Proximal connection of hypotube to the hub, and interlocking tool for handling hypotube.

Abstract

A medical device is disclosed comprising an elongated hypotube having an inner liner and an outer jacket, and a hub adhesively attached to the proximal end of the hypotube. The hub bonding region at the proximal end of the hypotube to which the hub is adhesively attached has an opening notch pattern, through which the inner liner can be bonded to the outer jacket. This facilitates effective bonding between the hypotube and the hub, preventing air intrusion and delamination of the outer jacket from the hypotube. A workpiece holding device for securing the hypotube during processing is also disclosed. This workpiece holding device includes a tube at its distal end having an interlock junction for coupling to an engagement junction at the proximal end of the hypotube.

Description

Technical Field

[0001] The field of the present disclosure generally relates to medical devices and methods for performing procedures within a patient's vasculature, and more specifically, to hypodermic tubes used in intravascular devices such as catheters, as well as methods and tools for manufacturing the same.

Background Art

[0002] Conventionally, medical catheters of various designs have been provided for performing various medical procedures such as interventional therapy, drug delivery, diagnosis, perfusion, etc. Generally, a medical catheter is inserted into a patient's vasculature such as a vein or artery from an insertion site of the patient. The catheter is guided and advanced from the insertion site through the vasculature to a target site where a medical procedure for treatment and / or diagnosis is performed.

[0003] A catheter is usually inserted into a patient's vasculature from a convenient location such as a blood vessel near the neck or groin. When the distal portion of the catheter (i.e., the portion furthest from the proximal handle of the catheter) enters the patient's vasculature, the distal end can be advanced towards the target site by applying an axial force to the proximal portion of the catheter. A catheter having a relatively high level of pushability and kink resistance transmits this axial force more effectively.

[0004] A catheter often travels within a vasculature having a serpentine path and is required to change direction and sometimes even reverse itself. A catheter can be "steered" by applying a torsional force to its proximal portion. A catheter having a relatively high level of torque transmissibility facilitates this steering process. Further, a catheter having a relatively high level of flexibility can effectively follow the patient's serpentine vasculature.

[0005] The distance between the access site and the target site often exceeds 100 cm. The inner diameter of the blood vessel at the access site is often less than 5 mm. Considering the patient's physiology, it is desirable to incorporate torque transmission, pushability, kink resistance, and flexibility into a relatively long and relatively small-diameter catheter. In many cases, it is desirable for the catheter to have relatively high levels of pushability and torque transmission, especially near its proximal end. It is also desirable for the catheter to be relatively flexible and maneuverable, especially near its distal end. Furthermore, it may be desirable for the catheter lumen to provide a passage with a low-friction surface through which other devices can pass.

[0006] Conventional plastic catheters, formed from polymer materials, are relatively easy and inexpensive to manufacture, but they may not provide sufficient pushability and torque transmission, especially at the extremely small diameters required to access certain very narrow lumens, such as those in the neurovascular system. For this reason, "hypotubes" have been used as components forming the entire length or most of the catheter, as part of the catheter, and / or as reinforcements for plastic catheters. Hypotubes are small-diameter, thin-walled tubes formed from metals or metal alloys such as stainless steel and nickel-titanium alloys (e.g., Nitinol). Metal hypotubes offer many desirable performance characteristics for intravascular catheters, including relatively high levels of pushability and torque transmission, as well as kink resistance. The thin walls, made possible by the strength of the metal tubing, also have the advantage of providing a larger inner diameter (lumen diameter) relative to a given outer diameter, allowing larger structures to pass through the hypotube. For example, the larger inner diameter of a hypotube allows for thrombus aspiration and the insertion and use of larger instruments.

[0007] However, hypotubes may lack sufficient flexibility to navigate tortuous anatomical pathways, such as the blood vessels of the neurovascular system. Therefore, hypotubes have been given features to improve flexibility, such as openings (e.g., notches) along their longitudinal direction in the tube wall. These openings include circumferential, helical, longitudinal, or other opening patterns that enhance the flexibility of the hypotube. Thin liners and / or jackets are often applied to hypotubes to seal the openings and provide a fluid-sealed tube, and to impart other desirable properties to the hypotube (e.g., to provide a smooth, low-friction surface). For example, Figures 1A and 1B show the proximal portion of a typical prior art hypotube assembly 10. The hypotube assembly 10 includes a hypotube 12 having multiple notches 11 to improve flexibility. The proportion of the opening space (holes in the tube wall created by the notches) relative to the tube wall, provided by these notches 11, is approximately 10% or less.

