Medical aspiration device and method

Abstract

To provide: a medical aspiration device mechanically disrupting a substance when the substance is aspirated into a catheter; and a corresponding method.SOLUTION: A medical aspiration device includes: an internal elongated element 20; and a bulbous tip 30 at a distal end 26 of the internal elongated element. Together, the internal elongated element and the bulbous tip may define a disruptor 12 of the medical aspiration device. The medical aspiration device may also include an outer elongated element, or a catheter, that includes a lumen 29 within which the internal elongated element may be disposed and relative to which the bulbous tip may be extended and retracted. Extension and retraction of the bulbous tip may provide control over an aspiration force, or suction, that has been applied through the catheter to a distal tip of the catheter. Extension and retraction of the bulbous tip may disrupt matter to be aspirated by the medical aspiration device in a manner that facilitates aspiration of the matter.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) Priority is hereby claimed to the filing date of U.S. Provisional Patent Application No. 63 / 061,785, entitled "MECHANICAL DILATOR, MACERATOR, ASPIRATOR AND METHODS TO START, STOP, STORE, AND DIRECT ASPIRATION FORCE," dated August 5, 2020 (the '785 Provisional Application). The entire disclosure of the '785 Provisional Application is hereby incorporated by reference herein.

[0002] The present disclosure relates generally to the removal of material such as emboli, thrombi, plaque, lesions, etc. from a subject's body. More specifically, the present disclosure relates to catheters that can be used to aspirate and optionally disintegrate material within a subject's body. Even more specifically, medical aspiration devices and corresponding methods are disclosed that mechanically disintegrate material as it is aspirated into the catheter. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] U.S. Patent Application Publication No. 2019 / 0232018 Summary of the Invention

[0004] A medical suction device is disclosed. The medical suction device according to the present disclosure includes an inner elongate element and a bulbous tip at the distal end of the inner elongate element. The inner elongate element and the bulbous tip can together define a disruptor for the medical suction device. The medical suction device is used with an outer elongate element or catheter that includes a lumen within which the inner elongate element can be disposed, and the bulbous tip can be extended and retracted relative to the outer elongate element or catheter.

[0005] The inner elongate element may comprise a tubular element, such as a hypotube, having a lumen extending therethrough. The lumen may have an inner diameter sufficient to accept a guidewire and an outer diameter small enough to allow fluid to flow between the inner elongate element and a catheter within which the inner elongate element is positioned.

[0006] The bulbous tip may be located at the distal end of the inner elongate element. The outer diameter of the bulbous tip may vary along its length. For example, the proximal end of the bulbous tip may have an outer diameter that allows it to fit within an opening to a catheter lumen. The bulbous tip, and more specifically, the outer surface and outer diameter of the bulbous tip, may taper outward relative to the longitudinal axis of the bulbous tip from the proximal end or portion of the bulbous tip to the intermediate or distal portion of the bulbous tip. In some embodiments, the taper may be off-center. In embodiments where the taper is off-center, the taper may extend only around a portion of the circumference of the proximal portion of the bulbous tip. Thus, the base of the circumference of the bulbous tip may have less or no tapering (i.e., the bulbous tip lies flat along its base), while the upper portion of the circumference may include a more pronounced taper. In other embodiments, the proximal portion of the bulbous tip may include an isometrically centered taper or a circumferential taper.

[0007] The maximum outer diameter of the bulbous tip, which may be located along the intermediate or distal portion of the bulbous tip, may be at least as large as the inner diameter of the lumen of the catheter in which the inner elongate element is positioned. The outer diameter of the proximal end of the bulbous tip, the shape of the proximal portion of the bulbous tip, and the outer diameter of the intermediate or distal portion of the bulbous tip may allow the bulbous tip to seal against the distal end of the catheter.

[0008] The bulbous tip's internal passageway may be in communication with the lumen of the inner elongate element. In some embodiments, the bulbous tip's internal passageway may be coaxial with the lumen of the inner elongate element. In such embodiments, the inner diameter of the bulbous tip's internal passageway may allow it to receive a guidewire, thus allowing the bulbous tip to move along the length of the guidewire.

[0009] The distal portion of the bulbous tip may include a slant, which may be flat or concave. When the bulbous tip is extended from the distal tip of the catheter, the edge of the slant may be spaced from the distal tip of the catheter to provide an opening between the bulbous tip and the distal tip of the catheter, or at least a larger opening between the slant of the bulbous tip and the distal tip of the catheter than the opening between the remainder of the bulbous tip and the distal tip of the catheter.

[0010] In some embodiments, the beveled portion may include an opening, such as an aperture or slot, that communicates with the internal passageway within the bulbous tip and thus with the lumen of the inner elongate element. The location of the opening on the beveled portion of the bulbous tip may allow the opening to be fully covered by the catheter when the inner elongate element is retracted relative to the catheter to a fully retracted position, and may allow the opening to be exposed when the inner elongate element extends the bulbous tip distally from the distal tip of the catheter.

[0011] The intermediate portion of the bulbous tip may provide a transition between the proximal and distal portions of the bulbous tip. The intermediate portion may have a substantially constant cross-sectional diameter along its length, and therefore a substantially constant outer diameter along its length. Alternatively, the outer diameter of the intermediate portion may gradually increase from its proximal side to a more central location, and then decrease from the more central location to the distal side of the intermediate portion.

