阅读说明：本技术 柔性内窥镜以及制造其的方法 (Flexible endoscope and method of manufacturing the same ) 是由 尼古拉斯·马修·格尔博 乔治·加里·文特雷拉 于 2016-02-26 设计创作，主要内容包括：内窥镜包括手柄,手柄连接到柔性的、可转向的抗扭结的插入管。内窥镜插入管可以包括轴、邻近轴的远端的较低硬度的部分和定位在较低硬度的部分和中间硬度的部分之间的较高硬度的部分。内窥镜插入管还可以包括第四热塑性塑料层压件部分,其邻近轴的近端并具有较高的硬度。制造内窥镜插入管的方法可以包括：将具有一个、两个或更多个侧部狭槽的心轴和衬里插入轴中,其中衬里定位在心轴和轴之间；使衬里的结合部分结合到轴的内表面；使衬里的其它部分与轴隔开；以及将第一偏转丝插入在轴和衬里的未结合部分之间的间隙中。(The endoscope includes a handle connected to a flexible, steerable, kink-resistant insertion tube. The endoscope insertion tube may include a shaft, a lower durometer section adjacent a distal end of the shaft, and a higher durometer section positioned between the lower durometer section and the intermediate durometer section. The endoscope insertion tube may further include a fourth thermoplastic laminate section adjacent the proximal end of the shaft and having a higher durometer. The method of manufacturing an endoscope insertion tube may include: inserting a mandrel having one, two, or more side slots and a liner into the shaft, wherein the liner is positioned between the mandrel and the shaft; bonding the bonding portion of the liner to the inner surface of the shaft; spacing the other portion of the liner from the shaft; and inserting a first deflection wire in a gap between the shaft and the unbonded portion of the liner.)

1. A method of manufacturing an endoscope insertion tube or a component of an endoscope insertion tube, the method comprising:

a. positioning a primary liner on a primary mandrel, the primary mandrel having an hourglass shape and having at least a first slot and a second slot;

b. positioning a secondary liner on each of the at least two secondary mandrels;

c. embedding each of the two secondary mandrels lined with a deflection channel within the first and second slots of the primary mandrel;

d. wherein the primary liner is located between the primary mandrel and the secondary mandrel;

e. braiding a shaft around the primary liner and the secondary mandrel;

f. positioning a plastic laminate on an exterior of the shaft;

g. bonding the primary liner and the portion of the plastic laminate to the shaft;

h. removing the primary mandrel from the primary liner such that the primary liner defines a hollow interior lumen; and

i. removing the secondary mandrel from the deflection channel liner such that the deflection channel liner defines at least two hollow deflection channels positioned within the shaft and outside the inner lumen of the primary liner.

2. A method of manufacturing an endoscope insertion tube or a component of an endoscope insertion tube, the method comprising:

a. positioning at least a portion of a primary mandrel within a primary liner, the primary mandrel having at least a first slot and a second slot;

b. positioning each of at least two secondary mandrels within the first slot and the second slot of the primary mandrel;

c. wherein the primary liner is positioned between the primary mandrel and the secondary mandrel;

d. braiding a shaft around the primary liner and the secondary mandrel, wherein the secondary mandrel is positioned between the primary liner and the braided shaft;

e. securing a portion of the primary liner to the shaft;

f. removing the primary mandrel from the primary liner such that the primary liner defines an inner lumen; and

g. removing the secondary mandrel to form at least two gaps between the shaft and the primary liner.

3. The method of claim 2, further comprising: positioning a plastic housing around at least a portion of the shaft.

4. The method of claim 3, further comprising: positioning a collapsible tube around at least a portion of the plastic housing.

5. The method of claim 2, further comprising: laminating at least two thermoplastic sections around at least a portion of the shaft.

6. The method of claim 5, wherein an end of the first thermoplastic portion at least partially overlaps an end of the second thermoplastic portion.

7. The method of claim 2, further comprising: inserting a deflection wire into each of the at least two gaps.

8. The method of claim 2, further comprising: positioning at least a working channel within the inner lumen of the primary liner.

9. The method of claim 2, further comprising: positioning at least two optical channels within the inner lumen of the primary liner.

10. The method of claim 9, further comprising: positioning at least a portion of at least one light source within at least one of the optical channels and adjacent to the distal end of the shaft; and

positioning at least a portion of at least one image sensor within at least one of the optical channels and adjacent the distal end of the shaft.

11. The method of claim 2, further comprising: a cap is attached to the distal end of the shaft.

12. The method of claim 11, further comprising: attaching the cap to a distal end of at least one deflection wire.

13. The method of claim 2, further comprising: a plastic housing is cast over at least a portion of an outer surface of the shaft.

14. The method of claim 2, wherein the primary mandrel has a width across the at least two slots that is less than a maximum diameter of the primary mandrel.

15. The method of claim 2, wherein the mandrel has a length and the width across the at least two slots, the width at a first point along the length of the mandrel being greater than the width at a second point along the length of the mandrel.

16. The method of claim 2, wherein the primary mandrel has a length and the slot of the primary mandrel has a depth that varies along the length of the primary mandrel.

17. The method of claim 2, wherein the shaft has a first end and a second end and the braid has a variable PIC rate such that the braid is more rigid at the first end than at the second end.