[0008] An inner polymer liner 14 is provided on the inner diameter side of the hypotube 12, and an outer polymer jacket 16 is provided on the outer diameter side of the hypotube 12. The polymer liner and / or jacket do not readily bond to the hypotube 12 and simply form along the walls of the hypotube 12.

[0009] Furthermore, elongated, flexible hypotubules are typically components of a catheter assembly and are attached to one or more other components of the catheter assembly. However, hypotubules are not easily and effectively bonded to other components using adhesives. For example, adhesives generally do not adhere well to metal surfaces, adhesives tend to shrink during curing or heat bonding, creating gaps and voids between bonded parts, and the fine shapes of catheter components also make bonding difficult. In the case of hypotubules with an inner liner and / or outer jacket, since the liner is not bonded to the hypotubule, bonding catheter components with adhesives can also cause delamination of the liner from the hypotubule.

[0010] For example, many catheter assemblies have a hub attached to the proximal end of the catheter to provide a handling structure for manipulating the catheter (e.g., applying axial forces (push / pull) and rotational forces (torque)) as it is advanced and maneuvered through the patient's vascular system to a target site. The hub may also have a channel through which other instruments are inserted or advanced within the catheter. The hub may also include one or more ports for introducing or removing fluid through the catheter. The hub needs to be bonded to the hypotube with hermetically sealed and sufficient tensile strength. The hub is typically attached to the proximal end of the slender tube of the catheter using adhesive. Examples in Figures 2A and 2B show the proximal end of a hypotube assembly 10 (including the hypotube 12, inner liner 14, and outer jacket 16) bonded to a hub 20 using a layer of adhesive 22. Because the notch 11 is narrow and the opening space ratio is low (about 10%), there is no or minimal bonding between the inner liner 14 and the outer jacket 16 through the notch. As shown in Figures 2A and 2B, an air gap 18 is likely to form between the outer surface of the hypotube assembly 10 (i.e., the outer surface of the outer jacket 16) and the inner surface of the hub 20. This is because the adhesive 22 shrinks during curing, creating a low-pressure (vacuum) region, and the resulting pressure gradient draws ambient air into the joint, creating an air gap 18 within the adhesive joint. This low pressure may also cause delamination 26 of the outer jacket 16 from the hypotube 12. The air gap 18 and delamination 26 can result in an incomplete seal between the hypotube assembly 10 and the hub 20, leading to insufficient joint strength to withstand the pressures and forces encountered during catheter use.

[0011] Another problem encountered in the catheter manufacturing process is the need to secure and manipulate the relatively fragile hypotube during handling during catheter manufacturing. For example, the hypotube needs to be secured and manipulated during inspection after processing the laser-cut notch 11, during the application of the shrink-fit sheath, liner, and jacket, and / or during the attachment of the hypotube assembly and other components of the catheter assembly. Current hypotube handling techniques utilize a mandrel inserted into the lumen of the hypotube. Figure 3 shows one currently available method for handling the hypotube 10 during processing. First, a loosely fitting mandrel 30 is inserted into the central lumen of the hypotube 10. The hypotube 10 is then manipulated using the mandrel 30 during processing such as inspection and assembly. However, while the mandrel 30 allows for axial movement of the hypotube assembly 10 while avoiding the risk of damaging the hypotube assembly 10 by touching it with one's hands, it is not possible to rotate the hypotube assembly 10 during inspection and processing.

[0012] Another method for handling the hypotube assembly 10 during processing is to use a support mandrel (not shown) with interference fit. However, this method results in a high waste rate (e.g., 40% waste rate) because the struts for improving the flexibility of the hypotube are prone to stretching and / or compressing, deviating from the strut design, and consequently causing the hypotube to deform beyond the design tolerance. Collets, clamps, and other workpiece holding solutions also cannot be used due to downstream processing requirements that require heat shrink tubing to be passed over the connection area of ​​the hypotube.

[0013] Therefore, an improved hypotube-hub interface design is needed to overcome the shortcomings of conventional catheter designs. Furthermore, a better workpiece holding device for hypotubes is required to secure and manipulate the hypotubes during the catheter manufacturing process. [Overview of the project]

[0014] This specification discloses a medical device comprising an elongated hypotubule and a hub adhesively attached to the proximal end of the hypotubule. The hub joint region at the proximal end of the hypotubule to which the hub is adhesively attached has an innovative open-cut pattern, which facilitates an effective and strong bond between the hypotubule and the hub while avoiding delamination of the inner liner and / or outer jacket and air gaps in the adhesive. This results in a hub joint with hermetically sealed and high tensile strength. In various embodiments, the elongated medical device may be a catheter, an intravascular catheter, a neurovascular catheter, a laparoscopic medical device, and the like.

