WO2023220571A1 - Systèmes de cathéters et méthodes d'utilisation - Google Patents

Systèmes de cathéters et méthodes d'utilisation Download PDF

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Publication number
WO2023220571A1
WO2023220571A1 PCT/US2023/066747 US2023066747W WO2023220571A1 WO 2023220571 A1 WO2023220571 A1 WO 2023220571A1 US 2023066747 W US2023066747 W US 2023066747W WO 2023220571 A1 WO2023220571 A1 WO 2023220571A1
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WO
WIPO (PCT)
Prior art keywords
catheter
hydrophilic coating
hypotube
coating
outer catheter
Prior art date
Application number
PCT/US2023/066747
Other languages
English (en)
Inventor
Jared Hutar
Original Assignee
Piraeus Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/064,843 external-priority patent/US20230181870A1/en
Application filed by Piraeus Medical, Inc. filed Critical Piraeus Medical, Inc.
Priority claimed from US18/314,082 external-priority patent/US20230270973A1/en
Publication of WO2023220571A1 publication Critical patent/WO2023220571A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A61L29/085—Macromolecular materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2400/00—Materials characterised by their function or physical properties
    • A61L2400/10—Materials for lubricating medical devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A61M2025/0046—Coatings for improving slidability

Definitions

  • the invention generally relates to medical devices and methods of use.
  • Embodiments of the invention include devices and methods for performing thrombectomy or embolectomy in a patient.
  • Acute Ischemic Stroke (AIS) can be caused by thrombus, embolus, or other occlusions in regions of the internal carotid artery (ICA) such as the Petrous part, Cavernous part, or Cerebral part.
  • ICA internal carotid artery
  • Approaches for performing thrombectomy or embolectomy to treat AIS include positioning a device — such as an aspiration catheter, a balloon guiding catheter, or other devices — in the carotid artery at a location upstream from the occlusion, typically at a proximal location in the artery such as the cervical part. Navigation to the proximal location can be difficult due to the tortuous nature and small vessel size of the vasculature usually involved in an AIS.
  • the disclosure includes a catheter system comprising an outer catheter having a proximal end, a distal end located 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 includes an inner catheter having a proximal hub, a distal portion having a distal end located opposite the proximal hub, an outer surface defining an outer diameter, an inner surface defining an inner diameter, and a pusher wire extending between the proximal hub and the distal portion.
  • the working lumen of the outer catheter may be configured to at least partially receive the inner catheter.
  • the distal portion of the inner catheter comprises a hypotube.
  • the hypotube may comprise a distal portion and a proximal portion located opposite the distal portion, wherein the proximal portion may be configured to taper to a proximal end coupled to the pusher wire.
  • the pusher way may be configured to facilitate navigation of the inner catheter through the working lumen of the outer catheter.
  • the hypotube comprises an inner surface and an outer surface.
  • the outer surface may be covered with a heatshrink material.
  • at least a portion of the heatshrink material and at least a portion of the inner surface of the hypotube are coated with a lubricious coating.
  • the lubricious coating may comprise one of a hydrophilic coating and silicone.
  • the outer surface may be covered with a reflown polymer material.
  • at least a portion of the reflown polymer material and at least a portion of the inner surface of the hypotube are coated with a lubricious coating.
  • the lubricious coating may comprise one of a hydrophilic coating and silicone.
  • the hypotube may comprise a stainless steel hypotube.
  • the hypotube comprises a nitinol hypotube.
  • the hypotube may comprise a combination of stainless steel and nitinol materials.
  • the hypotube comprises a laser-cut hypotube.
  • the hypotube may define a length of about twenty centimeters.
  • the outer catheter comprises a device wall
  • the inner catheter comprises a device wall
  • the device wall of the outer catheter includes at least one polymer coupled to an outer catheter reinforcement structure
  • the device wall of the inner catheter includes at least one polymer coupled to an inner catheter reinforcement structure.
  • the outer catheter reinforcement structure may comprise a braid and coil reinforcement structure
  • the inner catheter reinforcement structure may comprise a braid and coil reinforcement structure.
  • the device wall of the outer catheter may be located between a first hydrophilic coating and a second hydrophilic coating, and the device wall of the inner catheter may be located between a third hydrophilic coating and a fourth hydrophilic coating.
  • 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 a vessel wall.
  • the first hydrophilic coating may comprise 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 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 may comprise a textured surface.
  • the third hydrophilic coating is located on the outer surface of the inner catheter and 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 third hydrophilic coating may comprise a substantially smooth surface.
  • the fourth hydrophilic coating may be located on the inner surface of the inner catheter and may be configured to reduce surface friction and increase lubricity on the inner surface of the inner catheter.
  • the fourth hydrophilic coating may comprise a textured surface.
  • the pusher wire comprises a round wire.
  • the pusher wire may comprise a flat wire.
  • the outer catheter may comprise a device wall including at least one polymer coupled to an outer catheter reinforcement structure.
  • the outer catheter reinforcement structure includes a braid and coil reinforcement structure.
  • the device wall of the outer catheter may be located between a first hydrophilic coating and a second hydrophilic coating.
  • 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 a vessel wall.
  • the first hydrophilic coating may comprise 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 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 may comprise a textured surface.
