Endoscope insertion tube with graded static stiffness

Abstract

The invention provides an endoscope. The endoscope incorporates a single-use rod assembly having an insertion tube with a distal articulation section. The insert tube includes an outer coil, two or more stay wires, each stay wire positioned with a concentric compression coil, an outer braid, an outer sheath, and a reinforcing element. The distal articulation section includes a deformable element for articulating the distal tip. The reinforcing element may be made of a material having uniform elasticity or a variety of materials having different elasticity along its length. The reinforcing element may further include a cross-sectional geometry along a length of the reinforcing element. For graded stiffness along the length of the insert tube, the cross-sectional geometry may be uniform along the length or different along the length. Methods of manufacture are also disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 370,538, filed on August 5, 2022, which is incorporated herein by reference. Background Art

[0003] The present disclosure relates generally to endoscopes.

[0004] The endoscope insertion tube is typically a manually assembled composite of a coil, a braid, and one or more external extrusions (one or more different durometer polymers), which then flow back into a composite adhered to the outer polymer sheath by the backflow. Alternatively, the braided coil can be fed by an extruder with one or more extrusion resin heads (different durometer resins). Alternative configurations include changing the braid pattern and the coil pattern. The purpose of these changes along the length of the insertion tube is to obtain a varying stiffness along the length of the insertion tube. For example, when passing through the gastric cavity with a duodenoscope or a gastroscope, the stiffness increase of a specific section of the insertion tube helps to prevent circulation in the gastric cavity. Similarly, changing the stiffness along the length of the colonoscope can help navigate along the elastic wall of the colon while avoiding undesirable trauma. This process is usually quite expensive and requires a low-cost alternative.

[0005] Therefore, improvements in this area are needed. Summary of the invention

[0006] A disposable rod assembly for a medical device (e.g., an endoscope) is disclosed. The disposable rod assembly can be configured for use with a reusable handpiece assembly having one or more controls for manipulating the disposable rod assembly. The disposable rod assembly can include a disposable flexible endoscope rod having an insertion tube assembly. The insertion tube assembly can include an external coil having a length extending along at least a portion of the length of the insertion tube assembly. The insertion tube assembly can further include a braided sleeve surrounding at least a portion of the length of the external coil. An external sheath can be used to surround the braided sleeve and the external coil. The insertion tube assembly can further include a reinforcing element extending along at least a portion of the length of the insertion tube assembly.

[0007] The disposable flexible endoscope shaft of the present disclosure includes a proximal portion having an insertion tube assembly and a distal portion having an articulated section assembly.

[0008] The insertion tube assembly disclosed herein includes an external coil. A plurality of compression coils are positioned within the external coil. The compression coils may be arranged to increase the column strength of the external coil along the longitudinal direction. The compression coil may be a helically wound wire and / or a helically cut sleeve that provides lateral flexibility. The articulation line may be slidably positioned within the lumen defined by the compression coil.

[0009] The insertion tube assembly may include a sleeve (e.g., a braided sleeve) positioned around the outer coil. The sleeve preferably provides torsional strength to the insertion tube assembly. The braided sleeve may include a metal braid or a plastic braid such as PET.

[0010] The insert tube assembly includes an outer sheath positioned around the sleeve. The outer sheath can be applied as a return tube or by an extruder. The outer sheath can be bonded to the sleeve and / or the outer coil through the holes of the sleeve.

[0011] The articulated section assembly includes an articulated section having a plurality of hinges. Each hinge provides rotation about a pivot axis. The pivot axes of the hinges may extend transversely to the longitudinal axis of the articulated section. In addition, the pivot axes of one or more of the hinges may be in a different plane than the pivot axes of one or more other hinges. For example, when the articulated section is in a straight (e.g., unbent) configuration, the pivot axes of the hinges may alternatively be located in planes that are perpendicular to each other. Advantageously, such an arrangement may provide an articulated element capable of articulating the distal tip / camera in three dimensions.

[0012] One or more hinges of the articulated section may be living hinges. In some cases, the articulated section is in the form of an integral articulated section. The integral articulated section may be formed from a single piece of material. The integral articulated section structure may be manufactured using injection molding or additive material manufacturing techniques. Alternatively, the integral articulated section may be formed by extruding a cylinder and cutting the cylinder tube with a knife, laser, milling tool, water jet or other material removal mechanism to form a living hinge. As will be appreciated, the bending and torque fidelity characteristics of the articulated section may be configured by configuring the angle of the cutouts / recesses defining the hinges and / or the distance between adjacent hinges.

[0013] In another arrangement, the articulated section structure includes a plurality of discrete links that, when assembled, define a plurality of concentric tab and socket pivot joints that function as hinges. As described above, each hinge (e.g., tab and socket pivot joint) can provide rotation about a pivot axis in a single plane. Furthermore, when the central axes of all links are aligned, the plurality of concentric tab and socket joints can be alternately located in two perpendicular planes to provide an articulated section with multiple degrees of freedom.

[0014] An outer sheath may be positioned around the articulating section to prevent contaminants from entering one or more hinges and / or lumens defined by the articulating section.The articulating section may include a distal cover defining an air / water nozzle, an instrument tube outlet, a camera outlet, and / or an LED outlet.

