Medical device assemblies and components

Abstract

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

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority under 35 U.S.C. §119 to U.S. Provisional Application No. 63 / 489,933, filed on March 13, 2023, and U.S. Provisional Application No. 63 / 368,831, filed on July 19, 2022, the entire contents of each of which are incorporated herein by reference. Technical Field

[0002] The present invention generally relates to devices, systems and methods for medical device assemblies and components. More specifically, aspects of the present invention relate to devices, systems and / or methods that include flexible circuit boards or flexible circuit board assemblies. Background Art

[0003] During a medical procedure, an operator may insert a medical device, such as an endoscope or other type of scope, into a body cavity of a subject. To provide visibility to the operator during the procedure, the scope may include an imaging system disposed within a distal assembly of the scope. Such an imaging system may include an illumination element and a camera. Imaging system components may be incorporated onto a flat circuit board; however, such a flat circuit board may occupy a relatively large space within the distal assembly. Therefore, there is a need for systems, devices, and / or methods that include flexible circuit boards and / or flexible circuit board assemblies. Summary of the invention

[0004] Each of the aspects disclosed herein may include one or more of the features described in conjunction with any of the other disclosed aspects.

[0005] Various aspects of the present invention relate to systems, devices, methods, and the like related to flexible circuit board assemblies configured for use within medical devices.

[0006] According to one example, a flexible circuit assembly for a medical device may include a circuit board having at least one curved 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, wherein the at least one curved portion of the circuit board is part of an arm extending distally from the flat portion, and wherein the at least one curved portion of the circuit board is coupled to the second region of the mechanical support structure.

[0007] Any of the flexible circuit assemblies described herein may include any of the following features. The first region includes at least one extension, wherein the at least one extension is configured to receive a hinge line of a medical device. The at least one curved portion includes a first layered structure, and the at least one flat portion includes a second layered structure. The first layered structure includes fewer layers than the second layered structure. The first layered structure is configured to achieve a bending radius that is less than 6 times the thickness of the second layered structure. The circuit board includes at least one mounting portion, wherein the at least one curved portion is disposed on a proximal portion of 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 a lighting element. The at least one flat portion defines a first plane, wherein 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, wherein the third plane is perpendicular to each of the first plane and the second plane. The circuit board is coupled to the mechanical support structure with an adhesive. The 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 polymer 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.

[0008] According to another example, 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 curved portion within 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, wherein the at least one arm of the mechanical support structure is configured to couple to the at least one arm of the circuit board.

[0009] Any of the flexible circuit assemblies described herein may include any of the following features. At least one curved portion includes a first layered construction, and the flat portion includes a second layered construction. The first layered construction includes an adhesive layer, a conductive layer, and at least one flexible layer. The second layered construction includes an adhesive layer, a conductive layer, at least one flexible layer, and at least one dielectric layer.

[0010] According to another example, 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, wherein the first portion includes a first layered structure, and the second portion includes a second layered structure, wherein the second portion includes an arm, the arm includes a bent portion, wherein the circuit board is configured to bend at the bent portion and not bend at the first portion, and wherein the bent portion of the circuit board is coupled to a distal side of the second region of the mechanical support structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate examples of the present invention and, together with the description, serve to explain the principles of the present invention.

[0012] Figure 1A depicts a perspective view of a flexible circuit assembly according to some embodiments;

[0013] Figure 1B Depicted Figure 1A a plan view of a circuit board of a flexible circuit assembly;

[0014] Figure 2 Depicted Figure 1A A top perspective view of a flexible circuit assembly;

[0015] Figure 3 Depicted Figure 1A A side perspective view of a flexible circuit assembly;

[0016] Figure 4 depicts a perspective view of a flexible circuit assembly including a wire guide according to some embodiments;

[0017] Figure 5 depicts a layered construction of a flexible region of a flexible circuit according to some embodiments;

[0018] Figure 6 depicts a layered construction of a flexible circuit according to some embodiments;

[0019] Figure 7 depicts a flexible circuit assembly including a flexible circuit having a layered construction according to some embodiments;

[0020] Figure 8 depicts a flexible circuit in a flat configuration according to some embodiments;

[0021] Fig.9A depicts a perspective view of a distal assembly of a medical device according to some embodiments;

[0022] Fig. 9B Depicted Fig.9A a posterior view of the distal component of the;

[0023] Fig. 10A depicts a perspective view of a distal assembly of a medical device according to some embodiments;

[0024] Fig. 10B Depicted Fig. 10A A front view of the distal component of the invention;

[0025] Fig.11 Depicted Fig.11 A bottom cross-sectional view of the distal component;

[0026] Fig. 12A depicts a perspective view of a distal assembly of a medical device according to some embodiments;

[0027] Fig. 12B Depicted Fig. 12A A front view of the distal component of the invention;

[0028] Fig.13A depicts a proximal portion of a medical device according to some embodiments;

[0029] Fig. 13B Depicted Fig.13A The distal portion of the medical device. DETAILED DESCRIPTION

[0030] It is understood that the foregoing general description and the following detailed description are merely exemplary and explanatory of the invention as claimed, rather than restrictive descriptions. As used herein, the terms "include," "comprises," or any other variation thereof are intended to encompass non-exclusive inclusions, so that a process, method, article, or device comprising a list of elements may include not only those elements, but may include other elements that are not explicitly listed or are not inherent to such a process, method, article, or device. The term "exemplary" is used in the sense of "example" rather than "exemplary." The term "distal" refers to the direction away from the operator / toward the treatment site, and the term "proximal" refers to the direction toward the operator. The term "approximately" or similar terms (e.g., "substantially") include values ​​of + / -10% of the specified value.

