Tip structure for hydrodynamic catheter
The hydrodynamic catheter apparatus with a re-direction wall and monolithic distal tip member addresses tissue damage issues by redirecting fluid flow, ensuring efficient and damage-free removal of substances from body vessels.
Patent Information
- Application Number
- PCT/IB2024/063218
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-12-29
- Filing Date
- 2024-12-27
- Publication Date
- 2025-07-03
AI Technical Summary
Conventional hydrodynamic catheters cause tissue damage due to elevated shear stresses during the removal of substances from body vessels, and there is a need for an affordable and efficient distal tip adapter that maintains desired fluid dynamics.
A hydrodynamic catheter apparatus with a distal tip member featuring a re-direction wall that redirects distally oriented fluid flow to proximally oriented flow, minimizing shear stress and maintaining smooth fluid dynamics, using a monolithic molded structure with distinct lumens and a guidewire bore.
The solution effectively reduces tissue damage by minimizing shear stress and maintaining smooth fluid flow, while allowing efficient removal of substances from body vessels without the need for a suction pump.
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Figure IB2024063218_03072025_PF_FP_ABST
Abstract
Description
TIP STRUCTURE FOR HYDRODYNAMIC CATHETERBACKGROUND
[0001] Catheters can be utilized in various medical procedures to remove tissue or other materials, or to break up material, from a treatment site. One example of a catheter is a hydrodynamic catheter. Hydrodynamic catheters are capable of removing and / or breaking up material(s) from a treatment site, particularly from within body vessels. Such catheters can include a suction opening adjacent to a jet nozzle for generating an environment external to the distal end of the catheter that induces fluid flow into the suction opening. Collected material and the pressurized fluid are returned in a proximal direction through the catheter to remove the collected material from the vessel.
[0002] Conventional hydrodynamic catheters induce certain fluid dynamics surrounding the distal catheter tip which, while useful in collecting target material from the surrounding region, can disrupt and damage tissue cells as a result of the elevated shear stresses applied to such tissue. It is therefore an object of the invention to retain the functionality of removing substances from a body vessel with a catheter apparatus while avoiding unnecessary tissue damage and stress on fragile fluid(s) in the process. Further, catheter tubing can be manufactured with various diameters, compositions, and lengths. It is an object of the invention to provide a distal tip adapter for inexpensively constructing a hydrodynamic catheter apparatus while promoting desired fluid dynamics.SUMMARY
[0003] According to one aspect, a hydrodynamic catheter apparatus includes a tube having a tubular wall defining a tube lumen, the tube having a distal end and a proximal end, and an aperture in the tubular wall adjacent the distal end of the tube; and a distal tip member including a re-direction wall, the distal tip member positionable at the distal end of the tube with at least a proximal portion of the distal tip member being disposable in the tube lumen such that the proximal portion of the distal tip member at least in part defines a plurality of distinct tip lumens at a distal region of the tube, wherein the plurality of distinct tip lumens includes a first tip lumen and a second tip lumen, wherein the first tip lumen is defined by the proximal portion of the distal tip member in combination with the tube wall and wherein thefirst tip lumen is adjacent the aperture, and wherein the re-direction wall is adapted to redirect distally oriented fluid flow from the first tip lumen to proximally oriented flow in the second tip lumen.
[0004] According to another aspect, a hydrodynamic catheter apparatus includes a tube having a tubular wall defining a tube lumen, the tube having a distal end and a proximal end, and an aperture in the tubular wall adjacent the distal end of the tube; and a distal tip member positionable at the distal end of the tube with at least a proximal portion of the distal tip member being disposable in the tube lumen such that the proximal portion of the distal tip member at least in part defines a plurality of distinct tip lumens at a distal region of the tube, wherein a first tip lumen is in fluid communication with the aperture at the distal region, and a second tip lumen is in fluid communication with the first tip lumen at a junction region of the proximal portion of the distal tip member, with a re-direction wall of the distal tip member bounding a portion of the junction region for re-directing distally-oriented fluid flow in the first tip lumen to proximally-oriented fluid flow in the second tip lumen.
