Endoscope insertion tube having stepwise static stiffness

Abstract

An endoscope is provided. The endoscope includes a disposable shaft assembly having an insertion tube with a distal articulation section. The insertion tube comprises an outer coil, two or more pull wires respectively arranged together with a concentric compression coil, an outer braid, an outer sheath, and a reinforcement element. The distal articulation section includes a deformable element for articulating the distal tip. The reinforcement element may be manufactured from a material having uniform elasticity, or may be manufactured from a plurality of materials having different elasticities along the length. The reinforcement element can be made to further include a cross-sectional shape along the length of the reinforcement element. The cross-sectional shape may be uniform along the length, or may vary along the length to obtain a stepped rigidity along the length of the insertion tube. A manufacturing method is also disclosed.

Description

Technical Field

[0001] Cross-reference This application claims the benefit of U.S. Provisional Application No. 63 / 370,538, filed Aug. 5, 2022, which is incorporated herein by reference.

[0002] This disclosure generally relates to endoscopes.

Background Art

[0003] Endoscope insertion tubes are typically manually assembled composites incorporating coils, braids, and one or more outer extrusions (polymers of one or more different durometers), which are then reflowed to be integrally joined by a reflowed outer polymer jacket. Alternatively, the braided coil can be passed through an extruder equipped with one or more extrusion resin heads (resins of different durometers). Other configurations vary the braid pattern and coil pattern. The purpose of applying these variations along the length of the insertion tube is to vary the stiffness along the length of the insertion tube. For example, when moving through the gastric cavity with a duodenoscope or gastroscope, increasing the stiffness of a particular section of the insertion tube helps prevent looping (bending) in the gastric cavity. Similarly, varying the stiffness along the length of a colonoscope helps move along the elastic walls of the colon while avoiding unnecessary damage. This process is generally quite costly, and a lower-cost alternative is desired.

[0004] Accordingly, there is a need for improvement in this field.

Summary of the Invention

Means for Solving the Problems

[0005] A medical device, such as a disposable shaft assembly for an endoscope, is disclosed. The disposable shaft assembly can be configured to be used with a reusable handpiece assembly having one or more control units for operating the disposable shaft assembly. The disposable shaft assembly can include a disposable flexible endoscope shaft having an insertion tube assembly. The insertion tube assembly can include an outer 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 outer coil. An outer sheath can be used to surround the braided sleeve and the outer 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.

[0006] The disposable flexible endoscope shaft of the present disclosure includes a proximal portion having an insertion tube assembly and a distal portion having an articulation assembly.

[0007] The insertion tube assembly disclosed herein includes an outer coil. A plurality of compression coils are disposed within the outer coil. The compression coils can be configured to increase the column strength of the outer coil along the longitudinal direction of the outer coil. The compression coils can be helically wound metal wires and / or spiral cut cannulas that provide lateral flexibility. The articulation wires can be slidably disposed within the lumen defined by the compression coils.

[0008] The insertion tube assembly can include a sleeve (e.g., a braided sleeve) disposed around the outer coil. The sleeve preferably provides torsional strength to the insertion tube assembly. The braided sleeve can include a metal braid or a plastic braid such as PET.

[0009] The insertion tube assembly includes an outer sheath disposed around the sleeve. The outer sheath can be formed as a reflow tube or by an extruder. The outer sheath can be joined to the outer coil through the sleeve and / or the holes of the sleeve.

[0010] The joint assembly includes a joint portion having a plurality of hinges. Each hinge allows rotation about a pivot axis. The pivot axis of the hinge can extend transversely to the longitudinal axis of the joint portion. Further, one or more pivot axes of the hinges can be in a different plane from the pivot axes of one or more other hinges. For example, when the joint portion is in a linear (e.g., not bent) configuration, the pivot axes of the hinges can be alternately positioned in planes perpendicular to each other. Advantageously, such a configuration can provide a joint movement element that can articulate the distal tip / camera in three dimensions.

[0011] One or more hinges of the joint portion can be living hinges. In some examples, the joint portion is in the form of a one-piece joint portion. The one-piece joint portion can be formed from a single material. The one-piece joint portion structure can be manufactured using injection molding or additive manufacturing techniques. Alternatively, the one-piece joint portion can be formed by extruding a cylinder and then cutting the cylinder tube with a knife, laser, milling machine, water jet, or other material removal mechanism to form a living hinge. As will be appreciated, the bending and torque fidelity characteristics of the joint portion can be set by adjusting the angle of the cut / indentation defining the hinge and / or the distance between adjacent hinges.

[0012] In another configuration, the articulation structure comprises a plurality of individual links that define a plurality of concentric tab-and-socket pivot joints that function as hinges when assembled. As described above, each hinge (e.g., a tab-and-socket pivot joint) can provide rotation about a pivot axis in a single plane. Further, the plurality of concentric tab-and-socket joints can be alternately arranged in two perpendicular planes when the central axes of all the links are aligned in a straight line, so as to give the articulation a plurality of degrees of freedom.

