Medical device assembly and components

Abstract

A flexible circuit assembly for a medical device includes a circuit board having at least one bend and at least one flat portion, and a mechanical support structure coupled to the circuit board. The mechanical support structure includes a first region and a second region extending distally from the first region. At least one bend of the circuit board is part of an arm extending distally from the flat portion, and at least one bend of the circuit board is coupled to the second region of the mechanical support structure.

Description

Technical Field

[0001] The present disclosure generally relates to devices, systems, and methods for medical device assemblies and components. Specifically, aspects of the present disclosure relate to devices, systems, and / or methods that include a flexible circuit board or a flexible circuit board assembly. This application claims priority to U.S. Provisional Patent Application No. 63 / 489,933, filed on March 13, 2023, and U.S. Provisional Patent Application No. 63 / 368,831, filed on July 19, 2022, each of which is hereby incorporated by reference in its entirety.

Background Art

[0002] In a medical procedure, an operator may insert a medical device, such as an endoscope or another type of scope, into a body lumen of a subject. To provide visibility to the operator during the procedure, the scope may include an imaging system disposed within the distal assembly of the scope. Such an imaging system may include an illumination element and a camera. The components of the imaging system may be incorporated on a flat circuit board, but such a flat circuit board may occupy a relatively large amount of space within the distal assembly. Accordingly, there is a need for systems, devices, and / or methods that include a flexible circuit board and / or a flexible circuit board assembly.

Summary of the Invention

[0003] Each of the aspects disclosed herein may include one or more of a plurality of features described with respect to any of the other disclosed aspects. Aspects of the present disclosure relate, among other things, to systems, devices, and methods related to a flexible circuit board assembly configured for use in a medical device.

[0004] According to one embodiment, a flexible circuit assembly for a medical device may include a circuit board having at least one bent portion and at least one flat portion, and a mechanical support structure coupled to the circuit board. The mechanical support structure may include a first region and a second region extending distally from the first region. At least one bent portion of the circuit board is part of an arm extending distally from the flat portion, and the at least one bent portion of the circuit board is coupled to the second region of the mechanical support structure.

[0005] Any of the flexible circuit assemblies described herein may include any of the following features. The first region includes at least one extension configured to receive an articulation movement wire of the medical device. The at least one bent portion includes a first layer structure, and the at least one flat portion includes a second layer structure. The first layer structure includes fewer layers than the second layer structure. The first layer structure is configured to achieve a bending radius less than six times the thickness of the second layer structure. The circuit board includes at least one mounting portion, and the at least one bent portion is disposed proximal to the at least one mounting portion. The at least one mounting portion is coupled to a mounting pad. The mounting pad is configured to receive one of a camera or an illumination element. The at least one flat portion defines a first plane, and the flat portion of the arm defines a second plane parallel to the first plane. The distal portion of the arm defines a third plane perpendicular to each of the first plane and the second plane. The circuit board is coupled to the mechanical support structure by an adhesive. At least one flat portion of the circuit board is coupled to the first region of the mechanical support structure. The mechanical support structure includes at least one of a polymeric material or a metal. The mechanical support structure includes at least one of a thermoplastic material or a thermosetting material. The flexible circuit assembly is configured to be incorporated into a distal assembly of an endoscope.

[0006] According to another embodiment, a flexible circuit assembly for a medical device may include a circuit board having at least one arm extending distally from a flat portion of the circuit board, and at least one bend in the at least one arm, and a mechanical support structure coupled to the circuit board. The mechanical support structure may have at least one arm extending distally from a first portion of the mechanical support structure. The at least one arm of the mechanical support structure is configured to be coupled to the at least one arm of the circuit board.

[0007] Any of the flexible circuit assemblies described herein may include any of the following features. The at least one bend includes a first layer structure, and the flat portion includes a second layer structure. The first layer structure includes an adhesive layer, a conductive layer, and at least one flexible layer. The second layer structure includes an adhesive layer, a conductive layer, at least one flexible layer, and at least one dielectric layer.

[0008] According to another embodiment, a flexible circuit assembly for a medical device may include a circuit board having a first portion and a second portion extending distally from the first portion, and a mechanical support structure coupled to the circuit board. The mechanical support structure may include a first region and a second region extending distally from the first region. The first portion includes a first layer structure, the second portion includes a second layer structure, the second portion includes an arm including a bend, the circuit board is configured to be bent at the bend and non-bent at the first portion, and the bend of the circuit board is coupled to a distal surface of the second region of the mechanical support structure.

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the disclosure and, together with the description, serve to explain the principles of the disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0010]

Figure 1A

Figure 1B

Figure 2

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9A

Figure 9B

Figure 10A

Figure 10B

Figure 11

Figure 12A

Figure 12B

Figure 13A

Figure 13B

DETAILED DESCRIPTION OF THE INVENTION

[0011] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the claimed invention. As used herein, the terms "comprising," "comprises," or other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. The term "exemplary" is used in the sense of "example" rather than "ideal." The term "distal" refers to the direction away from the operator / towards the treatment site, and the term "proximal" refers to the direction towards the operator. The term "about" or similar terms (e.g., "substantially") includes values within + / - 10% of the recited value.

[0012] The distal assembly of a medical device such as an endoscope may include a substrate (e.g., a circuit board) on which elements such as imaging elements and / or illumination elements may be implemented. Although the present disclosure may refer to an "endoscope" (or "scope"), it encompasses duodenoscopes, choledochoscopes, bronchoscopes, gastroscopes, endoscopic ultrasound ("EUS"), colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, cystoscopes, aspiration scopes, sheaths, catheters, or similar devices. When referring to an "endoscope", it includes any of the above devices. The imaging element may include one or more image sensors, cameras, or fiber optic light guides. The illumination element may include one or more (e.g., two) light emitting diodes ("LEDs") or fiber optic light guides. The circuit board may implement one or more position sensing systems, capacitors, diodes, resistors, digital processing chips, analog / digital converters, and / or additional sensors, such as force, pressure, or temperature sensors.