[0015] The insertion tube assembly and the articulation section can be joined together (e.g., heat or friction welding, adhesive, etc.) and / or attached with mating features (e.g., threads) on the contact surface or with a transition tube, as shown in the illustrated embodiment. The midplane of the transition tube can be located at the transition between the insertion tube assembly and the articulation section, and the transition tube can be joined (e.g., swaged or adhered with an adhesive) to both the insertion tube assembly and the distal articulation section to form a secure attachment. The transition tube can be deformable to allow the flexible endoscope shaft to deflect at the transition.

[0016] The insertion tube assembly disclosed herein can be manufactured using a continuous (e.g., roll-to-roll) manufacturing process. During the continuous manufacturing process, a braided sleeve can be applied around the external coil. In addition, the outer sheath can be applied during the continuous manufacturing process. For example, during the continuous manufacturing process, the assembly of the external coil and the surrounding braided sleeve can pass through one or more extrusion heads so that the outer sheath is applied to the portion of the insertion tube assembly. Such a process can produce a smooth outer sheath that is integrally bonded to the external coil and / or the braided sleeve. The outer sheath can have a durometer that varies along the length of the rod.

[0017] After positioning the outer sheath around the assembly, the rod may be cut to the desired length and the compression coil and / or articulation wire inserted inside the outer coil.

[0018] Advantageously, providing continuous manufacturing of the insertion tube assembly can reduce the cost of manufacturing the endoscope shaft assembly and increase production speed. Therefore, in certain aspects, the present disclosure provides a low-cost, flexible endoscope shaft and method of manufacturing the same. Because the insertion tube assembly can be manufactured continuously, the desired length of the insertion tube assembly, or a portion thereof, can be cut to length after the outer sheath extrusion process, or the desired length of the insertion tube assembly, or a portion thereof, can be cut from a finished product roll. Advantageously, a continuous technology (e.g., roll-to-roll technology) for manufacturing the insertion tube avoids the use of labor-intensive processes to weave and coat the insertion tube in discrete sections.

[0019] As will be appreciated, the disclosed insertion tube assembly can provide accommodation of the wires, tubes, and actuation wires of an endoscope shaft while having sufficient torsional and compressive strength to advance the articulating section assembly through the tortuous vasculature of a patient.

[0020] A method for manufacturing at least a portion of an insertion tube assembly is disclosed. The method may include forming a continuous first length, a second length, and a third length of an external coil using a continuous winding machine. Forming the first length defines a first time period. Forming the second length defines a second time period. Forming the third length defines a third time period. During the second time period, an external braid is formed around the external coil along the first length to form a braided assembly. During the third time period, an outer sheath may be extruded onto the braided assembly along the first length to form at least a portion of the insertion tube. Before or after the insertion tube is cut to length, a reinforcing element may be inserted into the insertion tube along at least a portion of the length of the insertion tube assembly.

[0021] In some embodiments, the reinforcement element can extend substantially along the entire length of the insertion tube.

[0022] In some examples, the reinforcing element can be secured to a portion of the endoscope handle (e.g., to the housing of a disposable rod assembly). In other embodiments, the reinforcing element can be secured to the proximal end of the insertion tube. The reinforcing element can be secured by a friction fit, an interference fit, a retaining geometry (e.g., a threaded interface), and / or an adhesive.

[0023] In some embodiments, the distal end of the reinforcing element is freely movable within the insertion tube. In other examples, the distal end of the reinforcing element is fixed at one or more positions along the length of the insertion tube. In yet other embodiments, the distal end of the reinforcing element is fixed to the distal portion of the insertion tube.

[0024] The reinforcing element may be composed of a uniform material having the same elasticity and cross-sectional geometry along substantially the entire length of the reinforcing element within the endoscope. The reinforcing element may extend along the length of the insertion tube. The reinforcing element may terminate prior to the distal end of the insertion tube.

[0025] In other embodiments, the reinforcing element may include a first length and a second length. The reinforcing element may be composed of a uniform material having the same elasticity along the first length and the second length of the reinforcing element. The reinforcing element may include a first cross-sectional geometry along the first length and a second cross-sectional geometry along the second length. The first cross-sectional geometry may be different from the second cross-sectional geometry.

[0026] In yet another embodiment, the reinforcing element may be composed of a uniform material having the same elasticity and cross-sectional geometry substantially along the entire length of the reinforcing element.The cross-sectional geometry may be asymmetric.

[0027] In another example, the reinforcement element may include a first length and a second length, wherein the first length may be comprised of a first material and the second length may be comprised of a second material.The first material may have an elastic modulus that is different than an elastic modulus of the second material.

[0028] The inventive aspects and embodiments discussed below in the following individual paragraphs of the Overview can be used independently or in combination with each other.

[0029] Further forms, objects, features, aspects, benefits, advantages and embodiments of the present disclosure will become apparent from the detailed description and drawings provided herewith. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1 A perspective view of a disposable flexible endoscope shaft assembly is illustrated.

[0031] Figure 2A A perspective view of an insertion tube assembly is illustrated.

[0032] Figure 2B A perspective view of the distal end of the insertion tube assembly is illustrated.

[0033] Figure 3 An exploded view of the insertion tube assembly is shown.

[0034] Figure 4 A perspective view of an articulated section assembly is illustrated.

[0035] Figure 5A An exploded view of the articulated section assembly is illustrated.

[0036] Figure 5B is a partially exploded view of the articulated section assembly.