[0013] An outer sheath can be disposed around the articulation to prevent foreign matter from entering one or more hinges and / or lumens defined by the articulation. The articulation can include a distal cap that defines an air / water nozzle, an instrument tube outlet, a camera outlet, and / or an LED outlet.

[0014] The insertion tube assembly and the articulation can be joined (e.g., by heat or friction welding, adhesives, etc.) and / or attached using a mating structure of the contact surfaces (e.g., threads) or a transition tube as shown in the illustrated embodiment. The intermediate surface of the transition tube can be disposed at the transition between the insertion tube assembly and the articulation, and the transition tube can be joined (e.g., by crimping or adhesive bonding) to both the insertion tube assembly and the distal articulation to form a secure attachment. The transition tube can be deformable to allow for the deflection of the flexible endoscope shaft at the transition.

[0015] The insertion tube assembly disclosed herein can be manufactured using a continuous (e.g., reel-to-reel) manufacturing process. The braided sleeve can be provided around the outer coil during the continuous manufacturing process. Further, the outer sheath can be provided during the continuous manufacturing process. For example, the assembly of the outer coil and the braided sleeve therearound can be passed through one or more extrusion heads during the continuous manufacturing process to form an outer sheath on a portion of the insertion tube assembly. Such a process can create a smooth outer sheath integrally coupled to the outer coil and / or the braided sleeve. The outer sheath can be made to have different durometers along the length of the shaft.

[0016] After disposing this outer sheath around the assembly, the shaft can be cut to a desired length, and the compression coil and / or the articulating wire can be inserted inside the outer coil.

[0017] Advantageously, by continuously manufacturing the insertion tube assembly, the manufacturing cost of the endoscope shaft assembly can be reduced and the production speed can be improved. Thus, in one aspect, the present disclosure provides a low-cost, flexible endoscope shaft and a method of manufacturing the same. Since the insertion tube assembly can be manufactured continuously, an insertion tube assembly of a desired length or a portion thereof can be cut out after the outer sheath extrusion process or cut out from a finished reel. The continuous technique (e.g., reel-to-reel technique) for manufacturing the insertion tube has the advantage of avoiding braiding and coating the insertion tube for each individual section using a labor-intensive process.

[0018] As will be appreciated, the disclosed insertion tube assembly can accommodate the wiring, tubes, and operating wires of the endoscope shaft while having sufficient torsional strength and compressive strength to advance the articulation assembly through the tortuous blood vessels of a patient.

[0019] A method of manufacturing at least a part of an insertion tube assembly is disclosed. The method can include using a continuous wire coil to form successive first, second, and third length portions of an outer coil. A first period is defined by forming the first length portion. A second period is defined by forming the second length portion. A third period is defined by forming the third length portion. During the second period, an outer braid is formed around the outer coil along the first length portion to create a braid assembly. During the third period, an outer sheath is extruded onto the braid assembly along the first length portion to form at least a part of the insertion tube. A reinforcing element can be inserted into the insertion tube along at least a part of the length of the insertion tube assembly either before or after the insertion tube is cut to a predetermined length.

[0020] In some embodiments, the reinforcing element can extend substantially the entire length of the insertion tube.

[0021] In some examples, the reinforcing element can be fixed to a part of an endoscope handle (e.g., the housing of a disposable shaft assembly). In other embodiments, the reinforcing element can be fixed to the proximal end of the insertion tube. The reinforcing element can be fixed by friction fit, interference fit, retention shape (e.g., threaded contact), and / or an adhesive.

[0022] 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.

[0023] The reinforcing element can be composed of a uniform material having the same elasticity and cross-sectional shape substantially throughout the entire length of the reinforcing element within the endoscope. The reinforcing element can extend along the length of the insertion tube. The reinforcing element can terminate short of the distal end of the insertion tube.

[0024] In other embodiments, the reinforcing element can be made to include a first length portion and a second length portion. The reinforcing element can be made of a uniform material having the same elasticity over the first length portion and the second length portion of the reinforcing element. The reinforcing element can be made to include a first cross-sectional shape along the first length portion and a second cross-sectional shape along the second length portion. The first cross-sectional shape can be different from the second cross-sectional shape.

[0025] In yet another embodiment, the reinforcing element can be composed of a uniform material having the same elasticity and cross-sectional shape over substantially the entire length of the reinforcing element. The cross-sectional shape can be asymmetric.

[0026] In another example, the reinforcing element can include a first length portion and a second length portion, where the first length portion is composed of a first material and the second length portion is composed of a second material. The first material can have an elastic modulus different from that of the second material.

[0027]

[0028] The aspects and embodiments of the invention described in the individual paragraphs of the summary below can be used either alone or in combination with each other.

