Catheter systems and methods of use

Abstract

The present disclosure includes a catheter system including an inner catheter and an outer catheter configured to at least partially receive the inner catheter. Each of the inner catheter and the outer catheter may include an outer surface and an inner surface, where each of the outer surface and the inner surface may be coated with a hydrophilic coating. In some embodiments, the hydrophilic coating is configured to reduce the surface tension and increase the lubricity of the inner and outer catheters.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 289,038, filed on December 13, 2021, entitled "CATHETER SYSTEMS AND METHODS OF USE."

[0003] The entire contents of the following application are incorporated herein by reference: U.S. Provisional Patent Application No. 63 / 340,276, filed on May 10, 2022, entitled “CATHETER SYSTEMS AND METHODS OF USE”. Summary of the invention

[0004] The present disclosure includes a catheter system, the catheter system includes an outer catheter, the outer catheter has a proximal end, a distal end positioned relative to 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 has a proximal end, a distal end positioned relative to 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, wherein the working lumen of the outer catheter is configured to receive the inner catheter at least in part. The catheter system may include a first hydrophilic coating, a second hydrophilic coating, a third hydrophilic coating, and a 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 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. 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 fourth hydrophilic coating can be located on the inner surface of the inner catheter and can be configured to reduce the surface friction on the inner surface of the inner catheter and increase the lubricity on the inner surface of the inner catheter.

[0005] 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 the outer catheter reinforcement structure, and wherein the device wall of the inner catheter comprises at least one polymer coupled to the inner catheter reinforcement structure. The outer catheter reinforcement structure may include a braided and coiled reinforcement structure, and the inner catheter reinforcement structure may include a braided and coiled reinforcement structure. In some embodiments, the at least one polymer is configured to provide at least one of flexibility and structural support to the outer catheter and the inner catheter. The braided and coiled reinforcement structure may include a coil defining a pitch of less than 0.03 inches. The device wall of the outer catheter may be located between the first hydrophilic coating and the second hydrophilic coating, and the device wall of the inner catheter may be located between the third hydrophilic coating and the fourth hydrophilic coating.

[0006] The catheter system may include a guidewire configured to extend through an inner catheter, wherein the fourth hydrophilic coating may be configured to reduce the surface friction between the guidewire and the inner surface of the inner catheter and increase the lubricity between the guidewire and the inner surface of the inner catheter. In certain embodiments, the first hydrophilic coating includes a substantially smooth surface, and the third hydrophilic coating includes a substantially smooth surface. The second hydrophilic coating may include a textured surface, and the fourth hydrophilic coating may include a textured surface.

[0007] In some embodiments, the first hydrophilic coating extends between the proximal end and the distal end of the outer catheter. The first hydrophilic coating can extend along the surface extending between the proximal end and the distal end of the outer catheter. In some embodiments, the second hydrophilic coating extends between the proximal end and the distal end of the outer catheter. The second hydrophilic coating can extend along the surface extending between the proximal end and the distal end of the outer catheter. In some embodiments, the third hydrophilic coating extends between the proximal end and the distal end of the outer catheter. The third hydrophilic coating can extend along the surface extending between the proximal end and the distal end of the outer catheter. In some embodiments, the fourth hydrophilic coating extends between the proximal end and the distal end of the outer catheter. The fourth hydrophilic coating can extend along the surface extending between the proximal end and the distal end of the outer catheter.

[0008] The catheter system may also include: an outer reinforcement structure located on the second hydrophilic coating, the outer reinforcement structure configured to provide structural support to the outer catheter; and an inner reinforcement structure located on the fourth hydrophilic coating, the inner reinforcement structure configured to provide structural support to the inner catheter. In some embodiments, the outer reinforcement structure includes a braided and coiled reinforcement structure, and the inner reinforcement structure includes a braided and coiled reinforcement structure. The catheter system may also include: an outer sheath structure coupled to the outer reinforcement structure, wherein the outer sheath structure can be configured to provide at least one of flexibility and structural support to the outer catheter; and an inner sheath structure coupled to the inner reinforcement structure, wherein the inner sheath structure can be configured to provide at least one of flexibility and structural support to the inner catheter. In some embodiments, the outer sheath structure includes a polymer sheath structure, and the inner sheath structure includes a polymer sheath structure. The catheter system may also include an outer sheath structure connected to the outer reinforcement structure, wherein the outer sheath structure can be configured to cover the outer reinforcement structure and thereby provide a substantially smooth surface for connecting to the first hydrophilic coating; and an inner sheath structure connected to the inner reinforcement structure, wherein the inner sheath structure can be configured to cover the inner reinforcement structure and thereby provide a substantially smooth surface for connecting to the third hydrophilic coating.

[0009] In some embodiments, the outer diameter of the outer conduit is approximately 0.111 inches, and the inner diameter of the outer conduit is approximately 0.100 inches. The outer diameter of the inner conduit can be approximately 0.098 inches, and the inner diameter of the inner conduit can be approximately 0.088 inches.

