Anchoring strain relief component

Abstract

For dislodgement from the hemostatic valve caused by forces tending to push the catheter proximally, the anchoring strain relief member provides resistance. The anchoring strain relief member is distal to the bushing, engages with the outer surface of the catheter, and includes a seal having at least one ridge with a ridge tip and a ridge height defined by the distance from the ridge tip to the catheter's central axis. A method for forming a nested catheter system using catheters with anchoring strain relief as inner catheters in a nested catheter assembly is described. A system of hemostatic valves with suitable catheters having anchoring strain relief members can provide the necessary components for assembly.

Description

Technical Field

[0001] This technical field relates to strain relief components for medical catheters, particularly strain relief components having surfaces for sealing and anchoring compressible materials such as elastomeric components. Catheters, methods, and systems used with strain relief components are also within this technical field. Background Technology

[0002] Medical catheters typically have a hub attached to a catheter shaft and a strain-relieving member distally (generally adjacent to or overlapping the hub, or continuously with it) tightly engaged with the shaft relative to the hub. The hub is a connector for an accessory that can be attached to a delivery system. The catheter provides passage for material between the delivery system, the hub, and the lumen of the catheter. The catheter terminates at its distal tip. The delivery system may also provide infusion, or alternatively, removal and / or retrieval of material via the catheter lumen.

[0003] Strain relief components are designed to prevent collapse of the catheter shaft under lateral (bending) forces. Additionally, they are designed to prevent excessive bending of the catheter shaft at or near the bushing / tube junction. The bushing is generally rigid relative to the catheter shaft, and lateral forces tend to concentrate, causing twisting within the shaft. Strain relief components distribute these lateral forces so that they do not twist or otherwise excessively bend the catheter shaft. Beyond their design considerations for lateral forces, strain relief components should be designed to prevent component breakage or separation from the catheter shaft and / or bushing. Summary of the Invention

[0004] In a first aspect, the present invention relates to a medical catheter comprising a strain-relieving member that provides a clamping surface in a sealing region, thereby providing resistance to movement and radial compression while facilitating sealing upon compression into a variable material. Strain-relieving members are not conventionally used or designed to provide sealing and clamping surfaces in the sealing region. Some embodiments include a strain-relieving member having a sealing region comprising multiple ridges. This design offers numerous advantages, which become apparent upon reading the disclosure provided herein.

[0005] One embodiment of the invention is a medical catheter having a proximal end and a distal end, the catheter comprising: a catheter shaft having one or more catheter lumens, a catheter central axis, an inner catheter surface, and an outer catheter surface separated from the inner catheter surface by a catheter wall thickness; a bushing attached to the proximal end of the catheter shaft; and an anchoring strain relief member distal to the bushing, hermetically engaged with the outer catheter surface, and including an integral seal comprising a plurality of ridges, each ridge having a ridge tip and a ridge height defined by a distance from the ridge tip to the catheter central axis, the distance being measured perpendicular to the central axis. Embodiments include, for example, an integral seal that is not tapered (tapered) or suitably tapered. Uses include the medical catheter for delivering substances for, for example, treating or diagnosing a disease or administering a therapy. In such uses, the integral seal provides a seal to an elastomeric peripheral sealing member (e.g., a hemostatic valve, such as a Tuohy-Borst adapter).

[0006] One embodiment of the present invention is a method for assembling a coaxial conduit system, the method comprising the steps of: providing an outer conduit including an outer conduit bushing and an outer conduit shaft, the outer conduit shaft including an outer conduit lumen, an outer conduit inner surface, and an outer conduit outer surface, wherein the outer conduit bushing is connected to the outer conduit shaft to provide fluid communication between the outer conduit bushing and the outer conduit shaft; providing an inner conduit including an inner conduit bushing, an anchoring strain relief member, and an inner conduit shaft, the inner conduit shaft including an inner conduit lumen having a central axis, an inner conduit inner surface, and an outer conduit outer surface, wherein the inner conduit bushing is connected to the inner conduit shaft to provide fluid communication between the inner conduit bushing and the inner conduit shaft, wherein the anchoring strain relief member is connected to the inner conduit shaft to provide fluid communication between the inner conduit bushing and the inner conduit shaft; and providing an inner conduit including an inner conduit bushing, an anchoring strain relief member, and an inner conduit shaft, the method comprising the steps of: providing an outer conduit including an outer conduit bushing, an outer conduit inner surface, and an outer conduit shaft, the method comprising the steps of: providing an outer conduit including an outer conduit bushing, an outer conduit inner surface, and an outer conduit shaft, wherein the outer conduit bushing is connected to the inner conduit shaft to provide fluid communication between the inner conduit bushing and the inner conduit shaft; and providing an inner conduit including an inner conduit bushing, an inner conduit inner surface, and an inner conduit outer surface, wherein the inner conduit bushing is connected to the inner conduit shaft to provide fluid communication between the inner conduit bushing and the inner conduit shaft; and providing an inner conduit including an inner conduit bushing, an inner conduit inner surface, and an inner conduit shaft, wherein the anchoring strain relief The outer surface of the internal catheter is sealed together; a connector is provided, the connector including a first opening and an elastomeric sealing member, wherein the sealing member provides a seal across the first opening; the connector is attached to the outer catheter bushing, the outer catheter bushing being in fluid communication with the outer catheter lumen and with a second opening between the connector and the outer catheter lumen; the inner catheter shaft is passed through the first opening and the sealing member and into the outer catheter shaft lumen, wherein the connector is in fluid communication through the second opening with an annular space formed between the outer surface of the internal catheter and the inner surface of the outer catheter; and a sealing portion of the strain relief member is disposed within the sealing member, wherein the sealing member is engaged to press against the portion of the strain relief member to establish a seal.

