US20230233218A1

US20230233218A1 - Catheter proximal joint

Info

Publication number: US20230233218A1
Application number: US18/125,901
Authority: US
Inventors: Karl KEATING; Ronald Kelly; David Vale
Original assignee: Neuravi Ltd
Current assignee: Neuravi Ltd
Priority date: 2020-03-05
Filing date: 2023-03-24
Publication date: 2023-07-27
Also published as: EP3875047C0; KR20210113565A; US11633198B2; JP2021137574A; EP3875047B1; CN113425369A; US20210275198A1; ES2999059T3; EP3875047A1

Abstract

An aspiration clot retrieval catheter to have profiled guidewire for deliverability that transitions at a proximal joint to a distal tubular section with a lumen for directing aspiration and facilitating the smooth passage of other products in performing mechanical thrombectomy procedures. The joint can have a low-profile proximal strut formed integrally with the distal tubular section and configured to interlock with a distal portion of the guidewire so that there is a smooth transition of stiffness between the guidewire and the tubular portion of the catheter to improve trackability and decrease the likelihood of kinking. The distal tubular section of the proximal joint can also have features to tailor flexibility. The distal tubular section can be configured to push radially outward to form a seal with an outer catheter to optimize aspiration transmission to the distal mouth of the aspiration clot retrieval catheter.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation application of U.S. Pat. Application No. 16/809,941 filed Mar. 5, 2020. The entire contents of which are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention generally relates proximal joints for linking a catheter body to a catheter guidewire. More specifically, the present invention relates to joints which provide a gradual stiffness change between the catheter body and guidewire.

BACKGROUND

Aspiration and clot retrieval catheters and devices are used in mechanical thrombectomy for endovascular intervention, often in cases where patients are suffering from conditions such as acute ischemic stroke (AIS), myocardial infarction (MI), and pulmonary embolism (PE). Accessing the neurovascular bed in particular is challenging with conventional technology, as the target vessels are small in diameter, remote relative to the site of insertion, and are highly tortuous. Traditional devices are often either too large in profile, lack the deliverability and flexibility needed to navigate tortuous vessels, or are not effective at removing a clot when delivered to the target site.
In delivering effective devices to the small and highly branched cerebral artery system, conventional catheters must try and balance a number of factors. The catheter must be sufficiently flexible to navigate the vasculature and endure high flexure strains, while also having the axial stiffness to offer smooth and consistent advancement along the route. Newer designs have been introduced which utilize various methods to alter the stiffness between the proximal and distal portions of the catheter. But abrupt stiffness or geometric changes can hinder trackability, introduce significant stress concentrations, and increase the likelihood of device kinking or buckling. This is especially true in regions where different portions of a catheter are manufactured separately and need to be joined securely by mechanical means. Such instances include when a guidewire or shaft for manipulability is connected to the tubular passageway of the catheter by a proximal joint.
Other designs for aspirating clot retrieval catheters have difficulty directing the full suction of aspiration to the volume of fluid and clot distal to the mouth. The suction must be strong enough such that any fragmentation that may occur as a result of aspiration or the use of a mechanical thrombectomy device can be held stationary so that fragments cannot migrate and occlude distal vessels. However, when aspirating with traditional catheters, such as a fixed-mouth catheter or a catheter which does not seal with an outer catheter, a significant portion of the aspiration flow ends up coming from vessel fluid proximal to the tip of the catheter, where there is no clot. This significantly reduces aspiration efficiency, lowering the success rate of clot removal.
Solutions, such as highly flexible catheter body designs, are often of a reduced diameter incapable of generating the required suction force. Improved aspiration designs, such as those with expandable members or separate suction extensions, typically lack the flexibility to navigate the neurovascular intact.
The present design is aimed at providing an improved proximal joint giving better performance characteristics to an aspirating retrieval catheter which addresses the above-stated deficiencies.