[0012] In embodiments where the bulbous tip includes both an intermediate portion and a distal portion, the distal portion may have any of a variety of suitable shapes. Without limitation, the distal portion of the bulbous tip may be blunt (i.e., flat), rounded, or tapered. The distal portion of the bulbous tip, or more specifically the outer surface and therefore the outer diameter of the distal portion, may taper downward relative to the longitudinal axis of the bulbous tip from the proximal side or portion of the distal portion of the bulbous tip toward the distal end of the bulbous tip.

[0013] In another aspect, a medical aspiration system is disclosed, which may include a medical aspiration device (i.e., an inner elongate element, a bulbous tip, and a catheter), an optional guidewire, an aspiration device, and, in some embodiments, a positioner.

[0014] In some embodiments, one or both of the inner elongate element and the catheter may include at least one bend or curvature. A bend in a catheter imparts a planar aspect to the catheter, and similarly, a bend in the inner elongate element may impart a planar aspect to the inner elongate element. When the inner elongate element is positioned within the catheter lumen, the inner elongate element may influence the bend of the catheter. The bend of the catheter and / or inner elongate element may be overcome by the catheter and / or inner elongate element resting on a guidewire. In embodiments in which both the catheter and the inner elongate element include a bend, the angle and / or shape of the bend of the inner elongate element, the longitudinal position of the bend of the inner elongate element relative to the longitudinal position of the bend of the catheter, and / or the rotational position of the bend of the inner elongate element relative to the rotational position of the bend of the catheter may influence or modify the bend of the catheter. Modifying the bend of the catheter and / or inner elongate element may enable steering of the catheter and / or inner elongate element.

[0015] The positioner of the medical aspiration system may be associated with the proximal portion of the inner elongate element and the proximal portion of the catheter in a manner that allows the inner elongate element to move distally and proximally through the catheter. Thus, the positioner may allow the bulbous tip to be at least partially extended from and partially retracted into the distal tip of the catheter. The positioner may be spring-loaded so that the spring can automatically return or urge the inner elongate element and the bulbous tip to their initial positions relative to the catheter after the inner elongate element and the distal tip are urged distally relative to the catheter.

[0016] According to another aspect of the present disclosure, an aspiration method may include positioning a guidewire within a subject's body and introducing a medical aspiration device into the subject's body along the guidewire. The medical aspiration device may be introduced into the subject's body as an assembly including a disruptor and a catheter over the disruptor. Alternatively, the catheter may be introduced into the subject's body over the inner elongate element of the disruptor. With the catheter and disruptor in place, aspiration force or suction may be applied to the catheter. When suction force is applied with the bulbous tip of the disruptor extended distally from the distal tip of the catheter, fluid and / or other material (e.g., emboli, thrombi, plaque (e.g., atheroma), lesions (e.g., tumors, polyps, cysts), organs, tissues, etc.) will be drawn between the proximal portion of the bulbous tip and the opening at the distal tip of the catheter. The bulbous tip can be moved relative to the distal tip of the catheter in a manner that disrupts fluids and / or other materials and facilitates aspiration of the fluids and / or other materials into the catheter. For example, repeated extension and retraction or forward and backward movement of the bulbous tip can disrupt (e.g., soften, pulverize (shred, shred, macerate), etc.) materials as they are aspirated into the opening in the distal catheter.

[0017] Other aspects of the disclosed subject matter, as well as features and advantages of various aspects of the disclosed subject matter, will become apparent to those skilled in the art through consideration of the following description, the accompanying drawings, and the appended claims. [Brief explanation of the drawings]

[0018] [Figure 1] 1 is a perspective view of an embodiment of a disruptor of a medical aspiration device according to the present disclosure, the disruptor including an inner elongate element and a bulbous tip at a distal end of the inner elongate element; FIG. [Figure 2]2 is a side view of the embodiment of the disruptor depicted in FIG. 1 with an embodiment of a positioner 60 at the proximal end of the internal elongate element of the disruptor. [Figure 3] 3 is a perspective view of an embodiment of a medical aspiration device or system including the disruptor embodiment shown in FIGS. 1 and 2, the positioner embodiment depicted in FIG. 2, and a catheter. [Figure 4] FIG. 4 is a partial perspective view showing the distal end of the embodiment of the medical aspiration device or system depicted by FIG. 3, with the bulbous tip of the disruptor in a retracted position relative to the distal tip of the catheter. [Figure 5] FIG. 4 is a partial perspective view of the distal end of an embodiment of a medical aspiration device or system depicted by FIG. 3, with the bulbous tip of the disruptor in a partially extended or partially open position relative to the distal tip of the catheter. [Figure 6] FIG. 4 is a partial perspective view showing the distal end of an embodiment of a medical aspiration device or system depicted by FIG. 3, with the bulbous tip of the disruptor in a fully extended or fully open position relative to the distal tip of the catheter. [Figure 7A] FIG. 10 illustrates another embodiment of a bulbous tip of a disruptor or medical suction device or system in which the proximal portion of the bulbous tip is tapered in a different manner than the proximal portion of the bulbous tip embodiment shown in FIGS. 1-6. [Figure 7B] Similar to FIG. 7A, this shows another embodiment of a bulbous tip of a disruptor or medical suction device or system in which the proximal portion of the bulbous tip is tapered in a different manner than the proximal portion of the bulbous tip embodiment shown in FIGS. 1-6. [Figure 8] FIG. 7 is a perspective view of a disruptor having a bulbous tip embodiment having a distal portion different from the distal portion of the bulbous tip embodiment shown in FIGS. 1-6. [Figure 9] FIG. 7 is a perspective view of a disruptor having a bulbous tip embodiment having a distal portion different from the distal portion of the bulbous tip embodiment shown in FIGS. 1-6. [Figure 10]1 depicts an embodiment of a medical aspiration device in which the inner elongate element and catheter include bends, showing the bends longitudinally and rotationally aligned with one another. [Figure 11] 11 illustrates the effect of a guidewire on the embodiment of the medical aspiration device shown in FIG. 10. [Figure 12] 10 illustrates an example of the effect of misalignment of the inner elongate element and the catheter on bending of the catheter. [Figure 13A] 1 is a partial perspective view of the distal end of an embodiment of a medical aspiration device showing the bulbous tip of the medical aspiration device in a fully extended position relative to the catheter of the medical aspiration device. FIG. [Figure 13B] 1 is a partial perspective view of the distal end of an embodiment of a medical aspiration device, showing the bulbous tip of the medical aspiration device in a partially extended position relative to the catheter of the medical aspiration device. FIG. [Figure 14] 10A-10C schematically illustrate the delivery of a substance to a site where a bulbous tip of a medical suction device is positioned. DETAILED DESCRIPTION OF THE INVENTION

