Catheter system and method of use

Abstract

The present disclosure includes a catheter system comprising an inner catheter and an outer catheter, wherein the outer catheter is configured to at least partially receive the inner catheter. In some embodiments, the inner catheter comprises a proximal seat, a distal portion, and a pusher wire extending between the proximal seat and the distal portion. The distal portion of the inner catheter may include a hypotube. In some embodiments, the inner surface of the hypotube is covered with a lubricating coating.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. non-provisional patent application No. 18 / 064,843, filed on December 12, 2022, entitled “CATHETER SYSTEMS AND METHODS OF USE”; the entire disclosure of the U.S. non-provisional patent application is incorporated herein by reference.

[0003] This application claims priority to U.S. Provisional Patent Application No. 63 / 340,276, filed on May 10, 2022, entitled “CATHETER SYSTEMS AND METHODS OF USE”; the entire disclosure of the U.S. Provisional Patent Application is incorporated herein by reference.

[0004] This application claims priority to U.S. Provisional Patent Application No. 63 / 289,038, filed on December 13, 2021, entitled “CATHETER SYSTEMS AND METHODS OF USE”; the entire disclosure of the U.S. Provisional Patent Application is incorporated herein by reference. Background Art

[0005] The present invention generally relates to medical devices and methods of use. Embodiments of the present invention include devices and methods for performing thrombectomy or embolectomy in a patient. Acute ischemic stroke (AIS) may be caused by a thrombus, embolism, or other occlusion in the region of the internal carotid artery (ICA), such as the petrous, cavernous, or cerebral segments. A method for performing thrombectomy or embolectomy to treat AIS includes positioning a device (such as an aspiration catheter, a balloon guide catheter, or other device) in the carotid artery at an upstream location of the occlusion, typically at a proximal location in the artery, such as at the cervical segment of the artery. Navigating to this proximal location may be difficult due to the tortuous nature of the vasculature and small vessel size typically involved in AIS. Summary of the invention

[0006] The present disclosure includes a catheter system, the catheter system comprising: an outer catheter, the outer catheter having a proximal end, a distal end opposite the proximal end, a working lumen extending between the proximal end and the distal end, an outer surface defining an outer diameter, and an inner surface defining an inner diameter. In some embodiments, the catheter system includes an inner catheter, the inner catheter having a proximal seat, a distal portion having a distal end opposite the proximal seat, an outer surface defining an outer diameter, an inner surface defining an inner diameter, and a pusher wire extending between the proximal seat and the distal portion. The working lumen of the outer catheter is configured to at least partially receive the inner catheter.

[0007] In some embodiments, the distal portion of the inner catheter includes a hypotube. The hypotube may include a distal portion and a proximal portion opposite the distal portion, wherein the proximal portion may be configured to taper to a proximal end coupled to the pusher wire. The pusher wire may be configured to facilitate navigation of the inner catheter through the working lumen of the outer catheter.

[0008] In some embodiments, the hypotube includes an inner surface and an outer surface. The outer surface may be covered with a heat shrink material. In some embodiments, at least a portion of the heat shrink material and at least a portion of the inner surface of the hypotube are covered with a lubricating coating. The lubricating coating may include one of a hydrophilic coating and a silicone resin. The outer surface may be covered with a reflowed polymer material. In some embodiments, at least a portion of the reflowed polymer material and at least a portion of the inner surface of the hypotube are covered with a lubricating coating. The lubricating coating may include one of a hydrophilic coating and a silicone resin. The hypotube may include a stainless steel hypotube. In some embodiments, the hypotube includes a nitinol hypotube. The hypotube may include a combination of stainless steel and nitinol materials. In some embodiments, the hypotube includes a laser cut hypotube. The hypotube may be limited to a length of about 20 centimeters.

[0009] In some embodiments, the outer catheter comprises a device wall, and the inner catheter comprises a device wall, wherein the device wall of the outer catheter comprises at least one polymer coupled to an outer catheter reinforcement structure, and wherein the device wall of the inner catheter comprises at least one polymer coupled to an inner catheter reinforcement structure. The outer catheter reinforcement structure may comprise a braid and a coil reinforcement structure, and the inner catheter reinforcement structure may comprise a braid and a coil reinforcement structure.

[0010] The device wall of the outer catheter can be located between the first hydrophilic coating and the second hydrophilic coating, and the device wall of the inner catheter can be located between the third hydrophilic coating and the fourth hydrophilic coating. In some embodiments, the first hydrophilic coating is located on the outer surface of the outer catheter and is configured to reduce the surface friction between the outer surface of the outer catheter and the blood vessel wall and increase the lubricity between the outer surface of the outer catheter and the blood vessel wall. The first hydrophilic coating may include a substantially smooth surface. The second hydrophilic coating may be located on the inner surface of the outer catheter and may be configured to reduce the surface friction between the inner surface of the outer catheter and the outer surface of the inner catheter and increase the lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter. The second hydrophilic coating may include a textured surface. In some embodiments, the third hydrophilic coating is located on the outer surface of the inner catheter and is configured to reduce the surface friction between the inner surface of the outer catheter and the outer surface of the inner catheter and increase the lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter. The third hydrophilic coating may include a substantially smooth surface. The fourth hydrophilic coating may be located on the inner surface of the inner conduit and may be configured to reduce surface friction and increase lubricity on the inner surface of the inner conduit.The fourth hydrophilic coating may include a textured surface.

[0011] In some embodiments, the pusher wire comprises a round wire.The pusher wire may comprise a flat wire.

[0012] The outer catheter may include a device wall comprising at least one polymer coupled to an outer catheter reinforcement structure. In some embodiments, the outer catheter reinforcement structure comprises a braid and a coil reinforcement structure. The device wall of the outer catheter may be located between a first hydrophilic coating and a second hydrophilic coating. In some embodiments, the first hydrophilic coating is located on the outer surface of the outer catheter and is configured to reduce the surface friction between the outer surface of the outer catheter and the vessel wall and increase the lubricity between the outer surface of the outer catheter and the vessel wall. The first hydrophilic coating may include a substantially smooth surface. The second hydrophilic coating may be located on the inner surface of the outer catheter and may be configured to reduce the surface friction between the inner surface of the outer catheter and the outer surface of the inner catheter and increase the lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter. The second hydrophilic coating may include a textured surface.

[0013] The present disclosure includes a catheter system comprising an outer catheter having a proximal end, a distal end opposite the proximal end, a working lumen extending between the proximal end and the distal end, an outer surface defining an outer diameter, and an inner surface defining an inner diameter. The catheter system may include an inner catheter having a proximal end and a distal end opposite the proximal end, wherein the working lumen is configured to at least partially receive the inner catheter, and wherein the inner catheter comprises a hypotube.

[0014] In some embodiments, the hypotube includes an inner surface and an outer surface. The outer surface may be covered with a heat shrink material. In some embodiments, at least a portion of the heat shrink material and at least a portion of the inner surface of the hypotube are covered with a lubricating coating. The lubricating coating may include one of a hydrophilic coating and a silicone resin. The outer surface may be covered with a reflowing polymer material. In some embodiments, at least a portion of the reflowing polymer material and at least a portion of the inner surface of the hypotube are covered with a lubricating coating. The lubricating coating may include one of a hydrophilic coating and a silicone resin.

[0015] The hypotube may include a stainless steel hypotube. In some embodiments, the hypotube includes a nitinol hypotube. The hypotube may include a combination of stainless steel and nitinol materials. In some embodiments, the hypotube includes a laser cut hypotube.