[0007] One embodiment of the invention is a system or kit comprising an elastomeric peripheral sealing member of a Tuohy-Borst adapter or other hemostatic valve and a medical catheter including an anchoring strain relief member, wherein the elastomeric peripheral sealing member provides a seal around the catheter when a portion of the anchoring strain relief member is disposed within the elastomeric sealing member of the Tuohy-Borst adapter. The system or kit may have a proximal and distal end, the catheter comprising: a catheter shaft having a catheter lumen, a catheter central axis, an inner catheter surface, and an outer catheter surface separated from the inner catheter surface by a catheter wall thickness; a bushing attached to the proximal end of the catheter shaft; and the anchoring strain relief member being distal to the bushing, sealingly engaging with the outer catheter surface, and including an integral anchoring portion comprising a plurality of ridges, each ridge having a ridge tip having a ridge height defined by a distance from the ridge tip to the catheter central axis, the distance being perpendicular to the central axis.

[0008] In another aspect, the present invention relates to a medical catheter having a proximal end and a distal end, the catheter comprising: a catheter shaft having a catheter lumen, an inner surface, and an outer surface separated from the inner surface by a catheter wall thickness; a bushing attached to the proximal end of the catheter shaft; and an anchoring strain relief member distal to the bushing and coupled to the outer surface of the catheter. The anchoring strain relief member may include a seal comprising at least one ridge having a ridge tip and a ridge height defined by a distance from the ridge tip to the central axis of the catheter, the distance being measured perpendicular to the central axis. Typically, the ridge forms a flow barrier between the outer surface of the catheter and the tip of the ridge, and if the seal comprises multiple ridges each having a ridge tip and a ridge height, a set of ridge tips does not taper gradually from proximal to distal, but tapers rearward (reverse taper) or tapers forward by no more than 5 degrees (forward taper).

[0009] In another aspect, the present invention relates to a method for assembling a nested catheter system, the method comprising:

[0010] An external catheter is provided, the external catheter comprising:

[0011] An external catheter bushing and an external catheter shaft, the external catheter shaft including an external catheter lumen, an external catheter inner surface and an external catheter outer surface, wherein the external catheter bushing is connected to the external catheter shaft to provide fluid communication between the external catheter bushing and the external catheter lumen;

[0012] An internal catheter is provided, the internal catheter comprising:

[0013] An internal conduit bushing, an anchoring strain relief member, and an internal conduit shaft, the internal conduit shaft including an internal conduit lumen having a central axis, an internal conduit inner surface, and an internal conduit outer surface, wherein the internal conduit bushing is connected to the internal conduit shaft to provide fluid communication between the internal conduit bushing and the internal conduit lumen, wherein the anchoring strain relief member is hermetically engaged with the internal conduit outer surface;

[0014] A connector is provided, the connector including a first opening and an elastomeric sealing member, wherein the sealing member provides a seal across the first opening;

[0015] The connector is attached to the external catheter bushing, the external catheter bushing being in fluid communication with the external catheter lumen and with a second opening between the connector and the external catheter lumen.

[0016] The inner conduit shaft passes through the first opening and the sealing member and enters the outer conduit shaft cavity, wherein the connector is in fluid communication with the annular space formed between the outer surface of the inner conduit and the inner surface of the outer conduit through the second opening, and

[0017] The sealing portion of the strain relief member is arranged within the sealing member, wherein the sealing member presses against the portion of the strain relief member to establish a seal.

[0018] In some aspects, the present invention relates to a system comprising a hemostatic valve and a medical catheter, the medical catheter including an anchoring strain relief member comprising an elastomeric polymer and having a sealing portion. The hemostatic valve includes a connector and a sealing member, and the sealing portion of the anchoring strain relief member is engageable by the sealing member of the hemostatic valve to form a seal to contain fluid. Attached Figure Description

[0019] Figure 1A This is an elevation side view showing one embodiment of a conduit with an anchoring strain relief member;

[0020] Figure 1B yes Figure 1A Enlarged view of the longitudinal cross-section of the anchorage strain relief member indicated by circle B in the figure;

[0021] Figure 2 This is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member;

[0022] Figure 3AThis is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member;

[0023] Figure 3B It is along Figure 3A The first embodiment of the ridge seen in the cross-sectional view taken from line BB;

[0024] Figure 3C It is along Figure 3A The second embodiment of the ridge seen in the cross-sectional view taken by line CC;

[0025] Figure 4 This is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member;

[0026] Figure 5A This is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member;

[0027] Figure 5B It is along Figure 5A A cross-sectional view taken from line BB in the diagram;

[0028] Figure 6 This is an elevation side view of an alternative embodiment of a conduit with an anchoring strain relief member that tapers rearward.

[0029] Figure 7 This is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member having a defined rearwardly tapering ridge tip;

[0030] Figure 8 This is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member having multiple ridges defined by multiple notches;

[0031] Figure 9A This is a perspective view showing an alternative embodiment of a conduit with an anchoring strain relief component;

[0032] Figure 9B yes Figure 9A Enlarged 3D view of the implementation plan;

[0033] Figure 10A yes Figure 9A Side elevation view of the implementation plan;

[0034] Figure 10B yes Figure 10A The elevation end view of the implementation plan presented in the document;

[0035] Figure 11A yes Figure 9A A top view of the implementation scheme;

[0036] Figure 11B yes Figure 11A The elevation end view of the implementation plan presented in the document;

[0037] Figure 12A This is an elevation side view showing an alternative embodiment of a conduit with an anchoring strain relief member;

[0038] Figure 12B It is along Figure 12A A cross-sectional view taken from section AA in the diagram;

[0039] Figure 12C It is along Figure 12A A cross-sectional view taken from section BB in the diagram;

[0040] Figure 12D It is along Figure 12A A cross-sectional view taken from section CC in the image;

[0041] Figure 13A An elevation side view of an alternative embodiment of a conduit with an anchoring strain relief component;

[0042] Figure 13B It is along Figure 13A A cross-sectional view taken from section DD in the diagram;

[0043] Figure 13C It is along Figure 13A A cross-sectional view of section EE in the diagram;