SUMMARY

It is an object of the present design to provide systems, devices, and methods to meet the above-stated needs. It is therefore desirable for an aspiration clot retrieval catheter with a proximal joint for transitioning from a profiled guidewire to a tubular support structure with a large lumen for aspiration and the passing of other devices for performing mechanical thrombectomy procedures. The transition joint can be low-profile and sufficiently flexible in multiple directions for deliverability to the target site, while providing a smooth transition in stiffness between catheter segments. The transition joint can include an outer seal that interacts with an outer catheter such that an aspiration source is connected to the proximal end of the outer catheter has a direct fluidic connection to the distal mouth of the aspiration clot retrieval catheter. The seal ensures there is little or no loss in negative pressure between the aspiration source and the mouth.
The transition can be a proximal joint for linking a catheter with a tubular body and a guidewire for manipulation. The proximal joint can have a distal tubular section defining an internal lumen therethrough and a proximal strut extending proximal to the distal tubular section. The distal tubular section can include one or more axial spines, a plurality of ribs along the one or more spines and disposed around a longitudinal axis, and a tapered opening. The internal lumen of the distal tubular section can be shared with the lumen of the tubular catheter body used for passing devices and directing aspiration. The proximal strut can be integral with and extend proximally from one of the one or more spines. The strut can be configured to overlap a distal portion of the guidewire to form a zone for mechanically locking the guidewire to the catheter body. At least a portion of the distal tubular section can be coated with a flexible and highly elastic polymeric cover which can be stretched to the contours of the tubular section and catheter body.
The distal tubular section can be formed integrally with the catheter body and help support the outer cover or membrane. For example, the structures could be cut from a single hypotube. Alternately, the tubular section could be a braided or coiled structure of sufficient density to support the cover. At least a portion of the tubular section of the proximal joint can be of a diameter larger than the diameter of the catheter body and sized to seal with an outer catheter such that aspiration is directed to the distal tip of the aspirating clot retrieval catheter. The ribs of the distal tubular section could be cut to this larger diameter, or they could be enlarged through plastic deformation. If constructed of a shape memory alloy, the tubular section could include a longitudinal slot or slots, and/or the ribs could be machined at an acute angle to the longitudinal axis such that they could be heat set to a larger diameter prior to applying the outer polymer cover or jacket. To further increase the flexibility of the tubular section, the perimeter of the tapered opening could have notches or cutouts to make the region more compliant in bending.
The guidewire can have a flattened or rounded distal end depending on the desired interface at the proximal joint of the catheter. The guidewire can be formed with features that interlock with features of the proximal strut of the catheter tubular support section such that the features form a mechanical constraint between the support structure and the guidewire. For example, locking arms could extend laterally away from the central proximal strut and could be configured to engage corresponding notches in the guidewire shaft within the locking zone. In another example, one or more pins could extend radially from the proximal strut and be configured to engage with thru holes or pockets in the locking zone of the guidewire shaft. The pins and pockets could also be divided between the proximal strut and guidewire and spaced for a smooth stiffness transition through the locking zone. These features deliver thrust from the user while preventing longitudinal translation between the guidewire and the proximal strut.
Heat-shrink, reflowed polymers, and/or adhesives can be used to reinforce the connection between the guidewire and tubular support section. The reinforcement can prevent a disengagement of the mechanical lock between the guidewire and catheter body. One or more polymer jacket could extend through at least a portion of the locking zone or could extend the entire length of the guidewire. The jacket or jackets could be made from a low-friction material and the edges could be tapered to be flush with the proximal strut and guidewire surfaces such that auxiliary devices used in the procedure are not snagged at the interface. Multiple jackets of differing stiffnesses could be used at different longitudinal sections of the guidewire and locking zone.
In another example, a proximal joint for connecting a guidewire to a catheter body can include a tubular support structure formed integrally with and proximal to the catheter body and a proximal strut extending proximal to the support structure and configured to mate with a distal portion of the guidewire. The tubular support structure can have a maximum radial size larger than a maximum radial size of the catheter body and sized to seal with the inner diameter of an outer delivery catheter. The support structure can be fabricated at the maximum radial size or it can be deformed to flare radially outward. Alternatively, a separate seal component can be provided with the joint which expands or swells to direct aspiration to the distal tip of the clot retrieval catheter and isolate fluid proximal of the seal component. In another embodiment, a highly flexible proximal joint can be positioned over a proximal section of the distal luminal catheter body and may include mechanical lock features similar to those disclosed between the guidewire and proximal joint. By mating a highly flexible section of the tubular section of the proximal joint with a highly flexible proximal section of the distal luminal catheter body, impact to the overall stiffness can be minimized.
A cover can be disposed around at least part of the support structure and can extend distally to enclose the catheter body. The tubular support structure can have one or more axial spines and a series of loop ribs to support the cover and define a hollow internal lumen for the catheter. The lumen can be coated with a low-friction liner to facilitate the passage of ancillary devices through the catheter. The cover could be reflowed, adhered, and/or stitched to the loop ribs of the support structure. The cover could further be coated with a low-friction film to improve trackability and mitigate the risk of binding when delivered through an outer catheter.
The proximal strut can be aligned with one of the one or more axial spines extending longitudinally down the support structure. The proximal strut can have locking arms that can extend laterally from the strut and bend to engage with notches machined into the distal end of a flattened guidewire. In another example, the proximal strut can have a concave face for receiving a guidewire with a rounded cylindrical distal end. A reinforcing polymer sleeve can be disposed around at least a length of the proximal strut and a length of the guidewire to bolster the joint and dampen the stiffness transition between the guidewire and support structure as well as provide a smooth profile for unhindered passage of ancillary devices.
Additionally, a clot retrieval catheter for capturing an occlusive thrombus can have a tubular suction section, a guidewire, and a proximal joint for securing the tubular suction section to the guidewire. The proximal joint of the catheter can include a distal tubular structure, a proximal strut extending in a proximal direction from the tubular structure, and a polymeric jacket bonding and securing a length of the proximal strut to a length of the guidewire. The proximal strut can be formed integrally with the distal tubular structure such that there is no abrupt stuffiness change or geometric stress concentration. The proximal joint can include features configured for mechanically securing the proximal strut and a distal portion of the guidewire, or the polymer jacket can be used to fix the position of and bond overlapped sections of the proximal strut and guidewire. This bond can allow thrust and torque applied to the guidewire by the user to be transmitted to the distal tubular section of the proximal joint and the distal luminal portion of the catheter body.
Where a polymer jacket is used, the jacket can be applied over just the overlapping portion of the proximal strut and guidewire or could continue proximally a further length of the guidewire. A low-friction coating can be applied to the jacket and/or guidewire, or lubricious particles can be impregnated within the jacket for easier navigation within an outer catheter.
The distal tubular structure can include a tapered opening at the proximal end, one or more axial spines along the longitudinal axis. A plurality of loop ribs can extend around the longitudinal axis from the one or more spines and define a hollow inner lumen for the distal tubular structure. The distal tubular structure and the catheter body tubular section can be formed integrally, such as when machined from a hypotube or with one or a series of cylindrical braids, such that the hollow inner lumen can be shared between the segments. When constructed in this fashion the magnitude of the stiffness transition between the distal tubular structure and the catheter body tubular section can be mitigated.
The distal tubular structure can be formed with features that allow some or all of the structure to be enlarged through permanent plastic deformation or a heat set. These features allow the enlarged region to have a greater diameter than the distal tubular catheter body. An enlarged region can expedite the passage of thrombectomy devices and/or can form a seal with an outer delivery catheter for the efficient direction of suction to the distal tip of the clot retrieval catheter. This sealed configuration takes advantage of the large proximal lumen of the outer catheter to enhance aspiration through the clot retrieval catheter.
For example, an enlarged section could be formed from one or more longitudinal slots incorporated into the distal tubular structure such that the ribs adjacent to the slot are not constrained tangentially so they can be deformed, or heat set to a larger radial size. As an alternative, the ribs of the distal tubular section could be formed or machined from a shape memory alloy at an angle less than 90 degrees to the longitudinal axis. These ribs could subsequently be heat set to an angle largely perpendicular to the longitudinal axis to achieve an enlarged section of the distal tubular structure. In a further example, the distal tubular section could effectively be enlarged through a hydrogel coating which swells in an isotropic fashion with hydration to achieve a seal with the outer delivery catheter.
If a complete seal is not desired, a flow restrictor can be used between the outer catheter and the clot retrieval catheter. The flow restrictor could have bristles, a dense framework, or some other form which could inhibit flow. The flow restrictor can be located on the outer surface of the distal tubular structure of the clot retrieval catheter.
The clot retrieval catheter can further have an expanding distal tip which can provide a larger opening into which a clot retrieval device and a captured thrombus can be withdrawn, lessening the risk of the tip shearing or dislodging the thrombus or fragments of the thrombus from the retrieval device and also providing a gradual compression of clot as the clot is drawn into the mouth of the clot retrieval catheter through aspiration, use of a retrieval device, or through a combination of aspiration and use of a retrieval device. Fragmentation can occur with catheters having a distal mouth with a cross-section smaller than that of the thrombus itself or if the clot enters the mouth of the catheter at an offset position.
Other aspects and features of the present disclosure will become apparent to those of ordinary skill in the art, upon reviewing the following detailed description in conjunction with the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