[0016] The outer catheter may include a device wall comprising at least one polymer coupled to an outer catheter reinforcement structure. In some embodiments, the outer catheter reinforcement structure comprises a braid and a coil reinforcement structure. The device wall of the outer catheter may be located between a first hydrophilic coating and a second hydrophilic coating. In some embodiments, the first hydrophilic coating is located on the outer surface of the outer catheter and is configured to reduce the surface friction between the outer surface of the outer catheter and the vessel wall and increase the lubricity between the outer surface of the outer catheter and the vessel wall. The first hydrophilic coating may include a substantially smooth surface. The second hydrophilic coating may be located on the inner surface of the outer catheter and may be configured to reduce the surface friction between the inner surface of the outer catheter and the outer surface of the inner catheter and increase the lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter. The second hydrophilic coating may include a textured surface.

[0017] The foregoing and other features and advantages of the invention will become apparent from the following more particular description of the preferred embodiments of the invention, the accompanying drawings, and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] These and other features, aspects and advantages are described below with reference to the accompanying drawings, which are intended to illustrate rather than limit the present invention. In the accompanying drawings, similar characters always represent corresponding features in similar embodiments.

[0019] Figure 1 Illustrated is a perspective view of a catheter system including an outer catheter and an inner catheter according to some embodiments.

[0020] Figure 2A and 2B

[0013] An example catheter system according to some embodiments is illustrated, the catheter system comprising an outer catheter and an inner catheter.

[0021] Figure 3 Illustrated is a cross section of an outer catheter according to some embodiments.

[0022] Figure 4 Illustrated is a cross section of an inner conduit according to some embodiments.

[0023] Figure 5 The illustration shows a cross-section of a catheter system according to some embodiments, the catheter system comprising an outer catheter and an inner catheter.

[0024] Figure 6 An outer catheter according to some embodiments is illustrated.

[0025] Figure 7 An inner catheter according to some embodiments is illustrated.

[0026] Figure 8 An outer catheter including various elements is illustrated according to some embodiments.

[0027] Fig. 9

[0013] An example catheter system according to some embodiments is illustrated, the catheter system comprising an outer catheter and an inner catheter.

[0028] Fig.10 An inner catheter including a hypotube is illustrated according to some embodiments.

[0029] Fig.11 An inner catheter including a coil structure is illustrated according to some embodiments.

[0030] Fig.12 An inner catheter including a braid structure is illustrated according to some embodiments.

[0031] 13A and 13B illustrate cross-sectional views of a hypotube according to some embodiments.

[0032] Fig.14

[0013] An example catheter system according to some embodiments is illustrated, the catheter system comprising an outer catheter and an inner catheter.

[0033] Fig.15 An inner catheter including a hypotube is illustrated according to some embodiments.

[0034] Fig.16A and 16B Illustrate a cross-sectional view of a hypotube according to some embodiments.

[0035] Fig.17 and Fig.18 An illustrated flow chart illustrating a process for applying a hydrophilic coating according to some embodiments.

[0036] Parts Index

[0037] 10-Catheter system

[0038] 12-External catheter

[0039] 14-Proximal end (outer catheter)

[0040] 16- Distal end (outer catheter)

[0041] 18-Outer surface (outer conduit)

[0042] 20-Inner surface (outer conduit)

[0043] 22-Outer diameter (outer conduit)

[0044] 24-Inner diameter (outer catheter)

[0045] 26-Inner catheter

[0046] 28-Proximal end (inner catheter)

[0047] 30-distal end (inner catheter)

[0048] 32-Outer surface (inner conduit)

[0049] 34-Inner surface (inner conduit)

[0050] 36-outer diameter (inner conduit)

[0051] 38-Inner diameter (inner catheter)

[0052] 40a-first hydrophilic coating

[0053] 40b- Second hydrophilic coating

[0054] 40c-third hydrophilic coating

[0055] 40d- fourth hydrophilic coating

[0056] 42-Device wall of the outer catheter

[0057] 44-Inner catheter device wall

[0058] 46-At least one polymer

[0059] 48-External catheter reinforcement structure

[0060] 50-Inner catheter reinforcement structure

[0061] 52- Seat (external conduit)

[0062] 54 seat (inner guide tube)

[0063] 100-catheter system

[0064] 102-External catheter

[0065] 104-Proximal end (external catheter)

[0066] 106-distal end (external catheter)

[0067] 108-Working Lumen

[0068] 110-Inner catheter

[0069] 112-Proximal seat (inner catheter)

[0070] 114-distal part (inner catheter)

[0071] 116-distal end (inner catheter)

[0072] 118-Pusher wire

[0073] 120-Hypotube

[0074] 122-Coil structure

[0075] 124- Braided fabric structure

[0076] 126-distal part (hypotube)

[0077] 128-Proximal part (hypotube)

[0078] 130-proximal end (hypotube)

[0079] 132-Inner surface (hypotube)

[0080] 134-Outer surface (hypotube)

[0081] 136-Heat shrink material

[0082] 138-Refluxing polymer

[0083] 140-Lubricating coating

[0084] 200-Catheter System

[0085] 202-External catheter

[0086] 204-Proximal end (external catheter)

[0087] 206-distal end (external catheter)

[0088] 208-working lumen (external catheter)

[0089] 210-Inner catheter

[0090] 212-Proximal end (inner catheter)

[0091] 214-distal end (inner catheter)

[0092] 216-Hypotube

[0093] 218-Inner surface (hypotube)

[0094] 220-outer surface (hypotube)

[0095] 222-Heat shrink material

[0096] 224-Refluxing polymer

[0097] 226-Lubricating coating DETAILED DESCRIPTION

[0098] Although certain embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. Therefore, the scope of the appended claims is not limited to any specific embodiment described below. For example, in any method or process disclosed herein, the actions or operations of the method or process may be performed in any suitable order and are not necessarily limited to any particular disclosed order. Various operations may be described in sequence as multiple discrete operations so that it may be helpful to understand certain embodiments; however, the order of description should not be interpreted as implying that the operations are sequence-dependent. In addition, the structures, systems, and / or devices described herein may be embodied as integrated components or separate components.

[0099] In order to compare various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or advantages are necessarily achieved by any particular embodiment. Thus, for example, various embodiments may be performed in a manner that achieves or optimizes one advantage or group of advantages taught herein without necessarily achieving other aspects or advantages also taught or suggested herein.

[0100] The present invention generally relates to medical devices and methods of use. Embodiments of the present invention include devices and methods for performing thrombectomy or embolectomy in a patient. Acute ischemic stroke (AIS) may be caused by a thrombus, embolism, or other occlusion in the region of the internal carotid artery (ICA), such as the petrous, cavernous, or cerebral segments. A method for performing thrombectomy or embolectomy to treat AIS includes positioning a device (such as an aspiration catheter, a balloon guide catheter, or other device) in the carotid artery at an upstream location of the occlusion, typically at a proximal location in the artery, such as at the cervical segment of the artery. Navigation to the proximal location may be difficult due to the tortuous nature of the vasculature and small vessel size typically involved in AIS.

[0101] Conventional methods for treating AIS and lesions in other areas of the body involve using multiple devices of different sizes and stiffnesses to achieve the proper balance of size and flexibility to enable navigation, tracking capabilities, and aspiration capabilities. As a result, thrombectomy procedures can take more time as physicians use a trial-and-error approach to determine which device / combination of devices will reach and remove the occlusion. In a situation where "time is brain," reducing the time required to remove a clot, embolus, or other occlusion is critical to achieving the best possible outcome for the patient.

