WIRE SUPPORTED EXPANDABLE CATHETER TIP
20230372670 · 2023-11-23
Assignee
Inventors
Cpc classification
A61M25/01
HUMAN NECESSITIES
International classification
Abstract
The designs disclosed herein are for a clot retrieval catheter with a large bore shaft and an expandable distal tip section. The catheter includes proximal elongate shaft comprising a distal end, a longitudinal axis, and a shaft braid member comprising a plurality of braid wires. The expandable distal tip section is located proximate the distal end of the proximal elongate shaft. The expandable distal tip sections can vary in design. In one example, the distal tip section includes a longitudinal array of hoops. The plurality of braid wires can be formed monolithically with the array of hoops. In another example, the distal tip section can include two sets of opposing ribs. A first rib can be formed from a first wire of the plurality of braid wires, and a second rib can be formed from a second wire of the plurality of braid wire.
Claims
1. A catheter comprising: a proximal elongate shaft comprising a distal end, a longitudinal axis, and a shaft braid member comprising a plurality of braid wires; and a distal tip section at the distal end of the elongate shaft, the distal tip section comprising a collapsed delivery configuration, an expanded deployed configuration, and a longitudinal array of hoops; the plurality of braid wires of the proximal elongate shaft formed monolithically with the array of hoops of the distal tip section, and each wire of the plurality of braid wires diverging from a final crossover point of the shaft braid member at the distal end of the proximal elongate shaft to form one of the hoops of the longitudinal array of hoops.
2. The catheter of claim 1, the distal tip section further comprising a collapsed inner diameter in the collapsed delivery configuration less than an expanded inner diameter in the expanded deployed configuration.
3. The catheter of claim 1, the wire of each hoop of the longitudinal array of hoops connected to the elongate shaft at the final crossover point by a pair of axially extending hoop runners.
4. The catheter of claim 3, each pair of axially extending hoop runners spaced evenly around the longitudinal axis.
5. The catheter of claim 3, each hoop of the longitudinal array of hoops diverging radially from a pair of hoop termini at the distal end of each pair of axially externing hoop runners to extend circumferentially around the tip section.
6. The catheter of claim 1, a first spacing between a pair of more proximal adjacent hoops of the longitudinal array of hoops being different than a second spacing between adjacent hoops in a more distal pair of adjacent hoops.
7. The catheter of claim 6, each hoop of the longitudinal array of hoops comprising a distally unconnected peak which moves distally when the distal tip section is folded to the collapsed delivery configuration.
8. The catheter of claim 1, each hoop of the longitudinal array of hoops defining a plane that is normal to the longitudinal axis of the elongate shaft.
9. A catheter comprising: a proximal elongate shaft comprising a distal end, a longitudinal axis, and a shaft braid member comprising a plurality of braid wires; and a distal tip section extending from the distal end of the elongate shaft, the distal tip section comprising two sets of opposing ribs; a first rib from the two sets of opposing ribs formed from a first wire of the plurality of braid wires of the proximal elongate shaft and a second rib from the two sets of opposing ribs formed from a second wire of the plurality of braid wires of the proximal elongate shaft, the first rib being spaced approximately 180 degrees about the longitudinal axis from the second rib.
10. The catheter of claim 9, the distal tip section further comprising a delivery configuration and a clot capture configuration; the distal tip section having a smaller delivery inner diameter in the delivery configuration and a larger expanded inner diameter when impinged radially by an ingested clot in the clot capture configuration.
11. The catheter of claim 9, the distal tip section further comprising a collapsed delivery configuration having a collapsed inner diameter and an expanded deployed configuration heat set to have an expanded inner diameter greater than the collapsed inner diameter.
12. The catheter of claim 9, each rib of the two sets of opposing ribs comprising a distally unconnected peak.
13. The catheter of claim 9, the two sets of opposing ribs formed monolithically with the plurality of braid wires of the shaft braid member.
14. The catheter of claim 9, each wire of the plurality of braid wires diverging radially from a final crossover point to form a v-shaped pattern.
15. A catheter comprising: a proximal elongate shaft comprising a distal end, a longitudinal axis, and a shaft braid member comprising a plurality of braid wires; a distal tip section at the distal end of the elongate shaft, the distal tip section comprising a longitudinal array of offset hoops defining a beveled plane; and a distal outer jacket surrounding the longitudinal array of offset hoops; the plurality of braid wires of the proximal elongate shaft formed monolithically with the array of offset hoops, each wire of the plurality of braid wires diverging from a final crossover point to extend circumferentially around the tip section. the beveled plane crossing the longitudinal axis at an acute angle.