18. The method of claim 2, wherein the shaft has a length and comprises a braided material having a variable PIC rate along the length of the shaft and having first, second, third, and fourth portions corresponding to first, second, third, and fourth portions of thermoplastic laminate laminated to an outer surface of the portion of the shaft, and wherein the first portion of the shaft has a PIC rate different than the PIC rates of the second, third, and fourth portions.

19. A product made according to the method of claim 1.

20. A product made according to the method of claim 2.

Background

The present disclosure relates generally to insertion tubes, and particularly (but not exclusively) to insertion tubes for endoscopes.

Flexible endoscopes are used to navigate, visualize, and manipulate within a variety of complex anatomical structures. Endoscopes can be designed to be strong, flexible, steerable, and pushable and designed to transmit torque. They should be resistant to crushing and kinking. For operation, the endoscope should accommodate the imaging channel and the working channel and deflection wires (deflection wires). Thus, conventional designs are typically small, fragile, and expensive to manufacture and repair, often using expensive materials (e.g., laser cut nitinol hypotube) and complex designs (e.g., riveted rings). Many conventional designs have a relatively high failure rate and are prone to catastrophic failure.

In contrast, the catheter design has a relatively simple structure. Their circular inner diameter is typically maximized to facilitate the flow of irrigation fluid therethrough, and they typically do not have imaging channels or deflection wires within their inner lumen that would impede the flow. To maximize flow in the lumen size and circular inner diameter, conventional catheter designs typically position deflection wires within the catheter wall. To minimize wall thickness and overall outer diameter dimensions, conventional catheters typically employ flat deflection wires. While a flat deflection wire can effectively move a catheter in two dimensions within a plane of motion, the wire will tend to resist movement out of that plane (i.e., in a third dimension), preventing optimal steering and potentially creating a "whipping" effect.

For endoscopes and catheters, a minimum outer diameter is desirable (e.g., to allow for a smaller percutaneous incision or because of anatomical limitations). Both typically have a circular inner diameter or internal lumen.

The following is incorporated herein by reference in its entirety: U.S. patent application publication nos. 2007/0299424, 2010/0056868, 2010/0312056 and 2013/0190561 and U.S. patent nos. 3,521,620, 3,739,770, 4,543,090, 5,176,660, 5,368,564, 5,383,852, 5,472,017, 5,702,433, 5,746,696, 6,991,616, 7,037,290, 7,766,821, 7,803,130, 8,123,721, 8,579,801, 8,721,826 and 8,834,356.

SUMMARY

Conventional endoscope designs are expensive, complex, and have a high failure rate. And when they fail, they may fail catastrophically. There is a need for a simpler, less expensive design with rheological properties that reduces the risk of catastrophic failure.

In one form, the endoscope includes an insertion tube connected to a handle. The endoscope insertion tube may include: a shaft comprising a braided alloy, the shaft having a lumen; an outer surface; an inner surface; a proximal end; and a distal end. The endoscope insertion tube may further include: a thermoplastic laminate laminated to at least a portion of the outer surface of the shaft, wherein the thermoplastic laminate comprises at least two portions. In some embodiments, the thermoplastic laminate may be laminated to at least a portion of the outer surface of the braided tubular shaft. Under normal operating conditions, the laminated braided shaft will be less likely to fail catastrophically.

In some forms, the thermoplastic laminate may include a first portion having a first hardness (durometer), a second portion having a second hardness, a third portion having a third hardness, and a fourth portion having a fourth hardness. Hardness (durometer) is a measure of the hardness (hardness) of a material. The form may further include: wherein at least a portion of the first portion may be adjacent the proximal end of the shaft, and wherein the fourth portion may be adjacent the distal end of the shaft. It may further include: wherein the second portion may be between the first portion and the third portion, and wherein the third portion may be between the second portion and the fourth portion. It may further include: wherein the fourth hardness may be less than the first hardness, the second hardness, and the third hardness. It may further include: wherein the second hardness may be less than the first hardness and the third hardness.

Additionally or alternatively, a liner may be secured to at least a portion of the inner surface of the shaft, wherein an interior of the liner defines a non-circular interior lumen. In some forms, the liner may be laminated to at least a portion of the outer surface of the shaft. It may further include: at least two gaps between the shaft and the liner, wherein the gaps define two deflection channels. In some forms, a deflection channel liner may be disposed within the gap, in which case an interior of the deflection channel liner may define the deflection channel. In the alternative, the gap may not accommodate the deflection channel liner, and the deflection wire may be disposed directly within the gap.

Additionally or alternatively, some versions may include at least two deflection wires, each having a proximal end and a distal end, wherein one deflection wire may be positioned in each of the at least two deflection channels. For example, in some forms, the deflection wire may be positioned within the lumen of the shaft rather than within the wall of the insertion tube shaft or the wall of the plastic housing.

Additionally or alternatively, the working channel may be positioned within the inner lumen. Further, at least two optical channels may be positioned within the inner lumen. At least one light source may be positioned within the optical channel and adjacent to the distal end of the endoscope insertion tube. At least one image sensor may be positioned within the optical channel and adjacent to the distal end of the endoscope insertion tube. In some forms, the image sensor may be an image-passing beam and/or an analog sensor. In additional or alternative forms, the image sensor may generate a digital signal. Further, a cap may be attached to the distal ends of the at least two deflection wires.

