Fast exchange system for OTW conveying

Abstract

A medical system includes an introducer device having an elongate shaft defining a shaft lumen and a hub secured to a proximal region of the elongate shaft. The hub includes a primary passage extending through the hub and fluidly coupled with the shaft cavity, and a secondary passage extending through the hub and fluidly coupled with the shaft cavity. A guide catheter is adapted to advance through the secondary channel into the shaft cavity. A guidewire is adapted to advance through the secondary channel into the shaft cavity. A working catheter is adapted to advance through the primary channel into the shaft lumen when the guide catheter is positioned with the distal end of the guide catheter within the secondary channel, the working catheter comprising a catheter shaft comprising a distal region adapted to releasably engage the guidewire.

Description

Cross-references to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 464,751, filed May 8, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention relates to an implant. More particularly, this invention relates to an implant that holds an OTW tool within a flow of saline solution. Background Technology

[0003] Various intravascular medical devices have been developed for medical applications, such as intravascular use. Some of these devices include guidewires, catheters, etc. These devices are manufactured using a wide variety of different methods and can be used according to a wide variety of methods. Each of the known medical devices and methods has certain advantages and disadvantages. There is currently a need to provide alternative medical devices and alternative methods for manufacturing and using these medical devices. Summary of the Invention

[0004] This invention relates to several alternative designs, materials, and methods for manufacturing medical device structures and components, and their uses. One example can be found within a medical system including an infeed device comprising an elongated shaft defining a cavity therethrough, the elongated shaft including a proximal region, and a proximal hub fixed relative to the proximal region of the elongated shaft. The proximal hub includes a primary channel extending through the proximal hub and fluidly connected to the cavity; and a secondary channel extending through the proximal hub and fluidly connected to the cavity. A guide tube is adapted to be advanced through the secondary channel and into the cavity. A guidewire is adapted to be advanced through the secondary channel. A working catheter is adapted to be advanced through the primary channel into the cavity when the guide tube has been withdrawn proximally such that the distal end of the guide tube is retained within the secondary channel. The working catheter includes a catheter shaft including a distal region, the distal region of which is adapted to releasably engage the guidewire.

[0005] Alternatively or additionally, the medical system may also include a first hemostatic valve fluidly connected to the primary channel and a second hemostatic valve fluidly connected to the secondary channel.

[0006] Alternatively or additionally, the medical system may also include a third hemostatic valve disposed between the proximal hub and the slender shaft, thereby providing fluid-impermeable volumes within the primary and secondary channels.

[0007] Alternatively or additionally, the guidewire may have a first diameter on the guidewire outside the junction area and a second diameter smaller than the first diameter within the junction area.

[0008] Alternatively or additionally, the distal end of the working catheter may include a distal body that defines key engagement features suitable for releasably engaging a guidewire.

[0009] Alternatively or additionally, the main engagement features may include a body cavity having a body cavity diameter and a channel operatively connected to the body cavity, the channel having a channel width smaller than the body cavity diameter.

[0010] Alternatively or otherwise, the channel width may be less than the first diameter of the guidewire and greater than the second diameter of the guidewire, and the body cavity diameter may be greater than the first diameter of the guidewire.

[0011] Alternatively or additionally, the engagement feature may also include one or more secondary engagement features disposed near the primary engagement feature.

[0012] Alternatively or additionally, each of one or more secondary engagement features may include a C-shaped feature having a lumen diameter greater than a first diameter of the guidewire and a channel width greater than a second diameter of the guidewire.

[0013] Alternatively or otherwise, the main channel may be curved, and the secondary channel may be straight and intersect with the main channel.

[0014] Another example can be found in an introducing device used with a guide tube and a working catheter. The introducing device includes an elongated shaft defining a cavity therethrough; and a hub fixed relative to a proximal region of the elongated shaft. The hub includes a first hemostatic valve disposed at a proximal end of the hub; a second hemostatic valve disposed at a proximal end of the hub, parallel to but spaced apart from the first hemostatic valve; a main channel extending distally from the first hemostatic valve through the hub to the cavity; and a secondary channel extending distally from the second hemostatic valve through the hub and fluidly connected to the main channel.