[0019] 1-3 illustrate one embodiment of a medical suction device 10 according to the present disclosure. As shown in FIG. 1, the medical suction device 10 includes a disruptor 12 having an inner elongate element 20 and a bulbous tip 30. The disruptor 12 may further include a connector 50 that facilitates placing the disruptor 12 in fluid communication with other components. Additionally, as shown in FIG. 3, the medical suction device 10 includes an outer element, such as a catheter 40, that may be assembled integrally with the disruptor 12. In some embodiments, the medical suction device may further include a positioner 60, as depicted by FIGS. 2 and 3.

[0020] The inner elongate element 20 has a tubular configuration and, as such, may include a wall 21 and a lumen 29 defined by the wall 21 and extending through the length of the inner elongate element 20. The inner diameter (ID) of the inner elongate element 20 or the diameter of its lumen 29 may allow the inner elongate element to receive the length of the guidewire 70 and move over it. The outer diameter (OD) of the inner elongate element 20 may allow the inner elongate element to be received by and move longitudinally through the lumen of the catheter 40, and may also allow fluids and / or other matter (e.g., emboli, thrombus, plaque (e.g., atheroma, etc.), lesions (e.g., tumors, polyps, cysts, etc.), organs, tissues, etc.) to flow between the inner elongate element 20 and the catheter or vessel within which it is positioned. Without limitation, the inner diameter of the inner elongate element 20 may be as small as about 0.010 inches (about 0.254 mm) (e.g., when used with a 0.010 inch (0.254 mm) guidewire 70), and the outer diameter of the inner elongate element 20 may be as small as about 0.015 inches (about 0.381 mm). The inner diameter of the inner elongate element 20 may be as large as about 0.040 inches (about 1.02 mm) (e.g., when used with a 0.038 inch (0.965 mm) guidewire 70), and the outer diameter of the inner elongate element 20 may be as large as about 0.045 inches (about 1.14 mm). In some embodiments, the inner elongate element 20 may have even larger dimensions.

[0021] The inner elongate element 20 may comprise a single piece or multiple pieces. Metals, polymers, or combinations of metals and polymers may be used to form the inner elongate element. In certain embodiments, the inner elongate element 20 may comprise a hypotube, which may be formed from stainless steel or nitinol. Such hypotubes may include features that enhance their flexibility (e.g., helical or circumferential slits or cuts, as disclosed by U.S. Patent Application Publication No. 2019 / 0232018 A1 ("the '018 Publication"), the disclosure of which is hereby incorporated by reference in its entirety). In such embodiments, the inner elongate element may further include one or more polymer coatings, which may be carried externally over the hypotube wall and / or internally within the hypotube wall, as also disclosed by the '018 Publication.

[0022] At least a portion of the outer surface of the inner elongate element 20 can facilitate the aspiration of material into and through the lumen 49 of the catheter 40 within which the inner elongate element 20 resides. Without limitation, the outer surface of the inner elongate element 20 can include disruptive features (features that cause disruption). The disruptive features can disrupt aspirated material in a manner that facilitates continuous, uninterrupted movement of such material proximally through the lumen 49 of the catheter 40. Examples of disruptive features include, but are not limited to, blades, fins or wings, other raised features (e.g., lattice edges, blades, etc.), fenestrations, and / or the like.

[0023] The inner elongate element 20 has a proximal end 22 and a distal end 26 .

[0024] The bulbous tip 30 of the medical suction device 10 may be located at the distal end 26 of the inner elongate element 20. The embodiment of the bulbous tip 30 depicted in Figures 1-3 includes, from proximal to distal, a proximal end 32, a proximal portion 33, an intermediate portion 34, a distal portion 35, and a distal end 36.

[0025] In some embodiments, the entire bulbous tip 30 may be positioned over the distal portion 25 of the inner elongate element 20 (i.e., the distal portion 25 of the inner elongate element 20 may extend through the bulbous tip 30). In such embodiments, the distal end 26 of the inner elongate element 20 may be coextensive with the distal end 36 of the bulbous tip 30. In other embodiments, the bulbous tip 30 may be fixed to the distal end 26 of the inner elongate element 20 (i.e., the distal portion 25 of the inner elongate element 20 may not extend into the bulbous tip 30 or may only extend partially through the bulbous tip 30).