Additionally or alternatively, the deflection wire may have a circular cross-section within the intermediate and distal portions of the insertion tube. Whereas flat wires may have a significantly different moment of inertia in their hinge plane compared to outside the plane, round wires do not. The resistance of the flat wire to movement out of its plane of articulation can be felt by the user when the device is deflected, which can produce a "whipping" effect when the insertion tube is realigned with the plane of articulation of the wire. This can be a problem for urology where the physician holds the endoscope vertically and bends the distal end of the insertion tube about 90 degrees into the patient. For example, if the kidney is in the horizontal plane, the endoscope insertion tube may deflect at a position where the moment of inertia is greatest, and unwanted force feedback may be generated when torque is applied to the handle to rotate the insertion tube. However, additionally or alternatively, one or more deflection wires may have a cross-section that may be circular, elliptical, flat, rectangular, or other suitable shape.

The deflection wire may comprise a braided or solid material, such as metal, carbon fiber, synthetic fiber (e.g. metal, carbon fiber) Or other stretch material.

This "whipping" effect can be further reduced by using a shaft made of a braided material. In some forms, the shaft may comprise steel. Additionally or alternatively, the shaft may comprise nitinol. In one embodiment, the shaft does not contain nitinol due to its high cost. However, other embodiments may have a shaft comprising nitinol.

In some forms, the endoscope may include a marker that includes a radiopaque material, and the marker may be positioned adjacent the cap. Additionally or alternatively, the thermoplastic laminate may comprise BaSO₄Or otherwiseRadiolucent material, BaSO₄Or other radiopaque material may make all or part of the insertion tube visible under fluoroscopy.

Additionally or alternatively, the first portion of the thermoplastic laminate may have a first outer diameter and the fourth portion of the thermoplastic laminate may have a fourth outer diameter, and wherein the fourth outer diameter may be less than the first outer diameter. In some forms, the deflection channel is not in fluid communication with the lumen. In the alternative, the deflection channel may be in fluid communication with the lumen.

Additionally or alternatively, a cap may be fixedly attached to the distal end of the shaft, the optical channel, and the working channel. Additionally or alternatively, the cap may be fixedly attached to the deflection wire. In one form, the wires may be attached by welding or by other suitable fixing means.

Additionally or alternatively, the endoscope insertion tube may include a preferential bend portion adjacent a distal end of the endoscope insertion tube. Preferably, the curved portion may comprise a shaft having an outer surface, an inner surface and a distal end. It may further include: at least three thermoplastic laminate sections bonded to at least a portion of the outer surface of the shaft, wherein the thermoplastic laminate sections are a lower durometer section, an intermediate durometer section, and a higher durometer section. It may further include: wherein the lower durometer section may be bonded adjacent the distal end of the shaft and the lower durometer section may have a durometer less than the durometer of the intermediate durometer section and the durometer of the higher durometer section. It may further include: wherein the higher durometer section may be between the lower durometer section and the intermediate durometer section, and the higher durometer section may have a durometer greater than the durometer of the lower durometer section and the intermediate durometer section.

Additionally or alternatively, the angle between the first portion and the third portion may be about 150-. The angle between the third portion and the fully deflected fourth portion may be about 250 degrees or more, more preferably about 300 degrees or more.

Additionally or alternatively, the endoscope insertion tube may include a liner bonded to at least a portion of an inner surface of the shaft, wherein an interior of the liner defines a lumen. It may further include: at least one gap between the shaft and the liner, wherein at least a portion of the gap defines a deflection channel. It may further include: at least one deflection wire positioned in the deflection channel.

Additionally or alternatively, the endoscope insertion tube may include a shaft having an outer surface and an inner surface. It may further include: a liner bonded to at least a portion of the inner surface of the shaft, wherein an interior of the liner defines an interior lumen. It may further include: at least one gap between the shaft and the liner, wherein the gap defines a deflection channel.

Additionally or alternatively, the endoscope insertion tube may include at least one deflection wire positioned in the deflection channel. In one embodiment, the endoscope insertion tube may include only one deflection wire to maximize the space within the lumen. In alternative embodiments, the endoscope insertion tube may include three, four, or more deflection wires to provide additional steering capabilities. In some forms, by placing the deflection wire and/or deflection channel within the inner lumen of the shaft, the wall of the endoscope insertion tube can be made significantly thinner (about 0.2mm) than many conventional catheter designs (about 0.4mm or greater) in which the deflection wire is positioned in the catheter wall.

In some forms, the endoscope insertion tube may include a lower durometer section incorporated adjacent the distal end of the shaft, wherein the lower durometer section may have a durometer less than the durometer of the intermediate durometer section and the durometer of the higher durometer section. It may further include: wherein the higher durometer section may be between the lower durometer section and the intermediate durometer section, and the higher durometer section may have a durometer greater than the durometer of the lower durometer section and the intermediate durometer section.

Additionally or alternatively, the endoscope insertion tube may comprise a fourth thermoplastic laminate section, wherein at least a portion of the fourth thermoplastic laminate section may be adjacent the proximal end of the shaft, wherein the fourth thermoplastic laminate section may have a stiffness greater than the lower stiffness section and the intermediate stiffness section.