[0029] Further forms, objects, features, aspects, advantages, merits, and embodiments of the present disclosure will become apparent from the detailed description and drawings provided herein.

Brief Description of the Drawings

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[0058] For the purpose of facilitating an understanding of the principles of the present disclosure, the embodiments shown in the drawings will be referred to below and described using specific terms. However, it should be understood that it is not intended to limit the scope of the disclosure thereby. All changes and further modifications in the described embodiments, and all further applications of the principles of the disclosure described herein, are contemplated to the extent that would normally occur to a person skilled in the art related to the present disclosure. Although one embodiment of the present disclosure is shown in detail, it will be apparent to those skilled in the relevant technical field that some features not related to the present disclosure may not be shown for clarity.

[0059] Regarding this specification and the claims, it should be noted that the singular form includes plural objects unless otherwise specifically mentioned. For example, the expressions "device" or "the device" include one or more devices and their equivalents. Also, terms indicating directions such as "up", "down", "top", "bottom", etc. are used only for the purpose of assisting the understanding of the reader of the illustrated embodiment, and the use of these terms indicating directions is not intended to limit the described, illustrated, and / or claimed features to a specific direction and / or orientation.

[0060] As used herein, "proximal" means the end or direction closer to the physician or other treating personnel during operation of the device, and "distal" means the opposite end (the "patient-side end / treatment-side end"). The drawings referred to in this specification 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 the possibility that they may not be drawn to scale.

[0061] FIG. 1 shows a disposable flexible endoscope shaft assembly 10 having a distal portion with a joint assembly 20 and a proximal portion with an insertion tube assembly 30.

[0062] Referring now to FIGS. 2A, 2B, and 3, the insertion tube assembly 30 includes an outer coil 60. A joint wire 140 and a compression coil 80 extend through the inside of the outer coil 60 along its length.

[0063] Surrounding the outer coil 60, a braided sleeve 70 is disposed between the outer coil and an outer sheath 90. The outer sheath 90 can be provided as a reflow tube (e.g., heat lamination) or by extrusion over the braided sleeve 70 and the outer coil 60.

[0064] FIG. 4 shows a cap 120 at the distal end of the joint portion 20 and an outer joint sheath 130. The joint assembly 20 is connected to the insertion tube assembly 30 by a transition tube 100. The transition tube 100 may be mechanically fixed to both the joint assembly 20 and the insertion tube assembly 30 by a process such as swaging.

[0065] Figures 5A and 5B show the articulation assembly 20. The articulation assembly 20 includes an articulation wire - termination ring assembly 40, and the articulation wire - termination ring assembly 40 has a termination ring 150 located at the distal end of the articulation wire 140, an integral articulation portion 110, an outer articulation sheath 130, a cap 120, an instrument tube 230, an air / water tube 220, a camera 240 and a camera wiring harness 250, a light emitter 260 (e.g., an LED) and a light emitter wiring 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 portion 110, the instrument tube 230 extends through the lumen 210, the camera wiring harness 242 extends through the lumen 210, and the light emitter wiring harness 270 extends through the lumen 210.

[0066] The cap 120 defines an air / water nozzle 280, an instrument tube outlet 290, a camera outlet 300, and a light emitter outlet 310. The cap 120 includes a cap alignment tab 124 configured to engage with a cap alignment notch of the articulation portion (e.g., the integral articulation portion 110).

[0067] Figures 6A - 6C show that when the integral articulation portion 110 is in a straight configuration, a plurality of living hinges 320 are alternately positioned in two perpendicular planes. Each variable living hinge element 320 provides means for rotation about a pivot axis within a single plane. The articulation wire lumen 330 passes through each living hinge element 320 and is arranged to receive the articulation wire 140.

[0068] The lumen 210 located within the integral articulation portion 110 can receive an air / water tube, an instrument tube, and / or wiring. The cap alignment notch 390 is located at the distal end of the integral articulation portion 110 and is configured to receive the cap alignment tab 124.

[0069] FIG. 6B shows the integrated joint portion 110 in a deformed state corresponding to a 180° articulating movement for rear viewing using the distally attached camera 240.

[0070] FIG. 7A shows the proximal end of the integrated joint portion 110, and FIG. 7B shows the distal end of the integrated joint portion 110. As seen in FIG. 7B, the distal opposing surface 334 extends inwardly from the inner surface 336 of the integrated joint portion 110. The distal opposing surface 334 is configured to contact the terminal ring 150 and transmit the tensile force from the articulating wire and terminal ring assembly 40 to the integrated joint portion 110.

[0071] FIGS. 8 - 9C show an articulating link assembly 50 comprising a proximal articulating link 350, an intermediate articulating link 340, and a distal articulating link 360. Each of the proximal articulating link 350, the intermediate articulating link 340, and the distal articulating link 360 defines a lumen 210 configured to receive air / water tubes, instrument tubes, and / or wiring.