[0026] In embodiments in which the distal portion 25 of the inner elongate element 20 extends into the bulbous tip 30, the distal portion 25 may be flared to provide a mechanical connection between the distal portion 25 and the bulbous tip 30. Alternatively or additionally, the distal portion 25 may include other features, such as slots, flanges or other protrusions, and / or the like, to facilitate the mechanical connection of the bulbous tip 30 to the distal portion 25.

[0027] The bulbous tip 30 may include an internal passageway 39 that communicates with the lumen 29 of the inner elongate element 20, or may comprise a distal portion of the lumen 29 of the inner elongate element 20. The internal passageway 39 and the lumen 29 may be coaxial. The inner diameter of the internal passageway 39 may allow the internal passageway 39 to receive and track over the guidewire 70, thus allowing the bulbous tip 30 to move along the length of the guidewire 70.

[0028] The shape and dimensions of the bulbous tip 30 may allow the bulbous tip 30 to be at least partially retracted into an opening 47 in the distal tip 46 of the catheter 40, as shown in Figure 4. When the bulbous tip 30, or more specifically the proximal portion 33 of the bulbous tip 30, is retracted into the opening 47 in the distal tip 46 of the catheter 40, the proximal portion 33 of the bulbous tip 30 may be adapted to seal against the distal tip 46 of the catheter 40.

[0029] 1-3 , at and near the proximal end 32 of the bulbous tip 30, the outer diameter of the proximal portion 33 may be smaller than the inner diameter of the opening 47 and lumen 49 of the catheter 40, allowing at least the proximal side of the proximal portion 30 to be retracted into the opening 47 and lumen 49. In some embodiments, the entire proximal portion 33 of the bulbous tip 30 may be adapted to be retracted into the opening 47 and lumen 49 of the catheter 40. In other embodiments, distal locations along the length of the proximal portion 33 may have an outer diameter that is equal to or exceeds the inner diameter of the opening 47 and lumen 49, allowing the proximal portion 33 of the bulbous tip 30 to abut and optionally seal against the distal tip 46 of the catheter 40.

[0030] The proximal portion 33 of the bulbous tip 30 may taper outward relative to the longitudinal axis of the bulbous tip 30 from the proximal end 32 to the intermediate portion 34. The taper provides a smooth transition between the outer surface of the inner elongate element 20 and the proximal portion 33 of the bulbous tip 30, allowing the inner elongate element 20 to be pulled proximally, causing the proximal portion 33 to be retracted into the opening 47 in the distal tip 46 of the catheter 40, or allowing the opening 47 in the distal tip 46 of the catheter 40 to be smoothly pushed over the proximal portion 33 of the bulbous tip 30. The taper may be a low angle taper (e.g., from about 5 degrees to about 40 degrees).

[0031] The taper of the proximal portion 33 may be off-center. In embodiments where the taper is off-center, the taper may extend only around a portion of the circumference of the proximal portion 33 of the bulbous tip 30. Thus, the proximal portion 33 of the bulbous tip 30 may include a slightly tapered or non-tapered base and a more tapered upper portion, allowing the proximal portion 33 to lie substantially flat (considering a slight taper) or completely flat (considering no taper) along its base. Such a taper may allow the bulbous tip 30 to focus aspiration or suction applied through the lumen 49 of the catheter 40 to one side of the opening 47 at the distal tip 46 of the catheter 40.

[0032] 7A and 7B, the taper of the proximal portion 33' of the bulbous tip 30' may comprise a conformally centered or circumferential taper, giving the proximal portion 33' a slightly conical or frustoconical shape. The circumferential taper may enable the bulbous tip 30' to focus suction forces applied through the lumen 49 of the catheter 40 in an annular manner around the outer edge of the opening 47 in the distal tip 46 of the catheter 40.

[0033] 1-3 , the proximal portion 33 may include a relatively flat section, which may be referred to as a “ramp 37,” along a portion of the length of the proximal portion 33. The ramp 37 may be flat or slightly concave. The location of the ramp 37 on the proximal portion 33 may facilitate full retraction of the proximal portion 33 into the opening 47 and lumen 49 of the catheter 40 when the disruptor 12 and its bulbous tip 30 are fully retracted relative to the catheter 40. For example, a location along the proximal portion 33 having the same or larger outer diameter as the opening 47 and lumen 49 of the catheter 40 may be located distal to the most distal extension of the ramp 37.

[0034] In embodiments in which the ramp 37 is concave, the concave shape can facilitate directing suction to a target location on the subject's body and / or shape the suction to be directed to a target location. The edge defined by the concave ramp 37 can facilitate disintegration of material (e.g., stirring, crushing, squeezing, biting, shaving, cutting, macerating, etc.) as the proximal portion 33 of the bulbous tip 30 is retracted (single, repeatedly, etc.) into the distal tip opening 47 while material is aspirated between the ramp 37 and the outer edge of the opening 47 through the distal tip 46 of the catheter 40.