Additionally or alternatively, the endoscope insertion tube may comprise: a second gap between the shaft and the liner, wherein the second gap defines a second deflection channel; and a second deflection wire positioned in the second deflection channel.

Additionally or alternatively, the endoscope insertion tube may include a cap attached to a distal end of the at least one deflection wire.

Additionally or alternatively, the endoscope insertion tube may include a marker comprising a radiopaque material, the marker being positioned adjacent to the cap.

Additionally or alternatively, the endoscope insertion tube may include a working channel positioned within the lumen and at least two optical beams.

In another form, a method of manufacturing an endoscope insertion tube may include positioning a first liner over a first mandrel, where the first mandrel may have at least a first slot parallel to a longitudinal axis of the mandrel. It may further include: a second liner is positioned over the second mandrel, wherein the second mandrel may be sized to fit at least partially within the first slot of the first mandrel. It may further include: a second mandrel and a second liner are positioned at least partially within the first slot of the first mandrel.

Additionally or alternatively, the method may include braiding the shaft around the first liner and a second liner, wherein the second liner may be between at least a portion of an inner surface of the shaft and an unbonded portion of the first liner. Additionally or alternatively, the flexible shaft may be positioned around the first liner and the second liner.

Additionally or alternatively, the method may include positioning a second mandrel at least partially within the slot and between the liner and the shaft. It may further include: a third mandrel is positioned at least partially within the second slot and between the liner and the shaft. It may further include: the shaft is positioned into at least two thermoplastic laminate sections having different sized outer diameters.

Additionally or alternatively, the method may further comprise: the shaft is positioned into at least two thermoplastic laminate sections having different durometers. It may further include: the shaft is positioned into a first thermoplastic laminate section having a first durometer, a second thermoplastic laminate section having a second durometer, a third thermoplastic laminate section having a third durometer, and a fourth thermoplastic laminate section having a fourth durometer. It may further include: wherein the fourth hardness may be less than the first hardness, the second hardness, and the third hardness. It may further include: wherein the second hardness may be less than the first hardness and the third hardness.

The method may also include heating at least the first mandrel, the first liner, the second mandrel, the second liner, and the shaft. It may further include: the bonded portion of the first liner is secured to at least a portion of the inner surface of the shaft, but wherein the unbonded portion is unbonded to the inner surface of the shaft.

The method may further include removing the first mandrel and the second mandrel. In some forms, the mandrel may be coated with a thermoplastic having a melting point above the thermoplastic melt bonding temperature of the plastic housing of the endoscope insertion tube. For example, the primary mandrel may be coated in PTFE, and the plastic housing may includeSuch coated mandrels can be removed from the shaft and reused. Additionally or alternatively, the mandrel may comprise a silver plated copper rod. For example, the auxiliary mandrel may be a silver plated copper bar and the auxiliary mandrel may be removed by applying a pulling force to the auxiliary mandrel, elongating the mandrel and thereby reducing its width, and removing it from the shaft.

Additionally or alternatively, the method may include inserting a deflection wire into the deflection channel liner. Additionally or alternatively, the method may include inserting a deflection wire between the shaft and the first unbonded portion of the liner without deflecting the channel liner.

In some forms, the mandrel may have a slot. Additionally or alternatively, the first unbonded portion or the second unbonded portion of the liner may be positioned adjacent to a bottom of the slot of the mandrel, wherein the unbonded portion may not be bonded to the inner surface of the shaft. Additionally or alternatively, the first and second slots may be positioned on opposite sides of the mandrel, and further comprising inserting a second deflection wire between the shaft and the second unbonded portion of the liner. In some forms, the mandrel may have four slots and the liner may have four unbonded portions.

Additionally or alternatively, the mandrel for shaping the liner within the insert tube may comprise a generally cylindrical mandrel having two side elliptical slots. The mandrel may be positioned within the liner. The spindle may have one, two, three or four slots.

Several exemplary embodiments are described below.

Brief Description of Drawings

The accompanying figures, in which like reference numerals refer to identical or functionally-similar elements throughout the separate views and which are not drawn to scale, illustrate exemplary embodiments, forms and aspects of the present invention and serve to explain the principles and advantages of the present invention:

fig. 1A is a side view of an embodiment described herein.

FIG. 1B is a detailed view of FIG. 1A.

Fig. 2 is a perspective view of the embodiment of fig. 1.

Fig. 3A is a cross-sectional view taken along line 3-3 in fig. 2.

Fig. 3B is a cross-sectional view of another embodiment described herein.

Fig. 4 is a perspective end view of the embodiment of fig. 1.

Fig. 5A is a cross-sectional view of an embodiment described herein featuring a primary mandrel 135 having an hourglass shape.

Fig. 5B is a cross-sectional view of another embodiment described herein featuring a primary mandrel 135 having an hourglass shape.

Fig. 5C is a cross-sectional view of another embodiment described herein featuring a primary mandrel 135 having an hourglass shape.

Fig. 6A is a side view of the handle 200.

Fig. 6B is a side view of the handle 200.