[0010] The present disclosure includes a method of using a catheter system, the method comprising: inserting an outer catheter into a patient's vasculature, wherein the outer catheter includes a proximal end and a distal end positioned 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 is 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 also include advancing the inner catheter through the outer catheter toward the first position. In some embodiments, when the inner catheter is in the first position, the method further includes aspirating the vascular lesion with the inner catheter.

[0011] The present disclosure includes a catheter system, the catheter system includes an outer catheter, the outer catheter having a proximal end, a distal end positioned relative to the proximal end, and a working lumen extending between the proximal end and the distal end. The catheter system may also include an inner catheter, the inner catheter having a proximal seat, a distal portion having a distal end positioned relative to the proximal seat, and a pusher wire extending between the proximal seat and the distal portion. In some embodiments, the working lumen is configured to at least partially receive the inner catheter. The distal portion of the inner catheter may include one of a hypotube, a coil structure, and a braided structure. In some embodiments, the hypotube includes a distal portion and a proximal portion positioned relative to the distal portion, wherein the proximal portion is configured to taper to the proximal end connected to the pusher wire. The pusher channel can be configured to facilitate guiding the inner catheter through the working lumen of the outer catheter.

[0012] 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 coated with a lubricious coating. The lubricious coating may include one of a hydrophilic coating and a silicone. In some embodiments, substantially the entire heat shrink material and substantially the entire inner surface of the hypotube are coated with a lubricious coating.

[0013] The outer surface may be covered with a reflow polymer material. In some embodiments, at least a portion of the reflow polymer material and at least a portion of the inner surface of the hypotube are coated with a lubricious coating. The lubricious coating may include one of a hydrophilic coating and a silicone. In some embodiments, substantially the entire reflow polymer material and substantially the entire inner surface of the hypotube are coated with a lubricious coating.

[0014] The hypotube may include a stainless steel hypotube. In some embodiments, the hypotube includes a nitinol hypotube. The hypotube may define a length of approximately twenty centimeters. In some embodiments, the pusher wire includes a round wire. The pusher wire may include a flat wire.

[0015] The present disclosure includes a catheter system, which includes: an outer catheter, the outer catheter having a proximal end, a distal end positioned opposite to the proximal end, and a working lumen extending between the proximal end and the distal end; and an inner catheter, the inner catheter having a proximal end and a distal end positioned opposite to the proximal end, wherein the working lumen is configured to at least partially receive the inner catheter, and wherein the inner catheter includes a sea wave tube.

[0016] 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 coated with a lubricious coating. The lubricious coating may include one of a hydrophilic coating and a silicone. In some embodiments, substantially the entire heat shrink material and substantially the entire inner surface of the hypotube are coated with a lubricious coating.

[0017] The outer surface may be covered with a reflow polymer material. In some embodiments, at least a portion of the reflow polymer material and at least a portion of the inner surface of the hypotube are coated with a lubricious coating. The lubricious coating may include one of a hydrophilic coating and a silicone. In some embodiments, substantially the entire reflow polymer material and substantially the entire inner surface of the hypotube are coated with a lubricious coating.

[0018] The hypotube may comprise a stainless steel hypotube. In some embodiments, the hypotube comprises a nitinol hypotube. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0020] Figure 2A and Figure 2B A catheter system including an outer catheter and an inner catheter is shown according to some embodiments.

[0021] Figure 3 A cross-section of an outer catheter is shown according to some embodiments.

[0022] Figure 4 A cross-section of an inner catheter is shown according to some embodiments.

[0023] Figure 5 A cross-section of a catheter system including an outer catheter and an inner catheter is shown according to some embodiments.

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

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

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

[0027] Fig. 9 A catheter system including an outer catheter and an inner catheter is shown according to some embodiments.

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

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

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

[0031] Fig.13A and Fig. 13B A cross-sectional view of a hypotube is shown in accordance with some embodiments.

[0032] Fig.14 A catheter system including an outer catheter and an inner catheter is shown according to some embodiments.

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

[0034] Fig.16A and Fig. 16B A cross-sectional view of a hypotube is shown in accordance with some embodiments.

[0035] Fig.17 and Fig.18 A flow chart is shown explaining a process for applying a hydrophilic coating, according to some embodiments. DETAILED DESCRIPTION

[0036] Although certain embodiments and examples are disclosed below, the subject matter of the invention extends beyond the specifically disclosed embodiments and 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 as multiple separate operations in turn in a manner that helps to understand certain embodiments; however, the order of description should not be interpreted as implying that these operations are sequence-dependent. In addition, the structures, systems and / or devices described herein may be implemented as integrated components or separate components.

[0037] For the purpose of comparing various embodiments, some aspects and advantages of these embodiments are described. Not all of these aspects or advantages may be 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 as taught herein without necessarily achieving other aspects or advantages as may also be taught or suggested herein.

[0038] The present invention generally relates to medical devices and methods of using the same. Embodiments of the present invention include devices and methods for performing thrombectomy or embolectomy on a patient. Acute ischemic stroke (AIS) can be caused by a thrombus, embolus, or other occlusion within a region of the internal carotid artery (ICA) (e.g., the petrous, cavernous, or cerebral portions). Methods of performing thrombectomy or embolectomy to treat AIS include positioning a device (e.g., an aspiration catheter, a balloon guide catheter, or other device) in the carotid artery at a location upstream of the occlusion (typically located proximal to the artery, such as the neck). Guidance to this proximal location can be difficult due to the tortuous nature of the vasculature typically involved in AIS and the small size of the vessels.