[0031] A medical device, such as a distal assembly of an endoscope, may include a substrate (e.g., a circuit board) that may have elements mounted thereon, such as imaging elements and / or lighting elements. Although the present invention may refer to an "endoscope" (or "scope"), it should be understood that the present invention also covers duodenoscopes, choledochoscopes, bronchoscopes, gastroscopes, endoscopic ultrasound ("EUS") scopes, colonoscopes, ureteroscopes, bronchoscopes, laparoscopes, cystoscopes, suction scopes, sheaths, catheters, or similar devices. Reference to "endoscope" should be understood to include any of the above devices. The imaging element may include one or more image sensors, cameras, or fiber optic light guides. The lighting element may include one or more (e.g., two) light emitting diodes ("LEDs") or fiber optic light guides. The circuit board may also have one or more position sensing systems, capacitors, diodes, resistors, digitizing chips, analog-to-digital converters, and / or additional sensors, such as force, pressure, or temperature sensors, mounted thereon.

[0032] A circuit board having a flat configuration may be incorporated into the distal assembly described above. However, if the size of the distal assembly is reduced, for example, to fit into a smaller body cavity or to be inserted into the working channel of another endoscope, the amount of space occupied by the flat circuit board in the distal assembly may be greater than required. Smaller circuit boards may be used, but the smaller surface area may create difficulties during the manufacturing process or may prevent the inclusion of components such as position sensing systems, capacitors, diodes, resistors, digitizing chips, analog-to-digital converters, and / or additional sensors, such as force, pressure, or temperature sensors. Therefore, embodiments of flexible circuit boards are disclosed herein that can be assembled in a flat configuration before being bent into a shape configured to fit within a distal assembly of a scope, such as an endoscope. By assembling the circuit board while the circuit board is in a flat configuration, various components may be mounted on the flat circuit board using automated pick-and-place assembly or other methods, thereby simplifying the manufacturing process. The circuit board may then be bent and assembled within / on the distal tip assembly. Embodiments of the flexible circuit boards described herein may be incorporated into a flexible circuit assembly, which may additionally include a mechanical support structure configured to provide rigidity to the flexible circuit during manufacturing and to assist in forming the final geometry of the circuit, as well as to facilitate assembly of the distal tip assembly.

[0033] For example, Figures 1A to 3 An exemplary flexible circuit assembly 100 and components thereof are depicted in accordance with some embodiments. Figure 1A and Figure 1B The proximal direction is indicated by arrow "P", and Figure 1A and Figure 1B The distal direction is indicated by arrow “D”. In some embodiments, flexible circuit assembly 100 can include flexible circuit 110 (which can include a flexible circuit board and / or one or more components mounted thereon) coupled to a mechanical support structure, such as a skeleton 120 . Figure 1A , Figure 2 and Figure 3 A flexible circuit 110 is depicted incorporated into a flexible circuit assembly 100 , wherein the flexible circuit 110 has a curved portion, as described below. Figure 1B The flexible circuit 110 is depicted in a flattened configuration prior to assembly on the skeleton 120. The flexible circuit 110 may include, for example, a polyimide or other flexible medium, such as a liquid crystal polymer ("LCP"), and may or may not include a hardener. The flexible circuit 110 may be designed to have a desired (e.g., predetermined) impedance. The flexible circuit 110 may include a solder mask layer and / or a cover layer. Alternatively, the flexible circuit 110 may also include a via-in-pad configuration instead of a solder mask layer (e.g., to avoid the use of a solder mask layer).

[0034] The flexible circuit 110 may include a flat (ie, unbent) portion 112 and bent portions 113 and 114a, 114b, 114c. In some examples, the entirety of the flexible circuit 110 may be flexible. The bent portions 113, 114a, 114b, 114c ( Figure 1B ) can be portions of the flexible circuit 110 that bend / flex when built into the flexible circuit assembly 100. For example, the bent portions 113, 114a, 114b, 114c can be incorporated into the layered construction 500, which will be discussed below with respect to Figure 5 Other portions of the flexible circuit 110 (i.e., portions of the flexible circuit 110 that remain flat or unbent) may be incorporated into the layered construction 600, as discussed below. Figure 6 Have a discussion. Figures 1A to 3 The portions of the flexible circuit 110 indicated as bent portions 113, 114a, 114b, 114c are merely exemplary, and other portions of the flexible circuit 110 may additionally or alternatively be bent in constructing the flexible circuit assembly 100. In other examples, portions of the flexible circuit 110 may be rigid, such that the flexible circuit 110 is a rigid-flex circuit. For example, Figure 1B The bent portions 113, 114a, 114b, 114c shown in FIG. 1 may be flexible, while other portions of the flexible circuit 110 may be rigid.

[0035] In some embodiments, the flexible circuit 110 may include at least one arm 115 extending distally from the flat portion 112, and the curved portions 114a, 114b, 114c may be incorporated into the arm 115 (e.g., as shown in FIG. Figure 1B ). The arms 115 may be configured to bend at the bends 114a, 114b, 114c to allow the flexible circuit 110 to achieve a particular geometry (e.g., Figure 1A , Figure 2 and Figure 3 shown). Figure 1B The positions of the bent portions 114a, 114b, 114c shown in the figure are merely exemplary. Other portions of the arm 115 may also be bent in constructing the flexible circuit assembly 100. Figures 1A to 3 As shown, the flexible circuit 110 may include two arms 115. However, in some embodiments, the flexible circuit 110 may include at least three arms. Figure 1B As shown, each of the arms 115 may have a corresponding curved portion 114a, 114b, 114c.