[0044] Figure 14A This is a plan view of a delivery system including a coaxial catheter;

[0045] Figure 14B It is the assembled Figure 14A A floor plan of the implementation scheme;

[0046] Figure 15A It is a graph showing the experimental results of the force that caused the anchoring strain to eliminate the displacement of the member during the counter-pressure test;

[0047] Figure 15B Is with Figure 15A The graphs using the same counter-pressure test show the results for a conventional strain-relieved component;

[0048] Figure 16A This is a graph showing the experimental results of the pull-out force required to move the anchor strain relief member in the sealed position within the Tuohy-Borst adapter; and

[0049] Figure 16BIs with Figure 16A A graph showing the experimental results of a conventional strain-relieved sheath under the same pull-out force test. Detailed Implementation

[0050] One embodiment of an anchoring strain relief member includes a strain relief member having surfaces suitable for clamping and sealing. The member may have one or more, typically multiple ridges, projecting from the member, which can engage a deformable sealing member compressed toward the anchoring strain relief member. The term ridge refers to a structure on the strain relief member that projects from the member relative to its immediate periphery. Ridges can protect the catheter from proximal disengagement from a hemostatic valve by providing an anchoring surface to engage an elastomeric sealing member and / or by providing a physical check or barrier to prevent disengagement. The anchoring strain relief member has a sealing portion that provides a sealing surface when engaged with a sealing member such as the sealing member of a hemostatic valve. The sealing portion providing the sealing surface can be made from a semi-rigid unit, such as a single molded plastic part or a single part overmolded on the catheter, or the sealing portion can be assembled from multiple parts. The sealing portion typically does not taper practically, but tapers rearward in a proximal-to-far direction, or tapers forward with a taper of no more than about 5 degrees.

[0051] Catheters with anchoring strain relief components are particularly useful for delivering a second lumen through a larger catheter. The resulting nested catheter system provides two lumens, which may, but are not necessarily, coaxial. An external catheter can be attached to an accessory at the proximal liner, and the accessory includes a suitable connector for attaching the catheter liner and a hemostatic valve that provides a sealing member to engage the seal of the anchoring strain relief component of the catheter. One embodiment of the delivery system is described below, in which a dual-channel delivery device delivers two chemical components through the separate lumens of the nested catheter system for merging at a distal location normally within the patient's body.

[0052] Figure 1A A conduit 100 is shown, which has a bushing 102, a conduit shaft 104 having a distal tip 106, and an anchoring strain relief member 108 having a barb 110 having a tip 112 proximal to the barb base 114. Figure 1B yes Figure 1BAn enlarged view of region B shows the top surface 116 and bottom surface 118 of the strain relief member 108. The catheter shaft 104 has an outer surface 120 and an inner surface 122 separated by a wall 124, and a cavity 126 with a central axis 128. The gaps between the barbs 110 and the proximal side of the barb 110 can serve as notches that can engage with the resilient sealing member of the hemostatic valve using the barbs, which in turn act as check devices for any movement of the catheter within the valve. For the following... Figure 2-5B The structure within follows a similar inherent function.

[0053] Figure 2 A conduit 130 is shown, which has a bushing 132, a conduit shaft 134, and an anchoring strain relief member 136 with a circular ring 138 having a tip 140. Figure 3A A conduit 150 is shown, which has a bushing 152, a conduit shaft 154, and an anchoring strain relief member 156 having a flat ring 158 having a tip 160. Figure 3B This is a cross-sectional view of a first embodiment of a flat ring 158 having a cylindrical surface at its tip 160, wherein the top surface 162 of the conduit shaft 154 is directly coupled to the flat ring 158. The conduit shaft 154 has an inner surface 164 surrounding a lumen 166. Figure 3C A second embodiment is a flat ring 158 having a polyhedral surface, wherein the polyhedral surface is square 168.

[0054] Figure 4 A conduit 170 is shown, which has a bushing 172, a conduit shaft 174, and an anchoring strain relief member 176 with a circular pawl 178 having a tip 180. Figure 5A A conduit 190 is shown, which has a bushing 192, a conduit shaft 194, and an anchoring strain relief member 196 with a circular pawl 198 having a tip 200. Figure 5B A plurality of pawls 198 are shown, spaced apart around the periphery of the strain relief member 196 and perpendicular to each other in this embodiment. The conduit shaft 194 has a first hollow tube 201 and a second hollow tube 202 mounted on the first hollow tube 201.

[0055] Figure 6 A conduit 210 is shown, having a bushing 212, a conduit shaft 214, and an anchoring strain-relieving member 216 that tapers rearward 218. The taper diameter increases from proximal to distal. The rearward taper, utilizing the elastic sealing member of the engaging strain-relieving member, naturally acts as a check for proximal movement of the conduit relative to the valve. Figure 7A conduit 220 is shown, having a bushing 222, a conduit shaft 224, and an anchoring strain relief member 226 having barbs 228, 228', 228" with corresponding tips 229, 229', 229" as shown by tangent 230. The height of the tips increases from proximal to distal, thus providing a rearward taper 232 defined by the tips of the barbs. The barbs 228, 228', and 228" have proximal surfaces that can be used as check valves for proximal movement of the conduit by means of a sealing member engaging a valve.

[0056] Figure 8 A catheter 240 is shown, having a bushing 242, a catheter shaft 244, and an anchoring strain relief member 246 having ridges 248, 248', 248" defined by a notch 250. The notch 250 may also engage a resilient sealing member of a hemostatic valve to provide a check valve function.