[0039] Traditional approaches to treating lesions in AIS and other areas of the body involve using several devices of varying sizes and stiffness to strike the right balance between size and flexibility for guideability, trackability, and aspiration power. As a result, thrombectomy procedures may take longer as physicians use trial and error to determine which device / device combination will reach and remove the occlusion. In situations where “time is of the essence,” shortening the time required to clear a clot, embolus, or other occlusion is critical to achieving the best outcome for the patient.

[0040] There is a continuing need for improved devices and methods for mechanical revascularization, such as thrombectomy and embolectomy in ICA and other vasculature. In particular, there is a need for devices and methods that provide enhanced efficacy and efficiency of treatment.

[0041] Parts Index

[0042] 10-Catheter system

[0043] 12-External catheter

[0044] 14-Proximal end (outer catheter)

[0045] 16- Distal end (outer catheter)

[0046] 18-Outer surface (outer conduit)

[0047] 20-Inner surface (outer conduit)

[0048] 22-Outer diameter (outer conduit)

[0049] 24-Inner diameter (outer catheter)

[0050] 26-Inner catheter

[0051] 28-Proximal end (inner catheter)

[0052] 30- Distal end (inner catheter)

[0053] 32-Outer surface (inner conduit)

[0054] 34-Inner surface (inner conduit)

[0055] 36-outer diameter (inner conduit)

[0056] 38-Inner diameter (inner catheter)

[0057] 40a-First hydrophilic coating

[0058] 40b- Second hydrophilic coating

[0059] 40c-third hydrophilic coating

[0060] 40d-Fourth hydrophilic coating

[0061] 42-Device wall of the outer catheter

[0062] 44-Inner catheter device wall

[0063] 46-At least one polymer

[0064] 48-External catheter reinforcement structure

[0065] 50-Inner catheter reinforcement structure

[0066] 52- Seat (external conduit)

[0067] 54- Seat (inner conduit)

[0068] 100-catheter system

[0069] 102-External catheter

[0070] 104-Proximal end (outer catheter)

[0071] 106-distal end (outer catheter)

[0072] 108-working cavity

[0073] 110-Inner catheter

[0074] 112-Proximal seat (inner catheter)

[0075] 114-distal part (inner catheter)

[0076] 116- Distal end (inner catheter)

[0077] 118-Thruster wire

[0078] 120-Hypotube

[0079] 122-Coil structure

[0080] 124- Braided structure

[0081] 126-distal part (hypotube)

[0082] 128-Proximal part (hypotube)

[0083] 130-Proximal end (hypotube)

[0084] 132-Inner surface (hypotube)

[0085] 134-Outer surface (hypotube)

[0086] 136-Heat shrink material

[0087] 138-Reflow Polymer

[0088] 140-Lubricating coating

[0089] 200-Catheter System

[0090] 202-External catheter

[0091] 204-Proximal end (outer catheter)

[0092] 206-distal end (external catheter)

[0093] 208-working lumen (external catheter)

[0094] 210-Inner catheter

[0095] 212-Proximal end (inner catheter)

[0096] 214-distal end (inner catheter)

[0097] 216-Hypotube

[0098] 218-Inner surface (hypotube)

[0099] 220-outer surface (hypotube)

[0100] 222-Heat shrink material

[0101] 224-Reflow Polymer

[0102] 226-Lubricating coating

[0103] Figure 1 1 shows a perspective view of a catheter system 10 according to some embodiments. Figure 1 As shown, 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. The catheter system 10 will be described in greater detail throughout this disclosure.

[0104] Figure 2A and Figure 2B Shown in more detail Figure 1 The catheter system 10. Figure 2A As shown, the seat 52 of the outer catheter 12 can be located at the proximal end 14 of the outer catheter 12, and the seat 54 of the inner catheter 26 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 positioned opposite the proximal end 14, and the inner catheter 26 includes a distal end 30 positioned 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 Figure 2B As shown. In some embodiments, the working lumen of the outer catheter 12 is configured to at least partially receive the inner catheter 26. The size and configuration of the outer catheter 12 can also be configured to receive other devices, such as guidewires, microcatheters, intermediate catheters, and / or stent retrievers, to name a few non-limiting examples. Therefore, the catheter system 10 can be considered to be a combination of an inner device and an outer device (i.e., 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, during an operation such as a thrombectomy, the outer catheter 12 can first be inserted into the patient's body to initially attempt to track the outer catheter 12 distally within the anatomical structure to the surface of the clot. 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 does not successfully track to the surface of the clot, the outer catheter 12 may still be used as a guide or support catheter to help deliver the inner catheter 26 through the outer catheter 12 to the surface of the clot.

[0106] The possibility of using only a single device (i.e., outer catheter 12) to remove the clot allows the procedure to be more efficient than current surgical practice, which typically involves multiple steps to introduce and remove multiple devices. The catheter system 10, including the inner catheter 26 and the outer catheter 12, allows the procedure to be performed based on the patient's anatomy, rather than following the same steps for each patient as is currently practiced.