[0035] The beveled portion 37 may include an opening 38 (e.g., an aperture, a slot, etc.) that communicates with an internal passageway 39 within the bulbous tip 30 and, therefore, with the lumen 29 of the inner elongate element 20. The location of the opening 38 on the beveled portion 37 of the bulbous tip may allow the opening 38 to be received, and optionally sealed, within the catheter 40 when the bulbous tip 30 is retracted to a fully retracted position relative to the catheter 40. Conversely, the opening 38 may be exposed when the bulbous tip 30 is extended distally relative to the distal tip 46 of the catheter 40, as shown in Figure 5 (partial distal extension of the bulbous tip 30) and Figure 6 (full distal extension of the bulbous tip 30).

[0036] In some embodiments, the sloped portion 37 may include fenestrations, raised features (e.g., lattice edges, blades, etc.), or the like that may disrupt aspirated material in a manner that facilitates its entry into the opening 47 at the distal tip 46 of the catheter 40 and its continued, uninterrupted flow in a proximal direction through the lumen 49 of the catheter 40.

[0037] 1-3 , the intermediate portion 34 of the bulbous tip 30 may provide a transition between the proximal portion 33 and the distal portion 35 of the bulbous tip 30. As depicted, the outer diameter of the intermediate portion 34 may gradually increase from its proximal side toward a more central location and then decrease from the more central location toward the distal side of the intermediate portion, such that the central location has the largest or greatest outer diameter of the bulbous tip 30. The proximal location of the intermediate portion 34 where the outer diameter of the intermediate portion 34 equals or exceeds the inner diameter of the catheter opening 47 and lumen 49 may abut and optionally seal against the distal tip 46 of the catheter 40. Alternatively, in embodiments in which the proximal portion 33 of the bulbous tip 30 abuts and optionally seals against the distal tip 46 of the catheter 40, the intermediate portion 34 may have a substantially constant outer diameter, which in turn comprises the maximum outer diameter of the bulbous tip 30. The maximum outer diameter of the bulbous tip 30 may be approximately the same as or less than the outer diameter of the distal tip of the catheter. In some embodiments, including embodiments in which the outer diameter of the distal tip of the catheter is tapered, the maximum outer diameter of the bulbous tip 30 may be less than the outer diameter along most of the length of the catheter 40 or less than the outer diameter of the catheter 40.

[0038] The distal portion 35 of the bulbous tip 30 may taper inwardly relative to the longitudinal axis of the bulbous tip 30 from the intermediate portion 34 to the distal end 36 of the bulbous tip 30. The taper of the distal portion 35 may mirror the taper of the proximal portion 33, or it may be different from the taper of the proximal portion 33. The taper may be a low angle taper (e.g., about 5 degrees to about 40 degrees). Such a taper may allow the bulbous tip 30 to track over a guidewire 70 within a subject's body.

[0039] The taper of the distal portion 35 of the bulbous tip 30 may be off-center. In embodiments where the taper is off-center, the taper may extend only around a portion of the circumference of the proximal portion 33 of the bulbous tip 30. The proximal portion 33 of the bulbous tip 30 may include a slightly tapered or non-tapered base and a more tapered upper portion, allowing the proximal portion 33 to lie substantially flat (considering a slight taper) or completely flat (considering no taper) along its base. Alternatively, as shown in FIG. 7, the taper of the distal portion 35 may comprise a circumferential taper, giving the distal portion 35 a slightly conical or frusto-conical shape.

[0040] As an alternative to the just-described gradually tapered distal portion 35, the distal portion 35'' of the bulbous tip 30'' may have a steeper taper (e.g., greater than 45 degrees), as shown in FIG. 8, or the distal portion 35''' of the bulbous tip 30''' may define a rounded or blunt distal end 36''', as shown in FIG. 9. Such an embodiment may be useful in certain situations (i.e., situations where the distal purchase is short) where the anatomy limits how far the distal end 36 can be advanced beyond the material to be aspirated.

[0041] 1-3 , the material or materials of the bulbous tip 30 allow the bulbous tip 30 to seal against the distal tip when the proximal portion 33 of the bulbous tip 30 is retracted into the opening 47 of the distal tip 46 of the catheter 40, allowing the bulbous tip 30 to control the communication of aspiration or suction from within the lumen 49 of the catheter 40 to beyond the distal tip 46 of the catheter 40. Thus, the material(s) of the bulbous tip 30 may render the bulbous tip 30 inflexible or rigid, and may optionally provide some compliance to the surface of the proximal portion 33. In some embodiments, the bulbous tip 30 may comprise a polymer. Suitable polymers include polyethylene (PE), polypropylene (PP), fluorinated ethylene propylene (FEP), among others. Alternatively, the bulbous tip 30 may be made from metal.

[0042] The bulbous tip 30 may be manufactured separately from the inner elongate element 20 and then integrally assembled with and secured to the distal end 26 of the inner elongate element 20. The bulbous tip 30 may be secured to the distal end 26 in any suitable manner (e.g., mechanically, adhesively, using a weld, etc., or any combination of the foregoing).

[0043] Alternatively, in embodiments in which the bulbous tip 30 is formed from a polymer, the bulbous tip 30 may be molded in place on the distal end 26 of the inner elongate element 20 .

[0044] As another alternative, the inner elongate element 20 and the bulbous tip 30 may be manufactured as an integral unit. For example, in embodiments in which the inner elongate element 20 and the bulbous tip 30 are formed from a polymer, they may be co-extruded or molded. As another example, the inner elongate element and the bulbous tip 30 may be formed by modifying (e.g., cutting, machining, expanding, compressing, etc.) different sections of the same hypotube.