[0015] Alternatively or otherwise, the main channel may bend from the first hemostatic valve through the hub toward the shaft cavity.

[0016] Alternatively or otherwise, the secondary channel may extend linearly from the second hemostatic valve through the hub to the intersection between the primary and secondary channels.

[0017] Alternatively or otherwise, the diameter of the secondary channel may narrow from the proximal side to the distal side.

[0018] Alternatively or additionally, the infusion device may also include a third hemostatic valve fluidly connected between the main channel and the shaft cavity, thereby providing a fluid-impermeable volume between the first, second, and third hemostatic valves.

[0019] Another example can be found in a working conduit suitable for use in conjunction with an introducer device having a bifurcated hub, the hub defining a first passage suitable for receiving a working channel and a second passage suitable for receiving a guide tube and a guidewire, the second passage intersecting the first passage, the guidewire having a first diameter outside the engagement region and a second diameter smaller than the first diameter within the engagement region. The working conduit includes an elongated conduit shaft extending from a proximal region to a distal region; and a working member fixed within the distal region. The working member includes a primary engagement feature suitable for releasably securing a main member to the guidewire; and one or more secondary engagement features, each suitable for releasably securing the main member to the guidewire.

[0020] Alternatively or additionally, the working component may also include working features.

[0021] Alternatively or additionally, the main engagement features may include a body cavity having a body cavity diameter greater than a first diameter of the guidewire; and a channel operatively coupled to the body cavity having a channel width smaller than the first diameter of the guidewire and larger than a second diameter of the guidewire.

[0022] Alternatively or additionally, each of one or more secondary engagement features may include a C-shaped feature having a lumen diameter greater than a first diameter of the guidewire and a channel width greater than a second diameter of the guidewire.

[0023] The foregoing summary is provided to facilitate understanding of some of the innovative features unique to this invention and is not intended to be an exhaustive description. The invention will be fully understood by considering the entire specification, claims, drawings, and abstract as a whole. Attached Figure Description

[0024] The invention can be more fully understood by considering the following description of various examples in conjunction with the accompanying drawings, wherein:

[0025] Figure 1 It is a schematic diagram illustrating a medical system;

[0026] Figure 2 yes Figure 1 A partial cross-sectional view of a portion of an illustrative medical system;

[0027] Figure 3 yes Figure 1 A partial cross-sectional view of an illustrative medical system, including a portion of a guiding catheter;

[0028] Figure 4 yes Figure 1 A partial cross-sectional view of an illustrative medical system, including a portion of the guiding catheter and a working catheter;

[0029] Figure 5 yes Figure 1A partial cross-sectional view of a portion of a multi-diameter guidewire in an illustrative medical system;

[0030] Figure 6 yes Figure 1 A partial cross-sectional view of an illustrative medical system, including a portion of the guiding catheter and a working catheter;

[0031] Figure 7 yes Figure 1 A partial cross-sectional view of an illustrative medical system, including a portion of the guiding catheter and a working catheter;

[0032] Figure 8 This is an enlarged view showing the working catheter for connecting the guidewire;

[0033] Figure 8A This is an enlarged end view of the main engagement features of the working conduit;

[0034] Figure 9 This is an enlarged view showing the working catheter for connecting the guidewire;

[0035] Figure 10 This is an enlarged view of the working catheter showing the guidewire; and

[0036] Figure 11 This is an enlarged view of the working catheter used to attach the guidewire.

[0037] While the invention is adaptable to various modifications and alternatives, its specific details have been shown by way of example in the accompanying drawings and will be described in more detail. However, it should be understood that the invention is not intended to limit its aspects to the specific examples described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the invention. Detailed Implementation

[0038] The following detailed description should be read with reference to the accompanying drawings, in which similar elements in different drawings are numbered in a similar manner. The drawings, which are not necessarily drawn to scale, depict examples that are not intended to limit the scope of the invention. Although examples for various elements are shown, those skilled in the art will recognize that many of the examples provided have suitable alternatives available.

[0039] All numbers are assumed to be modified by the term "about" in this document unless the content explicitly indicates otherwise. A description of a range of numbers indicated by an endpoint includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0040] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless otherwise expressly indicated. As used in this specification and the appended claims, the term “or” is generally used in the sense that it includes “and / or” unless otherwise expressly indicated.