[0107] Figure 3 and Figure 4 1 and 2 show cross-sectional views of the outer conduit 12 and the inner conduit 26, 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 4As shown, 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 of the outer conduit 12 and the inner conduit 26 listed here are included as non-limiting examples. The outer conduit 12 and the inner conduit 26 may each define a wide range of dimensions not explicitly listed in the present disclosure.

[0108] like Figure 2A As shown, Figure 5 1 shows a cross-section of a catheter system 10, which includes an outer catheter 12 and an inner catheter 26, and a seat 54 of the inner catheter 26. In some embodiments, as Figure 5 As shown, the outer conduit 12 includes a device wall of the outer conduit 42, and the inner conduit 26 includes a device wall of the inner conduit 44. The device walls 42, 44 will be referred to as Figure 6 and Figure 7 Further discussion. The catheter system 10 may also include a first hydrophilic coating 40a, a second hydrophilic coating 40b, a third hydrophilic coating 40c and a fourth hydrophilic coating 40d, such as Figure 5 shown.

[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. Therefore, the device wall of the outer catheter 42 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 catheter 12, 26. The surface can extend less than the entire length, for example, 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, e.g., 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 catheters 12, 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 may 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 (including hydrophilic coatings, silicone coatings, PTFE powders, and any other suitable lubricants) that reduces the friction of the outer catheter 12 and the inner catheter 26 and increases the trackability of the outer catheter 12 and the inner catheter 26. The hydrophilic coating may include a biocoat ® HYDAK Co., Ltd. ® 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 catheters 12, 26. The device walls 42, 44 may define a thickness between 0.001 and 0.04 inches.

[0111] Reference now Figure 6 , showing the outer catheter 12. As previously described, the outer catheter 12 can define the device wall 42. In some embodiments, as Figure 6 As shown, the device wall 42 includes at least one polymer 46 and an outer catheter reinforcement structure 48. It should be noted that the at least one polymer 46 may also be referred to as a "polymer sheath structure". The outer catheter reinforcement structure 48 may include a metal braid and coil structure, wherein the at least one polymer 46 fills any space within the braid and coil structure. The at least one polymer 46 may also cover the outer catheter reinforcement structure 48. In general, the device wall 42 can be considered to be similar to the structure of a garden hose, wherein a layer of hydrophilic coating 40a, 40b is provided on the inner and outer surfaces of the device wall 42. In some embodiments, the outer catheter reinforcement structure 48 is configured to provide stiffness to the proximal portion of the outer catheter 12 and to provide 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] Similar to Figure 6 , Figure 7An inner catheter 26 is shown, comprising a device wall 44 comprising the 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, which comprises a garden hose-like structure immersed in the at least one polymer 46. In some embodiments, the inner catheter reinforcement structure 50 is configured to provide stiffness 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 device wall of the outer catheter 42 and the device wall of the inner catheter 44 can be substantially the same and can include the same type of one or more polymers in the at least one polymer 46, as well as the same type of braid and coil structures in the outer catheter reinforcement structure 48 and the inner catheter reinforcement structure 50. The inner catheter 26 can be considered a scaled-down version of the outer catheter 12, having the same elements but in a smaller size.

[0113] Figure 8 also with Figure 6 Similarly, it shows another view of the outer catheter 12 including various layers of material. Figure 8 The device comprises a first hydrophilic coating 40a, a second hydrophilic coating 40b, a device wall 42, the at least one polymer 46, and an outer catheter reinforcement structure 48. Figure 6 As discussed, the structure of the device wall 42 can be similar to that of a garden hose, wherein the at least one polymer 46 and the outer conduit reinforcement structure 48 are fused together, wherein the first hydrophilic coating 40a is located on the outer surface and the second hydrophilic coating 40b is located on the inner surface.

[0114] In some embodiments, the device wall 42 has a "sandwich" structure that includes two layers of the at least one polymer 46, wherein the outer catheter reinforcement structure 48 is located between the polymer layers 46. As previously described, the outer catheter reinforcement structure 48 can include braided and coiled structures. The outer catheter reinforcement structure 48 can include individual coils and braided structures, such as Figure 8 The different appearances of the inner and outer catheter reinforcement structures 48 are shown. For example, the coil structure can be composed of Figure 8 The outer catheter reinforcement structure 48 is shown on the left side, and the braided structure can be composed of Figure 8 The portion of the outer catheter reinforcement structure 48 is shown on the right. In some embodiments, the "sandwich" type device wall 42 includes an inner layer of at least one polymer 46, a coil structure located on top of the inner polymer layer, a braided structure located on top of the coil structure, and an outer layer of at least one polymer 46. In the "sandwich" type, the device wall 42 can 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 a more open coil pitch in the coil structure, thereby enabling the outer catheter 12 to be softer than embodiments in which the coil structure has a tighter or more closed pitch. For certain uses, such as when navigating in tortuous anatomical structures, a softer and more flexible outer catheter 12 may be desirable to give the user (i.e., the physician) greater freedom to move the device at different angles. From a manufacturing perspective, this "sandwich" type can also provide benefits because a more open coil pitch can be easier to produce and have a greater margin of error than a closed pitch.