[0015] In one embodiment, an elongated medical device includes a hypotube having a tubular wall extending from a proximal end to a distal end. The hypotube also has a hub junction region at its proximal end. The hub junction region includes a pattern of openings penetrating the tubular wall. For example, the pattern of openings is cut into the tubular wall by laser cutting, etching, or the like. This pattern of openings provides a ratio of opening space to the tubular wall of 35-75%, 60-70%, more than 50%, or more than 20%. The hypotube may also have a proximal opening pattern in the tubular wall for the proximal region of the hypotube located proximal to the hub junction region.

[0016] Furthermore, the hypotube has an inner liner provided on the inner diameter side of the hypotube. The inner liner may be a polymer liner or any other suitable material. In yet another embodiment, the hypotube also has a polymer outer jacket provided on the outer diameter side of the hypotube. The inner liner and outer jacket are provided on the hypotube so that they bond to each other through a pattern of openings in the tube wall of the hypotube.

[0017] The hub is joined to the hypotube. The hub includes a hub body having a tubular lumen for receiving the proximal end of the hypotube. The proximal end of the hypotube is positioned within the tubular lumen of the hub. The hub is joined to the hypotube using an adhesive applied to the hub joining area. This adhesive flows through the opening, bonding the inner polymer layer of the adhesive within the tube wall to the outer polymer layer between the outer surface of the hypotube and the inner wall of the tubular lumen.

[0018] In yet another embodiment, the pattern of openings includes openings having a width of 0.003 to 0.02 inches (0.076 to 0.51 mm). Alternatively, the openings may have a width of 0.150 mm ± 0.2 mm.

[0019] In another embodiment, the pattern of openings includes a plurality of circumferential slits arranged in the tube wall at an angle and at an axial distance along the tube wall.

[0020] In yet another embodiment, the pattern of the openings includes a plurality of spirally oriented slits extending along the tube wall.

[0021] In another embodiment, the opening pattern includes a plurality of circular openings extending along the tube wall.

[0022] In another embodiment, the pattern of openings includes a plurality of axially oriented slits that are angularly spaced around the outer circumference of the tube wall and axially spaced along the tube wall.

[0023] In yet another embodiment, the hypotube includes a pattern of flexible openings extending along the longitudinal direction of the hypotube on the tube wall distal to the pattern of openings, wherein the ratio of the opening space of the flexible opening pattern to the tube wall is less than 50%. In other embodiments, the ratio of the opening space of the flexible opening pattern to the tube wall is less than 45%, less than 40%, less than 35%, less than 25%, less than 20%, or less than 15%.

[0024] In another embodiment of an elongated medical device, the most proximal edge of the hypotube has a rook-shaped pattern that forms a circumferential rectangular wave pattern. This rook-shaped pattern provides an additional polymer bonding area prior to the proximal cut. This reduces the risk of the instrument inserted through the lumen of the hypotube delaminating the inner liner from the catheter.

[0025] Furthermore, this specification discloses an innovative workpiece holding tool for handling hypotubes during the manufacturing process of catheters or other medical devices that include hypotubes. The tool is a workpiece holding device configured to fix and manipulate hypotubes during downstream processing of hypotubes during catheter manufacturing. In one embodiment, the workpiece holding device includes a tube of a fixed length having a proximal end and a distal end. The tube has an outer diameter substantially the same as ("substantially the same" means within 5% dimensionally of the other structure) as the product hypotube that is fixed by the workpiece holding device. The distal end of the tube has an interlock junction configured to releasably engage with an engagement junction at the proximal end of the product hypotube. The interlock junction is configured to provide axial movement of the engaged product hypotube in both the proximal and distal directions, and rotational movement of the engaged product hypotube about a central longitudinal axis.

[0026] In another embodiment of the workpiece holding device, the interlock junction has a serrated shape at the proximal end of the tube, which has an axial locking projection configured to abut against an engaging projection of the engaging junction in order to allow the workpiece holding device to pull the product tube in the proximal direction.

[0027] In another embodiment, the interlock junction includes an interlock key-shaped projection configured to couple with an engaging key-shaped projection of the engaging junction.