[0041] It should be noted that references to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the embodiments may include specific features, structures, or characteristics, but not every embodiment includes that specific feature, structure, or characteristic. Furthermore, these phrases do not necessarily refer to the same embodiment. Moreover, when a specific feature, structure, or characteristic is described in connection with an embodiment, whether or not it is explicitly described, that feature, structure, or characteristic may also be applied to other embodiments, unless expressly stated otherwise.

[0042] Many medical procedures may utilize multiple medical devices, such as catheters. For example, a guiding catheter can be used to access a specific treatment area. In some cases, a guiding catheter can be used to guide a guidewire to a specific treatment area. In some cases, the guidewire can be advanced through the vascular system before the guiding catheter and any subsequent working catheters are advanced over the guidewire. In some cases, multiple working catheters can be advanced over the guidewire. In some cases, it may be beneficial to be able to exchange multiple devices, such as by removing one catheter and subsequently advancing another over the guidewire. In some cases, it may be beneficial to perform such exchanges in a saline environment to reduce or even eliminate the possibility of air bubbles being drawn into the patient's body during the advancement of medical devices, such as catheters, through the vascular system.

[0043] An illustrative but non-limiting example of this type of procedure is a heart valve repair process, in which multiple working catheters are used to deliver and deploy repair components close to the heart valve to be repaired. A guiding catheter can be advanced to a position immediately adjacent to the heart valve to guide a guidewire to the appropriate location within the vascular system. Once the guidewire is properly deployed, a series of working catheters can be used to deliver and deploy the repair component.

[0044] Figure 1 This is a schematic diagram of an illustrative medical system 10. The exemplary medical system 10 can be used in a variety of different medical procedures, and valve repair is only one example of such a procedure. The medical system 10 includes an infeeder device 12. The infeeder device 12 includes an elongated shaft 14 defining a cavity 16 extending through the elongated shaft 14. The elongated shaft 14 extends between a proximal region 18 and a distal region 20. A hub 22 is attached to the proximal region 18 of the elongated shaft 14. The hub 22 includes a hub body 24 and a port 25 extending from the hub body 24. In some cases, the port 25 can be used to connect a source of saline solution to flush the interior of the hub body 24.

[0045] The infusion device 12 includes a first hemostatic valve 26 and a second hemostatic valve 28. In some cases, as shown, the infusion device 12 may include a third hemostatic valve 30. It should be understood that including the first hemostatic valve 26, the second hemostatic valve 28, and the third hemostatic valve 30 can provide a fluid-impermeable volume between the first hemostatic valve 26, the second hemostatic valve 28, and the third hemostatic valve 30. Each of the first hemostatic valve 26, the second hemostatic valve 28, and the third hemostatic valve 30 (if included) is adapted to provide a fluid-impermeable seal when no device extends through the hemostatic valve, and to provide a fluid-impermeable seal against any device extending through the hemostatic valve.

[0046] As shown in the figure, the working catheter 32 extends through the first hemostatic valve 26 and at least partially through the hub 22. The guiding catheter 34 extends through the second hemostatic valve 28 and at least partially through the hub 22. The guidewire 36 is shown within the guiding catheter 34 and extends through the hub 22 and through the elongated shaft 14. In some cases, the guiding catheter 34 may be steerable and thus can be used to accurately position the guidewire 36.

[0047] Figure 2 This is a partial cross-sectional view of the importer device 12. Figure 2 In the figure, a portion of the hub body 24 has been cut away to expose the structure within the hub 22. As shown, the hub 22 includes a main channel 38 extending from the first hemostatic valve 26 (or from a position immediately adjacent to the first hemostatic valve 26) toward a shaft cavity 16 extending through the elongated shaft 14 of the inlet device 12. As shown, the main channel 38 bends through the interior of the hub 22 to align with both the first hemostatic valve 26 and the shaft cavity 16 (and a third hemostatic valve 30 therebetween, if present). A secondary channel 40 extends distally from the second hemostatic valve 28 (or from a position immediately adjacent to the second hemostatic valve 28) and intersects with the main channel 38 at an intersection 42. In some cases, the main channel 38 may have a constant or substantially constant (limited to within ten percent) diameter, while the secondary channel 40 may have a diameter that narrows from proximal to distal. In some cases, hub 22 may be designed with the first hemostatic valve 26 and the second hemostatic valve 28 in other locations, meaning that the primary channel 38 and the secondary channel 40 may have different geometries. The only thing to note is that the infeeder device 12 is able to properly position the engagement area of ​​the guidewire 36 so that the corresponding engagement feature on the distal end 50 of the working catheter can be releasably engaged and disengaged from the guidewire 36.

