Thrombus removal assembly systems and methods including distal tip assembly for pressurized fluid delivery

Abstract

The present technology relates to methods, systems and apparatuses for cryo-swaging in thrombus device removal device assembly. In some embodiments, the present technology is directed to a medical device having: a catheter shaft; a distal shaft portion; and a distal end comprising a shape memory material that is friction-fit to the distal shaft portion. In other embodiments, the present technology is directed to systems including a thrombus removal device. Other embodiments are disclosed herein.

Description

THROMBUS REMOVAL ASSEMBLY SYSTEMS AND METHODS INCLUDING DISTAL TIP ASSEMBLY FOR PRESSURIZED FLUID DELIVERYPRIORITY CLAIM

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 63 / 581,205, titled “SYSTEMS, METHODS, AND APPARATUSES FOR CRYOSWAGING IN THROMBUS REMOVAL DEVICE ASSEMBLY,” and filed on September 7, 2023, which is herein incorporated by reference in its entirety.INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.FIELD

[0003] The present technology generally relates to medical devices and, in particular, to systems including cryo-swaging components of medical devices for increased engagement without adhesives or welding.BACKGROUND

[0004] Thrombotic material may lead to a blockage in fluid flow within the vasculature of a mammal. Such blockages may occur in varied regions within the body, such as within the pulmonary system, peripheral vasculature, deep vasculature, or brain. Pulmonary embolisms typically arise when a thrombus originating from another part of the body (e.g., a vein in the pelvis or leg) becomes dislodged and travels to the lungs.

[0005] Problematically, medical devices such as catheters that are used to break up or otherwise remove thrombotic material may be subject to various pull and strain forces that may break apart components including funnels or other accessories during thrombectomy procedures. Such components may include tips that may often be attached to medical devices via welding or adhesives, for example attached to a distal end of the medical device.

[0006] What is needed is a method for securely adhering components of medical devices together in a way that is resistant to strain and mechanical shearing forces during thrombectomy procedures that may damage or detach such components.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0008] FIGS. 1A-1B illustrate one embodiment of a thrombus removal system.

[0009] FIGS. 2A-2C illustrate various views of an expandable member disposed on a distal tip of the thrombus removal system.

[0010] FIGS. 3A-3B illustrate fluid channels having tapered and square ridges between them, respectively.

[0011] FIG. 4 illustrates an upright view of a funnel with funnel collar disposed on a distal tip of a catheter.

[0012] FIG. 5 illustrates a view looking down a distal tip of a catheter.

[0013] FIGS. 6A-6B illustrate a flow chart showing a method of assembling a distal tip and layers to form an annular space to an inner catheter shaft.

[0014] FIG. 7 illustrates a flow chart showing a method for assembling a distal end to a medical device.SUMMARY OF THE DISCLOSURE

[0015] The present technology is generally directed to thrombus removal systems and associated methods, systems and apparatuses for cryo-swaging in thrombus device removal device assembly. A system configured in accordance with an embodiment of the present technology can include, for example, a thrombus removal device having: an inner catheter shaft; a distal tip coupled to or integral with the inner catheter shaft, in which the distal tip includes a plurality of raised portions and at least one port that extends through the distal tip and is position between adjacent raised portions; a distal member disposed over to the plurality of raised portions and extending distally from the distal tip to form at least one fluid lumen between the distal member and the plurality of raised portions; an outer catheter layer disposed over the inner catheter shaft and the distal member to form an annular space between the outer catheter layer and the inner catheter shaft; and a fluid source fluidly coupled to the annular space, such that a flow of fluid from the fluid source flows through the annular space into the at least one fluid lumen towards the at least one port configured to produce at least one fluid stream into the distal member.

[0016] According to certain embodiments, the distal member is coupled to the distal tip with a cryo-swaging process.

[0017] According to certain embodiments of the thrombus removal device, the distal member is a funnel.

[0018] According to certain embodiments of the thrombus removal device, wherein the funnel further comprises a funnel collar is disposed over the plurality of raised portions.