[0013] A circuit board having a planar configuration can be incorporated into the distal assembly. However, for example, if the size of the distal assembly is reduced to accommodate a smaller body lumen or to be insertable within the working channel of another endoscope, the planar circuit board may occupy a larger amount of space within the distal assembly than desired. If a smaller circuit board is used, the smaller surface area may cause difficulties in the manufacturing process or may prevent the mounting of elements such as a position sensing system, capacitors, diodes, resistors, digital processing chips, analog-to-digital converters, and / or additional sensors, such as force, pressure, or temperature sensors. Accordingly, what is disclosed herein are embodiments of a flexible circuit board that can be bent into a shape that can be fitted within the distal assembly of a scope such as an endoscope after being assembled in a planar configuration. By assembling the circuit board when it is in a planar configuration, various components can be mounted onto the planar circuit board using an automated pick-and-place assembly or other methods, thereby simplifying the manufacturing process. The circuit board can then be bent and assembled within / onto the distal tip assembly. Embodiments of the flexible circuit board described herein can also be incorporated into a flexible circuit assembly that may further include a mechanical support structure. The mechanical support structure provides rigidity to the flexible circuit during manufacturing, helps to form the geometric shape of the circuit, and is further configured to assist in the assembly of the distal tip assembly.

[0014] For example, FIGS. 1A - 3 illustrate an exemplary flexible circuit assembly 100 and its components according to some embodiments. The proximal direction in FIGS. 1A and 1B is indicated by arrow "P", and the distal direction in FIGS. 1A and 1B is indicated by arrow "D". In some embodiments, the flexible circuit assembly 100 can include a flexible circuit 110 (which can include a flexible circuit substrate and / or one or more elements mounted thereon) coupled to a mechanical support structure, such as a backbone 120. FIGS. 1A, 2, and 3 show the flexible circuit 110 incorporated in the flexible circuit assembly 100, and the flexible circuit 110 is partially bent as described below. FIG. 1B shows the flexible circuit 110 in a flat configuration prior to assembly on the backbone 120. The flexible circuit 110 can include another flexible medium, such as polyimide or liquid crystal polymer ("LCP"). The flexible circuit 110 may or may not include a reinforcement. The flexible circuit 110 can be designed with a desired (e.g., predetermined) impedance. The flexible circuit 110 can include a solder mask and / or a coverlay. Alternatively, the flexible circuit 110 can include an in - pad via structure instead of (e.g., to avoid the use of) a solder mask.

[0015] The flexible circuit 110 may include a flat (i.e., not bent) portion 112, a bent portion 113, and bent portions 114a, 114b, 114c. In some examples, the entire flexible circuit 110 may be flexible. The bent portions 113, 114a, 114b, 114c (FIG. 1B) may be portions of the flexible circuit 110 that are bent / flexed when assembled within the flexible circuit assembly 100. The bent portions 113, 114a, 114b, 114c may incorporate, for example, the layer structure 500 described below with respect to FIG. 5. Other portions of the flexible circuit 110 (i.e., portions of the flexible circuit 110 that remain flat or are not bent) may incorporate the layer structure 600 described below with respect to FIG. 6. The positions of the bent portions 113, 114a, 114b, 114c shown in FIGS. 1A - 3 are merely exemplary, and other portions of the flexible circuit 110 may be additionally or alternatively bent when assembling the flexible circuit assembly 100. In other examples, a portion of the flexible circuit 110 may be rigid, such as when the flexible circuit 110 is a rigid - flex circuit. For example, while the bent portions 113, 114a, 114b, 114c shown in FIG. 1B may be flexible, other portions of the flexible circuit 110 may be rigid.

[0016] In some embodiments, the flexible circuit 110 may include at least one arm 115 that extends distally from the flat portion 112. The bending portions 114a, 114b, 114c may be incorporated into the arm 115 (as shown, for example, in FIG. 1B). The arm 115 may be configured to bend at the bending portions 114a, 114b, 114c to enable the flexible circuit 110 to achieve a particular geometric shape (as shown, for example, in FIGS. 1A, 2, and 3). The positions of the bending portions 114a, 114b, 114c shown in FIG. 1B are merely exemplary. Other portions of the arm 115 may also be bent when assembling the flexible circuit assembly 100. As shown in FIGS. 1A - 3, the flexible circuit 110 may include two arms 115. However, in some embodiments, the flexible circuit 110 may include at least three arms. Each of the arms 115 may have corresponding bending portions 114a, 114b, 114c, as shown in FIG. 1B.

[0017] Also, the flexible circuit 110 may have a mounting portion 111 that extends distally from the flat portion 112 between the plurality of arms 115. The bending portion 113 may be disposed at the proximal portion of the mounting portion 111.

[0018] Various components, such as the lighting element 102 and the camera 104, may be mounted on the flexible circuit 110. In some embodiments, the lighting element 102 may be connected to the distal portion 119 of each arm 115, while the camera 104 may be connected to the mounting portion 111. However, in some embodiments, both the camera 104 and the lighting element 102 may be mounted on the same portion of the flexible circuit 110 (e.g., the mounting portion 111 or the distal portion 119).