[0048] In some cases, the guidewire 36 and the guiding catheter 34 may be independently adapted to advance through the second hemostatic valve 28 and through the secondary channel 40 until reaching the main channel 38 at the intersection 42. From there, the guidewire 36 and the guiding catheter 34 may be independently adapted to advance through the third hemostatic valve 30 (if present) into the shaft cavity 16 of the elongated shaft 14. The working catheter 32 may be adapted to advance through the first hemostatic valve 26 and through the main channel 38 to a point where the working catheter 32 can releasably engage with the guidewire 36. In some cases, the reduced diameter region 44 of the secondary channel 40 may be sized to have an inner diameter approximately equal to or slightly larger than the outer diameter of the guiding catheter 34.

[0049] Figure 3 This is a partial cross-sectional view of the introducer device 12, showing the guide tube 34 extending through the introducer sheath 12. The guide tube 34 extends proximally from the second hemostatic valve 28 and distally through the elongated shaft 14. In some cases, the guide wire 36 can now be advanced through the guide tube 34 to an appropriate position near the treatment site. In some cases, the guide wire 36 can be advanced through the introducer device 12 to an appropriate treatment position near the treatment site before advancing the guide tube 34. It should be understood that the guide tube 34 has an outer diameter that can be considered approximately equal to the diameter of the reduced diameter region 44 of the secondary channel 40.

[0050] Figure 4 This is a partial cross-sectional view of the infeeder device 12, showing the guide tube 34 withdrawn proximally such that the distal end 46 of the guide tube 34 is positioned near the intersection 42. In some cases, positioning the guide tube 34 in this location means that the guide tube 34 helps to center and thus position the guide wire 36. In some cases, including the third hemostatic valve 30 also helps to center and thus position the guide wire 36. In some cases, centering and positioning the guide wire 36 within the distal region 48 of the main channel 38 facilitates the releasable engagement of the working catheter 32 with the guide wire 36, as will be discussed. The working catheter 32 includes a distal region 50 adapted for releasable engagement of the guide wire 36, as will be described.

[0051] Figure 5This is a schematic diagram of guidewire 36. In some cases, guidewire 36 extends from distal region 52 to proximal region 54. In some cases, distal region 52 of guidewire 36 has a diameter D1, and proximal region 54 of guidewire 36 has a diameter D2. In some cases, diameter D1 is equal to diameter D2. In some cases, as shown, diameter D1 may be smaller than diameter D2. In some cases, guidewire 36 includes a junction region 56 located between distal region 52 and proximal region 54. Junction region 56 may have a diameter D3 smaller than diameter D1 or diameter D2. In some cases, guidewire 36 may include a distal tapered region 58 that provides a smooth and gradual diameter change from diameter D1 to diameter D3. In some cases, guidewire 36 may include a proximal tapered region 60 that provides a smooth and gradual diameter change from diameter D2 to diameter D3.

[0052] In some cases, D1 and D2 are equal to each other and are defined at least in part by the overall size of guidewire 36. As an example, guidewire 36 may be referred to as a 0.035-inch guidewire, meaning that both D1 and D2 are equal to 0.035 inches. In some cases, D1 and D2 may vary depending on the specific guidewire, but remain equal to each other. Various sizes of guidewires may be used, at least in part depending on the size of the vascular system through which the guidewire is expected to pass, the size of the guiding catheter and working catheter to be advanced over the guidewire, and other requirements. In some cases, it is conceivable that D1 and D2 may differ from each other. As an example, D1 may be smaller than D2 where a smaller diameter distal region 52 may be advantageous.