[0028] In yet another aspect, the tube has a crimping section for crimping the tube onto a mandrel inserted within the lumen of the tube. The crimped crimping section secures a work holding device to the mandrel, such that the work holding device translates and rotates with the translation and rotation of the mandrel.

[0029] In another aspect, the tube has an inner diameter that is substantially the same as the inner diameter of the product hypo tube.

[0030] The work holding device can be used by engaging an interlock junction with an engagement junction of the product hypo tube during processing of the product hypo tube. Thereafter, the product hypo tube can be manipulated using the work holding device for downstream processing such as inspection and assembly with other components of a medical device such as a catheter. The work holding device can avoid forces being applied to the product hypo tube, such as forces resulting from an interference fit with the mandrel, that can damage the product hypo tube and cause its rejection.

[0031] Thus, the aspects of the disclosure described herein provide innovative hypo tube assemblies and tools for downstream processing of hypo tubes, thereby enabling improvements in devices, increased efficiency in manufacturing processes, and reduction of damaged and discarded materials.

Brief Description of the Drawings

[0032] The above matters, along with other aspects and further aspects of the disclosure, will be described in more detail in the following detailed description, with reference to the accompanying drawings. In those drawings, like reference numerals refer to like elements, and descriptions of like elements are applicable to all the described aspects related thereto. [Figure 1] FIG. 1A is a partial side view of a prior art hypo tube. FIG. 1B is a cross-sectional view of the prior art hypo tube of FIG. 1A. [Figure 2]Figure 2A is a partial side view of a prior art hypotube and hub assembly. Figure 2B is a cross-sectional view of the prior art hypotube and hub assembly shown in Figure 2A. [Figure 3] Figure 3 is a side view of a conventional mandrel for handling hypotubes during processing. [Figure 4] Figure 4 is a side view of a hypotube and hub assembly according to one embodiment disclosed herein. [Figure 5] Figure 5 is a partial cross-sectional view of the side of the hypo tube shown in Figure 4. [Figure 6] Figure 6A is a side view of yet another pattern of openings in the hub joint region of a hypotube according to another embodiment disclosed herein. Figure 6B is a side view of yet another pattern of openings in the hub joint region of a hypotube according to another embodiment disclosed herein. Figure 6C is a side view of yet another pattern of openings in the hub joint region of a hypotube according to another embodiment disclosed herein. Figure 6D is a side view of yet another pattern of openings in the hub joint region of a hypotube according to another embodiment disclosed herein. [Figure 7] Figure 7 is a side view of a workpiece holding device and a product hypotube that engages with it, according to one embodiment disclosed herein. [Figure 8] Figure 8 is a side view of another interlock junction and a product hypotube engagement junction of a workpiece holding device according to another embodiment disclosed herein. [Figure 9] Figure 9 is a side view of yet another interlock junction and product hypotube engagement junction of a workpiece holding device according to another embodiment disclosed herein. [Modes for carrying out the invention]

[0033] Referring here to the drawings, Figures 4 and 5 show a medical device assembly 100 including a hypotube assembly 102 attached to a hub 104 using adhesive 128. As shown in Figure 5, the hypotube assembly 102 includes a hypotube 108 having a tube wall 108 extending from a proximal end 110 to a distal end 112. The hypotube 108 is formed of metal or a metal alloy. Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316L stainless steel; nickel-titanium alloys such as superelastic (i.e., pseudoelastic) or linearly elastic nitinol; nickel-chromium alloys; nickel-chromium-iron alloys; cobalt alloys; tungsten or tungsten alloys; tantalum or tantalum alloys; gold or gold alloys; MP35-N (having a composition of approximately 35% Ni, 35% Co, 20% Cr, 9.75% Mo, up to 1% Fe, up to 1% Ti, up to 0.25% C, up to 0.15% Mn, and up to 0.15% Si); or other suitable metals, or combinations or alloys thereof.