[0102] There remains a need for improved devices and methods for mechanical vascular reconstruction, such as thrombectomy and embolectomy in ICA and other vasculature. In particular, there is a need for a device and method that provides enhanced treatment efficacy and treatment efficiency.

[0103] Figure 1 1 illustrates a perspective view of a catheter system 10 according to some embodiments. Figure 1 As illustrated in , the catheter system can include an outer catheter 12 and an inner catheter 26. In some embodiments, the outer catheter 12 includes a seat 52, and the inner catheter 26 includes a seat 54. Throughout this disclosure, the catheter system 10 will be described in more detail.

[0104] Figure 2A and 2B The catheter system 10 is illustrated in accordance with some embodiments. Figure 2A and 2B As illustrated in FIG, the catheter system may include an outer catheter 12 and an inner catheter 26. In some embodiments, the outer catheter 12 includes a seat 52, and the inner catheter 26 includes a seat 54. Figure 2AAs shown in , the seat 52 can be located at the proximal end 14 of the outer catheter 12, and the seat 54 can be located at the proximal end 28 of the inner catheter 26. In some embodiments, the outer catheter 12 includes a distal end 16 opposite the proximal end 14, and the inner catheter 26 includes a distal end 30 opposite the proximal end 28.

[0105] The outer catheter 12 may be sized and configured to at least partially receive the inner catheter 26, such as Figure 2A and 2B . The size and configuration of the outer catheter 12 can also be designed to receive other devices, such as guide wires, microcatheters, intermediate catheters, and / or stent retrievers, to name a few non-limiting examples. Therefore, the catheter system 10 can be considered as a combination of an inner device and an outer device (that is, an inner catheter 26 and an outer catheter 12), which can be used concentrically in a manner that the inner device is inside the outer device. In some embodiments, the outer catheter 12 and / or the inner catheter 26 can be used alone. For example, in an operation such as thrombectomy, the outer catheter 12 can be first inserted into the patient to initially attempt to track the outer catheter 12 distally to the surface of the clot within the anatomical structure. If the outer catheter 12 successfully tracks the surface of the clot, suction can be applied to the outer catheter 12 to remove the clot through the outer catheter 12. If the outer catheter 12 fails to successfully track the surface of the clot, the outer catheter 12 can still be used as a guide or support catheter to help deliver the inner catheter 26 to the surface of the clot through the outer catheter 12.

[0106] The possibility of using only a single device (i.e., outer catheter 12) to remove the clot enables the procedure to be more efficient than current surgical practice, which typically includes several steps of introducing and removing several devices. The catheter system 10 including inner catheter 26 and outer catheter 12 allows the patient's anatomy to drive the procedure, rather than following the same steps for every patient as is current practice.

[0107] Figure 3 and Figure 4 The cross-sectional views of the outer conduit 12 and the inner conduit 26 are illustrated respectively. Figure 3 , the outer conduit 12 may include an outer surface 18 defining an outer diameter 22 and an inner surface 20 defining an inner diameter 24. The outer diameter 22 and the inner diameter 24 may each define a wide range of sizes, including, for example, an outer diameter 22 of 0.111 inches and an inner diameter 24 of 0.100 inches. Figure 4, the inner conduit 26 may also include an outer surface 32 defining an outer diameter 36 and an inner surface 34 defining an inner diameter 38. In some embodiments, the outer diameter 36 of the outer surface 32 defines a measurement of 0.098 inches, and the inner diameter 38 of the inner surface 34 defines a measurement of 0.088 inches. It should be noted that the dimensions listed here for both the outer conduit 12 and the inner conduit 26 are included as non-limiting examples. Both the outer conduit 12 and the inner conduit 26 may define a wide range of dimensions that are not explicitly listed in the present disclosure. For example, the outer conduit 12 and the inner conduit 26 may be limited to an outer diameter and / or inner diameter dimension between 0.003 inches and 0.18 inches.

[0108] like Figure 2A As shown in Figure 5 The example illustrates a cross section of a catheter system 10 including an outer catheter 12 and an inner catheter 26 and a seat 52 of the outer catheter 12. In some embodiments, as Figure 5 As shown in FIG. 1 , the outer catheter 12 includes an outer catheter device wall 42, and the inner catheter 26 includes an inner catheter device wall 44. Figure 6 and Figure 7 The device walls 42, 44 are discussed further. Figure 5 As shown in FIG. 1 , the catheter system 10 may further include a first hydrophilic covering 40a, a second hydrophilic covering 40b, a third hydrophilic covering 40c, and a fourth hydrophilic covering 40d.

[0109] In some embodiments, the first hydrophilic coating 40a is located on the outer surface 18 of the outer catheter 12, and the second hydrophilic coating 40b is located on the inner surface 20 of the outer catheter 12. Thus, the device wall 42 of the outer catheter can be located between the first hydrophilic coating 40a and the second hydrophilic coating 40b. Similarly, the third hydrophilic coating 40c can be located on the outer surface 32 of the inner catheter 26, and the fourth hydrophilic coating 40d can be located on the inner surface 34 of the inner catheter 26. In some embodiments, the device wall of the inner catheter 44 is located between the third hydrophilic coating 40c and the fourth hydrophilic coating 40d. Each of the first, second, third, and fourth hydrophilic coatings 40a-d can extend along a surface extending between the proximal ends 14, 28 and the distal ends 16, 30 of the outer catheter 12 and the inner catheter 26. In some embodiments, the surface extends substantially the entire length of the outer catheter 12, the inner catheter 26. The surface can extend less than the entire length, such as 50%, 25%, or 10% of the entire length. In some embodiments, each of the hydrophilic coatings 40a-d can be configured to cover the most distal portion, such as 15 centimeters, of the outer catheter 12 and the inner catheter 26. It should be noted that each of the hydrophilic coatings 40a-d can be configured to cover any size portion of the outer catheter 12 and the inner catheter 26. It should also be noted that each of the hydrophilic coatings 40a-d does not necessarily define the same length, although they can each define the same length.

[0110] Each of the first hydrophilic coating 40a, the second hydrophilic coating 40b, the third hydrophilic coating 40c, and the fourth hydrophilic coating 40d can include the same material and thickness. In some embodiments, the thickness of each hydrophilic coating 40a-d is between 0.0001 and 0.001 inches. It should be noted that the term "hydrophilic coating" is used to refer to any general type of lubricating coating that reduces friction and increases the tracking ability of the outer catheter 12 and the inner catheter 26 when the outer catheter 12 and the inner catheter 26 move within the blood vessel and / or within each other (for example, the inner catheter 26 moves within the outer catheter 12). Some non-limiting examples of lubricating coatings include hydrophilic coatings, silicone coatings, PTFE dust, and any other suitable lubricants. In some embodiments, the hydrophilic coatings 40a-d allow the device walls 42, 44 to be thinner than conventional device walls while also improving the performance of the outer catheter 12 and the inner catheter 26. The device walls 42, 44 may define a thickness between 0.001 inches and 0.04 inches.