The above and further aspects of this invention are further discussed with the following description of 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 combining elements from multiple figures to better suit the needs of the user.

FIG. 1 is an isometric view of a proximal joint for an aspiration clot retrieval catheter according to aspects of the present invention;

FIGS. 2A-2B show an example locking mechanism for the proximal strut and guidewire using locking arms, according to aspects of the present invention;

FIG. 3 shows the proximal joint with the engagement of the proximal strut and guidewire using the locking mechanism of FIGS. 2A-2B, according to aspects of the present invention;

FIG. 4 shows another example locking mechanism for the proximal strut and guidewire using locking pins, according to aspects of the present invention;

FIG. 5A illustrates a polymer jacket applied over the locking zone of the proximal joint according to aspects of the present invention;

FIG. 5B illustrates a polymer jacket with tapered ends applied over the locking zone of the proximal joint according to aspects of the present invention;

FIG. 6A is a view of a proximal joint having two spines and an enlarged tubular section according to aspects of the present invention;

FIG. 6B is a cross-section view of FIG. 6A according to aspects of the present invention;

FIG. 6C is a cross-section view of FIG. 6B showing the radial transition between the enlarged tubular section and the catheter body according to aspects of the present invention;

FIG. 7A shows an alternative proximal joint with an enlarged tubular section according to aspects of the present invention;

FIG. 7B is a cross-section view of FIG. 7A according to aspects of the present invention;

FIG. 8 shows a proximal joint with an enlarged tubular section within an outer catheter according to aspects of the present invention;

FIG. 9A illustrates a proximal joint where the guidewire in the locking zone has a flattened, rectangular profile according to aspects of the present invention;

FIG. 9B illustrates a proximal joint where the guidewire in the locking zone has a rounded, cylindrical profile according to aspects of the present invention;

FIG. 10 is an overall view of a catheter with a flexible polymeric cover disposed around an expansile tip, a tubular body, and a portion of the proximal joint according to aspects of the present invention;

FIG. 11A is a top view of a proximal joint where a reinforcing polymer jacket covers a length of the catheter guidewire and locking zone, according to aspects of the present invention; and

FIG. 11B shows a side view of the proximal joint of FIG. 11A according to aspects of the present invention.