[0053] For the engagement region 56, the diameter D3 can be considered a fraction of D1 or D2. As an example, D3 may range from approximately 20% to 80% of D1 or D2. As another example, D3 may range from approximately 30% to 70% of D1 or D2, or possibly from approximately 40% to 60% of D1 or D2. In some cases, the guidewire 36 may be a guidewire of constant diameter, where the engagement region 56 has been ground to achieve the diameter D3. As will be discussed, the engagement region 56 allows the working catheter 32 to be releasably engaged and disengaged from the guidewire 36.

[0054] Figure 6 This is a partial cross-sectional view of the injector device 12, again showing the proximal withdrawal of the guide tube 34 such that the distal end 46 of the guide tube 34 is positioned near the intersection 42. Simultaneously, the working conduit 32 can be viewed as being advanced distally through the main channel 38. As shown, the working conduit 32 includes a conduit shaft 62 and a distal body 64 fixed relative to the conduit shaft 62 within its distal region 50. Figure 7In this configuration, the working catheter 32 is considered to be positioned near the engagement feature within the distal body 64, allowing the working catheter 32 to be releasably engaged and disengaged from the guidewire 36. In some cases, the engagement feature is adapted to engage with a reduced-diameter engagement portion 56 of the guidewire 36. In some cases, whether the engagement feature remains engaged or disengaged from the guidewire 36 can be affected by moving the guidewire 36 proximally or distally to position the reduced-diameter engagement portion 56 relative to the engagement feature as needed.

[0055] Figure 8 This is an enlarged view of the lower portion of the working catheter 32, including the distal body 64. The lower side of the distal body 64 (in the illustrated orientation) includes a primary engagement feature 66 adapted for releasably engaging a guidewire 36. In some cases, the primary engagement feature 66 may be considered to have a C-shaped cross-sectional profile. The primary engagement feature 66 includes a body lumen 68 having a lumen diameter represented by D4. The primary engagement feature 66 also includes a channel 70 operatively coupled to the body lumen 68. The channel 70 has a channel width represented by D5, which is smaller than the lumen diameter D4. In some cases, the channel width D5 is smaller than the diameter D1 or D2 of the guidewire 36, meaning that the guidewire 36 is held within the lumen 68 when either the distal region 52 or the proximal region 54 of the guidewire 36 extends through the primary engagement feature 66. In some cases, the channel width D5 is greater than the diameter D3, meaning that the engagement region 56 of the guidewire 36 can slide into and out of the lumen 68 through the channel 70. The diameter of the main cavity, D4, is greater than either D1 or D2, which means that the guidewire 36 can translate within the main cavity 68.

[0056] Figures 9 to 11 Additional details regarding the distal subject 64 are provided. It should be understood that... Figures 9 to 11 In the middle, for clarity, the far-side main body 64 is shown in an inverted form. Figures 9 to 11 A sequence is provided illustrating how the engagement region 56 of the guidewire 36 increasingly engages the primary engagement feature 66 as the working catheter 32 moves distally through the primary channel 38. Figure 9 In the middle, the engagement region 56 of the guidewire 36 has partially engaged the main engagement feature 66. In Figure 10 In the middle, the engagement region 56 of the guidewire 36 has almost completely engaged the main engagement feature 66. Figure 11In this configuration, the engagement region 56 of guidewire 36 is fully engaged with the primary engagement feature 66 and is in the process of engaging one or more secondary engagement features 72 (individually labeled 72a, 72b, and 72c). In some cases, the distal body 64 may not include any secondary engagement features 72, or may include only one or two secondary engagement features 72. In some cases, the distal body 64 may include four, five, or more secondary engagement features. As shown, each of the secondary engagement features 72 is C-shaped and has a cavity diameter greater than D1 or D2, and a channel width greater than D3 (but still less than D1 or D2).

[0057] In some cases, the distal body 64 may include a working feature 74. As shown, the working feature 74 includes a pair of forceps labeled 74a and 74b. This is merely an example, as the working catheter 32 may include any of a variety of different working features 74. In some cases, for example, the forceps 74a and 74b may be used to clamp and deliver components for repairing heart valves.