[0116] However, a device wall 42 comprising a more tightly pitched coil structure may also have benefits. For example, in an embodiment where the outer catheter reinforcement structure 48 comprises coils defining a pitch of less than 0.03 inches, the second hydrophilic coating 40b may be provided with a substantially solid and ribbed surface to be attached. 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.

[0117] In some embodiments, to ensure that the inner surface 20 of the outer catheter 12 is sufficiently solid, the coil comprises a 0.002 inch circular coil with a pitch of 0.004 inches. A tighter pitch coil may be more conducive to lubricity of the inner surface 20 of the outer catheter 12. In some embodiments, a coil having a pitch of less than 0.025 inches is desirable. The sufficiently tight pitch coil in the outer catheter reinforcement structure 48, combined with the second hydrophilic coating 40b on the inner surface 20 of the outer catheter 12, may provide sufficient lubricity to replace the need for a liner (such as a PTFE liner) conventionally used in catheter structures.

[0118] Regardless of the "type" of device wall 42 used (e.g., "sandwich" or close pitch coil), the use of first and second hydrophilic coatings 40a, 40b on the outer catheter 12 can allow for a thinner, 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 Either the outer catheter 12 or the inner catheter 26 may be considered to be depicted.

[0119] Fig. 9A catheter system 100 is shown that 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 positioned 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 An inner catheter 110 is shown, which in some embodiments includes a proximal seat 112, a distal portion 114 having a distal end 116 positioned opposite the proximal seat 112, and a pusher wire 118 extending between the proximal seat 112 and the distal portion 114. Fig.10 As shown 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 can be composed of any suitable material, and in some embodiments, the hypotube 120 is a laser cut hypotube. In some embodiments, the hypotube 120 includes a distal portion 126 and a proximal portion 128 positioned opposite the distal portion 126. As shown, the proximal portion 128 can be configured to taper toward a proximal end 130 coupled to the pusher wire 118. Unlike the hypotube 120, the distal portion 114 of the inner catheter 110 may include a proximal portion 130 coupled to the pusher wire 118. Fig.11 The coil structure 122 shown or Fig.12 Braided structure 124 is shown. It should be noted that distal portion 114 can include any suitable material configuration and is not limited to the examples shown in the figures and discussed in this disclosure.

[0121] like Figure 10-12 As shown, and 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 full length of the inner catheter 110. In contrast, Fig. 9 The outer catheter 102 shown can 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 braided structure 124, can define a length of approximately twenty centimeters. In some embodiments, the distal portion 114 defines a length less than twenty centimeters. The distal portion 114 can define a length greater than twenty centimeters.

[0122] In some embodiments, the pusher wire 118 is fixedly coupled (e.g., by welding, adhesive, etc.) to the distal portion 114 of the inner catheter 110. The pusher wire 118 can be configured to facilitate guiding the inner catheter 110 through the working lumen 108 of the outer catheter 102. For example, during surgery, a physician (or other qualified medical professional) can be configured to use the proximal seat 112 and / or the pusher wire 118 to "push" the inner catheter 110 through the outer catheter 102. The relative stiffness of the pusher wire 118 can help advance the inner catheter 110 while limiting 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 Fig.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 positioned opposite the inner surface 132. The outer surface 134 may be covered with a heat shrink material 136, such as Fig.13A As shown. The heat shrink material 136 may include a material laminated or fused 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 coated with a lubricious coating 140. In some embodiments, substantially the entire heat shrink material 136 and substantially the entire inner surface 132 are coated with the lubricious coating 140. At least a portion of the heat shrink material 136 and substantially the entire inner surface 132 may be coated with the lubricious coating 140. Alternatively, substantially the entire heat shrink material 136 and at least a portion of the inner surface 132 may be coated with the lubricious coating 140.

[0124] The lubricious coating 140 may include a hydrophilic coating. In some embodiments, the lubricious coating 140 includes silicone. The lubricious 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 lubricious coating 140 helps facilitate smooth guidance 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 lubricious coating 140 may also help facilitate smooth guidance of the hypotube 120 through the patient's vascular system. In some embodiments, the lubricious coating 140 on the inner surface 132 of the hypotube 120 helps an auxiliary device (e.g., a guidewire, a microcatheter, a dedicated device, etc.) to move smoothly through the hypotube 120.

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

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

[0127] Reference now Fig.14 , a catheter system 200 is shown. In some embodiments, the catheter system 200 includes an outer catheter 202 having a proximal end 204, a distal end 206 positioned 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 shown.

[0128] Fig.15 The inner catheter 210 is shown in more detail and includes a proximal end 212 and a distal end 214 positioned opposite the proximal end 212. Figure 9-1Unlike the inner catheter 110 of the catheter system 100 shown in FIG. 3 , the inner catheter 210 may include a “complete” catheter rather than a “partial” catheter. In other words, the inner catheter 210 may include a hypotube 216 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. In some embodiments, the hypotube 216 includes a stainless steel hypotube. The hypotube 216 may include a nitinol hypotube, or may be a hypotube made of any other suitable material.