  • the disclosure includes a catheter system comprising an outer catheter having a proximal end, a distal end located 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 located 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.
  • the hypotube comprises an inner surface and an outer surface. The outer surface may be covered with a heatshrink material.
  • At least a portion of the heatshrink material and at least a portion of the inner surface of the hypotube are coated with a lubricious coating.
  • the lubricious coating may comprise one of a hydrophilic coating and silicone.
  • the outer surface may be covered with a reflown polymer material.
  • at least a portion of the reflown polymer material and at least a portion of the inner surface of the hypotube are coated with a lubricious coating.
  • the lubricious coating may comprise one of a hydrophilic coating and silicone.
  • the hypotube may comprise a stainless steel hypotube.
  • the hypotube comprises a nitinol hypotube.
  • the hypotube may comprise a combination of stainless steel and nitinol materials.
  • the hypotube comprises a laser-cut hypotube.
  • the outer catheter may comprise a device wall including at least one polymer coupled to an outer catheter reinforcement structure.
  • the outer catheter reinforcement structure includes a braid and coil reinforcement structure.
  • the device wall of the outer catheter may be located between a first hydrophilic coating and a second hydrophilic coating.
  • 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 a vessel wall.
  • the first hydrophilic coating may comprise 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 surface friction and increase lubricity between the inner surface of the outer catheter and an outer surface of the inner catheter.
  • the second hydrophilic coating may comprise a textured surface.
  • Figure 1 illustrates a perspective view of a catheter system including an outer catheter and an inner catheter, according to some embodiments.
  • Figures 2A and 2B illustrate a catheter system including an outer catheter and an inner catheter, according to some embodiments.
  • Figure 3 illustrates a cross-section of an outer catheter, according to some embodiments.
  • Figure 4 illustrates a cross-section of an inner catheter, according to some embodiments.
  • Figure 5 illustrates a cross-section of a catheter system, including an outer catheter and an inner catheter, according to some embodiments.
  • Figure 6 illustrates an outer catheter, according to some embodiments.
  • Figure 7 illustrates an inner catheter, according to some embodiments.
  • Figure 8 illustrates an outer catheter including various elements, according to some embodiments.
  • Figure 9 illustrates a catheter system including an outer catheter and an inner catheter, according to some embodiments.
  • Figure 10 illustrates an inner catheter including a hypotube, according to some embodiments.
  • Figure 11 illustrates an inner catheter including a coil structure, according to some embodiments.
  • Figure 12 illustrates an inner catheter including a braid structure, according to some embodiments.
  • Figures 13 A and 13B illustrate cross-sectional views of a hypotube, according to some embodiments.
  • Figure 14 illustrates a catheter system including an outer catheter and an inner catheter, according to some embodiments.
  • Figure 15 illustrates an inner catheter comprising a hypotube, according to some embodiments.
  • Figures 16A and 16B illustrate cross-sectional views of a hypotube, according to some embodiments.
  • Figures 17 and 18 illustrate flow charts explaining the processes of applying hydrophilic coatings, according to some embodiments.
  • the invention generally relates to medical devices and methods of use.
  • Embodiments of the invention include devices and methods for performing thrombectomy or embolectomy in a patient.
  • Acute Ischemic Stroke (AIS) can be caused by thrombus, embolus, or other occlusions in regions of the internal carotid artery (ICA) such as the Petrous part, Cavernous part, or Cerebral part.
  • ICA internal carotid artery
  • Approaches for performing thrombectomy or embolectomy to treat AIS include positioning a device — such as an aspiration catheter, a balloon guiding catheter, or other devices — in the carotid artery at a location upstream from the occlusion, typically at a proximal location in the artery such as the cervical part. Navigation to the proximal location can be difficult due to the tortuous nature and small vessel size of the vasculature usually involved in an AIS.
  • Figure 1 illustrates a perspective view of a catheter system 10, according to some embodiments.
  • the catheter system may include an outer catheter 12 and an inner catheter 26, as illustrated in Figure 1.
  • the outer catheter 12 includes a hub 52
  • the inner catheter 26 includes a hub 54.
  • the catheter system 10 will be described in greater detail throughout this disclosure.
  • FIGs 2A and 2B illustrate a catheter system 10, according to some embodiments.
  • the catheter system may include an outer catheter 12 and an inner catheter 26, as illustrated in Figures 2 A and 2B.
  • the outer catheter 12 includes a hub 52
  • the inner catheter 26 includes a hub 54.
  • the hub 52 may be located at the proximal end 14 of the outer catheter 12
  • the hub 54 may be located at the proximal end 28 of the inner catheter 26.
  • the outer catheter 12 includes a distal end 16 located opposite the proximal end 14, and the inner catheter 26 includes a distal end 30 located opposite the proximal end 28.
  • the outer catheter 12 may be sized and configured to at least partially receive the inner catheter 26, as illustrated in Figures 2A and 2B.
  • the outer catheter 12 may also be sized and configured to receive other devices, such as a guidewire, a microcatheter, an intermediate catheter, and/or a stent retriever, to name a few non-limiting examples.
  • the catheter system 10 may be thought of as a combination of an inner and outer device (i.e., the inner and outer catheters 26, 12) that can be used concentrically with the inner inside of the outer.