[0058] Once the guidewire 36 has been advanced through the vascular system to the desired treatment site, the guiding catheter 34 can be withdrawn proximally to a position where the distal end 46 of the guiding catheter 34 is adjacent to the intersection 42 between the primary channel 38 and the secondary channel 40. A working catheter, such as the working catheter 32, can then be advanced distally through the primary channel 38 until the primary engagement feature 66 (and the secondary engagement feature 72, if present) engages the engagement region 56 of the guidewire 36. In some cases, this may include translating the guidewire 36 distally or proximally to properly position the engagement region 56 of the guidewire 36. Once engaged, the working catheter 32 can be moved distally (or the guidewire 36 can be moved proximally) to position the distal region 52 of the guidewire 36 within the primary engagement feature 66 (and optionally within the secondary engagement feature 72, if present).

[0059] Once the working catheter 32 is no longer needed, it can be withdrawn proximally until the distal body 64 is positioned within the main channel 38. The guidewire 36 can be translated to position its engagement region 56 within the main engagement feature 66 (and optionally within the secondary engagement feature 72, if present). With the guiding catheter 34 positioned so that its distal end 46 is immediately adjacent to the intersection 42, continued proximal withdrawal of the working catheter 32 will cause the engagement region 56 of the guidewire 36 to disengage from the main engagement feature 66, and optionally from the secondary engagement feature 72, if present.

[0060] In some cases, it may be necessary to use one or more additional working catheters. It should be understood that each of the one or more additional working catheters may be advanced through the infeeder device 12 in a manner similar to that described above with respect to working catheter 32. Due to hemostatic valves 26, 28, and 30, each additional working catheter will enter the hub 22 via the first hemostatic valve 26 into the saline region before engaging and following the guidewire 36 into the patient's body. This allows any air bubbles introduced and aspirated within the working catheter to escape into the saline within the saline region.

[0061] Materials that can be used for various components of the medical device described herein may include those commonly associated with medical devices. The medical device and its various components described herein may be made of metals, metal alloys, polymers (some examples of which are disclosed below), metal-polymer composites, ceramics, combinations thereof, or other suitable materials. Some examples of suitable metals and metal alloys include stainless steels such as 304V, 304L, and 316LV stainless steels; low-carbon steels; nickel-titanium alloys such as linear elastic and / or hyperelastic nickel-titanium; other nickel alloys such as nickel-chromium-molybdenum alloys (e.g., UNS: N06625, such as INCONEL® 625; UNS: N06022, such as HASTELLOY® C-22®; UNS: N10276, such as HASTELLOY® C276®, other HASTELLOY® alloys, etc.), nickel-copper alloys (e.g., UNS: N04400, such as MONEL® 400, NICKELVAC® 400, NICORROS® 400, etc.), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS: R30035, such as MP35-N®, etc.), and nickel-molybdenum alloys (e.g., UNS: N10665, such as HASTELLOY® ALLOY). B2®), other nickel-chromium alloys, other nickel-molybdenum alloys, other nickel-cobalt alloys, other nickel-iron alloys, other nickel-copper alloys, other nickel-tungsten or tungsten alloys, etc.; cobalt-chromium alloys; cobalt-chromium-molybdenum alloys (e.g., UNS: R30003, such as ELGILOY®, PHYNOX®, etc.); platinum-rich stainless steel; titanium; combinations thereof; etc.; or any other suitable material.

[0062] In at least some embodiments, the medical devices described herein may also be partially or entirely doped with, made of, or otherwise comprised of, a radiopaque material. A radiopaque material should be understood as a material capable of producing a relatively bright image on a fluorescent screen or using another imaging technique during medical procedures. This relatively bright image helps in determining the location of the medical device comprising the radiopaque material. Some examples of radiopaque materials may include, but are not limited to, gold, platinum, palladium, tantalum, tungsten alloys, polymeric materials loaded with radiopaque fillers, etc. Additionally, other radiopaque marking strips and / or coils may be incorporated into various medical devices to achieve the same result.

[0063] The medical device described herein, and its parts and components, may be made of the same material along its length, or in some embodiments, may include parts or segments made of different materials. In some embodiments, materials may be selected to impart different flexibility and stiffness properties to different parts. For example, different parts of a component, such as proximal and distal segments, may be formed of different materials, for example, materials with different elastic moduli, thereby producing different flexibility. In some embodiments, the material used to construct the proximal segment may be relatively stiff to achieve maneuverability and torsional control, and the material used to construct the distal segment may be relatively flexible in contrast to achieve better lateral tracking and steerability. For example, the proximal segment may be formed of straightened 304V stainless steel wire or strip, and the distal segment may be formed of straightened hyperelastic or linear elastic alloys, such as nickel-titanium alloy wire or strip.

