Abstract
A clot removal system for removing a clot from a body vessel, the clot removal system including: a microcatheter including: a distal segment comprising a first diameter; and a proximal segment comprising a second diameter; a stentriever positionable substantially within a lumen of a distal end of the microcatheter, the stentriever including: an engagement structure configured to expand when distal of the microcatheter in an expanded configuration, and an elongated member proximal of the engagement structure and extending to a proximal end of the microcatheter; and a hand control disposed on the proximal end of the microcatheter for controlling extending and retracting the engagement structure from the microcatheter.
Claims
1. A clot removal system for removing a clot from a body vessel, the clot removal system comprising: a microcatheter comprising: a distal segment comprising a first diameter; and a proximal segment comprising a second diameter; a stentriever positionable substantially within a lumen of a distal end of the microcatheter, the stentriever comprising: an engagement structure configured to expand when distal of the microcatheter in an expanded configuration, and an elongated member proximal of the engagement structure and extending to a proximal end of the microcatheter; and a hand control disposed on the proximal end of the microcatheter for controlling extending and retracting the engagement structure from the microcatheter.
2. The clot removal system of claim 1, wherein the engagement structure is configured to be prevented from sliding proximal of the distal segment in a collapsed configuration.
3. The clot removal system of claim 1, wherein the hand control comprises: a brace connected to the proximal end of the microcatheter; and a push-pull mechanism attached to the elongated member.
4. The clot removal system of claim 1, wherein the hand control comprises a lock to hold the engagement structure in a substantially fully retracted position.
5. The clot removal system of claim 1, wherein the microcatheter further comprises a rapid exchange port extending from an outer surface of the microcatheter to the lumen, the rapid exchange port being dimensioned to receive a guidewire, the engagement structure being disposed within microcatheter proximal to the rapid exchange port.
6. The clot removal system of claim 1, wherein the microcatheter further comprises: a rapid exchange port on an outer surface of microcatheter, the rapid exchange port being dimensioned to receive a guidewire; and a guide lumen extending from the rapid exchange port to the distal end of the microcatheter.
7. The clot removal system of claim 1, wherein microcatheter further comprises a rapid exchange port on an outer surface of the microcatheter, the elongated member comprises a substantially hollow body extending through the engagement structure, and the stentriever further comprises a stentriever port extending from an outer surface of the elongated member to an interior of the hollow body, the rapid exchange port, hollow body, and stentriever port being dimensioned to receive a guidewire.
8. The clot removal system of claim 7, wherein the stentriever port is proximal the rapid exchange port.
9. The clot removal system of claim 1, wherein the stentriever further comprises a nose cone on a distal end of the engagement structure.
10. The clot removal system of claim 1, wherein the lumen comprises: a distal shaft extending proximally from the distal end, the distal shaft having a third diameter; and a proximal shaft extending distally from the proximal end, the proximal shaft having a fourth diameter less than the third diameter.
11. The clot removal system of claim 10, wherein a diameter of the engagement structure in the expanded configuration is greater than the third diameter such that the engagement structure cannot be fully retrieved within the distal shaft.
12. The clot removal system of claim 1, wherein the microcatheter further comprises: a proximal shaft extending distally from the proximal end; and a distal shaft extending distally from the proximal shaft, the engagement structure being disposed within the distal shaft and being unable to be received within the proximal shaft.
13. The clot removal system of claim 1, wherein the microcatheter further comprises: a proximal shaft extending distally from the proximal end, the lumen comprising a first diameter through the proximal shaft; and a distal shaft extending distally from the proximal shaft, the lumen comprising a second diameter through the distal shaft, the first diameter being less than the second diameter such that the engagement structure cannot be received by the lumen in the proximal shaft.
14. The clot removal system of claim 1, wherein the microcatheter further comprises: a distal shaft extending proximally from the distal end; and a side port extending from an outer surface of the microcatheter at the distal shaft to the lumen, wherein the engagement structure is disposed within the distal shaft proximate the side port, the hand control is configured to control extending and retracting the engagement structure from the side port.
15. The clot removal system of claim 14, wherein a distal end of the engagement structure is attached to the microcatheter.
16. The clot removal system of claim 1, wherein the engagement structure comprises at least one stop configured to prevent full retraction of the engagement structure within the lumen after extension.
17. The clot removal system of claim 16, wherein the at least one stop prevents retraction of the engagement structure beyond a pinching configuration.
18. The clot removal system of claim 17, wherein the hand control further comprises a retrieval means to control withdrawing the at least one stop to enable full retraction of the engagement structure.