[0019] Additional components, such as capacitors, diodes, resistors, or other sensors, may be mounted on the flat portion 112 and / or the mounting portion 111 or the distal portion 119. The illumination element 102 may have any suitable features. For example, the illumination element 102 may include LEDs of any suitable size and characteristics. The camera 104 may have any suitable features. For example, the camera 104 may include a ball grid array (BGA)-type camera. The camera 104 may have any suitable size, any suitable shape, and any suitable image sensor / lens array. Components attached to the flexible circuit 110 may be attached using any suitable attachment methods known in the art, such as one or more of surface mount technology, reflow, soldering, potting, and / or encapsulation. In some embodiments, any of the components described above may be included in an assembly separate from the flexible circuit 110, configured to operate in conjunction with the flexible circuit 110, or may be completely omitted.

[0020] As particularly shown in FIG. 1A together with FIG. 1B, when the flexible circuit 110 is in the bent configuration (FIG. 1A), the flat portion 112 may define a first plane. Each arm 115 may include a flat first portion 117 that defines a second plane between the bent portions 114b, 114c. When incorporated within the assembly 100, the second plane of the first portion 117 may be substantially parallel to the first plane of the flat portion 112, but may be offset from the first plane. The inclined portion 118 may extend between the flat portion 112 and the first portion 117 (e.g., between the bent portions 114a, 114b). Alternatively, the second plane of the first portion 117 and the first plane of the flat portion 112 may be in the same plane. The distal portion 119 of the arm 115 may be located distally of the bent portion 114c and may define a third plane. The illumination element 102 may be mounted on the distal portion 119. The third plane of the distal portion 119 may be substantially perpendicular to the first plane of the flat portion 112 and / or the second plane of the first portion 117.

[0021] The mounting portion 111 (extending distally from the bending portion 113 in the flat configuration of FIG. 1B) may define a fourth plane that is substantially perpendicular to the first plane of the flat portion 112 and / or the second plane of the first portion 117 when the flexible circuit 110 is in the bent configuration of FIG. 1A (i.e., when the flexible circuit 110 is incorporated into the flexible circuit assembly 100). The fourth plane of the mounting portion 111 may be substantially parallel to the third plane of the distal portion 119. The relative angles described above are merely illustrative, and any suitable arrangement for achieving the desired placement of elements such as the camera 104 and the lighting element 102 may be utilized. For example, the substantially perpendicular relationship described above may have other oblique or parallel relationships. Similarly, the substantially parallel relationship described above may have an oblique relationship in other aspects.

[0022] As shown in FIGS. 1A - 3, the mounting portion 111 may be located proximal to the distal portion 119 when the flexible circuit 110 is in the bent configuration. The position of the mounting portion 111 may accommodate a greater (proximal / distal direction) depth of the camera 104 compared to the depth of the lighting element 102. The distal end of the camera 104 may be located distally of the distal end of the lighting element 102, particularly as shown in FIG. 2. Alternatively, the distal end of the camera 104 may be substantially in the same position as the distal end of the lighting element 102 or may be located proximal to the distal end of the lighting element 102.

[0023] In the flat configuration of the flexible circuit 110 shown in FIG. 1B, the arm 115 extends distally from the flat portion 112 such that the outer edge of the flexible circuit 110 extending in the proximal / distal direction can continue in a straight line along the flat portion 112 and the arm 115 (e.g., substantially parallel to the central longitudinal axis of the flexible circuit 110 and / or the central longitudinal axis of the endoscope in which the flexible circuit 110 is incorporated). In the flat configuration, the outer lateral edge 109b of the mounting portion 111 can abut or be located in the vicinity of the proximal inner edge 107b of the arm 115. The distal edge 109a of the mounting portion 111 can be located proximal to the distal edge 107a of the arm 115 in the flat configuration. The mounting portion 111 can be substantially rectangular in the flat configuration. The mounting portion 111 can have an inclined edge portion 109c extending between the distal edge 109a of the mounting portion 111 and the lateral edge 109b of the mounting portion 111. Each arm 115 can have a corresponding inclined edge portion 107c. This inclined edge portion 107c can abut or be located in the vicinity of the inclined edge portion 109c of the mounting portion 111. The inclined edge portion 107c of the arm 115 can extend between the proximal inner edge 107b and the distal inner edge 107d of the arm 115. In the portion of the arm 115 defined by the proximal inner edge 107b, the arm 115 can be narrower (along the up / down direction of FIG. 1B) than the portion of the arm 115 defined by the distal inner edge 107d.

[0024] Continuing to refer to FIGS. 1A - 3, during manufacturing, during assembly of the distal tip assembly, and during use of the endoscope, the backbone 120 can be coupled to the flexible circuit 110 to provide support for the flexible circuit 110. Thus, in some embodiments, the backbone 120 can have a geometry similar to, complementary to, or corresponding to that of the flexible circuit 110. For example, the backbone 120 can include a first region 122 configured to be coupled to or located adjacent to the flat portion 112 of the flexible circuit 110, and a second region 124 extending distally from the first region 122 and configured to be coupled to the arm 115 of the flexible circuit 110. In some embodiments, as will be described in more detail below, the backbone 120 can be coupled to the flexible circuit 110 only via (1) the connection between the second region 124 of the backbone 120 and the arm 115 (e.g., the distal portion 119) of the flexible circuit 110, and (2) the connection between the bend 113 and / or the mounting portion 111 and the distal end 123 of the first region 122. In other embodiments, the flat portion 112 can be coupled to the first region 122 (e.g., by an adhesive).

[0025] In some embodiments, the second region 124 can include at least one arm 125 that can reflect the geometry of the arm 115 of the flexible circuit 110. As shown in FIGS. 1A - 3, the second region 124 can include two arms 125. In some embodiments, the length of the arm 125 can be selected to determine the position of the illumination element 102. For example, the length of the arm 125 can be reduced compared to FIGS. 1A - 3 to move the position of the illumination element 102 behind the camera 104.