[0057] Figure 9A-11B Another embodiment is shown. The conduit 300 has a bushing 302, a shaft 304, and an anchoring strain relief member 306. The bushing 302 has a wing 308 and a connector 310. The conduit shaft 304 has an opening 312, a distal tip 314, and a non-transparent cable strip 316. Figure 12A-12D An alternative embodiment of the anchorage strain relief member 307 is shown. The difference between strain relief members 306 and 307 is that member 306 has a tapered portion 326 that is not present in member 307. Figure 9A ). Figure 9A Part 328 has a constant outer diameter, and it can be seen that part 328 is mounted within an imaginary cylinder of constant diameter, coaxial with the conduit shaft 304. (See also...) Figure 9A-12D The anchoring strain relief members 306 and 307 have a cylinder 318 and ridges 320' and 320" with corresponding flat surfaces 322' and 322" respectively. Notches 324' and 324" define the ridges 320' and 320" respectively. The heights of the cylinder 318 and the ridges 320' and 320" are shown as 330, 332', and 332" respectively. Figure 9A-11B The implementation scheme provides a continuous surface with good texture over a significant length for holding the hemostatic valve's elastomeric sealing member and for providing a check valve function.

[0058] Figures 13A-13CA catheter 340 is shown, having a bushing 342, a catheter shaft 344, and an anchoring strain relief member 346 having a ridge 348 defined by a notch 352. The ridge 348 is cylindrical with a height 354. The notch 352 provides a check for proximal movement of the catheter within a hemostatic valve by providing an engagement surface for an elastomeric sealing member below adjacent ridges. The ridge 348 is cylindrical with a height 356. The shaft 344 has an outer surface 358, an inner surface 360, and a lumen 362. In some embodiments, the ridges 348 may have a constant perimeter and their corresponding height relative to each other, such that the perimeter and surface area can be substantially equal. In this case, the term substantially equal means within 10% of the arithmetic mean of the members in the groups being compared. In one embodiment, the anchoring strain relief member 346 has a length of approximately 3 cm and a height of 0.13 cm (4 French). More generally, strain-relieving members of substantially constant diameter may have a length of about 0.5 cm to about 15 cm, and in another embodiment about 1 cm to about 12 cm, and a diameter of about 0.066 cm to about 0.34 cm, and in another embodiment about 0.1 cm to about 0.3 cm. Those skilled in the art will recognize that other ranges of length and diameter within the explicitly stated range above are also considered and are within the scope of this disclosure.

[0059] Figures 14A-14BA delivery system is shown, comprising a dual syringe 400, a connector 402, an external conduit 404, and an internal conduit 406. The dual syringe 400 includes a first syringe 408, a second syringe 410, a support 412, and a clamp 414. The support 412 and clamp 414 are shown conceptually in cross-sectional view; those skilled in the art are familiar with providing these functions. The syringes 408, 410 have corresponding barrels 416, 418 and plungers 420, 422, openings 424, 426, and connectors 428, 430. The connector 402 has a proximal connector 432 with a proximal opening 434, a distal connector 436 with a distal opening 438, a side port 440 with a side port opening 442, and a sealing member 444. A sealing member 444 is hermetically disposed within connector 402 to seal proximal opening 434 and provides opening 442 for side port 440 and opening 438 for distal connector 436, thereby providing internal fluid communication with connector 402. External conduit 404 has a bushing 446 with wings 448, connector 450, strain relief member 454, and external conduit shaft 456 with a distal tip 458. Internal conduit 406 has a bushing 460 with wings 462, connector 464, anchoring strain relief member 466, and internal conduit shaft 468 with a distal tip 470 and proximal hollow tube 472. Hollow tube 472 provides a thickened portion of internal conduit shaft 468. Details of anchoring strain relief member 466 are not shown; the ridge may or may not have the notch described elsewhere herein. During assembly, internal conduit shaft 468 may be arranged to extend beyond external conduit shaft 456 by a distance 474. The delivery system comprises a fluid-connecting conduit 476 to a connector 402 and a dual syringe 400. The delivery system can be assembled by engaging the connector 402 with an outer conduit 404, and by having an inner conduit shaft 468 pass through the connector 402 and a sealing member 444 to engage the inner conduit 406 with the connector 402. The dual syringe 400 is engaged with the connector 402 via the conduit 476 and with the inner conduit 406 via a bushing 460.

[0060] Technicians are familiar with methods of using catheters, introducing catheters into patients, and guiding catheters to deploy them in desired locations (including the placement of nested catheter systems such as coaxial catheter systems). However, in an improvement adapted from such familiar methods, the anchoring strain relief member in the device described herein can serve as a sealing and clamping surface. Specifically, a sealing member, such as an elastomeric material, can be pressed against the sealing portion of the anchoring strain relief member, causing the compressible member to deform to provide a seal with the sealing portion of the member, which has ridges protruding into the elastomeric material to provide resistance against movement of the member relative to the compressible material. Anchoring strain relief members have been found particularly useful for providing a seal and clamping when mounted on the inner catheter of a coaxial catheter system. The anchoring strain relief member can be arranged within the sealing member of a connector to provide a seal around the inner catheter. The sealing member can be an elastomeric sealing member.