16. The catheter of claim 15, the distal tip section further comprising a collapsed delivery configuration having a collapsed inner diameter and an expanded deployed configuration having an expanded inner diameter heat set to be greater than the collapsed inner diameter.
17. The catheter of claim 15, the distal tip section further comprising a larger expanded inner diameter when impinged radially by an ingested clot in an expanded clot capture configuration and a smaller delivery inner diameter in a delivery configuration.
18. The catheter of claim 17, wherein in the expanded clot capture configuration, the distal tip section further comprises a substantially circular cross section with a center radially offset from the longitudinal axis of the elongate shaft.
19. The catheter of claim 15, the array of offset hoops comprising distally unconnected peaks which move distally when the distal tip section is folded to a collapsed delivery configuration.
20. The catheter of claim 15, the array of offset hoops following a curvilinear profile circumferentially around the tip section.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0031] The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation. It is expected that those of skill in the art can conceive of and combine elements from multiple figures to better suit the needs of the user.
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DETAILED DESCRIPTION
[0045] Specific examples of the present invention are now described in detail with reference to the Figures, where identical reference numbers indicate elements which are functionally similar or identical. The examples address many of the deficiencies associated with traditional clot retrieval aspiration catheters, such as poor or inaccurate deployment to a target site and ineffective clot removal.
[0046] The designs herein can be for a clot retrieval catheter with a large internal lumen and a distal funnel tip that can self-expand to a diameter larger than that of the guide or sheath through which it is coaxially delivered. The designs can have a proximal elongate shaft for the shaft of the catheter, and a distal tip with an expanding braided support structure and outer polymeric jacket to give the tip atraumatic properties. The braided support can be designed so that the expansion capability is variably focused in an axial portion of the tip section. The braid can be capable of easily and repeatably collapsing for delivery and expanding for good clot reception and resistance under aspiration. The catheter's braid and tip designs can be sufficiently flexible to navigate highly tortuous areas of the anatomy and be able to recover its shape to maintain the inner diameter of the lumen when displaced in a vessel.
[0047] Accessing the various vessels within the vascular, whether they are coronary, pulmonary, or cerebral, involves well-known procedural steps and the use of a number of conventional, commercially-available accessory products. These products, such as angiographic materials, mechanical thrombectomy devices, microcatheters, and guidewires are widely used in laboratory and medical procedures. When these products are employed in conjunction with the devices and methods of this invention in the description below, their function and exact constitution are not described in detail. Additionally, while the description is in many cases in the context of thrombectomy treatments in intercranial arteries, the disclosure may be adapted for other procedures and in other body passageways as well.
[0048] Turning to the figures,
[0049] The clot retrieval catheter 100 can have a flexible elongate shaft 110 serving as a shaft with a large internal bore (which in some cases can be 0.070 inches or larger) and a distal tip section 210 (see also tips 310, 410, and 510 described herein) having a collapsible supporting braided structure. The large bore helps the catheter to be delivered to a target site by a variety of methods. These can include over a guidewire, over a microcatheter, with a dilator/access tool, or by itself.
[0050] In most cases, the design of the collapsible funnel tip can be configured so that the catheter 100 can be delivered through (and retrieved back through) commonly sized outer sheaths and guides. For example, a standard 6Fr sheath/8Fr guide, would typically have an inner lumen of less than 0.090 inches. The tip can then be designed with a collapsed delivery outer diameter of approximately 0.086 inches. The tip can self-expand once advanced to an unconstrained position distal to the distal end 32 of the guide sheath 30, capable of reaching expanded outer diameters as large as approximately 0.132 inches. As the catheter can be delivered independently to a remote occlusion, the tip section 210 (see also tips 310, 410, and 510 described herein) must be designed to be able to resist collapse from the forces of aspiration, have excellent lateral flexibility in both the expanded and collapsed states, and have an atraumatic profile to prevent snagging on bifurcations in vessels.