19. The clot removal system of claim 1 further comprising: a first radioactive marker disposed on the distal end of the elongated member; and a second radioactive marker disposed on a distal end of the engagement structure.
20. A method for removing a clot, comprising: operating a hand control to withdraw a microcatheter and extend an engagement structure of a stentriever from the microcatheter.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0062] While the specification concludes with claims, which particularly point out and distinctly claim the subject matter described herein, it is believed the subject matter will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings, in which like reference numerals identify the same elements and in which:
[0063] FIG. 1A illustrates a combination stentriever and microcatheter in a delivery configuration according to aspects of the present disclosure;
[0064] FIG. 1B illustrates a combination stentriever and microcatheter in a deployed configuration according to aspects of the present disclosure;
[0065] FIG. 1C illustrates a cross-sectional view of a distal portion of the combination stentriever and microcatheter of FIGS. 1A and 1B;
[0066] FIG. 1D illustrates a cross-sectional view of a proximal portion of the combination stentriever and microcatheter of FIGS. 1A and 1B;
[0067] FIGS. 2A-2B illustrate example hand controls for a combination stentriever and microcatheter according to aspects of the present disclosure;
[0068] FIGS. 3A-5 illustrate example combination stentriever and microcatheters according to aspects of the present disclosure;
[0069] FIGS. 6 and 7 illustrate example stentrievers according to aspects of the present disclosure;
[0070] FIG. 8 illustrates production of a stentriever according to aspects of the present disclosure;
[0071] FIGS. 9A-10B illustrates combination stentriever and microcatheters with a side port according to aspects of the present disclosure;
[0072] FIGS. 11A and 11B illustrate an operation of a stentriever having a stop according to aspects of the present disclosure;
[0073] FIG. 12 is a flowchart of a treatment incorporating an example clot removal device according to aspects of the present disclosure
[0074] FIG. 13 is a flowchart of producing a combination stentriever and microcatheter according to aspects of the present disclosure;
[0075] FIG. 14 illustrates a hand control with a lock according to aspects of the present disclosure;
[0076] FIG. 15 illustrates an engagement structure having scaffolding elements according to aspects of the present disclosure; and
[0077] FIG. 16 illustrates a combination stentriever and microcatheter with an engagement structure proximal to a rapid exchange port according to aspects of the present disclosure.
DETAILED DESCRIPTION
[0078] 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%.
[0079] FIGS. 1A and 1B illustrate a combination stentriever and microcatheter 100 (e.g., a clot removal device) in delivery and deployed configurations, respectively. FIGS. 1C and 1D illustrate cross-sectional views of distal and proximal portions of the combination stentriever and microcatheter 100, respectively. Combination stentriever and microcatheter 100 may include microcatheter 120, stentriever 140, and hand control 160. Microcatheter 120 has a proximal end 122 disposed near hand control 160, a distal end 124 disposed opposite thereof, and an outer surface 128. The a distal segment extending from the distal end 124 may have a first diameter D1, and a proximal segment extending from the proximal end 122 may have a second diameter D2. In some cases, the first diameter D1 may be greater than the second diameter D2. Microcatheter 120 includes a lumen 127 passing from the proximal end 122 to the distal end 124. The lumen 127 may have a distal shaft formed in the distal end 124 that has a third diameter D3 and a proximal shaft formed in the proximal end 126 that has a fourth diameter D4. The third diameter D3 may be greater than the fourth diameter D4. In some cases, the fourth diameter D4 may be dimensioned such that the engagement structure 142 cannot be received by the lumen 127 in a proximal portion of the microcatheter 120 (e.g., a proximal shaft). The catheter 120 may also have a rapid exchange port 129 extending from the outer surface 128 to the lumen 127. The rapid exchange port 129 may be dimensioned to receive the stentriever 140.
[0080] Stentriever 140 may include an engagement structure 142 and an elongated member 144 (e.g., a structural thread 144). The engagement structure 142 may include a chain 143 of pinching cells 150 including at least a first end and a second end pinching cell 150. The ends of the chain 143 can be connected to the structural thread 144. In some cases, in a delivery configuration, the engagement structure 142 may be disposed proximal the rapid exchange port 129 (i.e., nearer the hand control 160). In such a way, guidewire may avoid interfering with the stentriever 140. One of ordinary skill will recognize that the engagement structure 142 described herein is merely an example, and various additional or alternative engagement structures may be utilized according to aspects of the present disclosure.
[0081] Hand control 160 may be disposed on the proximal end 122 of the microcatheter 120. The hand control 160 may be able to extend and retract the engagement structure 142 from the microcatheter 120. The hand control 160 is single-handedly operable. The hand control 160 may include a brace 162 connected to the proximal end 122 of the microcatheter 120 and a push-pull mechanism 164 attached to the elongated member 144. The push-pull mechanism 164 may include a finger ring 164, but this is merely an example.
