Method for fixing a wire portion of an endoscope and endoscope

Abstract

A method for fixing a wire portion of an endoscope, the method comprising: pulling a fourth wire portion to tension the manipulation wire; positioning a second wire portion and a third wire portion adjacent to each other; applying an adhesive to at least one of the second wire portion and the third wire portion; positioning the crimping member near the second wire portion and the third wire portion; and applying a crimping force to the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive. An endoscope having: a manipulation wire having a first wire portion, a second wire portion, and a third wire portion; an adhesive provided on at least one surface of at least one of the second wire portion and the third wire portion; and a crimped crimping member forming a crimp that at least partially encapsulates at least a portion of the second wire portion, the third wire portion, and the adhesive.

Description

Technical Field

[0001] The present invention relates to a method for fixing a wire portion of an endoscope for lung exploration, and to an endoscope in which the tension of a manipulation wire is maintained. Background Art

[0002] An endoscope is a well-known device for visually examining parts of a human or animal body that may be difficult to access, such as body cavities of a human body. Typically, an endoscope includes an elongated insertion tube that has a handle at its proximal end as viewed from the operator, and a visual inspection device (e.g., a built-in camera) at the distal end of the elongated insertion tube. This definition of the terms far and near is used throughout this specification, i.e., near is the end closest to the operator, and far is the end furthest from the operator, as generally used herein for an endoscope. Electrical wiring for a camera and other electronic devices (e.g., LED lighting) typically extends along the inside of the elongated insertion tube from the handle to the tip at the distal end. Instead of using a camera, an endoscope can also be fiber optic, in which case the optical fibers typically extend along the inside of the elongated insertion tube. A working channel can extend along the inside of the insertion tube from the handle to the tip, for example, to allow removal of fluid from the body cavity or to allow surgical instruments, etc. to be inserted into the body cavity.

[0003] In order to be able to manipulate a camera, etc. of an endoscope within a body cavity, the distal end of the endoscope can also include a section with increased flexibility, in particular a hinged or bendable tip portion to allow the operator to bend this section and thereby move the camera. Typically, manipulation is performed by tensing or relaxing a manipulation wire in a guide tube that also extends along the inside of the elongated insertion tube from the hinged tip portion to a control element, which has an operating member that is located in the handle in an arrangement commonly referred to as a Bowden cable (see Bowden's original patent US-A-609570).

[0004] A manipulation wire that extends along the inside of a guide tube in a Bowden cable arrangement typically extends a predetermined length at each end, so as to allow the operating member to be attached to the free (proximal) end of the wire, and to allow the member to be operated to be attached to the other free (distal) end. When the two ends of the guide tube are held stationary, movement of the proximal end of the manipulation wire relative to the guide tube is transmitted to the distal end, resulting in a corresponding movement of the distal end of the manipulation wire relative to the guide tube, thereby affecting the movement of the operating member. Fixing the proximal end of the guide tube to the operating handle is typically achieved by mechanical means, where the guide tube is clamped, terminated in a stop member, or adhered to the operating handle.

[0005] In order for the operator to have a good and responsive experience in controlling the endoscope, the amount of play experienced by the operator should be as small as possible. The amount of play can depend on many factors, including the tension and friction of the wire.

[0006] In order to achieve a suitable tension of the control wire, the wire is usually maintained in a pre-tensioned state. However, if the maintained tension of the control wire is too large, the manipulable tip may be non-straight, or the mechanical parts of the endoscope may be damaged. On the other hand, if the tension of the control wire is too small, the control wire will have too much play and will be partially or completely unresponsive to the operator's control. Therefore, the tension of the control wire is usually adjusted before fixing the control wire, and fixing the control wire ensures the maintenance of the tension.

[0007] When fixing the control wire in the endoscope, it is desirable to provide a crimping portion that can resist a sufficiently large separating force. The separating force is understood as the force that attempts to break the attachment between the crimping portion and the wire by pulling the portion of the wire on one side of the crimping portion away from the portion of the wire on the other side of the crimping portion. The yield separating force is the separating force required to break the attachment between the crimping portion and the wire. In the present specification, this is also expressed as the yield strength of the crimping portion.

[0008] It is known from the prior art that, for example, in WO 2016 / 188537 A1, the control wire is fixed in the endoscope by crimping the control wire onto itself. SUMMARY OF THE INVENTION

[0009] Against this background, an object of the present invention is to provide an improved endoscope, preferably a disposable endoscope, and an improved method for fixing the wire portion of an endoscope. This object can be achieved by the first aspect and the second aspect of the present invention.

[0010] The first aspect of the present invention relates to a method for fixing a wire portion of an endoscope, the method comprising the following steps:

[0011] a) providing:

[0012] - an operating handle;

[0013] - an insertion tube having a proximal end and a distal end and having a manipulable tip at the distal end;

[0014] - a control element movable relative to the operating handle;

[0015] - a manipulable wire having a first wire portion, a second wire portion, a third wire portion, and a fourth wire portion, the first wire portion being connected to the manipulable tip, the second wire portion being located between the first wire portion and the third wire portion, the third wire portion being located between the second wire portion and the fourth wire portion; and

[0016] - a crimping member;

[0017] b) pulling the fourth wire portion to tension the control wire;

[0018] c) Position the second wire portion and the third wire portion adjacent to each other;

[0019] d) Apply an adhesive to at least one of the second wire portion and the third wire portion;

[0020] e) Position the crimping member near the second wire portion and the third wire portion; and

[0021] f) After steps c), d), and e), apply a crimping force to the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive.

[0022] The method according to the first aspect of the present invention may alternatively be provided as a method for fixing a wire portion in a set of parts of an endoscope, the method comprising the following steps:

[0023] a) Provide:

[0024] - An operating handle;

[0025] - An insertion tube having a proximal end and a distal end and having a manipulable tip at the distal end;

[0026] - A control element movable relative to the operating handle;

[0027] - A manipulable wire having a first wire portion, a second wire portion, a third wire portion, and a fourth wire portion, the first wire portion being connected to the manipulable tip, the second wire portion being between the first wire portion and the third wire portion, the third wire portion being between the second wire portion and the fourth wire portion; and

[0028] - A crimping member;

[0029] b) Pull the fourth wire portion to tension the manipulable wire;

[0030] c) Position the second wire portion and the third wire portion adjacent to each other;

[0031] d) Apply an adhesive to at least one of the second wire portion and the third wire portion;

[0032] e) Position the crimping member near the second wire portion and the third wire portion; and

[0033] f) After steps c) and d), apply a crimping force to the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive.