[0111] Reference now Figure 6 , showing the outer catheter 12. As previously discussed, the outer catheter 12 can define the device wall 42. In some embodiments, as Figure 6As illustrated in the example, the device wall 42 includes at least one polymer 46 and an outer catheter reinforcement structure 48. It should be noted that at least one polymer 46 may also be referred to as a "polymer sheath structure". In some embodiments, at least one polymer 46 is configured to provide at least one of flexibility and structural support to the outer catheter 12 and the inner catheter 26. The outer catheter reinforcement structure 48 may include a metal braid and coil structure, wherein at least one polymer 46 fills any space within the braid and coil structure. At least one polymer 46 may also cover the outer catheter reinforcement structure 48. Generally, the device wall 42 can be considered to be similar to the structure of a garden hose, wherein there is a layer of hydrophilic coating 40a, 40b on the inner and outer surfaces of the device wall 42. In some embodiments, the outer catheter reinforcement structure 48 is configured to provide rigidity to the proximal portion of the outer catheter 12 and flexibility to the distal portion of the outer catheter 12. Therefore, the number, coil tightness and / or composition of the outer catheter reinforcement structure 48 can vary depending on the position along the length of the outer catheter 12.

[0112] and Figure 6 similar, Figure 7 An inner catheter 26 is shown, comprising a device wall 44 comprising at least one polymer 46 and an inner catheter reinforcement structure 50. In some embodiments, the inner catheter reinforcement structure 50 is substantially similar to the outer catheter reinforcement structure 48, comprising a garden hose-like structure immersed in at least one polymer 46. In some embodiments, the inner catheter reinforcement structure 50 is configured to provide rigidity to the proximal portion of the inner catheter 26 and flexibility to the distal portion of the inner catheter 26. Thus, the number, coil tightness, and / or composition of the inner catheter reinforcement structure 50 can vary depending on the location along the length of the inner catheter 26. The outer catheter device wall 42 and the inner catheter device wall 44 can be substantially identical and can include the same type of polymer (one or more) in the at least one polymer 46, as well as the same type of braid and coil structure in the outer catheter reinforcement structure 48 and the inner catheter reinforcement structure 50. The inner catheter 26 can be considered a smaller version of the outer catheter 12, having the same elements but in a smaller size.

[0113] Figure 8 also with Figure 6 similar, Figure 8 Another view of the outer conduit 12 is illustrated, which includes various layers of material. Figure 8 The device comprises a first hydrophilic coating 40a, a second hydrophilic coating 40b, a device wall 42, at least one polymer 46, and an outer catheter reinforcement structure 48. Figure 6As discussed, the device wall 42 may have a structure similar to that of a garden hose, with at least one polymer 46 and an outer conduit reinforcement structure 48 fused together, with a first hydrophilic coating 40a on the exterior surface and a second hydrophilic coating 40b on the interior surface.

[0114] In some embodiments, the device wall 42 has a "sandwich" structure that includes two layers of at least one polymer 46, with the outer catheter reinforcement structure 48 located between the layers of polymer 46. As previously discussed, the outer catheter reinforcement structure 48 can include braid and coil structures. Figure 8 As shown in the different appearances of the outer catheter reinforcement structure 48 in FIG. 1 , the outer catheter reinforcement structure 48 can include separate coil and braid structures. For example, the coil structure can be composed of Figure 8 The outer catheter reinforcement structure 48 on the left side is shown, and the braided structure can be made of Figure 8 40a and 40b. In some embodiments, the "sandwich" type device wall 42 includes an inner layer of at least one polymer 46, a coil structure on top of the inner polymer layer, a braid structure on top of the coil structure, and an outer layer of at least one polymer 46. In a "sandwich" type device wall, the device wall 42 may also include a first hydrophilic coating 40a and a second hydrophilic coating 40b.

[0115] In some embodiments, the "sandwich" type device wall 42 allows for more open coil spacing in the coil structure, thereby enabling the outer catheter 12 to be more flexible than embodiments in which the coil structure has a tighter or more closed spacing. For certain uses, such as when navigating tortuous anatomical structures, a softer and more flexible outer catheter 12 may be ideal to give the user (i.e., a medical practitioner) more freedom to move the device at different angles. From a manufacturing perspective, this "sandwich" type device wall can also provide benefits because a more open coil spacing may be easier to produce and have a larger margin of error than a closed spacing.

[0116] However, a device wall 42 comprising a more closely spaced coil structure may also have benefits. For example, in an embodiment where the outer catheter reinforcement structure 48 includes coils defining a spacing of less than 0.03 inches, the second hydrophilic coating 40b may have a substantially solid and ribbed surface for adhesion. In this sense, the second hydrophilic coating 40b (and the fourth hydrophilic coating 40d of the inner catheter 26) may be considered to have a textured or "ribbed" surface. In contrast, the first hydrophilic coating 40a (and the third hydrophilic coating 40c) may be considered to have a substantially smooth surface. The combination of the textured and smooth surfaces of the hydrophilic coatings 40a-d may provide just enough friction to allow the user to easily control the movement of the outer catheter 12 and the inner catheter 26. For example, when the second hydrophilic coating 40b has a textured surface and the third hydrophilic coating 40c has a smooth surface, there may be sufficient friction between the two surfaces to prevent excessive and uncontrolled sliding of the inner catheter 26 within the outer catheter 12, as would be the case if both hydrophilic coatings 40b, 40c were smooth.

[0117] In some embodiments, to ensure that the inner surface 20 of the outer catheter 12 is sufficiently strong, the coils include 0.002 inch round coils with a spacing of 0.004 inches. Coils with tighter spacing can better promote lubricity of the inner surface 20 of the outer catheter 12. In some embodiments, coils with a spacing of less than 0.025 inches are ideal. The sufficiently tight spacing of the coils in the outer catheter reinforcement structure 48 combined with the second hydrophilic coating 40b on the inner surface 20 of the outer catheter 12 can provide sufficient lubricity to replace the need for gaskets (such as PTFE gaskets) traditionally used in catheter construction. The coils can include round coils, flat coils, or other types of coil designs.

[0118] Regardless of the "type" of device wall 42 used (e.g., "sandwich" coil or close pitch coil), the use of first and second hydrophilic coatings 40a, 40b on the outer catheter 12 can result in a thinner and more flexible device wall 42 than other types of catheter walls without inner and outer coatings. It should be noted that although Figure 8 The catheter is specifically labeled as outer catheter 12, but Figure 8 The layers shown in and the previous discussion also apply to the inner conduit 26, so Figure 8 It may be considered to depict either the outer catheter 12 or the inner catheter 26 .

[0119] Fig. 9The catheter system 100 is illustrated and includes an outer catheter 102 and an inner catheter 110. As shown, the outer catheter 102 can include a proximal end 104 and a distal end 106 opposite the proximal end 104. In some embodiments, the outer catheter 102 includes a working lumen 108 extending between the proximal end 104 and the distal end 106. The working lumen 108 can be configured to at least partially receive the inner catheter 110.

[0120] Figure 10-12 The inner catheter 110 is illustrated, and in some embodiments, the inner catheter 110 includes a proximal seat 112, a distal portion 114 having a distal end 116 opposite the proximal seat 112, and a pusher wire 118 extending between the proximal seat 112 and the distal portion 114. It should be noted that the working lumen 108 can be configured to at least partially receive the pusher wire 118, such as Fig. 9 As shown in Fig.10 As illustrated in the illustration of , the distal portion 114 may include a hypotube 120. In some embodiments, the hypotube 120 includes a stainless steel hypotube. The hypotube 120 may include a nitinol hypotube. It should be noted that the hypotube 120 may be made of any suitable material, and in some embodiments, is a laser cut hypotube. The hypotube 120 may include a non-laser cut hypotube. In some embodiments, the hypotube 120 includes a distal portion 126 and a proximal portion 128 opposite the distal portion 126. As shown, the proximal portion 128 may be configured to taper to a proximal end 130 and be connected to the pusher wire 118. In place of the hypotube 120, the distal portion 114 of the inner catheter 110 may include a Fig.11 The coil structure 122 illustrated in FIG. Fig.12 The distal portion 114 of the inner catheter 110 may include a combination of the coil structure 122 and the braid structure 124. It should be noted that the distal portion 114 may include any suitable material construction and is not limited to the examples shown in the figures and discussed in this disclosure.