DETAILED DESCRIPTION

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 offer many improvements over traditional catheters, such as excellent thrust response through a profiled guidewire, characteristics to tailor the stiffness of different catheter segments through a proximal joint, and a smooth transition in stiffness between the guidewire segment and the distal tubular body of the catheter. In the case of stroke intervention procedures, where vessels in the neurovascular bed are small and very tortuous, combining a tailored stiffness profile with smooth transitions inhibits kinking and binding while offering distinct deliverability advantages. These improvements can lead to safe and more rapid access of a catheter and other devices to complex areas of the intercranial arteries to remove occlusions and shorten procedure times.
Accessing the various vessels within the vasculature, 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, rotating hemostasis valves, and guidewires are widely used in laboratory and medical procedures. When these or similar products are employed in conjunction with the system and methods of this invention in the description below, their function and exact constitution are not described in detail.
Referring to the figures, in FIG. 1 there is illustrated a proximal joint 100 for connecting a body and a guidewire of an aspirating clot retrieval catheter according to this invention. The proximal joint can have a distal tubular section 210 which can include a plurality of loop ribs 216 disposed along one or more axial spines 220 and defining a longitudinal axis 111. The distal tubular section can taper proximally to form a tapered opening 212 which can serve as an entrance through which other treatment devices, such as a microcatheter and stentriever, can access the lumen 218 (shown in FIG. 6A) of the tubular section. The axially tapering profile of the opening relative to the longitudinal axis, as shown in the figure, can help to facilitate the introduction of these devices to the intralumenal section of the catheter. Alternatively, an opening at a right angle can be used if desired. The opening 212 can have notches or breaks 214 cut into the perimeter to reduce the bending stiffness of the opening as it transitions to one of the axial spines 220 to a tubular profile.
The terms distal tubular section, tubular support structure, and distal tubular structure as used herein are intended to refer to the same structure and are used interchangeably. It can be appreciated that other appropriate verbiage could also be substituted.
The proximal joint 100 can have an axial member which extends proximally from the distal tubular section 210 where the tapered opening 212 transitions away from the suction body of the catheter. The member can be a proximal strut 110 designed to provide an interface with which to link a pushable guidewire 30 (shown in FIG. 2B) to the catheter. In one example, the strut member can be a cylindrical or rectangular strut which can form a continuous extension from one of the axial spines 220 of the distal tubular section. In another example, the strut can be a flat wire or coil which is embedded into a polymeric anchor of the distal tubular section. The wall of the tubular section could be formed with a thicker section along one edge of the circumference to serve as the anchor and reinforce the interface.
The loop ribs 216 and the one or more axial spines 220 of the distal tubular section 210 could be formed from laser-cutting a hypotube or similar tube stock. Commonly used hypotube materials include Nitinol and familiar medical-grade stainless-steel alloys like 304 and 316. In one example, the distal tubular section is formed integrally with the proximal strut 110 and the tubular luminal body of the catheter. This configuration allows for one of the one or more axial spines 220 to continue proximal of the tapered opening 212 as a continuous proximal strut 110 member. A continuous spine and proximal strut combination could yield excellent pushability characteristics while maintaining a gentler bending stiffness transition between the proximal strut and the distal tubular section.
Tailoring of the stiffness and changes in stiffness for the catheter is important for situations where the distances and tortuosity can be significant, such as when it must be advanced from a patient’s inner thigh, over the cardiac arch, and up into the neurovascular vessels inside the skull. Adjusting the cuts in a hypotube which form the loop ribs 216 and axial spines 220 of the distal tubular section 210 can be used to tailor this stiffness. For example, the ribs can be cut to various widths and spacing density. The cuts could be circumferentially continuous and terminate on either side of an axial spine 220, or the cuts could be discontinuous in a repeating or non-repeating pattern around the circumference of the tubular section. If discontinuous cuts are aligned axially, they can form one or more additional axial spines 220 to bias bending and flexing planes of the catheter. As a further example, if circumferentially discontinuous cuts are mixed and aligned with circumferentially continuous cuts, as shown in FIG. 1 , they can form a discontinuous axial spine.
The axial spine or spines 220 themselves could be formed or cut at various thicknesses. A thicker spine could provide more column strength and axial stiffness for better kink resistance and insertion and retraction performance of the catheter. Conversely, a spine of a thinner thickness could provide more flexibility in bending for navigating tortuous areas of the vasculature. The spine or spines could also taper in thickness along the length of its axis in order to incorporate both of these advantages. A tapered spine or spines could be made`s stiffer proximally for good pushability characteristics and very flexible distally to allow the tubular section to contort and twist around the vessel paths.
In another example, the distal tubular section 210 of the proximal joint 100 can have a metal and/or polymer strand construction formed into a braided or coiled structure. The strands can form a radial array as a continuous structure with the tubular catheter body in order to approximate a singular support piece, similar to that of a laser-cut hypotube. The strands of the distal tubular section can be formed on a straight mandrel so that they flare radially outward to form a seal with the inner diameter of an outer or intermediate catheter. Instead of a seal, the strands form a braided or coiled structure of sufficient density that fluid flow is substantially impeded between the exterior and interior of the tubular section, such that a perfect seal is not necessary.