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

[0073] FIG. 10 shows an articulating wire and terminal ring assembly 40 comprising four articulating pull wires 140 and an articulating pull wire terminal ring 150. The interior of the articulating pull wire terminal ring 150 defines a lumen 210 for passing air / water tubes, instrument tubes, and wiring.

[0074] Next, referring to FIG. 11, a process for manufacturing the insertion tube assembly disclosed herein is described. The insertion tube assembly can be manufactured using a continuous manufacturing process (e.g., reel-to-reel). This process starts a continuous coil process at step 501 and continuously manufactures the coil (e.g., a continuous wire coiler).

[0075] At step 506, a braided sleeve can be provided around the outer coil. This can also be performed during the continuous manufacturing process.

[0076] At step 508, an outer sheath can be formed. This can also be performed during the continuous manufacturing process. For example, the outer coil - braided sleeve assembly can be passed through one or more extrusion heads that extrude an outer sheath around the assembly. Such a process can create a smooth outer sheath integrally bonded to the outer coil and / or the braided sleeve. The outer sheath can have different durometers along its length such that certain regions (e.g., length portions) of the outer sheath have a higher durometer than other regions. This can be achieved by extruding resins of different durometers (e.g., different resins) through individual extrusion heads of one or more extrusion heads or by extruding resins of different durometers through at least one of the one or more extrusion heads.

[0077] At stage 510, a desired length portion of the insertion tube assembly, or a part of the insertion tube assembly can be cut to a certain length. This can be done immediately after the outer sheath extrusion step or, for example, from the finished product spool. After cutting the assembly to the required length, the articulating wire and / or the compression coil is inserted into the lumen of the outer coil. This process ends at step 512.

[0078] As will be apparent to those skilled in the art, the continuous manufacturing technique of this insertion tube avoids the labor-intensive and time-consuming batch processes currently used to form the individual sections of the endoscope shaft. The applicant is confident that this can reduce the manufacturing cost of the endoscope shaft assembly and / or improve the production speed.

[0079] Figures 12 and 13 show the configuration of a manufacturing apparatus suitable for implementing the above-described process. In Figure 12, a first portion 600 of the manufacturing apparatus is shown. The first portion 600 includes an outer coil 60 extending from an outer coil reel 602 to a jig 610. The jig 610 is configured to form a braided sleeve around the outer coil as the outer coil and the compression coil continuously advance through the jig 610. For example, the jig 610 may include a braiding machine having a plurality of bobbins 612 that are woven together to form a braided (e.g., woven) sleeve around the outer coil. Thereafter, the outer coil-braided sleeve assembly 614 extends to a reel 616.

[0080] Figure 13 shows a second portion 620 of the manufacturing apparatus. In the second portion 620, the outer coil-braided sleeve assembly 614 extends from the reel 616 to an extrusion die 624. The extrusion die 624 is configured to continuously extrude an outer sheath around the assembly 614 as the assembly 614 advances therethrough. The outer sheath assembly 626 extends from the extrusion die 624 to a finished product reel 630.

[0081] Although one manufacturing configuration is illustrated and described, the present disclosure is not limited thereto. For example, the reel 616 can be omitted so that the outer coil-braided sleeve assembly 614 extends directly from the jig 610 to the extrusion die 624.

[0082] Referring to FIGS. 14 - 21, another exemplary example of the insertion tube 730 is shown. It is understood that the example shown in FIGS. 14 - 21 includes many of the same features as the embodiment shown in FIGS. 1 - 13. Accordingly, for ease of understanding, all of the disclosure related to FIGS. 1 - 13 is incorporated herein in connection with FIGS. 14 - 21.

[0083] The present disclosure relates to an insertion tube having a step - wise static stiffness along its length. The present disclosure can include a uniformly flexible insertion tube that can be manufactured at low cost by a continuous process including continuous coiling, continuous braiding, and continuous over - extrusion of a polymer jacket, as will be described in more detail below. The composite insertion tube assembly may have a uniform stiffness along its length. It may also include reinforcing elements made of glass fiber and resin. The reinforcing elements terminate in front of the distal end of the insertion tube and can be fixed along the length of the insertion tube to achieve a step - wise stiffness.

[0084] FIG. 14 shows an endoscope assembly 800. The endoscope assembly includes an endoscope handle 802 consisting of two components. FIG. 14 shows an endoscope assembly in which a reusable handpiece 804 is attached to a disposable shaft assembly 806.

[0085] The reusable handpiece can be selectively attached to and detached from the disposable shaft assembly, whereby the reusable handpiece can be continuously used with a plurality of disposable shaft assemblies, while the disposable shaft assembly can be discarded or readjusted after one use.

[0086] The disposable shaft assembly can include an insertion tube 730 for insertion into a patient's body.

[0087] Referring to FIGS. 15 and 16, the insertion tube 730 includes an outer coil 760. The articulation wire 840 and the compression coil 780 can extend along its length through the interior of the outer coil.