[0005] According to another aspect, an adapter for a hydrodynamic catheter tube having a tubular wall defining a tube lumen, the tube having a distal end and a proximal end, and an aperture in the tubular wall adjacent the distal end of the tube, includes a distal tip member including: a junction region at a proximal portion of the distal tip member; a re-direction wall bounding a portion of the junction region; a tapered wall at least partially adjacent the junction region; and a guidewire bore, wherein the distal tip member is positionable at the distal end of the tube with at least a proximal portion of the distal tip member being disposable in the tube lumen such that the proximal portion of the distal tip member at least in part defines a plurality of distinct tip lumens at a distal region of the tube, wherein the plurality of distinct tip lumens includes a first tip lumen, a second tip lumen, and a third tip lumen, wherein the first tip lumen is in fluid communication with the aperture at the distal region, the second tip lumen is in fluid communication with the first tip lumen at the junction region, and the guidewire bore at least partially defines the third tip lumen sufficient to accept a guidewire, wherein the re-direction wall is adapted to redirect distally oriented fluid flow from the first tip lumen to proximally oriented flow in the second tip lumen.BRIEF DESCRIPTION OF DRAWINGS
[0006] This written disclosure describes illustrative embodiments that are non-limiting and non-exhaustive. Reference is made to illustrative embodiments that are depicted in the figures, in which:
[0007] FIG. 1 illustrates a hydrodynamic catheter apparatus 100, according to some embodiments.
[0008] FIG. 2 illustrates a portion of hydrodynamic catheter apparatus 100, according to some embodiments.
[0009] FIG. 3 illustrates a top view of a portion of hydrodynamic catheter apparatus 100, according to some embodiments.
[0010] FIG. 4 illustrates a side view of a portion of hydrodynamic catheter apparatus 100, according to some embodiments.
[0011] FIG. 5 illustrates an isometric view of a distal tip member 150, according to some embodiments.
[0012] FIG. 6 illustrates a side view of a distal tip member 150, according to some embodiments.
[0013] FIG. 7 illustrates a side view of distal tip member 150, according to some embodiments.
[0014] FIG. 8A illustrates a top view of a portion of hydrodynamic catheter apparatus 100 in a body vessel 850, according to some embodiments.
[0015] FIG. 8B illustrates a top view of a portion of hydrodynamic catheter apparatus 100 in a body vessel 850, according to some embodiments.
[0016] FIG. 9 illustrates a bottom view of distal tip member 150, according to some embodiments.
[0017] FIG. 10 illustrates an enlarged isometric view of distal tip member 150, according to some embodiments.
[0018] FIG. 11 illustrates an isometric view of distal tip member 150, according to some embodiments.
[0019] FIG. 12 illustrates an isometric view of distal tip member 150, according to some embodiments.
[0020] FIG. 13A illustrates an end view of the proximal end of distal tip member 150, according to some embodiments.
[0021] FIG. 13B illustrates an end view of the distal end of distal tip member 150, according to some embodiments.
[0022] FIG. 14A illustrates a top view of a portion of distal end of distal tip member 150 including re-direction wall 330, according to some embodiments.
[0023] FIG. 14B illustrates a top view of a portion of distal end of distal tip member 150 including re-direction wall 330, according to some embodiments.
[0024] FIG. 14C illustrates a top view of a portion of distal end of distal tip member 150 including re-direction wall 330, according to some embodiments.
[0025] FIG. 14D illustrates a top view of a portion of distal end of distal tip member 150 including re-direction wall 330, according to some embodiments.
[0026] FIG. 14E illustrates a top view of a portion of distal end of distal tip member 150 including re-direction wall 330, according to some embodiments.DETAILED DESCRIPTION
[0027] The objects and advantages enumerated above together with other objects, features, and advances represented by the present invention will now be presented in terms of detailed embodiments described with reference to the attached drawing figures which are intended to be representative of various possible configurations of the invention. Other embodiments and aspects of the invention are recognized as being within the grasp of those having ordinary skill in the art.
[0028] Catheters of the present disclosure include hydrodynamic catheters. Hydrodynamic catheters may be used in various medical procedures to remove tissue or other target material(s) from a body vessel. For example, hydrodynamic catheters may be used in a thrombectomy procedure to remove blood clots or a thrombus from a body vessel, such as an artery or vein, using image guidance. Blood clots can disrupt and / or block the normal flow of blood through body vessels. This procedure can restore blood flow to vital organs such as arms, legs, kidneys, and the brain.
[0029] FIG. 1 illustrates a hydrodynamic catheter apparatus 100, according to some embodiments. Hydrodynamic catheter apparatus 100 may be designed to remove various substances, including thrombus, from a body vessel. For example, hydrodynamic catheter apparatus 100 may be used in a thrombectomy procedure as a thrombectomy catheter to remove blood clots or a thrombus from a body vessel, such as an artery or vein. FIG. 1 showshydrodynamic catheter apparatus 100 as a suction catheter which includes reservoir 110, pump 112, inlet tube 114, hub 120, optional valve 130, tube 140, distal tip member 150, guidewire 160, distal end 162, discharge tube 170, optional valve 172, and discharge reservoir 180. Tube 140 may include a suction opening or aperture near distal end 162 as shown in further detail in FIG. 4. At, or close to, a proximal end of tube 140 is connected to hub 120 which is shown in further detail in FIG. 2.