The proximal strut 110 can be formed with features that grip features of the catheter guidewire 30 such that the features form a mechanical lock between the support structure and the guidewire. The features can be chosen such that they prevent axial translation but do not inhibit the joint from bending or twisting about the longitudinal axis 111. For example, lateral material extensions can flank the proximal strut to form locking arms 114. The locking arms can be laser-cut such that they are integral with the proximal strut and radially perpendicular to the axis as shown in FIG. 2A. When the proximal joint is assembled, the locking arms can be heat set or plastically deformed to a position radially inward in order to engage with complimentary notches 32 or slots machined into the surfaces near the distal end 36 of the guidewire 30, as illustrated in FIG. 2B.
The guidewire 30 itself can have any of a number of reasonable cross-sectional profiles which can be different for different axial lengths of the guidewire. The guidewire can taper to a smaller profile or circumference at the distal end 36 of the guidewire, such that when joined with the proximal strut 110 or mating member of the proximal joint the sections share a composite stiffness more approximate that of wider proximal sections of the guidewire.
In general, the guidewire 30 can be a solid wire, braid, coil, or the like that provides for the smooth transmission of thrust and retraction forces to the distal tubular section 210 of the proximal joint 100 of the catheter, allowing the catheter to move with the tubular section relative to an outer catheter (not illustrated) in the assembled clot retrieval system. The guidewire can have a length longer than that of an outer catheter so that the proximal end of the guidewire extends from the proximal end of the outer catheter. The guidewire can be constructed of a high-modulus polymer, or any of a range of biocompatible metallic options such as titanium, Nitinol, or stainless-steel alloys as long as they have sufficient proportions of flexibility and column stiffness necessary to navigate requisite areas of the vasculature.
The significant change in geometry between the low-profile guidewire 30 and the elongate tubular section of the catheter can lead to substantial bending strains and/or stresses where the transition takes place. Independently, the proximal strut 110 of the proximal joint 100 and the portion of the guidewire 30 approximate the guidewire distal end 36 both resemble cantilever beams. To create a more gradual stiffness transition between the guidewire and proximal joint, a section of the guidewire can overlap longitudinally with a section of the proximal strut as illustrated in FIG. 3 . This overlap can define a locking zone 116 designating an engagement length over which the joint becomes a composite beam. The locking arms 114 or other geometric features of the proximal strut can then engage to secure the interface.
Another design for mechanically locking the proximal joint can be seen in FIG. 4 . In this example, the guidewire utilizes cylindrical locking pins 120 extending radially within the locking zone 116 near the distal end 36 of the guidewire 30. The locking pins can be configured for insertion into corresponding locking pockets 122 recessed into the proximal strut 110. The joint could be made more secure by having the locking pins and locking pockets interface as a snap fit or interference fit. Alternately, the pins could be machined as extensions of the proximal strut. Rounded pins can reduce the stress concentrations inherent at geometric corners and provide a proximal joint interface with additional torque carrying capacity.
It should be noted that the examples of the proximal joint locking systems shown and described herein are a small number of available designs, and one of skill in the art will recognize that many other configurations are possible beyond what is explicitly described.
FIG. 5A shows an example of a proximal joint where a polymer jacket 118 has been heat-shrunk or reflowed over the length of the locking zone 116 to reinforce the mechanical joint between the proximal strut 110 and the catheter guidewire 30. The polymer jacket 118 can further blend the geometric transition at the proximal and distal ends of the locking zone 116. The polymer jacket 118 can extend proximally along the guidewire beyond the edge of the locking zone and distally to the very proximal face of the enlarged tapered opening of the tubular section to completely bond and reinforce the joint assembly. As illustrated in FIG. 5B, the edges of the polymer jacket 118 can be made flush with the corresponding surfaces of guidewire and proximal strut so that there are no lips or corners of the locking zone interface or jacket which could otherwise snag or inhibit ancillary devices as they are delivered through the clot retrieval catheter.
In an alternative example, the guidewire 30 or the proximal strut 110 could be shaped to fit inside a hollow housing of the opposite number and a press-fit or adhering element used to secure the mating surfaces. A polymer jacket 118 could then be reflowed over the locking zone 116 to form a more continuous external profile. Additionally, adhesives could also be used with or without polymer jackets to constrain and/or fortify the proximal joint between the catheter
The interface of the guidewire 30 with the proximal strut 110 of the proximal joint 100 can serve the purpose of both securing the components together while also developing into the shape of the tapered opening 212 of the distal tubular section 210. Similar to other examples, the tapered opening 212 can have notches or breaks 214 machined into the perimeter to reduce the bending stiffness at the opening. The exterior of the distal tubular section 210 can be sized to form a desired interface between the aspirating clot retrieval catheter and an outer or intermediate catheter. The distal tubular section 210 can form a seal with the inner surface of the outer catheter, such that an aspiration source connected to the proximal end of the outer catheter has a direct connection to the distal mouth of the aspirating clot retrieval catheter with little or no negative pressure loss between the source and the mouth.
One example of a proximal joint 100 for an aspirating clot retrieval catheter that is capable of sealing with an outer catheter is shown in FIGS. 6A-6C. The distal tubular section 210 of the proximal joint can still be formed integrally with the tubular catheter body 40 (shown in FIG. 6B), such as when both are cut from the same hypotube or formed from a continuous coiled structure. The proximal strut can also be cut as a continuous extension of one of the catheter axial spines 220. The catheter body can have multiple designs, or be cut in different sections, to control the stiffness profile along the length of the body to minimize insertion and retraction forces of the catheter. Features can also be incorporated which bias bending about certain planes or encourage twisting to reduce the imparted strains. In this way the catheter will maintain excellent lateral flexibility but will not tend to expand or kink in compression.