[0019] According to certain embodiments of the thrombus removal device, the distal member is friction fit over the plurality of raised portions.

[0020] According to certain embodiments of the thrombus removal device, the plurality of raised portions has one or more of a tapered shape or a square shape.

[0021] According to certain embodiments of the thrombus removal device, the distal member is disposed over the plurality of raised portions with a cryo-swaging process.

[0022] According to certain embodiments of the thrombus removal device, the distal member is disposed over the plurality of raised portions without welding or adhesives.

[0023] According to certain embodiments of the thrombus removal device, the plurality of raised portions have a step-down portion.

[0024] According to certain embodiments of the thrombus removal device, the step-down portion increases engagement between the plurality of raised portions and the distal member.

[0025] According to certain embodiments of the thrombus removal device, the expandable member has a heat-treated state in which the expandable member is compliant, and a rest state at room temperature or internal patient temperature in which the expandable member is rigid, wherein when the expandable member is coupled to the distal tip, the expandable member applies a force against the distal tip as it attempts to contract towards it at rest state.

[0026] According to certain embodiments, the outer catheter layer is disposed over the distal member.

[0027] According to certain embodiments, the outer catheter layer abuts the distal member.

[0028] Another system configured in accordance with an embodiment of the present technology can include, for example, a medical device, including: an elongate catheter shaft having a distal shaft portion; and an expandable distal end comprising a shape memory material that is friction fit to the distal shaft portion.

[0029] According to certain embodiments of the medical device, the expandable distal end is friction fit to the distal shaft portion without a cryo-swaging process.

[0030] According to certain embodiments of the medical device, the distal shaft portion is attached to the distal end without adhesive or welding.

[0031] According to certain embodiments of the medical device, the distal shaft portion contains a plurality of raised portions.

[0032] According to certain embodiments of the medical device, the plurality of raised portions have one or more of a tapered shape or a square shape.

[0033] According to certain embodiments of the medical device, the raised portions contain step-down portions.

[0034] According to certain embodiments of the medical device, the step-down portion increases engagement between the plurality of raised portions of the distal shaft portion and the distal end.

[0035] According to certain embodiments, the elongate catheter shaft comprises an aspiration lumen and at least one fluid lumen.

[0036] According to certain embodiments, the aspiration lumen is coupled to a distal opening of the expandable distal end.

[0037] According to certain embodiments, the at least one fluid lumen is fluidly coupled to one or more fluid ports disposed in the distal shaft portion to direct pressurized fluid streams into the expandable distal end.

[0038] According to certain embodiments of the medical device, the distal shaft portion is attached to the distal end via cryo-swaging.

[0039] The present invention may include a method of assembling a distal tip and layers having an annular space to an inner catheter shaft, the method including: providing a distal tip that includes a plurality of raised portions and at least one port that extends through the distal tip and is positioned between raised portions; heat treating a shape memory member to increase a compliance of the shape member; placing the shape memory member over the plurality of raised portions of the distal tip; allowing the shape memory member to contract around the distal tip; disposing an outer catheter layer over or against the shape memory member to couple an annular space between the outer catheter layer and the inner catheter shaft to one or more lumens formed between the plurality of raised portions and the shape memory member.

[0040] According to certain examples of the method, the shape memory member is a funnel.

[0041] According to certain examples of the method, the shape memory member includes a funnel collar of the funnel is disposed over the plurality of raised portions.

[0042] According to certain examples of the method, the shape memory member is friction fit over the plurality of raised portions.

[0043] According to certain examples of the method, the plurality of raised portions has one or more of a tapered shape or a square shape.

[0044] According to certain examples of the method, the expandable member is disposed over the plurality of raise portions without welding or adhesives.

[0045] According to certain examples of the method, the plurality of raised portions have a step-down portion.

[0046] According to certain examples of the method, the step-down portion increases engagement between the plurality of raised portions and the expandable member.