[0026] In addition, the backbone 120 may include a third region 126. This third region 126 may extend proximally from the first region 122. The third region 126 may serve to maintain the position of a cable extending from the flexible circuit 110, adapt to the shape of the distal assembly housing, and / or function to provide a gripping point for a user to hold during assembly of the distal assembly (Figs. 9A and 9B). In some embodiments, the third region 126 may be tapered inwardly in a lateral direction with respect to the first region 122.

[0027] In some embodiments, the backbone 120 may fix the flexible circuit 110 in a set position after it is bent, thereby preventing further bending both during assembly into the distal assembly of the endoscope and during use of the endoscope. In other words, the backbone 120 may hold the flexible circuit 110 in a desired shape / configuration.

[0028] In the bent configuration of the flexible circuit 110, the flat portion 112 of the flexible circuit 110 may extend along the first region 122 and along the first side portion 128 of the backbone 120. The first side portion 128 of the first region 122 may have substantially the same shape (e.g., rectangular as shown in Figs. 1A - 3) as the flat portion 112. The first side portion 128 may be substantially planar and substantially parallel to the flat portion 112.

[0029] The distal portion 119 of the flexible circuit 110 may be coupled to the backbone 120 at the joint 130. The joint 130 may be located between the distal surface of the arm 125 and the proximal surface of the distal portion 119 of the flexible circuit 110. The distal surface of the arm 125 may be substantially perpendicular to the flat portion 112 / first side portion 128 of the flexible circuit 110 and substantially parallel to the distal portion 119 of the flexible circuit 110. The distal portion 119 may extend from the first side portion 128 of the backbone 120 toward the second side portion 129 of the backbone 120. Since the distal portion 119 is attached to the distal surface of the arm 125 at the joint 130, the arm 125 may serve to hold the distal portion 119 in a desired configuration (e.g., substantially perpendicular to the flat portion 112).

[0030] The mounting portion 111 can be attached to the distal end 123 of the first region 122 among the plurality of arms 125. As shown in FIGS. 1A to 3, the mounting portion 111 can occupy substantially the entire part of the distal end 123 of the skeleton 120 that is between the plurality of arms 125. As described above, the mounting portion 111 can be held closer to the proximal side than the distal portion 119 of the arm 11 (by being coupled to the distal end 123). The mounting portion 111 can extend from the first side portion 128 of the skeleton 120 toward the second side portion 129 of the skeleton 120. By coupling the mounting portion 111 to the distal end 123, the mounting portion 111 can be held in a desired configuration (for example, substantially perpendicular to the flat portion 112).

[0031] The flexible circuit 110 can be coupled to the skeleton 120 by an adhesive (for example, a UV-curable adhesive). In some embodiments, the adhesive 106 can be disposed between the first surface 116 of the flexible circuit 110 and the first side portion 128 of the skeleton 120 (FIG. 3). The adhesive 106 can be used to couple the flexible circuit 110 to the skeleton 120 at the joint 130 behind the illumination element 102 and / or to couple the mounting portion 111 to the distal end 123.

[0032] In some embodiments, the skeleton 120 can include at least one recess 140 disposed on the second side portion 129 of the skeleton 120 adjacent to the mounting portion 111. The recess 140 can facilitate the coupling of the skeleton 120 to the flexible circuit 110 by allowing the adhesive to flow from the second side portion 129 to the mounting portion 111 through the recess 140. Additionally or alternatively, the recess 140 can function to accommodate any component that can be mounted on the rear side of the mounting portion 111.

[0033] The backbone 120 supports the elements of the flexible circuit 110 and may have any suitable shape to conform to the shape / configuration of the distal tip assembly of the endoscope. For example, the backbone 120 may have a substantially constant thickness between the first side portion 128 and the second side portion 129 in the first region 122 and the second region 124 of the backbone 120. Alternatively, the second region 124 (including the arm 125) may have a greater thickness than the first region 122 (e.g., the arm 125 may extend beyond the first side portion 128). The third region 126 of the backbone 120 may have a smaller thickness between the first side portion 128 and the second side portion 129 or may have the same or a similar thickness as the first region 122 and the second region 124. The configurations described above are merely exemplary, and other arrangements are also included within the scope of the present disclosure.

[0034] In some embodiments, the backbone 120 may be made from at least one of a polymeric material, a ceramic, or a metal. In some embodiments, the backbone 120 may be made from at least one of a thermoplastic material or a thermosetting material. However, in some embodiments, the backbone 120 may be made from a thermally conductive metal, such as copper. The backbone 120 may be manufactured by an additive manufacturing process or an injection molding process, but any material processing technique suitable for manufacturing a metal or polymeric article may be utilized to manufacture the backbone 120.

[0035] In some embodiments, for example, as shown in FIG. 4, the backbone 420 may include an additional wire guiding mechanism. Unless otherwise specified herein, the flexible circuit assembly 400 may have any of the features of the flexible circuit assembly 100. The flexible circuit assembly 400 may include a flexible circuit 410 coupled to the backbone 420. Similar to the flexible circuit 110 described above, the flexible circuit 410 may include a flat portion (not shown) and an arm 415 extending distally from the flat portion. The arm 415 may include at least one bend configured to be bendable to enable the flexible circuit 410 to achieve a particular geometric shape. Similar to the flexible circuit 110, components such as, for example, the lighting element 402 and the camera 404 may be mounted on the flexible circuit 410. Additional components, such as capacitors, diodes, resistors, or other sensors may also be mounted on the flexible circuit 410.

[0036] Continuing to refer to FIG. 4, the backbone 420 may include features similar to those of the backbone 120 described above. For example, the backbone 420 may include a first region 422 configured to be adjacent to the flat portion of the flexible circuit 410 along a first side portion 428 of the backbone 420, and a second region 424 extending distally from the first region 422 and configured to be coupled to the arm 415 of the flexible circuit 410. In some embodiments, the second region 424 may include at least one arm 425 that may reflect / complement the geometric shape of the arm 415 of the flexible circuit 410. The backbone 420 may also include a third region 426 that may extend proximally from the first region 422 and may be tapered inwardly with respect to the first region 422.