[0082] FIGS. 2A-2B illustrate example hand controls 270 for a combination stentriever and microcatheter according to aspects of the present disclosure. Hand control 270 may include a base 272 attached to the proximal end of a microcatheter 220 and a push-pull mechanism 274 attached to a proximal end of a stentriever. For example, push-pull mechanism 274 may include a pull-tab 274.
[0083] FIGS. 3A-5 illustrate example combination stentriever and microcatheters 300-500 according to aspects of the present disclosure. One of ordinary skill will recognize that the combination stentriever and microcatheters 300-500 may be substantially similar to the combination stentriever and microcatheter 100 described above with reference to FIGS. 1A and 1B, and/or aspects of combination stentriever and microcatheter 300-500 may be incorporated into combination stentriever and microcatheter 100.
[0084] Referring to FIG. 3A, combination stentriever and microcatheter 300 may include a microcatheter 320 and a stentriever with an engagement structure 342. A cross-section of microcatheter 320 is illustrated in FIG. 3B. Microcatheter 320 may include a lumen 327 for receiving the stentriever and a guide lumen 330 for receiving a guidewire 395. In some cases, microcatheter 320 may include a rapid exchange port 329, and the guide lumen 330 may only extend from the rapid exchange port 329 to a distal end of the microcatheter 320.
[0085] Referring to FIG. 4A, combination stentriever and microcatheter 400 may include a microcatheter 420 and a stentriever with an elongated member an engagement structure 442 having a nose cone 448 and an elongated member 444 having a hollow or partially body 449. A cross-section of combination stentriever and microcatheter 400 is illustrated in FIG. 4B. The hollow body 449 may be dimensioned to receive a guidewire 495. In some cases, microcatheter 420 may include a rapid exchange port 429. The rapid exchange port 429 may be dimensioned to receive a guidewire, and the guidewire may be fed through a stentriever port into the hollow interior of the stentriever and through a distal end of the stentriever. Nose cone 448 may be configured to drive through a clot (e.g., as a puncturing element).
[0086] Referring to FIG. 5, combination stentriever and microcatheter 500 may include a microcatheter having a first radioactive marker 538 disposed on its distal end. For example, radioactive marker 538 may be disposed on an outer surface 528 of the microcatheter. Combination stentriever and microcatheter 500 may also include a stentriever having an engagement structure 542 and an elongated member 544. A second radioactive marker 558 may be disposed on a distal end of the stentriever. By utilizing the first and second radioactive markers 538, 558, an operator may be able to more accurately determine a positioning and extend/retract status of combination stentriever and microcatheter 500.
[0087] FIGS. 6 and 7 illustrate example stentriever engagement structures according to aspects of the present disclosure. Referring to FIG. 6, engagement structure 644 includes a nose cone 648 and a series of inner pinching cells 650 and outer pinching cells 650′. Referring to FIG. 7, engagement structure 742 includes one or more pinching cells 750 with a shaped wire 744 threaded therethrough.
[0088] FIG. 8 illustrates production of a stentriever according to aspects of the present disclosure. Referring to FIG. 8, a wire 844 is shaped by wrapping the wire around an object (e.g., a substantially cylindrical object). The shaped wire 844 is then threaded through and/or attached to one or more pinching cells 850. In this way, the engagement structure may be more readily developed than the processes utilized in the related art.
[0089] FIGS. 9A-10B illustrates combination stentriever and microcatheters with a side port according to aspects of the present disclosure. Referring to FIGS. 9A and 9B, microcatheter 920 includes a side port 936. Side port 936 may extend from an outer surface of the microcatheter to the lumen formed therein. An engagement structure 942 of a stentriever may be configured to extend and retract through the side port 936 (e.g., via operation of hand control 160). The engagement structure 942 may include a single pinching cell, but this is merely an example. In some cases, a distal end of the stentriever may be connected (e.g., permanently or semi-permanently) to an inner portion of the microcatheter 920.
[0090] Referring to FIGS. 10A and 10B, microcatheter 1020 includes a side port 1036. Side port 1036 may extend from an outer surface of the microcatheter to the lumen formed therein. An engagement structure 1042 of a stentriever may be configured to extend and retract through the side port 1036 (e.g., via operation of hand control 160) to engage with a clot 2. The engagement structure 1042 may include a plurality of pinching cells, but this is merely an example. In some cases, a distal end of the stentriever may be connected (e.g., permanently or semi-permanently) to an inner portion of the microcatheter 1020.
