Multi-lumen catheter

Abstract

A medical device comprising: an elongate catheter body defining a proximal segment, a distal segment, and a first lumen through the catheter body; and a tube attached to the distal segment of the catheter body, the tube defining a proximal end, a distal end, and a second lumen through the tube, wherein the proximal end of the tube is attached to the catheter body at a first junction and the distal end of the tube is attached to the catheter body at a second junction, and a portion of the tube extending between the first and second junctions is movable relative to the catheter body.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to intravascular medical devices and methods of use thereof. [Background technology]

[0002] A variety of catheter systems have been developed for intravascular delivery of medical devices such as stents or angioplasty balloons. Typically, a guidewire is introduced into the blood vessel and advanced through the vascular system to the treatment site. A catheter is then advanced over the guidewire such that the distal end of the catheter is positioned at the treatment site. The catheter and / or guidewire can then be used to transport and position any of a variety of medical devices, such as stents, grafts, angioplasty balloons, atherectomy devices, etc., in proximity to the treatment site.

[0003] The success of many minimally invasive medical procedures depends on the ability to precisely position such medical devices within such target tissue regions. Such precise placement can be complicated when the treatment requires accessing and navigating bifurcations within the target vasculature. The present disclosure provides devices and methods of use for improving access and navigation of such vascular bifurcations and other multiple tortuous pathways. Summary of the Invention

[0004] The present invention advantageously provides a medical device comprising an elongate catheter body defining a proximal segment, a distal segment, and a first lumen through the catheter body, and a tube attached to the distal segment of the catheter body, the tube defining a proximal end, a distal end, and a second lumen through the tube, wherein the proximal end of the tube is attached to the catheter body at a first junction and the distal end of the tube is attached to the catheter body at a second junction, and a portion of the tube extending between the first and second junctions is movable relative to the catheter body.

[0005] The first joint may include a first cap concentrically mounted onto a proximal end of the tube, the first cap being affixed to the catheter body. The second joint may include a second cap concentrically mounted onto a distal end of the tube, the second cap being affixed to the catheter body. At least one of the first and second joints may include attachment of the tube to the catheter body by heat shrink tubing. At least one of the first and second joints may include attachment of the tube to the catheter body by adhesive. The tube may be at least partially constructed from a polymer, and at least one of the first and second joints may include attachment of the tube to the catheter body by fusing a portion of the tube to a portion of the catheter body. The first lumen may not be concentric with the second lumen.

[0006] The medical device may further include a deflection element attached to the distal segment of the catheter body, the deflection element defining an arcuate surface aligned adjacent to the first lumen. The arcuate surface may define an arc between 45 degrees and 135 degrees.

[0007] The deflection element may define a first opening generally coaxial with the first lumen and a second opening generally perpendicular to the first opening, and the arcuate surface may extend between the first and second openings.

[0008] The deflecting element may define a third opening generally perpendicular to each of the first and second openings. The deflecting element may be radiopaque and / or movable relative to the catheter body. The deflecting element may be movable along a longitudinal axis of the catheter body.

[0009] The present disclosure also provides a medical device comprising an elongate catheter body defining a proximal segment, a distal segment, and a first lumen through the catheter body, a tube attached to the distal segment of the catheter body defining a second lumen through the tube that is not concentric with the first lumen, and a deflecting element attached to the distal segment of the catheter body defining an arcuate surface aligned adjacent a distal end of the first lumen, the arcuate surface defining an arc of between 45 degrees and about 135 degrees.

[0010] The deflecting element may define a first opening generally coaxial with the first lumen and a second opening generally perpendicular to the first opening, and the arcuate surface may extend between the first and second openings. The deflecting element may define a third opening generally perpendicular to each of the first and second openings. The deflecting element may be radiopaque and / or movable relative to the catheter body. The deflecting element is movable along a longitudinal axis of the catheter body. At least a portion of the tube may be movable independently of the catheter body.