  • the outer and/or inner catheters 12, 26 can be used individually.
  • the outer catheter 12 may be inserted into the patient first in an initial attempt to track the outer catheter 12 distally within the anatomy to a surface of a clot. If the outer catheter 12 successfully tracks the surface of the clot, an aspiration force may be applied to the outer catheter 12, thereby removing the clot through the outer catheter 12. If the outer catheter 12 is unsuccessful in tracking to the surface of the clot, the outer catheter 12 may still serve as a guide or support catheter to help deliver the inner catheter 26 through the outer catheter 12 to the surface of the clot.
  • Figures 3 and 4 illustrate cross-section views of the outer catheter 12 and inner catheter 26, respectively.
  • the outer catheter 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 inner diameter 24 may each define a broad range of dimensions, including, for example, 0.111 inches for the outer diameter 22 and 0.100 inches for the inner diameter 24.
  • the inner catheter 26 may also include an outer surface 32 defining an outer diameter 36 and an inner surface 34 defining an inner diameter 38.
  • the outer diameter 36 of the outer surface 32 defines a measurement of 0.098 inches
  • the inner diameter 38 of the inner surface 34 defines a measurement of 0.088 inches.
  • outer catheter 12 and the inner catheter 26 are included as non-limiting examples.
  • the outer catheter 12 and inner catheter 26 may both define a wide range of dimensions not explicitly listed in this disclosure.
  • the outer catheter 12 and inner catheter 26 may define outer and/or inner diameter dimensions between 0.003 inches and 0.18 inches.
  • Figure 5 illustrates a cross-section of the catheter system 10, including both the outer catheter 12 and inner catheter 26, as well as the hub 52 of the outer catheter 12.
  • the outer catheter 12 comprises a device wall of the outer catheter 42
  • the inner catheter 26 comprises a device wall of the inner catheter 44.
  • the device walls 42, 44 will be discussed further with reference to Figures 6 and 7.
  • 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, as shown in Figure 5.
  • 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.
  • the device wall of the outer catheter 42 may be located between the first hydrophilic coating 40a and the second hydrophilic coating 40b.
  • the third hydrophilic coating 40c may be located on the outer surface 32 of the inner catheter 26, and the fourth hydrophilic coating 40d may be located on the inner surface 34 of the inner catheter 26.
  • 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 may extend along a surface extending between the proximal ends 14, 28 and distal ends 16, 30 of the outer and inner catheters 12, 26.
  • the surface extends substantially an entire length of the catheters 12, 26. The surface may extend less than a full length, such as 50%, 25%, or 10% of the entire length.
  • each of the hydrophilic coatings 40a-d may be configured to cover a distalmost portion, such as 15 centimeters, of the outer and inner catheters 12, 26. It should be noted that each of the hydrophilic coatings 40a-d may 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, though they may each define the same length.
  • each of the first hydrophilic coating 40a, second hydrophilic coating 40b, third hydrophilic coating 40c, and fourth hydrophilic coating 40d may comprise the same material and thickness.
  • the thickness of each hydrophilic coating 40a-d is between 0.0001 and 0.001 inches.
  • hydrophilic coating is used to refer to any general type of lubricious coating that reduces friction and increases trackability of the outer and inner catheters 12, 26, as they move within vessels and/or within one another (e.g., the inner catheter 26 moving within the outer catheter 12).
  • Some nonlimiting examples of lubricious coatings include hydrophilic coatings, silicone coatings, PTFE dust, and any other suitable lubricants.
  • the hydrophilic coating 40a-d allows the device walls 42, 44 to be thinner than traditional 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.
  • the outer catheter 12 may define a device wall 42.
  • the device wall 42 comprises at least one polymer 46 and an outer catheter reinforcement structure 48.
  • the at least one polymer 46 may also be referred to as a “polymer jacket structure.”
  • the 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 comprise a metallic braid and coil structure, with the at least one polymer 46 filling any space within the braid and coil structure.
  • the at least one polymer 46 may also cover the outer catheter reinforcement structure 48.
  • the device wall 42 may be thought of as similar to the structure of a garden hose, with a layer of hydrophilic coating 40a, 40b on the inner and outer surfaces of the device wall 42.
  • the outer catheter reinforcement structure 48 is configured to provide stiffness to a proximal portion of the outer catheter 12 and flexibility to a distal portion of the outer catheter 12. Accordingly, the amount, coil tightness, and/or composition of the outer catheter reinforcement structure 48 may vary depending on the location along the length of the outer catheter 12.
  • Figure 7 shows the inner catheter 26 including the device wall 44 comprising the at least one polymer 46 and the inner catheter reinforcement structure 50.
  • the inner catheter reinforcement structure 50 is substantially similar to the outer catheter reinforcement structure 48, including the garden-hose-like structure immersed in the at least one polymer 46.
  • the inner catheter reinforcement structure 50 is configured to provide stiffness to a proximal portion of the inner catheter 26, and flexibility to a distal portion of the inner catheter 26. Accordingly, the amount, coil tightness, and/or composition of the inner catheter reinforcement structure 50 may 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 may be substantially the same and may comprise the same type of polymer(s) 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 inner catheter reinforcement structure 50.