[0121] like Figure 10-12 As shown in , due to the inclusion of the pusher wire 118, in some embodiments, the length defined by the distal portion 114 of the inner catheter 110 is significantly less than the entire length of the inner catheter 110. In contrast, Fig. 9The outer catheter 102 shown in the figure may include a single tube that substantially defines the entire length of the outer catheter 102 minus the proximal end 104. Therefore, in the catheter system 100, the outer catheter 102 can be considered a "full catheter" and the inner catheter 110 can be considered a "partial catheter". The distal portion 114 of the inner catheter 110 (whether it is a hypotube 120, a coil structure 122 or a braid structure 124) can define a length of about 20 centimeters. In some embodiments, the distal portion 114 defines a length of less than 20 centimeters. The distal portion 114 can define a length greater than 20 centimeters.

[0122] In some embodiments, the pusher wire 118 is fixedly coupled (e.g., via welding, bonding, adhesive bonding, etc.) to the distal portion 114 of the inner catheter 110. The pusher wire 118 can be configured to facilitate navigation of the inner catheter 110 through the working lumen 108 of the outer catheter 102. For example, during a procedure, a physician (or another qualified medical professional) can use the proximal seat 112 and / or the pusher wire 118 to "push" the inner catheter 110 through the outer catheter 102. The relative rigidity of the pusher wire 118 can help advance the inner catheter 110 and limit twisting, kinking, bending, etc. of the distal portion 114. In some embodiments, the pusher wire 118 comprises a round wire. The pusher wire 118 can comprise a flat wire.

[0123] Now turn to Figures 13A and Fig. 13B , showing a cross-sectional view of the hypotube 120. In some embodiments, the hypotube 120 includes an inner surface 132 and an outer surface 134 opposite the inner surface 132. Fig.13A , the outer surface 134 may be covered with a heat shrink material 136. The heat shrink material 136 may include a material that is laminated or melted to the outer surface 134 of the hypotube 120. In some embodiments, at least a portion of the heat shrink material 136 and at least a portion of the inner surface 132 of the hypotube 120 are covered with a lubricious coating 140. In some embodiments, substantially the entire heat shrink material 136 and substantially the entire inner surface 132 are covered with a lubricious coating 140. At least a portion of the heat shrink material 136 and substantially the entire inner surface 132 may be covered with a lubricious coating 140. Alternatively, substantially the entire heat shrink material 136 and at least a portion of the inner surface 132 may be covered with a lubricious coating 140.

[0124] The lubricating coating 140 may include a hydrophilic coating. In some embodiments, the lubricating coating 140 includes silicone. The lubricating coating 140 may include any suitable type of coating and is not intended to be limited to the examples discussed in the present disclosure. In some embodiments, the lubricating coating 140 helps facilitate smooth navigation of the hypotube 120 through the working lumen 108 of the outer catheter 102. In embodiments where the inner catheter 110 extends distally from the outer catheter 102, the lubricating coating 140 may also help facilitate smooth navigation of the hypotube 120 through the patient's vascular system. In some embodiments, the lubricating coating 140 on the inner surface 132 of the hypotube 120 facilitates smooth movement of an auxiliary device (e.g., a guidewire, a microcatheter, a dedicated device, etc.) through the hypotube 120.

[0125] Fig. 13B Illustratively, in some embodiments, the outer surface 134 of the hypotube 120 is covered with a reflowed polymer 138 instead of the heat shrink material 136. At least a portion of the reflowed polymer 138 and at least a portion of the inner surface 132 of the hypotube 120 may be covered with a lubricious coating 140. In some embodiments, substantially the entire reflowed polymer 138 and substantially the entire inner surface 132 of the hypotube 120 are covered with a lubricious coating 140. At least a portion of the reflowed polymer 138 and substantially the entire inner surface 132 may be coated with the lubricious coating 140. Alternatively, substantially the entire reflowed polymer 138 and at least a portion of the inner surface 132 may be coated with the lubricious coating 140.

[0126] The outer surface 134 of the hypotube 120 may be covered with a combination of a heat shrink material 136 and a reflown polymer 138. In some embodiments, at least a portion of the hypotube 120 includes a PTFE liner instead of a lubricating coating 140. For example, one half of the hypotube 120 may include a PTFE liner while the other half includes a lubricating coating 140. Alternatively, one half of the hypotube 120 may include a PTFE liner while the other half does not include a lubricating coating 140. The hypotube 120 may also include neither a PTFE liner nor a lubricating coating 140. It should also be noted that, if applicable, the respective Fig.11 and Fig.12 As illustrated in the drawings, the embodiments of the catheter system 100 including the coil structure 122 or the braid structure 124 may also include a heat shrink material 136, a reflowed polymer 138, or a combination thereof, to cover the coil structure 122 or the braid structure 124. In addition, the embodiments having the coil structure 122 and / or the braid structure 124 may include a lubricious coating 140, such as Fig.13A and 13B As shown in the example.

[0127] Reference now Fig.14 , showing a catheter system 200. In some embodiments, the catheter system 200 includes an outer catheter 202 having a proximal end 204, a distal end 206 opposite the proximal end 204, and a working lumen 208 extending between the proximal end 204 and the distal end 206. The catheter system 200 may also include an inner catheter 210, and the working lumen 208 may be configured to at least partially receive the inner catheter 210, such as Fig.14 as shown in .

[0128] Fig.15 The inner catheter 210 is illustrated in more detail, and includes a proximal end 212 and a distal end 214 opposite to the proximal end 212. Figure 9-1 3), the inner catheter 210 may include a "full" catheter, rather than a "partial" catheter. In other words, the inner catheter 210 may include a hypotube 216 that is configured to extend the entire length from the proximal end 212 to the distal end 214. Similar to the hypotube 120 of the inner catheter 110, the hypotube 216 of the inner catheter 210 may include a laser cut hypotube. The inner catheter 210 may include a non-laser cut hypotube. In some embodiments, the hypotube 216 includes a stainless steel hypotube. The hypotube 216 may include a nitinol hypotube, or a hypotube made of any other suitable material.

[0129] Fig.16A and 16B and Fig.13A and 13B Similar, but they illustrate hypotube 216 instead of hypotube 120. Fig.16A and 16B 2 shows a cross-sectional view of a hypotube 216, wherein the hypotube 216 includes an inner surface 218 and an outer surface 220 opposite the inner surface 218. Fig.16A , the outer surface 220 may be covered with a heat shrink material 222. The heat shrink material 222 may include a material that is laminated or melted to the outer surface 220 of the hypotube 216. In some embodiments, at least a portion of the heat shrink material 222 and at least a portion of the inner surface 218 of the hypotube 216 are covered with a lubricious coating 226. In some embodiments, substantially the entire heat shrink material 222 and substantially the entire inner surface 218 are coated with the lubricious coating 226. At least a portion of the heat shrink material 222 and substantially the entire inner surface 218 may be covered with the lubricious coating 226. Alternatively, substantially the entire heat shrink material 222 and at least a portion of the inner surface 218 may be covered with the lubricious coating 226.