[0061] Connector 402 is an example of a hemostatic valve, such as a Tuohy-Borst adapter. These are known to those skilled in the art and are commercially available. Hemostatic valves can be opened and closed using various actions such as sliding / snapping, movement of a lever, or rotation of a knob, and for the purposes of this application, a rotational implementation may be preferred, although any form may be used. Examples of suitable valves include, for example: valves with rotatable caps, such as Bales et al., US 4,723,550, entitled "Leak-proof hemostatic valve with a single valve member"; valves with rotary knobs, such as Stevens' US 5,591,137, entitled "Hemostatic valve with a locking seal"; Barry et al., US 5,911,710, entitled "Medical insertion device with a hemostatic valve"; and valves having a first sealing member that opens when the knob is turned and a second sealing member that closes when the knob is further turned, such as Agrawal et al.'s published US patent application 2018 / 0256872, entitled "Hemostatic valve and method for preparing and using a hemostatic valve," all of which are incorporated herein by reference. Such adapters have an elastomeric member that seals the opening of the adapter. In some embodiments, the elastomeric sealing member is a membrane, which is engaged to form a seal and disengaged to allow relative movement of the membrane. Embodiments of the membrane are, for example, continuous membranes or membranes with slits, slots, or openings in various configurations available in commercial devices, and see the examples below. Other embodiments of the sealing member are one or more sealing elements, such as sealing rings, that engage the surface of the catheter. The Tuohy-Borst adapter may include operable fastening features for increasing compression between the catheter assembly and the sealing member after the catheter assembly is in place near the sealing member. When connected to a shaft via an interface, the elastomeric member provides a seal around the shaft. Materials for the elastomeric member are known, including silicone, fluoropolymers, rubber, etc. Connectors such as the Tuohy-Borst adapter may optionally include a drive member that is, for example, rotatably movable to provide additional compressive force to the elastomeric member (e.g., FLO40 Tuohy-Borst adapter, Merit Medical, Salt Lake City, Utah). The Tuohy-Borst adapter can be used with or without side ports. If the Tuohy-Borst adapter is used without a side port, this additional connector can be used in a nested (e.g., coaxial) conduit system, for example, by placing another connector with a side port between the Tuohy-Borst adapter and the external conduit. The fluid conduit leading to the delivery system can then be appropriately connected to establish communication with the internal and / or external conduits. References to connecting connectors in a conduit system refer to establishing communication that seals off the fluid, and unless otherwise specified, this can be a direct or indirect connection.

[0062] Typically, inserting a catheter with a sealing strain relief member through a hemostatic valve and sealing the strain relief member into the valve provides a particularly useful configuration for the delivery of an inner catheter within an outer catheter. For convenience, such a configuration is generally referred to herein as a nested catheter configuration. If the outer catheter is a cylindrical, symmetrical, single-lumen catheter, the nested configuration may be referred to as coaxial, even if not strictly coaxial; however, the nested catheters need not be coaxial. Generally, the use of nested catheters can be convenient and useful for a variety of medical procedures, and the length and diameter of the catheter can be selected to suit a particular procedure. The catheter with a sealing strain relief member described herein can generally be used for these various procedures. [Refer to...] Figure 14A and 14B The above describes a more detailed embodiment of delivering different fluids via nested catheters for merging fluids at the distal end of the catheter; however, this detailed discussion is not intended to reveal anything other than this embodiment of particular interest.

[0063] Dual-injector system 400 is a dual-injector system and one embodiment of a delivery system. The delivery system can provide the removal, extraction, or both of material via a catheter lumen. For example, a peristaltic pump can be used instead of a syringe, or an injection pump can be used instead of a manually operated dual-injector system. Other flow systems are known and can be used with catheters. Similarly, delivery systems that use syringes, pumps, or other means to remove fluids and / or other materials are known and can be used.

[0064] The catheter comprises a hollow tube providing the catheter shaft. A bushing is attached to the proximal end of the catheter. The distal end of the catheter is the portion introduced into the patient. This invention is suitable for use with various catheter lengths and diameters, such as medical catheters with a length of at least 10 cm and not exceeding 12-160 cm; those skilled in the art will directly understand that all ranges and values ​​between the clearly stated boundaries are taken into account, and 10, 12, 15, 20, 25, 35, 40, 50, 75, 100, 125, 150, and 160 cm may be used as lower or upper limits. The inner and outer diameters of the catheter may, for example, be 0.2-10 mm; those skilled in the art will directly understand that all ranges and values ​​between the clearly stated boundaries are taken into account, and for example, 0.2, 0.4, 0.6, 0.8, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.9, 2, 3, 4, 4.5, 5, and 10 mm are available. The inner diameter is always smaller than the outer diameter. Furthermore, a technician can select the inner and outer diameters for multiple nested catheters to be used with an inner catheter, the inner catheter having an outer diameter capable of passing through the inner diameter of an outer catheter. The catheter can have a constant shaft inner and outer diameter and be directly connected to the bushing, or the shaft inner and / or outer diameter can vary along the entire shaft or a portion of the shaft. A catheter shaft with an increased wall thickness at its proximal end can usefully incorporate a strain relief member and can be located below the entire strain relief member or a portion thereof, and / or extend beyond the strain relief member. For example, a second hollow tube can be overlaid on a smaller hollow tube to provide the catheter shaft.

[0065] Many materials are known for use in catheters, including, for example, one or more biocompatible materials, such as metals like stainless steel or alloys, for example. Or polymers, such as polyether-amide block copolymers. Nylon (polyamide), polyolefin, polytetrafluoroethylene, polyester, polyurethane, polycarbonate, polysiloxane (organosilicon), polycarbonate polyurethane (e.g.) The polymer can be a mixture of these polymers, or other biocompatible polymers. Radiopaque linearity can be achieved by incorporating metallic markers or plastics loaded with a dense material (i.e., metal or mineral powder), which can be made of gold, platinum-iridium, radiopaque compounds, or other suitable elements. The catheter body can be extruded or formed using other suitable polymer processes. The catheter wall can include fine metallic reinforcements that can be melted into the polymer or otherwise treated for embedding into the polymer, such as by polymer shrink wrapping. Fittings and strain-relieving components can be overmolded onto the catheter shaft, or otherwise thermally bonded, adhesively bonded, or a combination thereof.

[0066] The inventors have determined that an anchoring strain-relieving component can be fabricated to relieve strain in a conduit, but it further provides an anchoring feature. This anchoring feature allows for higher pressures in the conduit because it provides a better seal compared to the conduit shaft, thereby resisting the linear forces generated at higher pressures that could potentially dislodge the conduit. The higher pressure is useful not only for fluid flow rates but also for moving highly viscous materials or for using conduits with smaller diameters than would otherwise be suitable.

[0067] Anchored strain relief components can be made from multiple parts or as a single, continuous piece. The strain relief component can be molded in place, formed together with the conduit, or formed separately and then attached to the conduit shaft, such as using thermal bonding / adhesive bonding or other suitable methods. Materials used in the strain relief component can be, for example, metals, elastomers, thermoplastics, thermosetting plastics, silicones, fluoropolymers, combinations thereof, etc.