[0034] The proximal end 110 of the hypotube 108 has a hub joint region 114 having a hub joint region pattern 116 of the opening 118. As shown in the embodiments of Figures 4 and 5, the pattern 116 of the opening 118 includes multiple rows of circumferentially arranged slits 118 that are angularly spaced apart. Each row of slits 118 may contain 2, 3, 4, 5 or more angularly spaced slits 118. Each row of slits 118 is axially spaced along the longitudinal axis of the tube wall 109. In addition, each row of slits 118 is angularly offset with respect to adjacent rows so that the slits 118 in one row are not angularly aligned with the respective slits 188 in the immediately adjacent row. For example, the angular offset may form a helical pattern or any other suitable pattern along the tube wall 108. Each slit 118 can have a width of 0.003 to 0.02 inches (0.076 to 0.51 mm) or a width of 0.150 ± 0.2 mm and a length of approximately 5 to 15 mm. The slits 118 in each row are spaced approximately 0.18 mm ± 0.5 mm apart, and each row is spaced approximately 0.175 ± 0.5 mm axially from adjacent rows. The openings 118 are configured to be large enough for the inner liner 120 and outer jacket 122 laminated on both sides of the hypo tube 108 to connect to each other through the openings 118, as will be described later. The pattern 116 of the openings 118 can be formed in the tube wall 109 by any suitable method, such as cutting, laser cutting, or etching. The pattern 116 of the openings 118 is formed such that the ratio of the opening space to the tube wall 109 is 35 to 75%.

[0035] Furthermore, the hypotube 108 has a distal opening pattern 119 in the tube wall 109 for the distal region 117 (or second portion 117) of the hypotube 108 distal to the hub joint region 114. The distal opening pattern 119 is provided as a feature for improved flexibility, and the hypotube 108 is typically more rigid in this region to ensure indentation and maneuverability. The distal opening pattern 119 includes a number of openings 115 that are considerably narrower than the openings 118, resulting in minimal or no bonding between the inner liner 120 and the outer jacket 122 through the openings 115 during the lamination process described later. The transition from the pattern 116 of openings 118 along the length of the hypotube 108 to the distal opening pattern 119 may be included within the hub joint region 114 where the hub 104 is joined to the hypotube 108. By including this transition area within a more rigid hub / adhesive region, it is possible to prevent kinking points from occurring in the hypotube 108.

[0036] A proximal end pattern 124 is provided at the most proximal edge of the proximal end 110 of the hypotube 108. In the illustrated embodiment, the end pattern 124 is a rook-shaped pattern that forms a rectangular wave pattern around the outer circumference of the proximal edge. As will be described later, the end pattern 124 includes an opening region 125 that serves as an additional polymer bonding region between the inner liner 120 and the outer jacket 122 of the hypotube assembly 102. The proximal end pattern 124 can be formed on the hypotube 108 by any suitable process, such as cutting, laser cutting, or etching. The proximal end pattern 124 has a length of approximately 0.612 mm, or in the range of 0.3 mm to 1.3 mm (i.e., the height of the rectangular wave pattern), and has 4 to 12 peaks and associated opening regions (troughs) around the outer circumference, with an opening region (trough) to peak width ratio in the range of 0.5:1 to 3:1.

[0037] The hypotube assembly 102 also includes an inner liner 120 provided on the inner diameter side (i.e., the inner surface of the hypotube 108) of the hypotube 108. The inner liner 120 may be a polymer liner such as PTFE or another suitable material. The inner liner 120 may have a thickness of about 0.001 inches (0.025 mm), or in the range of 0.00050 to 0.0050 inches (0.013 to 0.13 mm). For example, the inner liner 120 can be provided on the inner diameter side of the hypotube 108 by drawing the liner through the lumen of the hypotube 108, expanding the inner liner 120 using PTFE beading, and thereby pressing it against the inner diameter of the hypotube 108 to laminate the inner liner 120 to the inner diameter side of the hypotube 108. The proximal end 121 of the inner liner 120 extends proximal beyond the proximal end 110 (i.e., end pattern 124) of the hypotube 108.

[0038] The hypotube assembly 102 also includes an outer jacket 122 provided on the outer diameter side of the hypotube 108. The outer jacket 122 may be a polymer jacket such as a co-extruded jacket of PEBAX® (a thermoplastic elastomer containing polyamide and polyether) and AESNO® (a nylon material), or another suitable material. The outer jacket 122 is fitted over the outer diameter side of the hypotube 108 and laminated along the outer diameter of the hypotube 108. The proximal end 123 of the outer jacket 122 also extends proximal beyond the proximal end 110 (i.e., end pattern 124) of the hypotube 108.

[0039] During the lamination of the inner liner 120 and / or outer jacket 122 to the hypo tube 108, the inner liner 120 and outer jacket 122 are joined to each other through the opening 118, the opening region 125 of the end pattern 124, and along the longitudinal direction of the inner liner 120 and outer jacket 122 extending proximal beyond the proximal end 110 of the hypo tube 108. The proximal ends of the laminated inner liner 120 and outer jacket 122 may be trimmed to a predetermined length after lamination. The opening region 125 of the end pattern 124 creates an additional joining area for the inner liner 120 to bond to the outer jacket 122, thereby reducing the risk of delamination between the layers of material inserted through the lumen formed by the joined inner liner 120 and outer jacket 122.

