Connector assembly for vascular embolic capture device

Abstract

The present invention is entitled "Connector assembly for a vascular embolic capture device". A connector assembly for an intravascular device is disclosed, comprising a shaft including a body and an enlarged end, a proximal strut including a slot, wherein the slot engages the enlarged end of the shaft, and a locking collar including a proximal side and a distal side and at least partially covering the enlarged end of the shaft and the slot of the proximal strut, so that the locking collar constrains the proximal strut so that the proximal strut cannot be disengaged from the enlarged end of the shaft when the connector assembly and the clot retrieval device are subjected to a load.

Description

Technical Field

[0001] The present invention relates generally to intravascular devices and methods, and more particularly to an intravascular connector assembly that can be used as a component of an intravascular device for removing vascular occlusions. Background Art

[0002] Recent clinical studies have shown that mechanical thrombectomy is an increasingly effective method for removing acute emboli from blood vessels. Acute emboli can include clots, misplaced devices, migrating devices, large emboli, etc. If the embolism is lodged in the cerebral vasculature, it may cause ischemic stroke. If the embolism (such as a clot) originates from the venous system or the right side of the heart and is lodged in the pulmonary artery or its branches, it may cause pulmonary embolism. Mechanical thrombectomy generally involves advancing a thrombectomy device or stent into the obstructing clot, engaging the clot, and withdrawing the clot into a safe position in a proximally placed guide or sheath.

[0003] However, despite the benefits provided by mechanical thrombectomy devices, there are limitations. For example, there are many process challenges that can apply excessive tension or compression to device components. In cases where access involves navigating the aortic arch (such as coronary artery or cerebral occlusion), the arch configuration of some patients makes it difficult to position the stent. These difficult arch configurations are classified as type 2 or type 3 aortic arches, with type 3 arches presenting the greatest difficulty. In arteries close to the brain, the tortuosity challenge is even more severe. For example, at the distal end of the internal carotid artery, it is not uncommon for the device to have to navigate a vascular segment with a 180° bend, a 90° bend, and a 360° bend in rapid succession in a few centimeters of blood vessels. Delivering the device to the target location through a curved anatomical structure can apply compressive loads to the device components and the joint between the distal segment and the shaft. In addition, the separation force of the embolism in the blood vessel and the withdrawal through the tortuous vascular system can apply high tensile loads on the joint. The withdrawal of the embolism entering the access catheter can also apply great forces to the proximal joint of the device components and the shaft.

[0004] These intravascular devices may be integrally formed with a joint assembly, typically connecting the clot engaging portion to the elongated shaft. These assemblies may be joined by adhesive or welding, or the joints may be welded. Adhesives may be applied to ensure that the components maintain the correct position and orientation, but in some cases increased bond strength and integrity may be required. Figure 1 As shown, the previously disclosed joint assembly may include: a shaft 10 including a body 12 and an enlarged step 14, a proximal stay 18 engaged with the shaft 10, and a locking collar 16 engagingly receiving at least a portion of the body 12 and at least a portion of the proximal stay 18 to lock the assembly in place. However, as Figure 2As shown, excessive tension can cause excessive tensile stress on the shaft, causing the proximal struts to disengage from the enlarged step of the shaft and deform the enlarged end. This can lead to disassembly of the connector of the stent or thrombectomy device when detaching an embolism or when it is retracted proximally around a bend in a tortuous vessel, or potential escape of a captured blood clot.

[0005] Therefore, a need exists for an intravascular device having sufficient integrity to effectively capture an embolus for safe retrieval from a patient.

[0006] Summarize

[0007] Various exemplary devices of the present invention that can meet the above needs are disclosed herein, and the device can be a joint assembly that can generally include a shaft, a proximal strut, and a locking collar. The joint assembly can be integrally coupled to an intravascular device between a clot engagement portion and an elongated shaft. In this way, the joint assembly allows the capture of an embolism by the clot engagement portion of the intravascular device while providing increased load support by the joint assembly.