[0030] Valve 130 may be incorporated with tube 140 to allow high-frequency cycling or pulsation of pressurized fluid (such as saline or other physician specified fluids) to a pressure channel. As shown, guidewire 160 may extend through tube 140 and / or distal tip member 150 to assist in guiding hydrodynamic catheter apparatus 100 through a body vessel. First tube 114 is in fluid communication with hub 120. For example, pump 112 draws liquid from reservoir 110 and delivers the pressured fluid through a pressure channel (as shown in FIG. 2). Furthermore, discharge tube 170 fluidically connects hub 120 to discharge reservoir 180.
[0031] FIG. 2 illustrates a portion of hydrodynamic catheter apparatus 100, according to some embodiments. As discussed, pump 112 draws liquid from reservoir 110 and delivers the pressurized liquid through inlet tube 114 to pressure channel 210 toward the distal end 162 of the catheter. Pressure channel 210 may be a lumen defined by hub 120 and tube 140, or by a tube disposed within hub 120 and tube 140. In one example, pressure channel 210 is fluidically connected with inlet tube 114.
[0032] Fluid under pressure delivered through pressure channel 210 is emitted in the form of ajet at a relatively high velocity through tube 140 and / or distal tip member 150, thus creating a pressure difference which results in suction at the location of a suction opening or aperture in tube 140. The removal of material brought into the suction catheter through a suction opening or aperture is supported by means of this suction. Together with fluid delivered through pressure channel 210, the sucked up material is removed through discharge tube 170 in a proximal direction to discharge reservoir 180. In one example, discharge tube 170 is connected to hub 120 leading to discharge reservoir 180. Accordingly, tube 140 may include pressure channel 210, and a discharge channel in fluidic connection with discharge tube 170.
[0033] FIG. 3 illustrates a top view of a portion of hydrodynamic catheter apparatus 100, according to some embodiments. Hydrodynamic catheter apparatus 100 includes tube 140 and distal tip member 150. Tube 140 includes tube / tubular wall 312, tube lumen 314, proximal end 316, and distal end 318. Tube wall 312 may define the tube lumen 314, and the cross-sectionalshape of tube 140 may be substantially annular. In one example, the cross-sectional shape of tube lumen 314 is substantially circular. Distal tip member 150 may include separation wall 324, tapered wall 326, junction region 328, re-direction wall 330, and end member 340. Distal tip member 150 is positionable at distal end 318 of tube 140. For example, a portion of distal end 318 of tube 140 may abut end member 340 as shown in FIG. 3, and / or a portion of distal end 318 of tube 140 may surround at least a portion of end member 340. Importantly, distal tip member 150 creates a plurality of distinct lumens within a single lumen, such as tube lumen 314. In one example, hydrodynamic catheter apparatus 100 is configured as a hydrodynamic suction catheter.
[0034] Hydrodynamic catheter apparatus 100 may include first tip lumen 322 and second tip lumen 332. In one example, the first tip lumen 322 may be defined by a portion of the distal tip member 150 in combination with the tube wall 312. In another example, first tip lumen 322 is defined by a portion of distal tip member 150. In one example, the second tip lumen 332 may be defined by a portion of the distal tip member 150 in combination with the tube wall 312. In another example, the second tip lumen 332 may be defined by a portion of the distal tip member 150. Re-direction wall 330 is adapted to redirect distally oriented fluid flow from first tip lumen 322 to proximally oriented fluid flow in second tip lumen 332. First tip lumen 322 and second tip lumen 332 may be fluidically independent or in fluid communication. In one example, first tip lumen 322 may be in fluid communication with second tip lumen 332 at junction region 328. In another example, re-direction wall 330 bounds a portion of junction region 328. In yet another example, separation wall 324 is in fluidic communication with first tip lumen 322 and second tip lumen 332. Accordingly, separation wall 324 may separate first tip lumen 322 and second tip lumen 332.