[0040] Returning to Figure 4, the hypotube assembly 102 is assembled to the hub 104 by inserting the proximal end 110 of the hypotube assembly 102 into the tubular hub lumen 126 of the hub 104. Adhesive 128 is applied between the inner wall of the hub lumen 126 and the outer surface of the outer jacket 122 of the hypotube assembly 102. As the adhesive 128 hardens and bonds the hypotube assembly 102 to the hub 104, the adhesive 128 shrinks, creating a low-pressure (vacuum) area that tends to pull the outer jacket 122 toward the inner wall of the hub lumen. At this time, the outer jacket 122 is thought to bend flexibly in response to the pressure gradient, thereby preventing the pressure gradient from drawing air into the adhesive joint 128 and avoiding the formation of an air gap in the adhesive joint 128. This results in a stronger and more stable bond between the hypotube assembly 102 and the hub 104. Furthermore, the bonding between the outer jacket 122 and the inner liner 120 via the opening 118 prevents the outer jacket 122 and the inner liner 120 from delaminating from the hypotube 108.

[0041] Referring here to Figures 6A to 6D, several alternative hub joint region patterns 116 and proximal end patterns 124 for the hypotube 108 are shown. Figure 6A shows a portion of the joint region pattern 116a of the hub opening 118a, which includes multiple short angled openings 118a arranged in multiple helical patterns along the length of the hub joint region 114. Figure 6A also shows a portion of the proximal end pattern 124a, which includes a short-wavelength sinusoidal shape around the outer circumference of the proximal edge of the hypotube 108. Figure 6B shows a portion of the hub joint region pattern 116b of the opening 118b, which includes multiple long angled openings 118b (longer than the short angled openings 118a) arranged in multiple helical patterns along the length of the hub joint region 114. Figure 6B also shows a portion of the proximal end pattern 124b, which has a sinusoidal shape with a long wavelength (longer than the wavelength of pattern 124a) around the outer circumference of the proximal edge of the hypotube 108. Figure 6C shows a portion of the hub joint region pattern 116c of the opening 118c, which includes a plurality of axial slits 118c having longitudinal dimensions parallel to the longitudinal axis of the hypotube 108. Figure 6C also shows a portion of the proximal end pattern 124c, which has a rook-shaped pattern forming a rectangular wave pattern around the outer circumference of the proximal edge of the hypotube 108. Figure 6D shows a portion of the hub joint region pattern 116d of the opening 118d, which includes a plurality of circular openings 118d arranged in a row of a plurality of circular openings 118d extending along the longitudinal direction of the hub joint region 114. Figure 6D also shows a portion of the proximal end pattern 124d, which has a rook-shaped pattern forming a rectangular wave pattern around the outer circumference of the proximal edge of the hypotube 108. Each of the openings 118a to 118d is large enough and configured so that the inner liner 120 is laminated to the outer jacket 122 through the openings 118a to 118d. Similar to the proximal end pattern 116 of the hypotube 108 in Figures 4 and 5, the proximal end patterns 116a to 116d each provide a ratio of opening space to the tube wall 109 ranging from approximately 40% or 35 to 75%.As a result, the inner liner 120 and the outer jacket 122 are joined to each other through the openings 118a to 118d, respectively, preventing an air gap from forming in the adhesive joint 128 between the hypotube assembly 102 and the hub 104.

[0042] As shown in Figure 7, another aspect disclosed herein relates to a workpiece holding device 200 for handling the hypotube 100 (also referred to as the product hypotube 100) during processing and when incorporating the hypotube 100 into a catheter or other medical device containing the hypotube 100. The workpiece holding device 200 includes a cylindrical tube 202 having a proximal end 204 and a distal end 206. The tube 202 has substantially the same outer diameter as the product hypotube to which the workpiece holding device 200 secures. The distal end 206 of the tube 202 has an interlock junction 208 configured to be releasably connected to an engagement junction 210 located at the proximal end 213 of the product hypotube 100. The interlock junction 208 is configured to apply an axial force to the engaged product hypotube 100, thereby holding the engaged product hypotube 100 against axial forces in both proximal and distal directions, and / or to move the engaged product hypotube 100 axially in both proximal and distal directions, and furthermore, to apply torque to the engaged product hypotube 100, thereby rotating the hypotube 100 around its central longitudinal axis.