[0129] Fig.16A and Fig. 16B Similar to Fig.13A and Fig. 13B , although they show hypotube 216 instead of hypotube 120. Fig.16A and Fig. 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 positioned opposite the inner surface 218. The outer surface 220 may be covered with a heat shrink material 222, such as Fig.16A As shown. The heat shrink material 222 may include a material laminated or fused 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 coated 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 coated 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 coated with the lubricious coating 226.

[0130] In some embodiments, the lubricious coating 226 is substantially similar to the lubricious coating 140 of the catheter system 100. The lubricious coating 226 may include a hydrophilic coating. In some embodiments, the lubricious coating 226 includes silicone. The lubricious 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 lubricious coating 226 helps to facilitate the smooth guidance 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 lubricious coating 226 may also help to facilitate the smooth guidance of the hypotube 216 through the patient's vascular system. In some embodiments, the lubricious coating 226 on the inner surface 218 of the hypotube 216 facilitates the smooth movement of auxiliary devices (e.g., guidewires, microcatheters, special devices, etc.) through the hypotube 216.

[0131] Fig. 16BIt is shown that in some embodiments, the outer surface 220 of the hypotube 216 is covered with a reflow polymer 224 instead of the heat shrink material 222. At least a portion of the reflow polymer 224 and at least a portion of the inner surface 218 of the hypotube 216 can be coated with a lubricious coating 226. In some embodiments, substantially the entire reflow polymer 224 and substantially the entire inner surface 218 of the hypotube 216 are coated with the lubricious coating 226. At least a portion of the reflow polymer 224 and substantially the entire inner surface 218 can be coated with the lubricious coating 226. Alternatively, substantially the entire reflow polymer 224 and at least a portion of the inner surface 218 can be coated 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 reflow polymer 224. In some embodiments, at least a portion of the hypotube 216 includes a PTFE liner instead of a lubricious coating 226. For example, half of the hypotube 216 can include a PTFE liner while the other half includes a lubricious coating 226. Alternatively, half of the hypotube 216 can include a PTFE liner while the other half does not include a lubricious coating 226. The hypotube 216 can also include neither a PTFE liner nor a lubricious coating 226. It should also be noted that the inner catheter 210 can include a coil structure or a braided structure instead of a hypotube 216, which is different from the inner catheter 210 in that it is provided with a PTFE liner and a lubricious coating 226. Fig.11 and Fig.12 In some embodiments, the inner catheter 210 including the coil structure and / or the braided structure further includes a heat shrink material 222, a reflow polymer 224, or a combination thereof to cover the coil structure and / or the braided structure (if applicable). In addition, embodiments having the coil structure and / or the braided structure may include a lubricating coating 226, such as Fig.16A and 16B shown.

[0133] Fig.17 A flow chart showing the process of coating and curing the inner surface of a catheter is included. For purposes of this disclosure, Fig.17 The "catheter" described in the present disclosure may include elements of catheter system 10 (i.e., outer catheter 12 or inner catheter 26), elements of catheter system 100 (i.e., outer catheter 102 or inner catheter 110), and / or elements of 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.17The process shown in 1700 begins with a clean conduit at 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 other suitable cleaning fluids. The next step is to place the conduit in an oven for drying in step 1702. 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 in order 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 to implement one of two possible steps. One option is to apply a first layer of hydrophilic coating to the inner surface of the catheter, as shown in step 1706. Alternatively, in step 1708, a primer can be applied to the inner surface of the catheter. Both steps 1706 and 1708 can use positive or negative pressure to fill the catheter with a hydrophilic coating (step 1706) or a primer (step 1708). The catheter can be filled with the relevant coating material from either end of the catheter body. In some embodiments, the relevant coating material flows through the catheter substantially continuously for a predetermined amount of time to ensure that a sufficient amount of coating is applied. The relevant coating material can reside in the catheter for a predetermined amount of time instead of flowing through the catheter.

[0136] After step 1706 or step 1708, at step 1710, the process can continue by placing the catheter back into the oven to dry. Similar to the first drying step (i.e., step 1702), step 1710 can involve placing the clean 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. Step 1710 can be considered a "heat curing" step because heat is used to dry (i.e., cure) the coating. Next, at step 1712, the positive or negative pressure source is disconnected and the dry catheter is removed from the oven.

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

[0138] Next, at step 1718, the process continues by placing the catheter back into the oven to dry again (or "heat cure"). Similar to the first and second drying steps (steps 1702 and 1710), step 1718 may involve 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. At 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 and includes a flow chart showing a slightly different 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 catheter system 10 (i.e., outer catheter 12 or inner catheter 26), elements of catheter system 100 (i.e., outer catheter 102 or inner catheter 110), and / or elements of 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 begins with cleaning the conduit at 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 to dry the conduit in an oven at step 1802. 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 1804: removing the dried conduit from the oven.