[0130] In some embodiments, the lubricating coating 226 is substantially similar to the lubricating coating 140 of the catheter system 100. The lubricating coating 226 may include a hydrophilic coating. In some embodiments, the lubricating coating 226 includes silicone. The lubricating coating 226 may include any suitable type of coating and is not intended to be limited to the examples discussed in the present disclosure. In some embodiments, the lubricating coating 226 helps to facilitate the smooth navigation of the hypotube 216 through the working lumen 208 of the outer catheter 202. In embodiments where the inner catheter 210 extends distally from the outer catheter 202, the lubricating coating 226 may also help facilitate the smooth navigation of the hypotube 216 through the patient's vascular system. In some embodiments, the lubricating coating 226 on the inner surface 218 of the hypotube 216 helps the smooth movement of auxiliary devices (e.g., guidewires, microcatheters, special devices, etc.) through the hypotube 216.

[0131] Fig. 16B Illustratively, in some embodiments, the outer surface 220 of the hypotube 216 is covered with a reflowed polymer 224 instead of the heat shrink material 222. At least a portion of the reflowed polymer 224 and at least a portion of the inner surface 218 of the hypotube 216 may be coated with a lubricious coating 226. In some embodiments, substantially the entire reflowed polymer 224 and substantially the entire inner surface 218 of the hypotube 216 are covered with the lubricious coating 226. At least a portion of the reflowed polymer 224 and substantially the entire inner surface 218 may be covered with the lubricious coating 226. Alternatively, substantially the entire reflowed polymer 224 and at least a portion of the inner surface 218 may be covered with the lubricious coating 226.

[0132] The outer surface 220 of the hypotube 216 can be covered with a combination of a heat shrink material 222 and a reflowed polymer 224. In some embodiments, at least a portion of the hypotube 216 includes a PTFE liner instead of a lubricating coating 226. For example, half of the hypotube 216 can include a PTFE liner and the other half includes a lubricating coating 226. Alternatively, half of the hypotube 216 can include a PTFE liner and the other half does not include a lubricating coating 226. The hypotube 216 can also include neither a PTFE liner nor a lubricating coating 226. It should also be noted that the inner catheter 210 can include a coil structure or a braid structure instead of a hypotube 216, which structures are similar to Fig.11 and Fig.12 In some embodiments, the inner catheter 210 including the coil and / or braid structure also includes a heat shrink material 222, a reflowed polymer 224, or a combination thereof to cover the coil structure and / or braid structure, if applicable. In addition, embodiments having a coil structure and / or braid structure may include the following: Fig.16A and 16BThe lubricating coating 226 illustrated in FIG.

[0133] Fig.17 Contains a flow chart illustrating a non-limiting example process for coating and curing the inner surface of a catheter. For purposes of this disclosure, Fig.17 The "catheter" described in the present disclosure may include elements of the catheter system 10 (i.e., outer catheter 12 or inner catheter 26), elements of the catheter system 100 (i.e., outer catheter 102 or inner catheter 110), and / or elements of the catheter system 200 (i.e., outer catheter 202 or inner catheter 210). The steps of the process should be considered applicable to any catheter described in the present disclosure.

[0134] Fig.17 The process shown in 1700 begins by cleaning the conduit in step 1700. In some embodiments, cleaning the conduit includes flushing the conduit with purified water, isopropyl alcohol ("IPA"), a mixture of IPA and water, or some other suitable cleaning fluid. The next step is step 1702 of drying the conduit in an oven. The drying step can include placing the clean conduit in an oven set at a temperature between 0° C. and 400° C., and applying positive or negative pressure air (e.g., oxygen, a mixture of oxygen and nitrogen, etc.) to the seat of the conduit to dry the inner surface of the conduit. The process continues to step 1704: removing the dried conduit from the oven.

[0135] Next, the process can continue in one of two possible steps. As shown in step 1706, one option is to apply a first coating of a hydrophilic coating to the inner surface of the conduit. Alternatively, in step 1708, a bottom coating can be applied to the inner surface of the conduit. Steps 1706 and 1708 can both use positive or negative pressure to fill the conduit with a hydrophilic coating (step 1706) or a bottom coating (step 1708). The conduit can be filled with the relevant coating material from either end of the conduit body. In certain embodiments, the relevant coating material flows through the conduit substantially continuously within a predetermined time to ensure that a sufficient amount of coating is applied. The relevant coating material can stay in the conduit for a predetermined time, rather than flowing through the conduit.

[0136] After step 1706 or step 1708, the process can continue in step 1710 to place the conduit back into the oven for drying. Similar to the first drying step (i.e., step 1702), step 1710 can include placing the clean conduit in an oven set at a temperature between 0°C and 400°C, and applying positive or negative pressure air (e.g., oxygen, a mixture of oxygen and nitrogen, etc.) to the seat of the conduit to dry the inner surface of the conduit. Step 1710 can be considered a "heat curing" step because heat is used to dry (i.e., cure) the coating. Next, in step 1712, the positive or negative pressure source is disconnected, and the dried conduit is removed from the oven.

[0137] At this point, the process is again divided into two different options. One option is to apply a second coating of a hydrophilic coating to the inner surface of the conduit in step 1714. Another option is to apply a top coating to the inner surface of the conduit in step 1716. Similar to the application of the first coating of the hydrophilic coating (in step 1706) and the application of the bottom coating (in step 1708), both steps 1714 and 1716 can use positive or negative pressure to fill the conduit with the relevant coating material from either end of the conduit body. In some embodiments, the relevant coating material flows through the conduit substantially continuously within a predetermined time to ensure that a sufficient amount of coating is applied. The relevant coating material can stay in the conduit for a predetermined time instead of flowing through the conduit.

[0138] Next, the process continues in step 1718 to place the catheter back into the oven for drying (or "heat curing") again. Similar to the first and second drying steps (steps 1702 and 1710), step 1718 may include placing the catheter in an oven set at a temperature between 0° C. and 400° C., and applying positive or negative pressure air (e.g., oxygen, a mixture of oxygen and nitrogen, etc.) to the seat of the catheter to dry the inner surface of the catheter. In step 1720, the process ends by disconnecting the positive or negative pressure source and removing the dried, coated catheter from the oven.

[0139] Fig.18 and Fig.17 is similar to, and includes a flow chart illustrating a slightly different non-limiting example process for coating and curing the inner surface of a catheter. Fig.17 For the purposes of this disclosure, Fig.18 The "catheter" described in the present disclosure may include elements of the catheter system 10 (i.e., outer catheter 12 or inner catheter 26), elements of the catheter system 100 (i.e., outer catheter 102 or inner catheter 110), and / or elements of the catheter system 200 (i.e., outer catheter 202 or inner catheter 210). The steps of the process should be considered applicable to any catheter described in the present disclosure.

[0140] Fig.18 The process shown in 1800 begins by cleaning the conduit in step 1800. In some embodiments, cleaning the conduit includes flushing the conduit with purified water, IPA, a mixture of IPA and water, or some other suitable cleaning fluid. The next step is step 1802 of drying the conduit in an oven. The drying step may include placing the clean conduit in an oven set at a temperature between 0° C. and 400° C., and applying positive or negative pressure air (e.g., oxygen, a mixture of oxygen and nitrogen, etc.) to the seat of the conduit to dry the inner surface of the conduit. The process continues to step 1804: removing the dried conduit from the oven.