[0043] The tube 202 also has a crimping section 205 for crimping the tube 202 onto a mandrel 30 inserted into the lumen of the tube 202. The crimped crimping section 205 secures the workpiece holding device 200 to the mandrel 30, so that the workpiece holding device 200 moves and rotates along with the translation and rotation of the mandrel 30.

[0044] As shown in Figure 7, the interlock junction 208 includes a serrated shape at the distal end 206 of the tube 202, and the engaging junction 210 at the proximal end 213 of the hypo tube 100 includes an engaging serrated shape that engages with the interlock junction 208. The interlock junction 208 may include an axial locking projection (not shown) configured to abut against an engaging projection (not shown) of the engaging junction 210 in order to allow the workpiece holding device 200 to pull the product hypo tube 100 in the proximal direction.

[0045] Referring to Figure 8, another embodiment of the interlock junction 208a and the corresponding engagement junction 210a is shown. The interlock junction 208a and the engagement junction 210a include interlocking key shapes, and they engage with each other by a combination of rotation and axial movement toward each other until the interlock teeth or projections 214 of the interlock junction 208a engage with the engagement teeth 212 of the engagement junction 210a. The engagement of the interlock teeth 214 with the engagement teeth 212 provides the workpiece holding device 200 with a support surface that resists axial forces attempting to pull the hypotube 100 distally and allows the hypotube 100 to be pulled proximal.

[0046] Referring to Figure 9, another embodiment of the interlock junction 208b and the engagement junction 210b is shown. The interlock junction 208b and the engagement junction 210b are similar to the interlock junction 208a and the engagement junction 210a, except that the former interlocks to allow the workpiece holding device 200 to apply torque to the product hypotube 100 in both rotational directions (i.e., clockwise and counterclockwise). The interlock junction 208b includes an interlock tooth or projection 218 that bends about 180 degrees, and the engagement junction 210b includes an engagement tooth or projection 216 that bends about 180 degrees in the opposite direction to the interlock tooth 218, so that the interlock tooth 218 engages with the engagement tooth 216 in such a way that the interlock junction 208b provides corresponding support surfaces that allow the engagement junction 210b and the hypotube 100 to be pushed and pulled in both the proximal and distal directions, respectively.

[0047] Furthermore, the engaging junctions 210, 210a, and 210b also function as end patterns 124 having an opening region 125, thus providing an additional polymer bonding region between the inner liner 120 and the outer jacket 122 of the hypotube assembly 102, as described above. Accordingly, any of the hypotubes 100 described herein may include the features of interlock junctions 208 and can be processed using the same method with the workpiece holding device 200 disclosed herein.

[0048] The workpiece holding device 200 can be used during processing of the product hypotube 100 by engaging the interlock junction 208 with the engagement junction 200 of the product hypotube 100. The product hypotube 100 can be manipulated using the workpiece holding device 200 for downstream processing such as inspection or assembly with other components of medical devices such as catheters. This prevents the product hypotube 100 from being subjected to forces or manual handling that could damage the hypotube 100 (e.g., forces resulting from tightening with a mandrel or manual mishandling) that could cause the hypotube 100 to break and lead to its disposal.

[0049] While specific embodiments have been disclosed and described, it should be understood that the above descriptions are not intended to limit the scope of these embodiments. Many variations of the embodiments of this disclosure have been disclosed and described, but such disclosures are provided for illustrative purposes only. Therefore, various changes and modifications are possible without departing from the scope of the claims. For example, not all components described in this disclosure are necessary, and the devices disclosed herein may include any suitable combination of the components described, and the overall shape and relative size of the device components may also be modified. Thus, each embodiment is intended to illustrate alternatives, modifications, and equivalents that may fall within the scope of the claims. Accordingly, this disclosure should not be limited by anything other than the following claims and their equivalents.

Claims

1. In medical devices, An elongated hypo tube having a tube wall extending from the proximal end to the distal end, comprising a hypo tube having an inner diameter and an outer diameter, with a hub joint region near the proximal end. The hub joint region has a pattern of openings that penetrate the tube wall, and the pattern of openings is formed such that the proportion of the opening space created by the openings is 35 to 75% of the tube wall. The medical device further comprises an inner liner provided on the inner diameter side of the hypotube and extending to the hub joint region of the hypotube, and an outer jacket provided on the inner diameter side of the hypotube and extending to the hub joint region of the hypotube, wherein the inner liner and the outer jacket are arranged such that they are connected to each other through the opening. The medical device further comprises a hub having a hub body with a tubular lumen for receiving the proximal end of the hypotube, A medical device characterized in that the hub is joined to the hypotube using an adhesive applied to the hub joining region, thereby joining the hub to the outer jacket of the hypotube.

