7. The elongate device according to claim 6, wherein, The winding angle is defined by the angle between the longitudinal axis of the one or more FPCs and the longitudinal axis of the elongate body.

8. The elongate device according to claim 6, wherein, The winding angle is 45 degrees.

9. The elongate device according to claim 6, wherein, The winding angle is from 30 degrees to 60 degrees.

10. The elongate device according to claim 6, wherein, The one or more FPCs include a proximal end and a distal end; and wherein the proximal end and / or the distal end are characterized by being diagonally cut at the same angle as the winding angle.

11. The elongate device according to claim 6, wherein, The elongate body is characterized by rigidity, and wherein, The winding angle affects the rigidity.

12. The elongate device according to claim 11, wherein, When the winding angle approaches 90 degrees, the rigidity increases.

13. The elongate device according to claim 11, wherein, When the winding angle approaches 0 degrees, the rigidity increases.

14. The elongate device according to claim 6, wherein, The winding angle is fixed along the entire length of the elongate body.

15. The elongate device according to claim 6, wherein, The winding angle varies along the length of the elongate body.

16. The elongate device according to any one of claims 1-15, wherein, All of the plurality of electronic components are located on one side of the one or more FPCs.

17. The elongate device according to any one of claims 1 - 16, wherein, Some of the plurality of electronic components are located on one side of the one or more FPCs, while other of the plurality of electronic components are located on the other side of the one or more FPCs.

18. The elongate device according to any one of claims 1-17, wherein, The one or more sensor arrays are wound helically around the elongate body, and at least a portion of the plurality of electronic components face the elongate body.

19. The elongate device according to claim 18, wherein, The elongate body includes one or more openings; and wherein at least a portion of the plurality of electronic components that face the elongate body are inserted into the one or more openings.

20. The elongate device according to claim 19, wherein, At least a portion of the plurality of electronic components are shielded from external electrical interference when inserted into the one or more openings.

21. The elongate device according to any one of claims 1 - 20, wherein, The one or more FPCs are adhered to the elongate body by at least one adhesive.

22. The elongate device according to any one of claims 1-21, wherein, The one or more FPCs widen around the position where each of the plurality of electronic components is located on the one or more FPCs.

23. The elongate device according to any one of claims 1-22, wherein, The one or more FPCs narrow between the locations on the one or more FPCs where each of the plurality of electronic components is located.

24. The elongate device according to any one of claims 1-23, further comprising: One or more conductive wires wound helically around the elongated body.

25. The elongate device according to claim 24, wherein, The positions of the one or more conductive wires wound helically around the elongated body are different from the positions of the one or more sensor arrays wound helically around the elongated body.

26. The elongate device according to claim 24, wherein, The one or more conductive wires are one or more insulated conductive wires.

27. The elongate device according to claim 24, wherein, One or more electronic components are connected to the one or more conductive wires.

28. The elongate device according to claim 24, wherein, The one or more conductive wires are printed conductive ink.

29. The elongate device according to any one of claims 1 - 28, wherein, Electronic components different from the plurality of electronic components are located on an FPC different from the one or more FPCs.

30. The elongate device according to claim 2, further comprising: A dedicated FPC for the optical sensor.

31. The elongate device according to any one of claims 1-30, wherein, All of the plurality of electronic components are located on the same FPC.

32. The elongate device according to any one of claims 1-31, wherein, The one or more FPCs include small copper weight pieces.

33. The elongate device according to any one of claims 1-32, wherein, The one or more FPCs include small holes to allow plastic material to flow through the one or more FPCs during the reflow process.

34. The elongate device according to any one of claims 1 - 33, wherein, At least some of the plurality of electronic components are SMT components; and wherein, the SMT components are soldered to the plated holes in the one or more FPCs.

35. The elongate device according to any one of claims 1-34, wherein, The one or more FPCs include a solder mask between the pads.

36. The elongate device according to any one of claims 1-35, further comprising: At least one camera.

37. The elongate device according to claim 36, wherein, The power signal, clock signal, and data signal of the camera are arranged on the same FPC as the one or more sensor arrays.

38. The elongate device according to claim 36, wherein, The power signal, clock signal, and data signal of the camera are arranged on a separate dedicated FPC.

39. The elongate device according to claim 36, wherein, The clock signal and digital / analog data signal of the camera are shielded from electrical interference.

40. The elongated device according to claim 36, further comprising: Dedicated camera power and ground planes configured to shield the elongated device from other camera signals.

41. The elongate device according to any one of claims 1 - 40, wherein, The one or more FPCs are multi-layer FPCs.

42. The elongate device according to any one of claims 1-41, wherein, The one or more FPCs contain only camera traces but no actual camera components.

43. The elongate device according to claim 10, further comprising: An electrical connector attached to at least one of the proximal and distal ends of the one or more FPCs.

44. The elongate device according to any one of claims 1-43, wherein, The one or more FPCs include male connectors located at at least one of the proximal and distal ends of the one or more FPCs.

45. The elongate device according to any one of claims 1-44, further comprising: Inter-integrated circuit I2C bus or improved inter-integrated circuit I3C bus.

46. The elongate device according to any one of claims 1 - 45, wherein, One or more FPCs are connected to components in the handle.

47. The elongate device according to any one of claims 1 - 46, wherein, The one or more FPCs include one or more creases in one or more connection regions between the soldered components.

48. An elongated device, comprising: a. A handle; b. An elongated body, the elongated body including a proximal end and a distal end, the proximal end being connected to the handle; c. One or more sensor arrays, each sensor array including: i. One or more printed circuits; and ii. A plurality of electronic components located on the one or more printed circuits, wherein, the one or more sensor arrays are wound helically around the elongated body, and wherein, the plurality of electronic components are aligned with respect to the longitudinal axis of the elongated body, wherein, the printed circuit design is directly printed onto the elongated body of the elongated device.

49. A method of manufacturing an elongate device, wherein, The elongate device includes one or more sensor arrays, the one or more sensor arrays including one or more flexible printed circuits (FPCs) and a plurality of electronic components located on the one or more FPCs, and the method includes helically winding the one or more sensor arrays around the elongate device, wherein the method includes positioning the plurality of electronic components along the one or more FPCs such that when the one or more sensor arrays are wound around the elongate device, the plurality of electronic components are aligned relative to the longitudinal axis of the elongate device.

50. The method according to claim 49, wherein, At least one of the FPCs has a helical FPC design and can be wound as a helical structure onto the elongate device.

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