[0037] Fig. 6A A perspective view of the overall articulated section in a straight configuration is illustrated.

[0038] Figure 6B A perspective view of the overall articulated section in a deflected configuration is illustrated.

[0039] Figure 6C A close-up view of the overall articulated section is illustrated.

[0040] Fig. 7A Picture shows Figure 6A-6C Close-up of the proximal end of the integral articulated section.

[0041] Figure 7B Pictured Figures 6A-7A Close-up of the distal end of the integral articulated section.

[0042] Figure 8 A perspective view of an articulated link assembly is illustrated.

[0043] Fig.9A A perspective view of an articulated link is shown.

[0044] Fig. 9B A perspective view of a proximal articulation link is shown.

[0045] Fig. 9C A perspective view of a distal articulation link is shown.

[0046] Fig.10 A perspective view of an articulated pull wire and terminal ring assembly is shown.

[0047] Fig.11 is a flow chart illustrating a process for manufacturing a disposable flexible endoscope shaft disclosed herein.

[0048] Fig.12 A first portion of the manufacturing apparatus is illustrated.

[0049] Fig.13 A second portion of the manufacturing apparatus is illustrated.

[0050] Fig.14 A stereoscopic view of an endoscope is shown.

[0051] Fig.15 A perspective view of the distal end of the insertion tube is shown.

[0052] Fig.16 A perspective view of the distal end of an insertion tube with various tubes and lines extending through and from the insertion tube is illustrated.

[0053] Fig.17 A cross-sectional view of an insertion tube having a reinforcement element extending substantially along the entire length of the insertion tube is illustrated.

[0054] Fig.18 Illustrated is a cross-sectional view of an insertion tube having a reinforcement element extending along a portion of the length of the insertion tube.

[0055] Fig.19 A cross-sectional view of an insertion tube having a tapered reinforcement element is illustrated.

[0056] FIG. 20A to FIG. 20E Illustrated are cross-sectional views of cross-sectional geometry options for the reinforcement element: A) solid circle B) hollow circle C) octagon D) square E) T-shaped.

[0057] Fig.21 A cross-sectional view of an insertion tube is shown having a reinforcing element constructed of one or more materials having different elastic moduli along the length. DETAILED DESCRIPTION

[0058] In order to promote the understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the accompanying drawings and specific language will be used to describe these embodiments. However, it should be understood that it is not intended to limit the scope of the present disclosure thereby. Any changes and further modifications in the described embodiments, and any further application of the principles of the present disclosure as described herein are considered to be what a person of ordinary skill in the art to which the present disclosure relates would normally think of. An embodiment of the present disclosure is shown in great detail, although it is obvious to a person skilled in the relevant art that, for the sake of clarity, some features not relevant to the present disclosure may not be shown.

[0059] With respect to the specification and claims, it should be noted that the singular forms "a," "an," "the," etc. include plural referents unless explicitly discussed otherwise. By way of illustration, reference to "a device" or "the device" includes one or more such devices and their equivalents. It should also be noted that directional terms (such as "upwardly," "downwardly," "top," "bottom," etc.) are used herein merely as a convenience to the reader in order to aid the reader in understanding the illustrated embodiments, and are not intended to limit the described, illustrated, and / or claimed features to a particular direction and / or orientation in any way using these directional terms.

[0060] As used herein, "proximal" refers to the end or direction associated with a physician or other medical personnel during operation of the device, and "distal" refers to the opposite end ("patient end / medical end"). The drawings referred to herein are provided for illustrative purposes only. They should not be construed as limiting the scope of the present disclosure as defined by the claims, including that they may not necessarily be drawn to scale.

[0061] Figure 1 A disposable flexible endoscope shaft assembly 10 is illustrated having a distal portion including an articulating section assembly 20 and a proximal portion including an insertion tube assembly 30 .

[0062] Now turn to Figure 2A , Figure 2B and Figure 3 , the insertion tube assembly 30 includes an outer coil 60. An articulation line 140 and a compression coil 80 extend along the length of the outer coil 60 through the interior thereof.

[0063] The braided sleeve 70 surrounds the outer coil 60 and is positioned between the outer coil and the outer sheath 90. The outer sheath 90 may be applied over the braided sleeve 70 and outer coil 60 as a return tube (eg, heat lamination) or by extrusion.

[0064] Figure 4Illustrated is a cap 120 at the distal end of the articulating section 20 and an articulating section outer sheath 130. The articulating section assembly 20 is connected to the insert tube assembly 30 using a transition tube 100. The transition tube 100 may be mechanically secured to both the articulating section assembly 20 and the insert tube assembly 30 by a process such as swaging.

[0065] Figure 5A and Figure 5B The articulation section assembly 20 is depicted. The articulation section assembly 20 includes an articulation line and terminal ring assembly 40 having a terminal ring 150 positioned at the distal end of the articulation line 140, an integral articulation section 110, an articulation section outer sheath 130, a cap 120, an instrument tube 230, an air / water tube 220, a camera 240 and a camera harness 250, a light emitter 260 (e.g., an LED), and a light emitter harness 270. When the disposable flexible endoscope shaft assembly 10 is assembled, the air / water tube 220 extends through the lumen 210 defined by the articulation section 110, the instrument tube 230 extends through the lumen 210, the camera harness 242 extends through the lumen 210, and the light emitter harness 270 extends through the lumen 210.