Description of the invention

Flexible endoscopes and components thereof, and methods of making flexible endoscopes and components thereof are described. In the interest of clarity and conciseness, not all features of an actual implementation, such as dimensions, tolerances, etc., are described in this disclosure. As used in this disclosure, the term "about" or "approximately" applies to all numerical values, whether or not explicitly indicated. These terms generally refer to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (i.e., having the same function or result). It will of course be appreciated that in the development of any such actual embodiment, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with manufacturing and business-related constraints, which will vary from one implementation to another. Moreover, it will be appreciated that such a development effort might be complex and time-consuming, but would nevertheless be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

An apparatus embodying features of the invention is shown in fig. 1A and 1B. The flexible endoscope 10 includes an endoscope insertion tube 100 connected to a handle 200. The insertion tube 100 has a distal end 108 and a proximal end 106 opposite the handle 200.

In one form of the invention, the endoscope insertion tube 100 remains in the neutral position 102 until the user actuates the trigger 220 (see FIGS. 1A and 6A) causing the distal end 108 to deflect and assume the deflected position 104. In one plane, the angle of deflection of the distal end 108 may vary from 0 degrees at the neutral position 102 to angles of preferably plus or minus 270 degrees or more preferably plus or minus 300 degrees or more (i.e., in either direction) at full deflection and any angle therebetween. In some embodiments, deflection may occur in two or three dimensions. When the trigger 220 is released, the handle 200 biasing force may return the trigger to its neutral position, moving the distal end 108 toward the neutral position 102. The ability to articulate the distal end 108 of the endoscope insertion tube 100 enhances steering capabilities.

In one form, the endoscope insertion tube 100 comprises a plastic laminate comprising four sections: (i) a relatively higher durometer proximal portion 112, preferably beginning at proximal end 106 and extending for most of the length of endoscope insertion tube 100; (ii) a middle portion 114 of intermediate hardness; (iii) a relatively higher durometer middle portion 116; and (iv) a relatively lower durometer distal end portion 118 adjacent the distal end 108 of the endoscope insertion tube 100. The particular hardness used may depend on the application, but for each of these parts, the preferred ranges are:

the first portion 112 preferably has a hardness of about 50-140 or greater, and more preferably about 65-130, and even more preferably about 70-120;

the second portion 114 preferably has a hardness of about 40-100, and more preferably about 45-75, and even more preferably about 50-60;

the third portion 116 preferably has a hardness of about 50-140 or greater, and more preferably about 65-130, and even more preferably about 70-120;

the fourth portion 118 preferably has a durometer of about 15-55 degrees or less, and more preferably about 20-50 degrees, and even more preferably about 30-40 degrees.

However, regardless of the preferred ranges described above, the second portion 114 preferably has a hardness that is less than the hardness of the first and third portions 112, 116, and the fourth portion 118 preferably has a hardness that is less than the hardness of the first, second, and third portions 112, 114, 116. The hardness of the first portion 112 and the third portion 116 may be the same or different. Other embodiments may have one, two or three sections, or even five or more sections, each section having the same or different hardness.

Additionally or alternatively, the second portion 114 may be more flexible (i.e., less rigid) than the first and third portions 112, 116, and the first, second, and third portions 112, 114, 116 may be less flexible (i.e., more rigid) than the fourth portion 118. The flexibility or rigidity of the first portion 112 and the third portion 116 may be the same or different.

Additionally or alternatively, the second portion 114 may have a smaller radius of curvature than the first and third portions 112, 116, and the fourth portion 118 may have a smaller radius of curvature and a shorter deflection tangent than the second portion 144 when in the deflected position 104. The radii of curvature of the first portion 112 and the third portion 116 may be the same or different.

In one embodiment, the length of the first portion 112 may be about 50cm to 70cm, the second portion 114 may be about 1cm to 3cm, the third portion 116 may be about 1cm to 3cm, and the fourth portion 118 may be about 4cm to 6 cm.

In one embodiment, the laminate may be made of a plastic or thermoplastic, such as a polyether block amide (also known as polyether block amide)) Polytetrafluoroethylene ("PTFE"), or nylon. Different portions of the laminate may comprise the same or different materials (including combinations of the foregoing) as the other portions.

Turning to fig. 2 and 3, the distal end 108 of the endoscope insertion tube 100 is shown without the cap 160. The endoscope insertion tube 100 includes a tubular shaft 120, preferably the tubular shaft 120 comprises an alloy, and more preferably a steel alloy. In a preferred embodiment, the shaft 120 comprises a flexible braided flat wire. Additionally or alternatively, the shaft 120 may comprise a wire comprising a titanium-nickel alloy.

In one form, as best seen in fig. 4, the distal portion 118 of the plastic laminate terminates adjacent the distal end 108, leaving an exposed portion 122 of the shaft 120. The marker 158 may be positioned on the exposed portion 122 or near the exposed portion 122. In the alternative, distal portion 118 may extend to cover shaft 120 until cap 160 is covered.

The different stiffness and flexibility in the two different portions of the endoscope insertion tube 100 may be achieved, for example, by using different thicknesses of material bonded to the outer surface of the shaft 120. For example, the higher durometer proximal portion 112 may have a thermoplastic laminate thickness (and thus outer diameter) that is greater than the thermoplastic laminate thickness (and outer diameter) of the lower durometer distal portion 118.