[0037] Also, in some embodiments, the backbone 420 may include at least one extension 430 that extends laterally from the first region 422 (along the direction “A” shown in FIG. 4). As shown in FIG. 4, the backbone 420 may include two extensions 430. In some embodiments, the extension 430 may include a chamfered or filleted upper surface 432 that extends downwardly at an angle with respect to the second side portion 429 of the backbone 420. Further, in some embodiments, each extension 430 may include a recess 434 within the upper surface 432 that may function as a pocket for receiving a mechanism, such as a steering wire mechanism. Thus, in some embodiments, a through-hole 436 configured to receive a wire or cable, such as a steering wire, may penetrate into the recess 434 through the proximal end 438 of the extension 430. Although not shown in FIG. 4, another hole may penetrate through the distal end of the extension 430 and / or the extension 430 may include other features for holding a steering wire within the recess 434. Alternatively, the steering wire may be fixed to the extension 430 via the through-hole 436.

[0038] Thus, the backbone 420 may provide a distal attachment point for a steering / articulation wire that extends from the handle of the endoscope through the shaft of the endoscope. The backbone 420 may include any suitable number of attachment points (e.g., one for each steering / articulation wire) for the steering / articulation wire. Alternatively, only some of the plurality of steering wires may extend to / within the backbone 420.

[0039] Next, referring to FIGS. 5 and 6, in some embodiments, the disclosed flexible circuits, such as the flexible circuits 110, 410 described above, may include a layer structure in both the flat and bent portions of the circuit. For example, as shown in FIG. 5, the flexible region of the circuit may have a layer structure 500 that may include at least a first layer 502, a second layer 504, a third layer 506, and a fourth layer 508. In some embodiments, the first layer 502 and the fourth layer 508 may be flexible dielectric layers, the second layer 504 may be an adhesive layer, and the third layer 506 may be a signal layer.

[0040] In some embodiments, each of the layers 502-508 may have a thickness in the range of about 0.005 mm to about 0.1 mm (including partial ranges). In some embodiments, the first layer 502 may have a thickness of about 0.012 mm. The second layer 504 may have a thickness of about 0.02 mm. The third layer 506 may have a thickness of about 0.009 mm. The fourth layer 508 may have a thickness of about 0.025 mm. In some embodiments, the overall thickness of the layer structure 500 may be in the range of about 0.02 mm to about 0.4 mm (including partial ranges).

[0041] In some embodiments, the second layer 504 may include a polypropylene adhesive. In some embodiments, the third layer 506 may be made of copper (or another conductive material), but may have a potential for trace cracking during bending when subjected to tension or compression. Such trace cracking can potentially cause a disconnection between the flexible circuit board and any components mounted thereon when the circuit board is bent to a predetermined position. However, in some embodiments, the third layer 506 may be sandwiched between the first layer 502 and the fourth layer 508, each of which may be made from a flexible material, such as a polymer like polyimide, polyamide, or polyester. Thus, during bending, when the first layer 502 is in a compressed state and the fourth layer 508 is in a tensile state (or vice versa), the third layer 506 can remain on the neutral bending axis. By maintaining the third layer 506 within the neutral bending axis, the third layer 506 is not subjected to tension or compression, and trace cracking can be significantly reduced or prevented. For example, the third layer 506 can withstand at least 20 bending cycles without breaking. Furthermore, with this layer structure, the flexible circuit may be able to achieve a bending radius less than six times the thickness of the circuit while maintaining the durability of the entire circuit.

[0042] In contrast, as shown in FIG. 6, in some embodiments, the flat (i.e., non-bent) portion of the disclosed flexible circuit may include a layer structure 600 that may be different from the layer structure 500 of the flexible (i.e., bent) portion of the flexible circuit. For example, the layer structure 600 may include a first layer 602, a second layer 604, a third layer 606, a fourth layer 608, a fifth layer 610, and a sixth layer 612. In some embodiments, the first layer 602, the fourth layer 608, and the sixth layer 612 may each be a signal layer. In some embodiments, the second layer 604 and the fifth layer 610 may be dielectric layers, and in some embodiments, the third layer 606 may be an adhesive layer. Each layer of the layer structure 600 may have the same or similar materials as the corresponding layers of the layer structure 500 described above. For example, the first layer 602, the fourth layer 608, and the sixth layer 612 may include the material of the third layer 506. The second layer 604 and the fifth layer 610 may include the materials of the first layer 502 and the fourth layer 508. The third layer 606 may include the material of the second layer 504. Further, in an example where a portion of the circuit is rigid, the second layer 604 and the fifth layer 610 (dielectric layers) of the rigid portion may include, for example, a glass-reinforced epoxy laminate such as FR-4 (Flame Retardant 4), a synthetic resin-bonded paper such as FR-2 (Flame Retardant 2), a composite epoxy material such as CEM-1 or CEM-3 ( "CEM"), or any combination thereof. Alternative materials may also be used within the scope of the present disclosure.

[0043] In some embodiments, the layer structure 600 may further include at least one via 620 configured to transmit electrical wiring to different layers 602-610 within the layer structure 600. As described above, the layer structure 600 may further include a solder mask layer (which may include a solder resist material) adjacent to the side of the first layer 602 that is opposite the second layer 604. The layer structure 600 may further have such a solder mask layer adjacent to the side of the sixth layer 612 that is opposite the fifth layer 610. The overlay / coverlay may be adjacent to one or more of the plurality of solder mask layers (e.g., adjacent to the side of the solder mask layer that is opposite the first layer 602 or the sixth layer 612).