[0036] The flexible circuit 110 can also have a mounting portion 111 that can extend distally from the flat portion 112 between the arms 115. The curved portion 113 can be disposed on a proximal portion of the mounting portion 111.

[0037] Various components, such as the lighting element 102 and the camera 104, can be mounted to the flexible circuit 110. In some embodiments, the lighting element 102 can be connected to the distal portion 119 of each arm 115, and the camera 104 can be connected to the mounting portion 111. However, in some embodiments, the camera 104 and the lighting element 102 can all be mounted to the same portion of the flexible circuit 110 (e.g., the mounting portion 111 or the distal portion 119).

[0038] Additional components, such as capacitors, diodes, resistors, or other sensors may be mounted to the flat portion 112 and / or to the mounting portion 111 or the distal portion 119. The lighting element 102 may have any suitable features and may include, for example, an LED having any suitable size and properties. The camera 104 may have any suitable features and may include, for example, a ball grid array ("BGA") type camera. The camera 104 may have any suitable size, any suitable shape, and any suitable image sensor / lens arrangement. The components attached to the flexible circuit 110 may be attached using any suitable attachment method known in the art, such as, for example, one or more of surface mount technology, reflow, soldering, potting, and / or encapsulation. In some embodiments, any of the above components may be included in a component separate from the flexible circuit 110, which may be configured for use in conjunction with the flexible circuit 110 or may be omitted entirely.

[0039] like Figure 1A Together with Figure 1B As shown in particular, when the flexible circuit 110 is in a bent state ( Figure 1A ), the flat portion 112 may define a first plane. Each arm 115 may include a first flat portion 117 that defines a second plane between the curved portions 114b and 114c. When incorporated into 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 deviate from the first plane. The ramp portion 118 may extend between the flat portion 112 and the first portion 117 (e.g., between the curved portions 114a and 114b). Alternatively, the second plane of the first portion 117 and the first plane of the flat portion 112 may be coplanar. The distal portion 119 of the arm 115 may be located distal to the curved portion 114c and may define a third plane. The lighting element 102 may be mounted to 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.

[0040] Installation part 111 (in Figure 1BThe fourth plane may be defined when the flexible circuit 110 is in a flat configuration and extends distally from the curved portion 113. Figure 1A 100). When the flexible circuit 110 is in a bent configuration (i.e., when the flexible circuit 110 is incorporated into the flexible circuit assembly 100), the fourth plane is substantially perpendicular to the first plane of the planar portion 112 and / or the second plane of the first portion 117. The fourth plane of the mounting portion 111 can be substantially parallel to the third plane of the distal portion 119. The relative angles discussed above are merely exemplary, and any suitable arrangement can be utilized to achieve the desired arrangement of elements, such as the camera 104 and the lighting element 102. For example, a relationship discussed above as being substantially perpendicular can have an alternative lateral angle or parallel relationship. Similarly, in alternative aspects, a relationship described above as being substantially parallel can have a lateral relationship.

[0041] like Figures 1A to 3 As shown, when the flexible circuit 110 is in a bent configuration, the mounting portion 111 can be located proximal to the distal portion 119. The location of the mounting portion 111 can accommodate a greater depth (in the proximal / distal direction) of the camera 104 than the depth of the lighting element 102. In particular, as shown in FIG. Figure 2 As shown, the distal end of the camera 104 can be located distal to the distal end of the lighting element 102. Alternatively, the distal end of the camera 104 can be substantially flush with the distal end of the lighting element 102, or located proximal to the distal end of the lighting element 102.

[0042] exist Figure 1B In the flattened configuration of the flexible circuit 110 shown, the arm 115 can extend distally from the flattened portion 112 such that the outer edge of the flexible circuit 110 traveling in the proximal / distal direction can continue along the flattened portion 112 and the arm 115 in a straight line (e.g., generally parallel to the central longitudinal axis of the flexible circuit 110 and / or the central longitudinal axis of the endoscope into which the flexible circuit 110 is incorporated). In the flattened configuration, the outer side edge 109b of the mounting portion 111 can abut or be proximal to the proximal inner edge 107b of the arm 115. In the flattened configuration, the distal edge 109a of the mounting portion 111 can be located proximal to the distal edge 107a of the arm 115. The mounting portion 111 can be generally rectangular in the flattened configuration and can have a diagonal edge portion 109c extending between the distal edge 109a of the mounting portion 111 and the side edge 109b of the mounting portion 111. The arms 115 can each have a complementary diagonal edge portion 107c that can abut or be proximate to the diagonal edge portion 109c of the mounting portion 111. The diagonal 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. At the portion of the arm 115 defined by the proximal inner edge 107b, the arm 115 can be narrower (along the width of the arm 115) than at the portion of the arm 115 defined by the distal inner edge 107d. Figure 1B up / down direction).

[0043] Still reference Figures 1A to 3 In order to provide support for the flexible circuit 110 during manufacture, assembly of the distal tip assembly, and use of the endoscope, the skeleton 120 can be coupled to the flexible circuit 110. Thus, in some embodiments, the skeleton 120 can have a geometry that is similar, complementary, or corresponding to the flexible circuit 110. For example, the skeleton 120 can include a first region 122 that is configured to be coupled to or otherwise adjacent to the flat portion 112 of the flexible circuit 110, and a second region 124 that extends distally from the first region 122 and is configured to be coupled to the arm 115 of the flexible circuit 110. In some embodiments, the skeleton 120 can be coupled to the flexible circuit 110 only via (1) a connection between the second region 124 of the skeleton 120 and the arm 115 (e.g., the distal portion 119) of the flexible circuit 110, and (2) a connection between the bend portion 113 and / or the mounting portion 111 and the distal end 123 of the first region 122, as discussed in more detail below. In other embodiments, the planar portion 112 may be coupled to the first region 122 (eg, via an adhesive).