[0034] The method according to the first aspect of the present invention can alternatively be provided as a method for fixing a wire portion of an endoscope, the method comprising the following steps:

[0035] a) Providing:

[0036] - An operating handle;

[0037] - An insertion tube having a proximal end and a distal end and having a steerable tip at the distal end;

[0038] - A control element movable relative to the operating handle;

[0039] - A steerable wire having a first wire portion, a second wire portion, a third wire portion, and a fourth wire portion, the first wire portion being connected to the steerable tip, the second wire portion being located between the first wire portion and the third wire portion, and the third wire portion being located between the second wire portion and the fourth wire portion; and

[0040] - An attachment member;

[0041] c) Positioning the second wire portion and the third wire portion adjacent to each other;

[0042] d) Applying an adhesive to at least one of the second wire portion and the third wire portion;

[0043] e) Positioning the attachment member near the second wire portion and the third wire portion; and

[0044] f) After steps c), d), and e), applying the attachment member to fix the second wire portion and the third wire portion relative to each other, the attachment member at least partially encapsulating at least a portion of the adhesive.

[0045] The method according to the first aspect of the present invention can alternatively be provided as a method for fixing a wire portion in a set of parts of an endoscope, the method comprising the following steps:

[0046] a) Providing:

[0047] - An operating handle;

[0048] - An insertion tube having a proximal end and a distal end and having a steerable tip at the distal end;

[0049] - A control element movable relative to the operating handle;

[0050] - A steerable wire having a first wire portion, a second wire portion, a third wire portion, and a fourth wire portion, the first wire portion being connected to the steerable tip, the second wire portion being located between the first wire portion and the third wire portion, and the third wire portion being located between the second wire portion and the fourth wire portion; and

[0051] - Attachment member;

[0052] c) Position the second wire portion and the third wire portion adjacent to each other;

[0053] d) Apply an adhesive to at least one of the second wire portion and the third wire portion;

[0054] e) Position the attachment member near the second wire portion and the third wire portion; and

[0055] f) After steps c) and d), apply the attachment member to fix the second wire portion and the third wire portion relative to each other, the attachment member at least partially encapsulating at least a portion of the adhesive.

[0056] In the prior art, steel is typically used as the control wire material. Steel control wires can achieve an appropriate crimp yield strength and an acceptable amount of friction. It has been recognized that, among other factors, the yield strength of the crimp depends on the friction of the wire, where high friction of the wire provides high yield strength to the crimp. The surface friction of steel control wires is typically high, which results in a high crimp yield strength. However, there is a risk of creating an electrical connection between the operating handle and the manipulable tip of the insertion tube with steel control wires.

[0057] It has also been recognized that the amount of friction of the control wire, and thus the amount of play, depends on the friction between the control wire and the guide tube or a similar object in which the control wire is guided. As the friction of the control wire increases, the amount of play also increases. Therefore, in order to achieve smooth control of the manipulable tip, it has been recognized that the coefficient of friction of the control wire should be low. However, if a wire with a lower surface friction is used, the yield strength of the crimp may potentially be reduced to an inappropriate level.

[0058] Surprisingly, it has been found that even with an adhesive having poor shear adhesion, the method according to the present invention can still significantly increase the yield separation force of the crimp connection. Therefore, the method according to the present invention can allow the use of a wider range of control wire materials, including polymeric plastics. In addition, the same tensioning method can be used for steel control wires. In addition, tests have shown that an endoscope manufactured according to the present invention can resist aging, thereby obtaining a satisfactory shelf life.

[0059] The term "endoscope" can be defined as a device adapted to examine natural and / or artificial body openings, such as examining the lung cavity. Additionally or alternatively, the term "endoscope" can be defined as a medical device.

[0060] The term "control wire" can be defined as an elongated member adapted to control a manipulable tip portion by a control element and may for this purpose be defined as part of a cable drive or Bowden cable arrangement. The control wire can further be tensionable. The term "control wire" can include one or more of the group consisting of: wire, rope, filament, string, cord, wire rope, standard wire rope, cable, and fishing line. Additionally or alternatively, the control wire can be a single-strand, monofilament, multi-strand, or multifilament structural wire. A multi-strand wire can also be referred to as a wire rope. In the case of a multi-strand wire, the strands can be braided, knotted, woven, coiled, or wrapped.

[0061] The control wire can include metal, possibly steel. The control wire can include the following, preferably consisting essentially of: polymer or plastic polymer or a polymer combination suitable for use as a wire. Alternatively or additionally, the control wire can include one or more materials selected from the group consisting of: metal, steel, carbon steel, non-alloy carbon steel, non-alloy carbon steel with a carbon content of 0.3% to 1%, polymer, plastic polymer, polyethylene (PE), polyamide (PA), polyamide-imide (PAI), ultra-high molecular weight polyethylene (UHMWPE), high-density polyethylene (HDPE), low-density polyethylene (LDPE), high molecular weight polyethylene (HMWPE), natural fiber, man-made fiber, glass fiber, and carbon fiber. The control wire can consist essentially of one or more of the above materials. In the case of a plastic polymer, such as PE, the fiber can be gel spun. The plastic polymer can be defined as a synthetic plastic polymer, such as PE. Examples of suitable wires include wires containing fibers sold under the Dyneema and Honeywell

[0062] trademarks.

[0063] The control wire can have a diameter less than 1 mm, 0.75 mm, 0.60 mm, 0.40 mm, or 0.30 mm.

[0064] The third wire portion and the fourth wire portion of the control wire can coincide with each other or can be the same wire portion. Alternatively, the third wire portion and the fourth wire portion of the control wire can be provided separately or positioned at a distance from each other.