[0088] The braided sleeve 770 may surround the outer coil and be disposed between the outer coil and the outer sheath 790. The outer sheath may be provided on the braided sleeve and the outer coil as a reflow tube (e.g., heat lamination) or by extrusion.

[0089] The outer coil can define a lumen 762 that passes through the interior of the insertion tube. Various tubes and electrical components can extend through the insertion tube, thereby allowing various fluids, instruments, and signals to be sent to and from 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, as shown in FIG. 16, an air release tube 763, a camera flash release tube 764, an irrigation release tube 765, an instrument channel release tube 766, an LED or camera at the distal end of the insertion tube, an endoscope handle, a console, the articulation wire 840, the compression coil 780, and / or a reinforcing element 900 may extend at least partially through the insertion tube.

[0090] The reinforcement element may include a distal end 902 and a proximal end 904. The reinforcement element may be inserted into the insertion tube to create variable stiffness along substantially the entire length or a portion of the insertion tube. The proximal end of the reinforcement element may be fixed to the reusable handpiece 804 and / or the handle body of the disposable shaft assembly 806 connected to the proximal end 731 of the insertion tube. In some examples, a pocket is used to hold the proximal end of the reinforcement element within the disposable shaft assembly 806. The reinforcement element may be fixed at one or more positions along the length of the disposable shaft assembly. In some examples, the proximal end of the reinforcement element is fixed at an intermediate position along the length of the disposable shaft assembly. The reinforcement element can be held in various ways, such as, for example, by friction fit, interference fit, retention shape, and / or adhesives within a pocket that holds the proximal end of the reinforcement element. For example, the proximal end of the reinforcement element can be fixed to the disposable shaft assembly using an adhesive.

[0091] FIG. 17 shows that the reinforcement element extends from the endoscopic handle to the distal end 732 of the insertion tube that connects to the articulation link assembly 50. FIG. 18 shows a configuration in which the reinforcement element extends along a portion of the length of the insertion tube from the endoscopic handle. In various embodiments, the reinforcement element may extend along various lengths of the insertion tube. In some examples, the reinforcement element may extend from a proximal side, central, or any position within the insertion tube rather than from the endoscopic handle. Preferably, the reinforcement element terminates in front of the articulation link assembly. The articulation link assembly may include overmolded rubber on the link as shown to the right of the distal end 732 in FIGS. 17-19 and 21.

[0092] In some examples, the distal end of the reinforcement element can move freely (e.g., slide and / or rotate) within the insertion tube.

[0093] In other embodiments, the distal end of the reinforcement element is fixed within the insertion tube along the length of the insertion tube. For example, the distal end of the reinforcement element may be fixed at an appropriate position at the distal end of the insertion tube.

[0094] The reinforcement element may be composed of a uniform material having the same elastic modulus over substantially the entire length of the reinforcement element. In some embodiments where the reinforcement element does not extend over substantially the entire length of the insertion tube, this results in a stepwise stiffness along the length of the insertion tube. That is, a first stiffness at a first portion 916 having the reinforcement element and a second stiffness at a second portion 917 not having the reinforcement element.

[0095] Referring to FIG. 19, a cross-section of an insertion tube with a tapered reinforcement element 918 is shown. This results in a stepwise stiffness along the length of the insertion tube.

[0096] FIGS. 20A-E show examples of various cross-sectional shape options for the reinforcement element. In some embodiments, one shape is used over a first length portion of the reinforcement element and a second different shape is used over a second length portion of the reinforcement element. This configuration results in a stiffness that varies stepwise along the length of the insertion tube. In some examples, three or more different cross-sectional shapes may be used along the length of the reinforcement element.

[0097] In other embodiments, an asymmetric cross-sectional shape may be used to provide a tendency to bend in a particular direction.

[0098] Furthermore, by varying the asymmetric cross-sectional shape along the length of the reinforcement device, it is possible to change in which direction the insertion tube is more likely to bend at different positions along the length of the insertion tube.

[0099] Referring to FIG. 21, an insertion tube with a reinforcing element having a uniform cross-sectional shape is shown, where one or more materials with different elastic moduli are used along the length of the reinforcing element. In other words, a first material having a first elasticity is used over a first length portion 932 of the reinforcing element. A second material having a second elasticity is used over a second length portion 934 of the reinforcing element. The second elasticity is different from the first elasticity. In some examples, three or more materials with different elasticities may be used along the length of the reinforcing element.

[0100] In some examples, the reinforcing element is composed of a uniform material having substantially the same elastic modulus and cross-sectional shape over its entire length, but terminates in front of the distal end of the insertion tube to provide a fixed but stepped 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 over its length, but the cross-sectional shape (see FIGS. 20A - E) varies along its length to provide a fixed but stepped stiffness along the length of the insertion tube.