[0044] In some embodiments, the second region 124 may include at least one arm 125, which may reflect the geometry of the arm 115 of the flexible circuit 110. Figures 1A to 3 As shown, the second region 124 may include two arms 125. In some embodiments, the length of the arms 125 may be selected to determine the position of the lighting element 102. Figures 1A to 3 In contrast, the length of the arm 125 may be shortened to position the lighting element 102 recessed behind the camera 104 .

[0045] Additionally, the skeleton 120 may include a third region 126 that may extend proximally from the first region 122 and may be used to help maintain the position of cables extending from the flexible circuit 110, accommodate the shape of the distal assembly housing, and / or provide a gripping point for the user to hold when assembling the distal assembly. Fig.9A and Fig. 9B ). In some embodiments, the third region 126 may be tapered inwardly in a lateral direction relative to the first region 122.

[0046] In some embodiments, the skeleton 120 can fix the flexible circuit 110 to a set position after it is bent, thereby preventing further bending during assembly into the distal assembly of the endoscope and during use. In other words, the skeleton 120 can keep the flexible circuit 110 in a desired shape / form.

[0047] In the bent configuration of the flexible circuit 110, the flat portion 112 of the flexible circuit 110 can extend along the first region 122 along the first side 128 of the skeleton 120. The first side 128 of the first region 122 can have substantially the same shape as the flat portion 112 (e.g., a rectangular shape, such as Figures 1A to 3 The first side 128 may be substantially planar and substantially parallel to the planar portion 112 .

[0048] The distal portion 119 of the flexible circuit 110 can be coupled to the skeleton 120 at an interface 130. The interface 130 can be located between the distal side of the arm 125 and the proximal surface of the distal portion 119 of the flexible circuit 110. The distal side of the arm 125 can be generally perpendicular to the flat portion 112 / first side 128 of the flexible circuit 110, and generally parallel to the distal portion 119 of the flexible circuit 110. The distal portion 119 can extend from the first side 128 of the skeleton 120 toward the second side 129 of the skeleton 120. Since the distal portion 119 is mounted to the distal side of the arm 125 at the interface 130, the arm 125 can be used to maintain the distal portion 119 in a desired configuration (e.g., generally perpendicular to the flat portion 112).

[0049] The mounting portion 111 may be mounted to the distal end 123 of the first region 122 between the arms 125. Figures 1A to 3 As shown, the mounting portion 111 may occupy substantially all of a portion of the distal end 123 of the backbone 120 located between the arms 125. As discussed above, the mounting portion 111 may be retained (via coupling to the distal end 123) proximal to the distal portion 119 of the arm 11. The mounting portion 111 may extend from a first side 128 of the backbone 120 toward a second side 129 of the backbone 120. The coupling of the mounting portion 111 to the distal end 123 may be used to retain the mounting portion 111 in a desired configuration (e.g., substantially perpendicular to the flat portion 112).

[0050] The flexible circuit 110 can be coupled to the skeleton 120 by an adhesive (e.g., a UV-curable adhesive). In some embodiments, the adhesive 106 can be disposed between the first side 116 of the flexible circuit 110 and the first side 128 of the skeleton 120 ( Figure 3 ). Adhesive 106 may be used to couple flexible circuit 110 to backbone 120 at interface 130 , behind lighting element 102 and / or to couple mounting portion 111 to distal end 123 .

[0051] In some embodiments, the skeleton 120 may include at least one recess 140 disposed in the second side 129 of the skeleton 120, adjacent to the mounting portion 111. The recess 140 may facilitate coupling of the skeleton 120 to the flexible circuit 110, as the adhesive may flow from the second side 129 to the mounting portion 111 via the recess 140. Additionally or alternatively, the recess 140 may be used to accommodate any components that may be mounted on the rear side of the mounting portion 111.

[0052] The skeleton 120 can have any suitable shape so as to support the elements of the flexible circuit 110 and adapt to the shape / morphology of the distal tip assembly of the endoscope. For example, the skeleton 120 can have a substantially constant thickness between the first side 128 and the second side 129 at the first region 122 and the second region 124 of the skeleton 120. Alternatively, the thickness of the second region 124 (including the arm 125) can be greater than the first region 122 (e.g., the arm 125 can extend beyond the first side 128). The third region 126 of the skeleton 120 can have a lesser thickness between the first side 128 and the second side 129, or can have the same or similar thickness as the first region 122 and the second region 124. The above-described morphologies are merely exemplary, and other arrangements are also within the scope of the present invention.

[0053] In some embodiments, the skeleton 120 can be made of at least one of a polymer material, a ceramic, or a metal. In some embodiments, the skeleton 120 can be made of at least one of a thermoplastic material or a thermosetting material. However, in some embodiments, the skeleton 120 can be made of a thermally conductive metal, such as copper. The skeleton 120 can be manufactured by an additive manufacturing process or an injection molding process; however, any material processing technology suitable for manufacturing metal or polymer products can be used to manufacture the skeleton 120.