[0065] During step b) of the method according to the first aspect of the invention, the wire can be tensioned to a first wire tension, and after step f) and / or step g), the tension of the wire can be maintained as a second wire tension. The first wire tension can be substantially the same as the second wire tension. Alternatively, the first wire tension and the second wire tension are different from each other.

[0066] In an endoscope assembled with the method according to the invention, the control element can be configured to allow an operator to control the manipulable tip of the insertion tube via at least one manipulation wire. The control element can allow the manipulable tip to bend in at least one direction, possibly two directions, which two directions may be opposite. The control element can be housed in the operating handle. The control element can include a lever that allows the operator to control the control element. The lever can extend outwards from the control element, possibly through the operating handle. The control element can be in the form of a roller or a roller disc.

[0067] The operating handle can be adapted to allow the operator to grip and operate the endoscope, possibly with one hand. The operating handle can include a handle housing arranged at the proximal end of the insertion tube. The handle housing can house the control element.

[0068] The insertion tube or its distal end can be adapted to be inserted into a body cavity (possibly the lung) through a body opening (possibly the mouth). The body can be a natural and / or artificial body, possibly a human body. The insertion tube can extend from the operating handle towards the distal end of the endoscope.

[0069] The attachment member can be a crimping member.

[0070] The crimping member can be a possibly elongated and / or hollow member adapted for crimping. The crimping member can have a tubular shape or a cylindrical outer shell shape. The crimping member can include a space configured to receive a part, possibly two parts, of the manipulation wire. The outer contour of the cross-sectional shape of the crimping member in a plane orthogonal to its longitudinal axis can be circular or arc-shaped, elliptical, triangular, ellipsoidal, square, rectangular, polygonal, U-shaped, V-shaped, L-shaped, C-shaped, or lenticular, where the lenticular shape can be defined as the combination of two intersecting discs. The crimping member can be open or partially open, for example including a slit extending along the longitudinal axis, or the crimping member can be circumferentially closed.

[0071] The length of the crimping member can be at least 2 mm, 3 mm, 5 mm, 6 mm, or 7 mm. The length of the crimping member can be less than 30 mm, 25 mm, 20 mm, 17 mm, or 15 mm. The length of the crimping member can be 2 - 30 mm, 3 - 25 mm, 5 - 20 mm, 6 - 17 mm, or 7 - 15 mm.

[0072] The crimping member may include one or more materials selected from the group consisting of: metals, steel, aluminum, and titanium, polymers, and plastic polymers. The crimping member may consist essentially of a material selected from this group of materials.

[0073] The term (noun) "crimped portion" may be defined as this part of the crimping member that has deformed after a crimping force has been applied and / or the crimping member after it has deformed. The crimped portion length may be defined as the length of the crimping member that has been crimped. The crimped portion length may be a small fraction of the length of the crimping member.

[0074] The adhesive may be applied as a liquid adhesive, particularly glue, and / or may be a reactive adhesive and / or a chemically curable adhesive, and / or may be transformed from a liquid state to a solid state by a chemical reaction. Such a chemical reaction may be caused by heat, moisture, radiation, and / or pressure. The adhesive may be a one-component adhesive selected from the group consisting of: anaerobic, cyanoacrylate, thermally curable, moisture curable, radiation curable, and silicone adhesives. The cyanoacrylate adhesive may be an ethyl 2-cyanoacrylate adhesive.

[0075] In the method according to the first aspect of the present invention, step b) may include pulling the fourth wire portion to tension the control wire that may be between the first wire portion and the third wire portion.

[0076] Step c) may include positioning the control wire around the wire guide such that the third wire portion is positioned adjacent to the second wire portion.

[0077] The second wire portion and the third wire portion may be positioned adjacent to each other such that they extend substantially parallel to each other.

[0078] The second wire portion and the third wire portion may be positioned such that they extend in opposite, possibly parallel, directions.

[0079] Step d) may include applying the adhesive to at least one of the second wire portion and the third wire portion through an opening or through-hole of the crimping member, possibly a lateral opening or through-hole.

[0080] Step d) may include applying the adhesive directly to at least one of the second wire portion and the third wire portion.

[0081] Step d) may include: indirectly applying the adhesive to at least one of the second wire portion and the third wire portion, possibly by applying the adhesive to the crimping member, possibly to the interior of the crimping member; and then optionally positioning the crimping member near the second wire portion and the third wire portion.

[0082] Step d) may be performed before step e).

[0083] Step e) may include positioning the crimping member near the second wire portion and the third wire portion such that the crimping member at least partially encapsulates the second wire portion and the third wire portion.

[0084] Step e) may include positioning the crimping member near the second wire portion and the third wire portion such that the crimping member abuts at least one of the second wire portion and the third wire portion.

[0085] The term "partially encapsulate" in step f) may alternatively be expressed as partially surround or partially cover.

[0086] Step f) may alternatively be defined as, after steps c) and d), compressing the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive.

[0087] Step f) may include applying a crimping force to and / or compressing the crimping member around at least a portion of the second wire portion and the third wire portion to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive.

[0088] Step f) may include positioning the crimping member between a first tool portion and a second tool portion and then moving the first tool portion and the second tool portion towards each other, thereby applying a crimping force to the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive.

[0089] Step f) may include applying a crimping force to the crimping member by heating or cooling the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive. The crimping member may include a heat-shrinkable material or a cold-shrinkable material.

[0090] The crimp may fix the second wire portion and the third wire portion to each other and / or fix the second wire portion and / or the third wire portion to the crimping member.

[0091] In step e) and / or step f), the crimp may at least partially encapsulate the second wire portion and the third wire portion.

[0092] The steps of the method according to the first aspect of the present invention may be performed in sequence, possibly in the order of a), b), c), d), e), f); in the order of a), c), b), d), e), f); in the order of a), b), c), e), d), f); or in the order of a), c), b), e), d), f). However, steps a)-e) do not have to be performed in sequence. For example, step a) may be performed during step b) and / or step c).