[0011] A more complete understanding of the present disclosure, together with its attendant advantages and features, will be readily appreciated by reference to the following detailed description, when considered in conjunction with the accompanying drawings, in which: [Brief description of the drawings]

[0012] [Figure 1] 1 illustrates an example of a medical device constructed according to the principles of the present disclosure. [Diagram 2] FIG. 2 is a detailed view showing a distal segment of the medical device of FIG. 1. [Diagram 3] FIG. 2 is a side view of a distal segment of the medical device of FIG. 1. [Figure 4] 2 is another view of the distal segment of the medical device of FIG. 1. [Diagram 5] FIG. 2 is a distal end view of the medical device of FIG. 1. [Figure 6]FIG. 2 is a proximal end view of the medical device of FIG. 1. [Figure 7] 1 is a side view of an example of a medical device constructed in accordance with the principles of the present disclosure, showing a curved configuration. [Figure 8] 8 is a perspective view of the example medical device shown in FIG. 7 in a bent configuration. [Figure 9] 8 is a front view of the example medical device shown in FIG. 7 in a bent configuration. [Figure 10] 1 illustrates another example of a medical device constructed in accordance with the principles of the present disclosure. [Figure 11] 1 illustrates another example of a medical device constructed in accordance with the principles of the present disclosure. [Figure 12] FIG. 12 is a side view of a distal segment of the medical device of FIG. [Figure 13] 12 is a cross-sectional view of a distal segment of the medical device of FIG. 11. [Figure 14A] 12A-12C show examples of deflection elements of the medical device of FIG. 11. [Figure 14B] 12A-12C show examples of deflection elements of the medical device of FIG. 11. [Figure 15] 1 illustrates another example of a deflection element of a medical device constructed in accordance with the principles of the present disclosure. [Figure 16] FIG. 12 is a proximal end view of the medical device of FIG. [Figure 17] FIG. 12 is a distal end view of the medical device of FIG. [Figure 18] 12 is another view showing a distal segment of the medical device of FIG. 11. [Figure 19] 12 is yet another view showing a distal segment of the medical device of FIG. 11. [Figure 20] 16 shows a medical device including the deflection element of FIG. 15 constructed in accordance with the principles of the present disclosure. [Figure 21] 21 is another view showing a distal segment of the medical device of FIG. 20. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The present disclosure provides intravascular medical devices and methods of use thereof. In particular, the present disclosure provides multi-lumen medical devices operable to facilitate procedures using multiple guidewires or other auxiliary devices that are independently and / or manipulated along different segments of the vasculature.

[0014] Referring now to the drawings, Figures 1-9 show an example of an intravascular medical device 10, such as a catheter, constructed in accordance with the principles and advantages disclosed herein. The device 10 is a minimally invasive device that can be introduced and manipulated intravenously in conjunction with one or more other devices as disclosed herein, such as those used in interventional cardiology to evaluate and / or treat blockages or other vascular disorders or conditions. The device 10 generally includes an elongated catheter body 12 having sufficient length, flexibility and torque transmission characteristics to be introduced and manipulated from outside the patient, through the vascular system, and aligned proximate to the area to be evaluated or treated. The catheter body 12 generally includes a proximal segment 14, which may connect to and / or terminate at a hub 16, and a distal segment 18. The catheter body 12 further includes or defines a first lumen 20 that extends through the catheter body 12 and exits at the distal segment 18, the lumen 20 having a diameter sufficient to allow passage of a guidewire and / or introduction of one or more fluids through the catheter body 12 at the distal segment 18.

[0015] The catheter body 12 may include one or more sections constructed from metals, polymers, or combinations of polymers and metals. Examples of materials that may be used include stainless steel (SST), nickel titanium (nitinol), or polymers. Examples of other metals that may be used include superelastic nickel titanium, shape memory nickel titanium, Ti-Ni, nickel titanium, about 55-60% Ni by weight, Ni-Ti-Hf, Ni-Ti-Pd, Ni-Mn-Ga, SAE grade stainless steels (SST) in the 300-400 series, e.g., 304, 316, 402, 440 series, MP35N, and 17-7 precipitation hardened (PH) stainless steels, other spring steels, or other high tensile strength materials, or other biocompatible metallic materials.