[0035] FIG. 4 illustrates a side view of a portion of hydrodynamic catheter apparatus 100, according to some embodiments. As shown in FIG. 4, tube 140 includes aperture 410 in tube wall 312. Aperture 410 may be positioned in tube wall 312 adjacent distal end 318 of tube 140. In one example, the cross-sectional shape of aperture 410 may be selected from a circle and an oval. The shape and size of aperture 410 may be selected based on the desired fluid dynamics of fluid(s) and materials entering hydrodynamic catheter apparatus 100 from a body vessel.
[0036] Tube 140 may convey pressurized fluid, such as saline or other physician specified fluids, in a distal direction past aperture 410. At least a portion of distal tip member 150 may function as a jet. Substances outside the catheter, in vicinity of distal tip member 150,are sucked into tube 140 at distal end 318 through aperture 410 due to the pressurized fluid flowing through first tip lumen 322 at a relatively high velocity creating a pressure difference which results in suction. In one example, one or more fragile fluid(s) and a target substance, such as thrombus, are removed from the body vessel through aperture 410 and join / merge with distally oriented fluid flow in distal tip member 150. Re-direction wall 330 of distal tip member 150, bounding a portion of junction region 328, re-directs distally-oriented fluid flow to proximally-oriented fluid flow in distal tip member 150. Accordingly, the target substance may be removed from the body vessel and conveyed to discharge reservoir 180 without the need for a suction pump.
[0037] FIG. 5 illustrates an isometric view of a distal tip member 150, according to some embodiments. As shown in FIG. 5, distal tip member 150 may include separation wall 324, tapered wall 326, end member 340, and distal end 510 of distal tip member 150. In one example, distal tip member 150 is a monolithic molded structure. For example, distal tip member 150 may be a single-piece construction. Accordingly, distal tip member 150 may be manufactured as a single component by machining and / or molding to eliminate the need for multiple assemblies. Alternatively, distal tip member 150 may be constructed using two or more distinct pieces attached at a seam. Distal tip member 150 may be an adapter for tube 140 having a tube wall 312 defining a tube lumen 314, the tube 140 having a distal end 318 and a proximal end 316, and an aperture 410 in tube wall 312 adjacent the distal end 318 of tube 140.
[0038] End member 340 may be in the form of a truncated cone with a hollow portion within the truncated cone. The hollow portion may extend from distal end 510 throughout the entire truncated cone. Alternatively, end member 340 may be in the form of a shape other than a truncated cone sufficient for safe movement through a body vessel. Since one or more surfaces of end member 340 may be tapered, distal tip member 150 may easily be guided through a body vessel.
[0039] FIGS. 6-7 illustrate side views of distal tip member 150, according to some embodiments. As shown in FIG. 6, distal tip member 150 may include separation wall 324, tapered wall 326, re-direction wall 330, proximal portion 610 of distal tip member 150, and distal portion 620 of distal tip member 150. As shown in FIG. 7, distal tip member 150 may include separation wall 324, re-direction wall 330, proximal portion 610 of distal tip member 150, and distal portion 620 of distal tip member 150. Proximal portion 610 of distal tip member150 is disposable in tube lumen 314 such that proximal portion 610 of distal tip member 150 at least in part defines a plurality of distinct tip lumens at or near distal end 318 of tube 140.
[0040] The plurality of distinct tip lumens may include one or more of first tip lumen 322 and second tip lumen 332. First tip lumen 322 may be defined by proximal portion 610 of distal tip member 150 in combination with tube wall 312. First tip lumen 322 may be defined by proximal portion 610 of distal tip member 150 in combination with tube wall 312 such that first tip lumen 322 is adjacent the aperture 410. In one example, proximal portion 610 of distal tip member 150 includes tapered wall 326 that is juxtaposed with aperture 410 when proximal portion 610 of distal tip member 150 is disposed in tube lumen 314.
[0041] FIGS. 8A-8B illustrate a top view of hydrodynamic catheter apparatus 100 in a body vessel 850, according to some embodiments. As shown in FIGS. 8A-8B, hydrodynamic catheter apparatus 100 may include tube 140, pressure channel 210, tube wall 312, distal tip member 150, aperture 410, and guidewire 160. Pressure channel 210 may be in fluidic communication with, and / or disposed within, first tip lumen 322. As previously discussed, distal tip member 150 may include separation wall 324, tapered wall 326, junction region 328, and re-direction wall 330. Guidewire 160 may be utilized to guide and / or navigate one or more of tube 140 and distal tip member 150 to a target location within body vessel 850. Accordingly, guidewire 160 may be extended through body vessel 850. Since guidewire 160 may also extend through distal tip member 150, distal tip member 150 may be delivered to the target location by moving distal tip member 150 along guidewire 160. Body vessel 850 may include one or more target substances to be removed through aperture 410.