[0141] Next, the process can continue with one of two possible steps. One option is to apply a first layer of hydrophilic coating to the inner surface of the catheter, as shown in step 1806. Alternatively, in step 1808, a primer can be applied to the inner surface of the catheter. Both steps 1806 and 1808 can use positive or negative pressure to fill the catheter with a hydrophilic coating (step 1806) or a primer (step 1808). The catheter can be filled with the relevant coating material from either end of the catheter body. In some embodiments, the relevant coating material flows through the catheter substantially continuously for a predetermined amount of time to ensure that a sufficient amount of coating is applied. The relevant coating material can reside in the catheter for a predetermined amount of time, rather than flowing through the catheter.

[0142] After step 1806 or step 1808, at step 1810, the process can continue by inserting a UV 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. In some embodiments, the UV device is inserted into the inner diameter of the catheter to cure the coating on the inner surface. Next, at step 1812, the positive or negative pressure source is disconnected and the UV device is removed from the catheter.

[0143] At this point, the process is again divided into two different options. One is to apply a second layer of hydrophilic coating to the inner surface of the catheter at step 1814. The other is to apply an outer coating to the inner surface of the catheter at step 1816. Similar to applying the first layer of hydrophilic coating (at step 1806) and applying the primer (at step 1808), both steps 1814 and 1816 can use positive or negative pressure to fill the catheter with the relevant coating material from either end of the catheter body. In some embodiments, the relevant coating material flows through the catheter substantially continuously for a predetermined amount of time to ensure that a sufficient amount of coating is applied. The relevant coating material can reside in the catheter for a predetermined amount of time instead of flowing through the catheter.

[0144] Next, at step 1818, the process continues with another round of UV curing. Similar to the first UV curing step (step 1810), step 1818 can involve inserting a UV 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 device can be inserted into the inner diameter of the catheter to cure the coating on the inner surface. At step 1820, the process ends by disconnecting the positive or negative pressure source and removing the UV device from the catheter.

[0145] It should be noted that the catheter system 10 can be configured for use in a variety of procedures performed in a variety of locations of 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 surgery. The catheter system 10 can be used to aspirate clots throughout a patient's body, and the various aspects of the catheter system 10 discussed above can improve clot removal rates in a variety of surgical locations.

[0146] The catheter system may include a complete outer catheter 102 and a portion of the inner catheter 110 (e.g., catheter system 100), or may include a complete outer catheter 202 and a complete inner catheter 210 (e.g., catheter system 200). In some embodiments, the catheter system includes a portion of the outer catheter and a complete inner catheter. The catheter system may also include a portion of the outer catheter and a portion of the inner catheter.

[0147] explain

[0148] None of the steps described herein are necessary or indispensable. Any step may be adjusted or modified. Other or additional steps may be used. Any part of any step, process, structure and / or device disclosed or described in one embodiment, flow chart or example of this specification may be used in combination with or in place of any other part of any step, process, structure and / or device disclosed or described in a different embodiment, flow chart or example. The embodiments and examples provided herein are not intended to be independent and separate from each other.

[0149] The section titles and subtitles provided herein are non-limiting. The section titles and subtitles do not represent or limit the full scope of the embodiments described in the sections to which the titles and subtitles belong. For example, a section entitled "Topic 1" may include 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] To increase the clarity of various features, other features are not labeled in each figure.

[0151] The various features and processes described above can be used independently of each other or in combination in various ways. All possible combinations and sub-combinations are intended to fall within the scope of the present disclosure. In addition, certain methods, events, states or process blocks can be omitted in certain embodiments. The methods, steps and processes described herein are not limited to any particular order, and the blocks, steps or states associated therewith can be performed in other appropriate orders. For example, the tasks or events described can be performed in an order different from the order specifically disclosed. Multiple steps can be combined in a single block or state. Example tasks or events can be performed serially, in parallel or in some other manner. Tasks or events can be added to or removed from the disclosed example embodiments. The example systems and components described herein can be configured differently from those described. For example, compared to the disclosed example embodiments, elements can be added, removed or rearranged.

[0152] Conditional language used herein, such as "may", "can", "might", "perhaps", "for example", etc., unless otherwise specifically stated or otherwise understood in the context of use, is generally intended to express that certain embodiments include certain features, elements and / or steps, while other embodiments do not include these features, elements and / or steps. Therefore, such conditional language is generally not intended to mean that features, elements and / or steps are required by one or more embodiments in any way, nor does it mean that one or more embodiments must include logic for determining whether these features, elements and / or steps are included in any particular embodiment or will be implemented in any particular embodiment with or without author input or prompting. The terms "comprise", "include", "have", etc. are synonymous and are used inclusively in an open-ended manner, and do not exclude additional elements, features, actions, operations, etc. In addition, the term "or" is used in its inclusive meaning (rather than its exclusive meaning), so, for example, when used to connect a list of elements, the term "or" means one, some or all of the elements in the list. Unless expressly stated otherwise, linking language such as the phrase "at least one of X, Y, and Z" should be understood, depending on the context, as generally used to convey that an item, term, etc. may be at least one of X, Y, or Z. Thus, such linking language is not generally intended to mean that some embodiments require that each of at least one of X, at least one of Y, and at least one of Z be present.

[0153] The term "and / or" means that "and" applies to some embodiments and "or" applies to some embodiments. Thus, A, B, and / or C can be replaced by writing A, B, and C in one sentence and A, B, or C 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.