[0016] The catheter body 12 may include one or more tubular components having one or more cut patterns therein to provide a gradual transition in bending flexibility as measured by pushability, kink resistance, axial torque transmission for rotational response, and / or torque to failure along its length.

[0017] Modulation of flexibility / stiffness over the length of the catheter body 12 can be achieved in several ways. For example, the flexibility / stiffness of the tubular components of the catheter body 12 may be controlled by varying the spiral cut pattern variables (pitch, number of interruptions) and transitioning between spiral cut patterns. Furthermore, the spiral cut pattern allows the cross-sectional diameter of the lumen to be preserved when the tubular module is bent or curved. Spiral cut sections with different cut patterns may be distributed along the length of the tubular module. The spiral cut pattern may be continuous or discontinuous along the length of the catheter body 12. For example, there may be 1, 2, 3, 4, 5, 6, 7, ... n spiral cut sections along the length of the device. The spiral cut sections may be continuous or interrupted. Within each section, there may be a constant cut pattern, but between different sections within the tubular module, the cut pattern may vary, for example, in pitch.

[0018] One or more sections of the catheter body 12 may also include a variable pitch pattern within a particular section. Each spiral cut section may have a constant pitch, for example within a range of about 0.05 mm to about 10 mm, for example pitches 0.1 mm, 0.2 mm, 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm, 0.7 mm, 0.8 mm, 0.9 mm, 1.0 mm, 1.5 mm, 2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0 mm, etc. The pitch may also vary within each section. The pitch of different spiral cut sections may be the same or different compared to other sections of the catheter body 12. Alternatively, the catheter body 12 may be formed from tubular modules having a spiral cut pattern that varies continuously along the length of the catheter. The orientation or handedness of the spiral cut sections within a module may also vary within the spiral cut section.

[0019] One or more portions of the catheter body 12 can be coated with a lining that protects the cut pattern components of the catheter body 12 and facilitates the transport of additional tool devices, such as guidewires and balloons, through the tube components of the catheter body 12 to a distal location. The outer and / or inner lining can be made of a polymer, for example, by encapsulating the tube wall with one of multiple layers of a coextruded polymer tubular structure and heat shrinking the tubular structure or coating the tube wall by a dip coating process. The material of the polymer jacket can be nylon, polyether block amide, PTFE (polytetrafluoroethylene), FEP (fluorinated ethylene propylene), PFA (perfluoroalkoxyalkane), PET (polyethylene terephthalate) or PEEK (polyether ether ketone). Additionally, the distal tube portion 120 (or the entire length of the catheter 100) can be coated with a hydrophilic polymer coating to enhance lubricity and trackability. The hydrophilic polymer coating can include, but is not limited to, polyelectrolyte polymers and / or non-ionic hydrophilic polymers, where the polyelectrolyte polymers can include poly(acrylamide-co-acrylic acid) salts, poly(methacrylamide-co-acrylic acid) salts, poly(acrylamide-co-methacrylic acid) salts, etc., and the non-ionic hydrophilic polymers can be poly(lactams) such as polyvinylpyrollidone (PVP), polyurethanes, homopolymers and copolymers of acrylic and methacrylic acid, polyvinyl alcohol, polyvinyl ethers, snapic anhydride based copolymer, polyesters, hydroxypropylcellulose, heparin, dextran, polypeptides, etc.

[0020] A lubricious coating or film may be added on the catheter body 12 to facilitate movement of the device 10 through the blood vessel. The lubricious coating may be composed of, for example, silicone or hydrogel polymers such as vinyl polymers, polyalkylene glycols, polymeric networks of alkoxypolyethylene glycols or the like, or uncrosslinked hydrogels such as polyethylene oxide (PEO). The coatings and liners disclosed herein may be applied by a dip coating process or by spraying the coating onto the exterior and interior surfaces of the tube.