[0042] As shown in FIG. 8 A, pressurized fluid (from pressure channel 210) in a distally oriented fluid flow direction 810 may be in fluidic communication with aperture 410. In one example, this fluid includes saline or other physician specified fluids. As fluid flowing in distally oriented fluid flow direction 810 flows past one or more of tapered wall 326 and aperture 410, a jet is created to create suction. Fluid in first tip lumen 322 may jet one or more substances from body vessel 850 through aperture 410 toward tapered wall 326. In one example, as fluids and other substances are sucked through aperture toward tapered wall 326, these fluids and other substances may contact tapered wall 326. Tapered wall 326 is specifically shaped to reduce the turbulent flow and pressure drop of fluid(s) in distal tip member 150. Importantly, tapered wall 326 may redirect materials from body vessel 850 toward re-directionwall 330 while maintaining a smooth flow profile of fluid(s). For example, reducing turbulent flow of fluid(s) reduces shear stresses on fragile fluids.
[0043] As such, one or more fluids, and optionally a target substance, flow through aperture 410 to join the fluid stream in distally oriented fluid flow direction 810. Re-direction wall 330 redirects fluid(s) flowing in distally oriented fluid flow direction 810 to a proximally oriented fluid flow direction 820. Accordingly, fluid(s) and a target substance(s) may be removed from body vessel 850. One example of a fluid removed from body vessel 850 is blood, and blood is considered a fragile fluid.
[0044] As shown in FIG. 8B, re-direction wall 330 redirects pressurized fluid (from pressure channel 210) in distally oriented fluid flow direction 810 to proximally oriented fluid flow direction 820. Pressure channel 210 may be in fluidic communication with, and / or disposed within, second tip lumen 332. Accordingly, re-direction wall 330 may redirect fluid(s) from second tip lumen 332 to first tip lumen 322. Fluid in proximally oriented fluid flow direction 820 may be in fluidic communication with aperture 410. In one example, this fluid includes saline or other physician specified fluids. As fluid flowing in proximally oriented fluid flow direction 820 flows past one or more of tapered wall 326 and aperture 410, a proximally- oriented jet is created to create suction. Fluid in first tip lumen 322 may jet one or more substances from body vessel 850 through aperture 410 toward tapered wall 326. As such, one or more fluids, and optionally a target substance, flow through aperture 410 to join the fluid stream in proximally oriented fluid flow direction 820. Accordingly, fluid(s) and a target substance(s) may be removed from body vessel 850. Importantly, tapered wall 326 and redirection wall 330 are specifically shaped to reduce turbulent flow and pressure drop of fluid(s) in distal tip member 150.
[0045] FIG. 9 illustrates a bottom view of distal tip member 150, according to some embodiments. As shown, guidewire 160 may extend through distal tip member 150. This allows guidewire 160 to be extended to a target location in body vessel 850 before guiding distal tip member 150 to the target location in body vessel 850. As shown in FIG. 9, guidewire 160 may not be entirely surrounded by distal tip member 150 at all portions of distal tip member 150. This reduces the total material cost of distal tip member 150. Alternatively, a channel may be formed in distal tip member 150 that extends throughout distal tip member 150 to surround guidewire 160.
[0046] FIG. 10 illustrates an enlarged isometric view of distal tip member 150, according to some embodiments. As shown in FIG. 10, tapered wall 326 may include a first region 1010, a second region 1020, and a third region 1030. Tapered wall 326 may be at least partially adjacent junction region 328. In one example, first region 1010 is the most proximal region of tapered wall 326 and third region 1030 is the most distal region of tapered wall 326. Accordingly, second region 1020 may be adjacent to first region 1010 and third region 1030, and second region 1020 may abut both first region 1010 and third region 1030.
[0047] First region 1010 may include a rounded outer surface or a substantially planar outer surface. First region 1010 may be adjacent aperture 410 when proximal portion 610 of distal tip member 150 is disposed in tube lumen 314. Distance 1040 is the width of the outer surface of tapered wall 326. Distance 1040 of tapered wall 326 may remain constant and / or decrease as tapered wall 326 extends distally. As first region 1010 extends distally, distance 1040 may remain substantially constant. Second region 1020 may include a rounded outer surface or a substantially planar outer surface. Third region 1030 may include a rounded outer surface or a substantially planar outer surface.