[0064] In embodiments of the medical device described herein, where different parts are made of different materials, suitable connection techniques and / or connectors can be used to connect the different parts. For example, welding (including laser welding), soldering, brazing, adhesives, or combinations thereof can be used to connect the different parts. These techniques can be utilized regardless of whether connectors are used. An example of a connector is a result such as a hypotube or coiled wire, having an inner diameter whose dimensions are generally set to receive and connect to the ends of the proximal and distal portions.

[0065] A sheath or covering (not shown) may be provided on part or all of the medical device described herein. However, in other embodiments, such a sheath or covering may be omitted. The sheath may be made of a polymer or other suitable material. Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxyethylene (POM, e.g., DELRIN®, available from DuPont), polyether block copolymers, polyurethanes (e.g., polyurethane 85A), polypropylene (PP), polyvinyl chloride (PVC), polyether copolymers (e.g., ARNITEL®, available from DSM Engineering Plastics), ether- or ester-based copolymers (e.g., phthalate / poly(hydrocarbon ether) and / or other polyester elastomers, such as HYTREL®, available from DuPont), polyamides (e.g., DURETHAN®, available from Bayer, or CRISTAMID®, available from ElfAtochem), elastomeric polyamides, block polyamides / ethers, polyether block amides (PEBA, e.g., available under the trade name PEBAX®), ethylene-vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex® high-density polyethylene, Marlex® low-density polyethylene, Linear low-density polyethylene (e.g., REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly(p-phenylene terephthalamide) (e.g., KEVLAR®), polysulfone, nylon, nylon-12 (such as those available from EMS) AmericanGrilon commercially available GRILAMID®, perfluoro(propyl vinyl ether) (PFA), ethylene-vinyl alcohol, polyolefins, polystyrene, epoxy resins, polyvinylidene chloride (PVdC), poly(styrene-b-isobutylene-b-styrene) (e.g., SIBS and / or SIBS50A), polycarbonate, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers, polymer / metal composites, etc. In some embodiments, the sheath may be mixed with a liquid crystal polymer (LCP). For example, the mixture can contain up to about 6 percent LCP.

[0066] In some embodiments, the outer surface of the medical device described herein may be sandblasted, beaded, sprayed with sodium bicarbonate, electropolished, etc. In these and other embodiments, a coating may be applied to part or all of the medical device described herein, for example, a lubricating, hydrophilic, protective, or other type of coating. Alternatively, the sheath may include a lubricating, hydrophilic, protective, or other type of coating. Hydrophobic coatings, such as fluoropolymers, provide dry lubrication, which improves guidewire handling and device exchange. Lubricating coatings improve steerability and lesion crossing ability. Suitable lubricating polymers are well known in the art and may include silicone resins, hydrophilic polymers such as high-density polyethylene (HDPE), polytetrafluoroethylene (PTFE), polyaryl oxides, polyvinylpyrrolidone, polyvinyl alcohol, hydroxyalkyl cellulose, algae, sugars, caprolactone, etc., and mixtures and combinations thereof. Hydrophilic polymers may be mixed with each other or with formulated amounts of water-insoluble compounds, including some polymers, to produce a coating with suitable lubricity, adhesion, and solubility. Other examples of such coatings and materials and methods for creating such coatings can be found in U.S. Patent Nos. 6,139,510 and 5,772,609, which are incorporated herein by reference.

[0067] Having described several illustrative embodiments of the invention, those skilled in the art will readily understand that other embodiments may be made and used within the scope of the appended claims. However, it should be understood that the invention is merely illustrative in many respects. Changes may be made in details, particularly in terms of shape, size, arrangement of components, and exclusion and order of steps, without departing from the scope of the invention. The scope of the invention is, of course, defined by the language of the appended claims.