[0021] Additional features of the device 10 and catheter body 12 are described in U.S. Patent Application No. 15 / 726,024, entitled “MODULAR VASCULAR CATHETER” (U.S. Patent Publication No. 2018 / 0093070), which is incorporated by reference in its entirety.

[0022] The device 10 may include a secondary lumen assembly 22 coupled to the distal segment 18 of the catheter body 12. The secondary lumen assembly 22 may generally include a tube or tube segment 24 defining a lumen 26 therein operable to receive a guidewire or other instrument / auxiliary device therethrough. The tube segment 24 may be constructed similarly to the catheter body 12 and / or may have certain characteristics and properties similar to the catheter body 12. The tube segment 24 may be affixed to an exterior surface of the catheter body 12 such that the tube segment 24 is not concentric or coaxial with the catheter body 12, but instead is in a side-by-side configuration.

[0023] The tube segment 24 may be partially coupled to the catheter body 12 to allow a degree of rotational freedom, movement, bending, and / or displacement from the catheter body 12. For example, the tube segment 24 may be coupled to the catheter body 12 at a proximal portion of the tube segment 24 to form a proximal junction 28, and may be coupled to the catheter body 12 at a distal portion of the tube segment 24 to form a distal junction 30. A substantial portion of the remaining tube segment 24 between the proximal and distal junctions 28, 30 may be free and / or unattached to the catheter body.

[0024] The proximal and distal joints 28, 30 may include one or more of a variety of different attachment modalities. For example, the joints 28, 30 may each include a preformed molded cap that receives a portion of the tube segment 24 therein, the joints 28, 30 may be formed from a sheath and / or heat shrink tubing that surrounds the end of the tube segment 24, and / or the joints 28, 30 may include adhesive, fuse and / or weld attachments. For example, the proximal and distal joints 28, 30 may be formed by melting or fusing an outer polymer layer of the tubular components that make up the joints 28, 30 or the tube segment 24 to the catheter body 12, which may be constructed from a metal such as Nitinol.

[0025] The partial attachment of the secondary lumen assembly 22 to the catheter body 12 provides improved rotational and torque transmission characteristics compared to conventional offset dual lumen catheters that are substantially and / or completely attached along their length. Attempting to rotate such a conventional device about the longitudinal axis of the primary lumen / catheter body while within the tortuous anatomy of a patient's vessel can result in offset, inharmonious and / or asymmetric bending at its distal segment. Such inharmonious bending and rotation can substantially increase the difficulty for a physician attempting to access, manipulate or align the device in a specific rotational orientation at a precise location. In contrast, the device 10 can bend and assume a contoured curved shape more quickly, as shown, for example, in FIGS. 7-9, due to the freedom of movement between the tube segment 24 and the distal segment 18 of the catheter body 12. The partial attachment between the tube segment 24 and the distal segment 18 of the catheter body 12 allows the two components to shift relative to one another and follow the path of least resistance as they bend around one or more bends in the vasculature.

[0026] In another example, the device may include proximal and distal junctions 28, 30 that are fixed and / or attached to the distal segment 18 of the catheter body 12 without a tube segment 24 in between, as shown in Figure 10. In this example, a guidewire (not shown) or other device may be routed through the lumens / openings of the proximal and distal junctions 28, 30 and exit at the distal end 36. The guidewire will thus have the same freedom of movement relative to the catheter body 12 as previously described, allowing its independent movement, bending and rotation during use.

[0027] 11-21, additional examples of devices 10 are shown having a deflection element 32 coupled to the catheter body 12 distal to and / or adjacent to the exit of the lumen 20 that may assist in deflecting or otherwise steering the guidewire GW and / or other auxiliary devices at a substantial angle away from the longitudinal axis LA of the catheter body 12 and lumen 20. Such angled exits may be at an angle α of between 45 degrees and about 135 degrees from the longitudinal axis LA of the lumen 20 and may facilitate placement of the guidewire GW or other instruments / auxiliary devices into a side branch or other vascular pathway represented by and generally labeled as "100".