[0093] In some embodiments of the method according to the first aspect of the present invention, the adhesive is curable or coagulable, and the method further comprises the step of: g) allowing the adhesive to harden or coagulate. Preferably, step g) is performed after step f).

[0094] In some embodiments, the method further comprises the step of: h) releasing the fourth wire portion.

[0095] Step h) may be performed after step f), preferably after steps f)-g). Step h) may be performed after steps a)-f), preferably after steps a)-g). In step b) of the method, the pulling can be achieved by applying a tensile force to the fourth wire portion, and in step h), the tensile force can be released.

[0096] In some embodiments, the control wire comprises at least two strands, wherein step d) of the method comprises applying an adhesive to at least one of the second wire portion and the third wire portion such that the adhesive is distributed between at least two strands of the second wire portion and / or the third wire portion. A "strand" may be defined as a wire strand. Additionally or alternatively, a "strand" may be defined as an elongated, filamentous material wire adapted to be connected to other strands, possibly by braiding, kinking, weaving, coiling, or winding, to form a wire.

[0097] The control wire may be a multi-strand wire or a steel wire rope. The wire may be braided, kinked, woven, coiled, or wound. This can reduce the elasticity of the control wire, which may be desirable as it can reduce the amount of play experienced by the operator and can increase the fatigue resistance of the crimp and extend the working life of the endoscope.

[0098] Experiments have shown that the yield strength of the crimp increases particularly when the control wire comprises multiple strands. The currently proposed theory is that applying the adhesive such that it is distributed between the multiple strands and hardens increases the local stiffness of the wire. This can ensure that if the wire is subjected to a separating force, the local stiffness of the wire will increase the yield separating force of the crimp, and thus increase the yield strength of the crimp.

[0099] The control wire may comprise at least 5, 10, 30, 100, or 1000 strands.

[0100] At least one, at least a quarter, at least most, all, or substantially all of these strands of the control wire may comprise one or more materials selected from the group consisting of: metal, steel, polymer, plastic polymer, polyethylene (PE), polyamide (PA), polyamide-imide (PAI), ultra-high molecular weight polyethylene (UHMWPE), high density polyethylene (HDPE), low density polyethylene (LDPE), high molecular weight polyethylene (HMWPE), natural fiber, man-made fiber, glass fiber, and carbon fiber. At least one, at least a quarter, most, or all or substantially all of these strands may consist essentially of one or more of the above materials.

[0101] In some embodiments, step d) of the method according to the first aspect of the invention comprises applying the adhesive, optionally as droplets, as a liquid adhesive, to at least one of the second wire portion and the third wire portion. This can have the advantage of increasing the stiffness of the wire, which in turn can increase the separation force of the crimp connection.

[0102] In addition, or alternatively, step d) of the method comprises applying a volume of the adhesive, optionally as droplets, as a liquid adhesive, to at least one of the second wire portion and the third wire portion, the volume optionally being 0.001 mL - 1 mL, 0.005 mL - 0.5 mL, 0.0075 mL - 0.25 mL, or 0.01 mL - 0.1 mL.

[0103] In some embodiments, step d) of the method according to the first aspect of the invention comprises distributing the adhesive over a length of at least one of the second wire portion and the third wire portion, the length being equal to or greater than the diameter or cross-sectional width of the control wire. This can have the advantage of increasing the stiffness of the wire, which in turn can increase the separation force of the crimp connection. Alternatively or in addition, the length may be at least one fifth, a quarter, half, or the length of the crimp portion. Alternatively or in addition, the length may be at least 1 mm, 2 mm, 3 mm, 4 mm, or 5 mm.

[0104] In some embodiments, step d) of the method according to the first aspect of the invention comprises applying the adhesive at least to the second wire portion and the third wire portion, at least partially between the second wire portion and the third wire portion. This can have the advantage of increasing the stiffness of the wire, which in turn can increase the separation force of the crimp connection. Step d) may comprise applying the adhesive at least to the second wire portion and the third wire portion, at least partially between the second wire portion and the third wire portion.

[0105] In some embodiments, step a) of the method according to the first aspect of the invention further comprises the following steps:

[0106] A crimping tool is provided that includes a first tool portion and a second tool portion. The first tool portion optionally includes at least one protrusion, and / or the second tool optionally includes at least one recess, and the at least one recess preferably corresponds to the at least one protrusion of the first tool portion; and wherein,

[0107] Optionally, in step e), the crimping tool further applies a crimping force by compressing opposite possible sides of the crimping member to provide a crimp portion that fixes the second wire portion and the third wire portion relative to each other, and the crimp portion at least partially encapsulates the second wire portion, the third wire portion, and at least a portion of the adhesive.

[0108] Step e) may include positioning the crimping member between the first tool portion and the second tool portion, and then applying a crimping force by optionally moving the first tool portion and the second tool portion towards each other, whereby the protrusion of the first tool portion moves into the recess of the second tool portion to provide a crimp portion that fixes the second wire portion and the third wire portion relative to each other, and the crimp portion at least partially encapsulates the second wire portion, the third wire portion, and at least a portion of the adhesive.

[0109] In some embodiments, the manipulation wire includes a polymer, possibly a plastic polymer. Thus, the manipulation filament may include one or more materials selected from the group consisting of: polymers, plastic polymers, polyethylene (PE), polyamide (PA), polyamide-imide (PAI), ultra-high molecular weight polyethylene (UHMWPE), high-density polyethylene (HDPE), low-density polyethylene (LDPE), high-molecular weight polyethylene (HMWPE). The manipulation wire may consist essentially of one or more of the materials mentioned later. The advantage of using a polymer material for the manipulation wire may be that the polymer material may have a lower electrical conductivity and a lower coefficient of friction compared to steel. By using a manipulation wire with low or no electrical conductivity, it is easier to provide a configuration of the endoscope that meets the desired electrical safety requirements. By providing a lower coefficient of friction, the moving resistance can be reduced when using a control element to control the endoscope, which can ensure smoother operation of the endoscope.