[0008] In one example, a connector assembly for an intravascular device may include: a shaft having a body and an enlarged end, a proximal strut, and a locking collar, the shaft having a body and an enlarged end, the proximal strut including a slot, wherein the slot engages the enlarged end of the shaft, the locking collar including a proximal side and a distal side and at least partially covering the enlarged end of the shaft and the slot of the proximal strut. In some embodiments, at least a portion of the enlarged end is received in the proximal strut slot. In some embodiments, the enlarged end of the shaft and the body of the shaft define a shaft step.

[0009] As another example, a connector assembly for an intravascular device may include: a shaft having a body and an enlarged end, a proximal strut and a locking collar, wherein the shaft has a body and an enlarged end, the proximal strut has a narrow slot, wherein the body of the shaft is received in the narrow slot, and the locking collar has a proximal side, a distal side and at least partially covers the enlarged end of the shaft and the narrow slot of the proximal strut. In some embodiments, the proximal strut slot may include a first height and a second height. In some embodiments, the body of the shaft is inserted into the proximal strut slot at a first height, the enlarged end engages the proximal strut slot at a second height, and the proximal strut slot is inclined downward from the second height and away from the enlarged end.

[0010] For another example, a connector assembly for an intravascular device may include: a shaft having a body and an enlarged end, a proximal strut, and a locking collar, wherein the shaft has a body and an enlarged end; the proximal strut has a cross-shaped member, and the locking collar has a proximal side, a distal side, and at least partially covers the enlarged end of the shaft and the slot of the proximal strut. In some embodiments, the cross-shaped member engages the distal side of the locking collar.

[0011] In another example, a method of assembling a joint assembly may include the following steps: providing a shaft having a body and an enlarged end, a proximal strut, and a locking collar, the shaft having a body and an enlarged end, the proximal strut including a slot, wherein the slot engages the enlarged end of the shaft, the locking collar having a proximal side and a distal side and engaging the enlarged end of the shaft and the slot of the proximal strut, sliding the locking collar onto the body of the shaft, positioning at least a portion of the proximal strut proximate the enlarged end of the shaft, and repositioning the collar so that it at least partially covers the enlarged end of the shaft and the slot of the proximal strut. In some embodiments, when the locking collar is repositioned, the collar constrains the proximal strut so that when the joint assembly is loaded into an intravascular device and the intravascular device is subjected to a load, the proximal strut slot cannot disengage from the enlarged end of the shaft. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The above and other aspects of the present invention are further discussed with reference to the following detailed description and in conjunction with the accompanying drawings, in which the same reference numerals indicate the same structural elements and features in various figures. The accompanying drawings are not necessarily drawn to scale, but instead, the emphasis is placed on illustrating the principles of the present invention. The accompanying drawings depict one or more specific implementations of the apparatus of the present invention by way of example only and not by way of limitation.

[0013] Figure 1 The configuration of an exemplary prior art joint assembly is shown;

[0014] Figure 2 shows the configuration of an exemplary prior art joint assembly under tensile loading;

[0015] Figure 3 shows a perspective view of an exemplary joint assembly of the present invention;

[0016] FIG. 4A to FIG. 4B side and end views of an exemplary locking collar of the connector assembly of the present invention are shown;

[0017] FIG. 5A to FIG. 5C The assembly method of the joint assembly of the present invention is shown;

[0018] FIG. 6A to FIG. 6D The configuration of an exemplary joint assembly of the present invention is shown;

[0019] FIG. 7A to FIG. 7D The configuration of an exemplary joint assembly of the present invention is shown;

[0020] FIG. 8A to FIG. 8C The configuration of an exemplary joint assembly of the present invention is shown;

[0021] FIG. 9A to FIG. 9B shows a side view of an exemplary joint assembly of the present invention;

[0022] FIG. 10A to FIG. 10CThe configuration of an exemplary joint assembly of the present invention is shown;

[0023] Fig.11 shows a perspective view of an exemplary connector assembly of the present invention; and

[0024] FIG. 12A to FIG. 12B A perspective view of an exemplary connector assembly integrally formed into an intravascular device is shown. DETAILED DESCRIPTION

[0025] Specific embodiments of the present invention are now described in detail with reference to the accompanying drawings, wherein the same reference numerals represent the same or functionally similar elements. The terms "distal" or "proximal" are used in the following descriptions of positions or directions relative to the treating physician. "Distal" or "towards the distal side" is a position away from the physician or in a direction away from the physician. "Proximal" or "towards the proximal side" or "at the proximal side" is a position close to the physician or in a direction toward the physician.