[0141] Next, the process can continue in one of two possible steps. As shown in step 1806, one option is to apply the first coating of the hydrophilic coating to the inner surface of the conduit. Alternatively, in step 1808, the bottom coating can be applied to the inner surface of the conduit. Steps 1806 and 1808 can both use positive or negative pressure to fill the conduit with the hydrophilic coating (step 1806) or the bottom coating (step 1808). The conduit can be filled with the relevant coating material from either end of the conduit body. In certain embodiments, the relevant coating material is substantially continuously flowed through the conduit within a predetermined time to ensure that a sufficient amount of coating is applied. The relevant coating material can stay in the conduit for a predetermined time, rather than flowing through the conduit.

[0142] After step 1806 or step 1808, the process can continue in step 1810 to insert a UV light device to cure the coating and apply positive or negative pressure air (e.g., oxygen, a mixture of oxygen and nitrogen, etc.) to the seat of the catheter to dry the inner surface of the catheter. In some embodiments, the UV light device is inserted into the inner diameter of the catheter to cure the coating on the inner surface. Next, in step 1812, the positive pressure source or negative pressure source is disconnected and the UV light device is removed from the catheter.

[0143] At this point, the process is again divided into two different options. One option is to apply a second coating of a hydrophilic coating to the inner surface of the conduit in step 1814. Another option is to apply a top coating to the inner surface of the conduit in step 1816. Similar to the application of the first coating of the hydrophilic coating (in step 1806) and the application of the bottom coating (in step 1808), both steps 1814 and 1816 can use positive or negative pressure to fill the conduit with the relevant coating material from either end of the conduit body. In some embodiments, the relevant coating material flows through the conduit substantially continuously within a predetermined time to ensure that a sufficient amount of coating is applied. The relevant coating material can stay in the conduit for a predetermined time, rather than flowing through the conduit.

[0144] Next, in step 1818, the process continues with another round of UV light curing. Similar to the first UV curing step (step 1810), step 1818 can include inserting a UV light device to cure the coating, and applying positive or negative pressure air (e.g., oxygen, a mixture of oxygen and nitrogen, etc.) to the seat of the catheter to dry the inner surface of the catheter. The UV light device can be inserted into the inner diameter of the catheter to cure the coating on the inner surface. In step 1820, the process ends by disconnecting the positive or negative pressure source and removing the UV light device from the oven.

[0145] The catheter system 10 can be configured to be used in a variety of procedures performed in a variety of locations within a patient's anatomy. Although brain-specific thrombectomy is discussed, the present disclosure should not be considered limited to any particular type or location of the procedure. The catheter system 10 can be used to aspirate clots throughout a patient's body, and the various aspects of the catheter system 10 described above can improve clot removal rates at a variety of surgical sites.

[0146] The catheter system can include a complete outer catheter 102 and a partial inner catheter 110, such as catheter system 100, or can include a complete outer catheter 202 and a complete inner catheter 210, such as catheter system 200. In some embodiments, the catheter system includes a partial outer catheter and a complete inner catheter. The catheter system can also include a partial outer catheter and a partial inner catheter.

[0147] Although not shown in the figures, a method of using any of the catheter systems described herein (such as catheter system 10, catheter system 100, and / or catheter system 200) may include inserting an outer catheter (such as outer catheter 12, outer catheter 102, and / or outer catheter 202) into a patient's vasculature, wherein the outer catheter includes a proximal end and a distal end opposite the proximal end; advancing the outer catheter through the patient's vasculature toward a vascular lesion; and advancing the outer catheter to a position selected from the group consisting of a first position and a second position. In some embodiments, the first position is within a first predetermined distance from the vascular lesion, and the second position is within a second predetermined distance from the vascular lesion. When the outer catheter is in the first position, the outer catheter may be able to aspirate the vascular lesion, and when the outer catheter is in the second position, the outer catheter may not be able to aspirate the vascular lesion. In some embodiments, when the outer catheter is in the first position, the method further includes aspirating the vascular lesion with the outer catheter. When the outer catheter is in the second position, the method may further include advancing an inner catheter (such as inner catheter 26, inner catheter 110, and / or inner catheter 210) through the outer catheter toward the first position. In some embodiments, when the inner catheter is in the first position, the method further comprises aspirating the vascular lesion with the inner catheter.

[0148] The steps described herein are all non-essential or indispensable. Any step can be adjusted or modified. Other or additional steps can be used. Any part of any step, process, structure, and / or device disclosed or illustrated in an embodiment, flow chart, or example in this specification can be combined with any other part of any step, process, structure, and / or device disclosed or illustrated in different embodiments, flow charts, or examples or used together with it or used instead of it. The embodiments and examples provided herein are not intended to be discrete and separated from each other.

[0149] The section titles and subheadings provided herein are non-limiting. The section titles and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the titles and subheadings belong. For example, a section entitled "Topic 1" may contain embodiments that do not belong to Topic 1, and embodiments described in other sections may be applicable to and combined with the embodiments described in the "Topic 1" section.

[0150] The various features and processes described above can be used independently of each other, or used in combination in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. In addition, in some embodiments, certain methods, events, states, or process blocks may be omitted. The methods, steps, and processes described herein are not limited to any particular order, and the blocks, steps, or states associated therewith may be performed in other appropriate orders. For example, the tasks or events described may be performed in an order different from the order specifically disclosed. Multiple steps may be combined in a single block or state. Example tasks or events may be performed serially, in parallel, or in some other manner. Tasks or events may be added to the disclosed example embodiments or removed from the disclosed example embodiments. The example systems and components described herein may be constructed differently from those described. For example, compared to the disclosed example embodiments, elements may be added, removed, or rearranged.

[0151] Unless otherwise specifically stated, or otherwise understood in the context in which it is used, the conditional language used herein, such as "may", "might", "can", "can", "for example", etc., is generally intended to express that certain embodiments include certain features, elements and / or steps, while other embodiments do not include certain features, elements and / or steps. Therefore, such conditional language is generally not intended to imply that features, elements and / or steps are in any way necessary for one or more embodiments, or that one or more embodiments must include logic for determining whether these features, elements and / or states are included in any particular embodiment or whether they will be executed in any particular embodiment with or without designer input or prompting. The terms "include", "comprise", "have", etc. are synonymous and are used inclusively in an open manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in its inclusive sense (rather than in its exclusive sense) so that when used, for example, to connect a list of elements, the term "or" means one, some or all of the elements in the list. Unless specifically stated otherwise, or understood otherwise in the context of use, connective language, such as the phrase "at least one of X, Y, and Z," is generally used to express that an item, term, etc. may be any of X, Y, or Z. Thus, such connective language is generally not intended to imply that certain embodiments require that at least one of X, at least one of Y, and at least one of Z, respectively, be present.

[0152] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Thus, A, B, and / or C may be replaced with A, B, and C written in one sentence and A, B, or C written in another sentence. A, B, and / or C means that some embodiments may include A and B, some embodiments may include A and C, some embodiments may include B and C, some embodiments may include only A, some embodiments may include only B, some embodiments may include only C, and some embodiments may include A, B, and C. The term "and / or" is used to avoid unnecessary redundancy.