[0045] The catheter 40 may have a tubular configuration and thus include a wall 41 and a lumen 49 defined by the wall 41. The lumen 49 may extend through the length of the catheter 40 from its proximal end 42 to its distal tip. The lumen 49 may communicate through an opening 47 in the distal tip.

[0046] The inner diameter (ID) of the catheter 40, or the diameter of its lumen 49, may allow the catheter 40 to receive the inner elongate element 20 and allow the inner elongate element 20 to move longitudinally through the lumen 49. The ID of the catheter 40 may also allow fluids and other substances to be aspirated between the outer surface of the inner elongate element 20 and the surface of the lumen 49 or the inner surface of the catheter 40. The outer diameter (OD) of the catheter 40 may allow the catheter 40 to be inserted into a subject's body and moved through a desired opening (e.g., a blood vessel, other hollow organ, duct, cavity, etc.). Without limitation, the ID of the catheter 40 may be as small as about 0.015 inches (about 0.381 mm), and the OD of the catheter 40 may be as small as about 0.020 inches (about 0.508 mm). The inner diameter of catheter 40 may be as large as about 0.045 inches (about 1.14 mm), and the outer diameter of catheter 40 may be as large as about 0.050 inches (about 1.27 mm). In some embodiments, catheter 40 may have even larger dimensions.

[0047] In some embodiments, the catheter 40 may be 8F (i.e., 0.105 inches; 2.67 mm) or larger (e.g., 10F, 11F, etc.). As an example, a 10F or 11F catheter with an inner diameter of 0.125 inches (3.175 mm) has a lumen 49 with a cross-sectional area of ​​0.0122 square inches (7.88 square mm). When such a catheter 40 is placed over an inner elongate element 20 with an outer diameter of 0.035 inches (0.889 mm) (i.e., a cross-sectional area of ​​0.001 square inches or 0.62 square mm), the remaining cross-sectional area through which the material to be aspirated can flow is still approximately 0.011 square inches (7.26 square mm). Similarly, if such a catheter 40 is placed over an inner elongate element 20 having an outer diameter of 0.042 inches (1.07 mm) (i.e., a cross-sectional area of ​​0.0014 square inches or 0.90 square mm), the remaining cross-sectional area through which the aspirated material can flow is still 0.010 square inches (6.98 square mm). Thus, the reduction in area and volume for the flow of aspirated fluids and / or other materials is only about 5% when a larger inner elongate element 20 is used, allowing the use of a larger guidewire 70 (e.g., 0.035 inches (0.889 mm)) to improve trackability with minimal reduction in flow.

[0048] The connector 50 of the medical suction device 10 can be coupled to the proximal end 42 of the catheter 40. The connector 50 can comprise any suitable type of catheter connector known in the art and can facilitate coupling of the catheter 40 to other devices or equipment, including, but not limited to, the disintegrator 12 and suction devices of types known in the art (e.g., syringes, aspirators, wall suction, electromechanical suction pumps, etc.).

[0049] In some embodiments, a Y-adapter 52 may be coupled to the connector 50 to allow communication to be established between the suction device and the lumen 49 of the catheter 40, and thus to allow suction force to be applied to the lumen 49 of the catheter 40.

[0050] The positioner 60 of the medical aspiration device 10 can be coupled to the proximal end 22 of the inner elongate element 20 of the disruptor 12. More specifically, the positioner 60 can include a coupler 61 that couples the positioner 60 to the Y-connector 52 and / or connector 50 on the proximal end 42 of the catheter 40. The connector 50 and the Y-connector 52 can be adapted to seal against the outer surface of the inner elongate element 20 (e.g., using a hemostatic valve, etc.).

[0051] Additionally, the positioner 60 includes an actuator 62 that allows selective longitudinal movement of one or both of the inner elongate element 20 and the catheter 40 relative to the other. Stated another way, the actuator 62 can move the inner elongate element 20 distally and proximally through the lumen 49 of the catheter 40 and / or the actuator 62 can move the catheter 40 proximally and distally over the inner elongate element 20. Thus, the actuator 62 can extend the bulbous tip 30 distally away from the distal tip 46 of the catheter 40, and the actuator 62 can retract the bulbous tip 30 at least partially into the distal tip 46 of the catheter 40.

[0052] In the embodiment depicted by FIGS. 2 and 3, actuator 62 includes a distal surface 63, a spring 64, and a proximal surface 65.

[0053] The distal face 63 of the actuator 62 may be positioned adjacent to, fixed to, or continuous with the coupler of the positioner 60. The position of the distal face 63 may be fixed relative to the length of the catheter 40, but the inner elongate element 20 may slide through the distal face 63. Thus, as the distal face 63 is drawn closer to the proximal face 65, the catheter 40 is pulled proximally over the inner elongate element 20.

[0054] The position of the proximal face 65 of the actuator 62 may be fixed relative to the length of the inner elongate element 20, i.e., the proximal face 65 may be coupled to the inner elongate element 20. As a result, as the proximal face 65 is urged toward the distal face 63, the inner elongate element 20 is also urged distally through the lumen 49 of the catheter 40. Thus, movement of the distal and proximal faces 63, 65 toward each other extends the bulbous tip 30 distally from the distal tip 46 of the catheter 40, as shown in FIG. 5 (partial distal extension of the bulbous tip 30) and FIG. 6 (full distal extension of the bulbous tip 30). Conversely, movement of the distal and proximal faces 63, 65 away from each other moves the proximal portion 33 of the bulbous tip 30 toward and retracts into the distal tip 46 of the catheter 40, as shown in FIG. 4.