[0051] A closer view of the distal portion of the catheter 100 with the tip section 210 in the expanded deployed configuration as a funnel is illustrated in
[0052] The distal tip section 210 can further include a longitudinal array of hoops 220 extending around the distal tip section 210. This longitudinal array of hoops 220 (also referred to herein as hoops 220 or an array of hoops 220) can be formed continuously from the plurality of braid wires 121. For example, the plurality of braid wires 121 can be formed monolithically with the array of hoops 220 of the distal tip section 210 such that the individual braid wires 121 extend continuously from the elongate shaft 110 to the distal tip section 210. Each wire of the plurality of braid wires 121 can diverge from a final crossover point 218 of the shaft braid member 120 to form one of the hoops 220. In some examples, the catheter 100 can include hoop runners 221 extending between the final crossover point 218 and the hoops 220. For example, at the final crossover point 218 for two braid wires 121, the two braid wires 121 can turn longitudinally along the longitudinal axis 111 of the and extend a certain distance as two hoop runners 221 before diverging to form a single hoop 220 that extends circumferentially around the tip section 210. This points of divergence of the two braid wires 121 to form the hoop 220 can be called hoop termini 223. Referring again to the hoop runners 221, the hoop runners 221 can provide a degree of pushability for the distal tip 210, since their longitudinal direction can resist axial force as the catheter 110 is pushed through a target vessel. In some examples, each pair of axially extending hoop runners 221 can be spaced evenly, and circumferentially, around the longitudinal axis 111.
[0053] Referring to the array of hoops 220 of the distal tip section 210, the spacing between two adjacent hoops can vary depending on where the individual hoops are positioned on the distal tip section 210. To illustrate, a first spacing 224 between a pair of more proximal adjacent hoops of the longitudinal array of hoops 220 can be different than a second spacing 226 between adjacent hoops in a more distal pair of adjacent hoops 220. In some examples, the second spacing 226 of adjacent hoops 220 that are near the distal end 214 of the distal tip section 210 can be tighter than the first spacing 224 of adjacent hoops 220 that are more proximal. The tighter spacing at the distal end 214 of the distal tip section 210 can help improve clot retention and reduce crushability of the distal tip section 210 when it is in the expanded deployed configuration. In the expanded deployed configuration, each hoop of the longitudinal array of hoops 220 can define a plane that is normal to the longitudinal axis 111 of the elongate shaft 110. Further, the longitudinal array of hoops 220 can form a series of rings concentric with the longitudinal axis 111 when the distal tip section 210 is in the expanded deployed configuration.
[0054] As described above, the distal tip section 210 can have an expanded deployed configuration and a collapsed delivery configuration. As will be described in greater detail with reference to
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[0056] The plurality of braid wires 121 can be formed monolithically with the sets of opposing ribs 320. For example, the individual braid wires 121 can extend continuously from the elongate shaft 110 to the distal tip section 310. The braid wires 121 of the proximal elongate shaft 110 can diverge when transitioning into the distal tip section 310. Each wire of the plurality of braid wires 121 can diverge radially from a final crossover point 318 to form a v-shaped pattern 329. After the final crossover point 318, the first rib 330 and the second rib 332 can extend partially around the distal tip section 310. Each rib of the two sets of opposing ribs 320 can include a distally unconnected peak 228 at the distal end 314 of the distal tip section 310, as similarly shown in
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[0059] The distal tip 410 is offset from the longitudinal axis 111, which can help to reduce the likelihood of tip collapse during aspiration compared to expandable catheters with mouths normal to the longitudinal axis 111, since the membrane (e.g., outer jacket 180) for the offset mouth does not fully extend around the diameter of the distal tip section 410. The catheter 100 can further include the outer jacket 180 surrounding the longitudinal array of offset hoops 420. The plurality of braid wires 121 of the proximal elongate shaft 110 can be formed monolithically with the array of offset hoops 420. Each wire of the plurality of braid wires 121 can diverge from a final crossover point 418, wherein beyond the final crossover point 418 the plurality of braid wires 121 extend circumferentially around the tip section 410. Stated otherwise, the plurality of braid wires 121 can discontinue their braided orientation at the final crossover point 418, bend, and continue distally to follow a curvilinear profile circumferentially around the distal tip section 410. The array of offset hoops 420 can include distally unconnected peaks 428 which move distally when the distal tip section 210 is folded to the collapsed delivery configuration.
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[0067] The invention is not necessarily limited to the examples described, which can be varied in construction and detail. The terms “distal” and “proximal” are used throughout the preceding description and are meant to refer to a positions and directions relative to a treating physician. As such, “distal” or distally” refer to a position distant to or a direction away from the physician. Similarly, “proximal” or “proximally” refer to a position near or a direction towards the physician. Furthermore, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
[0068] As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values ±20% of the recited value, e.g. “about 90%” may refer to the range of values from 71% to 99%.
[0069] In describing example embodiments, terminology has been resorted to for the sake of clarity. As a result, not all possible combinations have been listed, and such variants are often apparent to those of skill in the art and are intended to be within the scope of the claims which follow. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents that operate in a similar manner to accomplish a similar purpose without departing from the scope and spirit of the invention. It is also to be understood that the mention of one or more steps of a method does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Similarly, some steps of a method can be performed in a different order than those described herein without departing from the scope of the disclosed technology.