[0066] The cover 120 defines an air / water nozzle 280, an instrument tube outlet 290, a camera outlet 300, and a light emitter outlet 310. The cover 120 includes a cover alignment tab 124 arranged to engage a cover alignment recess of a hinge section (eg, integral hinge section 110).

[0067] Figure 6A-6C An integral articulated section 110 is depicted that includes a plurality of living hinges 320 that are alternately located in two perpendicular planes when the integral articulated section is in a straight configuration. Each deformable living hinge element 320 provides a means for rotating about a pivot axis in a single plane. An articulation line lumen 330 passes through each living hinge element 320 and is arranged to receive an articulation line 140.

[0068] The lumen 210 located within the integral articulating section 110 can receive air / water tubes, instrument tubes, and / or wires. The cover alignment notch 390 is located at the distal end of the integral articulating section 110 and is arranged to receive the cover alignment tab 124.

[0069] Figure 6B The integral articulated section 110 is illustrated in a deformed configuration consistent with 180° of articulation for retrograde viewing using a distally mounted camera 240 .

[0070] Fig. 7A The proximal end of the integral articulated section 110 is shown, and Figure 7B The distal end of the integral articulated section 110 is shown. Figure 7B As seen in FIG. 1 , the distally facing surface 334 extends inwardly from the inner surface 336 of the integral articulation section 110 . The distally facing surface 334 is arranged to contact the terminal ring 150 and transfer tension from the articulation line and terminal ring assembly 40 to the integral articulation section 110 .

[0071] Figure 8-9C An articulation link assembly 50 is illustrated that includes a proximal articulation link 350, an intermediate articulation link 340, and a distal articulation link 360. The proximal articulation link 350, the intermediate articulation link 340, and the distal articulation link 360 each define a lumen 210 arranged to receive air / water tubes, instrument tubes, and / or wires.

[0072] The proximal articulation link 350 includes a pivot tab 370 located in a first (e.g., vertical) plane. The intermediate articulation link 340 includes an articulation wire lumen 330, a pivot tab 370 located in a first plane, and a pivot socket 380 located in a second plane. The distal articulation link 360 includes a cover alignment notch 390 for controlling alignment of the camera 240 relative to each of the four articulation wires 140 and two pivot sockets 380 located in the first plane or the second plane. When assembled, the pivot tab 370 is received within the pivot socket 380 and is pivotable relative to the pivot socket.

[0073] Fig.10 The articulation pull wire and terminal ring assembly 40 is illustrated and includes four articulation pull wires 140 and an articulation pull wire terminal ring 150. The interior of the articulation pull wire terminal ring 150 defines a lumen 210 for passage of air / water tubes, instrument tubes, and wires.

[0074] Now turn to Fig.11 , describes a process for manufacturing the insertion tube assembly disclosed herein. The insertion tube assembly can be manufactured using a continuous manufacturing process (e.g., roll-to-roll). The process can begin in stage 501 with a continuous winding process, where the coil is manufactured in a continuous manner (e.g., a continuous winding machine).

[0075] A braided sleeve may be applied around the outer coil in stage 506. This may also occur in a continuous manufacturing process.

[0076] In stage 508, an outer sheath may be applied. This may also occur in a continuous manufacturing process. For example, an outer coil and braided sleeve assembly may pass through one or more extrusion heads, which extrude the outer sheath around the assembly. Such a process may produce a smooth outer sheath, which is integrally bonded to the outer coil and / or braided sleeve. The outer sheath may have a varying durometer along its length, so that some regions (e.g., length) of the outer sheath have a greater durometer than other regions. This may be accomplished by extruding resins of different durometers (e.g., different resins) through a separate extrusion head in one or more extrusion heads or by extruding resins of different durometers through at least one extrusion head in one or more extrusion heads.

[0077] In stage 510, the desired length of the insertion tube assembly or a portion thereof may be cut to length. This may occur immediately after the outer sheath extrusion process, or, for example, from a finished roll. After the assembly is cut to length, the articulation wire and / or compression coil may be inserted into the lumen of the outer coil. The process ends at stage 512.

[0078] As will be appreciated by those skilled in the art, this continuous technique for manufacturing the insertion tube avoids the labor and time intensive batch processes currently used to form discrete sections of endoscope shafts. Applicants believe this may reduce the cost of manufacturing endoscope shaft assemblies and / or increase production speeds.

[0079] Fig.12 and Fig.13 A manufacturing apparatus suitable for carrying out the process described above is shown in the figure. Fig.12 , a first portion 600 of a manufacturing apparatus is shown. The first portion 600 includes an external coil 60 extending from an external coil roll 602 to a fixture 610. The fixture 610 is arranged to form a braided sleeve around the external coil as the external coil and the compression coil are continuously advanced through the fixture 610. For example, the fixture 610 may include a braiding machine having a plurality of spools 612 that are interwoven relative to each other to form a braided (e.g., interwoven) sleeve around the external coil. The external coil and braided sleeve assembly 614 can then extend to a roll 616.

[0080] Fig.13 A second portion 620 of the manufacturing apparatus is illustrated. In the second portion 620, the outer coil and braided sleeve assembly 614 extends from a roll 616 to an extrusion die 624. The extrusion die 624 is arranged to continuously extrude an outer sheath around the assembly 614 as the assembly 614 advances through the extrusion die 624. The outer sheath assembly 626 extends from the extrusion die 624 to a finished roll 630.