[0048] Third region 1030 may extend distally from second region 1020 to re-direction wall 330. Further, an outer surface of third region 1030 may be substantially shaped as a triangle. In one example, as third region 1030 extends distally, distance 1040 decreases until the outer edges of third region 1030 merge to form a point 1060. In another example, distal end of third region 1030 forms an angle ranging from about 1° to about 45°. In yet another example, distal end of third region 1030 forms an angle ranging from about 3° to about 25°. For example, distal end of third region 1030 may form an angle ranging from 5° to 20°. Third region 1030 may form a substantially planar outer surface or a rounded outer surface.
[0049] In one example, distance 1040 ranges from 0 mm to about 2 mm. In another example, distance 1040 ranges from about 0 mm to about 0.5 mm. In yet another example, distance 1040 ranges from about 0 mm to about 0.2 mm. Distance 1050 is a measure of the distance between separation wall 324 and tapered wall 326. Distance 1050 may increase as tapered wall 326 extends distally. In one example, distance 1050 ranges from 0 mm to about 3 mm. In another example, distance 1050 ranges from about 0 mm to about 0.5 mm. In another example, distance 1050 ranges from about 0 mm to about 0.3 mm. In one example, as second region 1020 extends distally, distance 1040 decreases and distance 1050 increases. In another example, distance 1040 decreases by over 5%, over 10%, or over 20% as second region 1020extends from first region 1010 to third region 1030. In another example, as third region 1030 extends distally, distance 1040 decreases and distance 1050 increases.
[0050] Importantly, the widths and / or shapes of outer surfaces of one or more of first region 1010, second region 1020, and third region 1030 are beneficial for decreasing stresses on one or more fluids flowing through tube 140 and / or distal tip member 150. Since the one or more fluids may include blood, which is considered a fragile fluid, decreasing shear stress on the fluid(s) is important. Decreasing shear stress may include creating / maintaining a smoother or more laminar flow profile of fluid(s) across tapered wall 326. For example, the fluid(s) may travel smoothly through aperture 410 and across tapered wall 326 instead of undergoing irregular fluctuations and mixing. This decreases the turbulence of blood and / or saline flow (or other physician specified fluids) through aperture 410 and / or first tip lumen 322.
[0051] FIGS. 11-12 illustrate isometric views of distal tip member 150, according to some embodiments. As shown, distal tip member 150 includes proximal end 1110 of distal tip member 150. Accordingly, distal tip member 150 extends from proximal end 1110 to distal end 510. In one example, proximal end 1110 includes a planar surface with channels for accepting tubes and / or a guidewire. In another example, proximal end 1110 includes a planar surface forming two or more, or three or more, channels when proximal portion 610 of distal tip member 150 is disposed in tube lumen 314. One or more of these channels may be defined by a portion of distal tip member 150 and tube wall 312.
[0052] FIG. 13 A illustrates an end view of the proximal end 1110 of distal tip member 150, according to some embodiments. FIG. 13B illustrates an end view of the distal end 510 of distal tip member 150, according to some embodiments. As shown in FIG. 13 A, distal tip member 150 includes proximal end 1110 of distal tip member 150, guidewire bore 1310, and guidewire bore wall 1320. Guidewire bore wall 1320 may define at least a portion, or all of, third tip lumen 1330. Guidewire bore 1310 may have a substantially circular cross-section. Therefore, third tip lumen 1330 is adapted to accept guidewire 160. Third tip lumen 1330 may extend from distal portion 620 of distal tip member 150 to proximal portion 610 of distal tip member 150 when proximal portion 610 of distal tip member 150 is disposed in tube lumen 314. Accordingly, third tip lumen 1330 may be defined by a portion of distal tip member 150 in combination with tube wall 312 when proximal portion 610 of distal tip member 150 is disposed in tube lumen 314. At least a portion of distal tip member 150 may have a substantially circular cross-section.
[0053] As shown in FIG. 13B, distal tip member 150 includes distal end 510 of distal tip member 150, guidewire bore 1310, and guidewire bore wall 1320. In one example, third tip lumen 1330 may extend through a portion of distal tip member 150. In another example, third tip lumen 1330 extends from distal end 510 of distal tip member 150 to proximal end 1110 of distal tip member 150. Third tip lumen 1330 may have a diameter greater than the width or diameter of guidewire 160. Accordingly, distal tip member 150 may include guidewire bore 1310 sufficient to accept guidewire 160 for navigating hydrodynamic catheter apparatus 100 through body vessel 850.