[0047] The present invention may include another method for assembling a medical device, including: friction-fitting a distal end of a medical device comprised of a shape memory material to a distal shaft portion of the medical device with a cryo-swaging process.

[0048] According to certain examples of this method, the distal shaft portion is attached to the distal end without welding or adhesives.DETAILED DESCRIPTION

[0049] This application is related to disclosure in International Application No. PCT / US2021 / 020915, filed March 4, 2021 (the ‘915 application), and International Application No. PCT / US2022 / 033024, filed June 10, 2022 (the ‘024 application), the disclosures of which are incorporated by reference herein for all purposes. The ‘915 and ‘024 applications describe general mechanisms for capturing and removing a clot. By example, multiple fluid streams are directed toward the clot to fragment the material.

[0050] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to the figures.

[0051] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various placesthroughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0052] Reference throughout this specification to relative terms such as, for example, "generally," "approximately," and "about" are used herein to mean the stated value plus or minus 10%.

[0053] Although some embodiments herein are described in terms of thrombus removal, it will be appreciated that the present technology can be used and / or modified to remove other types of emboli that may occlude a blood vessel, such as fat, tissue, or a foreign substance. Additionally, although some embodiments herein are described in the context of thrombus removal from a pulmonary artery (e.g., pulmonary embolectomy), the technology may be applied to removal of thrombi and / or emboli from other portions of the vasculature (e.g., in neurovascular, coronary, within chambers of the heart, or peripheral applications). Moreover, although some embodiments are discussed in terms of maceration of a thrombus with a fluid, the present technology can be adapted for use with other techniques for breaking up a thrombus into smaller fragments or particles (e.g., ultrasonic, mechanical, enzymatic, etc.).

[0054] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed present technology.Systems for Thrombus Removal

[0055] As provided above, the present technology is generally directed to thrombus removal systems. Such systems include an elongated catheter having a distal portion positionable within a blood vessel of the patient (e.g., an artery or vein), a proximal portion positionable outside the patient's body, a fluid delivery mechanism configured to fragment the thrombus with pressurized fluid, an aspiration mechanism configured to aspirate the fragments of the thrombus, and one or more lumens extending at least partially from the proximal portion to the distal portion. In some embodiments, the systems herein are configured to engage a thrombus in a patient's blood vessel, break the thrombus into small fragments, and aspirate the fragments out of the patient's body. The pressurized fluid streams (e.g., jets) function to cut or macerate thrombus, before, during, and / or after at least a portion of the thrombus has entered the aspiration lumen or a funnel of the system. Fragmentation helps to prevent clogging of the aspiration lumen and allows the thrombus removal system to macerate large, firm clots that otherwise could not be aspirated. As used herein, “thrombus” and “embolism” are used somewhat interchangeably in various respects. Typically a thrombus is a portion of clotted blood that has stopped moving through the vasculature and islodged or stuck and the emboli is a portion of clotted blood that is moving in the vasculature that can eventually become a thrombus and additionally seed a larger thrombus either by collecting other emboli or blood clotting on the thrombus.

[0056] It should be appreciated that while the description may refer to removal of “thrombus,” this should be understood to encompass removal of thrombus fragments and other emboli as provided herein.

[0057] According to embodiments of the present technology, a fluid delivery mechanism can provide a plurality of fluid streams (e.g., jets) to fluid apertures of the thrombus removal system for macerating, cutting, fragmenting, pulverizing and / or urging thrombus to be removed from a proximal portion of the thrombus removal system. The thrombus removal system can include an aspiration lumen extending at least partially from the proximal portion to the distal portion of the thrombus removal system that is adapted for fluid communication with an aspiration pump (e.g., vacuum source). In operation, the aspiration pump may generate a volume of lower pressure within the aspiration lumen near the proximal portion of the thrombus removal system, urging aspiration of thrombus from the distal portion to the proximal portion.Systems and methods for attachment of distal tip or element to medical device shaft

[0058] The present technology is directed to attaching (e.g., by cryo-swaging) components to catheter shafts of medical devices. In some examples, the components can comprise distal expandable elements such as a funnel that is configured to fit over a distal tip of a medical device. The attachment can be implemented via a cryo-swaging technique to provide resistance to pull forces and axial strain without requiring welding, adhesive, or other attachment techniques. In some examples, cryo-swaging may be a forging process in which the dimensions of an object are altered using dies into which the object is forced into, to result in permanently joining pieces of metal together under cold temperatures. In other examples, the forging process may be performed under hot working temperatures to plastically deform metals.