[0102] In yet another example, the reinforcing element is composed of a uniform material having the same elastic modulus along its longitudinal direction, but the cross-sectional shape is asymmetric with respect to the cross-section. This results in a biased bending stiffness in different directions along the length of the insertion tube.

[0103] In other embodiments, the reinforcing element has a uniform cross-sectional shape, but one or more materials with different elastic moduli are used along the length of the reinforcing element to provide a fixed but stepped stiffness along the length of the insertion tube.

[0104] In some embodiments, the reinforcing element is removable from the insertion tube. In these embodiments, depending on the patient and the procedure being performed, reinforcing elements with various different characteristics as described above can be used with the same insertion tube.

[0105] After the method described in connection with FIG. 11, the reinforcing element can be inserted into the insertion tube either before or after cutting the insertion tube to the desired length. The proximal end of the reinforcing element may be fixed to the disposable shaft assembly after at least a portion of the reinforcing element has been inserted into the insertion tube.

[0106] As will be appreciated by those skilled in the art, this continuous manufacturing technique for the insertion tube avoids the labor-intensive and time-consuming batch processes currently used to form the individual sections of the endoscopic shaft. The applicant is confident that this can thereby reduce the manufacturing cost of the endoscopic shaft assembly and / or improve the production rate.

[0107] Although the present disclosure has been illustrated and described in detail in the drawings and foregoing description, it should be regarded as illustrative and not restrictive. It is understood that only the preferred embodiments have been shown and described, and it is desired that all changes, equivalents, and modifications included within the spirit of the disclosure defined by the following claims be protected. All publications, patents, and patent applications cited herein are hereby incorporated by reference in their entirety as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated by reference and were set forth herein in its entirety. Clause

[0108] In the following numbered clauses, specific embodiments that may be helpful in understanding the present disclosure are described.

[0109] Clause 1: A method of manufacturing a flexible endoscopic shaft assembly, comprising a proximal insertion tube and a distal articulation section, the proximal insertion tube comprising two or more pull wires, an outer coil, an outer braid, and an outer smooth sheath, each disposed within a concentric compression coil, the outer coil being made in a continuous process and the outer braid being formed using individual wires in a continuous process.

[0110] Clause 2: The method according to clause 1, further comprising the step of advancing the braided assembly through the opening of the die of the extrusion mold to continuously form an outer sheath on the braided assembly in a reel-to-reel process.

[0111] Clause 3: The method according to clause 2, further comprising two or more extruders for supplying resin to the extrusion die, wherein the plurality of extruders supply resins of different durometers, and the rigidity of the shaft can be changed by supplying resins of different durometers, and a marker or unique identifier for specifying the cutting position is applied to the shaft, and the desired rigidity is provided in two or more segments of the shaft after being cut.

[0112] Clause 4: A method for manufacturing at least a part of a flexible endoscope shaft, comprising the step of forming a continuous first length portion, a second length portion, and a third length portion of an outer coil using a continuous wire coil, wherein a first period is defined by forming the first length portion, a second period is defined by forming the second length portion, and a third period is defined by forming the third length portion, and further comprising the step of forming an outer braid around the outer coil along the first length portion during the second period to create a braided assembly.

[0113] Clause 5: The method according to clause 4, comprising the step of disposing two or more pull wires, each located within a concentric compression coil, within the outer coil.

[0114] Clause 6: The method according to any one of the above clauses, wherein the flexible endoscope shaft comprises a distal articulation portion extending distally from the proximal insertion tube.

[0115] Clause 7: The method according to any one of the above clauses, wherein the outer braid is formed of individual wires.

[0116] Clause 8: The method according to any one of the above clauses, comprising the step of advancing the braided assembly through the opening of the die of the extrusion mold during the third period.

[0117] Clause 9: The method according to any one of the above clauses, comprising the step of forming an outer braid around the outer coil along the second length portion during the third period.

[0118] Clause 10: The method according to any one of the above clauses, further comprising the step of applying resins of different durometers along the first length portion.

[0119] Clause 11: The method according to any one of the above clauses, comprising the step of applying an identifier identifying a cutting position to the assembly.

[0120] Clause 12: The method according to any one of the above clauses, wherein a length portion of the assembly having resins of different durometers does not include an identifier.

[0121] Clause 13: A method of manufacturing at least a part of a disposable shaft assembly of an endoscope, inserting a reinforcing element into an insertion tube formed by a continuous process, the continuous process including forming continuous first, second, and third length portions of an outer coil using a continuous wire coiler, wherein a first period is defined by forming the first length portion, a second period is defined by forming the second length portion, and a third period is defined by forming the third length portion, and the continuous process further includes forming an outer braid around the outer coil along the first length portion during the second period to create a braid assembly, and forming an outer sheath around the braid assembly along the first length portion during the third period to create an insertion tube, fixing the reinforcing element to a part of the disposable shaft assembly, and a method including the above steps.