Additionally or alternatively, the different stiffness and flexibility in the intermediate portion of the endoscope insertion tube 100 may be achieved by overlapping two adjacent laminate portions. For example, as shown in fig. 5C, two laminate sections may overlap. Fig. 5C shows a cross-section of the end of intermediate portion 114 overlapping the end of proximal portion 112. In some forms, two or more or all of the laminate sections may have at least some overlap with one or two adjacent sections. The order of overlap is reversible and so another form may have the ends of section 112 overlapping the ends of section 114. If the overlapping laminate sections have different stiffness, the overlapping sections may have an intermediate stiffness, i.e. smaller than the higher stiffness section and larger than the lower stiffness section.

In one form, the endoscope insertion tube 100 includes a liner 130, the liner 130 having a bonded portion 132 secured to a portion of the inner surface of the shaft 120 and an unbonded portion 133 unsecured to the shaft 120 (see, e.g., fig. 5, where the unbonded portion 133 is adjacent to the slot 134 of the mandrel 135). The interior of the liner 130 may define the boundaries of the interior lumen 150. One or more gaps between the liner 130 and the shaft 120 may serve as the deflection channel 142.

In some forms, as shown in fig. 3A and 3B, the shaft liner 130 and one or more gaps between the liner 130 and the shaft are positioned within a lumen (not labeled) of the shaft 120. The shaft liner 130 may have an internal lumen 150.

The shaft 120 includes a lumen including a liner, the space between the shaft liner and the shaft,

as shown in fig. 3B, the deflection wire 140 may be positioned in one or more deflection channel liners 143 or in each of one or more deflection channel liners 143. Liner 143 may be plastic, or more preferably a thermoplastic, such as PTFE.

As in fig. 2, 3A, and 5A, the second liner 143 may be positioned within the gap (between the liner 130 and the shaft 120), wherein an interior of the second liner 143 may define the deflection channel 142.

There are various possibilities for what may be positioned within the inner lumen 150, depending on the application for which the insertion tube is used. In one form, at least one working channel 152 and at least one optical channel 155 can be positioned within the inner lumen 150. One optical channel 155 may house an imaging optical beam 156 comprising a complementary metal oxide semiconductor ("CMOS") or other suitable image sensor, such as a camera or a charge coupled device sensor. The imaging optics bundle 156 may also include a solid core optical fiber (solid core optical fiber) connected to the image sensor. The one or more optical channels 155 may house one or more light sources, such as illuminated optical fibers or light emitting diodes ("LEDs"). Alternatively, the LED may be positioned at the distal end 108 of the shaft without an accompanying optical channel 155. In some embodiments, two working channels 152 may be positioned within the inner lumen 150.

The preferred embodiment, which has minimized wall thickness by positioning the deflection wire 140 within the lumen 150 of the shaft 120, allows for efficient utilization of space within the lumen 150. The outer diameter of insertion tube 100 may be the size of a typical ureteroscope (e.g., 2mm-3mm), but full-size optics and working channel 152 may be used. Smaller optical elements may produce poorer images, and smaller working channels may not allow the use of common tools, and may also slow down the flushing flow.

Turning to fig. 4, the endoscope insertion tube 100 may include a marker portion 158 and a cap 160. The marker 158 may comprise a radiopaque material, such as a high density metal. One or more markers 158 may be positioned anywhere along the length of the endoscope insertion tube 100; one preferred location is adjacent the distal end 108 of the endoscope insertion tube 100 so that a user can visualize or otherwise detect the approximate location of the distal end 108 within the patient.

The cap 160 may be attached to the distal end of the deflection wire 140, such as by welding or other suitable means. In some embodiments, the deflection channel 142 is not in fluid communication with the lumen 150. The cap 160 can include one or more apertures for the distal ends of the working channel 152 and the optical channel 155 to interact with the environment adjacent the distal end 108 of the endoscope insertion tube 100.

In some forms, the indicia 158 and optical channel 155 are about 3mm-4mm or less in length. Preferably, the length of the rigid marker 158 is minimized because it increases the deflection tangent of the preferentially curved portions (e.g., portion 114, portion 116, and portion 118) of the insertion tube 100.

Fig. 6 shows a handle 200 for steering the insertion tube 100. In one embodiment, the handle 200 includes a tip 202, a luer lock 210, and a trigger 220. The tip 202 of the handle 200 is connected to the proximal end 106 of the endoscope insertion tube 100. The trigger 220 actuates the deflection wire 140.

The handpiece 200 may also include a light pin 230, an imaging optics beam terminal 256, and an eyepiece 258. The light source column 230 illuminates one or more illumination optical beams 157. The image captured and transmitted by the imaging optics 156 is displayed on an eyepiece 258, the eyepiece 258 being connected to an imaging optics terminal 256. The eyepiece 258 may be removable or permanently attached.

One embodiment of the present invention is a method of manufacturing an endoscope insertion tube 100 using a mandrel 135. As shown in fig. 5, the main mandrel 135, the liner 130, and the two auxiliary mandrels 141 may be inserted into the shaft 120.

In some forms, as shown in fig. 5A-5C, the mandrel 135 may have two slots 134 on opposite sides of the mandrel. Preferably, each slot 134 is a groove or notch along at least a portion of the mandrel length, wherein the slots 134 are sized to form a deflection channel 142 between the liner 130 and the shaft 120 that can receive the deflection wire 140. In the alternative, the mandrel 135 may have only one slot 134 or two, three, four, or more slots 134 corresponding to a predetermined number of deflection passages 142 for deflecting the wire 140. For a mandrel 135 having a plurality of slots 134, the plurality of slots 134 may be regularly or irregularly spaced about the circumference of the mandrel 135. In some forms, the one or more slots 134 may be shaped to substantially conform to at least a portion of the exterior of the secondary mandrel 144.