[0059] FIG. 1 A illustrates a side view of a thrombus removal device 100. As shown here, a distal region of the device includes an inner catheter shaft 102 and a funnel 104 that can include a funnel collar 103 at the base of funnel 104. In some embodiments, the inner catheter shaft 102 extends to the distal tip of the device. In other embodiments, described below, the distal tip of the device can include a separate coupling element connected or coupled to the inner catheter shaft. The distal tip of the device can include additional functionality which will be described herein, including one or more fluid or jet ports for delivering fluid or jet streams into the lumen to disrupt or macerate thrombus therein. Thefunnel and funnel collar can comprise a shape memory material such as nitinol or other similar materials as known in the art. A lumen of the inner catheter shaft 102 can be coupled to an aspiration or vacuum source (not shown) to form an aspiration lumen 107 within the thrombus removal device 100.

[0060] The device 100 can further include an outer catheter shaft 101 which may comprise, for example, a braided catheter layer. In the example of FIG. 1A, the outer catheter shaft is pulled back proximally to reveal the inner catheter shaft 102 underneath. However, it should be understood that the braided catheter layer can be flush with or disposed over / under the funnel collar 103 to avoid such gaps, and to fluidly couple the annular space between the outer catheter shaft and the inner catheter shaft to any lumens formed between the funnel collar 103 and the distal tip of the device. Collectively, the inner and outer catheter shafts can be bendable and / or flexible to allow for navigation within a patient’s vasculature. As described herein, spacing can be provided between the inner catheter shaft 102 and the outer catheter shaft 101 to form an annular space that can be used for a number of purposes in the system. In some embodiments, some or all of the annular space between the inner catheter shaft 102 and outer catheter shaft 101 can be used as a fluid lumen to direct fluid from a proximal end of the system shaft to the distal tip and / or funnel. For example, the annular space between the inner catheter shaft 102 and the outer catheter shaft 101 can comprise a fluid lumen 105 that traverses the length of the inner catheter shaft 102. In some examples, the fluid lumen can be fluidly coupled to a fluid source at a proximal end of the inner catheter shaft (not shown). The fluid lumen can terminate near one or more fluid ports 106 in the distal tip, the one or more fluid ports being configured to direct one or more pressurized fluid streams into the funnel 104 or the aspiration lumen 107 of the device.

[0061] FIG. IB is a cross-sectional view of device 100 including inner catheter shaft 102 and outer catheter shaft 101, forming fluid lumen 105 which traverses the length of the catheter shaft to the distal tip. As shown in FIG. IB, the inner catheter shaft 102 also forms an aspiration lumen 107 in the center of the catheter shaft, which can provide aspiration to the distal tip (e.g., to the funnel 104) via a vacuum or aspiration source. Details on additional catheter lumen designs between an inner and outer catheter shaft, as well as fluid port locations and jet / fluid stream configurations can be found in International Patent Application No. PCT / US2022 / 033024, which is incorporated herein by reference in its entirety.