  • the inner catheter 26 may be considered a scaled-down version of the outer catheter 12, with the same elements but smaller dimensions.
  • Figure 8 is also similar to Figure 6 in that it illustrates another view of the outer catheter 12, including the various layers of materials. Included in Figure 8 are the first hydrophilic coating 40a, the second hydrophilic coating 40b, the device wall 42, the at least one polymer 46, and the outer catheter reinforcement structure 48. As discussed with reference to Figure 6, the device wall 42 may have a structure similar to that of a garden hose, where the at least one polymer 46 and the outer catheter reinforcement structure 48 meld together, with the first hydrophilic coating 40a located on the outer surface and the second hydrophilic coating 40b located on the inner surface.
  • the device wall 42 has a “sandwich” structure comprising two layers of the at least one polymer 46, with the outer catheter reinforcement structure 48 between the polymer layers 46.
  • the outer catheter reinforcement structure 48 may comprise a braid and coil structure.
  • the outer catheter reinforcement structure 48 may include individual coil and braid structures, as indicated by the different appearances of the outer catheter reinforcement structure 48 in Figure 8.
  • the coil structure may be represented by the portion of the outer catheter reinforcement structure 48 to the left in Figure 8
  • the braid structure may be represented by the portion of the outer catheter reinforcement structure 48 to the right in Figure 8.
  • the “sandwich” style device wall 42 comprises an inner layer of at least one polymer 46, the coil structure on top of the inner polymer layer, the braid structure on top of the coil structure, and an outer layer of at least one polymer 46.
  • the device wall 42 may also include the first hydrophilic coating 40a and the second hydrophilic coating 40b.
  • the “sandwich” style device wall 42 allows for a more open coil pitch in the coil structure, thereby enabling the outer catheter 12 to be softer than an embodiment where the coil structure has a tighter or more closed pitch.
  • a softer and more flexible outer catheter 12 can be desirable for certain uses, such as when navigating tortuous anatomy, to give the user (i.e., a medical practitioner) more freedom to move the device at different angles.
  • This “sandwich” style may also provide benefits from a manufacturing standpoint, as a more open coil pitch may be easier to produce with a larger margin of error than a closed pitch.
  • the second hydrophilic coating 40b may be provided with a substantially solid and ribbed surface to adhere to.
  • the second hydrophilic coating 40b (as well as the fourth hydrophilic coating 40d of the inner catheter 26) may be thought of as having a textured, or “ribbed,” surface.
  • the first hydrophilic coating 40a (and the third hydrophilic coating 40c) may be thought of as having a substantially smooth surface.
  • the combination of textured and smooth surfaces of the hydrophilic coatings 40a-d may provide just enough friction to allow a user to easily control movement of the outer catheter 12 and the inner catheter 26.
  • the second hydrophilic coating 40b has a textured surface
  • the third hydrophilic coating 40c has a smooth surface
  • the coil comprises a 0.002 inch round coil with a 0.004 inch pitch.
  • a tighter pitch coil may be better for facilitating lubricity of the inner surface 20 of the outer catheter 12.
  • a coil with a pitch less than 0.025 inches is desirable.
  • a 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 enough lubricity to replace the need for a liner, such as a PTFE liner, which is traditionally used in catheter construction.
  • the coil may comprise a round coil, a flat coil, or other types of coil design.
  • first and second hydrophilic coating 40a, 40b on the outer catheter 12 may allow for a thinner, more flexible device wall 42, as compared to other types of catheter walls without inner and outer coatings.
  • Figure 8 specifically labels the catheter as the outer catheter 12, the layers shown in Figure 8 and the preceding discussion also apply to the inner catheter 26, such that Figure 8 may be considered as depicting either the outer catheter 12 or the inner catheter 26.
  • Figure 9 illustrates a catheter system 100 comprising an outer catheter 102 and an inner catheter 110.
  • the outer catheter 102 may include a proximal end 104 and a distal end 106 located opposite the proximal end 104.
  • the outer catheter 102 includes a working lumen 108 extending between the proximal end 104 and the distal end 106.
  • the working lumen 108 may be configured to at least partially receive the inner catheter 110.
  • Figures 10-12 illustrate the inner catheter 110, which, in some embodiments, comprises a proximal hub 112, a distal portion 114 having a distal end 116 located opposite the proximal hub 112, and a pusher wire 118 extending between the proximal hub 112 and the distal portion 114.
  • the working lumen 108 may be configured to at least partially receive the pusher wire 118, as shown in Figure 9.
  • the distal portion 114 may comprise a hypotube 120.
  • the hypotube 120 comprises a stainless steel hypotube.
  • the hypotube 120 may comprise a nitinol hypotube.
  • the hypotube 120 may be comprised of any suitable material, and, in some embodiments, is a laser-cut hypotube.
  • the hypotube 120 may comprise a non- laser-cut hypotube.
  • the hypotube 120 comprises a distal portion 126 and a proximal portion 128 located opposite the distal portion 126.
  • the proximal portion 128 may be configured to taper to a proximal end 130 coupled to the pusher wire 118.
  • the distal portion 114 of the inner catheter 110 may comprise a coil structure 122, as illustrated in Figure 11, or a braid structure 124, as illustrated in Figure 12.