One or more secondary mandrels 144 may be nested within the slot 134 (see, e.g., fig. 5A).

Additionally or alternatively, the height 137 and/or width 138 of the cross-section of the mandrel 135 may vary along its length. In a preferred embodiment, for example, the width (i.e., across the diameter of one or more slots 134) may be a certain value along the higher durometer proximal portion 112 and less wide at one or more of the intermediate portions 114, 116 and distal portion 118. Preferably, the width 138 of mandrel 135 is measured at the bottom of slot 134 (see arrow for feature 138 in fig. 5A-5C). In this form, the portions 114, 116, 118 will have an increased preferential deflection relative to the portion 112. Additionally or alternatively, height 137 may be a certain value at a portion of proximal portion 112, and height 137 may be greater at one or more of intermediate portions 114, 116 and distal portion 118. These forms may also provide the distal end 108 of the insertion tube 100 with enhanced deflection tangents.

Additionally or alternatively, the depth of the groove 134 may be different at different portions along the length of the mandrel 135 to create a variable cross-section. The variable cross-section may impart a variable moment of inertia (i.e., resistance to bending) to the insertion tube 100. In one form, the mandrel 135 may have a deeper slot 134 at a portion near the proximal end 106 of the endoscope insertion tube 100, which may allow the proximal end of the deflection wire 140 to be positioned adjacent to a center point of the inner lumen 150. The mandrel 135 may also have a shallower slot 134 at a portion near the distal end 108 of the endoscope insertion tube 100, which may allow the distal end of the deflection wire 140 to be positioned away from the center point of the inner lumen 150. Additionally or alternatively, this configuration may enhance the effect of the variable durometer laminate at the intermediate portions 114, 116 and distal portion 118 of the insertion tube 100.

The auxiliary mandrel 141 is positioned between the shaft 120 and the liner 130 to hold open what will become the deflection channel 142.

As shown in fig. 1, 2, and 5C, one or more laminate sections 110 may be positioned over a shaft 120. One preferred method of bonding the plastic laminate 110 to the shaft 120 is by using an additional heat shrink tube (not shown) comprising any suitable thermoplastic material, such as fluorinated ethylene propylene copolymer ("FEP"). Once the plastic laminate section 110 is in place around the outer surface of the shaft 120, the tube is positioned around the section 110.

The primary mandrel 135, the liner 130, the secondary mandrel 141, the shaft 120, the laminate section 110, and the shrink tube may be heated to bond the shaft 120 to the liner 130 and the laminate section 110. A laminator may be used to apply hot dry forced air convection over the stinger assembly. The temperature and time may vary depending on the different hardness of each portion of the insertion tube 100. The heat may simultaneously shrink the outer tube and melt the plastic layer. If a shrink tube is used, the shrink tube is removed after the stinger assembly has cooled.

In the alternative, the plastic housing 110 may be molded over the exterior of the shaft 120. Casting the plastic housing 110 onto the shaft 120 may be accomplished by presenting the shaft 120 in a liquid plastic, such as a molten thermoplastic, adding thin layers (each less than about 0.01mm-0.1mm) until the desired thickness is achieved.

In some forms, the shaft 120 comprises braided wire, such as steel or alloys thereof, and the plastic laminate section 110 may be laminated to the shaft 120. Plastic laminate 110 may at least partially melt into and/or at least partially melt through the voids of braided shaft 120 and may attach to shaft liner 130 to secure at least a portion of shaft liner 130 to the inner surface of shaft 120. The molten plastic laminate 110 may also be attached to one or more deflection channel liners 143. The molten plastic laminate 110 can also fill most of the gap between and around the mandrel 144 (see fig. 5A-5C) and the shaft 120.

The braid may have a variable PIC rate (i.e., turns per centimeter of braid) such that it is more rigid in proximal portion 112 than in one or more of the other portions 114, 116, 118. Additionally or alternatively, the braid may be reinforced with coils (not shown). Additionally or alternatively, the braid may be plated over at least portion 112 to further increase its rigidity. In some forms, the braid may not be plated except for portion 112.

Additionally or alternatively, heating the plastic laminate section 110 causes the plastic laminate 110 to melt and bond the plastic laminate 110 to the shaft 120 without the use of heat shrink tubing.

During the heating step, at least the bonded portion 132 of the liner 130 is bonded to the inner surface of the shaft 120, and the unbonded portion 133 is spaced from the inner surface of the shaft 120 by the auxiliary mandrel 141 to form a gap that can serve as a deflection channel 142.

In some embodiments, primary mandrel 135 may be coated with PTFE, which will coat inner lumen 150.

In operation, the endoscope insertion tube 100 is connected to the handle 200.

Proximal portion 112, which in some embodiments may form a majority of the length of insertion tube 100, may be rolled up during packaging. The insertion tube 100 may be unfolded and the proximal optical connections (not shown) of the imaging optics 156 and illumination optics 157 may be operably connected to the eyepiece 258 and light source post 230, respectively, through the handpiece 200. The working channel 152 may be connected to the flushing part.