[0062] FIGS. 2A-2C illustrate various views of a distal portion of a medical device (e.g., thrombectomy device) that includes an expandable member such as a funnel 204 disposed on a distal tip 209 of the device. As shown in perspective view FIG. 2A, the distal tip 209 can be, for example, a coupler between a catheter shaft of the device and a distal element orexpandable member such as a funnel. However in other embodiments, it should be understood that the functionality and features of the distal tip could be incorporated into other components of the device, such as into the inner catheter shaft. In the illustrated embodiment, the funnel 204 can include a funnel collar 203 which is configured to be attached or coupled to the distal tip 209. In some aspects, the funnel 204 and funnel collar 203 are attached or coupled to the distal tip 209 with a cryo-swaging technique that includes cooling the funnel collar 203 and funnel 204 into a cold state in which the material can become compliant such that it can be bent or stretched over the raised portions 210 of the distal tip 209, and then heating or allowing the material to return to its rigid and at-rest shape. When the funnel 204 and funnel collar 203 are in the at rest shape, a pressure or friction coupling is formed between the funnel collar 203 and the distal tip 209.

[0063] According to certain embodiments, distal tip 209 has a plurality of raised portions 210 which are configured to create radial space or separation between the funnel collar 203 and the distal tip 209. As shown in FIG. 2B, separation between adjacent raised portions 210 also creates additional fluid lumens 231 in the axial direction of the device which can be in fluid communication with the previously described fluid lumens in the catheter shaft. Therefore, fluid flowing through the catheter fluid lumen(s) described above (e.g., fluid lumen 105 in FIGS. 1 A-1B between the inner and outer catheter shafts) can enter additional fluid lumens 231 in the tip between adjacent raised portions 210 and exit distal tip 209 at fluid ports in the distal tip (e.g., fluid ports 106 in FIG. 1 A).

[0064] As described above, funnel collar 203 and funnel 204 can be comprised of shape memory material such as nitinol that is configured to contour around distal tip 209 using cryo-swaging in which funnel collar 203 is temperature treated (e.g., cooled) to be compliant enough to expand and contour around distal tip 202. While cryo-swaging is a preferred embodiment to provide a friction fit between the funnel collar and the distal tip, it should be understood that other attachment techniques can be used, including welding or adhesives.

[0065] FIG. 2B illustrates an axial cross section of the device between raised portions 210. As shown here, a distal element such as funnel collar 203 may be disposed or blanketed over raised portions 210 and extend over the distal tip 209 to funnel 204 which extends distally past the distal tip. According to the previously mentioned embodiment in which funnel collar 203 is shape memory material such as nitinol configured to contour around distal tip 202 using cryo-swaging, the cryo-swaging process may produce a seal 203A between funnel collar 203 and distal tip 209 and / or raised portions 210 that securely adheres these two components and which may be impermeable to fluid. According to this or other embodiments, the radial space between the distal tip 209 and the funnel collar 203 forms fluidlumens 231, as described above. The fluid lumens 231 can provide a path for fluid to flow from the fluid lumen defined by the annular space between the inner and outer catheters, towards fluid ports of the distal tip. According to certain embodiments, additional fluid lumens 231 may be a fluid manifold formed in the radial space between distal tip 209 and funnel collar 203, the fluid manifold to receive the path of fluid flow from one or more proximal fluid lumens, such as fluid lumens formed in the annular space between the inner catheter shaft and outer catheter shaft. Also shown below raised portions 210 is inner wall 212 of distal tip 209 which according to certain embodiments may form a wall of the aspiration lumen of the device, and may have panels 207.

[0066] FIG. 2C shows a side view of the device including raised portions 210 of distal tip 209. As shown here, a distal element such as funnel collar 203 and funnel 204 is disposed on or blanketed over raised portions 210. One or more of the raised portions 210 may include step-down portions 299 allow for the funnel collar 203 to contour and provide an improved friction-fit against raised portions 210. As shown, the step-down portions 299 may comprise a section of the raised portion 210 that suddenly or drastically reduces from a first height 297 to a second height 298. The step-down portions 299 can provide a sharp edge 296 in the raised portion 210 that, when the funnel collar is cryo-swaged onto the raised portion 210, increases the axial pulling forces that would be required to remove the funnel collar 203 from the distal tip 209. According to certain embodiments, distal elements such as funnel collar 203 are configured to contour to raised portions 210 and step-down portions 299 during the cryo-swaging process. Cryo-swaging allows the attachment of funnel collar 203 to distal tip 209 as well as withstanding high jetting pressures and pull-off forces on funnel collar 203, without requiring adhesive, welding, or other fixation techniques that are more susceptible to damage and deformation. Also shown is a panel 207 of an inner wall of distal tip 209.