  • the distal portion 114 of the inner catheter 110 may comprise a combination of the coil structure 122 and the braid structure 124. It should be noted that the distal portion 114 may comprise any suitable material configuration and is not limited to the examples shown in the Figures and discussed in this disclosure.
  • the distal portion 114 of the inner catheter 110 defines a length substantially less than the full length of the inner catheter 110.
  • the outer catheter 102 shown in Figure 9 may comprise a single tube defining substantially the full length of the outer catheter 102, minus the proximal end 104. Accordingly, in the catheter system 100, the outer catheter 102 may be considered a “full catheter” and the inner catheter 110 may be considered a “partial catheter.”
  • the distal portion 114 of the inner catheter 110 whether a hypotube 120, coil structure 122, or braid structure 124, may define a length of about twenty centimeters. In some embodiments, the distal portion 114 defines a length less than twenty centimeters. The distal portion 114 may define a length greater than twenty centimeters.
  • the pusher wire 118 is fixedly coupled (e.g., via welding, bonding, adhesive, or the like) to the distal portion 114 of the inner catheter 110.
  • the pusher wire 118 may be configured to facilitate navigation of the inner catheter 110 through the working lumen 108 of the outer catheter 102.
  • a physician or another qualified medical professional
  • the relative rigidity of the pusher wire 118 may help advance the inner catheter 110 with limited twisting, kinking, bending, etc. of the distal portion 114.
  • the pusher wire 118 comprises a round wire.
  • the pusher wire 118 may comprise a flat wire.
  • the hypotube 120 comprises an inner surface 132 and an outer surface 134 located opposite the inner surface 132.
  • the outer surface 134 may be covered in a heatshrink material 136, as shown in Figure 13A.
  • the heatshrink material 136 may comprise a material laminated or melted onto the outer surface 134 of the hypotube 120.
  • at least a portion of the heatshrink material 136 and at least a portion of the inner surface 132 of the hypotube 120 are coated with a lubricious coating 140.
  • substantially the entirety of the heatshrink material 136 and substantially the entirety of the inner surface 132 are coated with the lubricious coating 140. At least a portion of the heatshrink material 136 and substantially the entirety of the inner surface 132 may be coated with the lubricious coating 140. Alternatively, substantially the entirety of the heatshrink material 136 and at least a portion of the inner surface 132 may be coated with the lubricious coating 140.
  • the lubricious coating 140 may comprise a hydrophilic coating.
  • the lubricious coating 140 comprises silicone.
  • the lubricious coating 140 may comprise any suitable type of coating, and is not intended to be limited to the examples discussed in this disclosure.
  • the lubricious coating 140 helps facilitate smooth navigation of the hypotube 120 through the working lumen 108 of the outer catheter 102.
  • the lubricious coating 140 may also help facilitate smooth navigation of the hypotube 120 through a patient’s vasculature.
  • the lubricious coating 140 on the inner surface 132 of the hypotube 120 facilitates smooth movement of a secondary device (e.g., a guidewire, microcatheter, specialized device, etc.) through the hypotube 120.
  • a secondary device e.g., a guidewire, microcatheter, specialized device, etc.
  • Figure 13B illustrates that, in some embodiments, the outer surface 134 of the hypotube 120 is covered in a reflown polymer 138 rather than a heatshrink material 136. At least a portion of the reflown polymer 138 and at least a portion of the inner surface 132 of the hypotube 120 may be coated with the lubricious coating 140. In some embodiments, substantially the entirety of the reflown polymer 138 and substantially the entirety of the inner surface 132 of the hypotube 120 are coated with the lubricious coating 140. At least a portion of the reflown polymer 138 and substantially the entirety of the inner surface 132 may be coated with the lubricious coating 140. Alternatively, substantially the entirety of the reflown polymer 138 and at least a portion of the inner surface 132 may be coated with the lubricious coating 140.
  • the outer surface 134 of the hypotube 120 may be covered with a combination of the heatshrink material 136 and the reflown polymer 138.
  • at least a portion of the hypotube 120 includes a PTFE liner rather than the lubricious coating 140.
  • half of the hypotube 120 may include a PTFE liner while the other half includes the lubricious coating 140.
  • half of the hypotube 120 may include a PTFE liner while the other half includes no lubricious coating 140.
  • the hypotube 120 may also include neither a PTFE liner nor a lubricious coating 140.
  • embodiments of the catheter system 100 including the coil structure 122 or braid structure 124 may also include a heatshrink material 136, reflown polymer 138, or combination thereof to cover the coil structure 122 orbraid structure 124, as applicable.
  • embodiments with the coil structure 122 and/or braid structure 124 may include the lubricious coating 140 as illustrated in Figures 13A and 13B.
  • the catheter system 200 comprises an outer catheter 202 having a proximal end 204, a distal end 206 located 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, as demonstrated in Figure 14.
  • Figure 15 illustrates the inner catheter 210 in more detail, including the proximal end 212 and the distal end 214 located opposite the proximal end 212.
  • the inner catheter 210 may comprise a “full” catheter rather than a “partial” catheter.
  • the inner catheter 210 may comprise a hypotube 216 configured to extend the full length from the proximal end 212 to the distal end 214.