[0044] In some embodiments, each of layers 602 - 612 may have a thickness in the range of about 0.005 mm to about 0.1 mm (including partial ranges). In some embodiments, the first layer 602 may have a thickness of about 0.009 mm. The second layer 604 may have a thickness of about 0.012 mm. The third layer 606 may have a thickness of about 0.02 mm. The fourth layer 608 may have a thickness of about 0.009 mm. The fifth layer 610 may have a thickness of about 0.025 mm. The sixth layer 612 may have a thickness of about 0.009 mm. In some embodiments, the overall thickness of the layer structure 600 may be in the range of about 0.03 mm to about 0.6 mm (including partial ranges).

[0045] In some embodiments, the layer structure 600 may include additional or alternative dielectric layers disposed adjacent to either or both of the first layer 602 and the fourth layer 608. In some embodiments, the additional dielectric layer may be a polymer material or a glass epoxy. Inclusion of additional or alternative dielectric layers in the layer structure 600 can provide additional rigidity, thereby reducing the bending ability of the circuit board in the region where the layer structure 600 is incorporated.

[0046] Referring now to FIG. 7, in some embodiments, layer structure 500 can be incorporated into layer structure 600. For example, in some embodiments, flexible circuit assembly 700 (which can have any of the characteristics of flexible circuit assemblies 100, 200) can include flexible circuit 710 having flat portion 712, arm 715, and mounting portion 711. Arm 715 can have any of the characteristics of arms 115, 415 described above and can have lighting element 702 mounted thereon. Although not explicitly shown in FIG. 7, arm 715 can include a plurality of bending portions having any of the characteristics and / or arrangements of bending portions 114a, 114b, 114c (FIG. 1B). Mounting portion 711 can have any of the characteristics of mounting portions 111, 411 and can have camera 704 mounted thereon. Although not explicitly shown in FIG. 7, mounting portion 711 can include a bending portion having any of the characteristics and / or arrangements of bending portion 113 (FIG. 1B).

[0047] In some embodiments, each bending portion of arm 715 and mounting portion 711 can include a layer structure having four layers, such as layer structure 500 described above. Flat portion 712, as well as the non-bent (i.e., non-bending portion) portions of arm 715 and mounting portion 711, can include a layer structure having six layers, such as layer structure 600 described above. In some embodiments, layer structure 500 defines the four inner layers of layer structure 600. In other words, layer structure 600 is obtained by adding additional outer layers 602, 612 to layer structure 500. The first layer 502 of layer structure 500 can correspond to the second layer 604 of layer structure 600. The second layer 504 of layer structure 500 can correspond to the third layer 606 of layer structure 600. The third layer 506 of layer structure 500 can correspond to the fourth layer 608 of layer structure 600. The fourth layer 508 of layer structure 500 can correspond to the fifth layer 610 of layer structure 600.

[0048] When the flexible circuit assembly 700 is in a flat configuration (a configuration similar to that shown in FIGS. 1B and 8, which will be described in detail below), the illumination element 702 and the camera 704 can be disposed on the first side surface 718 of the flexible circuit 710. The electronic component 717 (which can be any type of electronic component including the examples described above with respect to FIGS. 1A - 3) can be disposed on the second side surface 719 of the flexible circuit 710. The illumination element 102, the camera 104, and the electronic component 717 can be disposed on the flexible circuit 710 using any suitable automatic or manual method. Each bend of the arm 715 and the mounting portion 711 can then be bent by an automatic or manual method into the configuration described with respect to FIGS. 1A - 3 and can be optionally coupled to a framework such as the framework 120.

[0049] As described above, various components can be implemented on the flexible circuit substrate described herein. As shown in FIG. 8, for example, the flexible circuit 800 can have any features of the flexible circuits 110, 410, 710 and can include several pads on which components can be implemented. For example, the flexible circuit 800 can include at least one illumination element mounting pad 810, at least one camera mounting pad 811, and at least one capacitor pad 814. However, the flexible circuit 800 can include more or fewer mounting pads depending on the intended use of the circuit. Also, in some embodiments, the illumination element cable 804 and the camera cable 806 can be coupled to the flexible circuit 800 by an adhesive 802. The illumination element cable 804 and / or the camera cable 806 can include, for example, any combination of coaxial cables (e.g., impedance - matched ones) and / or ribbon cables. The illumination element cable 804 and / or the camera cable 806 can have any suitable type of insulator and / or conductor. Instead of cables (e.g., the illumination element cable 804 and the camera cable 806), an elongate flexible circuit substrate may be utilized.

[0050] Continuing to refer to FIG. 8, all of the above-described components can be mounted on the flexible circuit 800 while the flexible circuit 800 is in a flat configuration. The circuit 800 can then be coupled to a backbone, such as any of the backbones described herein. Also, the circuit 800 can be bent into a bent configuration (such as those shown in FIGS. 1A, 2, 3, 4, and / or 7, etc.) prior to insertion into the distal assembly of the endoscope.

[0051] As shown in FIGS. 9A and 9B, when the flexible circuit assembly is assembled, the flexible circuit assembly can be incorporated into the distal assembly of the endoscope. For example, in some embodiments, the flexible circuit assembly 100 can be incorporated into the distal assembly 900. The distal assembly 900 includes a body 902, and the body 902 can have at least one cleaning channel 906 and at least one working channel 904 that penetrate the body 902. As shown in FIG. 9B, the flexible circuit assembly 100 can be inserted into a cavity 908 that extends distally within the body 902 from the proximal surface 910 of the body 902. As shown in FIG. 9A, when the flexible circuit assembly 100 is fully inserted into the body 902, the illumination element 102 and the camera 104 can be flush with the distal surface 912 of the body 902 or can be slightly recessed with respect to the distal surface 912.