[0026] Accessing the cerebral, coronary, and pulmonary vessels involves the use of a number of commercially available products and conventional procedural steps. Access products such as stents and thrombectomy devices are described elsewhere and are often used in endovascular procedures. In the following description it is assumed that these products and methods are used in conjunction with the devices and methods of the present invention and do not require detailed description.

[0027] The following detailed description is merely exemplary in nature and is not intended to limit the invention or its applications and uses. Although the invention is described in many cases in the context of treating vascular obstructions, the invention may also be used in other body passages as described herein.

[0028] like Figure 3 The example of the joint assembly shown may have a shaft 100, a proximal strut 120, and a locking collar 130. The proximal strut 120 is distal to the shaft but at the proximal end of the stent (see Fig. 12A). In some embodiments, the shaft 100 may include a body 110 and an enlarged end 112. In some embodiments, the proximal strut 120 may include a slot 122. In some embodiments, the slot 122 may engage the enlarged end 112 of the shaft 100. In some embodiments, the locking collar 130 may at least partially cover the enlarged end 112 of the shaft 100 and the slot 122 of the proximal strut 120. In some embodiments, at least a portion of the enlarged end 112 is received in the proximal strut slot 122. In some embodiments, the enlarged end 112 of the shaft 100 and the body 110 of the shaft 100 define a shaft step. In some embodiments, the proximal strut further includes a tail 124. In some embodiments, the slot 122 or an auxiliary slot of the proximal strut 120 may be adjacent to the tail 124 and facilitate wicking of the adhesive into the proximal strut 120 to maintain the correct orientation of the joint assembly components.

[0029] Suitable materials for forming the shaft, proximal struts and bushings ideally have high tensile strength so that sufficient integrity can be produced for manufacture and use, such as polymer materials such as UHMWPE, aramid, LCP, PET or PEN, or metals such as tungsten, MP35N, stainless steel or nitinol. The proximal support slot 122 can be any suitable shape for engaging the enlarged end 112.

[0030] In some embodiments, the joint assembly can be any suitable size and shape to be compatible with a microcatheter for neurovascular device delivery. Suitable shapes of the proximal strut slot 122 may include approximately square, approximately rectangular, approximately circular, etc. The locking collar 130 may be any suitable shape for covering or encapsulating at least a portion of the proximal strut slot 122 and the enlarged end 112 of the shaft 100. Suitable shapes of the locking collar 130 may include approximately cylindrical, approximately elliptical cylindrical, etc. The enlarged end 112 of the body 110 and the shaft 100 may have any suitable size and shape to engage the proximal strut 120 and be at least partially received in the locking collar 130. Suitable shapes of the body 110 may include approximately cylindrical, approximately elliptical cylindrical, etc. Suitable shapes of the enlarged end 112 may include approximately cylindrical, approximately elliptical cylindrical, etc. In some embodiments, the connector assembly can be sized to be compatible with microcatheters having an inner diameter of 0.027 inches or less (e.g., 0.026 inches, 0.024 inches, 0.022 inches, 0.019 inches, 0.017 inches, 0.015 inches, 0.013 inches, 0.011 inches, 0.009 inches, 0.007 inches, 0.005 inches, 0.003 inches, 0.001 inches) and preferably with microcatheters having an inner diameter of 0.021 inches or less (e.g., 0.019 inches, 0.017 inches, 0.015 inches, 0.013 inches, 0.011 inches, 0.009 inches, 0.007 inches, 0.005 inches, 0.003 inches, 0.001 inches).