[0110] Manipulating wires using polymers with low coefficient of friction can be challenging because the manipulation wire is attached to itself through a crimp (which can be generally defined as a friction joint), and the separation force can generally decrease when the coefficient of friction is decreased. Nevertheless, and as described above, applying an adhesive to the crimp connection has been shown to increase the separation force of the crimp, particularly when using polymer manipulation wires, to a level that can exceed that of a crimp of a steel manipulation wire without adhesive, see further below. Particularly in the case of stranded wires, the theory currently proposed is that this technical effect is achieved by increasing the stiffness of that part of the manipulation wire that is located within the crimp, such that a relatively rigid wire portion having a crimp deformation portion that is not easily deflected to match the crimp blocks an attempt to break the crimp connection by pulling the wire portion on one side of the crimp away from the wire portion on the other side of the crimp.

[0111] A second aspect of the invention relates to an endoscope comprising:

[0112] - an operating handle;

[0113] - an insertion tube having a proximal end and a distal end and having a manipulable tip at the distal end;

[0114] - a control element movable relative to the operating handle;

[0115] - a manipulable wire having a first wire portion, a second wire portion, and a third wire portion, the first wire portion being connected to the manipulable tip, the second wire portion being located between the first wire portion and the third wire portion;

[0116] - an adhesive provided on at least one surface of at least one of the second wire portion and the third wire portion; and

[0117] - a crimped crimp member forming a crimp that at least partially encapsulates the second wire portion, the third wire portion, and at least a portion of the adhesive.

[0118] The endoscope according to the second aspect of the invention may alternatively be provided as an endoscope comprising:

[0119] - an operating handle;

[0120] - an insertion tube having a proximal end and a distal end and having a manipulable tip at the distal end;

[0121] - a control element movable relative to the operating handle;

[0122] - A manipulable wire having a first wire portion, a second wire portion, and a third wire portion, the first wire portion being connected to the manipulable tip portion, and the second wire portion being located between the first wire portion and the third wire portion;

[0123] - An adhesive provided on at least one surface of at least one of the second wire portion and the third wire portion; and

[0124] - A crimping attachment member that fixes and at least partially encapsulates the second wire portion, the third wire portion, and at least a portion of the adhesive.

[0125] The crimping portion and the adhesive in combination can fix the second wire portion and the third wire portion relative to each other or both contribute to such fixation.

[0126] An endoscope according to the second aspect of the present invention can be manufactured by the first aspect of the present invention.

[0127] An endoscope according to the second aspect of the present invention can alternatively be provided as a set of parts of an endoscope, the set of parts including:

[0128] - An operating handle;

[0129] - An insertion tube having a proximal end and a distal end and having a manipulable tip portion at the distal end;

[0130] - A control element movable relative to the operating handle;

[0131] - A manipulable wire having a first wire portion, a second wire portion, and a third wire portion, the first wire portion being connected to the manipulable tip portion, and the second wire portion being located between the first wire portion and the third wire portion;

[0132] - An adhesive provided on at least one surface of at least one of the second wire portion and the third wire portion; and

[0133] - A crimped crimping member forming a crimping portion that at least partially encapsulates the second wire portion, the third wire portion, and at least a portion of the adhesive.

[0134] An endoscope according to the second aspect of the present invention can alternatively be provided as a set of parts of an endoscope, the set of parts including:

[0135] - An operating handle;

[0136] - An insertion tube having a proximal end and a distal end and having a manipulable tip portion at the distal end;

[0137] - A control element movable relative to the operating handle;

[0138] - A manipulable wire having a first wire portion, a second wire portion, and a third wire portion, the first wire portion being connected to the manipulable tip portion, and the second wire portion being located between the first wire portion and the third wire portion;

[0139] - An adhesive provided on at least one surface of at least one of the second wire portion and the third wire portion; and

[0140] - An attachment - type attachment member that fixes and at least partially encapsulates the second wire portion, the third wire portion, and at least a part of the adhesive.

[0141] Preferably, the crimping portion and the adhesive cooperate to fix the second wire portion and the third wire portion relative to each other or both contribute to such fixation.

[0142] In some embodiments of the endoscope according to the second aspect of the present invention, the adhesive is provided to:

[0143] - Adhere the crimping portion to at least one of the second wire portion and the third wire portion; and / or

[0144] - Adhere the second wire portion and the third wire portion to each other; and / or

[0145] - Adhere at least two strands of one of the second wire portion and the third wire portion to each other; and / or

[0146] - Adhere the crimping portion to the second wire portion and / or adhere the crimping portion to the third wire portion.

[0147] In some embodiments, the adhesive is a one - component, anaerobic, cyanoacrylate, heat - curable, moisture - curable, radiation - curable, and / or silicone adhesive.

[0148] In some embodiments, the crimping portion includes at least one crimping - portion deformation portion. The crimping - portion deformation portion can be defined as a material section deformed by a pair of protrusions and depressions of a crimping tool. The crimping portion can include at least two, three, or four crimping - portion deformation portions. The crimping tool can include at least the same number of pairs of protrusions and depressions as the number of crimping - portion deformation portions.

[0149] In some embodiments, the manipulable wire includes a polymer, possibly a plastic polymer.

[0150] In some embodiments, the manipulable wire includes at least two strands. These strands can be arranged similar to the embodiments related to strands in the first aspect of the present invention, see above.

[0151] In some embodiments, two or more of these strands of the manipulation wire are braided and / or woven and / or kinked. This can reduce the elasticity of the manipulation wire, which can correspond to a reduced elongation at the same load. This is desirable as it reduces the amount of play experienced by the operator.

[0152] In some embodiments, at least a portion of the adhesive is at least between at least two strands of at least one of the second wire portion and the third wire portion. This can increase the stiffness of the manipulation wire in the crimp and thus increase the separation force required to break the crimp.