[0052] In some embodiments, the rigidity provided by the backbone 120 described above can assist in inserting the flexible circuit assembly 100 into the cavity 908 and can facilitate the process of adhering or otherwise securing the flexible circuit assembly 100 to the body 902. For example, the backbone 120 can provide a large surface area to which an adhesive can be applied. Alternatively, in some embodiments, the backbone 120 can simply be cast (e.g., sealed) in a predetermined position within the cavity 908.

[0053] Also, the cavity 908 may have a geometry corresponding to the geometry of the framework 120 to help the framework 120 fit snugly within the body 902. Thus, the cavity 908 may have a width and a height corresponding to the width and height of the framework 120 and / or the elements disposed on the flexible circuit assembly 100, respectively. However, the geometry of the cavity 908 may include any shape or configuration suitable for receiving the circuit assembly.

[0054] In some embodiments, an alternative flexible circuit assembly may be incorporated into the distal assembly of the endoscope. For example, as shown in FIGS. 10A-11, the flexible circuit assembly 1100 may be incorporated into the distal assembly 1000. Similar to the distal assembly 900 described above, the distal assembly 1000 includes a body 1002, and the body 1002 may have at least one cleaning channel 1006 and at least one working channel 1004 that penetrate the body 1002.

[0055] The flexible circuit assembly 1100 may include a backbone 1120 similar to the backbones 120, 420 described above. Instead of lighting elements implemented on the flexible circuit, at least one optical fiber 1102, such as a plastic optical fiber, may be coupled to the backbone 1120 or may extend adjacent to the backbone 1120. As shown in FIGS. 10A and 10B, the optical fibers 1102 may be disposed along both sides of the backbone 1120 adjacent to the flexible circuit 1110 (FIG. 10B). Thus, since the flexible circuit 1110 may not include an arm portion on which lighting elements may be implemented, the backbone 1120 may be formed without an arm portion. Rather, as shown in FIG. 10B, the flexible circuit 1110 may include only a mounting portion 1111 on which a camera 1104 may be mounted. In some embodiments, the optical fibers 1102 may extend adjacent to the mounting portion 1111 on both sides of the mounting portion 1111. For example, the first optical fiber 1102 may extend adjacent to the mounting portion 1111 on the first side surface of the mounting portion 1111. The second optical fiber 1102 may extend adjacent to the mounting portion 1111 on the second side surface of the mounting portion 1111, which is opposite to the first side surface. The surfaces of the flexible circuit 1110 other than the mounting portion 1111 may support the optical fibers 1102 or may be adjacent to the optical fibers 1102 and may assist in positioning the optical fibers 1102 in a desired position.

[0056] As shown in FIG. 11, for example, a plurality of optical fibers 1102 may be mounted on the flexible circuit 1110 in a y-shaped configuration such that each optical fiber 1102 extends directly adjacent to each other from the proximal end of the flexible circuit assembly 1000 until reaching the junction 1130. At the junction 1130, each optical fiber 1102 extends away from each other at an angle and then may extend parallel to the longitudinal axis of the flexible circuit assembly 1000 and adjacent to the mounting portion 1111. As shown in FIG. 11, each optical fiber 1102 may include a first portion, a second portion, and a third portion. The first portion and the third portion may be substantially parallel to each other and / or substantially parallel to the longitudinal axis of the flexible circuit assembly 1000. The second portion may extend between the first portion and the third portion and may be bent or non-parallel to the first portion and the third portion. Alternatively, these portions may have other angles with respect to each other.

[0057] In some embodiments, the optical fiber 1102 may optionally be coupled to the backbone 1120 via a sheath 1108. Alternatively, the optical fiber 1102 may be coupled to the backbone 1120 using an adhesive, molded into the backbone 1120, or press-fitted into the backbone 1120 using mechanical interference.

[0058] Alternatively, as shown, for example, in FIGS. 12A and 12B, a flexible circuit assembly 1300 including only one lighting element 1302 can be incorporated within the distal assembly 1200. Similar to the distal assemblies 900, 1000 described above, the distal assembly 1200 includes a body 1202, which may have at least one cleaning channel 1206 and at least one working channel 1204 that penetrate the body 1202. As shown in FIG. 12B, the flexible circuit 1310 may be coupled to the skeleton 1320 and may include a mounting portion 1311 configured to receive both the camera 1304 and a single lighting element 1302. Since the mounting portion 1311 can receive both the camera 1304 and the lighting element 1302, the flexible circuit 1310 and the skeleton 1320 can both be formed without having an arm portion. Thus, the width of the flexible circuit assembly 1300 can be minimized. This can facilitate the insertion of the flexible circuit assembly 1300 into the distal assembly 1200.

[0059] In some embodiments, for example, as shown in FIG. 12A, the lighting element 1302 can be disposed proximal to the camera 1304. However, in some embodiments, the lighting element 1302 can be disposed adjacent to the camera 1304 such that the lighting element 1302 and the camera 1304 are flush with each other. Alternatively, the lighting element 1302 can be configured to extend distally beyond the camera 1304.

[0060] Figures 13A and 13B illustrate aspects of an exemplary medical device 1410. The assembly described above may be incorporated into the medical device 1410. Figure 13A shows a proximal portion of the medical device 1410. Figure 13B shows a distal tip 1444 of the medical device 1410 that may incorporate an assembly such as any of the distal assemblies 900, 1000, 1200. The medical device 1410 may include a handle portion 1412 for gripping and manipulation by an operator and an insertion portion 1414 for at least partial insertion into a subject's body (e.g., a body lumen). As shown in Figures 13A and 13B, the medical device 1410 may include an endoscope.