[0081] Although one manufacturing apparatus has been illustrated and described, the present disclosure is not limited thereto. For example, the roll 616 may be omitted, and the outer coil and braided sleeve assembly 614 may extend directly from the fixture 610 to the extrusion die 624 .

[0082] Steering Figure 14-Figure 21 , shows another exemplary example of an insertion tube 730. It should be understood that Figure 14-Figure 21 The examples shown in include Figure 1-Figure 13 Therefore, for readability, the embodiments shown in FIG. Figure 1-Figure 13 All disclosures of Figure 14-Figure 21 Related here.

[0083] The present disclosure relates to insertion tubes having statically graded stiffness along their length. As discussed in more detail below, the present disclosure may include a uniformly flexible insertion tube (along its length) that may be made in a low-cost manner by a continuous process that includes continuous winding, continuous braiding, and continuous over-extrusion of a polymer sheath. The composite insertion tube assembly may have uniform stiffness along its length. It may also include a reinforcing element made of fiberglass and resin. The reinforcing element may terminate prior to the distal end of the insertion tube to achieve a fixed but graded stiffness along the length of the insertion tube.

[0084] Fig.14 An endoscope assembly 800 is illustrated. The endoscope assembly includes an endoscope handle 802 that is made of two parts. Fig.14 An endoscope assembly is illustrated having a reusable handpiece 804 attached to a single-use shaft assembly 806 .

[0085] The reusable handpiece is selectively attachable and detachable from the disposable rod assembly such that the reusable handpiece can be used in series with multiple disposable rod assemblies, while the disposable rod assemblies can be discarded and / or reconditioned after a single use.

[0086] The disposable rod assembly may include an insertion tube 730 for insertion into a patient.

[0087] See also Fig.15 and Fig.16 , the insertion tube 730 includes an outer coil 760. The articulation line 840 and the compression coil 780 can extend through the interior of the outer coil along the length thereof.

[0088] The braided sleeve 770 may surround the outer coil and may be positioned between the outer coil and the outer sheath 790. The outer sheath may be applied over the braided sleeve and outer coil as a return tube (eg, heat lamination) or by extrusion.

[0089] The external coil may define a lumen 762 extending through the interior of the insertion tube. Various conduits and electrical components may extend through the insertion tube to allow various fluids, tools, and signals to be transferred between the distal end of the insertion tube and the proximal end of the insertion tube to and from the handle, console, and / or monitor. For example, Fig.16 As illustrated, the air extrusion / tube 763, camera flush extrusion / tube 764, irrigation extrusion / tube 765, tool channel extrusion / lumen 766, wiring harness 767 for electrically connecting an LED or camera at the distal end of the insertion tube to an endoscope handle, console and / or monitor, articulation wire 840, compression coil 780 and / or reinforcement element 900 may extend at least partially through the insertion tube.

[0090] The reinforcing element may include a distal end 902 and a proximal end 904. The reinforcing element may be inserted into the insertion tube to produce a variable stiffness along the substantially entire length or a portion of the length of the insertion tube. The proximal end of the reinforcing element may be fixed to the handle body of the disposable rod assembly 806, which is connected to the proximal end 731 of the reusable handpiece 804 and / or the insertion tube. In some examples, a pocket is used to keep the proximal end of the reinforcing element in the disposable rod assembly 806. The reinforcing element may be fixed at one or more positions along the length of the disposable rod assembly. In some examples, the proximal end of the reinforcing element is fixed in the middle along the length of the disposable rod assembly. The reinforcing element may be maintained in a variety of ways, such as being fixed in the pocket of the proximal end of the reinforcing element via friction fit, interference fit, retaining geometry and / or adhesive. For example, an adhesive may be used to fix the proximal end of the reinforcing element to the disposable rod assembly.

[0091] Fig.17 A reinforcement element is illustrated extending from the endoscope handle to the distal end 732 of the insertion tube where it is connected to the articulation link assembly 50 . Fig.18 The illustration shows a reinforcement element extending from the endoscope handle along a portion of the length of the insertion tube. In different embodiments, the reinforcement element can extend along different lengths of the insertion tube. In some examples, the reinforcement element can extend from the proximal, central, or any location within the insertion tube instead of extending from the endoscope handle. Preferably, the reinforcement element terminates outside of the articulation link assembly. The articulation link assembly can include an overmolded rubber over the links, such as Figure 17-Figure 19 and Fig.21 As shown to the right of the distal end 732.

[0092] In some cases, the distal end of the stiffening element is free to move (eg, slide and / or rotate) within the insertion tube.

[0093] In other embodiments, the distal end of the reinforcing element is fixed within the insertion tube along the length of the insertion tube. For example, the distal end of the reinforcing element can be fixed in place at the distal end of the insertion tube.

[0094] The reinforcing element can be composed of a uniform material having the same elastic modulus along substantially the entire length of the reinforcing element. In some embodiments where the reinforcing element does not extend substantially along the entire length of the insertion tube, this creates a graded stiffness along the length of the insertion tube. A first portion 916 having a reinforcing element and a second stiffness of a second portion 917 without the reinforcing element.

[0095] Steering Fig.19 , shows a cross section of an insertion tube having a tapered stiffening element 918. This creates a graded stiffness along the length of the insertion tube.