[0028] 14A-14B, the deflection element 32 may include or define a proximal end 34, a distal end 36, and a ramp or contoured surface 38 that deflects the guidewire or ancillary instrument / device away from the longitudinal axis of the catheter body 12. The contoured surface 38 may include a rounded or arcuate shape to provide the desired angular deflection, and may define an arc of about 45 degrees to about 135 degrees, as shown in the cross-sectional side view of FIG.

[0029] The deflection element 32 may include or define side walls 39a, 39b that extend from or border the contoured surface 38 to help direct or guide a guidewire or other instrument into a first opening or guidewire inlet 41a adjacent to and generally coaxial with the lumen 20, toward the contoured surface 38, and are deflected toward a second opening or guidewire outlet 41b generally perpendicular to the inlet 41a to extend outwardly from the device 10. In the illustrated example, the first and second openings 41a, 41b form a continuous open area across the deflection element 32, although it is contemplated that additional walls or other structures may form and / or frame a deflection path through which a guidewire or other interventional device may traverse and exit the device 10.

[0030] The catheter body 12 may define an opening 41d adjacent to and / or coplanar with the guidewire exit opening 41b of the deflection element 32, as shown in Figures 18-19. The opening 41d increases the overall space in which the guidewire can exit the catheter body 12 at an angle away from the longitudinal axis. The guidewire typically has a varying degree of stiffness along its length, with the distal end of the guidewire typically being more flexible than the proximal portion of the guidewire. The larger exit window formed by the openings 41b and 41d allows the stiffer portion of the guidewire to exit the catheter body 12 without requiring a sharper turn or bend that the stiffer portion of the guidewire can withstand. Thus, the larger exit facilitates easier relative motion between the device 10 and the guidewire when moving or pulling the catheter body 12 off the guidewire.

[0031] To further aid in routing the stiffer portion of the guidewire through and out of the catheter body 12, the deflecting element 32 and / or the distal exit of the lumen 20 may include one or more soft or elastic edges that can stretch under the load of the guidewire. In addition to and / or instead of soft components, the deflecting element 32 and / or the distal exit of the lumen 20 may include one or more rounded interior segments that provide a curved interior surface for the guidewire to traverse as it exits the catheter body, rather than simply a vertical sidewall. For example, the edge or sidewall 41e shown in FIG. 15, which has a vertical edge that the guidewire contacts as it exits the lumen 20, could also include one or more elastic components and / or be modified in thickness, roundness, etc. to reduce friction with the guidewire and / or prevent kinking of the guidewire.

[0032] The deflection element 32 may include or define a complementary surface or segment 40 that is sized and shaped to mateably attach or couple to the secondary lumen assembly 22. In the illustrated example, the surface 40 is cylindrical to correspond to the rounded shape of the tube segment 24.

[0033] 15, the deflection element 32 may define a third opening or guidewire exit 41c in its sidewall 39b. The third opening 41c may allow the guidewire to exit the deflection element in a plane alternate to that of the first opening 41b and at an angle generally perpendicular to the longitudinal axis of the lumen 20. The third opening 41c allows the device 10 to be rotated about an aligned guidewire to retract the device 10 while reducing guidewire displacement, as described further herein.

[0034] The device 10 may include one or more features to aid the physician in visualizing the location and orientation of the device 10 within the patient's vasculature and to enhance the physician's ability to align a guidewire and / or other auxiliary instrument / device through the lumen adjacent to a desired tissue as desired. For example, the catheter body 12 and / or the deflecting element 32 may include one or more radiopaque markers and / or may be constructed from a radiopaque material. The deflecting element 32 and / or the catheter body 12 may include one or more elastic, deformable and / or movable components to allow the deflecting element 32 to move relative to the exit of the catheter body 12 and / or lumen 20, thereby providing the physician with a degree of longitudinal maneuverability to position or orient a guidewire or other auxiliary instrument / device into a side branch or other vascular pathway away from the longitudinal axis of the catheter body 12.