  • the hypotube 216 of the inner catheter 210 may comprise a laser-cut hypotube.
  • the inner catheter 210 may comprise a non-laser-cut hypotube.
  • the hypotube 216 comprises a stainless steel hypotube.
  • the hypotube 216 may comprise a nitinol hypotube, or a hypotube constructed of any other suitable material.
  • Figures 16A and 16B are similar to Figures 13 A and 13B, though they illustrate the hypotube 216 rather than the hypotube 120.
  • Figures 16A and 16B show cross-sectional views of the hypotube 216, wherein the hypotube 216 comprises an inner surface 218 and an outer surface 220 located opposite the inner surface 218.
  • the outer surface 220 may be covered in a heatshrink material 222, as shown in Figure 16A.
  • the heatshrink material 222 may comprise a material laminated or melted onto the outer surface 220 of the hypotube 216.
  • at least a portion of the heatshrink material 222 and at least a portion of the inner surface 218 of the hypotube 216 are coated with a lubricious coating 226.
  • substantially the entirety of the heatshrink material 222 and substantially the entirety of the inner surface 218 are coated with the lubricious coating 226. At least a portion of the heatshrink material 222 and substantially the entirety of the inner surface 218 may be coated with the lubricious coating 226. Alternatively, substantially the entirety of the heatshrink material 222 and at least a portion of the inner surface 218 may be coated with the lubricious coating 226.
  • the lubricious coating 226 is substantially similar to the lubricious coating 140 of the catheter system 100.
  • the lubricious coating 226 may comprise a hydrophilic coating.
  • the lubricious coating 226 comprises silicone.
  • the lubricious coating 226 may comprise any suitable type of coating, and is not intended to be limited to the examples discussed in this disclosure.
  • the lubricious coating 226 helps facilitate smooth navigation of the hypotube 216 through the working lumen 208 of the outer catheter 202.
  • the lubricious coating 226 may also help facilitate smooth navigation of the hypotube 216 through a patient’s vasculature.
  • the lubricious coating 226 on the inner surface 218 of the hypotube 216 facilitates smooth movement of a secondary device (e.g., a guidewire, microcatheter, specialized device, etc.) through the hypotube 216.
  • a secondary device e.g., a guidewire, microcatheter, specialized device, etc.
  • Figure 16B illustrates that, in some embodiments, the outer surface 220 of the hypotube 216 is covered in a reflown polymer 224 rather than a heatshrink material 222. At least a portion of the reflown polymer 224 and at least a portion of the inner surface 218 of the hypotube 216 may be coated with the lubricious coating 226. In some embodiments, substantially the entirety of the reflown polymer 224 and substantially the entirety of the inner surface 218 of the hypotube 216 are coated with the lubricious coating 226. At least a portion of the reflown polymer 224 and substantially the entirety of the inner surface 218 may be coated with the lubricious coating 226. Alternatively, substantially the entirety of the reflown polymer 224 and at least a portion of the inner surface 218 may be coated with the lubricious coating 226.
  • the outer surface 220 of the hypotube 216 may be covered with a combination of the heatshrink material 222 and the reflown polymer 224.
  • at least a portion of the hypotube 216 includes a PTFE liner rather than the lubricious coating 226.
  • half of the hypotube 216 may include a PTFE liner while the other half includes the lubricious coating 226.
  • half of the hypotube 216 may include a PTFE liner while the other half includes no lubricious coating 226.
  • the hypotube 216 may also include neither a PTFE liner nor a lubricious coating 226.
  • the inner catheter 210 may comprise, rather than the hypotube 216, a coil structure or braid structure, similar to those illustrated in Figures 11 and 12, respectively.
  • the inner catheter 210 comprising a coil and/or braid structure also includes a heatshrink material 222, reflown polymer 224, or combination thereof to cover the coil structure and/or braid structure, as applicable.
  • embodiments with the coil structure and/or braid structure may include the lubricious coating 226 as illustrated in Figures 16A and 16B.
  • Figure 17 includes a flowchart illustrating a nonlimiting example process of coating and curing an inner surface of a catheter.
  • the “catheter” recited in Figure 17 may comprise elements of the catheter system 10 (i.e., the outer catheter 12 or the inner catheter 26), elements of the catheter system 100 (i.e., the outer catheter 102 or the inner catheter 110), and/or elements of the catheter system 200 (i.e., the outer catheter 202 or the inner catheter 210).
  • the steps of the process should be considered as applying to any of the catheters recited in this disclosure.
  • cleaning the catheter includes flushing the catheter with purified water, isopropyl alcohol (“IP A”), a mix of IP A and water, or some other suitable cleansing fluid.
  • IP A isopropyl alcohol
  • the next step is to dry the catheter in an oven, at step 1702.
  • the drying step may include placing the clean catheter in an oven set to a temperature between 0°C and 400°C and applying positive or negative pressured air (e.g., oxygen, a mix of oxygen and nitrogen, etc.) to the hub of the catheter in order to dry the inner surface of the catheter.
  • positive or negative pressured air e.g., oxygen, a mix of oxygen and nitrogen, etc.
  • the process can continue in one of two possible steps.
  • One option is to apply a first coat of hydrophilic coating to the inner surface of the catheter, shown at step 1706.