[0067] FIGS. 3A-3B illustrate two embodiments of a distal tip 309, which can correspond to the distal tips previously described above. As described herein, the distal tip can include raised portions 310 that include tapered ends 320 in FIG. 3 A and square ends 321 in FIG. 3B. Fluid channels 331 are formed between adjacent raised portions 310, as previously described. The fluid channels 331 can provide a flow of fluid (e.g., saline) towards fluid ports 306 to produce a plurality of jets or fluid streams near the distal end of the device, such as into a funnel or other expandable element of the device. As described above, the fluid channels 331 are formed between the raised portions when the funnel collar and funnel of the device are placed over the distal tip. In some aspects, the tapered ends 320 of FIG. 3 A can provide less turbulent flow into fluid channels 331 compared to the square ends 321 of the FIG. 3B embodiment.

[0068] FIG. 3 A shows a side view of distal tip with raised portions 310 having a tapered end 320 and step-down portions 399. According to certain embodiments, there is at least one tapered flow end 320 on the raised portions 310. Adjacent raised portions 310 form fluid lumens 331, which are in fluid communication with fluid lumen 305 of the catheter (e.g., formed between inner and outer catheter shafts). Fluid flow traverses through fluid lumen(s) 305 into fluid lumens 331 of the distal tip and egresses or is ejected at fluid ports 306, exiting distal tip and entering the space within an expandable element such as a funnel. According to certain embodiments, tapered ends 320 reduce flow circulation and / or turbulence in the distal tip 302. Additionally, the embodiment of FIG. 3 A is shown with an optional collar 313, which can optionally provide another friction mounting point for either the outer catheter layer and / or the funnel collar. It should be understood that the collar could disrupt or diver the flow of fluid from lumen 305. In some aspects, the flow of fluid can pass through collar 313, and in other embodiments the flow of fluid can pass around the collar. Both fluid paths are shown in FIG. 3 A.

[0069] FIG. 3B shows a side view of distal tip 302 with raised portions having a squared end 321 and step-down portions 399. According to certain embodiments, there is at least one squared end 321 on the raised portions 310. Adjacent raised portions 310 form fluid lumens 331, which are in fluid communication with fluid lumen 305 of the catheter (e.g., formed between inner and outer catheter shafts). Fluid flow traverses through fluid lumen(s) 305 into fluid lumens 331 of the distal tip and egresses or is ejected at fluid ports 306, exiting distal tip and entering the space within an expandable element such as a funnel.

[0070] FIG. 4 illustrates an upright view of the device which can include a funnel 404 with funnel collar 403 disposed on a distal tip 409 of a thrombectomy device. According to certain embodiments, funnel collar 403 may have a necked down section 433 as a result of the cryo-swaging process when the funnel collar 403 is constrained upon the distal tip and the raised portions previously described. The necked down section 433 can correspond to the funnel collar 403 compressing or retracting down into the space between the adjacent raised portions that form the fluid lumens (e.g., fluid lumens 231 / 331) described above.

[0071] FIG. 5 illustrates a cross-sectional view looking down on the device that includes a distal tip 509 of a catheter. As shown here, distal tip 509 forms fluid lumens 531 interspersed between raised portions 510 of the distal tip. According to certain embodiments, funnel collar 503 of the distal element or funnel 504 is cryo-swaged onto the distal tip, to provide a friction-fit between the distal element or funnel 504 and the distal tip, and form the fluid lumens 531 in the distal tip. The cryo-swaging process causes the funnel collar 503 tocompress down upon the raised portions 510, thereby locking the funnel collar 503 onto the device without the need for adhesives or welding.

[0072] FIGS. 6A-6B illustrate a flow chart showing a method 600-601 of assembling a distal tip and layers to form an annular space to an inner catheter shaft.