[0153] Any one or more of the embodiments relating to the first aspect or the second aspect of the present invention can be combined with any one or more of the embodiments relating to the same aspect or a different aspect. BRIEF DESCRIPTION OF THE DRAWINGS

[0154] Hereinafter, the present invention will be described in more detail with reference to the drawings, in which:

[0155] Figure 1 is a perspective view of the endoscope;

[0156] Figure 2 is Figure 1 an exploded perspective view of the endoscope of

[0157] Figure 3 is a side view schematically showing the operation of the manipulable distal end portion of the endoscope;

[0158] Figure 4a is a schematic view of the crimping tool;

[0159] Figure 4b is a schematic cross-sectional view of the crimping tool;

[0160] Figure 5 is a schematic view of the crimping tool and the crimping member before crimping, where hidden lines are shown as dashed lines;

[0161] Figure 6 is similar to Figure 5 and shows the crimping member after crimping;

[0162] Figure 7a is a schematic cross-sectional view of the crimping member after crimping;

[0163] Figure 7b is Figure 7a another schematic cross-sectional view of the crimping member of

[0164] Figure 8 is a schematic view of a test device for testing the yield separation force of the crimp. DETAILED DESCRIPTION

[0165] Figure 1 Figure 1 shows an endoscope 1 according to an embodiment of the second aspect of the present invention assembled by a method according to an embodiment of the second aspect of the present invention. The endoscope is a medical device adapted to examine natural and / or artificial body openings, such as to explore the lung cavity. Also see Figure 2 , the endoscope 1 includes an operating handle 2, an insertion tube 3, and a control element 4.

[0166] The operating handle 2 is a handle adapted to allow an operator to grasp and operate the endoscope 1 with one hand. The handle housing 21 including two outer shells 21a, 21b houses the control element 4.

[0167] The insertion tube 3 is an elongated member adapted to be inserted into a patient, such as through the patient's mouth into the patient's lung. The insertion tube 3 extends from the operating handle 2 towards the distal end ( Figure 1 right side) of the endoscope 1. The insertion tube 3 has a proximal end 31 which is connected to the handle housing; and a distal end 32; wherein a manipulable tip 33 is located at the distal end 32.

[0168] Also see Figure 2 , the control element 4 is configured to allow the operator to control the manipulable tip 33 of the insertion tube 3 through two control wires 5, 5'. The control element 4 allows the manipulable tip 33 to bend in two directions. The control element 4 includes an operating member 41 to allow the operator to control the control element 4. The operating member 41 is connected to a lever 42 which is connected to the control element 4 and extends outwardly therefrom through the handle housing 21 and is movable relative to the operating handle 2.

[0169] Figure 2 Figure 2 shows Figure 1 a set of parts of the endoscope 1, and further shows that the endoscope includes a first control wire 5 and a second control wire 5', each in the form of a first guide tube and a second guide tube respectively located in a first wire support 6 and a second wire support 6. The apostrophe suffix of the reference numeral indicates an element associated with the second control wire 5' corresponding to a similar element associated with the first control wire 5, for example, the first wire support 6 is associated with the first control wire 5, and the second wire support 6' is associated with the second control wire 5'.

[0170] Each control wire 5, 5' is an elongated braided steel wire rope forming part of a Bowden cable device for controlling the manipulable tip 33 through the control element 4. Each control wire 5, 5' is substantially composed of a plastic polymer in the form of ultra-high molecular weight polyethylene (UHMWPE) polymer. Each control wire 5, 5' has a diameter of approximately 0.25 mm.

[0171] Each control wire 5, 5' has a first wire portion (not shown); a second wire portion 52, 52'; a third wire portion 53, 53'; and a fourth wire portion 54, 54'. The first wire portions are each connected to the manipulable tip portion 33. These wire portions are arranged along each control wire 5, 5' in the order from the first wire portion to the third wire portion, such that starting from the first wire portion and arranged along the corresponding control wire 5, 5', the next wire portion is the second wire portion 52, 52', then the third wire portion 53, 53' and finally the fourth wire portion 54, 54', which terminates at the wire end.

[0172] Each control wire 5, 5' extends from the second wire portion 52, 52', forms a loop 56, 56' and extends back parallel to the second wire portion 52, 52', such that the second wire portion 52, 52' and the third wire portion 53, 53' are positioned adjacent to each other. Adhesives 7, 7' are applied to the second wire portion 52, 52' and the third wire portion 53, 53' before the crimping operation. Two crimping members 8, 8' enclose the corresponding second wire portion 52, 52' and third wire portion 53, 53'.

[0173] The control element 4 has two wire guides (not shown): a first wire guide for receiving the loop 56 of the first control wire 5, and a second wire guide for receiving the loop 56' of the second control wire 5'.

[0174] The lever 42 is attached to the control element 4 and allows the operator to rotate the control element 4 about the axis 43 in a known manner.

[0175] Each crimping member 8, 8' is an elongated and hollow member adapted for crimping. Each crimping member 8, 8' has a cylindrical outer shell shape, and its internal space is configured to receive two portions of the control wires 5, 5'. The outer contour of the cross-sectional shape of each crimping member 8, 8' in a plane orthogonal to its longitudinal axis is circular. The length of each crimping member 8, 8' is approximately 10 mm. Each crimping member 8, 8' is substantially composed of steel.

[0176] The adhesive is a cyanoacrylate adhesive, particularly ethyl 2-cyanoacrylate adhesive, which is a reactive one-component adhesive. When chemically cured, the adhesive changes from a liquid state to a solid state through a chemical reaction caused by moisture, particularly air humidity. This chemical reaction is also known as hardening or solidification.

[0177] Figures 3 to 5 An embodiment of the method according to the present invention is shown, which is used to attach two control wires 5, 5' in the endoscope 1 to allow control of the manipulable tip portion 33 by enabling the control element 4. The method can be provided in a similar manner to attach a single control wire. The guide tubes 6, 6' are schematically shown as a single guide tube 6, 6' in FIG. 4, asFigure 2 As shown, the guide tube includes two separate guide tubes 6, 6'.

[0178] Refer to Figure 3 , and the following method for attaching two control wires 5, 5' is performed:

[0179] First, pass the first control wire 5 through the guide tube 6 and attach it to the manipulable tip 33 such that when pulled, the manipulable tip bends along a first direction 33a, which is shown by a dashed line in Figure 3 . Pass the second control wire 5' through the guide tube 6' and attach it to the manipulable tip 33 such that when pulled, the manipulable tip 33 bends along a second direction 33b, which is shown by a solid line in Figure 3 .