[0096] Figure 20A-Figure 20E Examples of different cross-sectional geometry options for reinforcing elements are illustrated. In some embodiments, one geometry can be used along a first length of the reinforcing element, and a different second geometry can be used along a second length of the reinforcing element. This arrangement creates a graded stiffness along the length of the insertion tube. In some examples, three or more different cross-sectional geometries can be used along the length of the reinforcing element.

[0097] In other embodiments, asymmetric cross-sectional geometries may be used to create a bias to bend in a particular direction.

[0098] Further, varying asymmetric cross-sectional geometries may be used along the length of the reinforcement device to vary the direction in which the insertion tube is biased to rotate at different points along the length of the insertion tube.

[0099] Steering Fig.21 , shows an insertion tube having a reinforcing element constructed of uniform cross-sectional geometry, but one or more materials having different elastic moduli are used along the length of the reinforcing element. In other words, along a first length 932 of the reinforcing element, a first material having a first elasticity is used. Along a second length 934 of the reinforcing element, a second material having a second elasticity is used. The second elasticity is different from the first elasticity. In some examples, three or more materials having different elasticities may be used along the length of the reinforcing element.

[0100] In some examples, the reinforcement element is constructed of a uniform material having substantially the same elastic modulus and cross-sectional geometry along its entire length, but the reinforcement element terminates prior to the distal end of the insertion tube to achieve a fixed but graded stiffness along the length of the insertion tube.

[0101] In other examples, the reinforcing element is composed of a uniform material having the same elastic modulus along its length, but with a different cross-sectional geometry (see Figure 20A-Figure 20E ) varies along its length to achieve a fixed but graded stiffness along the length of the insertion tube.

[0102] In yet another example, the reinforcing element is constructed of a uniform material having the same elastic modulus along its length, but the cross-sectional geometry is asymmetric about its cross section. This creates a biased bending modulus in different directions along the length of the insertion tube.

[0103] In other embodiments, the reinforcing element is constructed of a uniform cross-sectional geometry, wherein one or more materials having different elastic moduli are used along the length of the reinforcing element to achieve a fixed but graded stiffness along the length of the insertion tube.

[0104] In some embodiments, the reinforcement element may be removable from the insertion tube. In these embodiments, reinforcement elements having a variety of different features (as described in detail above) may be used in the same insertion tube, depending on the patient and the procedure being performed.

[0105] In About Fig.11 Following the described method, the reinforcing element may be inserted into the insertion tube before or after the insertion tube is cut to length. After at least a portion of the reinforcing element is inserted into the insertion tube, the proximal end of the reinforcing element may be secured to the disposable rod assembly.

[0106] As will be appreciated by those skilled in the art, this continuous technique for manufacturing the insertion tube avoids the labor and time intensive batch processes currently used to form discrete sections of endoscope shafts. Applicants believe this may reduce the cost of manufacturing endoscope shaft assemblies and / or increase production speeds.

[0107] Although the present disclosure has been illustrated and described in detail in the drawings and the foregoing description, it is considered to be illustrative rather than restrictive in nature, and it should be understood that only preferred embodiments have been shown and described, and it is desired to protect all changes, equivalents and modifications that fall within the spirit of the present disclosure as defined by the appended claims. All publications, patents and patent applications cited in this specification are incorporated herein by reference, as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference, and set forth herein in its entirety.

[0108] Terms

[0109] The following numbered clauses set forth specific embodiments that may be useful in understanding the present disclosure:

[0110] Item 1: A method of manufacturing a flexible endoscope shaft assembly comprising: a proximal insertion tube and a distal articulated section, wherein the proximal insertion tube is composed of two or more pull wires each located within a concentric compression coil, an outer coil, an outer braid, and an outer smooth sheath, wherein the outer coil is produced using a continuous process and the outer braid is applied using discrete wires in a continuous process.

[0111] Clause 2: The method of Clause 1 further comprises advancing the braided component through an opening in a die of an extrusion die to continuously apply the outer jacket to the braided component in a reel-to-reel process.

[0112] Clause 3: The method of clause 2 further comprises feeding resin to two or more extruders in an extrusion die, wherein the multiple extruders apply resins of different durometers, wherein the stiffness of the rod can be changed by applying the resins of different durometers, wherein a mark or unique identifier is applied to the rod, the mark or unique identifier identifying a cutting location, wherein cutting the rod provides a desired stiffness in two or more sections of the rod.

[0113] Item 4: A method of manufacturing at least a portion of a flexible endoscope shaft, comprising: using a continuous winding machine to form a continuous first length, a second length, and a third length of an external coil, wherein forming the first length defines a first time period, forming the second length defines a second time period, and forming the third length defines a third time period; and forming an external braid around the external coil along the first length during the second time period to produce a braided assembly.

[0114] Clause 5: The method of clause 4 includes positioning two or more puller wires within the outer coil, each puller wire positioned within a concentric compression coil.

[0115] Clause 6: The method of any preceding clause, wherein the flexible endoscopic shaft comprises a distal articulating section extending distally of the proximal insertion tube.

[0116] Clause 7: The method of any preceding clause, wherein the outer braid is formed using discrete strands.

[0117] Clause 8: The method of any preceding clause, comprising advancing the braided component through an opening in a die of an extrusion die during the third time period.

[0118] Clause 9: The method of any preceding clause, comprising forming an outer braid around the outer coil along the second length during the third time period.