[0031] like Figure 4A and Figure 4B As shown, in some embodiments, the locking collar 130 may include a proximal side 136 and a distal side 134. In some embodiments, the locking collar may include a first slit and a second slit 132. FIG. 5A to FIG. 5C As shown, in some embodiments, assembly of the joint assembly may include providing a shaft 100, a proximal strut 120, and a locking collar 130. Figure 5A As shown, assembly may also include sliding the locking collar 130 onto the body 110 of the shaft 100 away from the enlarged end 112. Figure 5B As shown, assembly may also include positioning at least a portion of the proximal strut 120 proximate the enlarged end 112 of the shaft 100. Figure 5CAs shown, assembly may further include repositioning the collar 130 so that it at least partially covers the enlarged end 112 of the shaft 100 and the slot 122 of the proximal strut 120. In some embodiments, when the locking collar is repositioned, the locking collar 130 at least partially encloses the enlarged end 112 of the shaft 100 and the slot 122 of the proximal strut 120. Due to this configuration, when the joint assembly is under tension, the locking collar 130 supports the enlarged end 112, allowing the previously Figure 2 The deformation shown in the joint disclosed in is minimized. This makes the joint assembly stronger and able to withstand higher tensile loads than existing designs.

[0032] like Fig. 6A As shown, in some embodiments, the proximal support slot 140 may include a first height 144 and a second height 146. In some embodiments, the body 110 of the shaft 100 is inserted into the proximal strut slot 142 at the first height 144, and the expansion member 112 engages the proximal strut slot 142 at the second height. FIG. 6B to FIG. 6D As shown, in some embodiments, the proximal strut 640 includes a proximal strut slot 642, which includes a first height 644 and a second height 646. In some embodiments, the shaft 600 may include a body 610 and an enlarged end 612, such that the shaft 600 is inserted into the proximal strut slot 642 at a first height 644, and the proximal strut slot 642 engages the enlarged member 612 at the second height and tapers downward and away from the first height 644. The taper assists the proximal strut 640 in engaging the distal end of the shaft enlarged end 612. This increases the tension and compression forces that can be transmitted from the shaft 600 to the distal end of the joint assembly through the joint assembly. The locking collar 130 constrains the proximal strut 122 relative to the enlarged end 112 so that the proximal strut 122 remains engaged with the enlarged end 112 under a tensile load force of up to approximately 2N to 15N (e.g., 3N, 4N, 5N, 6N, 7N, 8N, 9N, 10N, 11N, 12N, 13N, 14N).

[0033] like FIG. 7A to FIG. 7DAs shown, the locking bushing 150 may also include a proximal side 152 and a distal side 156, and the proximal strut 160 may include a cross member 162. In some embodiments, the cross member 162 may engage the proximal side 152 of the locking bushing 150. In some embodiments, the cross member 162 may lockably engage the proximal side 150 of the locking bushing 152. In some examples, the cross member 162 can be used to prevent the proximal strut 160 from rotating or provide additional locking support. In some examples, the locking bushing 150 may have an oval shape, and the cross member 162 passes through the locking bushing 156 from the distal side 150 to the proximal side 152 because the major axis of the ellipse is greater than the arms of the cross member. The cross member 162 is then rotated 90° to engage the slit on the proximal side 152. In this way, the minor axis of the ellipse is shorter than the arms of the cross member. In some embodiments, the joint assembly may also include a shaft and an enlarged end (not shown in the figure).

[0034] like FIG. 8A to FIG. 8C As shown, in some embodiments, the locking collar 170 may include a first slit 180 formed in a proximal side of the locking collar 170 and a polygonal hole 174 positioned opposite the first slit 180. In some embodiments, at least a portion of the proximal strut 172 may engage the slit 180. In some embodiments, at least a portion of the proximal strut may engage the polygonal hole 174. In some embodiments, a portion of the proximal strut 172 surrounding the proximal strut slot 178 may engage the first slit 180 and the polygonal hole 174. In some embodiments, a portion of the proximal strut 172 surrounding the proximal strut slot 178 may lockably engage the first slit 180 and the polygonal hole 174. In some embodiments, the first slit 180 may be formed from the distal side of the collar 170 into at least a portion of the first side of the collar 170, and the polygonal hole 174 is formed in the second side of the collar 170. This design may minimize deformation of the locking collar 170 when the exemplary joint assembly is subjected to high tension.