[0154] 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 smooth or almost completely smooth surface.

[0155] Although some 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 suggest that any particular feature, characteristic, step, module, or block is necessary or indispensable. In fact, the novel methods and systems described herein may be embodied in a variety of other forms; furthermore, various omissions, substitutions, and changes may be made to the methods and systems in the form described herein 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 positioned 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; an inner catheter having a proximal end, a distal end positioned opposite the proximal end of the inner catheter, a working lumen extending between the proximal end of the inner catheter and the distal end of the inner catheter, an outer surface defining an outer diameter, and an inner surface defining an inner diameter, wherein the working lumen of the outer catheter is configured to at least partially receive the inner catheter; a first hydrophilic coating on an outer surface of the outer catheter, the first hydrophilic coating configured to reduce surface friction and increase lubricity between the outer surface of the outer catheter and a blood vessel wall, the first hydrophilic coating comprising a substantially smooth surface; a second hydrophilic coating on the inner surface of the outer catheter, the second hydrophilic coating configured to reduce surface friction and increase lubricity between the inner surface of the outer catheter and the outer surface of the inner catheter, the second hydrophilic coating comprising a textured surface; a third hydrophilic coating on the outer surface of the inner conduit, the third hydrophilic coating configured to reduce surface friction 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 A fourth hydrophilic coating is located on the inner surface of the inner conduit, the fourth hydrophilic coating being configured to reduce surface friction and increase lubricity on the inner surface of the inner conduit, the fourth hydrophilic coating comprising a textured surface.

2. The catheter system according to 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.

3. The catheter system of claim 2, 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.

4. The catheter system of claim 3, wherein: The at least one polymer is configured to provide at least one of flexibility and structural support to the outer catheter and the inner catheter.

5. The catheter system of claim 4, wherein: The braided and coiled reinforcement structure includes coils defining a pitch of less than 0.03 inches.

6. The catheter system of claim 2, wherein: The device wall of the outer catheter is located between the first hydrophilic coating and the second hydrophilic coating, and wherein the device wall of the inner catheter is located between the third hydrophilic coating and the fourth hydrophilic coating.

7. The catheter system of claim 1, wherein: The catheter system also includes a guidewire configured to extend through the inner catheter, wherein the fourth hydrophilic coating is configured to reduce surface friction and increase lubricity between the guidewire and the inner surface of the inner catheter.

8. The catheter system of claim 1, wherein: The first hydrophilic coating extends between a proximal end of the outer catheter and a distal end of the outer catheter.

9. The catheter system of claim 1, wherein: The first hydrophilic coating extends along a surface extending between a proximal end of the outer catheter and a distal end of the outer catheter.

10. The catheter system of claim 1, wherein: The second hydrophilic coating extends between a proximal end of the outer catheter and a distal end of the outer catheter.

11. The catheter system of claim 1, wherein: The second hydrophilic coating extends along a surface extending between a proximal end of the outer catheter and a distal end of the outer catheter.

12. The catheter system of claim 1, wherein: The third hydrophilic coating extends between a proximal end of the inner catheter and a distal end of the inner catheter.

13. The catheter system of claim 1, wherein: The third hydrophilic coating extends along a surface extending between a proximal end of the outer catheter and a distal end of the outer catheter.

14. The catheter system of claim 1, wherein: The fourth hydrophilic coating extends between a proximal end of the inner catheter and a distal end of the inner catheter.

15. The catheter system of claim 1, wherein: The first hydrophilic coating extends along a surface extending between a proximal end of the outer catheter and a distal end of the outer catheter.

16. The catheter system of claim 1, wherein: The catheter system further comprises: an outer reinforcement structure located on the second hydrophilic coating, the outer reinforcement structure configured to provide structural support to the outer conduit; and An inner reinforcement structure is located on the fourth hydrophilic coating, and the inner reinforcement structure is configured to provide structural support to the inner conduit.

17. The catheter system of claim 16, wherein: The outer reinforcement structure includes a braided and coiled reinforcement structure, and the inner reinforcement structure includes a braided and coiled reinforcement structure.

18. The catheter system of claim 16, wherein: The catheter system further comprises: an outer jacket structure coupled to the outer reinforcement structure, wherein the outer jacket structure is configured to provide at least one of flexibility and structural support to the outer catheter; and An inner jacket structure is coupled to the inner reinforcement structure, wherein the inner jacket structure is configured to provide at least one of flexibility and structural support to the inner catheter.

19. The catheter system of claim 18, wherein: The outer jacket structure comprises a polymer jacket structure and the inner jacket structure comprises a polymer jacket structure.

20. The catheter system of claim 16, wherein: The catheter system further comprises: an outer jacket structure coupled to the outer reinforcement structure, wherein the outer jacket structure is configured to cover the outer reinforcement structure thereby providing a substantially smooth surface for coupling to the first hydrophilic coating; and An inner jacket structure is coupled to the inner reinforcement structure, wherein the inner jacket structure is configured to cover the inner reinforcement structure thereby providing a substantially smooth surface to couple to the third hydrophilic coating.

Images