[0054] In some embodiments, for example, Figure 4 As shown, the skeleton 420 can include additional wire guiding features. Except as specified herein, the flexible circuit assembly 400 can have any of the features of the flexible circuit assembly 100. The flexible circuit assembly 400 can include a flexible circuit 410 coupled to the skeleton 420. Similar to the flexible circuit 110 described above, the flexible circuit 410 can include a flat portion (not shown) and an arm 415 extending distally from the flat portion. The arm 415 can include at least one curved portion, which can be configured to bend to allow the flexible circuit 410 to achieve a specific geometry. Like the flexible circuit 110, for example, components such as the lighting element 402 and the camera 404 can be mounted to the flexible circuit 410. Additional components, such as capacitors, diodes, resistors, or other sensors can also be mounted to the flexible circuit 410.

[0055] Still reference Figure 4 , the skeleton 420 may include features similar to the skeleton 120 described above. For example, the skeleton 420 may include a first region 422 that is configured to be adjacent to a flat portion of the flexible circuit 410 along a first side 428 of the skeleton 420; and a second region 424 that extends distally from the first region 422 and is configured to couple 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 geometry of the arm 415 of the flexible circuit 410. The skeleton 420 may also include a third region 426 that may extend proximally from the first region 422 and may taper inwardly relative to the first region 422.

[0056] Additionally, in some embodiments, the skeleton 420 may include at least one extension 430 extending laterally from the first region 422 (along the Figure 4 direction "A" as shown). Figure 4 As shown, the skeleton 420 may include two extensions 430. In some embodiments, the extensions 430 may include a chamfered or rounded upper surface 432, which may extend downward at an angle relative to the second side 429 of the skeleton 420. In addition, in some embodiments, each extension 430 may include a recess 434 within the upper surface 432, which may function as a pocket to receive 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 extend through the proximal end 438 of the extension 430 into the recess 434. Although not shown in FIG. Figure 4 434, but another hole may extend through the distal end of extension 430 and / or extension 430 may include other features for retaining the steering wire within recess 434. Alternatively, the steering wire may be secured to extension 430 via through hole 436.

[0057] Thus, the skeleton 420 can provide distal attachment points for steering / articulation lines extending from the handle of the endoscope through the shaft of the endoscope. The skeleton 420 can include any suitable number of attachment points for the steering / articulation lines (e.g., one for each steering / articulation line). Alternatively, only some of the steering lines can extend to / into the skeleton 420.

[0058] Reference now Figure 5 and Figure 6 In some embodiments, the disclosed flexible circuits, such as the flexible circuits 110 and 410 described above, may include layered constructions in both the flat and curved portions of the circuit. Figure 5As shown, the flexible region of the circuit can have a layered construction 500, which can 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 can be flexible dielectric layers, while the second layer 504 can be an adhesive layer, and the third layer 506 can be a signal layer.

[0059] In some embodiments, layers 502-508 can each have a thickness in the range of about 0.005 mm to about 0.1 mm, including sub-ranges. In some embodiments, first layer 502 can have a thickness of about 0.012 mm, second layer 504 can have a thickness of about 0.02 mm, third layer 506 can have a thickness of about 0.009 mm, and fourth layer 508 can have a thickness of about 0.025 mm. In some embodiments, the total thickness of layered construction 500 can be in the range of about 0.02 mm to about 0.4 mm, including sub-ranges.

[0060] 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), which may crack slightly during bending if stretched or compressed. When the circuit board is bent into position, this slight cracking may cause the flexible circuit board to be disconnected from any component mounted thereon. However, in some embodiments, the third layer 506 may be sandwiched between the first layer 502 and the fourth layer 508, which may each be made of a flexible material, for example, a polymer, such as polyimide, polyamide or polyester. Therefore, during bending, the third layer 506 can be kept in the neutral bending axis, while the first layer 502 is in compression and the fourth layer 508 is in tension (or vice versa). By keeping the third layer 506 in the neutral bending axis, the third layer 506 is neither in tension nor in compression, and slight cracking can be significantly reduced or prevented. For example, the third layer 506 may undergo at least 20 bending cycles without failure. Additionally, due to the layered construction, the flexible circuit is able to achieve a bend radius of less than 6 times the circuit thickness while maintaining continuity throughout the circuit.

[0061] On the contrary, Figure 6As shown, in some embodiments, the flat (i.e., non-bending) portion of the disclosed flexible circuit may include a layered construction 600 that may be different from the layered construction 500 in the flex (i.e., bending) portion of the flexible circuit. For example, the layered construction 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 a dielectric layer, and in some embodiments, the third layer 606 may be an adhesive layer. The layers of the layered construction 600 may have the same or similar materials as the corresponding layers of the layered construction 500 discussed above. For example, the first layer 602, the fourth layer 608, and the sixth layer 612 may include any of the materials of the third layer 506. The second layer 604 and the fifth layer 610 may include any of the materials of the first layer 502 and the fourth layer 508. The third layer 606 may include any of the materials of the second layer 504. Additionally, in examples where portions of the circuit are rigid, the second layer 604 and the fifth layer 610 (dielectric layer) 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 ("CEM") such as CEM-1 or CEM-3, or any combination thereof. Alternative materials may also be used within the scope of the present invention.

[0062] In some embodiments, the layered construction 600 may additionally include at least one via 620, which may be configured to transfer electrical traces to different layers 602 to 610 within the layered construction 600. As discussed above, the layered construction 600 may also include a solder resist layer (which may include a solder resist material) adjacent to a side opposite the first layer 602 and the second layer 604. The layered construction 600 may also have such a solder resist layer adjacent to a side opposite the sixth layer 612 and the fifth layer 610. The cover / cover layer may be adjacent to one or more of the solder resist layers (e.g., adjacent to a side opposite the solder resist layer and the first layer 602 or the sixth layer 612).

