The present application relates generally to clot retrieval devices, and specifically to combination stentriever and microcatheters.
Deflectable or steerable catheters are used in various medical and surgical procedures, including ablation, such as arrhythmia ablation, mapping, such as cardiac mapping, and drug delivery, such as intracardial drug delivery. The steerable function can be accomplished by three modes of actions: straight translational movement along the direction of the catheter length; deflection of an end or distal section in one direction or in one plane; and turning of the catheter shaft to direct the deflected end toward the desired point. A control wire or pull wire positioned inside the catheter, usually connecting to the distal end, is used to direct the degree of deflection of the distal section. The degree of pulling on the mechanism directs the movement of the control wire and thus the degree of deflection of the distal end of the catheter shaft.
In the related art, the control wire is included within the catheter is a substantially straight lumen path. Thus, deflection is generally within one plane, having only a curl or sweep profile. operably connected to some type of a pulling mechanism, which is connected to a control device at the proximal end of the catheter shaft. This type of defection creates an “S” shape between a sheath and the catheter where the deflection mechanisms are in opposing directions.
Thus, catheters capable of improved control of the distal tip and those capable of forming a loop of variable sizes are desired in the art.
A clot removal system is presented herein which includes a clot removal system for removing a clot from a body vessel, the clot removal system. The clot removal system includes: 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.
The microcatheter may be prevented from sliding proximal of the distal segment in a collapsed configuration.
The engagement structure may be configured to prevent the microcatheter from sliding proximal of the distal segment in a collapsed configuration.
The first diameter may be greater than the second diameter.
The hand control may include: a brace connected to the proximal end of the microcatheter; and a push-pull mechanism attached to the elongated member.
The push-pull mechanism may include a finger ring.
The hand control may include a lock to hold the engagement structure in a substantially fully retracted position.
The hand control may be single-handedly operable.
The microcatheter may further include 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 may be disposed within microcatheter proximal to the rapid exchange port.
The microcatheter may further include: 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.
The microcatheter may further include a rapid exchange port on an outer surface of the microcatheter. The elongated member may include a substantially hollow body extending through the engagement structure. The stentriever may further include 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.
The stentriever port may be proximal the rapid exchange port.
The stentriever may further include a nose cone on a distal end of the engagement structure.
The lumen may include: 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.
A diameter of the engagement structure in the expanded configuration may be greater than the third diameter such that the engagement structure cannot be fully retrieved within the distal shaft.
The microcatheter may further include: 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.
The microcatheter may further include: 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.
The hand control may be configured to control extending and retracting of the engagement structure from the distal end of the microcatheter.
The microcatheter may further include: 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. The engagement structure may be 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.
A distal end of the engagement structure may be attached to the microcatheter.
The engagement structure may include at least one scaffolding element to receive the clot and at least on pinching cell to pinch the clot.
The engagement structure may include: one or more pinching cells; and a shaped wire threaded through the one or more pinching cells.
The engagement structure may include a series of inner pinching cells and outer pinching cells.
The engagement structure may include: a structural thread; and a chain of pinching cells comprising a first end and a second end opposite each other, the first end and the second end of the chain being connected to the structural thread.
The engagement structure may include at least one stop configured to prevent full retraction of the engagement structure within the lumen after extension.
The at least one stop may prevent retraction of the engagement structure beyond a pinching configuration.
The hand control may further include a retrieval means to control withdrawing the at least one stop to enable full retraction of the engagement structure.
The clot removal system may further include: 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.
According to aspects of the present disclosure, there is provided A method for removing a clot, the method including: operating a hand control to withdraw a microcatheter and extend an engagement structure of a stentriever from the microcatheter.
The method may further include embedding at least a portion of the engagement structure with at least a portion of the clot; and removing at least a portion of the clot by withdrawing the microcatheter and stentriever.
The method may further include operating the hand control to at least partially retract the engagement structure within the microcatheter prior to withdrawing the microcatheter and stentriever.
The engagement structure may move from a collapsed configuration within the microcatheter to an expanded configuration when the microcatheter is withdrawn.
The engagement structure may be prevented from sliding proximal of a distal segment of the microcatheter in the collapsed configuration.
The microcatheter may include: a distal segment comprising a first diameter; and a proximal segment comprising a second diameter, the first diameter being greater than the second diameter.
The hand control may include: a brace connected to a proximal end of the microcatheter; and a push-pull mechanism attached to the stentriever.
The push-pull mechanism may include a finger ring.
The method may further include operating the hand control to unlock a lock of the hand control prior to withdrawing the microcatheter, the lock holding the engagement structure in a substantially fully retracted position.
The hand control may be operated single-handedly.
The microcatheter may include a rapid exchange port extending from an outer surface of the microcatheter to a lumen of the microcatheter, the rapid exchange port being dimensioned to receive a guidewire.
The microcatheter may include: 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 a distal end of the microcatheter.
The microcatheter may further include a rapid exchange port on an outer surface of the microcatheter.
The stentriever may include: a substantially hollow body extending through the engagement structure; and a stentriever port extending from through the hollow body, the rapid exchange port, hollow body, and stentriever port being dimensioned to receive a guidewire.
The stentriever port may be proximal the rapid exchange port in a fully-retracted configuration.
The stentriever may include a nose cone on a distal end of the engagement structure.
The stentriever may be positioned within a lumen of the microcatheter. The lumen may include: a distal shaft extending proximally from a distal end of the microcatheter, the distal shaft having a third diameter; and a proximal shaft extending distally from a proximal end of the microcatheter, the proximal shaft having a fourth diameter less than the third diameter.
A diameter of the engagement structure in an expanded configuration may be greater than the third diameter such that the engagement structure cannot be fully retrieved within the distal shaft.
The microcatheter may include: a proximal end; 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.
The microcatheter may include: a lumen; a proximal end; 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.
The engagement structure may include at least one scaffolding element to receive the clot and at least on pinching cell to pinch the clot.
The engagement structure may include: one or more pinching cells; and a shaped wire threaded through the one or more pinching cells.
The engagement structure may include a series of inner pinching cells and outer pinching cells.
The engagement structure may include: a structural thread; and a chain of pinching cells comprising a first end and a second end opposite each other, the first end and the second end of the chain being connected to the structural thread.
The engagement structure may include at least one stop configured to prevent full retraction of the engagement structure within the microcatheter after extension.
The at least one stop may prevent retraction of the engagement structure beyond a pinching configuration.
The hand control further include a retrieval means to control withdrawing the at least one stop to enable full retraction of the engagement structure.
The microcatheter may include: a distal end; and a first radioactive marker disposed on the distal end of the microcatheter. The stentriever may include a second radioactive marker disposed on a distal end of the engagement structure.
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:
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%.
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.
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.
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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.
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.
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.