A cross-sectional view from FIG. 6A through a part of the tubular section of the catheter is illustrated in FIG. 6B. The distal tubular section 210 can generally be distinguishable from the catheter body 40 by having an outer diameter 224 larger than the outer diameter 222 of the catheter body extending downstream along the catheter spine or axial spines 220. The example illustrated in FIG. 6A has two axial spines spaced 180 degrees apart. Use of a double spine yields good thrust and trackability characteristics to aid in advancing the catheter to the target location, while reducing the possibility of elongation under tensile loads, such as when a large clot is retracted into the mouth of an expandable tip at the distal end of the catheter or an outer catheter. Spacing the spines 180 degrees apart also biases the catheter body and tubular section to flex about a single plane in order to transmit a more balanced push force to the catheter. The created bending plane passes through the spines of the dual spine layout of FIG. 6B. The stepped profile of a spine at the transition between the catheter body 40 and the enlarged outer diameter of the proximal joint tubular section 210 is illustrated in cross-section in FIG. 6C.
FIG. 7A illustrates a further example of a proximal joint 100 formed integrally with the tubular catheter body 40 where both structures are cut from the same hypotube. Similar to FIG. 6A, the adjacent catheter body 40 can have a stepped down diameter from that of the distal tubular section 210 of the proximal joint. In these examples, the enlarged tubular section can be formed in multiple ways. In one case, the loop ribs 216 of the tubular section can be machined at an angle less than 90 degrees to the longitudinal axis so that the ribs can be heat set to an angle approximately perpendicular to the axis to achieve the enlarged distal tubular section 210 proximal to the catheter body 40. Alternately, the machined pattern of the distal tubular section 210 can include one or more longitudinal slots 226 so that the ribs are not constrained tangentially around the circumference. The ribs can then be reset or deformed to a position radially outward of the more distal portion of the catheter body to achieve an enlarged diameter.
The longitudinal slot or slots 226 could be machined such that they are aligned with or offset from any of the one or more axial spines 220. If aligned, one or more of the spines could be discontinuous at the transition interface between the enlarged distal tubular section 210 and the catheter body 40, as seen in the top view of FIG. 7A and in FIG. 7B. A discontinuous spine can help the catheter proximal joint further transition the bending stiffness between the downstream catheter body and the connection between proximal strut 110 and the catheter guidewire.
Alternately, the distal tubular section 210 can taper gradually inward from the maximum radial size 224 to assume the outer diameter 222 of the catheter body 40. The catheter body in these examples can be balanced to transmit a substantial suction force while being capable of further reach into more distant and narrow neurological vessels. The diameter of the catheter body shown in FIGS. 7A and 7B could also be an intermediate diameter, where the catheter body is formed from further tubular sections which step down to a progressively smaller size, giving enhanced bending flexibility to distal regions of the body. The distal end of the catheter body could have an expandable member to recover a large distal mouth for aspirating a clot.
The interface between the outer diameter of the enlarged distal tubular section 210 of the proximal joint 100 and the inner diameter of a section of the outer catheter 50 can be seen in FIG. 8 . When the catheter has been longitudinally positioned for the procedure, this junction can reduce or eliminate any flow between the surfaces so that essentially all of the suction flow passes through the shared lumen 218 of the tubular section and catheter body 40 to the distal tip of the clot retrieval catheter. The enlarged distal tubular section 210 can be positioned by the user at a desired axial location of the outer catheter such that an adequate seal and functionality are obtained.
A seal 52 between the proximal joint 100 and the outer catheter 50 can be created in several ways. The distal tubular section 210 can be enlarged to extend radially outward to generate a circumferential sealing surface with the inner wall of the outer catheter 50. The ribs or the distal tubular section 210 can be cut or heat set to a larger diameter prior to applying an outer polymer jacket. Slots or strain relief features machined into the cut pattern of the tubular section can also be used to create a geometry that will deform or be effectively spring-loaded to a larger outer diameter. As an alternative, the outer jacket or membrane could be formed with a soft elastomeric rib disposed around the distal tubular section 210. The maximum radial dimensions can thus be designed to interface with commonly sized commercial outer catheters such that a seal is developed at the contact surface.
Alternatively, a portion of the distal tubular portion 210 of the proximal joint 100 can be enlarged through coating with a hydrogel that swells with hydration in order to achieve a seal with the inner surface of the outer catheter 50. Hydrogels offer the advantages of biocompatibility, relative tackiness as an adhesive, and flexibility enough to accommodate comparative motion of the joint while maintaining molecular stability when swelled.
Proximal to a seal, the shape and profile of the overlap and the contact surface developed within the locking zone 116 of the proximal joint 100 can be tailored for both the guidewire 30 and the proximal strut 110 to eliminate stiff transitions inherent with assembly of multiple parts. Components which overlap can form weak transitions which are prone to buckling or kinking when butted together. A smoother contact profile between mating parts is typically desirable, so in the illustrated example of FIG. 9A the guidewire transitions from a cylindrical profile to a flattened wire profile near the distal end 36 in order align with the proximal strut extending from an axial spine 220 of the laser-cut portion of distal tubular support section 210. In a different example, the catheter guidewire within the locking zone can maintain the substantially cylindrical structure of FIG. 9B up to the distal end 36. The corresponding mating surface of the proximal strut within the locking zone can have a face which forms an extended concave arc with a matching radius of curvature.
The axial length of the locking zone 116 and the type of mechanical locking joint used will also determine the final bending stiffness properties of the proximal joint. It can be appreciated that longer locking zones allow more material to carry the bending load and thus a more gradual change in stiffness while reducing the bend radius capacity of the joint.