[0153] The term "substantially" is used to mean "completely" or "almost completely." For example, the present disclosure includes, "the first hydrophilic coating includes a substantially smooth surface." In this context, "substantially" is used to mean that the first hydrophilic coating may include a completely or almost completely smooth surface.

[0154] Although certain example embodiments have been described, these embodiments are presented by way of example only and are not intended to limit the scope of the invention disclosed herein. Therefore, nothing in the foregoing description is intended to imply that any particular feature, characteristic, step, module, or block is necessary or indispensable. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes in the form of the methods and systems described herein may be made without departing from the spirit of the invention disclosed herein.

Claims

1. A catheter system, comprising: an outer catheter having a proximal end, a distal end opposite the proximal end, a working lumen extending between the proximal end and the distal end, an outer surface defining an outer diameter, and an inner surface defining an inner diameter; as well as an inner catheter having a proximal seat, a distal portion having a distal end opposite the proximal seat, an outer surface defining an outer diameter, an inner surface defining an inner diameter, and a pusher wire extending between the proximal seat and the distal portion, Wherein, the working lumen of the outer catheter is configured to at least partially receive the inner catheter.

2. The catheter system according to claim 1, wherein: The distal portion of the inner catheter includes a hypotube.

3. The catheter system of claim 2, wherein: The hypotube includes a distal portion and a proximal portion opposite the distal portion of the hypotube, wherein the proximal portion of the hypotube is configured to taper to a proximal end coupled to the pusher wire.

4. The catheter system of claim 3, wherein: The pusher wire is configured to facilitate navigation of the inner catheter through the working lumen of the outer catheter.

5. The catheter system according to claim 2: in, The hypotube comprises an inner surface and an outer surface covered with a heat shrink material, wherein at least a portion of the heat shrinkable material and at least a portion of the inner surface of the hypotube are covered with a lubricating coating, and Wherein, the lubricating coating includes one of a hydrophilic coating and a silicone resin.

6. The catheter system according to claim 2: in, The hypotube comprises an inner surface and an outer surface covered with a reflowing polymer material, wherein at least a portion of the reflowing polymer material and at least a portion of the inner surface of the hypotube are coated with a lubricating coating, and Wherein, the lubricating coating includes one of a hydrophilic coating and a silicone resin.

7. The catheter system of claim 2, wherein: The hypotube comprises a material selected from the group consisting of stainless steel, nitinol, and combinations thereof.

8. The catheter system of claim 7, wherein: The hypotube comprises a laser cut hypotube.

9. The catheter system of claim 2, wherein: The hypotube defines a length of approximately 20 centimeters.

10. The catheter system of claim 1, wherein: The outer catheter comprises a device wall and the inner catheter comprises a device wall, wherein the device wall of the outer catheter comprises at least one polymer coupled to an outer catheter reinforcement structure and wherein the device wall of the inner catheter comprises at least one polymer coupled to an inner catheter reinforcement structure.

11. The catheter system of claim 10, wherein: The outer catheter reinforcement structure includes a braid and coil reinforcement structure, and the inner catheter reinforcement structure includes a braid and coil reinforcement structure.

12. The catheter system of claim 11, wherein: The device wall of the outer conduit is located between the first hydrophilic coating and the second hydrophilic coating, and wherein the device wall of the inner conduit is located between the third hydrophilic coating and the fourth hydrophilic coating, wherein the first hydrophilic coating is located on the outer surface of the outer catheter and is configured to reduce surface friction and increase lubricity between the outer surface of the outer catheter and the blood vessel wall, the first hydrophilic coating comprising a substantially smooth surface; wherein the second hydrophilic coating is located on the inner surface of the outer conduit and is configured to reduce surface friction between the inner surface of the outer conduit and the outer surface of the inner conduit and increase lubricity between the inner surface of the outer conduit and the outer surface of the inner conduit, the second hydrophilic coating comprising a textured surface; wherein the third hydrophilic coating is located on the outer surface of the inner conduit and is configured to reduce surface friction between the inner surface of the outer conduit and the outer surface of the inner conduit and increase lubricity between the inner surface of the outer conduit and the outer surface of the inner conduit, the third hydrophilic coating comprising a substantially smooth surface; and The fourth hydrophilic coating is located on the inner surface of the inner conduit and is configured to reduce surface friction on the inner surface of the inner conduit and increase lubricity on the inner surface of the inner conduit, and the fourth hydrophilic coating includes a textured surface.

13. The catheter system of claim 1, wherein: The pusher wire includes one of a round wire and a flat wire.

14. The catheter system according to claim 2: in, The outer catheter comprises a device wall comprising at least one polymer coupled to an outer catheter reinforcement structure, Wherein, the outer catheter reinforcement structure includes a braid and a coil reinforcement structure, Wherein, the device wall of the outer catheter is located between the first hydrophilic coating and the second hydrophilic coating, wherein the first hydrophilic coating is located on the outer surface of the outer catheter and is configured to reduce surface friction between the outer surface of the outer catheter and the blood vessel wall and increase lubricity between the outer surface of the outer catheter and the blood vessel wall, the first hydrophilic coating comprising a substantially smooth surface, and The second hydrophilic coating is located on the inner surface of the outer conduit and is configured to reduce surface friction between the inner surface of the outer conduit and the outer surface of the inner conduit and increase lubricity between the inner surface of the outer conduit and the outer surface of the inner conduit, and the second hydrophilic coating includes a textured surface.

15. A catheter system comprising: an outer catheter having a proximal end, a distal end opposite the proximal end, a working lumen extending between the proximal end and the distal end, an outer surface defining an outer diameter, and an inner surface defining an inner diameter; as well as An inner catheter having a proximal end and a distal end opposite the proximal end of the inner catheter, wherein the working lumen is configured to at least partially receive the inner catheter, and wherein the inner catheter comprises a hypotube.

16. The catheter system according to claim 15: in, The hypotube comprises an inner surface and an outer surface covered with a heat shrink material, wherein at least a portion of the heat shrinkable material and at least a portion of the inner surface of the hypotube are covered with a lubricating coating, and Wherein, the lubricating coating includes one of a hydrophilic coating and a silicone resin.

17. The catheter system of claim 15: in, The hypotube comprises an inner surface and an outer surface covered with a reflowing polymer material, wherein at least a portion of the reflowing polymer material and at least a portion of the inner surface of the hypotube are coated with a lubricating coating, and Wherein, the lubricating coating includes one of a hydrophilic coating and a silicone resin.

18. The catheter system of claim 15, wherein: The hypotube comprises a material selected from the group consisting of stainless steel, nitinol, and combinations thereof.

19. The catheter system of claim 18, wherein: The hypotube comprises a laser cut hypotube.

20. The catheter system of claim 14, wherein: The outer catheter comprises a device wall comprising at least one polymer coupled to an outer catheter reinforcement structure, Wherein, the outer catheter reinforcement structure includes a braid and a coil reinforcement structure, Wherein, the device wall is located between the first hydrophilic coating and the second hydrophilic coating, wherein the first hydrophilic coating is located on the outer surface of the outer catheter and is configured to reduce surface friction and increase lubricity between the outer surface of the outer catheter and the blood vessel wall, the first hydrophilic coating comprising a substantially smooth surface; The second hydrophilic coating is located on the inner surface of the outer conduit and is configured to reduce surface friction between the inner surface of the outer conduit and the outer surface of the inner conduit and increase lubricity between the inner surface of the outer conduit and the outer surface of the inner conduit, and the second hydrophilic coating includes a textured surface.

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