[0035] like Fig.9A and Fig. 9BAs shown, in some embodiments, an exemplary joint assembly may include: a shaft 200, a proximal strut 220, and a collar 230, the shaft including a body 210 and an enlarged end 212, and the collar including a first slit and a second slit 232. In some embodiments, the first slit and the second slit 232 may be tapered. In some embodiments, the proximal strut 220 may engage the first tapered slit and the second tapered slit 232. In some embodiments, the locking collar 230 may abut the enlarged end 212 of the shaft 200. In some embodiments, the proximal strut 220 may engage the tapered slit 232 of the locking collar 230, so that the locking collar 230, the shaft 200, and the proximal strut 220 are locked in engagement. In some embodiments, the proximal strut 220 may engage the tapered slit 232 of the locking collar 230, so that the locking collar 230, the shaft 200, and the proximal strut 220 are locked in engagement by friction fit. In some embodiments, the proximal stay 220 can engage the tapered slit 232 of the locking collar 230 such that the locking collar 230, the shaft 200, and the proximal stay 220 are locked into engagement by a friction fit such that when the connector assembly is integrated into the intravascular device and the intravascular device is subjected to a load, the proximal stay 220 cannot disengage from the enlarged end 212 of the shaft 200. The taper of the slit can compensate for component dimensional tolerances during assembly and can ensure that the proximal stay 220 remains in contact with the enlarged end 212 of the shaft 200.

[0036] like Fig. 10A As shown, in some embodiments, an exemplary joint assembly may include a shaft 300, a proximal stay 320 including a proximal stay slot 322, and a locking collar 330. In some embodiments, the shaft 300 may include a body 310 and a shaft hook 302. Fig. 10B As shown, when assembled, the shaft hook 302 of the shaft 300 can be hooked into the proximal strut slot 322. Fig. 10C As shown, assembly may also include repositioning the collar 330 so that it at least partially covers the shaft hook 302 of the shaft 300 and the proximal strut slot 322 of the proximal strut 320. This prevents the shaft hook 302 from being unhooked from the proximal strut slot 322. The shaft hook 300 may be formed by heat setting or cutting to shape. In some embodiments, the collar 330 completely covers the shaft hook 302, thereby ensuring that the hook is atraumatic to the vessel wall into which the connector assembly is inserted.

[0037] like Fig.11As shown, in some embodiments, an exemplary joint assembly may include a shaft 400, a proximal strut 420, and a locking collar 430. The shaft 400 may include a body 410 and an enlarged end 412. In some embodiments, the proximal strut 420 may also include a proximal support slot 422 and a proximal strut arm 424 protruding from the proximal strut 420 on either side of the proximal support slot 422. The locking collar 430 may also include a locking slit 432. In some embodiments, during assembly, the proximal strut 420 may engage the locking collar 430 such that the proximal strut arm 424 is inserted and rotated to lockingly engage the locking collar slit 432. Examples may also include a bayonet-style installation.

[0038] Fig. 12A and Fig. 12B An exemplary connector assembly integrally coupled to an intravascular device is shown. In some embodiments, connector assembly 560 can be integrally coupled to an intravascular device between clot engaging portion 540 and elongated shaft 550. Examples of intravascular devices can include stents, thrombectomy devices, coil retrievers, equivalents now known or later discovered, or combinations thereof.

[0039] The descriptions contained herein are examples of embodiments of the present invention and are not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of the joint assembly, including, for example, different positioning of the shaft, proximal stays, and bushings, utilizing any of a variety of materials for each element or component, incorporating additional elements or components. These modifications will be apparent to those of ordinary skill in the art and are intended to be within the scope of the following claims.