A construction view for a suitable aspirating clot retrieval catheter 35 for thrombectomy procedures with aspects of the current design is illustrated in FIG. 10 . The catheter can comprise an expandable tip 42 with a collapsed delivery configuration and expanded deployed configuration at the distal end. The tip can seal with the walls of an occluded vessel when expanded to direct efficient aspiration. A proximal joint 100 with a distal tubular section 210 can transition an elongate suction catheter body 40 to a guidewire 30 serving as a control element for the catheter. In some cases, the overall length of the guidewire 30 can be substantially greater than the length of the tubular catheter body 40 such that the column strength of the guidewire offers excellent pushability characteristics over the majority of the insertion length. The proximal joint 100 manages the transition between these lengths to mitigate the likelihood of binding or kinking at this interface in the complex anatomy of the neurovasculature.
An outer liner or cover 228 can be disposed around at least a portion of the expandable tip 42, catheter body 40, and the distal tubular section 210 of the proximal joint 100. The cover can be a membrane constructed of a highly elastic material, such as a low-modulus elastomer, so that it stretches as the tip expands and can follow the contours of the underlying framework of the catheter. The cover can run the entire length of the catheter body and tubular section or it can terminate at or some distance distal to the tapered opening 212.
The exact composition and structure of the cover 228 can be configured depending on the needs of the procedure. The cover can be used for creating the seal with an outer catheter, or it can be used to provide a lubricious surface for limiting the transmission forces needed to deliver and deploy the catheter 35. The cover could also be used to adjust the desired stiffness qualities of differing axial portions of the catheter.
If the support framework of the catheter body 40 and distal tubular section 210 is cut from a hypotube, spaces, slots, or patterns can be laser-cut into the outer surface of the hypotube and the cover 228 could be reflowed or injection molded into the spaces during manufacturing. The cover could be adhered to the struts and ribs using heat and/or adhesive. The spines and ribs of the support structure could also be embedded or encapsulated in a polymeric tube. The tube could be embedded with reinforcing metallic elements or particles with low-friction characteristics to reduce the static and dynamic coefficients of friction for the outer surfaces. A low-friction liner, such as a fluoropolymer, can also extend through the lumen 218 around the inner diameter of the distal tubular section 210 and the connecting section of the catheter body 40 to facilitate the feeding of other devices through the aspirating clot retrieval catheter.
Alternatively, the cover 228 could also be a formed from a series of polymer jackets. Different jackets or sets of jackets could be configured in an axial series to transition the overall stiffness of the catheter from being stiffer at the proximal end to extremely flexible at the distal end. Alternately, the polymer jackets of the cover could be radially disposed about the support tube in order to tailor the material properties through the thickness. The expandable tip 42 could have the same or a separate jacket or jackets that can be dip coated and can butt against or extend to be situated under or over the jackets of the support tube.
FIG. 11A and FIG. 11B show top and side views of the proximal joint 100 from the catheter 35 of FIG. 10 . The polymeric membrane cover 228 can be disposed around the distal catheter body 40, but the cover can also enclose all, some, or none of the tubular section 210 of the proximal joint 100. If the membrane is to enclose only a part of the tubular section, the membrane proximal edge could cease just distal of the tapered opening 212. The membrane could be reflowed into place as a sleeve, or alternately a dip coating procedure could be used to form the cover. Similar to a reflowed cover, a dip coat could cease just distal of the tapered opening for ease of manufacture, thereby covering only the cylindrical section of the tubular section. In another example the entire proximal joint could be dip coated and the tapered opening trimmed from the resulting membrane. The properties of the membrane could be tuned by adjusting the controlled immersion factors of the dip coating process. For instance, where the membrane is not needed as part of a seal with the outer catheter, the cover can end distal of the distal tubular section 210 and does not stretch to the increased maximum radial size 224 of the tubular section.
In some examples the reinforcing polymer jacket 118 buttressing the proximal joint 100 in the locking zone 116 can extend the full length of the catheter guidewire 30. A longer jacket could further distribute the stiffness changes in the locking zone over a more substantial length. Similar to the cover 228 on the distal tubular section 210 of the catheter and catheter body 40, the polymer jacket 118 could also comprise a series of jackets having different moduli or thicknesses.
For some acute stroke conditions or embolic events, the therapy for retrieving an occlusion using aspiration alone is not possible. In situations where mechanical engagement of the occlusion is necessary, it can be desirable for the lumen 218 of the aspirating clot retrieval catheter to serve as a conduit for delivering a microcatheter and a thrombectomy clot retrieval device to a target occlusion. The clot retrieval device can be any of a number of commercially available products, many of which share similar common features. The expanded radial size 224 of the distal tubular section 210 of the proximal joint 100 still provides a seal with an outer catheter so that a suction source, such as a syringe or pump, can be applied to the outer catheter and transferred through to the tip of the clot retrieval catheter. The protective seal prevents the distal migration of any liberated clot debris from the thrombectomy procedure while also focusing the aspiration suction distally and restricting fluid proximal of the tip from being drawn into the catheter.
The invention is not limited to the examples described, which can be varied in construction and detail. The invention contemplates substitutions of component parts illustrated herein with other well-known and commercially available products. To those having ordinary skill in the art, these modifications are often apparent and are intended to be within the scope of the claims which follow.
The terms “distal” and “proximal” are used throughout the preceding description and are meant to refer to 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 to or a direction towards the physician. Furthermore, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
In describing example embodiments, terminology is resorted to for the sake of clarity. 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. 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. While particular examples of the present invention are described, various modifications to devices and methods can be made without departing from the scope and spirit of the invention. Similarly, it is also to be understood that the mention of one or more components in a device or system does not preclude the presence of additional components or intervening components between those components expressly identified.
By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