  • a basecoat may be applied to the inner surface of the catheter, at step 1708.
  • Both steps 1706 and 1708 may use positive or negative pressure to fill the catheter with either the hydrophilic coating (step 1706) or the basecoat (step 1708).
  • the catheter may be filled with the relevant coating material from either end of the catheter body.
  • the relevant coating material substantially continuously flows through the catheter for a predetermined amount of time to ensure an adequate amount of coating is applied.
  • the relevant coating material may dwell within the catheter, rather than flow through, for a predetermined amount of time.
  • step 1710 may involve placing the clean catheter in an oven set to a temperature between 0°C and 400°C and applying positive or negative pressured air (e.g., oxygen, a mix of oxygen and nitrogen, etc.) to the hub of the catheter in order to dry the inner surface of the catheter.
  • Step 1710 may be considered a “heat curing” step, as heat is used to dry (i.e., cure) the coating.
  • the positive or negative pressure source is disconnected and the dry catheter is removed from the oven, at step 1712.
  • both steps 1714 and 1716 may use positive or negative pressure to fill the catheter with the relevant coating material from either end of the catheter body.
  • the relevant coating material substantially continuously flows through the catheter for a predetermined amount of time to ensure an adequate amount of coating is applied.
  • the relevant coating material may dwell within the catheter, rather than flow through, for a predetermined amount of time.
  • step 1718 may involve placing the catheter in an oven set to a temperature between 0°C and 400°C and applying positive or negative pressured air (e.g., oxygen, a mix of oxygen and nitrogen, etc.) to the hub of the catheter in order to dry the inner surface of the catheter.
  • positive or negative pressured air e.g., oxygen, a mix of oxygen and nitrogen, etc.
  • Figure 18 is similar to Figure 17, and includes a flowchart illustrating a slightly different nonlimiting example process of coating and curing an inner surface of a catheter.
  • the “catheter” recited in Figure 18 may comprise elements of the catheter system 10 (i.e., the outer catheter 12 or the inner catheter 26), elements of the catheter system 100 (i.e., the outer catheter 102 or the inner catheter 110), and/or elements of the catheter system 200 (i.e., the outer catheter 202 or the inner catheter 210).
  • the steps of the process should be considered as applying to any of the catheters recited in this disclosure.
  • cleaning the catheter includes flushing the catheter with purified water, IP A, a mix of IP A and water, or some other suitable cleansing fluid.
  • the next step is to dry the catheter in an oven, at step 1802.
  • the drying step may include placing the clean catheter in an oven set to a temperature between 0°C and 400°C and applying positive or negative pressured air (e.g., oxygen, a mix of oxygen and nitrogen, etc.) to the hub of the catheter in order to dry the inner surface of the catheter.
  • positive or negative pressured air e.g., oxygen, a mix of oxygen and nitrogen, etc.
  • the process can continue in one of two possible steps.
  • One option is to apply a first coat of hydrophilic coating to the inner surface of the catheter, shown at step 1806.
  • a basecoat may be applied to the inner surface of the catheter, at step 1808.
  • Both steps 1806 and 1808 may use positive or negative pressure to fill the catheter with either the hydrophilic coating (step 1806) or the basecoat (step 1808).
  • the catheter may be filled with the relevant coating material from either end of the catheter body.
  • the relevant coating material substantially continuously flows through the catheter for a predetermined amount of time to ensure an adequate amount of coating is applied.
  • the relevant coating material may dwell within the catheter, rather than flow through, for a predetermined amount of time.
  • the process may continue by inserting aUV light apparatus to cure the coating and applying positive or negative pressured air (e.g., oxygen, a mix of oxygen and nitrogen, etc.) to the hub of the catheter in order to dry the inner surface of the catheter, at step 1810.
  • positive or negative pressured air e.g., oxygen, a mix of oxygen and nitrogen, etc.
  • the UV light apparatus is inserted into the inner diameter of the catheter to cure the coating on the inner surface.
  • the positive or negative pressure source is disconnected and the UV light apparatus is removed from the catheter, at step 1812.
  • both steps 1814 and 1816 may use positive or negative pressure to fill the catheter with the relevant coating material from either end of the catheter body.
  • the relevant coating material substantially continuously flows through the catheter for a predetermined amount of time to ensure an adequate amount of coating is applied.
  • the relevant coating material may dwell within the catheter, rather than flow through, for a predetermined amount of time.
  • step 1818 may involve inserting a UV light apparatus to cure the coating and applying positive or negative pressured air (e.g., oxygen, a mix of oxygen and nitrogen, etc.) to the hub of the catheter in order to dry the inner surface of the catheter.
  • the UV light apparatus may be inserted into the inner diameter of the catheter to cure the coating on the inner surface.
  • the process concludes by disconnecting the positive or negative pressure source and removing the UV light apparatus from the catheter, at step 1820.
  • the catheter system 10 may be configured for use in various procedures conducted in a variety of locations of a patient's anatomy.
  • the catheter system 10 may be used for the aspiration of clots throughout a patient’s body, and the various aspects of the catheter system 10 discussed above may improve the rate of clot removal in a number of procedure locations.