[0180] Second, position the loops 56, 56' of the respective control wires 5, 5' in their corresponding wire guides (not shown) in the control element 4. Then position the second wire portions 52, 52' and the third wire portions 53, 53' adjacent to each other such that they extend in opposite and parallel directions.

[0181] Third, pull the fourth wire portions 54, 54' with a force Ft to tension the control wires 5, 5' to a first wire tension between the first wire portions 51, 51' and the fourth wire portions 54, 54'. Adjust the tension of each wire such that the manipulable tip 33 is straight.

[0182] Fourth, apply the adhesives 7, 7' as liquid adhesive droplets directly onto the lengths of the second wire portions 52, 52' and the third wire portions 53, 53' of each respective control wire 5, 5'. This length is approximately four control wire diameters or approximately 1 mm. Apply the liquid adhesive such that the liquid adhesive is distributed between the strands 55, 55' of the second wire portions 52, 52' and the third wire portions 53, 53', which is shown in more detail in Figures 7a - 7b .

[0183] Refer to Figure 5 , a crimping tool 83 having a first tool portion 84 and a second tool portion 86 is located near the crimping member 8. The crimping tool 83 has multiple pairs of corresponding protrusions 85 and depressions 87, wherein the first tool portion 84 includes one of a pair of corresponding protrusions 85 and depressions 87, and the second tool portion 86 includes the other of this pair of corresponding protrusions 85 and depressions 87, and wherein the multiple pairs are alternately positioned through each tool portion 84, 86 such that the protrusions 85 have adjacent depressions 87 on each side, and the depressions 87 have adjacent protrusions 85 on each side.

[0184] Fifth, as shown in Figure 5As shown for the single crimping member 8, the crimping member 8 is located near the second wire portion 52 and the third wire portion 53 such that the crimping member encapsulates the second wire portion 52, the third wire portion 53, and the adhesive 7.

[0185] Sixth step, move the crimping tool 83 so that the crimping member 8 is located between the first tool portion 84 and the second tool portion 86. See Figure 6 , then, move the first tool portion 84 and the second tool portion 86 towards each other so that the tool portions 84, 86 abut the crimping member 8 and then move further, thereby applying a crimping force to compress the crimping member 8 until the protrusions 85 in a pair project into the corresponding recesses 87 in the pair to provide a crimp portion 81 that fixes the second wire portion relative to the third wire portion. The crimped crimping member 8 encapsulates the second wire portion 52, the third wire portion 53, and the adhesive 7. The crimp portion 81 has a plurality of crimp portion deformation portions 82, each deformation portion being formed by a pair of protrusions 85 and recesses 87. This is Figure 6 As seen for the single crimping member 8 in

[0186] The crimp portion 81 is the portion of the crimping member 8 that is deformed after the crimping force is applied.

[0187] Seventh step, allow the adhesive 7 to harden to maintain the tension of the wire 5 as the second wire tension. The second wire tension is substantially the same as the first wire tension.

[0188] In Figure 7a and Figure 7b a crimping member 8 manufactured according to the above method is shown, the crimping member having a crimp portion 81 that encapsulates the second wire portion 52 and the third wire portion 53 of the single control wire 5. The second wire portion 52 is located above the third wire portion 53, and droplets of the adhesive 7 are located and distributed between the strands 55 of the control wire inside the crimp portion. The adhesive 7 is positioned such that:

[0189] - adheres the second wire portion 52 and the third wire portion 53 to each other; and

[0190] - adheres the multiple strands of both the second wire portion 52 and the third wire portion 53 to each other; and

[0191] - adheres the crimp portion 81 to the second wire portion 52 and adheres the crimp portion 81 to the third wire portion 53.

[0192] Experiment

[0193] Experiments were carried out to measure the yield separation force of the crimp portion. As Figure 8As shown, multiple test samples are provided. One test sample includes a single control wire, wherein the right half 5 forms a right loop 56 that defines the right eye, and the left half 5' forms a left loop 56' that defines the left eye. The right half 5 and the left half 5' of the control wire are crimped at the right crimping portion 81 and the left crimping portion 81' according to the method described in combination Figure 3 described, and thus cyanoacrylate is applied as an adhesive within the crimping portions 81, 81', as described above.

[0194] Test samples including steel wires and polymer wires were tested. Table 1 below describes the items used.

[0195] Table 1: List of Items

[0196]

[0197] The yield separation force between the crimping portion and the wire was measured by applying a first tensile force F1 to the right eye of the test sample and a second tensile force F2 to the left eye of the test sample. The first tensile force F1 and the second tensile force F2 extend in parallel and opposite directions. The speed for pulling the test sample was 25 mm / min. Then the separation force was measured.

[0198] Four experiments were conducted, and each experiment was repeated 8 - 12 times. The yield separation forces for each repetition in these experiments are listed in Tables 2 and 3, in units of Newton (N). Each row corresponds to the number of single repetitions of the corresponding experiment. The last row is the average result of all repetitions of that experiment.

[0199] The variables in these experiments are whether an adhesive is applied and the material of the control wire.

[0200] The first experiment and the second experiment shown in Table 2 were performed using steel control wires, wherein, in the first experiment, the steel wires 5, 5' and there is no adhesive in the crimping portions 81, 81', and wherein, in the second experiment, the same type of steel wire is used and there is a hardened cyanoacrylate adhesive in the crimping portions 81, 81'.

[0201] Table 2: Columns 1 and 2 relate to experiments with steel wires and no adhesive in the crimping portion. Columns 3 and 4 relate to experiments with steel wires and a cyanoacrylate (CA) adhesive in the crimping portion.

[0202]

[0203]

[0204] The third and fourth experiments shown in Table 3 were performed using polymer manipulation wires, in particular braided ultra-high molecular weight polyethylene (UHMWPE) wire ropes. The third experiment was with the same type of polymer wire ropes 5, 5' and without an adhesive in the crimp portions 81, 81'. The fourth experiment was with the same type of polymer wire ropes 5, 5' as in the previous experiments, this time with a hardened cyanoacrylate adhesive in the crimp portions 81, 81'.