[0122] Clause 14: The method according to Clause 13, wherein after the step of fixing the reinforcing element to a part of the disposable shaft assembly, the reinforcing element extends substantially over the entire cut length of the insertion tube.

[0123] Clause 15: The step of fixing the reinforcing element to a part of the disposable shaft assembly includes fixing the proximal end of the reinforcing element to a part of the housing of the disposable shaft assembly, and the method according to any one of Clauses 13 to 14.

[0124] Clause 16: The step of fixing the reinforcing element to a part of the disposable shaft assembly includes fixing the proximal end of the reinforcing element to the proximal end of the insertion tube, and the method according to any one of Clauses 13 to 15.

[0125] Clause 17: After the step of inserting the reinforcing element into the insertion tube, the distal end of the reinforcing element is freely movable within the insertion tube, and the method according to any one of Clauses 13 to 16.

[0126] Clause 18: The fixing step includes fixing the distal end of the reinforcing element to a part of the insertion tube, and the method according to any one of Clauses 13 to 17.

[0127] Clause 19: The fixing step includes fixing the distal end of the reinforcing element to the distal portion of the insertion tube, and the method according to any one of Clauses 13 to 18.

[0128] Clause 20: The reinforcing element is composed of a uniform material having a constant cross-sectional shape over substantially the entire length of the reinforcing element, The reinforcing element terminates in front of the distal end of the insertion tube after the step of fixing the reinforcing element to a part of the disposable shaft assembly, and the method according to any one of Clauses 13 to 19.

[0129] Clause 21: The method according to any one of Clauses 13 to 20, wherein the reinforcing element includes a first length portion and a second length portion, the reinforcing element is composed of a uniform material over the first length portion and the second length portion of the reinforcing element, the reinforcing element includes a first cross-sectional shape along the first length portion and a second cross-sectional shape along the second length portion, and the first cross-sectional shape is different from the second cross-sectional shape.

[0130] Clause 22: The method according to any one of Clauses 13 to 20, wherein the reinforcing element is composed of a uniform material and a cross-sectional shape over substantially the entire length of the reinforcing element, and the cross-sectional shape is asymmetric.

[0131] Clause 23: The method according to any one of Clauses 1 to 20, wherein the reinforcing element includes a first length portion and a second length portion, the first length portion is composed of a first material, the second length portion is composed of a second material, and the first material has an elastic modulus different from that of the second material.

[0132] Clause 24: A disposable shaft assembly of an endoscope assembly, An insertion tube having an outer coil, a braided sleeve, and an outer sheath, and having a length portion, wherein the braided sleeve surrounds the outer coil, and the outer sheath surrounds the braided sleeve and the outer coil, the insertion tube; A reinforcing element extending over at least a part of the length portion of the insertion tube, wherein a proximal end of the reinforcing element is fixed to a proximal end of the insertion tube, the reinforcing element; A disposable shaft assembly comprising.

[0133] Clause 25: The disposable shaft assembly according to Clause 24, wherein the reinforcing element extends over substantially the entire length of the insertion tube.

[0134] Clause 26: The disposable shaft assembly according to any one of Clauses 24 to 25, wherein the reinforcing element is fixed to a part of the housing of the disposable shaft assembly using an adhesive.

[0135] Clause 27: The disposable shaft assembly according to any one of Clauses 24 to 26, wherein the reinforcing element is fixed to the proximal end of the insertion tube.

[0136] Clause 28: The disposable shaft assembly according to any one of Clauses 24 to 27, wherein the distal end of the reinforcing element is freely movable within the insertion tube.

[0137] Clause 29: The disposable shaft assembly according to any one of Clauses 24 to 28, wherein the distal end of the reinforcing element terminates near the distal end of the insertion tube.

[0138] Clause 30: The disposable shaft assembly according to any one of Clauses 24 to 29, wherein the distal end of the reinforcing element terminates near the articulation link of the disposable shaft assembly.

[0139] Clause 31: The disposable shaft assembly according to any one of Clauses 24 to 30, wherein the reinforcing element is composed of a uniform material and cross-sectional shape over substantially the entire length of the reinforcing element, and the reinforcing element terminates near the distal end of the insertion tube.

[0140] Clause 32: The disposable shaft assembly according to any one of Clauses 24 to 30, wherein the reinforcing element includes a first length portion and a second length portion, the reinforcing element is composed of a uniform material over the first length portion and the second length portion of the reinforcing element, the reinforcing element includes a first cross-sectional shape over the first length portion and a second cross-sectional shape over the second length portion, and the first cross-sectional shape is different from the second cross-sectional shape.

[0141] Clause 33: The reinforcing element is composed of a uniform material and cross-sectional shape over substantially the entire length of the reinforcing element, and the cross-sectional shape is asymmetric, the disposable shaft assembly according to any one of Clauses 24 to 30.