  • Catheter systems may include a full outer catheter 102 and partial inner catheter 110, like the catheter system 100, or may include a full outer catheter 202 and a full inner catheter 210, like the catheter system 200.
  • a catheter system includes a partial outer catheter and a full inner catheter.
  • a catheter system may also include a partial outer catheter and a partial inner catheter.
  • a method of using any of the catheter systems described herein, such as the catheter system 10, the catheter system 100, and/or the catheter system 200 may comprise inserting an outer catheter, such as the outer catheter 12, the outer catheter 102, and/or the outer catheter 202, into a patient's vasculature, wherein the outer catheter includes a proximal end and a distal end located opposite the proximal end, advancing the outer catheter through the patient's vasculature toward a vascular lesion, and advancing the outer catheter to a location selected from the group consisting of a first location and a second location.
  • an outer catheter such as the outer catheter 12, the outer catheter 102, and/or the outer catheter 202
  • the first location is within a first predetermined distance from the vascular lesion
  • the second location is within a second predetermined distance from the vascular lesion.
  • the outer catheter may be able to aspirate the vascular lesion
  • the outer catheter may be unable to aspirate the vascular lesion.
  • the method further comprises aspirating the vascular lesion with the outer catheter.
  • the method may further comprise advancing an inner catheter, such as the inner catheter 26, the inner catheter 110, and/or the inner catheter 210, through the outer catheter toward the first location.
  • the method further comprises aspirating the vascular lesion with the inner catheter.
  • section headings and subheadings provided herein are nonlimiting.
  • the section headings and subheadings do not represent or limit the full scope of the embodiments described in the sections to which the headings and subheadings pertain.
  • a section titled “Topic 1” may include embodiments that do not pertain to Topic 1 and embodiments described in other sections may apply to and be combined with embodiments described within the “Topic 1” section.
  • Conditional language used herein such as, among others, “can,” “could,” “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or steps. Thus, such conditional language is not generally intended to imply that features, elements and/or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without author input or prompting, whether these features, elements and/or steps are included or are to be performed in any particular embodiment.
  • A, B, and/or C can 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 can include A and B, some embodiments can include A and C, some embodiments can include B and C, some embodiments can only include A, some embodiments can include only B, some embodiments can include only C, and some embodiments can include A, B, and C.
  • the term “and/or” is used to avoid unnecessary redundancy.
  • the term “substantially” is used to mean “completely” or “nearly completely.”
  • the disclosure includes, “the first hydrophilic coating comprises a substantially smooth surface.”
  • “substantially” is used to mean that the first hydrophilic coating may comprise a completely or nearly completely smooth surface.

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Abstract

La divulgation comprend un système de cathéter comprenant un cathéter interne et un cathéter externe conçu pour recevoir au moins partiellement le cathéter interne. Dans certains modes de réalisation, le cathéter interne comprend un moyeu proximal, une partie distale et un fil poussoir s'étendant entre le moyeu proximal et la partie distale. La partie distale du cathéter interne peut comprendre un hypotube. Dans certains modes de réalisation, la surface interne de l'hypotube est revêtue d'un revêtement lubrifiant.
PCT/US2023/066747 2022-05-10 2023-05-08 Systèmes de cathéters et méthodes d'utilisation WO2023220571A1 (fr)

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US202263340276P 2022-05-10 2022-05-10
US63/340,276 2022-05-10
US18/064,843 US20230181870A1 (en) 2021-12-13 2022-12-12 Catheter systems and methods of use
US18/064,843 2022-12-12
US18/314,082 2023-05-08
US18/314,082 US20230270973A1 (en) 2021-12-13 2023-05-08 Catheter systems and methods of use

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070055338A1 (en) * 2003-05-09 2007-03-08 Jurgen Dorn Strain management in stent delivery system
US20070088257A1 (en) * 2005-10-13 2007-04-19 Conor Medsystems, Inc. Rapid exchange catheter with hypotube and short exchange length
EP1635900B1 (fr) * 2003-06-10 2009-04-01 Lumend, Inc. Systemes de catheter et methodes de traversee d'occlusions vasculaires
JP2013192885A (ja) * 2012-03-22 2013-09-30 Terumo Corp 医療用具およびその製造方法
US20170100142A1 (en) * 2015-10-09 2017-04-13 Incuvate, Llc Systems and methods for management of thrombosis
US20210252252A1 (en) * 2016-12-08 2021-08-19 Sanford Health Slide Guide Catheter and Methods for Use Thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070055338A1 (en) * 2003-05-09 2007-03-08 Jurgen Dorn Strain management in stent delivery system
EP1635900B1 (fr) * 2003-06-10 2009-04-01 Lumend, Inc. Systemes de catheter et methodes de traversee d'occlusions vasculaires
US20070088257A1 (en) * 2005-10-13 2007-04-19 Conor Medsystems, Inc. Rapid exchange catheter with hypotube and short exchange length
JP2013192885A (ja) * 2012-03-22 2013-09-30 Terumo Corp 医療用具およびその製造方法
US20170100142A1 (en) * 2015-10-09 2017-04-13 Incuvate, Llc Systems and methods for management of thrombosis
US20210252252A1 (en) * 2016-12-08 2021-08-19 Sanford Health Slide Guide Catheter and Methods for Use Thereof

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