[0063] In some embodiments, layers 602 to 612 can each have a thickness in the range of about 0.005 mm to about 0.1 mm, including sub-ranges. In some embodiments, first layer 602 can have a thickness of about 0.009 mm, second layer 604 can have a thickness of about 0.012 mm, third layer 606 can have a thickness of about 0.02 mm, fourth layer 608 can have a thickness of about 0.009 mm, fifth layer 610 can have a thickness of about 0.025 mm, and sixth layer 612 can have a thickness of about 0.009 mm. In some embodiments, the total thickness of layered construction 600 can be in the range of about 0.03 mm to about 0.6 mm, including sub-ranges.

[0064] In some embodiments, layered construction 600 can include an additional or alternative dielectric layer disposed adjacent to one or both of first layer 602 and fourth layer 608. In some embodiments, the additional dielectric layer can be a polymer material or a glass epoxy. Including an additional or alternative dielectric layer in layered construction 600 can provide additional rigidity, thereby reducing the ability of the circuit board to flex in areas where layered construction 600 is incorporated.

[0065] Reference now Figure 7 , in some embodiments, layered construction 500 can be incorporated into layered construction 600. For example, in some embodiments, flexible circuit assembly 700 (which can have any of the properties of flexible circuit assemblies 100, 200) can include flexible circuit 710 having a flat portion 712, an arm 715, and a mounting portion 711. Arm 715 can have any of the properties of arms 115, 415 described above, and can have lighting element 702 mounted thereon. Although in Figure 7 Although not explicitly shown in FIG. 1 , the arm 715 may include a plurality of curved portions having curved portions 114a, 114b, 114c ( Figure 1B ) in any of the properties and / or positions. The mounting portion 711 may have any of the properties of the mounting portions 111, 411, and may have a camera 704 mounted thereon. Figure 7 Although not explicitly shown, the mounting portion 711 may include a curved portion having a curved portion 113 ( Figure 1B )’s nature and / or location.

[0066] In some embodiments, the bent portions of the arm 715 and the mounting portion 711 can each include a layered construction having four layers, such as the layered construction 500 described above. The flat portion 712 and the unbent portions (i.e., non-bent portions) of the arm 715 and the mounting portion 711 can include a layered construction having six layers, such as the layered construction 600 described above. In some embodiments, the layered construction 500 can define four innermost layers of the layered construction 600. In other words, the layered construction 600 can add additional outer layers 602, 612 to the layered construction 500. The first layer 502 of the layered construction 500 can correspond to the second layer 604 of the layered construction 600, the second layer 504 of the layered construction 500 can correspond to the third layer 606 of the layered construction 600, the third layer 506 of the layered construction 500 can correspond to the fourth layer 608 of the layered construction 600, and the fourth layer 508 of the layered construction 500 can correspond to the fifth layer 610 of the layered construction 600.

[0067] When the flexible circuit assembly 700 is in a flat configuration (similar to Figure 1B and Figure 8 When the flexible circuit 710 is used as shown in FIG. 1 and described in detail below, the lighting element 702 and the camera 704 can be disposed on the first side 718 of the flexible circuit 710. The electronic component 717 (which can be any type of electronic component, including the electronic components described above) can be disposed on the first side 718 of the flexible circuit 710. Figures 1A to 3 The example shown) can be disposed on the second side 719 of the flexible circuit 710. The lighting element 102, the camera 104, and the electronic components 717 can be placed on the flexible circuit 710 using any suitable automated or manual method. The arm 715 and the curved portion of the mounting portion 711 can then be manually or automatically bent into a shape related to the flexible circuit 710. Figures 1A to 3 In the described form, and can optionally be connected to a skeleton, such as skeleton 120.

[0068] As described above, various components may be mounted to any of the flexible circuit boards described herein. Figure 8As shown, the flexible circuit 800 has any of the features of the flexible circuits 110, 410, 710, and may include several pads to which components may be mounted. For example, the flexible circuit 800 may include at least one lighting element mounting pad 810, at least one camera mounting pad 811, and at least one capacitor pad 814. However, the flexible circuit 800 may include more or fewer mounting pads, depending on the intended application of the circuit. Additionally, in some embodiments, the lighting element cable 804 and the camera cable 806 may be coupled to the flexible circuit 800 with an adhesive 802. For example, the lighting element cable 804 and / or the camera cable 806 may include any combination of coaxial cables (e.g., with matching impedance) and / or ribbon cables. The lighting element cable 804 and / or the camera cable 806 may have any suitable type of insulation and / or conductor. As an alternative to cables (e.g., the lighting element cable 804 and the camera cable 806), long-format flexible circuit boards may also be utilized.

[0069] Still reference Figure 8 , all of the above components can be mounted to the flexible circuit 800 when the flexible circuit 800 is in a flat configuration. The circuit 800 can then be coupled to a skeleton, such as any of the skeletons described herein, and can be bent into a curved configuration (such as, Figure 1A , Figure 2 , Figure 3 , Figure 4 and / or Figure 7 those shown in ).