[0142] Clause 34: The reinforcing element includes a first length portion and a second length portion, the first length portion is composed of a first material, the second length portion is composed of a second material, and the first material has an elastic modulus different from that of the second material, the disposable shaft assembly according to any one of Clauses 24 to 30.

Claims

1. A method of manufacturing at least a part 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 including using a continuous wire coil to form a continuous first length portion, a second length portion, and a third length portion of an outer coil, a first period being defined by forming the first length portion, a second period being defined by forming the second length portion, a third period being defined by forming the third length portion, the continuous process further including forming an outer braid around the outer coil along the first length portion during the second period to create a braid assembly, and forming an outer sheath around the braid assembly along the first length portion during the third period to create an insertion tube; fixing the reinforcing element to a part of the disposable shaft assembly; A method comprising the above steps.

2. The method according to claim 1, wherein after the step of fixing the reinforcing element to a part of the disposable shaft assembly, the reinforcing element extends substantially over the entire cut length of the insertion tube.

3. The method according to claim 1, wherein the step of fixing the reinforcing element to a part of the disposable shaft assembly includes fixing the proximal end of the reinforcing element to a part of the housing of the disposable shaft assembly.

4. The method according to claim 1, wherein the step of fixing the reinforcing element to a part of the disposable shaft assembly includes fixing the proximal end of the reinforcing element to the proximal end of the insertion tube.

5. The method according to claim 1, wherein after the step of inserting the reinforcing element 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 the fixing step includes fixing the distal end of the reinforcing element to a part of the insertion tube.

7. The method according to claim 1, wherein the fixing step includes fixing the distal end of the reinforcing element to the distal portion of the insertion tube.

8. The reinforcing element is composed of a uniform material having a constant cross-sectional shape over substantially the entire length of the reinforcing element. The method according to claim 1, wherein the reinforcing element terminates in front of the distal end of the insertion tube after the step of fixing the reinforcing element to a part of the disposable shaft assembly.

9. The method according to claim 1, wherein the reinforcing element includes a first length portion and a second length portion, the reinforcing element is composed of a uniform material over the first length portion and the second length portion of the reinforcing element, the reinforcing element includes a first cross-sectional shape along the first length portion and a second cross-sectional shape along the second length portion, and the first cross-sectional shape is different from the second cross-sectional shape.

10. The method according to claim 1, wherein the reinforcing element is composed of a uniform material and cross-sectional shape over substantially the entire length of the reinforcing element, and the cross-sectional shape is asymmetric.

11. The method according to claim 1, wherein the reinforcing element includes a first length portion and a second length portion, the first length portion is composed of a first material, the second length portion is composed of a second material, and the first material has an elastic modulus different from that of the second material.

12. A disposable shaft assembly of an endoscope assembly, An insertion tube having an outer coil, a braided sleeve, and an outer sheath, and having a length portion, wherein the braided sleeve surrounds the outer coil, and the outer sheath surrounds the braided sleeve and the outer coil, A reinforcing element extending over at least a part of the length portion of the insertion tube, wherein the proximal end of the reinforcing element is fixed to the proximal end of the insertion tube, A disposable shaft assembly comprising:

13. The disposable shaft assembly according to claim 12, wherein the reinforcing element extends over substantially the entire length of the insertion tube.

14. The disposable shaft assembly according to claim 12, wherein the reinforcing element is fixed to a part of the housing of the disposable shaft assembly using an adhesive.

15. The disposable shaft assembly according to claim 12, wherein the reinforcing element is fixed to the proximal end of the insertion tube.

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

17. The disposable shaft assembly according to claim 12, wherein the distal end of the reinforcing element terminates near the distal end of the insertion tube.

18. The disposable shaft assembly according to claim 12, wherein the distal end of the reinforcing element terminates near the articulation link of the disposable shaft assembly.

19. The disposable shaft assembly according to claim 12, wherein the reinforcing element is composed of a uniform material and cross-sectional shape over substantially the entire length of the reinforcing element, and the reinforcing element terminates near the distal end of the insertion tube.

20. The disposable shaft assembly according to claim 12, wherein the reinforcing element includes a first length portion and a second length portion, the reinforcing element is composed of a uniform material over the first length portion and the second length portion of the reinforcing element, the reinforcing element includes a first cross-sectional shape over the first length portion and a second cross-sectional shape over the second length portion, and the first cross-sectional shape is different from the second cross-sectional shape.

21. The disposable shaft assembly according to claim 12, wherein the reinforcing element is composed of a uniform material and cross-sectional shape over substantially the entire length of the reinforcing element, and the cross-sectional shape is asymmetric.

22. The disposable shaft assembly according to claim 12, wherein the reinforcing element includes a first length portion and a second length portion, the first length portion is composed of a first material, the second length portion is composed of a second material, and the first material has an elastic modulus different from that of the second material.

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