[0119] Clause 10: The method of any preceding clause, further comprising applying resins of different durometers along the first length.

[0120] Clause 11: The method of any preceding clause, comprising: applying an identifier to the component that identifies the cutting location.

[0121] Clause 12: The method of any preceding clause, wherein the lengths of the components having resins of different durometers are without identifiers.

[0122] Item 13: A method for manufacturing at least a portion of a disposable rod assembly for an endoscope, comprising: inserting a reinforcing element into an insertion tube formed by a continuous process, the continuous process comprising using a continuous winding machine to form a continuous first length, a second length, and a third length of an external coil, wherein forming the first length defines a first time period, forming the second length defines a second time period, and forming the third length defines a third time period, and during the second time period an outer braid is formed around the outer coil along the first length to manufacture a braided assembly, and during the third time period an outer sheath is formed around the braided assembly along the first length to form the insertion tube; and securing the reinforcing element to a portion of the disposable rod assembly.

[0123] Clause 14: The method of clause 13, wherein after attaching the reinforcement element to the portion of the disposable rod assembly, the reinforcement element extends along substantially the entire cut length of the insertion tube.

[0124] Clause 15: The method of any of clauses 13-14, wherein attaching the reinforcement element to a portion of the disposable shaft assembly comprises securing a proximal end of the reinforcement element to a portion of a housing of the disposable shaft assembly.

[0125] Clause 16: The method of any of clauses 13-15, wherein securing the stiffening element to a portion of the disposable shaft assembly comprises securing a proximal end of the stiffening element to a proximal end of the insertion tube.

[0126] Clause 17: The method of any of clauses 13-16, wherein, after inserting the reinforcement element into the insertion tube, the distal end of the reinforcement element is freely movable within the insertion tube.

[0127] Clause 18: The method of any of clauses 13-17, wherein securing comprises securing the distal end of the reinforcement element to a portion of the insertion tube.

[0128] Clause 19: The method of any of clauses 13-18, wherein securing comprises securing a distal end of the reinforcement element to a distal portion of the insertion tube.

[0129] Clause 20: The method of any of clauses 13-19, wherein the reinforcing element is comprised of a uniform material having a constant cross-sectional geometry substantially along the entire length of the reinforcing element; and wherein, after securing the reinforcing element to a portion of the disposable rod assembly, the reinforcing element terminates prior to the distal end of the insertion tube.

[0130] Clause 21: The method of any of clauses 13-20, wherein the reinforcing element comprises a first length and a second length, wherein the reinforcing element is comprised of a uniform material along the first length and the second length of the reinforcing element, wherein the reinforcing element comprises a first cross-sectional geometry along the first length and a second cross-sectional geometry along the second length, and wherein the first cross-sectional geometry is different from the second cross-sectional geometry.

[0131] Clause 22: The method of any of clauses 13-20, wherein the reinforcement element is comprised of a uniform material and cross-sectional geometry substantially along the length of the reinforcement element, and wherein the cross-sectional geometry is asymmetric.

[0132] Clause 23: The method of any of clauses 13-20, wherein the reinforcing element comprises a first length and a second length, wherein the first length is comprised of a first material and the second length is comprised of a second material, and wherein the first material has a different modulus of elasticity than the second material.

[0133] Item 24: A disposable rod assembly of an endoscope assembly, comprising: an insertion tube, the insertion tube including an outer coil, a braided sleeve and an outer sheath and having a certain length, the braided sleeve surrounding the outer coil, and the outer sheath surrounding the braided sleeve and the outer coil; and a reinforcement element, the reinforcement element extending along at least a portion of the length of the insertion tube, wherein the proximal end of the reinforcement element is fixed relative to the proximal end of the insertion tube.

[0134] Clause 25: The disposable rod assembly of clause 24, wherein the reinforcement element extends substantially along the entire length of the insertion tube.

[0135] Clause 26: The disposable rod assembly of any of clauses 24-25, wherein the reinforcement element is secured to a portion of the housing of the disposable rod assembly using an adhesive.

[0136] Clause 27: The disposable rod assembly of any of clauses 24-26, wherein the reinforcement element is secured to the proximal end of the insertion tube.

[0137] Clause 28: The disposable rod assembly of any of clauses 24-27, wherein the distal end of the reinforcement element is freely movable within the insertion tube.

[0138] Clause 29: The disposable rod assembly of any of clauses 24-28, wherein the distal end of the reinforcement element terminates proximal to the distal end of the insertion tube.

[0139] Clause 30: The disposable rod assembly of any of clauses 24-29, wherein the distal end of the reinforcement element terminates proximal to an articulation link of the disposable rod assembly.

[0140] Clause 31: The disposable rod assembly of any of clauses 24-30, wherein the reinforcing element is comprised of a uniform material and cross-sectional geometry along substantially the entire length of the reinforcing element, and wherein the reinforcing element terminates proximally of the distal end of the insertion tube.

[0141] Clause 32: The disposable rod assembly of any of clauses 24-30, wherein the reinforcing element comprises a first length and a second length, wherein the reinforcing element is comprised of a uniform material along the first length and the second length of the reinforcing element, wherein the reinforcing element comprises a first cross-sectional geometry along the first length and a second cross-sectional geometry along the second length, and wherein the first cross-sectional geometry is different from the second cross-sectional geometry.