2. In the medical device described in claim 1, A medical device characterized in that the pattern of the openings includes openings having a width of 0.003 to 0.02 inches.

3. In the medical device described in claim 1, A medical device characterized in that the pattern of the openings includes openings having a width of 0.130 mm to 0.170 mm.

4. In a medical device according to any one of claims 1 to 4, A medical device characterized in that the pattern of the opening includes a plurality of circumferential slits arranged in the tube wall at an angle and at an axial distance along the tube wall.

5. In a medical device according to any one of claims 1 to 4, A medical device characterized in that the pattern of the opening includes a plurality of spirally oriented slits extending along the wall of the tube.

6. In a medical device according to any one of claims 1 to 4, A medical device characterized in that the pattern of the openings includes a plurality of circular openings extending along the wall of the tube.

7. In a medical device according to any one of claims 1 to 4, A medical device characterized in that the pattern of the opening includes a plurality of axially oriented slits that are angularly spaced apart around the outer circumference of the tube wall and axially spaced apart along the tube wall.

8. In a medical device according to any one of claims 1 to 7, A medical device characterized in that the hypotube includes a pattern of flexible openings extending along at least the rigid portion of the hypotube on the distal tube wall of the pattern of openings, the ratio of the opening space of the flexible openings to the tube wall is less than 50%, and the rigid portion of the hypotube has higher rigidity than the hub joint region having the pattern of openings.

9. In a medical device according to any one of claims 1 to 7, A medical device characterized in that the hypotube includes a pattern of flexible openings extending along the longitudinal direction of the hypotube on the distal tube wall of the opening pattern, and the ratio of the opening space of the flexible opening pattern to the tube wall is less than 20%.

10. In a medical device according to any one of claims 1 to 9, A medical device characterized in that the transition portion from the pattern of the opening to the rigid portion of the hypotube is included within the hub joining region where the hub is joined to the hypotube.

11. In a medical device according to any one of claims 1 to 10, A medical device characterized in that the most proximal edge of the hypotube has a proximal end pattern that provides an additional polymer bonding region between the inner liner and the outer jacket.

12. In a medical device according to any one of claims 1 to 10, A medical device characterized in that the proximal end pattern includes a rook-shaped pattern that forms a circumferential rectangular wave pattern.

13. In a medical device according to any one of claims 1 to 12, A medical device characterized in that the inner liner contains a polymer material and the outer jacket contains a polymer material.

14. In a medical device according to any one of claims 1 to 13, A medical device characterized in that the inner liner is formed from PTFE, and the outer jacket is formed from co-extruded PEBAX® and AESNO.

15. A workpiece holding device for fixing and manipulating product hypo tubes, The tube has a proximal end and a distal end, and comprises a tube having substantially the same outer diameter as the product hypo tube, The proximal end of the hypo tube has an interlock junction configured to be releasably engaged with an engagement junction located at the proximal end of the product hypo tube, A workpiece holding device characterized in that the interlock junction is configured to provide axial movement of the product hypotube that engages with the interlock junction via the engagement junction, and rotational movement of the engaged product hypotube about the central longitudinal axis.

16. In the workpiece holding device according to any one of claims 15, A workpiece holding device characterized in that the interlock junction has a sawtooth shape at the proximal end of the tube, and the sawtooth shape has an axial locking projection configured to abut against an engaging projection of the engaging junction in order to allow the workpiece holding device to pull the product tube in the proximal direction.

17. In the workpiece holding device according to claim 15, A workpiece holding device characterized in that the interlock junction includes an interlock key-shaped projection configured to couple with an engagement key-shaped projection of the engagement junction.

18. In the workpiece holding device according to any one of claims 15 to 17, A workpiece holding device characterized in that the tube has a crimping section for crimping the tube to a mandrel inserted into the lumen of the tube.

19. In the workpiece holding device according to any one of claims 15 to 18, A workpiece holding device characterized in that the tube has substantially the same inner diameter as the inner diameter of the product hypo tube.

20. In the workpiece holding device according to any one of claims 15 to 19, A workpiece holding device characterized in that the interlock junction is configured to engage with the engagement junction by a combination of rotational and translational movements of the interlock junction relative to the engagement junction.

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