[0205] Table 3: Columns 1 and 2 relate to experiments with braided UHMWPE wire ropes and without an adhesive in the crimp portion. Columns 3 and 4 relate to experiments with the same type of braided UHMWPE wire ropes and with a cyanoacrylate (CA) adhesive in the crimp portion.

[0206]

[0207] In Table 4 below, the results are summarized. From these results, it can be seen that the yield separation force increases significantly when an adhesive is applied to the crimp portion. This effect is extremely significant for polymer wires, where these experiments show that the yield separation force is three times greater when an adhesive is used. In fact, the yield separation force of polymer wires with an adhesive is greater than that of steel wires with or without an adhesive.

[0208] Table 4: For the steel wire in row 2 and the polymer wire in row 3, the yield separation force increases in column 2 in Newtons and in column 3 in percentage. Based on the results of the experiments in Table 2 and Table 3.

[0209]

[0210] List of reference numerals

[0211] 1 Endoscope

[0212] 2 Operating handle

[0213] 21 Handle housing

[0214] 3 Insertion tube

[0215] 31 Proximal end

[0216] 32 Distal end

[0217] 33 Manipulable tip

[0218] 33a First direction

[0219] 33b Second direction

[0220] 4 Control element

[0221] 41 Operating member

[0222] 42 Lever

[0223] Axis 43

[0224] Control wire 5

[0225] First wire part 51

[0226] Second wire part 52

[0227] Third wire part 53

[0228] Fourth wire part 54

[0229] Strand 55

[0230] Ring 56

[0231] Wire support 6

[0232] Adhesive 7

[0233] Crimping member 8

[0234] Crimping part 81

[0235] Crimping part deformation part 82

[0236] Crimping tool 83

[0237] Convex tool part 84

[0238] Protrusion 85

[0239] Concave tool part 86

[0240] Depression 87

Claims

1. A method for fixing a wire portion of an endoscope, the method comprising the following steps: a) providing: - an operating handle; - an insertion tube having a proximal end and a distal end, and having a manipulable tip at the distal end; - a control element movable relative to the operating handle; - a manipulable wire having a first wire portion, a second wire portion, a third wire portion, and a fourth wire portion, the first wire portion being connected to the manipulable tip, the second wire portion being located between the first wire portion and the third wire portion, and the third wire portion being located between the second wire portion and the fourth wire portion; and - a crimping member; b) pulling the fourth wire portion to tension the manipulable wire; c) positioning the second wire portion and the third wire portion adjacent to each other; d) applying an adhesive to at least one of the second wire portion and the third wire portion; e) positioning the crimping member near the second wire portion and the third wire portion; and f) after steps c), d), and e), applying a crimping force to the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating at least a portion of the adhesive.

2. The method according to the above claims, wherein, the adhesive is curable or solidifiable, and the method further comprises the following step: g) allowing the adhesive to harden or solidify.

3. The method according to any one of the above claims, wherein, the manipulable wire comprises at least two strands, and wherein step d) of the method comprises applying an adhesive to at least one of the second wire portion and the third wire portion such that the adhesive is distributed between at least two strands of the second wire portion and / or the third wire portion.

4. The method according to claim 1 or 2, wherein, step d) of the method comprises applying the adhesive as a liquid adhesive to at least one of the second wire portion and the third wire portion.

5. The method according to claim 1 or 2, wherein, step d) comprises distributing the adhesive over a length of at least one of the second wire portion and the third wire portion that is equal to or greater than the diameter or cross-sectional width of the manipulable wire.

6. The method according to claim 1 or 2, wherein, step d) comprises applying the adhesive at least to the second wire portion and the third wire portion, at least partially between the second wire portion and the third wire portion.

7. The method according to claim 1 or 2, wherein, step a) of the method further comprises the following step: providing a crimping tool comprising a first tool portion and a second tool portion, the first tool portion comprising at least one protrusion, and / or the second tool comprising at least one recess; and wherein in step e), the crimping tool applies a crimping force by compressing both sides of the crimping member to provide a crimp that fixes the second wire portion and the third wire portion relative to each other, the crimp at least partially encapsulating the second wire portion and the third wire portion and at least a portion of the adhesive.

8. The method according to claim 1 or 2, wherein, the manipulable wire comprises a plastic polymer.

9. The method according to claim 7, wherein, the at least one recess corresponds to the at least one protrusion of the first tool part.

10. An endoscope, comprising: - an operating handle; - an insertion tube having a proximal end and a distal end and having a manipulable tip at the distal end; - a control element movable relative to the operating handle; - a manipulable wire having a first wire portion, a second wire portion, and a third wire portion, the first wire portion being connected to the manipulable tip, the second wire portion being located between the first wire portion and the third wire portion; - an adhesive provided on at least one surface of at least one of the second wire portion and the third wire portion; and - a crimping member forming a crimping portion that at least partially encapsulates the second wire portion, the third wire portion, and at least a portion of the adhesive.

11. The endoscope according to claim 10, wherein, the adhesive is provided for: - adhering the crimping portion to at least one of the second wire portion and the third wire portion; and / or - adhering the second wire portion and the third wire portion to each other; and / or - adhering at least two strands of one of the second wire portion and the third wire portion to each other; and / or - adhering the crimping portion to the second wire portion and / or adhering the crimping portion to the third wire portion.

12. The endoscope according to claim 10 or 11, wherein, the adhesive is a one-component, anaerobic, cyanoacrylate, thermosettable, moisture-curable, radiation-curable, and / or silicone adhesive.

13. The endoscope according to claim 10 or 11, wherein, the manipulable wire comprises a plastic polymer.

14. The endoscope according to claim 10 or 11, wherein, the manipulable wire comprises at least two strands.

15. The endoscope according to claim 14, wherein, two or more of these strands of the manipulable wire are braided and / or woven and / or kinked.

16. The endoscope according to claim 14, wherein, at least a portion of the adhesive is located at least between at least two strands of at least one of the second wire portion and the third wire portion.

Images