[0091] FIGS. 11A and 11B illustrate an operation of a combination microcatheter and stentriever 1100 having a stop 1156 according to aspects of the present disclosure. Microcatheter and stentriever 1100 may be moved within a blood vessel 1 to clot 2. The engagement structure 142 may be positioned within the microcatheter, e.g., in a collapsed configuration. Once positioned correctly, engagement structure 142 may be extended from microcatheter 120. The engagement structure 142 may interfere with clot 2. The engagement structure 142 may then be partially retracted into the microcatheter 120, for example, as shown in FIG. 11B. For example, stentriever 140 may include a stop 1156 configured to prevent full retraction of the engagement structure 142 within the microcatheter 120 after the engagement structure 142 is extended. Accordingly, engagement structure 142 may be prevented from being overly retracted, and pinch clot 2 against microcatheter 120 (e.g., in a pinching configuration). One of ordinary skill, in light of the present disclosure, understands that stop 1156 is only one example to prevent over-extension. In some cases, the diameter of the engagement structure 142 in the expanded configuration may be greater than the diameter of the lumen such that the engagement structure 142 cannot be fully retrieved within the microcatheter 120 following deployment.
[0092] In some cases, stop 1156 may be retractable, for example, via operation of hand control 160 (e.g., via retrieval means). Accordingly, an operator may retract engagement structure 142 as needed if complete retraction or retraction beyond what is allowed by stop 1156.
[0093] FIG. 12 is a flowchart 1200 of a treatment incorporating an example clot removal device (e.g., combination stentriever and microcatheter 100) according to aspects of the present disclosure. The method includes delivering 1210 a clot removal device in a blood vessel 1 (e.g., a body vessel) at or adjacent a site of the clot 2. The clot removal device may be a combination microcatheter and stentriever (e.g., 100) and may include a microcatheter (e.g., 120), a stentriever (e.g., 140), and a hand control (e.g., 160). The hand control 160 may be operated 1220 to withdraw the microcatheter 120 and extend an engagement structure 142 of the stentriever 140 from the microcatheter 120. The engagement structure may then embed 1230 within at least a portion of the clot 2. The stentriever and microcatheter 100 are then withdrawn, removing 1240 a portion of the clot 2. In some cases, the hand control 160 can be operated to at least partially retract the engagement structure 142 within the microcatheter 120 prior to withdrawing the microcatheter 120 and stentriever 140. In some cases, a stop or alternative structure may prevent over-retraction of stentriever 140.
[0094] FIG. 13 is a flowchart of producing a combination stentriever and microcatheter (e.g., 100) according to aspects of the present disclosure. There may be provided 1310 a microcatheter (e.g., 120). The microcatheter 120 may include an elongated body sized to traverse vasculature (e.g., 1) and including an outer surface (e.g., 18), a proximal end and a distal end disposed on opposite sides thereof, and a lumen (e.g., 127) extending through the elongated body from the proximal end to the distal end. The method may further include providing 1320 a stentriever (e.g., 140). The microcatheter may include an elongated body (e.g., 144) sized to traverse vasculature and an engagement structure (e.g., 142), a proximal end and a distal end disposed on opposite sides thereof, and a lumen extending through the elongated body from the proximal end to the distal end.
[0095] The method may further include feeding 1330 the proximal end of the elongated member through the lumen from the distal end of the elongated body to the proximal end of the elongated body. The engagement structure 142 may then be positioned 1340 within the distal end of the elongated body (e.g., 144 within lumen 127). Then a hand control (e.g., 160) may be attached 1350 to the distal end of the elongated body and the distal end of the elongated member.
[0096] FIG. 14 illustrates a hand control 1460 with a lock 1466 according to aspects of the present disclosure. Lock 1466 may hold hand control 1460 in a substantially retracted position. For example, hand control 460 may include a brace 1462 and a push-pull mechanism 1464. Lock 1466 may prevent push-pull mechanism 1464 from moving forward and extending engagement structure 142.
[0097] FIG. 15 illustrates an engagement structure 1542 having scaffolding elements 1555 according to aspects of the present disclosure. The scaffolding elements 1555 may be configured to receive a clot (e.g., 2). In some cases, scaffolding elements 1555 may be combined with one or more pinching cells (e.g., 150).
[0098] FIG. 16 illustrates a combination stentriever and microcatheter 1600 with an engagement structure 142 proximal to a rapid exchange port 129 according to aspects of the present disclosure.
[0099] The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the catheter 100 and methods for manufacturing and using the same. Additional modifications that are apparent to those having skill in the art to which this invention pertains and are intended to be within the scope of the claims which follow.