[0068] Anchoring strain relief components may have a sealing portion designed for sealing with the elastomeric component and other portions not designed for sealing with the elastomeric component. For example, Figure 9B One embodiment has a tapering portion 326 having an outer diameter unsuitable for placement within a Tuohy-Borst sealing member. The portion suitable for sealing is preferably not tapering, meaning it is not tapering in the proximal-to-far direction. Alternatively, the tapering in the proximal-to-far direction has a tapering angle not exceeding about 5 degrees, in other embodiments not exceeding about 3 degrees, and in yet another embodiment not exceeding about 1.5 degrees. Those skilled in the art will recognize that other ranges of cone angles within these defined ranges are also considered and are within the scope of this disclosure. A rearward tapering can be useful because it itself can provide some backstop function and naturally forms at least one ridge. It is also useful for sealing around portions of the member having substantially equal ridge heights.

[0069] Anchoring strain relief components may have surfaces comprising multiple ridges. The ridges are raised body sections or structures. Unless otherwise specified, the dimensions of the ridges are measured as vertical distances to the center of the conduit lumen, see, for example, [reference needed]. Figures 12A-13CWhen the ridges engage with compressive forces from the elastomeric member or other sources, their resistance to anchoring strain eliminates movement of the member. As further described below, surface texture can complement the sealing effect provided by the ridges. The ridges can be distributed such that multiple ridges or a predetermined number of ridges are used to cover the elastomeric member for sealing around the ridges. Thus, embodiments include a predetermined number of ridges / mm length (referred to herein as linear density), wherein the length is obtained on the outer surface of the member for a distance parallel to the central axis of the cavity, and the number of ridges / mm is 0.2-20; those skilled in the art will directly understand that all ranges and values ​​between the explicitly stated boundaries are considered, e.g., 0.2, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20 ridges / mm. The number of ridges per mm can advantageously be used to control resistance to movement of the inner catheter, particularly in coaxial catheter systems, where movement of the inner catheter relative to one or more other catheters is required. The ridge height is selected based on considerations such as the required pull-out strength of the conduit with the anchored strain relief member, the linear density of the ridge, the fill volume, and the dimensions. The ridge height can be, for example, 0.2–5 mm; those skilled in the art will directly understand that all ranges and values ​​between the explicitly stated boundaries are taken into account, such as 0.2, 0.3, 0.4, 0.5, 1, 1.5, 2, 2.5, 3, and 4 mm. Similarly, the difference between the ridge tip height and the radius of the outer conduit surface to which the strain relief member is attached can be 0.1–4 mm; those skilled in the art will directly understand that all ranges and values ​​between the explicitly stated boundaries are taken into account, such as 0.1, 0.2, 0.3, 0.4, 0.5, 1, 1.5, 2, 2.5, 3, and 4 mm. The radius of the conduit and / or the conduit surface is measured from the central axis of the conduit.

[0070] The space between the ridges is referred to as a notch, and some embodiments include anchoring strain relief members having surfaces comprising multiple notches. In one embodiment, the member has a constant perimeter and height, except for the notches, wherein the notches have a depth. The notches can be independently selected to have a depth of 0.05–4 mm; those skilled in the art will directly understand that all ranges and values ​​between the explicitly stated boundaries are considered, such as 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 1, 1.5, 2, 2.5, 3, and 4 mm.

[0071] Another measure for quantifying the characteristics of the ridge and / or notch is volume. The anchorage strain-relieving member is placed in an imaginary cylinder with a constant diameter, coaxial with the conduit lumen, wherein the imaginary cylinder is tangent to the ridge at both its proximal and distal ends; this volume measure is not used when these standards are not applicable, and it may be applied to the entire member or only to a portion of the anchorage strain-relieving member; furthermore, the imaginary cylinder has a length of at least 0.1 mm, and this length may be specified as a value or range of 0.1 mm to 10 cm, such as 0.01 mm, 0.25 mm, 0.5 mm, 1 mm, 2 mm, 5 mm, 7.5 mm, 1 cm, 2.5 cm, 5 cm, 7.5 cm, or 10 cm. The member is solid and occupies a certain percentage of the cylinder's volume. This measure is called the fill volume. The implementation plan includes anchorage strain relief components with a fill volume of 50-90%; technicians will directly understand that all ranges and values ​​between clearly stated boundaries are taken into account, such as 50%, 60%, 70%, 80%, 90%.

[0072] Because the anchoring strain relief member provides a seal together with the elastomeric member, it is part of or attached to a conduit, creating a fluid-tight seal between the strain relief member and the elastomeric sealing member. Furthermore, the member completely excludes any passage that would allow fluid flow from the distal to the proximal end of the member when it is in the sealed position with the elastomeric member, or at least has a sealing portion that excludes any such passage. Such passages are referred to herein as fluid channels. The exclusion of fluid channels allows for the establishment of a seal. The portion of the anchoring strain relief member excluding fluid channels can be, for example, 1-15 cm, and those skilled in the art will directly understand that all ranges and values ​​between the clearly stated boundaries are considered, such as 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 15 cm.