Claims

1. A medical system comprising: An injector device includes an elongated shaft defining a cavity therethrough, the elongated shaft including a proximal region and a proximal hub fixed relative to the proximal region of the elongated shaft, the proximal hub including: A main channel that extends through the proximal hub and is fluidly connected to the shaft cavity; A secondary channel extending through the proximal hub and fluidly connected to the shaft cavity; A guide tube suitable for advancing through the secondary channel and into the shaft cavity; Suitable for advancing the guidewire through the secondary channel; and A working catheter, the working catheter being adapted to be advanced through the primary channel into the shaft lumen when the guiding catheter has been withdrawn proximally such that the distal end of the guiding catheter remains within the secondary channel, the working catheter including a catheter shaft, the catheter shaft including a distal region, the distal region of the working catheter being adapted to releasably engage the guidewire.

2. The medical system according to claim 1, further comprising: A first hemostatic valve is fluidly connected to the main channel; A second hemostatic valve is fluidly connected to the secondary channel; as well as A third hemostatic valve is disposed between the proximal hub and the slender shaft, thereby providing an impermeable volume within the primary and secondary channels.

3. The medical system according to any one of claims 1 or 2, wherein the guidewire has a first diameter outside the junction region and a second diameter smaller than the first diameter within the junction region.

4. The medical system according to any one of claims 1 to 3, wherein the distal region of the working catheter includes a distal body defining a primary engagement feature adapted for releasable engagement of the guidewire.

5. The medical system of claim 4, wherein the main engagement feature comprises: A main cavity with the diameter of the main cavity; as well as A channel operatively connected to the main cavity, the channel having a channel width smaller than the diameter of the main cavity.

6. The medical system of claim 5, wherein the channel width is less than the first diameter of the guidewire and greater than the second diameter of the guidewire, and the body cavity diameter is greater than the first diameter of the guidewire.

7. The medical system according to any one of claims 1 to 6, wherein the primary channel is curved and the secondary channel is straight and intersects the primary channel.

8. An introjector device for use with a guide tube and a working catheter, the introjector device comprising: An elongated shaft defining a cavity therethrough, the elongated shaft including a proximal region; as well as A hub fixed relative to the proximal region of the elongated shaft, the hub comprising: A first hemostatic valve is disposed at the proximal end of the hub; A second hemostatic valve is disposed at the proximal end of the hub, the second hemostatic valve being parallel to but spaced apart from the first hemostatic valve; A main channel extending distally from the first hemostatic valve through the hub to the shaft cavity; and A secondary channel extends distally from the second hemostatic valve through the hub and is fluidly connected to the main channel.

9. The injector device of claim 8, wherein the main channel bends from the first hemostatic valve through the hub toward the shaft cavity.

10. The injector device according to any one of claims 8 or 9, wherein the secondary channel extends linearly from the second hemostatic valve through the hub to the intersection between the primary channel and the secondary channel.

11. The injector device according to any one of claims 8 to 10, further comprising a third hemostatic valve fluidly connected between the main channel and the shaft cavity, thereby providing a fluid-impermeable volume between the first hemostatic valve, the second hemostatic valve and the third hemostatic valve.

12. A working catheter suitable for use in conjunction with an introducing device having a bifurcated hub, the bifurcated hub defining a first passage suitable for receiving the working catheter and a second passage suitable for receiving a guide tube and a guidewire, the second passage intersecting the first passage, the guidewire having a first diameter outside an engagement region and a second diameter smaller than the first diameter within the engagement region, the working catheter comprising: A slender ductal axis extending from the proximal region to the distal region; A working component fixed in the distal region, the working component comprising: The main engagement features are suitable for releasably securing the main body component to the guidewire; as well as Each of the following is adapted to releasably secure the main component to one or more secondary engagement features of the guidewire.

13. The working conduit according to claim 12, wherein the working component further includes a working feature.

14. The working catheter according to any one of claims 12 or 13, wherein the main engagement feature comprises: A main cavity having a diameter larger than the first diameter of the guidewire; as well as A channel operatively connected to the main cavity, the channel having a channel width smaller than the first diameter of the guidewire and larger than the second diameter of the guidewire.

15. The working catheter according to any one of claims 12 to 14, wherein each of the one or more secondary engagement features includes a C-shaped feature having a lumen diameter greater than the first diameter of the guidewire and a channel width greater than the second diameter of the guidewire.

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