[0142] Clause 33: The disposable rod assembly of any of Clauses 24-30, wherein the reinforcing element is comprised of a uniform material and cross-sectional geometry along substantially the entire length of the reinforcing element, and wherein the cross-sectional geometry is asymmetric.

[0143] Clause 34: The disposable rod assembly of any of clauses 24-30, wherein the reinforcing element comprises a first length and a second length, wherein the first length is comprised of a first material and the second length is comprised of a second material, and wherein the first material has a different modulus of elasticity than the second material.

Claims

1. A method of manufacturing at least a portion of a disposable shaft assembly of an endoscope, comprising: inserting a reinforcing element into an insertion tube formed by a continuous process, the continuous process comprising forming a continuous first length, a second length, and a third length of an external coil using a continuous winding machine, wherein forming the first length defines a first time period, forming the second length defines a second time period, and forming the third length defines a third time period, and forming an outer braid around the external coil along the first length during the second time period to make a braided assembly, and forming an outer sheath around the braided assembly along the first length during the third time period to form the insertion tube; The reinforcing element is secured to a portion of the disposable rod assembly.

2. The method according to claim 1, wherein: After securing the reinforcement element to a portion of the disposable rod assembly, the reinforcement element extends substantially along the entire cut length of the insertion tube.

3. The method according to claim 1, wherein: Securing the reinforcing element to a portion of the disposable rod assembly includes securing a proximal end of the reinforcing element to a portion of a housing of the disposable rod assembly.

4. The method according to claim 1, wherein: Securing the stiffening element to a portion of the disposable rod assembly includes securing a proximal end of the stiffening element to a proximal end of the insertion tube.

5. The method according to claim 1, wherein: After the reinforcing element is inserted into the insertion tube, the distal end of the reinforcing element is freely movable within the insertion tube.

6. The method according to claim 1, wherein: Securing includes securing a distal end of the reinforcement element to a portion of the insertion tube.

7. The method according to claim 1, wherein: Securing includes securing the distal end of the reinforcement element to a distal portion of the insertion tube.

8. The method according to claim 1, wherein: The reinforcing element is comprised of a uniform material having a constant cross-sectional geometry along substantially the entire length of the reinforcing element; and wherein, after securing the reinforcing element to a portion of the disposable rod assembly, the reinforcing element terminates prior to the distal end of the insertion tube.

9. The method according to claim 1, wherein: The reinforcing element comprises a first length and a second length, wherein the reinforcing element is comprised of a uniform material along the first length and the second length of the reinforcing element, wherein the reinforcing element comprises a first cross-sectional geometry along the first length and a second cross-sectional geometry along the second length, and wherein the first cross-sectional geometry is different from the second cross-sectional geometry.

10. The method according to claim 1, wherein: The reinforcing element is comprised of a uniform material and cross-sectional geometry substantially along the length of the reinforcing element, and wherein the cross-sectional geometry is asymmetric.

11. The method according to claim 1, wherein: The reinforcement element includes a first length and a second length, wherein the first length is comprised of a first material and the second length is comprised of a second material, and wherein the first material has a different modulus of elasticity than the second material.

12. A disposable shaft assembly of an endoscope assembly, comprising: an insertion tube including an outer coil, a braided sleeve, and an outer sheath and having a length, the braided sleeve surrounding the outer coil, and the outer sheath surrounding the braided sleeve and the outer coil; as well as A reinforcement element extends along at least a portion of the length of the insertion tube, wherein a proximal end of the reinforcement element is fixed relative to the proximal end of the insertion tube.

13. The disposable rod assembly of claim 12, wherein: The reinforcement element extends along substantially the entire length of the insertion tube.

14. The disposable rod assembly of claim 12, wherein: The reinforcing element is secured to a portion of the housing of the disposable rod assembly using an adhesive.

15. The disposable rod assembly of claim 12, wherein: The reinforcement element is secured to the proximal end of the insertion tube.

16. The disposable rod assembly of claim 12, wherein: The distal end of the reinforcing element is freely movable within the insertion tube.

17. The disposable rod assembly of claim 12, wherein: The distal end of the reinforcement element terminates proximal to the distal end of the insertion tube.

18. The disposable rod assembly of claim 12, wherein: The distal end of the reinforcement element terminates proximally of an articulation link of the disposable rod assembly.

19. The disposable rod assembly of claim 12, wherein: The reinforcing element is comprised of a uniform material and cross-sectional geometry along substantially the entire length of the reinforcing element, and wherein the reinforcing element terminates proximal to the distal end of the insertion tube.

20. The disposable rod assembly of claim 12, wherein: The reinforcement element comprises a first length and a second length, wherein the reinforcement element is comprised of a uniform material along the first length and the second length of the reinforcement element, wherein the reinforcement comprises a first cross-sectional geometry along the first length and a second cross-sectional geometry along the second length, and wherein the first cross-sectional geometry is different from the second cross-sectional geometry.

21. The disposable rod assembly of claim 12, wherein: The reinforcing element is comprised of a uniform material and cross-sectional geometry along substantially the entire length of the reinforcing element, and wherein the cross-sectional geometry is asymmetrical.

22. The disposable rod assembly of claim 12, wherein: The reinforcement element includes a first length and a second length, wherein the first length is comprised of a first material and the second length is comprised of a second material, and wherein the first material has a different modulus of elasticity than the second material.

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