Claims

1. A connector assembly for an intravascular device, comprising: a shaft comprising a body and an enlarged end; a proximal stay comprising a slot, wherein the slot engages the enlarged end of the shaft; and a locking collar including a proximal side and a distal side and at least partially covering the enlarged end of the shaft and the slot of the proximal strut, The locking collar includes a first side and a second side, wherein a first slit is formed from the distal side of the collar into at least a portion of the first side of the collar, and a second slit is formed from the distal side of the collar into at least a portion of the second side of the collar. 2 . The connector assembly of claim 1 , wherein at least a portion of the enlarged end portion is received in the proximal strut slot. 3 . The joint assembly of claim 1 , wherein the enlarged end of the shaft and the body of the shaft define a shaft step.

4. The joint assembly of claim 1, wherein the locking collar is generally cylindrical.

5. The joint assembly of claim 1, wherein the locking collar is a generally oval cylindrical shape.

6. The joint assembly of claim 1, wherein the proximal struts comprise cross-shaped members.

7. The connector assembly of claim 1, wherein the first slot and the second slot are tapered.

8. The joint assembly of claim 1, wherein a first slit is formed from the distal side of the collar into at least a portion of the first side of the collar, and a polygonal hole is formed in the second side of the collar.

9. The connector assembly of claim 1, wherein the connector assembly is integrally coupled to the intravascular device between the clot engaging portion and the elongated shaft.

10. A joint assembly according to claim 1, wherein when the locking bushing at least partially covers the enlarged end of the shaft and the narrow groove of the proximal strut, the locking bushing constrains the proximal strut so that when the joint assembly is loaded into a clot retrieval device and the clot retrieval device is under load, the proximal strut groove cannot disengage from the enlarged end of the shaft.

11. A connector assembly for an intravascular device, comprising: a shaft comprising a body and an enlarged end; a proximal stay including a slot in which the body of the shaft is received; and a locking collar including a proximal side and a distal side and at least partially covering the enlarged end of the shaft and the slot of the proximal strut, The locking collar includes a first side and a second side, wherein a first slit is formed from the distal side of the collar into at least a portion of the first side of the collar, and a second slit is formed from the distal side of the collar into at least a portion of the second side of the collar.

12. The joint assembly of claim 11, wherein the proximal strut slot comprises a first height and a second height.

13. A joint assembly according to claim 12, wherein the body of the shaft is inserted into the proximal strut slot at the first height, the enlarged end engages the proximal strut slot at the second height, and the proximal strut slot is inclined downward from the second height and away from the enlarged end.

14. A method of assembling a joint assembly, comprising the steps of: providing a shaft including a body and an enlarged end, a proximal strut including a slot that engages the enlarged end of the shaft, and a locking collar including a proximal side and a distal side that engages the enlarged end of the shaft and the slot of the proximal strut; sliding the locking collar onto the body of the shaft; positioning at least a portion of the proximal strut proximate the enlarged end of the shaft; as well as repositioning the collar so that it at least partially covers the enlarged end of the shaft and the slot of the proximal strut, The locking collar includes a first side and a second side, wherein a first slit is formed from the distal side of the collar into at least a portion of the first side of the collar, and a second slit is formed from the distal side of the collar into at least a portion of the second side of the collar.

15. The method of claim 14, wherein the locking collar at least partially encloses the enlarged end of the shaft and the slot of the proximal strut when the locking collar is repositioned.

16. The method of claim 14, wherein the proximal struts further comprise a cross member.

17. The method of claim 16, wherein the cross member is lockingly engaged with a collar.

18. The method of claim 14, further comprising integrally coupling the connector assembly to an intravascular device between the clot engaging portion and the elongated shaft.

19. A method according to claim 14, wherein when the locking bushing is repositioned, the bushing constrains the proximal strut so that when the joint assembly is loaded into the clot retrieval device and the clot retrieval device is subjected to a load, the proximal strut slot cannot disengage from the enlarged end of the shaft.

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