[0073] Method 600-601 begins at block 605 of Fig. 6 A.

[0074] At block 605, a distal tip is coupled to an inner catheter shaft, in which the distal tip includes a plurality of raised portions and at least one port that extends through the distal tip and is positioned between adjacent raised portions.

[0075] At block 610, a shape memory member is heat treated (e.g., cryo-swaged) and placed over the plurality of raised portions to provide a friction fit between the shape memory member and the distal tip without welding or adhesives.

[0076] At block 615, an outer catheter layer is disposed over the inner catheter shaft and shape memory member to form an annular space between the outer catheter layer and the inner catheter shaft.

[0077] Method 600-601 continues at Fig. 6B.

[0078] At block 620, a fluid source is fluidly coupled to the annular space, in which the at least one port of the distal tip produces at least one fluid stream into an expandable member.

[0079] At block 625, at least one fluid stream is produced into the expandable member via the at least one port of the distal tip.

[0080] According to certain embodiments of method 600-601, the expandable member is a funnel.

[0081] According to certain embodiments of method 600-601, a funnel collar is disposed over the plurality of raised portions.

[0082] According to certain embodiments of method 600-601, the expandable member is friction fit over the plurality of raised portions.

[0083] According to certain embodiments of method 600-601, the plurality of raised portions has one or more of a tapered shape or a square shape.

[0084] According to certain embodiments of method 600-601, the plurality of raised portions is comprised of a shape memory material that is cryo-swaged.

[0085] According to certain embodiments of method 600-601, the expandable member is disposed over the plurality of raised portions without welding or adhesives.

[0086] According to certain embodiments of method 600-601, the plurality of raised portions have a step-down portion.

[0087] According to certain embodiments of method 600-601, the step-down portion increases engagement between the plurality of raised portions and the expandable member.

[0088] FIG. 7 illustrates a flow chart showing a method 700 for assembling a distal end to a medical device.

[0089] At block 705, a distal end for a medical device comprised of a shape memory material is friction fitted to a distal shaft portion of the medical device with a cryo-swaging process.

[0090] According to certain embodiments of method 700, the distal shaft portion is attached to the distal end without welding or adhesives.

[0091] According to certain embodiments of method 700, the distal shaft portion contains a plurality of raised portions.

[0092] According to certain embodiments of method 700, the plurality of raised portions have one or more of a tapered shape or a square shape.

[0093] According to certain embodiments of method 700, the raised portions contain step-down portions.

[0094] According to certain embodiments of method 700, the step-down portion increases engagement between the plurality of raised portions of the distal shaft portion and the distal end.

[0095] According to certain embodiments of method 700, the distal shaft portion is attached to the distal end via cryo-swaging.Conclusion

[0096] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise forms disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments.

[0097] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.

[0098] Unless the context clearly requires otherwise, throughout the description and the examples, the words "comprise," "comprising," and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of"including, but not limited to." As used herein, the terms "connected," "coupled," or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words "herein," "above," "below," and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase "and / or" as in "A and / or B" refers to A alone, B alone, and A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSWhat is claimed is:

1. A thrombus removal device, comprising: an inner catheter shaft; a distal tip coupled to or integral with the inner catheter shaft, wherein the distal tip includes a plurality of raised portions and at least one port that extends through the distal tip and is positioned between adjacent raised portions; a distal member disposed over the plurality of raised portions and extending distally from the distal tip to form at least one fluid lumen between the distal member and the plurality of raised portions; an outer catheter layer disposed over the inner catheter shaft to form an annular space between the outer catheter layer and the inner catheter shaft; and a fluid source fluidly coupled to the annular space, such that a flow of fluid from the fluid source flows through the annular space into the at least one fluid lumen towards the at least one port to produce at least one fluid stream into the distal member.

2. The thrombus removal device of claim 1, wherein the distal member is coupled to the distal tip with a cryo-swaging process.