[0073] Examples of ridges and / or notches in Figure 1A-13C The ridge and / or notch height, linear density, and infill volume are provided above and generally apply to the embodiments specifically described herein. Figure 1A-1B The barb is shown. The barb has a tapering protrusion that gradually decreases in height from a large height on the proximal side to a smaller height on the distal side. Figure 2 Circular rings are shown, each having a constant height substantially equal to that of the other rings shown. The rings have circular surfaces. Figures 3A-3C Flat rings, either circular or square, are shown. Each ring extends around the entire perimeter of the component and has a height at each point within the perimeter. Alternative embodiments offer independently selectable or gradually tapering ring shapes and / or heights. Figure 4-5B Various types of pawls are shown. Pawls are protrusions that do not extend around the entire perimeter of the component. Figure 6 and7 Different implementations of the anchorage strain relief member that tapers backward are shown. Figure 7 The barbs extend around the perimeter of the component. Figure 8 An anchoring strain relief member with sealing and clamping features is shown, which can be readily described by a notch relative to the outermost radius of the strain relief member, which is constant in the seal of the illustrated embodiment. The notch can be selected as described elsewhere herein, and the seal of the strain relief member can be constant or taper rearward. Figure 9A-13C A strain-relieving member comprising multiple rings of length separated by notches is shown. The term "ring" is general and includes a ridge extending around the periphery of the member's cross-section, such as a cylinder, right cylinder, cuboid, or cone. Figure 9B-12D In this design, the notch comprises a flat surface, wherein adjacent notches have flat surfaces perpendicular to each other. Offsetting the flat surfaces relative to each other by 10-90 degrees advantageously alters the vector of forces applied to the member in adjacent notches, thereby increasing resistance to tension. Those skilled in the art will readily understand that all ranges and values ​​within the explicitly stated 10-90 degree boundary are considered, such as 10, 20, 30, 40, 45, 50, 60, 70, 80, and 90 degrees.

[0074] There are no size limitations for catheters including anchoring strain relief components; however, the components have been observed to be particularly useful on the inner catheters of nested catheter systems having an outer diameter of 0.2–3 mm. Those skilled in the art will readily understand that all ranges and values ​​between the clearly stated boundaries are considered, e.g., 0.2, 0.3, 0.4, 0.5, 0.6, 0.8, 1, 1.2, 1.4, 1.5, 1.6, 2, 2.2, 2.4, 2.6, 2.8, 3 mm. Those skilled in the art are familiar with medical catheters and will recognize the scope and boundaries of this term. Medical catheters are sterilizable and / or can be supplied in a sterile form, for example, in packaging adapted for use with aseptic techniques.

[0075] Kits and systems can be used to provide catheters including anchoring strain relief components that mate with hemostatic valves such as Tuohy-Borst adapters for efficient sealing and pull-out force. Additionally or alternatively, the system may also include external catheters and / or other components, such as fluid delivery components, other accessories, or additional medical devices, for use with or delivery via the catheter. Adapters may have standardized connections for easy connection with external catheters of different sizes. Anchoring strain relief components may be one embodiment provided herein; catheters and Tuohy-Borst adapters may be selected from any source, provided they do not impede the operation of the anchoring strain relief component embodiment. Various components of the system may be generally packaged or unpackaged. Furthermore, various components may be provided in a range of sizes that can be selected differently for a particular patient.

[0076] As described above, one object of the catheter described in this application relates to the ability of the anchoring strain relief member to stably engage a hemostatic valve to withstand a greater amount of pressure without disengaging. In the following embodiments, tests are performed to quantify this sealing capability. Pull-out force can be measured using a general-purpose tester with a gantry speed of 300 mm / min and converted into a pressure value. In the case of the catheter embodiments described herein, the pull-out force, expressed as pressure, can be at least 9 N, at least about 10 N in other embodiments, and at least about 12 N in yet another embodiment. Those skilled in the art will recognize that other ranges of pressure within the explicitly stated range above are also considered and are within the scope of this disclosure.

[0077] All patents, publications and references provided in this patent application are incorporated herein by reference for all purposes; in case of conflict, this specification shall prevail.

[0078] Example 1 describes an embodiment of a conduit equipped with the anchoring strain relief member of the present invention. Example 2 describes a counter-pressure test. Compared with a conventional strain relief member, 214N (1,547 PSI) Figure 15B In comparison, anchored strain relief components require an average of 246 N (1,779 PSI) to displace the strain relief component under back pressure test conditions. Figure 15AThe anchored strain-relieving member moves slowly and stops moving, exhibiting no elongation after back pressure release. In contrast, conventional strain-relieving members exhibit tension and are eventually rapidly expelled from the assembly. Back pressure testing measures back pressure by observing the force applied to the plunger of a 1 ml syringe providing back pressure. Clearly, the anchored strain-relieving member provides significantly greater resistance. Example 2 describes a pull-out force test with the anchored strain-relieving member in the sealed position in the Tuohy-Borst adapter. The pull-out force is 15 N, compared to 7 N for a conventional strain-relieving member. These examples demonstrate the very superior anchoring properties of the anchored strain-relieving member. These are useful for applying increased pressure to the material passing through the conduit assembly, and also for the user manipulating the conduit assembly. Furthermore, the increased resistance, tensile strength, and seal integrity retention are useful for fine-tuning the arrangement of the conduit during use. Moreover, it is believed that the inventors are the first to prepare and use a strain-relieving member as a sealing member.

[0079] Example

[0080] Example 1: Strain-relieving anchorage component

[0081] preparation Figure 9A-11B The conduit features a strain-relieving anchoring element. The conduit is a stainless steel ring-reinforced polyamide shaft with an inner diameter of 0.014 inches and an outer diameter of 0.017 inches, and includes a strain-relieving element and a bushing assembly attached to the proximal end. The bushing assembly is a Luer bushing conforming to ISO 80369-7 (2016).

[0082] The strain relief member 306 is prepared by overmolding a thermoplastic elastomer onto the conduit shaft. The strain relief member cylinder 318 has a diameter of 0.051 inches, and the ridge 320 has a maximum diameter of 0.051 inches and a thickness of 0.015 inches relative to the outer surface of the conduit. The portion 328 has a length of 3 cm.