[0035] 20-21, an exemplary use of the device 10 is illustrated. The device 10 may be routed into a primary vessel or vasculature pathway 100a. Insertion and routing of the device 10 into the primary vessel 100a may be facilitated by traversing a first guidewire GW1 that is routed through a second lumen assembly including a tube segment 24, as described herein. The device 10 may be aligned adjacent to or otherwise proximate to a secondary vessel or side branch vessel pathway 100b. A second guidewire GW2 may be routed through the first lumen 20 of the catheter body 12 to a deflecting element 32. The deflecting element 32 may be oriented such that the second opening or guidewire exit 41b is generally aligned with the secondary vessel 100b. Such alignment and positioning may be accomplished by one or more medical imaging modalities. Once the desired alignment is achieved, the second guidewire GW2 may be routed through the deflection element 32 and deflected by the ramp face 38 out of the guidewire exit 41b into the secondary vessel 100b. The device 10 may then be rotated about the longitudinal axis of the second guidewire GW2 such that the portion of the second guidewire GW2 extending from the device 10 is aligned and exits out of the third opening 41c in the sidewall 39b of the deflection element, as shown in FIG. 21. The device 10 may then be pulled back from the primary vessel 100a, reducing the "pull" or deflection on the second guidewire GW2, which remains routed into the secondary vessel 100b for subsequent use.

[0036] It will be understood by those skilled in the art that the present disclosure is not limited to what has been specifically shown and described herein above. Moreover, unless previously noted to the contrary, it should be noted that all of the accompanying drawings are not to scale. It should be noted that system components are appropriately represented by conventional symbols in the figures showing only certain details relevant to understanding the embodiments of the present disclosure, so as not to obscure the present disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, although certain embodiments or figures described herein may show features that are not explicitly shown in other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily mutually exclusive, and thus may be included in various different combinations or configurations without departing from the scope and spirit of the present disclosure. In light of the above teachings, various modifications and variations are possible without departing from the scope and spirit of the present disclosure, which is limited only by the scope of the appended claims.

Claims

1. an elongate catheter body defining a proximal segment, a distal segment, and a first lumen through the catheter body; a tube attached to the distal segment of the catheter body, the tube defining a proximal end, a distal end, and a second lumen therethrough; a deflection element attached to the distal segment of the catheter body, the deflection element defining an arcuate surface aligned adjacent to the first lumen; Equipped with the proximal end of the tube is attached to the catheter body at a first joint; the distal end of the tube is attached to the catheter body at a second joint; a portion of the tube extending between the first and second junctions is movable relative to the catheter body; The deflection element is movable along a longitudinal axis of the catheter body. Medical devices.

2. the first joint includes a first cap concentrically mounted onto the proximal end of the tube; the first cap is attached to the catheter body; The medical device of claim 1.

3. the second joint includes a second cap concentrically mounted onto the distal end of the tube; the second cap is attached to the catheter body; The medical device of claim 2.

4. The medical device of claim 1 , wherein at least one of the first and second joints comprises attachment of the tube to the catheter body by heat shrink tubing.

5. the tube being constructed at least in part from a polymer; At least one of the first and second joints includes attachment of the tube to the catheter body by fusing a portion of the tube to a portion of the catheter body. The medical device of claim 1.

6. The medical device of claim 1 , wherein at least one of the first and second bonds comprises attachment of the tube to the catheter body by an adhesive.

7. The medical device of claim 1 , wherein the first lumen is not concentric with the second lumen.

8. The medical device of claim 1 , wherein the arcuate surface defines an arc of between 45 degrees and 135 degrees.

9. the deflection element defines a first opening generally coaxial with the first lumen and a second opening generally perpendicular to the first opening; the arcuate surface extends between the first and second openings; The medical device of claim 1.

10. The medical device of claim 9 , wherein the deflection element defines a third opening generally perpendicular to each of the first and second openings.

11. The medical device of claim 1 , wherein the deflecting element is radiopaque.

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