3. The thrombus removal device of claim 1, wherein the distal member is a funnel.

4. The thrombus removal device of claim 3, wherein the funnel further comprises a funnel collar disposed over the plurality of raised portions.

5. The thrombus removal device of claim 1, wherein the distal member is friction fit over the plurality of raised portions.

6. The thrombus removal device of claim 1, wherein the plurality of raised portions has one or more of a tapered shape or a square shape.

7. The thrombus removal device of claim 6, wherein the distal member is disposed over the plurality of raised portions with a cryo-swaging process.

8. The thrombus removal device of claim 7, wherein the distal member is disposed over the plurality of raised portions without welding or adhesives.

9. The thrombus removal device of claim 1, wherein the plurality of raised portions have a step-down portion.

10. The thrombus removal device of claim 9, wherein the step-down portion increases engagement between the plurality of raised portions and the distal member.

11. The thrombus removal device of claim 1, wherein the distal member has a heat- treated state in which the distal member is compliant, and a rest state at room temperature or internal patient temperature in which the distal member is rigid, wherein when the distal member is coupled to the distal tip, the distal member applies a force against the distal tip as it contracts towards its at rest state.

12. The thrombus removal device of claim 1, wherein the outer catheter layer is disposed over the distal member.

13. The thrombus removal device of claim 1, wherein the outer catheter layer abuts the distal member.

14. A medical device, comprising: an elongate catheter shaft comprising a distal shaft portion; and an expandable distal end comprising a shape memory material that is friction fit to the distal shaft portion.

15. The device of claim 13, wherein the expandable distal end is friction fit to the distal shaft portion with a cryo-swaging process.

16. The medical device of claim 13, wherein the distal shaft portion is attached to the distal end without welding or adhesives.

17. The medical device of claim 13, wherein the distal shaft portion contains a plurality of raised portions.

18. The medical device of claim 13, wherein the plurality of raised portions have one or more of a tapered shape or a square shape.

19. The medical device of claim 13, wherein the raised portions contain step-down portions.

20. The medical device of claim 19, wherein the step-down portion increases engagement between the plurality of raised portions of the distal shaft portion and the distal end.

21. The medical device of claim 13, wherein the elongate catheter shaft comprises an aspiration lumen and at least one fluid lumen.

22. The medical device of claim 21, wherein the aspiration lumen is coupled to a distal opening of the expandable distal end.

23. The medical device of claim 21, wherein the at least one fluid lumen is fluidly coupled to one or more fluid ports disposed in the distal shaft portion to direct pressurized fluid streams into the expandable distal end.

24. A method of assembling a distal tip and layers having an annular space to an inner catheter shaft, the method comprising: providing a distal tip that includes a plurality of raised portions and at least one port that extends through the distal tip and is positioned between raised portions; heat treating a shape memory member to increase a compliance of the shape member; placing the shape memory member over the plurality of raised portions of the distal tip; allowing the shape memory member to contract around the distal tip; disposing an outer catheter layer over or against the shape memory member to couple an annular space between the outer catheter layer and the inner catheter shaft to one or more lumens formed between the plurality of raised portions and the shape memory member.

25. The method of claim 24, wherein the shape memory member is a funnel.

26. The method of claim 24, wherein the shape memory member includes a funnel collar disposed over the plurality of raised portions.

27. The method of claim 24, wherein the shape memory member is friction fit over the plurality of raised portions.

28. The method of claim 24, wherein the plurality of raised portions has one or more of a tapered shape or a square shape.

29. The method of claim 24, wherein the expandable member is disposed over the plurality of raise portions without welding or adhesives.

30. The method of claim 24, wherein the plurality of raised portions have a step-down portion.

31. The method of claim 25, wherein the step-down portion increases engagement between the plurality of raised portions and the expandable member.

32. A method for assembling a medical device, the method comprising: friction-fitting a distal end of a medical device comprised of a shape memory material to a distal shaft portion of the medical device with a cryo-swaging process.

33. The method of claim 32, wherein the distal shaft portion is attached to the distal end without welding or adhesives.

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