[0061] The handle portion 1412 may include, for example, a knob 1422 on a proximal portion of the handle portion 1412. The knob 1422 may serve to assist in the articulation / steering of the insertion portion 1414 including the distal tip 1444. Although the knob 1422 is shown in Figure 13A, in addition to or instead of the knob 1422, any suitable actuator such as one or more knobs, buttons, sliders, or joysticks may be used. The port 1424 of the handle portion 1412 may provide access to a lumen or working channel of the medical device 1410. The operator may insert an instrument or other device into the port 1424 and extend the instrument or other device distally through the working channel. The working channel may extend longitudinally along the length of the insertion portion 1414. The umbilical portion 1430 may extend from the handle portion 1412 (e.g., from a proximal portion of the handle portion 1412). The umbilical portion 1430 may include, for example, wires, cables, and / or wiring for directing power, signals, or fluids to or from the handle portion 1412. For example, the umbilical portion 1430 may connect the handle portion 1412 to one or more user interfaces, monitors, displays, etc.

[0062] The insertion portion 1414 may include a shaft 1442 that extends distally from the handle portion 1412. The shaft 1442 may have any suitable characteristics. For example, the shaft 1442 may be flexible and may have wires, tubes, or other features passing through it. The distal tip 1444 of the medical device 1410 shown in FIG. 13B may be disposed at the distal end of the shaft 1442. As shown in FIG. 13B, the distal tip 1444 may include a most distal surface 1446. The most distal surface 1446 may define a working channel opening 1448. The working channel may extend between the port 1424 and the working channel opening 1448 such that an instrument or other device passes through the port 1424, through the working channel, and out of the working channel opening 1448. An instrument extending distally from the working channel opening 1448 may be used to perform a medical procedure on a subject.

[0063] Also, the distal tip 1444 may include imaging components such as one or more illumination elements 1450 and a camera 1452 (which may have any of the characteristics of the illumination elements and cameras disclosed above). Although two illumination elements 1450 and one camera 1452 are shown in FIG. 13B, other numbers of illumination elements 1450 and cameras 1452 may be utilized. Alternatively, the illumination elements 1450 and the camera 1452 may be combined in a single device. The illumination element 1450 may include an LED or any suitable alternative light source. The camera 1452 may be configured to capture video and / or still images. The camera 1452 may supply a signal to a monitor (not shown) such that an operator can view the visual images provided by the camera 1452 while maneuvering the medical device 1010 through the subject's body.

[0064] As shown in FIG. 13B and as described above, the medical device 1410 may be “forward facing”. In other words, the features of the distal tip 1444 (e.g., the working channel opening 1448, the illumination element 1450, and the camera 1452) may face distally (i.e., in front of the most distal plane 1446). The present disclosure also encompasses other configurations of the distal tip 1044. For example, the medical device 1410 may be “sideways facing”. In a sideways facing embodiment, the working channel opening 1448, the illumination element 1450, and / or the camera 1452 may be disposed radially outward of the distal tip 1444 such that they face in a radially outward direction that is substantially perpendicular to the longitudinal axis of the insertion portion 1414.

[0065] While the principles of the present disclosure have been described herein with reference to exemplary examples for specific applications, the present disclosure is not limited thereto. Those skilled in the art and those who utilize the teachings provided herein will recognize that all additional changes, applications, and substitutions of equivalents are within the scope of the embodiments described herein. Accordingly, the invention should not be regarded as limited by the foregoing description.

Claims

1. A flexible circuit assembly for medical devices, A circuit board having at least one bent portion and at least one flat portion, A mechanical support structure coupled to the circuit board, The first area and, A second region extending distally from the first region, The mechanical support structure includes, The at least one bent portion of the circuit board is part of an arm that extends distally from the flat portion, A flexible circuit assembly in which the at least one bent portion of the circuit board is coupled to the second region of the mechanical support structure.

2. The flexible circuit assembly according to claim 1, wherein the first region includes at least one extension, the at least one extension is configured to receive a joint movement wire of the medical device.

3. The flexible circuit assembly according to claim 1 or 2, wherein the at least one bent portion includes a first layer structure and the at least one flat portion includes a second layer structure.

4. The flexible circuit assembly according to claim 3, wherein the first layer structure comprises fewer layers than the second layer structure.

5. The flexible circuit assembly according to claim 3, wherein the first layer structure is configured to achieve a bending radius of less than six times the thickness of the second layer structure.

6. The flexible circuit assembly according to claim 1 or 2, wherein the circuit board includes at least one mounting portion, and the at least one bent portion is located on the proximal portion of the at least one mounting portion.

7. The flexible circuit assembly according to claim 6, wherein at least one of the mounting parts is coupled to a mounting pad.

8. The flexible circuit assembly according to claim 7, wherein the mounting pad is configured to accept one of a camera or a lighting element.

9. The flexible circuit assembly according to claim 1 or 2, wherein the at least one flat portion defines a first plane, and the flat portion of the arm defines a second plane parallel to the first plane.

10. The flexible circuit assembly according to claim 9, wherein the distal portion of the arm defines a third plane, and the third plane is perpendicular to the first plane and the second plane, respectively.

11. The flexible circuit assembly according to claim 1 or 2, wherein the circuit board is bonded to the mechanical support structure by an adhesive.

12. The flexible circuit assembly according to claim 1 or 2, wherein at least one flat portion of the circuit board is coupled to the first region of the mechanical support structure.

13. The flexible circuit assembly according to claim 1 or 2, wherein the mechanical support structure comprises at least one of a polymer material or a metal.

14. The flexible circuit assembly according to claim 1 or 2, wherein the mechanical support structure includes at least one of a thermoplastic material or a thermosetting material.

15. The flexible circuit assembly according to claim 1 or 2, wherein the flexible circuit assembly is configured to be incorporated into the distal assembly of an endoscope.

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