In one application, the endoscope insertion tube 100 may be afterloaded onto a guidewire placed with the cystoscope or introduced into the ureter with an access sheath (access sheath). To locate an abnormal condition, such as a kidney stone, the insertion tube 100 may be guided through the kidney assembly system using images provided by the imaging device and X-ray images provided by fluoroscopy. Various small tools may be passed through the working channel. For example, a laser may be used to fragment the stone, or the stone may be removed with a basket (basket).

The embodiments and examples shown in the drawings and described above are representative of many other embodiments and examples that may be formed within the scope of the appended claims. It is contemplated that many other configurations may be used and that the material of each component may be selected from many materials other than those specifically disclosed.

No special definition of a term or phrase, i.e., a definition that is different from the ordinary and customary meaning as understood by those skilled in the art, is intended to be implied by consistent usage of the term or phrase herein. The words and phrases used herein should be understood and interpreted to have a meaning consistent with the understanding of those words and phrases by those skilled in the relevant art. For example, an embodiment containing a singular element does not disclaim rights to multiple embodiments; that is, the indefinite articles "a" and "an" have a singular or plural meaning and the same element mentioned later reflects a possible plural of the same element. A structural element embodied as a single component or unitary structure may be composed of multiple components. The ordinal designations (first, second, third, etc.) are used merely as shorthand references to various elements and do not denote any sequential, spatial or positional relationship therebetween. Words such as "about", "approximately" or "substantially" that indicate an approximate meaning refer to a condition or measurement that, when so modified, is to be understood as not necessarily being absolute or perfect, but nevertheless being considered by one of ordinary skill to be sufficiently close to warrant an indication that the condition is present or that the measurement is satisfactory. For example, a numerical value or measurement modified by a term or words indicating approximate meaning, such as "about" or "approximately," can vary by 1%, 2%, 3%, 4%, 5%, 6%, 7%, 10%, 12%, and up to 15% relative to the stated value.

The foregoing descriptions of embodiments of the present disclosure have been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed, and modifications and variations are possible in light of the above teachings or may be acquired from practice of the invention. The embodiments were chosen and described in order to explain the principles of the invention and its practical application to enable one skilled in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. It is intended that the scope of the invention be limited only by the following claims as modified and equivalents thereof.

Description of the reference numerals

10 Flexible endoscope

100 endoscope insertion tube

102 neutral position

104 deflection position

106 proximal end of endoscope insertion tube 100

108 distal end of endoscope insertion tube 100

110 thermoplastic laminate

111 laminate part

112 higher durometer proximal portion

114 intermediate hardness intermediate portion

116 higher durometer middle section

118 lower durometer distal portion

120 shaft

122 exposed portion of the shaft

130 bush

132 bonded portion of liner 130

133 unbonded portion of liner 130

134 slots of spindle 135

135 main spindle

136 mandrel 135 surface

137 height of mandrel 135

138 width of mandrel 135

140 deflection wire

142 deflection channel

143 deflecting channel liner

144 auxiliary spindle

150 inner lumen of bushing 130

152 working channel

155 optical channel

156 imaging optical beam

157 illumination optical bundle

158 mark part

160 cap

200 handle

202 tip

210 luer lock

220 trigger

230 light source column

256 imaging optical beam termination

258 eyepiece.

Embodiment 1:

an endoscope insertion tube comprising:

a. a braided tubular shaft having an outer surface, an inner surface, a proximal end, a distal end, and a lumen;

b. a shaft liner comprising at least two bonded portions and at least two unbonded portions, wherein at least two bonded portions are fixedly attached to at least a portion of the inner surface of the shaft;

c. at least two gaps, one between each of the at least two unbonded portions of the shaft liner and the shaft;

d. wherein the interior of the shaft liner defines a non-circular interior lumen;

e. at least two deflection channel liners, wherein one deflection channel liner is positioned in each of the at least two gaps, and wherein an interior of each deflection channel liner defines a deflection channel;

f. at least two deflection wires, each deflection wire having a proximal end and a distal end, wherein at least a portion of the at least two deflection wires are positioned in each of at least two deflection channels;

g. wherein at least a portion of at least two deflection wires are positioned within the lumen of the shaft and outside of an inner lumen of the shaft liner;

h. a working channel positioned within the inner lumen;

i. at least two optical channels positioned within the inner lumen adjacent the distal end of the shaft;

a. at least a portion of at least one light source positioned within an optical channel and adjacent to the distal end of the endoscope insertion tube;

j. at least a portion of at least one image sensor positioned within an optical channel and adjacent to the distal end of the endoscope insertion tube;

k. a cap attached to the distal ends of the at least two deflection wires;

a thermoplastic laminate laminated to at least a portion of an outer surface of the shaft, the thermoplastic laminate comprising:

i. a first portion having at least a first hardness,

a second portion having at least a second hardness,

a third portion having at least a third hardness, and

a fourth portion having at least a fourth hardness,

wherein at least a portion of the first portion is adjacent the proximal end of the shaft, and wherein at least a portion of the fourth portion is adjacent the distal end of the shaft;

wherein the fourth portion is distal to the third portion and the third portion is distal to the second portion;

wherein the fourth hardness is less than the first hardness, the second hardness, and the third hardness; and is

p. wherein the second hardness is less than the first hardness and the third hardness.