[0054] FIGS. 14A-14E illustrate a top view of a portion of distal end of distal tip member 150 including re-direction wall 330, according to some embodiments. Re-direction wall 330 may include a surface in fluid communication with junction region 328 and may redirect fluid flow in one or more of the axial direction and the radial direction, or a combination thereof. A radius of curvature of re-direction wall 330 may range from about 2.5 mm to about 40 mm. In one example, the radius of curvature of re-direction wall 330 ranges from about 10 mm to about 28 mm. In another example, the radius of curvature of re-direction wall 330 ranges from about 20 mm to about 28 mm. In yet another example, the radius of curvature of re-direction wall 330 is about 25.4 mm. In one example, re-direction wall 330 includes a symmetric curve. The symmetric curve may be based on longitudinal axis 1410. In another example, re-direction wall 330 includes an asymmetric curve. The asymmetric curve may be based on longitudinal axis 1410. In one example, the radius of curvature and / or symmetry of re-direction wall 330 is beneficial for minimizing pressure drop of fluid(s) moving around re-direction wall 330. For example, a minimal fluid pressure drop in distal tip member 150 may result in maximum flow past aperture 410 while minimizing risk of damage to the fluid.
[0055] As shown in FIG. 14 A, a radius of curvature of re-direction wall 330 may be about 25 mm, and the curve may be a symmetric curve based on longitudinal axis 1410. The radius of curvature (R) is the reciprocal of the curvature, and it equals the radius of an approximate / imaginary circle formed by the curve. As shown in FIG. 14B, a radius of curvature of re-direction wall 330 may be about 12.5 mm, and the curve may be a symmetric curve based on longitudinal axis 1410. As shown in FIG. 14C, re-direction wall 330 may include a flat, planar surface with no radius of curvature. As shown in FIG. 14D, the radius of curvature of re-direction wall 330 may be about 25 mm, and the curve may be an asymmetric curve based on longitudinal axis 1410, about 90 ° to the outside. As shown in FIG. 14E, the radius ofcurvature of re-direction wall 330 may be about 25 mm, and the curve may be an asymmetric curve based on longitudinal axis 1410, about 90 ° to the inside.
[0056] Importantly, the shape and surface texture (or lack thereof) are important for maintaining desired flow properties in distal tip member 150 and tube 140. For example, a curved re-direction wall 330 featuring a symmetric curve based on longitudinal axis 1410 decreases shear stresses on fragile fluids being re-directed from distally oriented fluid flow direction 810 to a proximally oriented fluid flow direction 820. Further, a curved re-direction wall 330 featuring a symmetric curve based on longitudinal axis 1410 reduces pressure drop of fluids being re-directed from distally oriented fluid flow direction 810 to proximally oriented fluid flow direction 820. In another example, a re-direction wall 330 with a smooth surface may be desirable to decrease shear stress on fragile fluids and reduce pressure drop on fluids being removed.
[0057] While the disclosure has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made, and equivalents may be substituted for elements thereof without departing from the scope of the embodiment(s). In addition, many modifications may be made to adapt a particular situation or material to the teachings of the embodiment(s) without departing from the essential scope thereof. Therefore, it is intended that the disclosure is not limited to the disclosed embodiment(s), but that the disclosure will include all embodiments falling within the scope of the appended claims. Various examples have been described. These and other examples are within the scope of the following claims.
Claims
WHAT IS CLAIMED IS:
1. A hydrodynamic catheter apparatus, comprising: a tube having a tubular wall defining a tube lumen, the tube having a distal end and a proximal end, and an aperture in the tubular wall adjacent the distal end of the tube; and a distal tip member including a re-direction wall, the distal tip member positionable at the distal end of the tube with at least a proximal portion of the distal tip member being disposable in the tube lumen such that the proximal portion of the distal tip member at least in part defines a plurality of distinct tip lumens at a distal region of the tube, wherein the plurality of distinct tip lumens includes a first tip lumen and a second tip lumen, wherein the first tip lumen is defined by the proximal portion of the distal tip member in combination with the tube wall and wherein the first tip lumen is adjacent the aperture, and wherein the re-direction wall is adapted to redirect distally oriented fluid flow from the first tip lumen to proximally oriented flow in the second tip lumen.
2. The hydrodynamic catheter apparatus of claim 1, wherein the distal tip member further includes a guidewire bore defining at least a portion of a third tip lumen adapted to accept a guidewire.
3. The hydrodynamic catheter apparatus of claim 1, wherein the third tip lumen extends from a distal portion of the distal tip member to the proximal portion of the distal tip member when the proximal portion of the distal tip member is disposed in the tube lumen.