[0055] The spring 64 is positioned between the distal face 63 and the proximal face 65, forcing or biasing them away from one another. Thus, the spring 64 can ensure that, upon release of the force intended to extend the bulbous tip 30 distally from the distal tip 46 of the catheter 40, the proximal portion 33 of the bulbous tip 30 is retracted into the distal tip 46 of the catheter 40, optionally sealing against the distal tip 46 (e.g., using a hemostatic valve, etc.).

[0056] 10-12, in some embodiments, one or both of the inner elongate element 120 and the catheter 140 may include at least one bend or curvature B. Figure 10 depicts an embodiment in which the distal portion 145 of the catheter 140 is curved and thus includes a bend B. The inner elongate element 120 also has a bend B.

[0057] The bend B of the catheter 140 imparts a planar aspect to the catheter 140, and similarly, the bend B of the inner elongate element 120 may impart a planar aspect to the inner elongate element 120. When the inner elongate element 120 is positioned within the lumen 149 of the catheter 140, the inner elongate element 120 may affect the bend B of the catheter 140. The bend B of the catheter 140 and / or inner elongate element 120 may be eliminated by having the catheter 140 and / or inner elongate element rest on the guidewire 70, as shown in FIG. In embodiments in which both the catheter 140 and the inner elongate element 120 include a bend B, the angle and / or shape of the bend B of the inner elongate element 120, the longitudinal position of the bend B of the inner elongate element 120 relative to the longitudinal position of the bend B of the catheter 140, and / or the rotational position of the bend B of the inner elongate element 120 relative to the rotational position of the bend B of the catheter 140 may affect or modify the bend B of the catheter 140.

[0058] In the arrangement depicted by FIG. 10, the bend B of the inner elongate element 120 is longitudinally and rotationally aligned with the bend B of the catheter 140 (i.e., their planar extents are substantially coplanar).

[0059] When one or both of the inner elongate element 120 and the catheter 140 are rotated relative to the other, their planar extents diverge, influencing or correcting their bend B, as shown in Figure 12. Specifically, Figure 12 illustrates a 180 degree rotation of the inner elongate element 120 relative to the catheter 140, which may straighten the bend B of the catheter 140 somewhat as depicted, or may even be rotated 180 degrees depending on the relative stiffness of the catheter 140 and the inner elongate element 120.

[0060] Altering the bend B of the catheter 140 and / or inner elongate element 120 may allow steering of the catheter 140 and / or inner elongate element 120.

[0061] As shown in Figure 3, the collapser 12 and catheter 40 may be assembled together prior to their use. With the collapser 12 and catheter 40 in the assembled position, they may be assembled with a guidewire 70 and introduced over the guidewire 70 into and advanced through the subject's body until the bulbous tip 30 reaches a desired or target location within the subject's body.

[0062] One aspiration method may include positioning a guidewire 70 within the subject's body and introducing the medical aspiration device 10 into the subject's body along the guidewire. The medical aspiration device 10 is to be introduced into the subject's body. The medical aspiration device 10 may be introduced with the collapser 12 and catheter 40 in an assembled relationship. Alternatively, the collapser 12 may be introduced, and then the catheter 40 may be introduced over the collapser 12.

[0063] Once the catheter 40 and disruptor 12 are in place, suction or suction may be applied to the catheter 40 using, for example, a suction device in communication with the lumen 49 of the catheter 40 via the Y-adapter 52. The positioner 60 may initially hold the bulbous tip 30 of the disruptor 12 in its retracted position relative to the distal tip 46 of the catheter 40 so that suction is not communicated through the opening 47 in the distal tip 46 of the catheter 40.

[0064] Once suction is desired, the positioner 60 is actuated to extend the bulbous tip 30 from the distal tip 46 of the catheter 40, allowing suction to be communicated distally beyond the distal tip. As suction is applied, fluid and / or other material (e.g., emboli, thrombi, plaque (e.g., atheroma), lesions (e.g., tumors, polyps, cysts), organs, tissue, etc.) is drawn between the proximal portion 33 of the bulbous tip 30 and the opening 47 at the distal tip 46 of the catheter 40.

[0065] The extent to which suction is applied as well as the direction in which it is applied can be controlled. When the bulbous tip 30 is fully extended from the distal tip 46 of the catheter, as depicted by FIG. 13A, suction can be applied throughout the opening 47 through the distal tip 46. In contrast, when the bulbous tip 30 is only partially extended, as depicted in FIG. 13B, the size of the opening through which suction can be applied is smaller and the force can be increased. Additionally, the bevel 37 on the proximal portion 33 of the bulbous tip 30 can control or influence the direction in which suction is applied.

[0066] In some embodiments, the bulbous tip 30 can be moved relative to the distal tip 46 of the catheter 40 in a manner that breaks up fluids and / or other substances and facilitates their aspiration into the catheter 40. For example, repeated extension (FIGS. 5 and 6) and retraction (FIG. 4) or forward-backward motion of the bulbous tip 30 can break up (e.g., agitate, soften, pulverize (shred, chop), etc.) the substance and facilitate its aspiration into the opening 47 of the distal tip 46.