Claims

1. A proximal joint for linking a catheter body and a catheter guidewire, the proximal joint comprising:

a distal end of the catheter guidewire, the distal end terminating at the proximal joint;

a proximal end of a distal tubular section, the distal tubular section comprising:

one or more axial spines;

a tapered opening at the proximal end;

an open distal end;

a longitudinal axis; and

a plurality of ribs defining a hollow internal lumen shared with the catheter body;and

a proximal strut extending proximal to the distal tubular section from the one or more axial spines, the proximal strut formed integrally with the one or more axial spines;

wherein at least a portion of the proximal strut and a portion of the catheter guidewire are configured to overlap to form a locking zone;

wherein the catheter body and distal tubular section are distal to the catheter guidewire, and

wherein at least a portion of the distal tubular section is coated with a polymeric cover.

2. The proximal joint of claim 1, wherein at least a portion of the distal tubular section has a diameter larger than a diameter of the catheter body.

3. The proximal joint of claim 1, wherein the distal tubular section is formed integrally with the catheter body.

4. The proximal joint of claim 1, wherein the distal tubular section is cut from a hypotube.

5. The proximal joint of claim 1, wherein a perimeter of the tapered opening comprises one or more circumferential notches.

6. The proximal joint of claim 1, wherein one or more locking arms extend laterally from the proximal strut within the locking zone;

wherein the one or more locking arms are configured to engage with one or more notches in the catheter guidewire within the locking zone.

7. The proximal joint of claim 1, wherein one or more locking pins extend radially from the catheter guidewire within the locking zone;

wherein the one or more locking pins are configured to engage with one or more pockets in the proximal strut within the locking zone.

8. The proximal joint of claim 1, wherein at least a portion of the locking zone is covered by a reinforcing polymer jacket.

9. The proximal joint of claim 8, wherein a proximal end and a distal end of the reinforcing polymer jacket are tapered to be flush with surfaces of the proximal strut and catheter guidewire.

10. A proximal joint for connecting a catheter body and a catheter guidewire, the proximal joint comprising:

a proximal end of a tubular support structure, the tubular support structure having a proximal end, a distal end, and one or more axial spines, the tubular support structure formed integrally with the catheter body and having a maximum radial size larger than a maximum radial size of the catheter body; and

a proximal strut extending proximal to the tubular support structure and configured to mate with a distal portion of the catheter guidewire, the proximal strut formed integrally with the one or more axial spines;

wherein a reinforcing polymeric sleeve is disposed around a length of the proximal strut and a length of the catheter guidewire,

wherein the catheter body and tubular support structure are distal to the catheter guidewire, and

wherein the proximal end of the tubular support structure comprises a tapered opening, and the distal end comprises an open end.

11. The proximal joint of claim 10, wherein the tubular support structure comprises a plurality of loop ribs defining a hollow inner lumen shared with the catheter body.

12. The proximal joint of claim 10, wherein at least a portion of the distal end of the tubular section has a diameter larger than a diameter of the catheter body.

13. The proximal joint of claim 10, wherein one or more locking arms extend laterally from the proximal strut, wherein the one or more locking arms are configured to engage with one or more notches in the catheter guidewire.

14. The proximal joint of claim 10, wherein a cover is disposed around at least a portion of the tubular support structure.

15. The proximal joint of claim 14, wherein the cover is adhered and/or stitched to the tubular support structure.

16. The proximal joint of claim 10, wherein at least a portion of the tubular support structure is coated with a lubricious low-friction coating.

17. A proximal joint for a clot retrieval catheter comprising a tubular section and a guidewire, the proximal joint comprising:

a proximal end of a distal tubular structure, the distal tubular structure comprising:

a tapered opening at a proximal end of the distal tubular section,

an open distal end,

one or more axial spines, and

a plurality of loop ribs defining a hollow inner lumen shared with the clot retrieval catheter,

the distal tubular structure extending proximally from the tubular section of the clot retrieval catheter; and

a proximal strut extending proximal to one of the one or more axial spines of the distal tubular structure and configured to form a mechanical lock with a distal portion of the catheter guidewire, the proximal strut formed integrally with the one or more axial spines;

wherein a polymeric jacket bonds a length of the proximal strut and a length of the catheter guidewire, and

wherein the clot retrieval catheter and the distal tubular structure are distal to the catheter guidewire.

18. The proximal joint of claim 17, wherein at least a portion of the distal tubular structure is coated with a hydrogel.

19. The proximal joint of claim 17, wherein the tapered opening of the distal tubular structure contains one or more longitudinal slots.

20. The proximal joint of claim 17, wherein the distal tubular structure has a maximum radial size larger than a maximum radial size of the catheter body.