4. The hydrodynamic catheter apparatus of claim 1, wherein the re-direction wall includes a surface with a symmetric curve.
5. The hydrodynamic catheter apparatus of claim 1 , wherein the re-direction wall includes a surface with an asymmetric curve.
6. The hydrodynamic catheter apparatus of claim 1, wherein the re-direction wall includes a surface with a radius of curvature ranging from about 10 mm to about 28 mm.
7. The hydrodynamic catheter apparatus of claim 1 , wherein the re-direction wall redirects fluid flow in one or more of an axial and a radial direction.
8. The hydrodynamic catheter apparatus of claim 1, wherein the distal tip member is a monolithic molded structure.
9. The hydrodynamic catheter apparatus of claim 1, wherein the first tip lumen is configured to induce one or more substances from a body vessel through the aperture toward the re-direction wall.
10. The hydrodynamic catheter apparatus of claim 1 further comprising a junction region of the proximal portion of the distal tip member, wherein the first tip lumen is in fluid communication with the second tip lumen at the junction region, wherein the redirection wall bounds a portion of the junction region.
11. A hydrodynamic catheter apparatus, comprising: a tube having a tubular wall defining a tube lumen, the tube having a distal end and a proximal end, and an aperture in the tubular wall adjacent the distal end of the tube; and a distal tip member positionable at the distal end of the tube with at least a proximal portion of the distal tip member being disposable in the tube lumen such that the proximal portion of the distal tip member at least in part defines a plurality of distinct tip lumens at a distal region of the tube, wherein a first tip lumen is in fluid communication with the aperture at the distal region, and a second tip lumen is in fluid communication with the first tip lumen at a junction region of the proximal portion of the distal tip member, with a redirection wall of the distal tip member bounding a portion of the junction regionfor re-directing distally-oriented fluid flow in the first tip lumen to proximally- oriented fluid flow in the second tip lumen.
12. The hydrodynamic catheter apparatus of claim 11, wherein the first tip lumen is defined by the proximal portion of the distal tip member in combination with the tube wall.
13. The hydrodynamic catheter apparatus of claim 12, wherein the proximal portion of the distal tip member includes a tapered wall that is juxtaposed with the aperture when the proximal portion of the distal tip member is disposed in the tube lumen.
14. The hydrodynamic catheter apparatus of claim 13 further including a separation wall, wherein the separation wall is in fluidic communication with the first tip lumen and the second tip lumen, and wherein a distance from the separation wall to the tapered wall increases as the tapered wall extends distally.
15. The hydrodynamic catheter apparatus of claim 13, wherein a width of the tapered wall decreases as the tapered wall extends distally.
16. The hydrodynamic catheter apparatus of claim 13, wherein the tapered wall is configured to decrease stresses on one or more fragile fluids flowing through the aperture from a body vessel, and wherein the tapered wall is configured to reduce pressure drop of the one or more fragile fluids flowing through the aperture from the body vessel.
17. The hydrodynamic catheter apparatus of claim 11, wherein the distal tip member further includes a guidewire bore defining a third tip lumen adapted to accept a guidewire.
18. An adapter for a hydrodynamic catheter tube having a tubular wall defining a tube lumen, the tube having a distal end and a proximal end, and an aperture in the tubular wall adjacent the distal end of the tube, the adapter comprising: a distal tip member including: a junction region at a proximal portion of the distal tip member;a re-direction wall bounding a portion of the junction region; a tapered wall at least partially adjacent the junction region; and a guidewire bore, wherein the distal tip member is positionable at the distal end of the tube with at least a proximal portion of the distal tip member being disposable in the tube lumen such that the proximal portion of the distal tip member at least in part defines a plurality of distinct tip lumens at a distal region of the tube, wherein the plurality of distinct tip lumens includes a first tip lumen, a second tip lumen, and a third tip lumen, wherein the first tip lumen is in fluid communication with the aperture at the distal region, the second tip lumen is in fluid communication with the first tip lumen at the junction region, and the guidewire bore at least partially defines the third tip lumen sufficient to accept a guidewire, wherein the re-direction wall is adapted to redirect distally oriented fluid flow from the first tip lumen to proximally oriented flow in the second tip lumen.
19. The adapter of claim 18, wherein the first tip lumen is defined by the proximal portion of the distal tip member in combination with the tube wall.
20. The adapter of claim 18, wherein the tapered wall is juxtaposed with the aperture when the proximal portion of the distal tip member is disposed in the tube lumen.
21. The adapter of claim 18, wherein the re-direction wall includes a surface with a symmetric curve.
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