[0070] like Fig.9A and Fig. 9B As shown, once the flexible circuit assemblies are assembled, they 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 can include a body 902 having at least one irrigation channel 906 and at least one working channel 904 extending therethrough. Fig. 9B As shown, the flexible circuit assembly 100 can be inserted from the proximal side 910 of the body 902 into the cavity 908 extending distally into the body 902. Fig.9A As shown, when the flexible circuit assembly 100 is fully inserted into the body 902 , the lighting element 102 and the camera 104 can be flush with or slightly recessed relative to the distal side 912 of the body 902 .

[0071] In some embodiments, the rigidity provided by the above-described skeleton 120 can assist in inserting the flexible circuit assembly 100 into the cavity 908, and can further facilitate the process of adhering or otherwise securing the flexible circuit assembly 100 to the body 902. For example, the skeleton 120 can provide a larger surface area over which an adhesive can be applied. Alternatively, in some embodiments, the skeleton 120 can simply be cast into place (e.g., encapsulated) within the cavity 908.

[0072] Additionally, the cavity 908 can have a geometry that corresponds to the geometry of the skeleton 120 to help ensure that the skeleton 120 fits tightly within the body 902. Thus, the cavity 908 can have a width and height that correspond, respectively, to the width and height of the skeleton 120, and / or elements positioned on the flexible circuit assembly 100. However, the geometry of the cavity 908 can include any shape or form suitable for receiving a circuit assembly.

[0073] In some embodiments, alternative flexible circuit components may be incorporated into the distal assembly of an endoscope. FIG. 10A to FIG. 11 As shown, flexible circuit assembly 1100 can be incorporated into distal assembly 1000. Similar to distal assembly 900 described above, distal assembly 1000 can include a body 1002 having at least one irrigation channel 1006 and at least one working channel 1004 extending therethrough.

[0074] The flexible circuit assembly 1100 may include a backbone 1120 similar to backbones 120 and 420 discussed above; however, at least one optical fiber 1102, such as a plastic optical fiber, may be coupled to or extend adjacent to the backbone 1120 in place of a lighting element mounted to the flexible circuit. Fig. 10A and Fig. 10B As shown, the optical fiber 1102 can be positioned adjacent to the flexible circuit 1110 along either side of the skeleton 1120 ( Fig. 10B ). Therefore, the skeleton 1120 may be formed without an arm portion because the flexible circuit 1110 may not include an arm portion on which a lighting element may be mounted. Fig. 10BAs shown, the flexible circuit 1110 can include only a mounting portion 1111 to which the camera 1104 can be mounted. In some embodiments, the optical fibers 1102 can extend adjacent to the mounting portion 1111 on either side of the mounting portion 1111. For example, a first optical fiber 1102 can extend adjacent to the mounting portion 1111 on a first side of the mounting portion 1111, and a second optical fiber 1102 can extend adjacent to the mounting portion 1111 on a second side of the mounting portion 1111 opposite the first side. Surfaces of the flexible circuit 1110 other than the mounting portion 1111 can support or otherwise be adjacent to the optical fibers 1102 and can help position the optical fibers 1102 in a desired location.

[0075] like Fig.11 As shown, for example, the optical fibers 1102 can be mounted to the flexible circuit 1110 in a Y-shaped configuration such that each of the optical fibers 1102 extends directly adjacent to each other from the proximal end of the flexible circuit assembly 1000 until they reach a junction 1130. At the junction 1130, each of the optical fibers 1102 can extend away from each other at an angle before extending parallel to the longitudinal axis of the flexible circuit assembly 1000 and the adjacent mounting portion 1111. Fig.11 As shown, each optical fiber 1102 can include a first segment, a second segment, and a third segment. The first segment and the third segment can be substantially parallel to each other and / or substantially parallel to the longitudinal axis of the flexible circuit assembly 1000. The second segment can extend between the first segment and the third segment and can be curved or otherwise non-parallel to the first segment and the third segment. Alternatively, the segments can have other angles relative to each other.

[0076] In some embodiments, the optical fiber 1102 may be coupled to the backbone 1120, optionally via the jacket 1108. Alternatively, the optical fiber 1102 may be coupled to the backbone 1120 using an adhesive, may be molded to the backbone 1120, or may be pressed into the backbone 1120 using mechanical interference.

[0077] Alternatively, for example, Fig. 12A and Fig. 12B As shown, a flexible circuit assembly 1300 including only one lighting element 1302 can be incorporated into a distal assembly 1200. Similar to the distal assemblies 900 and 1000 described above, the distal assembly 1200 can include a body 1202 having at least one irrigation channel 1206 and at least one working channel 1204 extending therethrough. Fig. 12BAs shown, flexible circuit 1310 can be coupled to skeleton 1320 and can include mounting portion 1311 configured to receive both camera 1304 and single lighting element 1302. Since mounting portion 1311 can accommodate both camera 1304 and lighting element 1302, both flexible circuit 1310 and skeleton 1320 can be formed without arm portions. Therefore, the width of flexible circuit assembly 1300 can be minimized, which can facilitate insertion of flexible circuit assembly 1300 into distal assembly 1200.

[0078] In some embodiments, for example, Fig. 12A As shown, the lighting element 1302 can be positioned proximally relative to the camera 1304. However, in some embodiments, the lighting element 1302 can be positioned adjacent to the camera 1304 so 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.

[0079] Fig.13A and Fig. 13B Depicted are aspects of an exemplary medical device 1410. The components discussed above may be incorporated into the medical device 1410. Fig.13A A proximal portion of medical device 1410 is depicted. Fig. 13B Distal tip 1444 of medical device 1410 is depicted, which can be incorporated into an assembly, such as any of distal assemblies 900, 1000, or 1200. Medical device 1410 can include a handle portion 1412 for an operator to grasp and manipulate, and an insertion portion 1414 for at least partial insertion into a subject (e.g., into a body cavity). Fig.13A and Fig. 13B As shown, medical device 1410 may include an endoscope.