[0067] In embodiments in which an opening 38 is provided in the proximal portion 33 of the bulbous tip 30 (e.g., in the angled portion 37 of the proximal portion 33), as shown in FIG. 14 , a substance S that facilitates aspiration of fluids and / or other materials from a particular site may be injected through the lumen 29 of the inner elongate element 20, through the passageway 39 of the bulbous tip 30, and into the site through the opening 38. Such a substance S may reduce the viscosity of, dissolve, or lubricate the substance M to be aspirated. Alternatively, the substance S injected through the opening 38 may deliver therapy to the site where the bulbous tip 30 is positioned, facilitate diagnosis of the site, or perform some other function.

[0068] While the above disclosure provides many details, these should not be construed as limiting the scope of any appended claims, but merely as providing illustrations of some embodiments of the elements and features of the disclosed subject matter. Other embodiments of the disclosed subject matter and other embodiments of those elements and features may be devised that do not depart from the spirit or scope of any appended claim. Accordingly, the scope of each claim is limited only by its plain language and its legal equivalents. [Explanation of symbols]

[0069] 10 Medical suction devices 12 Disintegrator 20 internal elongated elements 21 Wall 22 proximal end 25 distal portion 26 Distal end 29 lumens 30, 30', 30'', 30''' bulbous tip 32 proximal end 33, 33' proximal part 34 Middle part 35, 35'', 35'' distal portion 36, 36''' distal end 37 Slope 38 Opening 39 Internal passage 40 Catheter 42 proximal end 46 Distal tip 47 Opening 49 lumens 50 connectors 52 Y adapter 60 Positioner 61 Coupler 62 Actuator 63 Distal surface 64 Spring 65 Proximal surface 70 Guidewire 120 Internal elongated element 140 Catheter 145 distal portion 149 lumens B bend M Substance to be aspirated S Substances that facilitate suction

Claims

1. 1. A medical suction device disruptor, comprising: A catheter, an inner elongate element comprising a hypotube comprising a metal, the inner elongate element including a lumen having a diameter sufficient to receive a guidewire, the inner elongate element being positioned within the catheter, the inner elongate element including an outer diameter small enough to allow fluid to flow between the inner elongate element and the catheter; a bulbous tip located at the distal end of the inner elongate element, the outer surface of the bulbous tip tapering along the longitudinal axis of the bulbous tip from a proximal portion of the bulbous tip to a distal end of the bulbous tip, the inner elongate element being positioned within a lumen of the catheter, the bulbous tip having a maximum outer diameter at least as large as a diameter of the catheter lumen.

2. The disintegrator according to claim 1, The metal comprises a shape memory alloy.

3. The disintegrator according to claim 2, A disruptor, wherein the shape memory alloy includes at least one bend.

4. The disintegrator according to any one of claims 1 to 3, The bulbous tip includes a proximal side that seals against a distal end of a catheter within which the inner elongate element is positioned.

5. The disintegrator according to any one of claims 1 to 4, The disruptor further comprising a positioner associated with a proximal portion of the inner elongate element to allow proximal and distal movement of the inner elongate element and the bulbous tip.

6. The disintegrator according to claim 5, The positioner is spring-loaded to urge the inner elongate element and the bulbous tip proximally.

7. The disintegrator according to any one of claims 1 to 6, A disruptor wherein the proximal side of the bulbous tip includes a slant.

8. The disintegrator according to any one of claims 1 to 7, A disruptor wherein the bulbous tip includes a center along a longitudinal axis of the bulbous tip and a proximal side of the bulbous tip includes an off-center taper.

9. The disintegrator according to any one of claims 1 to 8, A disruptor wherein the proximal side of the bulbous tip includes one or more disruptive features.

10. The disintegrator according to any one of claims 1 to 9, The bulbous tip includes a lumen having a diameter sufficient to receive the guidewire.

11. In a medical suction device, A guide wire; 11. A medical aspiration device comprising: a disruptor according to any one of claims 1 to 10, wherein the inner elongate element of the disruptor includes a lumen having a diameter sufficient to receive the guidewire and an outer diameter small enough to allow fluid to flow between the inner elongate element and the catheter, and the bulbous tip of the disruptor is located at a distal end of the inner elongate element.

12. 12. The medical suction device according to claim 11, A medical aspiration device, wherein the inner elongate element includes at least one bend.

13. 13. The medical suction device according to claim 12, A medical aspiration device, wherein the catheter includes at least one bend.

14. 14. The medical suction device according to claim 13, A medical aspiration device, wherein the at least one bend in the inner elongate element is capable of offsetting the at least one bend in the catheter.

15. In the suction system, a suction device assembled with a guidewire at a predetermined location within the subject's body, the suction device being introduceable into the subject's body along the guidewire; means for applying suction to the catheter of said aspiration device; and means for moving the position of the inner elongate element and the bulbous tip of the suction device into and out of contact with the distal end of the catheter to selectively define an opening through which the suction force is selectively transmitted between the bulbous tip and the distal end of the catheter.

16. 16. The aspiration system of claim 15, wherein the means for moving the position of the bulbous tip allows for suction through the side of an assembly including the catheter and the bulbous tip.

17. 16. The aspiration system of claim 15, wherein the means for moving the position of the bulbous tip allows for suction around the entire circumference of the proximal side of the bulbous tip.

18. 18. An aspiration system according to any one of claims 15 to 17, wherein the means for changing the position of the bulbous tip comprises means for moving the bulbous tip back and forth.

19. 20. The aspiration system of claim 18, wherein said bulbous tip and means for moving said bulbous tip back and forth comprise means for disrupting material to be aspirated.

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