[0083] Example 2: Reaction Force Pressure Test

[0084] This test measures the force required to displace the strain-relieving component from the Tuohy-Borst adapter. A commercial Tuohy-Borst adapter with an elastomer peripheral seal (having a 0.053-inch proximal opening, side port opening, and distal opening) was prepared with a closed end cap to prevent fluid from leaving the distal opening. A 1 ml syringe containing water was connected to the side port of the Tuohy-Borst adapter. The catheter of Example 1 was shortened and passed through the seal of the hemostatic adapter, positioned such that the strain-relieving component contacted the seal. The distal end of the catheter was blocked without fluid. The assembly was positioned... The force required to press the plunger of a 1ml syringe is measured in a (3343 model) universal testing instrument. A comparative assembly with the same dimensions is prepared, differing only in the use of a standard (smooth) strain relief element.

[0085] The frame travel speed was set to 300 mm / min, and the force on the plunger was measured. Figure 15A (Anchoring strain relief component) and Figure 15B (Comparison component). Three tests were performed for each component. The average displacement force of the anchor strain-eliminating component was 1,779 PSI with a standard deviation of 45 PSI; the maximum force was 1,822 PSI with a range of 87 PSI. The average displacement force of the comparison component was 1,547 PSI with a standard deviation of 112 PSI; the maximum force was 1,634 PSI with a range of 210 PSI.

[0086] Example 3: Pull-out force test

[0087] This test measures the force required to pull the anchorage strain relief member out of the hemostatic adapter. Anchorage strain relief members and contrast relief member assemblies were prepared as in Example 2. Each was placed in a commercial Tuohy-Borst adapter and installed to… In the (model 3343) tester, the Tuohy-Borst adapter is held in a fixed position, and the frame is fixed to the proximal end of the conduit. The frame travel speed is set to 300 mm / min.

[0088] The pull-out force of the anchorage strain-eliminating component averaged (through 3 tests) 15 N, with a standard deviation of 1.2, a maximum value of 16.6, and a range of 2.2. Figure 16A The average pull-out force of the strain-eliminating component (based on 3 tests) was 7 N, with a standard deviation of 0.6, a maximum value of 7.3, and a range of 1.3. Figure 16A .

[0089] The above embodiments are intended to be illustrative rather than restrictive. Other embodiments are also within the scope of the claims. Furthermore, although the invention has been described with reference to specific embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of the invention. Any combination of references cited above is limited to subject matter that does not contradict the explicit disclosure herein. In describing aspects of a particular structure, composition, and / or process herein using components, elements, ingredients, or other divisions, it should be understood that the disclosure herein covers specific embodiments, i.e., embodiments including specific components, elements, ingredients, other divisions, or combinations thereof, and embodiments primarily composed of such specific components, ingredients, or other divisions, or combinations thereof, as indicated in the discussion. Unless otherwise expressly stated, said embodiments may include additional features that do not alter the essential nature of the subject matter. Unless otherwise expressly stated, the term “about” used herein refers to the measurement error of a particular parameter.

Claims

1. A medical catheter having a proximal end and a distal end, said catheter comprising: A catheter shaft having a catheter lumen, an inner surface, and an outer surface separated from the inner surface by a catheter wall thickness. A bushing, the bushing being attached to the proximal end of the catheter shaft, and An anchoring strain relief member, which is distal relative to the bushing, is hermetically engaged with the outer surface of the conduit and includes a seal comprising at least one ridge having a ridge tip and a ridge height defined by a distance from the ridge tip to the central axis of the conduit, the distance being measured perpendicular to the central axis, wherein the ridge forms a flow barrier between the outer surface of the conduit and the ridge tip, and wherein if the seal comprises a plurality of ridges each having a ridge tip and a ridge height, a set of the ridge tips does not taper gradually in a proximal direction, tapers gradually rearward, or tapers gradually forward at no more than 5 degrees.

2. The medical catheter of claim 1, wherein the sealing portion does not taper gradually.

3. The medical catheter of claim 1, wherein the sealing portion does not include a fluid passage.

4. The medical catheter of claim 1, wherein each of the plurality of ridges has substantially equal ridge tip height.

5. The medical catheter of claim 1, wherein the longitudinal length of the sealing portion is 1-10 cm.

6. The medical catheter of claim 1, wherein at least three of the plurality of ridges define a first ring, a second ring, and a third ring, wherein a first flat surface separates the first ring and the second ring, and a second flat surface separates the second ring and the third ring, wherein the first flat surface and the second flat surface are parallel to the central axis of the catheter and offset relative to each other.

7. The medical catheter of claim 6, wherein the first flat surface and the second flat surface are perpendicular to each other.

8. The medical catheter of claim 6, wherein at least two cylinders in the ring define a constant circumference.

9. The medical catheter of claim 1, wherein at least two of the ridges each define a barb, wherein the base of the barb is distal relative to the tip of the barb.

10. The medical catheter of claim 1, wherein at least two of the ridges each define a ring.

11. The medical catheter of claim 1, wherein the strain relief member comprises one or more notches, the one or more notches being arranged such that engagement of the notch with the resilient sealing member of the valve arranges the ridge as a check for proximal movement of the catheter relative to the valve.

12. The medical catheter of claim 1, wherein at least two of the spines each define a pawl.

13. The medical catheter of claim 1, claim 3, or any one of claims 5 to 12, wherein the ridge height defines a gradual taper with a slope not exceeding 5% or a posterior taper.

14. The medical catheter of claim 1, wherein the sealing portion has a substantially constant outer diameter, and the plurality of ridges are defined by a plurality of notches in the anchoring strain relief member.

15. The medical catheter of claim 1, wherein the anchoring strain relief member comprises an elastomeric material.

16. The medical catheter of claim 1, wherein the ridge height is in the range of 0.2 mm to 3 mm.

17. The medical catheter of claim 1, wherein the difference between the ridge height of the plurality of ridges and the radius of the outer surface of the catheter is in the range of 0.05 mm to 3 mm.

18. The medical catheter of claim 1, wherein the plurality of ridges have a height of 2-50.

19. The medical catheter of claim 1, wherein the linear density of the plurality of ridge heights is 0.2-5 / mm.

20. The medical catheter of claim 1, wherein the diameter of the outer surface of the catheter shaft is 0.2 mm to 3 mm.

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