[0080] The handle portion 1412 can include, for example, a knob 1422 on a proximal portion of the handle portion 1412. The knob 1422 can help facilitate articulation / steering of the insertion portion 1414, including the distal tip 1444. Fig.13A1422 is depicted in the figure, but it should be understood that any suitable actuator, such as one or more knobs, buttons, sliders, or joysticks, can be used in addition to or in place of the knob 1422. The port 1424 of the handle portion 1412 can lead to a cavity or working channel of the medical device 1410. The operator can insert an instrument or other device into the port 1424 and can extend the instrument or other device distally through the working channel. The working channel can extend longitudinally through the length of the insertion portion 1414. The umbilicus 1430 can extend from the handle portion 1412 (e.g., from the proximal portion of the handle portion 1412) and can carry wires, cables, and / or catheters for, for example, providing power, signals, or fluids to or from the handle portion 1412. For example, the umbilicus 1430 can connect the handle portion 1412 to one or more user interfaces, monitors, displays, etc.

[0081] The insertion portion 1414 may include a shaft 1442 extending distally from the handle portion 1412. The shaft 1442 may have any suitable properties. For example, the shaft 1442 may be flexible and may have a wire, tube, or other feature passing through it. Fig. 13B The distal tip 1444 of the medical device 1410 depicted in FIG. 1440 may be disposed at the distal end of the shaft 1442. Fig. 13B As shown, distal tip 1444 can include a distal-most side 1446. Distal-most side 1446 can define a working channel opening 1448. A working channel can extend between port 1424 and working channel opening 1448 such that an instrument or other device can pass through port 1424, through the working channel, and out of working channel opening 1448. Instruments extending distally of working channel opening 1448 can be used to perform a medical procedure on a subject.

[0082] Distal tip 1444 may also include imaging components, such as one or more lighting elements 1450 and camera 1452 (which may have any of the properties of lighting elements and cameras disclosed above). Fig. 13B 1450 and a camera 1452 are depicted, but it should be understood that an alternative number of lighting elements 1450 and cameras 1452 may be utilized. Alternatively, the lighting elements 1450 and cameras 1452 may be combined into a single device. The lighting elements 1450 may include LEDs or any suitable alternative light sources. The cameras 1452 may be configured to capture video and / or still images. The cameras 1452 may provide signals to a monitor (not shown) so that an operator can view visual images provided by the cameras 1452 while navigating the medical device 1010 through the subject's body.

[0083] like Fig. 13B, and described above, the medical device 1410 can be "forward facing." In other words, the features of the distal tip 1444 (e.g., the working channel opening 1448, the lighting element 1450, and the camera 1452) can face distally (i.e., in front of the distal-most side 1446). The present invention also covers other configurations of the distal tip 1044. For example, the medical device 1410 can be "side-facing." In side-facing embodiments, the working channel opening 1448, the lighting element 1450, and / or the camera 1452 can be disposed on the radially outer side of the distal tip 1444 so that they point in a radially outward direction, substantially perpendicular to the longitudinal axis of the insertion portion 1414.

[0084] Although the principles of the present invention are described herein with reference to illustrative examples for specific applications, it should be understood that the present invention is not limited thereto. Personnel with ordinary skills in the art and access to the teachings provided herein will recognize that additional modifications, applications, and replacements of equivalents all fall within the scope of the examples described herein. Therefore, the present invention should not be considered to be limited by the foregoing description.

Claims

1. A flexible circuit assembly for a medical device, the circuit assembly comprising: a circuit board having at least one curved portion and at least one flat portion; as well as a mechanical support structure coupled to the circuit board, the mechanical support structure comprising: The first region, and a second region extending distally from the first region, wherein the at least one curved portion of the circuit board is part of an arm extending distally from the flat portion, and Wherein, 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 comprises at least one extension, and wherein the at least one extension is configured to receive a hinge line of the medical device.

3. The flexible circuit assembly of any one of the preceding claims, wherein: The at least one curved portion comprises a first layered configuration and the at least one flat portion comprises a second layered configuration.

4. The flexible circuit assembly according to claim 3, wherein: The first layered construction includes fewer layers than the second layered construction.

5. The flexible circuit assembly according to claim 3 or 4, wherein: The first layered construction is configured to achieve a bending radius that is less than six times a thickness of the second layered construction.

6. A flexible circuit assembly according to any one of the preceding claims, wherein: The circuit board includes at least one mounting portion, and wherein the at least one bent portion is disposed on a proximal portion of the at least one mounting portion.

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

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

9. The flexible circuit assembly of any preceding claim, wherein: The at least one planar portion defines a first plane, and wherein the planar portion of the arm defines a second plane parallel to the first plane.

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

11. The flexible circuit assembly of any preceding claim, wherein: The circuit board is coupled to the mechanical support structure with an adhesive.

12. The flexible circuit assembly of any preceding claim, wherein: The at least one planar portion of the circuit board is coupled to the first region of the mechanical support structure.

13. The flexible circuit assembly of any preceding claim, wherein: The mechanical support structure includes at least one of a polymer material or a metal.

14. The flexible circuit assembly of any preceding claim, wherein: The mechanical support structure includes at least one of a thermoplastic material or a thermoset material.

15. The flexible circuit assembly of any preceding claim, wherein: The flexible circuit assembly is configured to be incorporated into a distal assembly of an endoscope.

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